UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 1-A (Amended b )
REGULATION A OFFERING STATEMENT
UNDER THE SECURITIES ACT OF 1933
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STOCOSIL INC.
(Exact Name of Issuer as Specified in Its charter)
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Delaware
(State or Other Jurisdiction of Incorporation or Organization)
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17870 Castleton Street, Suite 250
City of Industry, California 91748
(626) 964-5788
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Issuer’s Principal Executive Office)
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Pyng Soon
Chief Executive Officer
Stocosil Inc.
17870 Castleton Street, Suite 250
City of Industry, California 91748
(626) 964-5788
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)
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2834
(Primary Standard Industrial Classification Code Number)
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47-2620984
(IRS Employer Identification Number)
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Minimum Offering:
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166,667 Shares of Common Stock ($2,500,005)
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Maximum Offering:
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733,340 Shares of Common Stock ($11,000,100)
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Offering Price:
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$15.00 per Share
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Price to Public
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Placement Agent Fees (1)
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Proceeds, before expenses (2)
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|||||||
Per share:
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$
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15.00
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$
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1.35
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$
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13.65
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Total Minimum:
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$
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2,500,005
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$
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225,000
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$
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2,275,005
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Total Maximum:
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$
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11,000,100
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$
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990,009
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$
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10,010,091
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_______________
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(1) Does not reflect Placement Agent’s right to acquire warrants to purchase 3% of the aggregate shares of common stock sold in this Offering at an exercise price of $17.25 per share. See “Plan of Distribution” beginning on page 33. Also does not reflect up to $30,000 of accountable expense reimbursement for the fees of underwriter’s counsel related to filings made pursuant to FINRA Rule 5110.
(2) We estimate Offering expenses will be $293,500 . See “Use of Proceeds” beginning on page 38.
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Page | |
Summary | 1 |
Risk Factors
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3 |
Special Note Regarding Forward-Looking Statements
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31 |
Dilution
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32 |
Plan of Distribution
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33 |
Use of Proceeds
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38 |
Business
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39 |
Description of Property
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51 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
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52 |
Directors, Executive Officers and Significant Employees
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57 |
Compensation of Directors and Executive Officers
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58 |
Security Ownership of Management and Certain Security holders
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59 |
Interest of Management and Others in Certain Transactions
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60 |
Securities Being Offered
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62 |
Financial Statements
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F-1 |
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We are a development-stage company subject to all of the risks and uncertainties of a new business, including the risk that we may never develop, complete development or market any of our products or generate product related revenues.
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We do not have any products that are approved for commercial sale and therefore do not expect to generate any revenues from product sales in the foreseeable future, if ever.
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We are heavily dependent on the success of ST-101 ST-102 and ST-103, and we cannot give any assurance that any of our products will receive regulatory approval, which is necessary before the products can be commercialized.
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We expect to rely on third parties to manufacture our clinical ST-101, ST-102 and ST-103 supplies and we intend to rely on third parties to produce commercial supplies of any approved product, and our commercialization of any of our products could be stopped, delayed or made less profitable if those third parties fail to obtain approval of the FDA or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of products or fail to do so at acceptable quality levels or prices.
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Even if we receive regulatory approval for any of our products, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our products, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
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No active market for our common stock exists or may develop, and you may not be able to resell your common stock at or above the initial public offering price.
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Common Stock Offered By Us
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Minimum: 166,667 shares
Maximum: 733,340 shares
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Common Stock Outstanding
After This Offering
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Minimum: 5,982,170 shares*
Maximum: 6,548,843 shares*
*includes 1,360,958 shares we intend to issue upon conversion of outstanding convertible notes upon the closing of this offering.
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Placement Agent
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We have engaged Boustead Securities, LLC, a Financial Industry Regulatory Authority (“FINRA”) and Securities Investors Protection Corporation (“SIPC”) broker dealer (“Boustead Securities;” “Placement Agent”) as the Placement Agent for this Offering. The Placement Agent must sell the minimum number of shares offered if any are sold. The Placement Agent is required to use only its best efforts to sell the shares offered.
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Use of proceeds
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We intend to use the net proceeds of this offering to undertake commercial launch activities for ST-101, to establish sales & marketing capabilities, and for other research and product development activities, working capital and general corporate purposes. See “Use of Proceeds” for a more detailed description of the intended use of proceeds from this offering.
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Offering price
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$15.00 per share
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Gross Proceeds
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Minimum: Offering: $2,500,005
Maximum Offering: $11,000,100
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Closing
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The offering will terminate upon the earlier of: (i) a date mutually acceptable to us and our Placement Agent after the minimum number of shares is sold, or (ii) February 28, 2017 (which date may be extended at our discretion) (the “Offering Termination Date”). . If we do not sell the minimum number of shares by February 28, 2017, all funds will be promptly returned to investors without interest or deduction. If we complete this offering, net proceeds will be delivered to us on the closing date.
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Risk Factors
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See “Risk Factors” and other information included in this Offering Circular for a discussion of factors that you should consider carefully before deciding to invest in our common stock.
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Secondary Trading
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We anticipate that the Placement Agent for this offering will apply for quoting of our common stock on the OTC Markets or an approved secondary marketplace upon the qualification of the offering statement of which this Offering Circular forms a part.
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the progress of the development of our products, ST-101, ST-102 and ST-103;
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the time and costs involved in obtaining regulatory approvals, including orphan drug approval for ST-103 HoFH;
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the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims;
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our plans to establish sales, marketing and/or manufacturing capabilities;
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the effect of competing technological and market developments;
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the terms and timing of any collaborative, licensing and other arrangements that we may establish;
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general market conditions for offerings from pharmaceutical companies;
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our ability to establish, enforce and maintain selected strategic alliances and activities required for product commercialization; and
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our revenues, if any, from successful development and commercialization of the products.
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developing both ST-101, ST-102 and ST-103;
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identifying, developing, manufacturing and commercializing the products;
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entering into successful licensing and other arrangements with product development partners;
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obtaining regulatory approval for the products;
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conducting sales and marketing activities.
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obtaining regulatory approval to commence a trial;
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reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtaining institutional review board, or IRB, approval at each site;
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recruiting suitable patients to participate in a trial;
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clinical sites deviating from the clinical trial protocol or dropping out of a trial;
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having patients complete a trial or return for post-treatment follow-up;
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developing and validating TDM companion diagnostics on a timely basis;
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adding new clinical trial sites; or
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manufacturing sufficient quantities of the products for use in clinical trials.
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our products are safe and effective for its proposed indication;
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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the FDA or comparable foreign regulatory authorities may fail to approve the TDM companion diagnostics we contemplate developing with partners;
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the FDA may disapprove the orphan drug designation for ST-103 HoFH; and
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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
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regulatory authorities may withdraw approvals of such products;
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regulatory authorities may require additional warnings on the label for such products;
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we may be required to create a medication guide outlining the risks of such side effects for distribution to patients
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer
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restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
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fines, warning letters or holds on clinical trials;
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refusal by the FDA to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals;
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product seizure or detention, or refusal to permit the import or export of products; and
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injunctions or the imposition of civil or criminal penalties.
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disruption of our business and diversion of our management’s time and attention to develop acquired products or technologies;
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incurrence of substantial debt, dilutive issuances of securities or depletion of cash to pay for acquisitions;
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higher than expected acquisition and integration costs;
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difficulty in combining the operations and personnel of any acquired businesses with our operations and personnel;
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increased amortization expenses;
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impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership;
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inability to motivate key employees of any acquired businesses; and
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assumption of known and unknown liabilities.
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the efficacy and safety as demonstrated in clinical trials;
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the timing of market introduction of such product candidate as well as competitive products;
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the clinical indications for which the drug is approved;
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acceptance by physicians and patients of the drug as a safe and effective treatment;
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the safety of such product seen in a broader patient group, including its use outside the approved indications;
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the availability, cost and potential advantages of alternative treatments, including individual generic drugs;
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the availability of adequate reimbursement and pricing by third-party payors and government authorities;
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the relative convenience and ease of administration of ST-101 for clinical practices;
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the product labeling or product insert required by the FDA or regulatory authority in other countries;
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the prevalence and severity of adverse side effects; and
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the effectiveness of our sales and marketing efforts.
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developing product candidates and technologies generally;
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undertaking preclinical testing and clinical trials;
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obtaining FDA and other regulatory approvals of product candidates;
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formulating and manufacturing product candidates; and
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launching, marketing and selling product candidates.
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successfully and efficiently complete clinical trials and submit for and obtain all requisite regulatory approvals in a cost-effective manner;
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maintain a proprietary position for our products and manufacturing processes and other related product technology;
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attract and retain key personnel;
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develop relationships with physicians prescribing these products; and
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build an adequate sales and marketing infrastructure for our product candidates.
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funding research, preclinical development, clinical trials and manufacturing;
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seeking and obtaining regulatory approvals; and
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successfully commercializing any future product candidates.
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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
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federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;
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HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; and
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state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
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decreased demand for our products;
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injury to our reputation;
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withdrawal of clinical trial participants;
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initiation of investigations by regulators;
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costs to defend the related litigation;
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a diversion of management’s time and our resources;
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substantial monetary awards to trial participants or patients;
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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loss of revenues from product sales; and
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the inability to commercialize our products.
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obtain licenses, which may not be available on commercially reasonable terms, if at all, and may be non-exclusive, thereby giving our competitors access to the same intellectual property licensed to us;
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redesign our products or processes to avoid infringement;
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stop using the subject matter validly claimed in the patents held by others;
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pay damages; and
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defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our valuable management resources.
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Others may be able to make compounds that are similar to our products but that are not covered by the claims of the patents that we own or have exclusively licensed;
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We or our licensors or strategic partners might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed;
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We or our licensors or strategic partners might not have been the first to file patent applications covering certain of our inventions;
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Others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
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It is possible that our pending patent applications will not lead to issued patents;
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Issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;
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Our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
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We may not develop additional proprietary technologies that are patentable; and
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The patents of others may have an adverse effect on our business.
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actual or anticipated adverse results or delays in our clinical trials;
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our failure to commercialize our products, if approved;
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unanticipated serious safety concerns related to the use of any of our products;
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adverse regulatory decisions;
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changes in laws or regulations applicable to our product candidates, including but not limited to clinical trial requirements for approvals;
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legal disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our product candidates, government investigations and the results of any proceedings or lawsuits, including patent or stockholder litigation;
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our decision to initiate a clinical trial, not initiate a clinical trial or to terminate an existing clinical trial;
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our dependence on third parties, including CROs;
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announcements of the introduction of new products by our competitors;
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market conditions in the pharmaceutical sectors;
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announcements concerning product development results or intellectual property rights of others;
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future issuances of common stock or other securities;
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the addition or departure of key personnel;
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failure to meet or exceed any financial guidance or expectations regarding development milestones that we may provide to the public;
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actual or anticipated variations in quarterly operating results;
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our failure to meet or exceed the estimates and projections of the investment community;
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overall performance of the equity markets and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies;
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introduction of new products offered by us or our competitors;
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announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
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issuances of debt or equity securities;
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sales of our common stock by us or our stockholders in the future;
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trading volume of our common stock;
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ineffectiveness of our internal controls;
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publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;
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failure to effectively integrate the acquired companies' operations;
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general political and economic conditions;
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effects of natural or man-made catastrophic events; and
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other events or factors, many of which are beyond our control.
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variations in the level of expenses related to our development programs;
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the addition or termination of clinical trials;
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any intellectual property infringement lawsuit in which we may become involved;
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regulatory developments affecting our product candidates;
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our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements; and
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if any of our products receive regulatory approval, the level of underlying demand for that product and wholesalers’ buying patterns.
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Initial public offering price per share
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$ 15.00
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(1)
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$ 15.00
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(2)
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||||
Historical net tangible book value per share
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$
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(0.51553
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)
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$
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(0.51553
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)
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Decrease attributable to the conversion of all outstanding notes
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$
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(0.14130
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)
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$
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(0.14130
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)
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Pro forma net tangible book value per share
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$
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(0.37423
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)
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$
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(0.37423
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)
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Increase in net tangible book value per share attributable to new investors
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$
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(0.31950
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)
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$
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(1.44998
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)
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Pro forma as adjusted net tangible book value per share after this offering
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(0.05473
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)
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1.07575
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Dilution per share to new investors
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$
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15.05473
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$
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13.92425
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Per Common Share
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Minimum Offering
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Maximum Offering
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||||||||||
Public offering price
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$ | 15.00 | $ | 2,500,005 | $ | 11,000,100 | ||||||
Placement agent fees(1)
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$ | 1.35 | $ | 225,000 | $ | 990,009 | ||||||
Proceeds to us, before expenses
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$ | 13.65 | $ | 2,275,005 | $ | 10,010,091 |
i.
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we and the Placement Agent mutually agree to terminate the engagement agreement;
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ii.
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either we or the Placement Agent unilaterally decide to terminate the engagement agreement upon thirty days’ prior written notice to the other party;
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iii.
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we fail to pay Placement Agent for services provided within 30 days of the date that payment is due.
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iv.
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we terminate the engagement agreement due to the Placement Agent’s material failure to provide the services contemplated by the engagement agreement; or
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v.
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we decide not to proceed with the offering or withdraw any offering statement filed with the Commission.
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·
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the history of, and the prospects for, our Company and the industry in which we compete;
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·
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an assessment of our management, its past and present operation, and the prospects for, and timing of, our future revenues; and
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the present state of our development.
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·
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offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant for the sale of, or otherwise dispose of or transfer any shares of our common stock or any securities convertible into or exchangeable or exercisable for our common stock, whether now owned or hereafter acquired by the undersigned or with respect to which the undersigned has or hereafter acquires the power of disposition; or
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enter into any swap or any other agreement or any transaction that transfers, in whole or in part, the economic consequence of ownership of our common stock, whether any such swap or transaction is to be settled by delivery of our common stock or other securities, in cash or otherwise.
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·
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the information set forth in this Offering Circular and otherwise available to the Placement Agent
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·
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our history and prospects and the history of and prospects for the industry in which we compete;
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our prospects for future earnings and the present state of our development;
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the general condition of the securities markets at the time of this offering;
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the recent market prices of, and demand for, publicly traded common stock of generally comparable companies; and
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·
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other factors deemed relevant by the Placement Agent and us.
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(i)
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You are a natural person who has had individual income in excess of $200,000 in each of the two most recent years, or joint income with your spouse in excess of $300,000 in each of these years, and have a reasonable expectation of reaching the same income level in the current year;
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(ii)
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You are a natural person and your individual net worth, or joint net worth with your spouse, exceeds $1,000,000 at the time you purchase Offered Shares (please see below on how to calculate your net worth);
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(iii)
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You are an executive officer or general partner of the issuer or a manager or executive officer of the general partner of the issuer;
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(iv)
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You are an organization described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, or the Code, a corporation, a Massachusetts or similar business trust or a partnership, not formed for the specific purpose of acquiring the Offered Shares, with total assets in excess of $5,000,000;
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(v)
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You are a bank or a savings and loan association or other institution as defined in the Securities Act, a broker or dealer registered pursuant to Section 15 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, an insurance company as defined by the Securities Act, an investment company registered under the Investment Company Act of 1940, as amended, or the Investment Company Act, or a business development company as defined in that act, any Small Business Investment Company licensed by the Small Business Investment Act of 1958 or a private business development company as defined in the Investment Advisers Act of 1940;
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(vi)
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You are an entity (including an Individual Retirement Account trust) in which each equity owner is an accredited investor;
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(vii)
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You are a trust with total assets in excess of $5,000,000, your purchase of Offered Shares is directed by a person who either alone or with his purchaser representative(s) (as defined in Regulation D promulgated under the Securities Act) has such knowledge and experience in financial and business matters that he is capable of evaluating the merits and risks of the prospective investment, and you were not formed for the specific purpose of investing in the Offered Shares; or
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(viii)
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You are a plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, if such plan has assets in excess of $5,000,000.
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1.
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Electronically receive, review, execute and deliver to us a subscription agreement; and
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2.
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Deliver funds to your brokerage account with the Placement Agent or a participating broker dealer.
|
·
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approximately $2.0 million for further development and filing NDA for ST-101;
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·
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the remaining net proceeds for other research and product development activities, working capital and general corporate purposes.
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·
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approximately $2.0 million for further development and filing NDA for ST-101;
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·
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approximately $4.0 million to launch for ST-101;
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approximately $2.3 million to support the operation for ST-101
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·
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approximately $1.4 million remits to Daewoong Pharmaceuticals Co. Ltd for milestone payments;
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·
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the remaining net proceeds for other research and product development activities, working capital and general corporate purposes.
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Status (Filed, Provisional, Approved)
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Number
|
Title
|
Date of Filing
|
Date of US patent Expiration if granted (expected)
|
Filed PCT Nationalized
|
PCT/US2013/046040
|
Methods and compositions for personalized medicine by POC devices for FSH, LH, hCG and BNP
|
06/15/2013
|
06/15/2033
|
United States
|
14/407,715
|
|||
Australia
|
2013274016
|
|||
CA
|
2876486
|
|||
Japan
|
2015517474
|
|||
South Korea
|
10-2015-7000756
|
|||
India
|
2472/MUMNP/2014
|
|||
EP
|
13805123.0
|
|||
P.R. China
|
2013800316648
|
|||
Filed PCT Nationalized
|
PCT/US2012/039993
|
Methods and Compositions for Therapeutic Drug Monitoring and Dosing by Point-of-Care Pharmacokinetic Profiling
|
05/30/2012
|
05/30/2032
|
United States
|
13/261,786
|
|||
Japan
|
2014513663
|
|||
P.R. China
|
201280038476.3
|
|||
CA
|
2837331
|
|||
Australia
|
2012262322
|
|||
EP
|
12792802.2
|
|||
India
|
2458/MUMNP/2013
|
|||
Filed PCT
|
PCT/US16/12884
|
Methods for Olmesartan Dosing by AUC
|
1/11/2016
|
1/11/2036
|
United States
|
14/992,898
|
|||
Taiwan
|
105102921
|
|||
South Korea | 10-2016-7002748 | |||
Filed Provisional
|
62/277,406
|
Device and Method for Improving Compliance in Treating Hypertension | 1/11/2016 | N/A- Not PCT yet |
-
|
A pharmaceutical composition in a single dosage form comprising:
|
-
|
A compartment comprising olmesartan medoxomil; and a compartment comprising rosuvastatin or a salt thereof, each of the compartments being formulated in a separate form, wherein the compartment comprising olmesartan medoximil comprises low substituted hydroxyproply cellulose, as a disintegrant, in an amount of 7.5 to 65% by weight based on the total weight of the compartment, and
|
-
|
The compartment comprising rosuvastatin or a salt thereof comprises one or more disintegrant selected from the group consisting of crospovidone, low substituted hydroxypropyl cellulose, croscarmellose sodium, and carboxymethylcellulose calcium, in an amount of 2 to 20% by weight based on the total weight of the compartment.
|
Country code
|
Status
|
Application No.
|
Entry Date
|
AU
|
Filed
|
2013240846
|
8/8/2014
|
CA
|
Filed
|
2866377
|
9/4/2014
|
EPO
|
Filed
|
20130769567
|
8/14/2014
|
JP
|
Filed
|
2015503112
|
9/29/2014
|
U.S.
|
Filed
|
14388115
|
9/25/2014
|
MX
|
Filed
|
2014011510
|
9/25/2014
|
PH
|
Filed
|
2013120145018
|
8/11/2014
|
HK
|
Filed
|
20150100605
|
|
CN
|
Filed
|
2013800180830
|
9/29/2014
|
CL
|
Filed
|
20140002581
|
|
KR
|
Granted
|
1020130030734
|
Filing date: 3/22/2013
|
·
|
FDA approval of ST-101;
|
·
|
FDA approval of the ST-101 coupled with a therapeutic drug monitoring device (ST-102); and
|
·
|
FDA approval of the high dose ST-101 coupled with a therapeutic drug monitoring device (ST-103).
|
For the Year Ended
June 30, 2016
(Audited)
|
For the Period
from Inception
(December 11, 2014)
to June 30, 2015
(Audited)
|
|||||||
Personnel and related benefits
|
$
|
1,432,759
|
$
|
500,384
|
||||
Third-party consulting and service fees
|
937,725
|
$
|
187,020
|
|||||
Development costs
|
81,000
|
$
|
67,057
|
|||||
Other
|
$
|
275,646
|
$
|
167,348
|
||||
Total
|
$
|
2,727,130
|
$
|
921,809
|
·
|
trials of our products and product candidates;
|
·
|
establishing manufacturing capabilities; and
|
·
|
commercialization of our prescription drug product candidates, if approved.
|
For the Year ended
June 30, 2016
(Audited)
|
For the Period from
December 11, 2014
(inception)
to June 30, 2015
(Audited)
|
|
||||||
Net Loss
|
$
|
(2,727,130
|
)
|
$
|
(921,809
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities
|
$
|
347,081
|
$
|
1,403
|
||||
Change in operating assets and liabilities
|
$
|
283,232
|
$
|
547,442
|
||||
Net cash used in operating activities
|
$
|
(2,096,817
|
)
|
$
|
(372,964
|
)
|
||
Net cash used in investing activities
|
$
|
(479
|
)
|
$
|
-
|
|||
Net cash provided by financing activities
|
$
|
866,000
|
$
|
1,719,600
|
||||
Cash at beginning of period
|
$
|
1,346,636
|
$
|
-
|
||||
Cash at end of period
|
$
|
115,340
|
$
|
1,346,636
|
Payments Due by Period
|
||||||||||||||||||||
Total
|
Less than 1
Year
|
1 to 3
Years
|
3 to 5
Years
|
More Than
5 Years
|
||||||||||||||||
Sublease Agreement
|
$
|
28,000
|
$
|
12,000
|
$
|
16.000
|
$
|
-
|
$
|
-
|
||||||||||
License Agreement
|
$
|
5,900,000
|
$
|
500,000
|
$
|
4,400,000
|
$
|
-
|
$
|
1,000,000
|
||||||||||
Master Service Agreement
|
$
|
334,391
|
$
|
334,391
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||||
Total
|
$
|
6,262,391
|
$
|
846,391
|
$
|
4,416,000
|
$
|
-
|
$
|
1,000,000
|
Name
|
Position
|
Age
|
Term of Office
|
Approximate hours per week for part-time employees
|
Executive Officers:
|
||||
Vuong Trieu, Ph.D.
|
President and Chief Regulatory Officer
|
54
|
Since December 2014
|
13.3
|
Pyng Soon, Esq., CPA
|
Chief Executive Officer, Chief Financial Officer, Secretary
|
54
|
Since December 2014
|
13.3
|
Chulho Park, Ph.D.
|
Chief Business Officer
|
51
|
Since December 2014
|
13.3
|
Directors:
|
||||
Vuong Trieu, Ph.D.
|
Director
|
54
|
Since December 2014
|
–
|
Significant Employees:
|
||||
Osmond D’Cruz, PH.D
|
Sr. Director of Drug Safety
|
63
|
Since December 2014
|
20
|
Annual Salary
|
|||||
Vuong Trieu
|
President
|
$
|
56,667
|
||
Pyng Soon
|
CEO/CFO/Secretary
|
$
|
56,667
|
||
Chulho Park
|
CBO
|
$
|
56,667
|
||
Osmond D’Cruz
|
Director of Drug Safety
|
$
|
35,000
|
Name
|
Amount and nature of beneficial ownership
|
Amount of beneficial ownership acquirable
|
Percent of class
|
|||||||||
Autotelic LLC
|
1,625,000
|
–
|
36.48
|
%
|
||||||||
Autotelic Inc.
|
500,000
|
–
|
(2)
|
11.22
|
%
|
|||||||
Vuong Trieu
|
2,829,545
|
(1)
|
–
|
(3)
|
63.52
|
%
|
||||||
Pyng Soon
|
500,000
|
–
|
(4)
|
11.22
|
%
|
|||||||
Chulho Park
|
1,000,000
|
–
|
22.45
|
%
|
||||||||
Director and Officers as a group
|
4,329,545
|
–
|
(5)
|
97.19
|
%
|
(1)
|
Includes 704,545 directly owned and 2,125,000 indirectly beneficially owned by Mr. Trieu. Of the shares indirectly beneficially owned, 1,625,000 shares are directly owned by Autotelic LLC as reflected in the table and 500,000 shares are directly owned by Autotelic Inc. as reflected in the table. Mr. Trieu is Chief Executive Officer of Autotelic Inc. and owns 64% of the common stock of Autotelic Inc. and 50% of Autotelic LLC. As a result, Mr. Trieu may be deemed the beneficial owner of shares held by Autotelic LLC and Autotelic Inc.
|
(2)
|
As described in the Interest of Management and Others in Certain Transactions section below, Autotelic Inc. directly beneficially owns 283,421 shares issuable upon exercise of a warrant which is expected to become exercisable in connection with this offering. Assuming the exercise of such warrant, then Autotelic Inc. will beneficially own 5.78% of our common stock if the minimum number of 166,667 shares are sold in this offering and 5.18% of our common stock if the maximum number of 733,340 shares are sold in this offering.
|
(3)
|
As described in footnote (1), Mr. Trieu may be deemed the beneficial owner of shares held by Autotelic Inc. and thus the indirect beneficial owner of the 283,421 shares issuable upon exercise of the warrant held by Autotelic Inc. described in footnote (2). Assuming the exercise of such warrant, then Mr. Trieu will beneficially own 5.78 % of our common stock if the minimum number of 166,667 shares are sold in this offering and 5.18% of our common stock if the maximum number of 733,340 shares are sold in this offering.
|
(4)
|
Mr. Soon directly beneficially owns 70,000 shares issuable upon conversion of convertible note. Assuming the conversion of all convertible notes, including Mr. Soon’s convertible note, expected to convert in connection with this offering, then Mr. Soon will beneficially own 1.49% of our common stock if the minimum number of 166,667 shares are sold in this offering and 1.33% of our common stock if the maximum number of 733,340 shares are sold in this offering.
|
(5)
|
Assuming the exercise of the warrant described in footnotes (2) and (3) and the convertible notes described in footnote (3), then our director and officers as a group will beneficially own 7.10% of our common stock if the minimum number of 166,667 shares are sold in this offering and 6.38% of our common stock if the maximum number of 733,340 shares are sold in this offering.
|
·
|
warrants to purchase 250,000 shares, one-third of which are exercisable on each of March 7, 2016, 2017, and 2018 and which expire on March 7, 2023, are held by Tae Hun Kim, a citizen of South Korea; and
|
·
|
warrants to purchase 500,000 shares, exercisable commencing upon the submission of ST-101 to the FDA and expiring five years thereafter, are held by Daewoong Pharmaceuticals Co., Ltd.
|
·
|
Unless and except to the extent that the by-laws of the corporation shall so require, the election of directors of this Corporation need not be by written ballot.
|
·
|
In furtherance and not in limitation of the powers conferred by the laws of the State of Delaware, the Board of Directors of this Corporation is expressly authorized to make, alter and repeal the by-laws of the Corporation, subject to the power of the stockholders of the corporation to alter or repeal any by-law whether adopted by them or otherwise.
|
·
|
No director of the Corporation shall be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, for any act or omission, except that a director may be liable (i) for breach of the director's duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL, or (iv) for any transaction from which the director derived an improper personal benefit.
This Corporation is authorized to provide indemnification of (and advancement of expenses to) directors, officers, employees and agents of this Corporation (and any other persons to which the DGCL permits this Corporation to provide indemnification) through Bylaw provisions, agreements with such agents or other persons, vote of stockholders or disinterested directors or otherwise, in excess of the indemnification and advancement otherwise permitted by Section 145 of the DGCL, whether involving criminal, civil, administrative, investigative or any other matters.
|
·
|
prior to the date of the transaction, our board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;
|
·
|
upon the closing of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, but not for determining the outstanding voting stock owned by the interested stockholder, (1) shares owned by persons who are directors and also officers, and (2) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
|
·
|
at or subsequent to the date of the transaction, the business combination is approved by our board of directors of the corporation and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.
|
Report of Independent Registered Public Accounting Firm
|
F-2
|
Balance Sheets as of June 30, 2016 and June 30, 2015
|
F-3
|
Statements of Operations for the year ended June 30, 2016
|
|
and for the period from inception (December 11, 2014) to June 30, 2015
|
F-4
|
Statement of Stockholder’s Deficit for the year ended June 30, 2016
|
|
and for the period from inception (December 11, 2014) to June 30, 2015
|
F-5
|
Statements of Cash Flows for the year ended June 30, 2016
|
|
and for the period from inception (December 11, 2014) to June 30, 2015
|
F-6
|
Notes to Financial Statements
|
F-7
|
June 30, 2016
|
June 30, 2015
|
||||||
Assets
|
|||||||
Current Assets
|
|||||||
Cash and cash equivalents
|
$
|
115,340
|
$
|
1,346,636
|
|||
Other current assets
|
6,441
|
5,318
|
|||||
Total current assets
|
121,781
|
1,351,954
|
|||||
Investment
|
479
|
-
|
|||||
Total Assets
|
$
|
122,260
|
$
|
1,351,954
|
|||
Liabilities and Shareholders' Equity
|
|||||||
Current Liabilities
|
|||||||
Accounts payable
|
$
|
11,710
|
$
|
1,000
|
|||
Accrued liabilities
|
357,486
|
79,244
|
|||||
Interests payables
|
42,129
|
8,194
|
|||||
Foreign tax payable
|
15,000
|
15,000
|
|||||
Accounts payable and accrual - related party
|
335,390
|
373,922
|
|||||
Total current liabilities
|
761,715
|
477,360
|
|||||
Noncurrent Liabilities
|
|||||||
Convertible debt
|
1,540,000
|
674,000
|
|||||
Convertible debt - related party
|
42,000
|
42,000
|
|||||
Deferred revenue
|
75,000
|
75,000
|
|||||
Total noncurrent liabilities
|
1,657,000
|
791,000
|
|||||
Total Liabilities
|
2,418,715
|
1,268,360
|
|||||
Stockholders' Equity
|
|||||||
Common stock, $0.0001 par value; 75,000,000 shares authorized; 4,454,545 shares issued and outstanding at June 30, 2016 and June 30, 2015
|
445
|
445
|
|||||
Additional paid-in-capital
|
1,352,039
|
1,004,958
|
|||||
Accumulated deficit
|
(3,648,939
|
)
|
(921,809
|
)
|
|||
Total stockholders' equity
|
(2,296,455
|
)
|
83,594
|
||||
Total Liabilities and Stockholders' Equity
|
$
|
122,260
|
$
|
1,351,954
|
For the Year Ended
June 30, 2016
|
For the Period
from Inception
(December 11,
2014) to
June 30, 2015
|
|||||||
Operating Expenses: | ||||||||
General and administrative
|
$
|
2,695,241
|
$
|
915,482
|
||||
Total operating expenses
|
2,695,241
|
915,482
|
||||||
Operating Loss
|
(2,695,241
|
)
|
(915,482
|
)
|
||||
Other Expense
|
||||||||
Interest expense, net
|
(31,889
|
)
|
(5,527
|
)
|
||||
Loss Before Income Taxes
|
(2,727,130
|
)
|
(921,009
|
)
|
||||
Provision For Income Taxes
|
-
|
800
|
||||||
Net Loss
|
$
|
(2,727,130
|
)
|
$
|
(921,809
|
)
|
||
Net loss per share – basic and diluted
|
$
|
(0.61
|
)
|
$
|
(0.21
|
)
|
||
Weighted average shares outstanding – basic and diluted
|
4,454,545
|
4,376,575
|
Common Stock
|
Additional Paid-In
|
Accumulated
|
||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
Balance at December 11, 2014 (date of inception)
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||||||||
Net loss
|
-
|
-
|
-
|
(921,809
|
)
|
(921,809
|
)
|
|||||||||||||
Issuance of founders' common stock
|
4,250,000
|
425
|
2,975
|
-
|
3,400
|
|||||||||||||||
Issuance of common stock for cash
|
204,545
|
20
|
999,980
|
-
|
1,000,000
|
|||||||||||||||
Issuance of warrants for cash
|
-
|
-
|
600
|
-
|
600
|
|||||||||||||||
Warrants expenses
|
-
|
-
|
1,403
|
-
|
1,403
|
|||||||||||||||
Balance at June 30, 2015
|
4,454,545
|
$
|
445
|
$
|
1,004,958
|
$
|
(921,809
|
)
|
$
|
83,594
|
||||||||||
Net loss
|
-
|
-
|
-
|
(2,727,130
|
)
|
(2,727,130
|
)
|
|||||||||||||
Issuance of warrants for service
|
-
|
49,875
|
-
|
49,875
|
||||||||||||||||
Warrants expenses
|
-
|
-
|
297,206
|
-
|
297,206
|
|||||||||||||||
Balance at June 30, 2016
|
4,454,545
|
$
|
445
|
$
|
1,352,039
|
$
|
(3,648,939
|
)
|
$
|
(2,296,455
|
)
|
For the Year Ended
June 30,
2016
|
For the Period
from Inception
(December 11, 2014)
to June 30, 2015
|
||||||
Cash Flows From Operating Activities:
|
|||||||
Net loss
|
$
|
(2,727,130
|
)
|
$
|
(921,809
|
)
|
|
Adjustments to reconcile net income (loss) to net cash used in operating activities:
|
|||||||
Shares issued for services
|
49,875
|
-
|
|||||
Warrants expenses
|
297,206
|
1,403
|
|||||
Changes in operating asset and liabilities:
|
|||||||
Other current assets
|
(1,124
|
)
|
(4,918
|
)
|
|||
Accounts payable
|
10,710
|
1,000
|
|||||
Accrued liabilities
|
278,243
|
79,244
|
|||||
Interests payable
|
33,935
|
8,194
|
|||||
Foreign tax payable
|
-
|
15,000
|
|||||
Accounts payable and accrual - related party
|
(38,532
|
)
|
373,922
|
||||
Deferred revenue
|
-
|
75,000
|
|||||
Net cash used in operating activities
|
(2,096,817
|
)
|
(372,964
|
)
|
|||
Cash Flows From Financing Activities:
|
|||||||
Proceeds from convertible debt
|
866,000
|
674,000
|
|||||
Proceeds from convertible debt - related party
|
-
|
42,000
|
|||||
Proceeds from sales of stock and warrants
|
-
|
1,003,600
|
|||||
Net cash provided by financing activities
|
866,000
|
1,719,600
|
|||||
Cash Flows From Investing Activities:
|
|||||||
Purchases of investment
|
(479
|
)
|
-
|
||||
Net cash used in financing activities
|
(479
|
)
|
-
|
||||
Net (decrease)/increase in cash and cash equivalents:
|
(1,231,296
|
)
|
1,346,636
|
||||
Cash and cash equivalents, beginning of period
|
1,346,636
|
-
|
|||||
Cash and cash equivalents, end of period
|
$
|
115,340
|
$
|
1,346,636
|
|||
Supplemental disclosure information:
|
|||||||
Income taxes paid
|
$
|
-
|
$
|
800
|
2.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
Years ending June 30
|
Future minimum
lease payments
|
|||
2017
|
$ | 12,000 | ||
2018
|
12,000 | |||
2019
|
4,000 | |||
Total
|
$ | 28,000 |
For the
Year Ended
June 30, 2016
|
For the Period
from Inception
(December 11, 2014)
to June 30, 2015
|
|||||||
Personnel costs
|
$
|
678,916
|
$
|
400,004
|
||||
Rent
|
12,000
|
6,000
|
||||||
Service expenses
|
904,146
|
310,842
|
||||||
Insurance expenses
|
-
|
5,901
|
||||||
Total
|
$
|
1,595,062
|
$
|
722,747
|
For the Year ended
June 30, 2015
|
For the Period from Inception (December 11, 2014) to June 30, 2015
|
|||||||
Current
|
||||||||
U.S. federal
|
$
|
-
|
$
|
-
|
||||
U.S. state and local
|
-
|
800
|
||||||
Total current income tax expense
|
$
|
-
|
$
|
800
|
June 30,
2016
|
June 30,
2015
|
|||||||
Current
|
$
|
-
|
$
|
800
|
||||
Deferred taxes
|
(1,507,629
|
)
|
(322,126
|
)
|
||||
Income tax provision
|
(1,507,629
|
)
|
(321,326
|
)
|
||||
Valuation allowance
|
1,507,629
|
322,126
|
||||||
Total provision for income taxes
|
$
|
-
|
$
|
800
|
Exhibit No.
|
Description
|
1.1
|
Placement Agent Agreement with Boustead Securities, LLC.
|
2.1
|
Amended and Restated Certificate of Incorporation of Stocosil Inc.
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2.2
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Bylaws of the Registrant
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3.1
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Specimen common stock certificate of Stocosil Inc.
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4.1
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Consulting Agreement with ASMX Capital
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6.1
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Product Development, License and Commercialization Agreement
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6.2
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Master Services Agreement
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6.3
|
Form of Convertible Note February 2015
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6.4
|
Form of Convertible Note December 2015
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6.5
|
Form of Convertible Note April 2016
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6.6
|
Warrant for 250,000 Common Shares
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6.7
|
Warrant for 500,000 Common Shares
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6.8
|
Warrant for 116,757 Common Shares
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6.9
|
Warrant for 33,621 Common Shares
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6.10
|
Warrant for 69,559 Common Shares
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6.11
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Warrant for 63,484 Common Shares
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9.1
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Indemnification Agreement: Vuong Trieu
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9.2
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Indemnification Agreement: Pyng Soon
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9.3
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Indemnification Agreement: Chulho Park
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9.4
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Indemnification Agreement: Osmond D'Cruz
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11.1
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Consent of Malone Bailey, LLP
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11.2
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Consent of Pyng Soon (contained in Exhibit 12.1 below)
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12.1
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Opinion of Pyng Soon
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15.1
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Escrow Services and Custody Agreement
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STOCOSIL INC.
By:
Name: Pyng Soon, Esq., CPA
Title: Chief Executive Officer, Chief Financial Officer, Secretary
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Signature
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Title
|
Date
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President and Chief Regulatory Officer
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, 2016
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|
Vuong Trieu
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||
Chief Executive Officer, Chief Financial Officer, Secretary
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, 2016
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|
Pyng Soon
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||
Chief Business Officer
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, 2016
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Chulho Park
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||
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(a)
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familiarize itself to the extent it deems appropriate with the business, operations, financial condition and prospects of the Client and the industry;
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(b)
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review to its satisfaction the offering documents (the “Offering Materials”) in connection with the offering of the Securities;
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(a)
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identify possible investors, which might have an interest in receiving the Offering Materials and evaluating participation in the Financing;
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(b)
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contact one or more possible investors in the Securities (the “Potential Investors”) and distribute the Offering Materials to those requesting receipt of the same;
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(c)
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attend meetings with the Client and Potential Investors; and assist the Client in responding to due diligence requests from Potential Investors; and
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(d)
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assist the Client in closing on the sale of Securities to those Potential Investors accepted by the Client in the Financing.
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(a)
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Placement Fee; Folio Reimbursement. The “Placement Fee” shall be equal to 9% of the total dollar amount of equity capital raised pursuant to the Financing during the Term. The Placement Fee shall be paid to Financial Adviser contemporaneously with the closing of the Financing directly from the escrow established for such Financing. Financial Adviser hereby agrees to pay or reimburse, solely out of its Placement Fee, an amount equal to up to 0.05% of the equity capital raised pursuant to the Financing during the Term to Folio Investments, Inc. (“Folio”) to cover up to such amount of “Private Placement Platform Fees” as defined in that certain Escrow Services and Custody Agreement between the Client and Folio. Any amounts payable to Folio shall be paid solely out of the Placement Fee, and Financial Adviser shall have no obligation to pay Folio or reimburse the Client for any fees paid to Folio until its receipt of applicable Placement Fees.
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(b)
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The Client shall deliver a warrant to the Placement Agent to purchase shares of the Client’s common stock equal to 3% of the number of shares of Common Stock underlying the Securities issued in the Offering, excluding any warrants issued to investors in the Offering. Such warrants will be issued at each closing, and shall provide, among other things, that the warrants shall, (i) be exercisable at an exercise price equal to 115% of the price of the Securities (or the exercise price of the Securities ) issued to the investors in the Offering, (ii) expire on the earlier to occur of five (5) years from the date of qualification of the Client’s Offering Statement on Form 1-A filed on September 14, 2016, File No. 024-10610, or a change of control, (iii) contain such anti-dilution protection, if any, as provided to the investors, (iv) contain provisions for cashless exercise and (vi) include other terms as are normal and customary for warrants of this type. The sample form of the warrant is attached.
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(a)
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In connection with Financial Adviser's activities hereunder, the Client will cooperate with Financial Adviser and provide it reasonable access to the officers, directors, employees and advisers of the Client, and furnish to Financial Adviser all information and data regarding the business and financial condition of the Client that Financial Adviser deems appropriate for purposes of the Financing (the “Information”).
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(b)
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The Client represents and warrants that:
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(i)
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as of each date of offer of the Securities and each date of closing of the Financing, the Offering Materials will be complete and correct in all material respects and, except for those statements for which written supplemental corrections or additions have been made or given to the investors participating in such closing, will not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements made, in light of the circumstances under which they were made, not misleading; and
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(ii)
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any projected financial information or other forward-looking information which the Client provides to Financial Adviser will be made by the Client in good faith, based on management's best estimates at the time and based on facts and assumptions, which management believes are reasonable. A full management’s discussion of the underlying assumptions and risks relating to not achieving such projections will accompany all such projections.
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(c) The Client acknowledges and agrees that Financial Adviser, in rendering its services hereunder:
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i.
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will be using and relying on the Information provided by Client (as well as information available from public sources and other sources deemed reliable by Financial Adviser) without independent investigation or verification thereof or independent appraisal or evaluation of the Client, or its respective subsidiaries or affiliates, or any of their respective businesses or assets;
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ii.
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is authorized to transmit to any Potential Investor the Offering Materials and forms of subscription agreements and any other legal documentation supplied to Financial Adviser for transmission to any Potential Investor by or on behalf of the Client in connection with the Offering; and
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iii.
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does not and will not assume responsibility for the accuracy or completeness of the Offering Materials or any Information or other Information regarding the Client. Financial Adviser reserves the right to investigate and independently verify the Client’s representations and claims.
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(d)
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If at any time prior to the completion of the offer and sale of the Securities an event occurs or circumstance exists and the Offering Materials (as then amended and supplemented) includes any untrue statement of a material fact or omits to state any material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading, the Client will promptly notify Financial Adviser of such event and Financial Adviser will suspend solicitations of prospective purchasers of the Securities until such time as the Client shall prepare (and the Client agrees that, if it shall have notified Financial Adviser to suspend solicitations after the Client has accepted orders from Potential Investors, it will promptly prepare) a supplement or amendment to the Offering Materials which corrects such statement(s) or omission(s).
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(e)
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The Client acknowledges and agrees that (i) any advice rendered or material provided by Financial Adviser during the Term or during the Financing process was and is intended solely for the benefit and confidential use of the Client and will not be reproduced, summarized, described or referred to or given to any other person or entity for any purpose without Financial Adviser's prior written consent; (ii) Financial Adviser will act as an independent contractor and is being retained solely to assist the Client in its efforts to effect the Financing; (iii) Financial Adviser is not and will not be construed as a fiduciary of the Client and will have no duties or liabilities to the equity holders or creditors of the Client or to any other person or entity by virtue of this Agreement, and the retention of Financial Adviser hereunder, all of which duties and liabilities are hereby expressly waived; (iv) Financial Adviser does not provide legal, accounting and/or tax advice and the Client agrees to retain its own counsel concerning any necessary legal, accounting and tax matters; and (v) nothing contained herein shall be construed to obligate Financial Adviser to purchase, as principal, any of the securities offered in the Financing.
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(f)
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The Client represents and warrants to Financial Adviser that there are no brokers, representatives or other persons which have an interest in compensation due to Financial Adviser from any transaction contemplated herein.
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(g)
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The Client represents to Financial Adviser that it has not taken, and agrees that it will not take, any action, directly or indirectly, so as to cause the Financing to fail to be entitled to the exemption from registration afforded by Regulation A+ of Section 401 of the JOBS Act Section 3(b), as amended. In effecting the Financing, the Client agrees to comply in all material respects with applicable provisions of the Securities Act of 1933, as amended (the “Securities Act”), and any regulations thereunder and any applicable state laws and requirements, as well as any federal, state or foreign judicial decisions or opinions related thereto.
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(h)
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The Client represents and warrants that it does not and will not make any sale of the Securities with a view to distribution of the Securities (until such Securities become appropriately registered), and that the Financing does not and shall not violate any federal, state, local, foreign or other laws, rules, regulations or interpretations, including those rules, regulations and interpretations of the Securities and Exchange Commission (the “SEC”), the Internal Revenue Service (the “IRS”), Financial Industry Regulatory Authority, Inc. (“FINRA”) and any other self-regulatory organization or domestic or foreign governmental agency or entity.
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(i)
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The Client will not at any time during the Term, or for a period of six months following completion of the placement of the Securities contemplated hereby, make any reference publicly to the transactions contemplated hereby, by way of the issuance of a press release, the placement of an advertisement or otherwise, without the prior consent of Financial Adviser.
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(j)
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The Client will provide copies to Financial Adviser of any current or previous filings with the SEC in the last twelve (12) months from the date of this Agreement.
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(k)
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The Client will take such action as is necessary to qualify the Securities for offer and sale under the securities laws of such states and other jurisdictions of the United States (including, but not limited to, Federal) and foreign jurisdictions as may be legally required. The Client agrees (i) that any subscription or other similar agreement pursuant to which Securities are sold shall be in form and substance reasonably satisfactory to Financial Adviser and its counsel, shall comply with all applicable federal, state and foreign laws, rules and regulations and such other terms and conditions as are customary for private placement transactions of securities of such nature (or registration statements), and shall contain a representation and warranty of the Potential Investor for the benefit of Financial Adviser to the effect that the Potential Investor has conducted its own due diligence and not relied on any representation or statement made by Financial Adviser in connection with making its investment decision and (ii) to provide a copy of such executed document to Financial Adviser promptly following the execution and delivery thereof by Potential Investor. The Client agrees that any representations and warranties made by it to any investor in the Financing shall be deemed also to be made to Financial Adviser for its benefit.
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(a)
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In the event that Financial Adviser becomes involved in any capacity in any action, proceeding investigation or inquiry in connection with any matter referred to in this Agreement or arising out of the matters contemplated by this Agreement (including, but not limited to, the Information and the Client’s failure to comply with, violation of, or alleged violation of the U.S. Securities laws and the rules promulgated thereunder and the securities laws and regulations of any state or other jurisdiction applicable to their conduct), other than any matter relating to any tax payments payable by Financial Adviser as a result of Financial Adviser’s activities under or in connection with this Agreement, and other than any matter arising as a result of a breach by Financial Adviser of its representations and warranties set forth in this Agreement (regarding compliance with securities laws), the Client agrees to promptly reimburse Financial Adviser for its legal and other expenses (including, but not limited to, the cost of any investigation and preparation as they are incurred by Financial Adviser in connection therewith), unless and to the extent that it shall be finally judicially determined by a court of competent jurisdiction that such action, proceeding, investigation or inquiry arose out of the gross negligence or willful misconduct of Financial Adviser in performing the services, which are the subject of this Agreement.
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(b)
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The Client also agrees to indemnify Financial Adviser and hold it harmless from and against any and all losses, claims, damages, liabilities, costs and expenses, of every kind, nature and description, fixed or contingent (including, without limitation, reasonable counsel’s fees and expenses and the costs of investigation and preparation for and any other costs associated with any action, proceeding, investigation or inquiry in which Financial Adviser may be involved in any capacity) incurred by Financial Adviser in connection with or as a result of any matter referred to in this Agreement or arising out of any matter contemplated by this Agreement (including, but not limited to, the Information and the Client’s failure to comply with violation of or alleged violation of the U.S. securities laws and the rules promulgated there under and securities laws and regulations of any state or other jurisdiction applicable to their conduct), other than any matter relating to any tax payments payable by Financial Adviser as a result of Financial Adviser’s activities under or in connection with this Agreement and other than any matter arising as a result of a breach by Financial Adviser of its representations and warranties set forth herein (regarding compliance with securities laws), unless and to the extent that it shall be finally judicially determined by a court of competent jurisdiction that such losses, claims, damages or liabilities arose out of the gross negligence or willful misconduct of Financial Adviser in performing the services which are the subject of this Agreement. For purpose of this paragraph, Financial Adviser shall include the officers, directors, employees, agents and controlling persons of the Placement Agent. The foregoing indemnification shall be in addition to any rights that any indemnified party may have at common law or otherwise.
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(a)
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In the event that the Client becomes involved in any capacity in any action, proceeding, investigation or inquiry in connection with any matter referred to in this Agreement, Financial Adviser agrees to reimburse the Client for its legal and other expenses (including, but not limited to, the cost of any investigation and preparation as they are incurred by the Client in connection therewith) if, and to the extent that (i) it shall be finally judicially determined by a court of competent jurisdiction that such action, proceeding, investigation or inquiry arose out of the gross negligence or willful misconduct of Financial Adviser in performing the services which are the subject of this Agreement; or (ii) such action, proceeding, investigation or inquiry arose out of Financial Adviser’s violation of its representations and warranties set forth in this Agreement regarding compliance with securities laws.
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(b)
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Financial Adviser also agrees to indemnify the Client and hold it harmless from and against any and all losses, claims, damages, liabilities, costs and expenses of every kind, nature, and description, fixed or contingent (including, without limitation, reasonable counsel’s fees and expenses and the costs of investigation and preparation for and any other costs associated with any action, proceeding, investigation or inquiry in which Client may be involved in any capacity) incurred by the Client in connection with or as a result of any matter referred to in this Agreement or arising out of any matter contemplated by this Agreement if (i) it shall be finally judicially determined by a court of competent jurisdiction that such losses, claims, damages or liabilities arose out of the gross negligence or willful misconduct of Financial Adviser or (ii) in the event of Financial Adviser’s violation of its representations and warranties set forth in this Agreement regarding compliance with securities laws.
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(a)
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it has and will maintain all registrations and memberships required to perform its obligations and services hereunder in accordance with applicable law;
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(b)
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it is in compliance and will comply with all applicable laws, rules and regulations regarding its provision of services hereunder;
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(c)
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it has not and will not knowingly take any action, directly or indirectly that would cause the Financing to violate the provisions of the Securities Act, the Securities Exchange Act of 1934, as amended (the “1934 Act”), Title IV of the JOBS Act, the respective rules and regulations promulgated thereunder (the “Rules and Regulations”) or applicable “blue sky” laws of any state or jurisdiction; and it will, insofar as is under its control, conduct the Financing in a manner prescribed by Title IV of the JOBS Act and Regulation A+.
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(d)
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The Placement Agent is a member in good standing of FINRA and is a broker-dealer registered as such under the 1934 Act and under the securities laws of the states in which the Securities will be offered or sold by it unless an exemption for such state registration is available; and
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(e)
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it has not taken and will not knowingly take any action, directly or indirectly, that may cause the Financing to fail to be entitled to exemption from registration under United States federal securities laws, or applicable state securities or “blue sky” laws, or the applicable laws of the foreign countries in which the securities may be offered or sold by it.
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(a)
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by either party, upon thirty (30) days’ prior written notice, if a closing with respect to investment commitments, $11 million in aggregate, does not occur within six (6) months of the date hereof; and
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(b)
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by Financial Adviser in the event that the Client fails to pay any amount due hereunder within thirty (30) days of that due date.
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(a)
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This Agreement and its interpretation and enforcement shall be governed by the laws of the State of Delaware applicable to contracts to be performed entirely within this state and without regard to its principles of conflicts of law.
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(b)
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If any provision of this Agreement is deemed by an authority of competent jurisdiction to be unenforceable or contrary to applicable law, such provision shall be enforced to the maximum extent permitted by law to affect our intentions hereunder, and the remainder of this Agreement shall continue in full force and effect.
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(c)
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Neither the failure to insist upon strict compliance with this Agreement nor any course of conduct, including, without limitation, failure on any party’s part to exercise or delay in exercising any rights, shall constitute a waiver by such party of any of its rights hereunder. No single or partial exercise by any party of any right shall preclude any other or future exercise by any party of any such right or the exercises by such party of any other single or partial right. Any waiver by any party must be in writing and signed by such party and shall be effective only for the purpose and in the specific instance for which it is given.
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ACCEPTED AND AGREED AS OF | |||
Boustead Securities, LLC
By: /s/ Keith Moore
Name: Keith Moore
Title: CEO
Address for notices:
Boustead Securities, LLC 898 N Sepulveda, Suite 475
El Segundo, CA 90245
|
Date:
Stocosil Inc.
By: /s/ Pyng Soon
Name: Pyng Soon
Title: CEO
Address for notices:
17870 Castleton St, Suite 250
City of Industry, CA 91748
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ARTICLE 1: OFFICES
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3
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Section 1. Registered Office
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3
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Section 2. Other Offices
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3
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ARTICLE II: MEETINGS OF STOCKHOLDERS
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3
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Section 1. Place of Meetings
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3
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Section 2. Annual Meeting
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3
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Section 3. Special Meeting
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3
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Section 4. Notice of Stockholders' Meetings
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3
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Section 5. List of Stockholders Entitled to Vote
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4
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Section 6. Quorum
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4
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Section 7. Adjourned Meeting; Notice
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4
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Section 8. Voting
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4
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Section 9. Waiver of Notice or Consent by Absent Stockholders
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5
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Section 10. Stockholder Action by Written Consent Without a Meeting
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5
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Section 11. Record Date for Stockholder Notice, Voting, and Giving Consents
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5
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Section 12. Proxies
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6
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Section 13. Inspectors of Election
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6
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ARTICLE III: DIRECTORS
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7
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Section 1. Powers
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7
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Section 2. Number and Qualification of Directors
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8
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Section 3. Election and Term of Office of Directors
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8
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Section 4. Vacancies
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8
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Section 5. Place of Meetings
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8
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Section 6. Annual Meeting
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8
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Section 7. Other Regular Meetings
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8
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Section 8. Special Meetings
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8
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Section 9. Quorum
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9
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Section 10. Waiver of Notice
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8
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Section 11. Action Without Meeting
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9
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Section 12. Telephonic Meetings
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9
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Section 13. Fees and Compensation of Directors
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9
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ARTICLE IV: COMMITTEES
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10
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Section 1. Committees of Directors
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10
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Section 2. Meetings and Action of Committees
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10
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ARTICLE V: OFFICERS
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10
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Section 1. Officers
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10
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Section 2. Election of Officers
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10
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Section 3. Subordinate Officers
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10
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Section 4. Removal and Resignation of Officers
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11
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Section 5. Vacancies in Offices
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11
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Section 6. Chairman of the Board
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11
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Section 7. President
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11
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Section 8. Vice Presidents
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11
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Section 9. Secretary
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11
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Section 10. Chief Financial Officer
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12
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ARTICLE VI: INDEMNIFICATION OF DIRECTORS, OFFICERS, EMPLOYEES, AND OTHER AGENTS
|
12
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Section 1. Right to Indemnification
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12
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Section 2. Advancement of Expenses
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12
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Section 3. Claims
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13
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Section 4. Non-Exclusivity of Rights
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13
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Section 5. Indemnification of Employees and Agents of the Corporation
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13
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Section 6. Other Indemnification
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13
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Section 7. Insurance
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13
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Section 8. Amendment or Repeal
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14
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ARTICLE VII: RECORDS AND REPORTS
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14
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Section 1. Form of Records
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14
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Section 2. Inspection by Stockholders
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14
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Section 3. Inspection by Directors
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14
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ARTICLE VIII: GENERAL CORPORATE MATTERS
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14
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Section 1. Certificates for Shares
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15
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Section 2. Lost Certificates
|
15
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Section 3. Registered Stockholders
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15
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Section 4. Representation of Shares of Other Corporations
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15
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Section 5. Construction and Definitions
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15
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ARTICLE IX: REGISTRATION LOCK-UP PERIOD
|
15
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Section 1. 180-Day Lock-up Period
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15
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ARTICLE X: RIGHT OF FIRST REFUSAL
|
15
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Section 1. Right of First Refusal
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15
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ARTICLE XI: AMENDMENTS
|
17
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Section 1. Amendment by Stockholders
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17
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Section 2. Amendment by Directors
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17
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·
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Coordinate all due diligence 3rd party reports for full underwriting by Placement Agent
|
·
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Arrange, coordinate and compile 3rd party due diligence reports for use by broker-dealers
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·
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Deliver completed due diligence packages to broker dealers as directed by Company
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·
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Prepare and deliver completed listing application package to ASMX Market for listing
|
·
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Prepare and coordinate PR and marketing/advertising materials, including but not limited to website review or revamp.
|
1.
|
Copy of Final Business Plan / Private Placement Memorandum
|
2.
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Copy of the Articles of Incorporation
|
3.
|
Details on Current Shareholders (Detail number of shares authorized, detailed number of shares issued and outstanding and who holds those shares).
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4.
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BIOGRAPHIES of each Executive Member of the Company, NO RESUMES
|
5.
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Details on any issued options or warrants of the Company (Capitalization Table)
|
6.
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Details on any debts of the Company
|
7.
|
Details on all Permitting, Licensing or Regulatory Approvals Required for operation
|
8.
|
Complete use of Funds Schedule
|
9.
|
Audited Financial Statements for past two years, or if not incorporated for the past two years, just back to the date of incorporation. Audited Financial Statements MUST include:
|
a.
|
Balance Sheets
|
b.
|
Profit & Loss Statements
|
c.
|
Cash Flow Statements
|
d.
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Statements of Shareholder Equity
|
e.
|
Notes to the Financial Statements
|
10.
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All financials to be prepared to GAAP standards
|
I.
|
DAEWOONG and its Affiliates (as defined below) control certain intellectual property and other rights in and to the Products and DAEWOONG Existing Product (as defined below).
|
II.
|
AUTOTELIC, STOCOSIL and its Affiliates (as defined below) have extensive experience in the discovery, developing and commercialization of pharmaceutical products in the USA.
|
III.
|
STOCOSIL desires to Develop and Commercialize (as defined below) Products (as defined below) in the Territory (as defined below).
|
IV.
|
The Parties desire to Develop and Commercialize the Products (as defined below) pursuant to the terms and conditions of this Agreement.
|
1.
|
DEFINITIONS AND INTERPRETATION
|
“Activ “Pharmaceutical Ingredient” or “API”
|
means in respect of the Product the active substance(s) contained in that Product.
|
“Adverse Event”
|
shall have the meaning as defined in Safety Data Exchange Agreement.
|
“Affiliates”
|
means, in relation to a Party, any person, which directly or indirectly through one or more intermediaries controls, is controlled by or is under common control with such Party. An entity shall be deemed to control another entity if it: (i) owns, directly or indirectly, at least fifty percent (50%) of the outstanding voting securities or capital stock (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of such other entity, or has other comparable ownership interest with respect to any entity other than a corporation; or (ii) has the power, whether pursuant to contract, ownership of securities or otherwise, to direct the management and policies of the entity. Further, they also mean that any companies whose, at least 50%, shareholders are also the shareholders of either of the Parties at the time of the inception of these companies, defined as “Common Control”.
|
“Agreement”
|
means this agreement, together with its Schedules, as amended from time to time by the Parties.
|
“Applicable Law”
|
means any domestic or foreign statute, law, ordinance, rule, administrative interpretation, regulation, order, writ, injunction, directive, judgment, decree or other requirement of any Regulatory Authority applicable to a Party or its properties, business, assets or a Product or any of the activities contemplated hereunder that may be in effect from time to time.
|
“Business Day”
|
means a day other than a Saturday or a Sunday when the banks in Los Angeles and Korea are open for normal business.
|
“Calendar Quarter”
|
means each successive period of three (3) consecutive calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.
|
“Calendar Year”
|
means each successive period of twelve (12) consecutive calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
|
“Claim”
|
means Third Party suits, claims, actions, proceedings or demands.
i
|
“Clinical Trials”
|
means Phase I, Phase II, Phase III, Phase IV or such other tests and studies in patients that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals, but excluding Post Approval Studies.
|
“Commercially Reasonable Efforts”
|
means, with respect to a Party’s obligation to perform or achieve a specified obligation or outcome of the Product and/or Optional Product or generally under this Agreement, the efforts, expertise, degree of skill, and resources that are comparable in quality and scope to those efforts, expertise, degree of skill and resources that are generally used by such Party to perform or achieve a comparable obligation or outcome for a pharmaceutical product owned or controlled by such Party, which has the same regulatory requirements or status (for example, requires a prescription or is available over-the-counter), is at a comparable stage of development or product life as the Product and/or Optional Product, and that has similar market potential as the Product and/or Optional Product, taking into account issues of patent coverage, relative safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, relevant regulatory circumstances, the profitability of the product (including pricing and reimbursement status achieved) and other relevant risk factors, including technical, legal, scientific, commercial and/or medical risk factors.
|
“Commercialization”
“Competitive Product”
|
means any and all activities (after Regulatory Approval) directed to the marketing, detailing and other promotion of the Product and/or Optional Product, after Regulatory Approval for commercial sale has been obtained. Commercialization shall include marketing, distributing, offering to sell, selling, importing, exporting or transporting for sale of the Product and/or Optional Product, but shall not include Post Approval Studies. When used as a verb, “Commercialising” means to engage in Commercialization and “Commercialize” and “Commercialized” shall have a corresponding meaning.
means any pharmaceutical product not manufactured by DAEWOONG or its Affiliates that (i) has same mechanism of action with that of the Product, and (ii) has same composition as olmesartan and rosuavastatin combination, and (iii) launched or manufactured or supplied in the Territory by any other persons than DAEWOONG, including but not limited to AUTOTELIC, STOCOSIL or Distributor, after the Effective Date of this Agreement.
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“Confidential Information”
|
means any and all information of a confidential or sensitive nature (including all Intellectual Property and Know-How) disclosed by a Party to the other pursuant to this Agreement including, without limitation, manufacturing, marketing, financial, personnel, scientific and other business information and plans, and the material terms of this Agreement, whether in oral, written, graphic or electronic form.
Failure to mark any of the Confidential Information as confidential or proprietary shall not affect its status as Confidential Information under the terms of this Agreement.
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“Control or Controlled”
|
means
(a)in respect of any partnership, corporation or other entity, the direct or indirect ownership of more than fifty percent (50%) of the outstanding shares or other voting rights of the subject entity having the power to vote on or direct the affairs of the entity, (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction); and
(b)in respect of any Patent, Know-How or other Intellectual Property whether owned by or licensed to an entity, the possession of the legal right and ability to grant the respective licenses or sublicenses as provided herein without violating the terms of any agreement or other arrangement with any Third Party;
and the expressions Controlling and Controlled by shall be interpreted accordingly.
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“Cost of Goods” or “COGS”
|
means the cost consisting of (a) Cost of materials used in production of Product including but not limited to APIs, additives, and packages, (b) labour and machine cost, and (c) overhead costs related to production.
DAEWOONG and STOCOSIL agree to review the market price of each API (Olmesartan, Rosuvastatin) for the Product during the 1st quarter of every year and calculate the average price of 3 suppliers registered in the US-DMF for each active ingredient. Then, that average price shall become effective on the last day of every 1st quarter and shall be applied to calculate a new COGS after such date.
Overhead cost for production shall be calculated as 0.4 times the sum of labour and machine cost.
* Overhead cost = (labour and machine cost)*0.4
COGS is to be no more than projected on Product COG (Date: Dec, 2014) as provided to STOCOSIL during its due diligence visit. This is to remains effective from the Effective Date until expiration of the agreement. Thereafter, pricing upper limit shal be permitted only at the time of contract renewal, provided that price increases shall not exceed five percent (5%) over the applicable price in effect for the expiring term. In the event that the relevant governmental pricing (e.g. Centers for medicare and Medicaid Services) authorities in the Territory reduced the maximum bidding/retail price of the Product/Optional Product making the current pricing uncompetitive, Parties shal discuss in good faith a Product price adjustment.
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“Delivery Terms”
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shall be on FOB Incheon airport.
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“Development”
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means, with respect to the Product and/or Optional Product, all activities related to research, preclinical and other non-clinical testing, test methods development and stability testing, toxicology, formulation, quality assurance/quality control, including the transfer of information, materials, Regulatory Documentation and other technology with respect to the Product and/or Optional Product, commercial scale-up, Clinical Trials and Post Approval Studies, including Manufacturing in support thereof, statistical analysis and report writing, market research and development, the preparation and submission of INDs and NDAs, regulatory affairs with respect to the foregoing, and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining, maintaining or expanding a Marketing Authorization. When used as a verb, “Develop” shall mean to engage in Development.
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“Development Costs”
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means any and all costs and expenses recorded as an expense in accordance with applicable accounting rules, related to the Development of a Product, approved by a Development Plan. Development costs shall include such costs in connection with the following activites:
(a)pre-clinical activity costs such as toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis;
(b)clinical costs including cost of goods for the conduct of the clinical trials;
(c)regulatory expenses relating to the conduct of Clinical Trials, wherever performed, for the Product;
(d)Manufacturing of Clinical Trial Supplies of Product for use in Clinical Trials and any pre-clinical activities in support thereof;
(e)Manufacture, purchase or packaging of comparators or placebo for use in Clinical Trials;
(f)Development of the Manufacturing process for Commercial Supplies of the Product, scale-up, Manufacturing process validation, Manufacturing improvements and qualification and validation of Third Party contract manufacturers;
(g)Direct charges for materials (including chemicals, animals and lab supplies).
(h)Regulatory filing costs including but not limited to manufacturing site registration fees, FOFA, PDUFA, MDUFFMA.
(i)Insurances such as product liability insurance, clinical trial insurance, etc.
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“Development Plan”
“Effective Date”
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means the plan for Development of the Product and/or Optional Product, including, without limitation, operating guidelines and estimated filing dates, guidelines for filing Marketing Authorization, and any pre-clinical trials and Clinical Trials to be conducted by STOCOSIL.
means the date on which all parties formally execute this Agreement.
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“First Commercial Sale”
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means, in respect of the Product and/or Optional Product in a country within the Territory, the date on which that Product is first shipped to wholesalers and retailers by STOCOSIL in commercial quantities from its distribution centres for commercial sale to a Third Party in such country after receipt of Marketing Authorisation approval for such Product in such country. Sales for test marketing, sampling and promotional uses or Clinical Trials or research purposes or compassionate uses will not be considered a First Commercial Sale.
Further means, in respect of the Product and/or Optional Product in a country outside of the Territory except in Korea, the date on which that Product is first shipped to wholesalers and retailers by DAEWOONG in commercial quantities from its distribution centres for commercial sale to a Third Party in such country after receipt of Marketing Authorisation approval for such Product in such country. Sales for test marketing, sampling and promotional uses or Clinical Trials or research purposes or compassionate uses will not be considered a First Commercial Sale.
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“Force Majeure”
|
has the meaning set out in Clause 21.5.
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“Good Clinical Practice” or “GCP”
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shall mean all applicable good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable: (i) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95); (ii) the Declaration of Helsinki (1964) as last amended at the 59th World Medical Association (WMA) General Assembly in October 2008 and any further amendments or clarifications thereto; (iii) regulations for “Protection of Human Subjects”, “Institutional Review Boards” and applications for IND, as set forth respectively under 21 C.F.R. Parts 50, 56, and 312, as may be amended from time to time;; and (iv) the equivalent Applicable Laws in any relevant country or jurisdiction, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reports results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.
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“Good Laboratory Practice” or “GLP”
“Good Manufacture Practice” or
“GMP”
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shall mean all applicable good laboratory practice standards, including: (i) 21 C.F.R. Part 58 (“Good Laboratory Practice for Nonclinical Laboratory Studies”), as may be amended from time to time, and (ii) the relevant Applicable Laws in any relevant country or jurisdiction in the Territory, each as may be amended and applicable from time to time
shall mean all applicable current good manufacturing practices including, as applicable: (i) the regulations for “Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General”, “Current Good Manufacturing Practice for Finished Pharmaceuticals, “Current Good Manufacturing Practice for Blood and Blood Components” “General Biological Products Standards” and the “Quality System Regulation”, as set forth respectively under 21 C.F.R. Parts 210, 211, 606, 610 and 820, as may be amended from time to time; (ii) the principles detailed in ICH Q7A ”Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”; and (iii) the equivalent Applicable Laws in any relevant country or jurisdiction, each as may be amended and applicable from time to time.
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“Intellectual Property Rights”
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means rights in any and all Patents, any industrial and intellectual property of any kind granted or recognised under the laws of any country including but not limited to (a) any copyright, designs rights, Patents, logos, business names or signs, domain names, database rights, moral rights, including all rights or forms of protection having an equivalent or similar nature or effect anywhere in the world, whether enforceable, registered, unregistered or registerable (including all renewals, extensions and applications for registration) in respect of the same; and (b) any and all rights relating to software, Confidential Information or Inventions. Trade Marks are excluded from this definition.
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“STOCOSIL & AUTOTELIC Arising IP”
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means any and all Intellectual Property Rights and Know-How which arise in connection with a Development Plan and this Agreement, to the extent it relates to Product and/or Optional Product or the Manufacture of the Optional Product. This to mean any and all Drug Monitoring IPs and Drug Monitoring/Drug combination IPs.
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“STOCOSIL & AUTOTELIC Background IP”
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means any Intellectual Property Rights and Know How owned by, assigned to or licensed to STOCOSIL and/or STOCOSIL Affiliates prior to the Effective Date, which are necessary for the performance of a Development Plan.
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“STOCOSIL Senior Representative”
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means: for all disputes relating to development or regulatory issues, STOCOSIL’s CEO
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“DAEWOONG Arising IP”
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means any and all Intellectual Property Rights and Know-How, which arise in connection with a Development Plan, Manufacture of the Product, and this Agreement, to the extent it relates to the Product which does not incorporate any STOCOSIL Confidential Information, STOCOSIL Background IP and/or STOCOSIL Arising IP.
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“DAEWOONG Background IP”
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means any Intellectual Property Rights and Know-How owned or Controlled, or licensed to or otherwise acquired by DAEWOONG and/or DAEWOONG’s Affiliates prior to the Effective Date of this Agreement and/or otherwise outside the scope of this Agreement which are necessary to perform the obligations pursuant to this Agreement.
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“DAEWOONG Senior Representative”
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means: (i) for disputes relating to development or regulatory issues, DAEWOONG’s Head of Products Development; or (ii) for all other disputes, DAEWOONG’s CEO.
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“Know-How”
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means any proprietary computer program(s), computer code(s), algorithm, treatment algorithm, technology, technical, scientific and medical information, methods of use, processes, techniques, ideas, inventions (excluding any inventions disclosed in any Patent, that is granted or published application), improvements, modifications, know-how, practices, trade secrets, chemistry, manufacturing and control data, quality control information and procedures, and pharmacological, toxicological and preclinical and clinical test data and results and regulatory information (including all documentation and correspondence submitted or required to be submitted to a Regulatory Authority, or received from a Regulatory Authority, in connection with a Regulatory Approval in any country), all of the foregoing pertaining to the Development, Manufacture and/or Commercialization of the Product, but excluding Patents associated with any of the foregoing.
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“Loss” or “Losses”
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means liabilities, damages, and losses to Third Parties, costs and expenses, including, but not limited to, the reasonable fees of attorneys and other professionals.
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“Manufacture”
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means, in respect of the Product, any and all activities related to the purchasing (and/or producing) of Materials, processing, production, sample retention, bulk packaging, primary & secondary packaging, labeling, storing, testing, release and shipping of such Product, including quality assurance and quality control and stability testing, and includes the performance of any such activity in connection with the Development of the Product, and “Manufactured” and “Manufacturing” shall be construed accordingly.
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“Manufacturing and Supply Agreement” or “MSA”
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means an agreement to be entered into by STOCOSIL and DAEWOONG which sets forth the terms and conditions under the Product to be Commercialized by STOCOSIL will be Manufactured and supplied by DAEWOONG to STOCOSIL. The key terms of this Manufacturing and Supply Agreement are summarised in Schedule 1.
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“Manufacturing Licence”
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means, in respect to the Product, all licences and/or approvals necessary for, or in connection with, the Manufacture of such Product at the Manufacturing Site(s).
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“Manufacturing Site(s)”
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means that (or those) manufacturing sites used or owned by DAEWOONG or its Affiliates or its or their respective permitted subcontractors at which the Product will be Manufactured, either pursuant to this Agreement or pursuant to the Manufacturing and Supply Agreement.
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“Marketing Authorizations"
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means, in respect of the Product and/or Optional Product in a country in the Territory, all approvals, licenses, registrations or authorizations issued by the relevant Regulatory Authority in such country of the Territory enabling STOCOSIL to commercialize the Product and/or Optional Product in that country, including Price and Reimbursement Approval.
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“Materials”
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means, in respect of a Product, all active and raw materials (including API), intermediates, processing aids, ingredients, components, packaging and labelling materials and other materials that are required to Manufacture that Product.
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“Net Sales”
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means, as to STOCOSIL or DAEWOONG and with respect to a given period of time, gross invoiced sales of the Product and/or Optional Product to Third Parties by either Party or its Affiliates or sublicensees in such period, less the following deductions from such gross amounts which are actually incurred, allowed, paid, accrued or specifically allocated:
(a) Cost of Good Sold, defined in above
(b) credits or allowances actually granted for damaged Product and/or Optional Product, returns or rejections of Product, price adjustments, and billing errors;
(c) governmental and other rebates (or equivalents thereof) granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), national, state/provincial, local, and other governments, their agencies and purchasers, and reimbursers, or to trade customers, including but not limited to, wholesalers and chain and pharmacy buying groups;
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(d) such Party’s normal and customary trade, cash and quantity discounts, allowances, and credits actually allowed or paid;
(e) commissions allowed or paid to Third Party distributors, brokers, or agents other than sales personnel, sales representatives, and sales agents employed by such Party;
(f) transportation costs, including insurance, for outbound freight related to delivery of Product to the extent included in the gross amount invoiced;
(g) sales taxes, value added taxes (VAT), and other taxes directly linked to the sales of Product to the extent included in the gross amount invoiced;
(h) the actual amount of any write offs for bad debt directly relating to sales of Product in the period; and
(i) any other items actually deducted from gross invoiced sales amounts as reported by such Party in its financial statements in accordance with the International Financial Reporting Standards. Sales between or among either Party and its Affiliates or sublicensees will be excluded from the computation of such Party’s Net Sales, but the subsequent final sales to a Third Party by such Affiliates or sublicensees will be included in the computation of such Party’s Net Sales.
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“Patent”
|
means (a) all national, regional and international patent applications, including priority and provisional patent applications, (b) all patent applications derived from or claiming priority from the foregoing patent applications (a), including divisionals, continuations, continuations-in-part, converted provisionals, and continued prosecution applications, (c) any and all patents that have issued or been granted or in the future issue or are granted from the foregoing patent applications ((a) and (b)), including without limitation patents for inventions, utility models, petty patents, design patents and certificates of invention, (d) any and all reissues, re-examinations, revalidations, confirmations, restorations or extensions, including any patent term extensions, supplementary protection certificates and the like of the foregoing patents or patent applications ((a), (b) and (c)).
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“Phase I”
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means, with respect to the Product, a clinical study identified as a Phase I Study in the Development Plan and conducted in humans on a pharmaceutical product with the primary purpose of determining safety, metabolism and pharmacokinetic properties, and clinical pharmacology of such pharmaceutical product, and that is consistent with 21 C.F.R. § 312.21(a) and/or, as applicable, other comparable Laws.
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“Phase II”
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means, with respect to the Product, a clinical study identified as a Phase II Study in the Development Plan and conducted in human patients designed to evaluate clinical efficacy and safety for such product for one or more indications and that is consistent with 21 C.F.R. § 312.21(b) and/or, as applicable, other comparable Laws.
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“Phase III”
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means, with respect to the Product, a clinical study identified as a Phase III Study in the Development Plan and conducted as a pivotal trial for purposes of filing an Marketing Authorisation application for the Product that provides for the clinical study of such Product on sufficient numbers of patients to confirm with statistical significance the efficacy, and confirm the safety of such Product sufficient to support such MAA for such Product, and is consistent with 21 C.F.R. § 312.21(c) and/or, as applicable, other comparable Laws.
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“Phase IV”
|
means a human clinical trial of a product that is not included in the original NDA submission for such product for an indication, but is required to obtain or maintain the approval by a competent Regulatory Authority of the NDA for such product for such indication, including studies conducted to fulfil commitments made as a condition of NDA approval or any subsequent human clinical trials requested or required by a competent Regulatory Authority as a condition of maintaining such approval.
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“Price and Reimbursement Approval”
|
means the approval of the price and the reimbursement category (where relevant) for the Product and/or Optional Product as established from time to time by the relevant Regulatory Authority in the applicable country in the Territory.
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“Product”
|
means a pharmaceutical product (including any future formulation), which contains only Olmesartan plus Rosuvastatin fixed dose combination (FDC) or its new formula, including but not limited to any modifications or update, for HTN.
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“Optional Product”
“Post Approval Studies”
|
means a pharmaceutical product (including any future formulation), which contains only Olmesartan plus Rosuvastatin fixed dose combination (FDC) to be used with Therapeutic Drug Monitoring (TDM)for recalcitrant or resistant HTN. All Intellecture Properties of TDM are exclusively owned by AUTOTELIC, and AUTOTELIC will grant a royalty bearing non-exclusive license to use in conjunction with the a pharmaceutical product (including any future formulation), which contains only Olmesartan plus Rosuvastatin fixed dose combination (FDC).
means a human clinical study, or other test or study with respect to a product for an indication that (a) is conducted solely in support of pricing or reimbursement for such product in the Territory or (b) is not required to obtain or maintain Marketing Authorization for such product for such indication (for clarity, any human clinical study that is intended to expand the label for a product shall be a Clinical Trial). Subject to the foregoing, Post Approval Studies may include epidemiological studies, modelling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and health economics studies, but shall exclude Phase IV Clinical Trials.
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“Regulatory Authority”
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means any applicable international, supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Development, Manufacturing and Commercialization of the Product and/or Optional Product.
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“Regulatory Dossier”
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means in relation to the Product and/or Optional Product, the technical registration dossier produced in relation to that Product and/or Optional Product (including any and all information, processes, techniques, data and Intellectual Property Rights) in an electronic format which allows for compilation into the relevant country format according to the regulatory requirements necessary to obtain and maintain Marketing Authorizations for the relevant Product in any country in the Territory and outside of the Territory.
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“Regulatory Documentation”
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means, with respect to the Product and/or Optional Product, all Regulatory filings and supporting documents created, submitted to a Regulatory authority, and all data contained therein, including, without limitation, any investigator’s brochures, study protocols, DMF (Drug Master File), correspondence to and from a Regulatory Authority, minutes from teleconferences with Regulatory Authorities, registrations and licences, regulatory drug lists, advertising and promotion documents shared with Regulatory Authorities, adverse event files, complaint files and manufacturing records.
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“Senior Representatives”
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means the DAEWOONG Senior Representative and the STOCOSIL Senior Representative.
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“Specifications”
“Sponsor”
|
means the technical specifications for the Product to be included in the relevant Quality Agreement.
means Autotelic, LLC, Autotelic, Inc. and its shareholders or members currently who own the majority shares of common stocks of Stocosil, Inc. And they will provide necessary capital and services until Stocosil is able to operate as a stand-alone company. For the purpose of this Agreement, Autotelic, LLC and Autotelic, Inc. will assume all of Stocosil Inc.’s responsibilities, obligations, and liabilities until Stocosil Inc. successfully raises total of $20 million in equity.
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“Step-In Rights”
|
has the meaning given in Clause 4.5 and 6.3.
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“Supply Price”
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means, in respect of the Product Manufactured and supplied by DAEWOONG to STOCOSIL pursuant to the Manufacturing and Supply Agreement, the price paid or payable by STOCOSIL for such Product under the Manufacturing and Supply Agreement, which is Cost of Goods plus 50%..
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“Term”
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means the term of this Agreement as set out in Clause 3.
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“Territory”
2.8.0
|
means the United States, Canada, Australia, Japan, Taiwan, and part of Latin American countries of which DAEWOONG are not currently marketing and/or have no plan to market the Product and/or Optional Product in the future.
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“Third Party”
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means a person other than STOCOSIL, AUTOTELIC, DAEWOONG or their respective Affiliates.
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“Trade Mark(s)”
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means in relation to any Party, registered and unregistered trademarks, including, inter alia, words and logos, and any applications for registration thereof, and any Intellectual Property rights residing in such trade marks owned and/or used by that Party and/or its Affiliates and which are used in relation to the Product and/or Optional Product.
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“Valid Claim”
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means a claim of any issued, unexpired Patent owned or Controlled by STOCOSIL that shall not have lapsed, been cancelled or abandoned, been donated to the public, finally disclaimed, nor held finally invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision and where the claim relates to composition of matter or method of use of the Product and/or Optional Product.
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“VAT"
2.8.1
|
means the value added taxes imposed by tax authority of each country of the Territory and outside of the Territory of which the Product and/or Optional Product are being marketed.
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“Waste”
|
means any unwanted substance including regulated waste, non product waste (such as packaging) and manufacturing waste (such as scrap material in factories), irrespective of whether it is capable of being recycled or recovered or has any value.
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2.
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GRANT OF RIGHTS
|
2.1
|
Grants to STOCOSIL
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(a)
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During the Term of Agreement, DAEWOONG grants STOCOSIL and its designated Affilate(s) for the development and commercialization of the Product and Optional Product, an exclusive right to register, import, promote, market, distribute (including through tiers of distributors), offer for sale, sell, have sold and otherwise commercialize the Product and Optional Product in the Territory below during the term of this Agreement.
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(b)
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an exclusive license (with the right to grant sub-license, as provided in Clause 2.3) under DAEWOONG Background IP, DAEWOONG’s Confidential Information, DAEWOONG’s Know-How and DAEWOONG Arising IP to (a) Develop,and Commercialize the Product and/or Optional Product in the Territory; (b) seek and obtain Regulatory Approvals for the Product and/or Optional Product in the Territory, and (c) use and reference, with the right to grant sublicenses, as provided in Clause 2.3, the DAEWOONG Regulatory Dossier; provided, however, DAEWOONG shall retain the right to practice or use the DAEWOONG Background IP, DAEWOONG’s Confidential Information, DAEWOONG’s Know-How and DAEWOONG Arising IP as may be necessary to conduct its Development obligations under the Development Plan in accordance with the terms and conditions of this Agreement. For the avoidance of doubt, the items under discussion are specific to the Product ie. formulation patent(s) for Product and/or Optional Product.
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2.2
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Grants to DAEWOONG
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2.2.1
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Subject to the terms and conditions of this Agreement, AUTOTELIC and/or STOCOSIL hereby grants to DAEWOONG, and DAEWOONG hereby accepts:
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2.3.1
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Subject to Clause 5.3, STOCOSIL may sublicense any of its rights under this Agreement to Develop, Manufacture and Commercialize the Product and/or Optional Product in whole or in part to one or more of its Affiliates or any Third Party performing work under this Agreement, provided that the rights sublicensed to any Affiliate shall automatically terminated upon a change of control of such Affiliate in connection with which such Affiliate ceases to be an Affiliate of STOCOSIL, or in the event of a Third Party, its service agreement with STOCOSIL expires or is terminated. Iin the event of Change in ownership or effective control, this Agreement shall remain in full force and effective with the acquirer and/or successor.
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2.3.2
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DAEWOONG may sublicense its right under this Agreement to Develop, Manufacture and Commercialize the Product and/or Optional Product outside the Territory in whole or in part to one or more of its Affiliates performing work under this Agreement, provided that the rights sublicensed or subcontracted to any Affiliate shall automatically terminate upon a change of control of such Affiliate in connection with which such Affiliate ceases to be an Affiliate of DAEWOONG.
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2.3.3
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Both Parties may sublicense its right under this Agreement to Develop, Manufacture and Commercialize the Product and/or Optional Product in whole or in part in appropriate Territories to one or more contract research organizations performing work under this Agreement, subject to prior a written consent from each other, such consent not to be unreasonably withheld. Both Parties shall have thirty (30) Business Days to review each other’s proposal.
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3.
|
EFFECTIVE DATE AND TERM
|
3.1
|
Unless earlier terminated in accordance with Clause 18, this Agreement shall remain in full force from the Effective Date and shall remain in force for a period of ten (10) years from the First date of Commerical Sale of the Optional Product in any country of the Territoryand thereafter shall be automatically renewed on an annual basis unless either Party gives a six (6) month notice to terminate the Agreement.
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4.
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DEVELOPMENT
|
4.1
|
Initial Obligations by AUTOTELIC and STOCOSIL
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|
4.2.1
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Development of the Product and/or Optional Product shall be governed by a multi-year Development Plan, which shall be prepared by STOCOSIL, and shall set forth material anticipated Development activities and timelines until the date that the corresponding Product receives Regulatory Authorization in the countries in the Territory specified in such Development Plan. Both Parties recognize that, in general, the Development Plans represent projections only and may be subject to change during the Development process and is not a guarantee that Marketing Authorization in any country is received in accordance with any timelines.
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(a)
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data being generated using sound scientific techniques and processes;
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|
(b)
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data being accurately and reasonably contemporaneously recorded in accordance with good scientific practices by the persons responsible for conducting the research under this Agreement;
|
|
(c)
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data being analysed appropriately without bias in accordance with good scientific practices; and
|
|
(d)
|
data and results being stored securely and in a form which can be easily retrieved.
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4.5
|
Step-In Rights at the Development Stage for DAEWOONG
|
|
(a)
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DAEWOONG shall reimburse STOCOSIL all Development Costs upto that point; and
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|
(b)
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STOCOSIL shall grant DAEWOONG an exclusive license, royalty-bearing under STOCOSIL Background IP, STOCOSIL Arising IP, STOCOSIL’s Confidential Information and STOCOSIL Know-How (with the right to grant sub-license, as provided in Clause 2.3) to make, have made, use, develop, sell, offer for sale and import the Retained Product in the Territory in the affected country or countries (except for the TDM owned by AUTOTELIC: but AUTOTELIC grants a non-exclusice license to use the TDM for the Optional Product of the Retained Product). For the Product of the “Retained Product”, DAEWOONG will not pay any further royalty or any other profit sharing payments. For the Optional Product of the “Retained Product”, DAEWOONG shall pay 5% of the annual Net Sales of the Optional Product as an annual royalty payment for the duration of this Agreement.
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|
(a)
|
STOCOSIL shall reimburse DAEWOONG all Development Costs upto that point; and
|
|
(b)
|
DAEWOONG shall grant STOCOSIL an exclusive license, royalty-free under DAEWOONG Background IP, DAEWOONG Arising IP, DAEWOONG’s Confidential Information and DAEWOONG Know-How (with the right to grant sub-license, as provided in Clause 2.3) to make, have made, use, develop, sell, offer for sale and import the Retained Product in Retained Countries outside of the Territory in the affected country or countries. DAEWOONG will be the main manufacturer and supplier of the Retained Product (except for the TDM owned by AUTOTELIC) to STOCOSIL under the same terms and conditions of this Agreement.
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5.1
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The Parties shall work together to produce high quality regulatory files relating to the Product and Optional Product. Regulatory Dossiers and Regulatory Documentation relating to the Product and Optional Product shall be prepared by the Parties so as to meet the standards and all Applicable Law requirements in each countries of the Territory. Nevertheless, DAEWOONG, or its affiliates, shall provide STOCOSIL all Regulatory Dossiers, Regulatory Documents and other related supporting documents it in order to support STOCOSIL for registration of the Product and/or Optional Product in the Territoy.
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5.2
|
STOCOSIL shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product in the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulatory Dossier and Regulatory Documentation other than as described in Clause 5.3 below. For the avoidance of doubt, registration fee for such filing in the Territory shall be borne by STOCOSIL.
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5.3
|
DAEWOONG shall be responsible for implementing all regulatory activities and all regulatory filings for each of the Product and/or Optional Product outside of the Territory in its own name and shall be the owner of all Marketing Authorisation, Regulator Dossier and Regulatory Documentation. For the avoidance of doubt, registration fee for such filing outside of the Territory shall be borne by DAEWOONG. The Parties shall work together to ensure a consistent global Regulatory strategy.
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5.4
|
DAEWOONG shall provide, as soon as physically possible, access to STOCOSIL of DAEWOONG’s existing Product ownership of all Korean Marketing Authorization, Regulatory Dossier and Regulatory Documentation.
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5.5
|
STOCOSIL, under Step-in Rights, shall transfer to DAEWOONG as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country within the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation. DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.
|
5.6
|
DAEWOONG will not have ownership to the Regulatory Documentation generated by STOCOSIL, unless it is transferred to DAEWOONG in accordance with Clause 5.5. DAEWOONG will, however, have rights to access to such Regulatory Documentation to the extent necessary for DAEWOONG to obtain its Marketing Authorisation for the Product and/or Optional Product outside of the Territory.
|
5.7
|
STOCOSIL will not have ownership to the Regulatory Documentation generated by DAEWOONG, unless it is transferred to STOCOSIL in accordance with Clause 5.5. STOCOSIL will, however, have access to such Regulatory Documentation to the extent necessary for STOCOSIL to obtain its Marketing Authorisation for the Product and/or Optional Product in the Territory.
|
5.8
|
Upon STOCOSIL’s request and at STOCOSIL’s expense (to the extent that it is necessary), DAEWOONG shall:
|
|
(a)
|
provide appropriate expertise to assist STOCOSIL to fulfil its obligations under Clause 5.2;
|
|
(b)
|
send appropriately qualified representatives to attend meetings with any Regulatory Authority in the Territory;
|
|
(c)
|
support STOCOSIL in replying to regulatory queries related to CMC and GMP; and
|
|
(d)
|
support STOCOSIL in cGMP audits by Regulatory Authorities.
|
5.9
|
Upon DAEWOONG’s request and at DAEWOONG’s expense (to the extent that it is necessary), STOCOSIL shall:
|
|
(a)
|
provide appropriate expertise to assist DAEWOONG to fulfil its obligations under Clause 5.3; and
|
|
(b)
|
send appropriately qualified representatives to attend meetings with any Regulatory Authority outside of the Territory.
|
5.10
|
Each Party shall maintain, or cause to be maintained, records of its respective Development activities in sufficient detail and in good scientific manner appropriate for Patent and Regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development activities, and which shall be retained by such Party for at least five (5) years after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records, except to the extent that a Party reasonably determines that such records contain Confidential Information that is not licensed to the other Party, or to which the other Party does not otherwise have a right of access hereunder.
|
5.11
|
In the event of a dispute with respect to the content of any regulatory filing or Regulatory Dossier, Regulatory Documentation, Product labelling, or the decision to file a drug approval application, the dispute will be resolved amicably. If there is no resolution, STOCOSIL will have the final decision making authority with respect to the Product and/or Optional Product in the Territory, and DAEWOONG will have the final decision making authority with respect to the Product and/or Optional Product outside of the Territory.
|
5.12
|
Each Party agrees to share relevant information in order to promote successful Development and Commercialization of the Product and Optional Product within the Territory as well as outside of the Territory. Each Party shall promptly notify each other of relevant information.
|
|
6.1.1
|
It is hereby agreed that:
|
|
(a)
|
subject to Clause 2.1, STOCOSIL shall have the sole and exclusive right to Commercialize the Product and/or Optional Product either itself or through its Affiliates and/or Third Parties in the Territory;
|
|
(b)
|
subject to Clause 2.2, DAEWOONG shall have the sole and exclusive right to Commercialize the Product and/or Optional Product either itself or through its Affiliates and/or Third Parties outside of the Territory.
|
|
(c)
|
STOCOSIL shall Commercialize the Product using a name and trade mark that is not the same as or confusingly similar to any name or DAEWOONG Trade Mark used/or owned by DAEWOONG or its Affiliates.
|
|
(d)
|
DAEWOONG shall Commercialize the Product and/or the Optional Product using a name and trade mark that is not the same as or confusingly similar to any name or STOCOSIL Trade Mark used/or owned by STOCOSIL or its Affiliates.
|
|
6.3.1
|
Where STOCOSIL decides to permanently stop Commercialize the Product and/or Optional Product in a Country within the Territory, it shall give written notice promptly to DAEWOONG of such fact setting out the countries to which the notice applies. Upon receipt of such notice, DAEWOONG will have the option (“Step-In Rights) to further Commercialize such Products (each, a “Retained Product”) in such country (each, a “Retained Countries”). In the event that DAEWOONG exercises its Step-In Rights under this Clause 6.3.1:
|
|
(a)
|
unless otherwise agreed with STOCOSIL, DAEWOONG agrees to Commercialize such Retained Products using a name and Trade Mark that it has come up with that is not the same as or confusingly similar to any name or STOCOSIL Trade Mark used and/or owned by STOCOSIL or its Affiliates;
|
|
(b)
|
DAEWOONG shall pay to STOCOSIL an annual royalty payment equal to five percent (5%) of the Product and seven percent (7%) of the Optional Product of DAEWOONG’s Net Sales of such Retained Products in such Retained Countries. For the avoidance of doubt, royalties are not based on Patents; and
|
|
(c)
|
STOCOSIL shall transfer the Marketing Authorisation to the extent legally permissible to do so and DAEWOONG shall reimburse STOCOSIL all costs associated with the transfer of the Marketing Authorisation.
|
|
(a)
|
unless otherwise agreed with DAEWOONG, STOCOSIL agrees to Commercialize such Retained Products using a name and Trade Mark that it has come up with that is not the same as or confusingly similar to any name or DAEWOONG Trade Mark used and/or owned by DAEWOONG or its Affiliates;
|
|
(b)
|
DAEWOONG will remain as the exclusive manufacturer and supplier of the Retained Products in the Retained Countries, except for the TDM owned by AUTOTELIC, for STOCOSIL under the same terms and conditions of this Agreement;
|
|
(c)
|
DAEWOONG shall transfer the Marketing Authorisation to the extent legally permissible to do so and STOCOSIL shall reimburse DAEWOONG all costs associated with the transfer of the Marketing Authorisation and development costs associated with obtaining the Marketing Authorisation; and
|
|
(d)
|
In order to avoid delay in commercialization of the Optional Product outside of the Territory, STOCOSIL and DAEWOONG will review the Development and Commercialization progress by DAEWOONG in countries outside of the Territory for the Product and Optional Product within six (6) month of obtaining an US FDA Marketing Authorizations for the Optional Product by STOCOSIL. At that time, STOCOSIL and DAEWOONG will, in good faith, discuss and negotiate whether STOCOSIL should exercise its Step-In rights in countires outside of the Territory where DAEWOONG has not made “Substantial Progress” in obtaining the Marketing Authorizations for the Product. “Substantial Progress” means DAEWOONG has already submitted an application for (NDA equivalent) the Markeing Authorization in affected countries outside of the Territoy within 6 months. Further, STOCOSIL will have an automatic right to exercise the Step-In right even without a written notice from DAEWOONG, if DAEWOONG has not obtained the Marketing Authorizations in the country(ies) outside of the Territory for the Product within two years an approved US FDA Marketing Authorization for the Optional Product by STOCOSIL. Not withstanding the above statement, DAEWOONG will have an unlimited timeline to Develop and Commercialize the Product and the Optional Product in Korea, China, Vietnam, Indonesia, Thailand, and Philippines without triggering the automatic Step-In right by STOCOSIL.
|
7.1
|
Neither Party shall Develop and Commercialize any Competiting Product with the Territory.
|
7.2
|
Further, neither party shall Develop and Commercialize any Competing Product within the Territory during the terms of this Agreement and three years thereafter the termination and/or expiration of this Agreement.
|
8.1
|
Manufacture and supply of Products for Development
|
|
8.1.1
|
Subject to the terms and conditions determined in the relevant Development Plan, DAEWOONG shall Manufacture or have Manufactured all quantities of the Product required by STOCOSIL for use in the course of Development of the Product. Without limiting the generality of the foregoing, DAEWOONG shall (subject to the relevant Development Plan):
|
|
(a)
|
Manufacture (or have Manufactured) batches of the Product required for use in Clinical Trials, bioavailability studies and bioequivalence studies if necessary;
|
|
(b)
|
Manufacture (or have Manufactured) suitable reference quantities of the Product for the purposes of Clinical Trials, bioavailability studies and bioequivalence studies (including any stability testing of the Product that may be required in connection with the Development of the Product);
|
|
(c)
|
Manufacture (or have manufactured) any matching placebo required in connection with a Clinical Trial of the relevant Product; and
|
|
(d)
|
Perform any stability testing required in connection with the Development of the Product.
|
|
8.1.2
|
DAEWOONG shall perform the activities contemplated by Clause 8.1.1 at the expenses of STOCOSIL. For the avoidance of doubt, the expenses related in the Clause 8.1.1 will be added to the COGS of the Product for the purpose of executing the Development Plan by STOCOSIL.
|
|
8.1.3
|
Any Manufacture by DAEWOONG of the Product for Commercialization by STOCOSIL in the Territory shall be governed by, and performed under and in accordance with, the Manufacturing and Supply Agreement in the Schedule 1.
|
|
8.1.4
|
DAEWOONG shall supply the Product Manufactured pursuant to Clause 8.1.1 in a form ready for clinical trial packaging. STOCOSIL shall be responsible for clinical trial packaging and distribution of the Product to investigator sites for any Clinical Trials.
|
|
8.1.5
|
DAEWOONG shall only be obliged to Manufacture and supply the Product and/or manufacture and supply matching placebo for Clinical Trials where such Product and/or matching placebo is Manufactured (or, as the case may be, manufactured) at its own manufacturing site. For the avoidance of doubt, if STOCOSIL requires that Clinical Trial supplies be Manufactured (and/or, in the case of a matching placebo, manufactured) at any non-DAEWOONG manufacturing site, then STOCOSIL shall pay the costs of such Manufacture (and/or manufacture) to the extent of the estimated costs to DAEWOONG of Manufacturing the same Product (and/or manufacturing the same matching placebo) in its own manufacturing site and STOCOSIL shall be responsible for any incremental costs of Manufacture (and/or, in the case of a matching placebo, manufacture) over-and-above such estimated costs.
|
9.
|
PAYMENTS
|
|
9.2.2
|
DAEWOONG shall pay STOCOSIL seven percent (7%) royalty on Net Sales of the Optional Product outside of the Territory including Korea.
|
|
9.6.1
|
STOCOSIL shall pay each milestone payment within 30 days of each vesting milestone event.
|
|
9.6.2
|
STOCOSIL is required to open a LC prior to the shipment and the payment will be made from the bank on the 45th day or within 45 days of the shipment.
|
|
9.6.3
|
DAEWOONG will pay appropriate royalty payments within 45 days of each Calendar Quarter.
|
|
9.6.4
|
During the Term, DAEWOONG shall furnish to STOCOSIL a written report within forty-five (45) days after the end of each Calendar Quarter showing (i) Net Sales during such Calendar Quarter, (ii) the calculation of royalties for such Calendar Quarter, (iii) withholding taxes, if any, required by Applicable Law to be deducted (the “Royalty Report”).
|
|
9.6.5
|
Payments under this Agreement made by a Party (the “Payor”) to the other Party (the “Payee”) shall be made in US Dollar and shall be effected by immediate bank transfer into such account as may be designated by the Payee to the Payor by notice in writing. All costs, bank charges or other related fees shall be borne by the Payor.
|
|
9.6.6
|
Any tax paid or required to be withheld by the Payor for the benefit of the Payee on account of any payments payable to the Payee under this Agreement shall be deducted from the amount of royalties or other payments otherwise due. The Payor shall secure and send to the Payee proof of any such taxes withheld and paid by the Payor for the benefit of the Payee, and shall, at the Payee’s request, provide reasonable assistance to the Payee in claiming exemption from such deductions or withholdings under any applicable double taxation or similar agreement or treaty.
|
|
9.6.7
|
All amounts referenced under this Agreement are exclusive of any VAT or similar taxes and payments hereunder shall be made without deduction for such taxes. Accordingly, if any VAT or similar tax is due with respect to such a payment, such tax shall be payable in addition to the amounts set out under this Agreement.
|
|
9.6.8
|
Any payments or portions thereof due under this Agreement which are not paid when due shall bear interest equal to the lesser of the average one-month London Inter-Bank Offering Rate (LIBOR) for Pounds Sterling, as reported in the Financial Times, on the due date (or, if the due date is not a Business Day, on the last Business Day prior to such due date), or the maximum rate permitted by applicable law, in each case calculated on the number of days such payment is delinquent. This Clause 9.6.8 shall in no way limit any other remedies available to either Party. Notwithstanding the foregoing: (a) in the event that any payment, or portion thereof, is disputed in good faith by the debtor, any subsequent settlement payment related to that dispute shall not include interest thereon; and (b) the Party due to make such payment shall not be liable to pay interest in the event that: (i) any payments are disputed or subject to resolution of interpretation of the terms hereof; (ii) payment has been delayed for reasons without the control of the Party due to receive payment (including without limitation due to invalid or late changes to bank details and non-compliant invoices); and (iii) the Party due to receive payment has not responded to genuine questions or queries from the Party due to make payment.
|
|
9.6.9
|
If any currency conversion shall be required in connection with the calculation of amounts payable hereunder, such conversion shall be made using the average exchange rates as calculated and utilised by the Payor’s group reporting system and as consistently applied in its external reporting. As of the date of this Agreement, the method utilised by STOCOSIL’s group reporting system uses spot exchange rates sourced from Reuters/Bloomberg and, if such method is changed during the term of this Agreement, STOCOSIL will provide the DAEWOONG with written notice of the revised method.
|
|
(a)
|
such Confidential Information has been placed in the public domain other than through such Party’s fault or that of a person who was provided with the information by such Party;
|
|
(b)
|
such Confidential Information has been independently developed by such Party or its Affiliates without reference to the protected Party’s Confidential Information;
|
|
(c)
|
the other Party has approved in writing the particular use or disclosure of such Confidential Information;
|
|
(d)
|
such Confidential Information is already known by such Party without an obligation of confidentiality;
|
|
(e)
|
such Confidential Information is independently or rightfully received from a Third Party without any obligation of confidence; or
|
|
(f)
|
such disclosure is expressly required by law or otherwise by any relevant stock exchange or national or supranational governmental or Regulatory Body or court entitled by law to disclosure of the same, but only to the extent of or for the purpose of such demand or order, provided that such Party:
|
|
(ii)
|
gives the other Party prompt notice of such requirement to disclose to enable the other Party to seek an appropriate protective order; and
|
|
(iii)
|
uses Commercially Reasonable Efforts to require the recipient of such Confidential Information to preserve the confidential nature of such Confidential Information once disclosed.
|
11.1.7
|
DAEWOONG may use its Confidential Information outside the scope of this Agreement without restriction. STOCOSIL may use its Confidential Information outside the scope of this Agreement without restriction.
|
11.3
|
Publications
|
|
(a)
|
the Party making the announcement or disclosure shall use its Commercially Reasonable Efforts to consult with the other Party in advance as to the form, content and timing of any such announcement or disclosure and shall take reasonable account of the other Party’s views;
|
|
(b)
|
the announcement or disclosure shall contain the minimum (and no more than the minimum) necessary to comply with the relevant requirements; and
|
|
(c)
|
such party shall have been advised by its external legal counsel that such announcement or disclosure is necessary to comply with the relevant requirements.
|
12.1
|
Pharmacovigilence
|
|
12.1.1
|
STOCOSIL shall be responsible for worldwide pharmacovigilance and will hold the Global Safety Data Sheet of the Product and Optional Product. STOCOSIL will bear the pharmacovigilance costs.
|
|
12.1.2
|
All Phase II and Phase III Clinical Trials related to the Product and Optional Product will require STOCOSIL’s Global Safety Board approval.
|
|
12.1.3
|
Subject to the terms of this Agreement, as soon as practicable following the Effective Date, STOCOSIL and DAEWOONG (under the guidance of their respective pharmacovigilance departments, or equivalent thereof) shall identify and finalize the responsibilities the Parties shall employ to protect patients and promote their well-being in a separate Safety Data Exchange Agreement (“SDEA”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication and exchange (as between the Parties) of safety information such as Adverse Events, pregnancy exposure, lack of efficacy, misuse/abuse, and any other information concerning the safety of the Product. Such guidelines and procedures will be in accordance with, and enable the Parties and their Affiliates to fulfill, local and international regulatory reporting obligations to government authorities and other applicable Laws. Furthermore, such agreed procedures shall be consistent with relevant FDA and International Council for Harmonization (ICH) guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The SDEA shall provide that: (i) STOCOSIL shall be responsible for all pharmacovigilance activities regarding the Product, including signal detection, medical surveillance, risk management, global medical literature review and monitoring, Adverse Event reporting and responses to regulatory authority requests or medical information enquiries and (ii) in the event DAEWOONG receives safety information regarding the Product, or information regarding any safety-related regulatory request or inquiry, DAEWOONG shall promptly notify STOCOSIL, but in no event later than three (3) Business Days, after it receives such safety information, regulatory authority request or query.
|
|
12.1.4
|
Medical Information. STOCOSIL shall respond to all reasonable requests for medical information. Promptly after the Effective Date, the Parties shall establish procedures in accordance with the applicable portions of STOCOSIL’s processes and standard operating procedures, to enable DAEWOONG to send such requests to specific parties to enable prompt response to any medical inquiries.
|
|
12.1.5
|
Product Withdrawals and Recalls. In the event that either Party (a) becomes aware of an event, incident or circumstance that has occurred which may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (b) becomes aware that a Regulatory Authority is threatening or has initiated an action to remove the Product from the market; (c) is required by any Regulatory Authority to distribute a “Dear Doctor” letter or its equivalent, regarding use of the Product; or (d) places a clinical trial for a Product on hold for clinical safety reasons, such Party shall promptly advise the other Party in writing with respect thereto, and shall provide to such other Party copies of all relevant correspondence, notices, and the like. The holder of the Marketing Authorization (if any) for the Product shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the jurisdiction covered by that Marketing Authorization and shall be responsible for conducting any recalls or taking such other remedial action, and each Party agrees, upon reasonable request by the Marketing Authorisation holder and at the expense of the Marketing Authorization holder, to assist with respect to such recalls or remedial actions. STOCOSIL shall have final authority to make all decisions relating to any recall, withdrawal or other corrective action with respect to the Product in use in a Clinical Trial, and DAEWOONG agrees, upon reasonable request and notice by STOCOSIL and at the expense of STOCOSIL, to assist with respect to such recall, withdrawal or other corrective action.
|
|
12.1.6
|
In the event that (i) any recall, market withdrawal or other corrective action is (or may be) required in relation to the Product Manufactured and supplied by DAEWOONG to STOCOSIL pursuant to the Manufacturing and Supply Agreement and (ii) there is any conflict or inconsistency between the provisions of that Manufacturing and Supply Agreement and the provisions of Clause 12.1.6, the provisions of the Manufacturing and Supply Agreement shall, to the extent of such inconsistency or conflict, prevail.
|
13.1
|
It is agreed that where in a clinical study relating to the Product:
|
|
(a)
|
the route of administration is to be changed;
|
|
(b)
|
patient exposure is designed to be significantly increased beyond that of the originator molecules; and/or
|
|
(c)
|
there is a high risk of drug on drug interactions (as assessed by STOCOSIL), no clinical studies shall be undertaken,
|
13.2
|
In the event that the Parties do not agree with the comments of STOCOSIL’s Global Safety Board made following a referral to it under Clause 13.1, the decision as to whether the Clinical Trial in question shall proceed and on what terms shall be made in accordance with the provisions set out in Clause 4.2.
|
13.3
|
The Parties agree at all times to comply with the Global Scientific Principles and Standards and that in particular any publicity and marketing relating to the Products shall comply with such principles and standards.
|
14.1
|
Conduct of Clinical Trials
|
|
14.1.1
|
STOCOSIL shall be responsible for conducting and funding, in its sole direction, all Phase III Clinical Trials for the Product and/or Optional Product in the Territory.
|
|
14.1.2
|
Unless otherwise agreed by the Parties or required by Applicable Law, STOCOSIL shall own all data and reports related to Clinical Studies in the Territory. All data, database information and safety reports from such Clinical Trials in the Territory for the Product and/or Optional Product shall be centralised and held by STOCOSIL with copies of such data, information or reports provided to DAEWOONG to the extent required as contemplated in this Agreement or the Development Plan to support application for Marketing Authorization outside of the Territory.
|
14.2
|
Clinical Trial Registry
|
|
14.2.1
|
To the extent required by Applicable Laws, STOCOSIL shall have the right at any time during and after the term of this Agreement to publish the results or summaries of results of all clinical trials conducted with respect to the Product and/or Optional Product in any clinical trial register maintained by STOCOSIL or its Affiliate and the protocols of clinical trials relating to such Product and/or Optional Product on www.ClinicalTrials.gov and/or in each case publish the results, summaries and/or protocols of clinical trials on such other websites and/or repositories and in a peer-reviewed journal within such timescales as required by law or STOCOSIL’s or its Affiliate’s standard operating procedures, irrespective of the outcome of such clinical trials. Each such publication made in accordance with this Clause 14 shall not be a breach of the applicable confidentiality obligations set out in the Agreement and STOCOSIL shall be entitled to maintain such publication even following any termination of STOCOSIL’s rights in respect of the relevant Product and/or Optional Product.
|
|
14.2.2
|
DAEWOONG shall have the right to publish the results or summaries of results of all Clinical Trials conducted with respect to the Product and/or Optional Product outside of the Territory as allowed by Applicable Laws. Prior to public disclosure or submission for publication of a proposed publication describing the results of any scientific or clinical activity relating to the Product and Optional Product outside of the Territory, DAEWOONG shall send STOCOSIL by expedited delivery a copy of the proposed publication to be submitted and shall allow STOCOSIL a reasonable time period (but no more than sixty (60) days from the date of confirmed receipt) in which to determine whether the proposed publication contains subject matter for which patent protection should be sought (prior to publication of such proposed publication) for the purpose of protecting an invention, or whether the proposed publication contains Confidential Information of STOCOSIL. Following the expiration of applicable time period for review, DAEWOONG shall be free to submit such proposed publication for publication and publish or otherwise disclose to the public such scientific or clinical results.
|
|
(a)
|
it has the necessary right and authority to enter into this Agreement and that to the best of its knowledge the execution, performance and delivery of this Agreement will not conflict with any obligation to which any of the Parties is subject;
|
|
(b)
|
it is carrying on its business in compliance with all Applicable Laws.
|
|
(a)
|
it has the title and/or right its Background IP and Know-How in relation to the Product and Optional Product and further that it has the title and/or right to grant the other the right to use such Background IP in accordance with the terms of this Agreement;
|
|
(b)
|
to the best of its knowledge and reasonable belief as of the Effective Date there is no claim or litigation pending, or, threatened, concerning any infringement or alleged infringement of any Third Party’s valid and enforceable Intellectual Property Rights in relation to the Development, Manufacture or Commercialization of the Product and/or Optional Product.
|
|
(a)
|
the manufacturing site and all equipment, tooling and moulds utilized in the performance of the Development of the Product hereunder by DAEWOONG shall, during the Term of this Agreement, be maintained in good operating condition and shall be maintained and operated in accordance with all Applicable Laws. The Manufacturing and storage operations, procedures and processes utilized in the Development and Manufacture and supply of the Products hereunder shall be in full compliance with all Applicable Laws, including GLP, GCP and cGMP and health and safety laws as necessary;
|
|
(b)
|
it shall perform all of its obligations under this Agreement in full compliance with all Applicable Laws, including but not limited to those laws and regulations applicable to DAEWOONG’s environment, health and safety guidelines;
|
|
(c)
|
all Waste, including but not limited to all Hazardous Waste, generated shall be disposed of in accordance with all Applicable Laws and regulations governing such matters in the Territory;
|
|
(d)
|
it shall hold during the Term of this Agreement all licences (including any Manufacturing Licence), permits and similar authorizations required by statutory authority and any other Regulatory authority to perform its obligations under this Agreement;
|
|
(e)
|
the Product supplied to STOCOSIL under this Agreement shall be produced and delivered in accordance with and shall be of the quality specified in and shall conform to, the Specifications, the Quality Agreement and Applicable Laws including, without limitation, GCP, GLP and GMP, and any other quality assurance requirements of STOCOSIL;
|
|
(f)
|
it is able to pass good title to the API or Product supplied to STOCOSIL pursuant to this Agreement;
|
|
(g)
|
the Product will not contain any Materials that has not been used, handled or stored in accordance with the relevant Quality Agreement, all Applicable Laws and any other quality assurance requirements of STOCOSIL;
|
|
(h)
|
DAEWOONG shall at all times be responsible for all the DAEWOONG employees operating within its Manufacturing Site and all obligations with respect to such DAEWOONG employes(s) shall be discharged by DAEWOONG at its own cost without reference to STOCOSIL. It is hereby clarified that at no time shall STOCOSIL be deemed to have any nexus or responsibility towards the employee(s) of DAEWOONG; and
|
|
(i) it has never been and is not currently (i) an individual who has been debarred by the FDA pursuant to 21 U.S.C. 335a(a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application, or an employer, employee or partner of such a debarred individual; or (ii) a corporation, partnership or association that has been debarred by FDA pursuant to 21 U.S.C. 335a(a) or (b) from submitting or assisting in the submission of a drug application, or a partner , shareholder, member, subsidiary, or Affiliate of a debarred entity. DAEWOONG has no reason to believe that any circumstances exist which may affect the accuracy of the foregoing representation, including without limitation any FDA investigations of, or debarment proceedings against Supplier or any other person or entity performing services or rendering assistance, which is in any way related to activities to be undertaken pursuant to this Agreement. DAEWOONG shall immediately notify STOCOSIL in writing if DAEWOONG at any time during the Term of this Agreement, becomes aware of any such circumstances;
|
|
(a)
|
DAEWOONG represents and warrants that to the best of its knowledge as of the Effective Date of this Agreement, there is no pending or likely governmental enforcement action or private claim against DAEWOONG regarding environmental matters that are reasonably likely to limit, impede or otherwise jeopardize DAEWOONG’s ability to meet its obligations under this Agreement;
|
|
(a)
|
the Product supplied hereunder shall conform to the Specifications and the requirements of the Marketing Authorisations relating thereto;
|
|
(b)
|
the Product shall be Manufactured, quality controlled and packed in accordance with relevant GCP, GLP and cGMP, the Quality Agreement and Applicable Laws.
|
|
(c)
|
it will convey good title to the Product supplied hereunder;
|
|
(d)
|
it holds all necessary consents, authorizations, registrations, certificates, licences, approvals, permits, authorities or exemptions from any regulatory authority which are required to perform its obligations under this Agreement and has paid all fees due in relation to them and is not in breach of any conditions under them where such breach would be likely to have a material and adverse effect on its ability to perform its obligations under this Agreement;
|
|
(e)
|
to the best of its knowledge it is not subject to any material administrative or governmental investigations, in respect of the Products and including without limitation any such investigation in relation to any Manufacturing Site; and
|
|
(f)
|
as at the date of this Agreement other than as disclosed to STOCOSIL in writing to the best of its knowledge there is no claim or litigation pending or threatened, concerning any infringement or alleged infringement of any third party’s registered Intellectual Property including without limitation any granted or pending patents or pending patent applications in relation to the Manufacture, import, release after import, marketing, promotion, distribution, sale and use of the Products, including under any trade marks already submitted to any regulatory authority as part of a Marketing Authorisation (or application relating thereto) in relation to the Products and that the Manufacture, import, release after import, marketing, promotion, distribution, sale and use under this Agreement of such products will not infringe the registered Intellectual Property rights of any third party including without limitation any granted or pending patents or pending patent applications and including in respect of the proposed or actual use of any trade marks already submitted to any regulatory authority as part of a Marketing Authorisation (or application relating thereto) in relation to the Products.
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(a)
|
it shall, and shall procure that its Affiliates and sublicensees shall, observe all Applicable Laws, including the terms of the relevant Marketing Authorizations, in relation to its Commercialization of the Product and/or Optional Product in the Territory and outside of the Territory; and
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(b)
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it shall not, and shall procure that its Affiliates and sublicensees shall not, make any false and/or misleading representation regarding the Product and/or Optional Product.
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16.1
|
DAEWOONG shall defend, indemnify and hold harmless STOCOSIL and its Affiliates from and against any and all Liabilities and Losses that may, respectively, be brought by a third party against, or be suffered or incurred by, STOCOSIL and/or any of its Affiliates and arising out of or in connection with:
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(a)
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any breach of any representation or warranty made by DAEWOONG under this Agreement;
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(b)
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any third party personal injury, illness or death, or loss or damage to third party property arising from DAEWOONG’s failure to Manufacture and/or supply the Products, or pharmaceutical product used in Optional Product according to the terms of this Agreement, including the Product Specification;
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(c)
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the cost of any recall of the Product or the Optional Product to the extent that recall is due to DAEWOONG’s failure to manufacture and supply according to the terms of this Agreement, including the Product Specification;
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(d)
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any fault, negligence or wilful misconduct of DAEWOONG, its Affiliates or any of their respective officers, employees and agents with respect to the performance of this Agreement except to the extent that the Liability or Loss in question resulted from the gross negligence act or wilful misconduct of STOCOSIL, or its Affiliate(s) or any of its or their employees, agents or subcontractors, or any breach by STOCOSIL of any of its obligations, representations or warranties under this Agreement; and
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(e)
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any infringement of any third party’s Intellectual Property as a result of any Manufacturing process used with respect to the Product or pharmaceutical product used in an Optional Product supplied to STOCOSIL under this Agreement to the extent that DAEWOONG has failed to disclose to STOCOSIL in writing prior to the date of this Agreement the specifics of such Manufacturing process which is the subject of the infringement.
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16.2
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STOCOSIL shall defend, indemnify and hold harmless DAEWOONG from and against any and all Liabilities and Losses that may be, respectively, brought by a third party against, suffered or incurred by DAEWOONG and/or any of its Affiliate(s) and arising out of or in connection with:
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(a)
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any third party personal injury, illness or death, or loss or damage to third party property arising from the use or sale by STOCOSIL of the non-pharmaceutical part of the Optional Product;
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(b)
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any fault, negligence or wilful misconduct of STOCOSIL, its Affiliates or any of their respective officers, employees, agents or subcontractors with respect to the performance of this Agreement except to the extent that the Liability or Loss in question resulted from the negligence or wilful misconduct of DAEWOONG, or its Affiliate(s) or any of its or their employees, agents or subcontractors, or any breach by DAEWOONG of any of its obligations, representations or warranties under this Agreement;
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(c)
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a breach of representation or warranty made by STOCOSIL under this Agreement;
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(d)
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the costs of any recall of the Optional Product to the extent that recall is due to the non-pharmaceutical portion of the Optional Product, TDM; and
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(e)
|
Any claim of infringement of any third party’s Intellectual Property of the non-pharmaceutical portion of the Optional Product, TDM outside of the Territory other than an infringement as a result of any Manufacturing process usedwith respect to the pharmaceutical product of Optional Product supplied to STOCOSIL under this Agreement,
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(a)
|
In the case of a claim for which any STOCOSIL, indemnified party seeks indemnification under Section 16.1, STOCOSIL will permit DAEWOONG to direct and control the defense of the claim and will provide such reasonable assistance as is reasonably requested by DAEWOONG (at DAEWOONG’s cost) in the defense of the claim; provided that nothing in this Section 16.3 will permit DAEWOONG to make any admission on behalf of STOCOSIL, or to settle any claim or litigation which would impose any financial obligations on STOCOSIL without the prior written consent of STOCOSIL, such consent not to be unreasonably withheld or delayed.
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(b)
|
In the case of a claim for which any DAEWOONG, indemnified party seeks indemnification under Section 16.2, DAEWOONG will permit STOCOSIL to direct and control the defense of the claim and will provide such reasonable assistance as is reasonably requested by STOCOSIL (at STOCOSIL’s cost) in the defense of the claim, provided that nothing in this Section 16.3 will permit STOCOSIL to make any admission on behalf of DAEWOONG, or to settle any claim or litigation which would impose any financial obligations on DAEWOONG without the prior written consent of DAEWOONG, such consent not to be unreasonably withheld or delayed.
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16.4.1
|
Except for a breach of Clause 11.1 (confidentiality) or for any claims of a third party which are subject to indemnification under this clause 18, neither STOCOSIL nor DAEWOONG, nor any of their respective affiliates or sublicensees will be liable to the other party to this agreement, its affiliates or any of their sublicensees for any indirect, incidental, consequential, special, reliance, exemplary or punitive damages or lost or imputed profits or royalties, lost data or cost of procurement of substitute goods or services, whether liability is asserted in contract, tort (including negligence and strict product liability), indemnity or contribution, and irrespective of whether that party or any representative of that party has been advised of, or otherwise might have anticipated the possibility of, any such loss or damage.
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16.4.2
|
Neither Party limits or excludes its liability for fraud, fraudulent concealment or fraudulent misrepresentation, nor for death or personal injury arising from its negligence.
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16.5.1
|
For any Product related liability without either party’s negligence and/or fault (“Inherent Risk” of the Product and/or Optional Product) within the Territory, STOCOSIL shall be responsible for Loss and damages directly related to the Inherent Risk. As specified in Clause 20, STOCOSIL shall carry proper and appropriate insurance coverage in the Territory.
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16.5.2
|
For any Product related liability without either party’s negligence and/or fault (“Inherent Risk” of the Product and/or Optional Product) outside of the Territory, DAEWOONG shall be responsible for Loss and damages directly related to the Inherent Risk. As specified in Clause 20, DAEWOONG shall carry proper and appropriate insurance coverage outside of the Territory.
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17.1
|
STOCOSIL may terminate this Agreement with sixty (60) Business Days notice in relation to the Product and/or Optional Product in a specific country if STOCOSIL reasonably determines, using the same standards it would use in assessing whether or not to continue Development, Manufacture or Commercialization of a Product of its own making, that the patient, medical/scientific, technical, Intellectual Property, regulatory or commercial profile of the Product does not justify continued Development, Manufacture or Commercialization of that Product in or for such country. For the avoidance of doubt, termination shall be on a country-by-country basis and product-by-product basis.
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17.2
|
Either party may terminate this Agreement with sixty (60) days’ notice if the other Party commits a material breach (excluding non-payment), unless the breach is cured within the sixty (60) day notice period; provided, that with respect to non-payment breaches the notice and cure period shall be reduced to thirty (30) days; and provided further, that the sixty (60) day cure period may be extended if the existence of a material breach is the subject of an arbitration request (independent third party/mediator).
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17.3
|
Either Party may terminate this Agreement if, at any time,
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(a)
|
if the other Party becomes insolvent or if proceedings are instituted against the other Party for re-organization or other relief under bankruptcy law, or if any substantial part of the other Party’s assets come under the jurisdiction of a receiver or trustee in an insolvency proceeding authorized by law;
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(b)
|
by either Party upon written notice if proceedings are instituted against any of the Party for reorganization or other relief under any bankruptcy law;
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(c)
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by either Party in the event of a force majeure in accordance with Clause 21.5 below.
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18.1
|
If STOCOSIL terminates in accordance with Clause 17.1, 17.2 and/or 17.3, DAEWOONG shall, no later than ten (10) Business Days after STOCOSIL’s request but at DAEWOONG’s cost if there is default on the part of DAEWOONG:
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(a)
|
In case of such termination DAEWOONG shall pay all non-cancellable expenses reasonably incurred by STOCOSIL, including costs STOCOSIL incurred in giving effect to such termination and costs of terminating any commitments entered into under the Agreement. Additionally, DAEWOONG will ensure the return or delivery to STOCOSIL (or its nominee) or destruction by DAEWOONG at STOCOSIL’s option of all copies of STOCOSIL’s Confidential Information, STOCOSIL Background, IP, STOCOSIL Arising IP, and STOCOSIL Know-How and Regulatory Documentation and Regulatory Dossiers (together with all the copies, abstracts or summaries thereof, any excess substances or trial batches of the Product produced by DAEWOONG and any quantities of Material, samples or consumables, including Materials purchased in furtherance of DAEWOONG’s obligations under this Agreement, remaining in DAEWOONG’s possession). DAEWOONG agrees that this obligation is not conditioned upon STOCOSIL’s prior payment of amounts due or agreement to pay any amounts in dispute;
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(b)
|
Discontinue Development and Manufacture, of the Product; and
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(c)
|
Deliver to STOCOSIL or to such other parties as STOCOSIL may designate any remaining deliverables (i.e. data, information, etc.) that may then be in possession or custody of DAEWOONG or dispose of them in such manner as STOCOSIL may specify;
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18.2
|
If STOCOSIL terminates this Agreement in accordance with Clause 17.1, 17.2 and/or 17.3, all rights and licenses granted by STOCOSIL to DAEWOONG hereunder shall immediately terminate and DAEWOONG shall have no right to any continued use of the STOCOSIL Background IP, STOCOSIL Arising IP, STOCOSIL’s Confidential Information and STOCOSIL’s Know-How.
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18.3
|
Notwithstanding the above, should DAEWOONG exercise its Step-In Rights in accordance with Clause 4.5 and/or Clause 6.3, STOCOSIL shall as reasonably practicable transfer all data and information in STOCOSIL’s control relating to a Product to (i) ensure that any ongoing Development or Commercialization continues with minimal disruption and to the extent any materials are not transferable, STOCOSIL shall use Commercially Reasonable Efforts to make such materials available to DAEWOONG and to practice any licence granted under 2.2.2.
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18.4
|
If DAEWOONG terminates in accordance with Clause 17.2 or 17.3, STOCOSIL shall, no later than ten (10) Business Days after DAEWOONG’s request but at STOCOSIL’s cost if there is default on the part of STOCOSIL:
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(a)
|
Ensure the return or delivery to DAEWOONG (or its nominee) or destruction by STOCOSIL at DAEWOONG’s option of all copies of DAEWOONG’s Confidential Information, and DAEWOONG Background IP, and DAEWOONG Know-How (together with all the copies, abstracts or summaries thereof, any excess substances or trial batches of the Product produced by DAEWOONG and any quantities of Material, samples or consumables, including Materials purchased in furtherance of DAEWOONG’s obligations under this Agreement, remaining in STOCOSIL’s possession). STOCOSIL agrees that this obligation is not conditioned upon DAEWOONG’s prior payment of amounts due or agreement to pay any amounts in dispute;
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18.5
|
In case of such termination STOCOSIL shall pay all non-cancellable expenses reasonably incurred by DAEWOONG, including costs DAEWOONG incurred in giving effect to such termination and costs of terminating any commitments entered into under the Agreement. Such final sum shall not exceed the price payable by STOCOSIL in accordance with the terminated service. If upon the effective date of termination, STOCOSIL has advanced funds which are unearned by DAEWOONG, DAEWOONG shall repay such funds to STOCOSIL within thirty (30) days of the effective date of termination.
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18.6
|
Furthermore, the Parties agree to provide each other with reasonable support with respect to any investigation required by any Regulatory Authority with respect to Development , Manufacture and Commercialization of the Product carried out prior to such termination and after such termination provided that the reasonable costs of the assisting party in providing such assistance shall be at the other Party’s cost.
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18.7
|
Termination shall not affect or prejudice any right to damages or other remedy which either party may have in respect of the event giving rise to the termination or any other right to damages or other remedy which either party may have in respect of any breach of this Agreement which existed at or before the date of termination.
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20.1
|
Each Party shall maintain at its own cost full and sufficient third party, public and product liability, and product recall insurance, to cover its actual and potential liabilities hereunder in the respective Territory (STOCOSIL shall cover the Territory, and DAEWOONG will cover the outside of the Territory) and shall provide to the other a certificate of such insurance (or equivalent) upon request.
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20.2
|
Each Party shall maintain the insurances referred to in Clause 20.1 above throughout the Term of this Agreement and thereafter for such period as shall be equal to the longest shelf life of all or any of the Products (provided always that such insurances will respond to claims made at any time before the end of the period of five (5) years after termination of this Agreement).
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20.3
|
Further, DAEWOONG will maintain a proper property & casualty insurance for its manufacturing sites.
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21.1
|
Governing Law and Alternative Dispute Resolution
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21.1.1
|
This Agreement and any non-contractual obligations arising out of or in connection with it shall be governed by the law of Singapore.
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21.1.2
|
Any dispute, claim, difference or controversy arising out of, relating to or having any connection with this Agreement, including any dispute as to its existence, validity, interpretation, performance, breach or termination or the consequences of its nullity and any dispute relating to any non-contractual obligations arising out of or in connection with it (for the purpose of this Clause 21, a Dispute), shall be referred to and finally resolved by arbitration under International Chamber of Commerce (ICC) (for the purpose of this clause, the Rules), which Rules are incorporated by reference into this clause. The number of arbitrators shall be three. The language of the arbitration shall be English. The seat, or legal place of arbitration, shall be Singapore. Nothing contained in this Clause 21 shall limit the right of any party to seek from any court of competent jurisdiction, pending appointment of an arbitral tribunal, interim relief in aid of arbitration or to protect or enforce its rights under this agreement.
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21.8.1
|
Any notice or other communication to be given under this agreement must be in writing (which excludes fax, email and any other form of electronic communication) and must be delivered or sent by post to the party to whom it is to be given as follows:
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(a)
|
to DAEWOONG at:
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(b)
|
to STOCOSIL at:
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21.8.2
|
Any notice or other communication shall be deemed to have been given:
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21.8.3
|
In proving the the giving of a notice or other communication, it shall be sufficient to prove that delivery was made or that the envelope containing the communication was properly addressed and posted by prepaid recorded delivery post or by prepaid airmail or that the fax was properly addressed and transmitted, as the case may be.
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21.8.4
|
This Clause 21 shall not apply in relation to the service of any claim form, notice, order, judgment or other document relating to or in connection with any proceedings, suit or action arising out of or in connection with this agreement.
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STOCOSIL, Inc.
_____________________________________
Signed
Name:
Position
Date:
AUTOTELIC, LLC
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DAEWOONG Pharmaceuticals Co. Ltd
_____________________________________
Signed
Name: Jongwook Lee
Position: CEO, President
Date:
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(1)Parties
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(i)DAEWOONG (or an appropriate Affiliate)
(ii)STOCOSIL (or an appropriate Affiliate)
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(2)Scope
|
Terms and conditions applicable to the Manufacture and supply by DAEWOONG to STOCOSIL of the Product for:
(i)Commercialization by STOCOSIL as Product or pharmaceutical product of the Optional Product in any country in the Territory
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(3)Exclusivity and exceptions
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(i)Subject to (3)(ii) below, STOCOSIL shall purchase all the Product for Commercialization in the Territory from DAEWOONG.
(ii)STOCOSIL shall no longer be required to purchase all of its requirements of Product from DAEWOONG and shall be entitled to Manufacture (or have Manufactured by a Third Party) the Product if, even though both Parties diligently pursue in good faith the remedy, :
(a)DAEWOONG is unable to Manufacture and supply sufficient quantities of the Product to satisfy STOCOSIL’s demand for that Product; or
(iii)DAEWOONG fails to remediate any quality issues identified by STOCOSIL,in accordance with Product Specifications, in respect of the manufacturing site(s) or the Products. In the event that STOCOSIL does Manufacture (or have Manufactured by a Third Party) any Product in accordance with the terms of the MSA, DAEWOONG shall provide (at its own cost, subject to (3)(v) below, and at STOCOSIL’s request):
(a)reasonable assistance to STOCOSIL in sourcing high quality API and all other Materials at a competitive price;
such technical transfer assistance (including the granting a fully-paid up, perpetual, royalty-free license, if required, on a non-exclusive basis,and disclosure of all relevant IP and Know-How under suitable conditions of confidentiality) as STOCOSIL or its Third Party contract manufacturer may reasonably require to enable them to manufacture the Product.
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(3)Exclusivity and exceptions (continued)
|
(iv)In the event that (3)(ii)(b) applies, the Parties shall discuss in good faith the extent (if any) to which DAEWOONG may continue to supply the affected Product taking into account all relevant circumstances (including the economic consequences to STOCOSIL of sourcing from a Third Party only the surplus volumes that DAEWOONG is unable to supply rather than sourcing all of its requirements for the affected Product from that Third Party), whether or not any such continued supply shall be under the MSA or another agreement and any appropriate amendments that may be required to be made to the MSA.
(v)In relation to any technical transfer assistance provided by DAEWOONG pursuant to (3)(iii) above, STOCOSIL (or its Third Party contract manufacturer) shall be responsible for the costs of the API, excipients and tooling required to Manufacture the relevant Product (including any such API and excipients required to Manufacture validation batches of such Product). Without limiting the generality of (3)(iii) above, DAEWOONG shall be responsible for all costs and expenses related to the involvement of its employees or consultants in the technical transfer process (including any travel and accommodation expenses incurred by such employees or consultants).
(vi)If STOCOSIL wishes to use an alternative source of supply for the Product in circumstances contemplated by (3)(ii) above, STOCOSIL shall be entitled to use DAEWOONG’s Regulatory Dossier in support of any regulatory submission that STOCOSIL may be required to make in relation thereto.
(vii)STOCOSIL may continue to order Product from DAEWOONG, and DAEWOONG shall continue to supply STOCOSIL with Product pursuant to the MSA until such time as STOCOSIL notifies DAEWOONG in writing that alternative source has been validated and all necessary Regulatory Approvals are in place to allow STOCOSIL (or its nominated Third Party manufacturer) to Manufacture the relevant Product.
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(4)Sourcing and storage of Materials
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(i)DAEWOONG shall be responsible for sourcing all API and other Materials required for the Manufacture of Products under the MSA. STOCOSIL (and not DAEWOONG) shall be responsible for sourcing API and Materials for the Manufacture of any Products by or on behalf of STOCOSIL pursuant to (3)(ii) above.
(ii)In the event that STOCOSIL supplies API or other Materials to DAEWOONG (or its permitted Third Party sub-contractor) for use in the Manufacture of Products on a tolling basis:
(a)those API and/or Materials shall be deemed to have zero cost to DAEWOONG for the purposes of calculating the Supply Price payable by STOCOSIL; but
(b)for the purposes of (3)(ii)(a) and (3)(ii)(b) above, the Supply Price shall be deemed to be the sum of (a) the Supply Price payable by STOCOSIL and (b) the costs and expenses incurred by STOCOSIL in sourcing the relevant API and/or Materials and in providing such API and/or Materials to DAEWOONG on a tolling basis.
(iii)The Party that is not responsible for sourcing the API and other Materials shall provide reasonable assistance to the other Party in sourcing high quality API and other Materials at a competitive price.
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(5)Inspection and analysis of Materials
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(i)DAEWOONG shall upon receipt of all Raw Materials or API (defined here as Materials), conduct such inspections and analysis of API and other Materials as may be specified in the Quality Agreement or required by cGMP, any Manufacturing Licence, any relevant Marketing Authorisation and/or Applicable Law.
(ii)DAEWOONG shall conduct the required inspection and analysis irrespective of whether the API or other Materials are sourced by DAEWOONG or by STOCOSIL.
(iii)In the event that any delivery of Materials is defective, DAEWOONG shall reject that delivery and promptly notify STOCOSIL (and, if DAEWOONG is responsible for sourcing the relevant Materials, the relevant supplier). The Party responsible for sourcing the relevant Materials shall procure that the supplier promptly provides additional Materials in substitution for the defective Materials.
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(6)Manufacture
|
(i)Subject to (6)(ii), DAEWOONG shall Manufacture the Product in accordance with cGMP, the Quality Agreement, the Manufacturing Licence, the relevant Marketing Authorisation, the applicable specifications for that Product and Applicable Law (including the Applicable Law of the country in which the Product is to be Commercialized by STOCOSIL).
(ii)DAEWOONG will perform primary, secondary packaging or leafleting in relation to the Product in accordance with the Marketing Authorisation . All such steps in the relation to the Product to be Commercialized by STOCOSIL shall be performed by (or on behalf of) DAEWOONG and shall be at DAEWOONG’s responsibility and costs. Such costs will be part of COGS by DAEWOONG.
(iii)DAEWOONG shall Manufacture (or have Manufactured) the Product only at its own manufacturing sites.
(iv)DAEWOONG shall (at its cost) obtain and maintain all Manufacturing Licences required to allow it to Manufacture Products in accordance with the MSA.
(v)The MSA will specify the agreed lead time, minimum order quantity (“MOQ”) and incremental order quantity (“IOQ”) for each Product. MOQ shall be one batch size. Where a Product is subsequently added to the scope of the MSA, the Parties shall agree such amendments to the MSA as may be necessary to document the lead time, MOQ and IOQ applicable to the Product.
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(7)Forecasts and orders
|
(i)To be furnished in Schedule 2. DAEWOONG shall deliver Product pursuant to STOCOSIL’s written purchase orders (“Firm Orer”) which have been confirmed in writing by DAEWOONG
(ii)DAEWOONG shall confirm each Firm Order within five (5) business days, confirming the date for Delivery and quantities of Products. If any discussion is required in respect of a Firm Order, the Parties will seek to agree any necessary amendments within two (2) business days of DAEWOONG’s response to the Firm Order.
(iii)STOCOSIL shall submit a Purchase Order reflecting each confirmed Firm Order. Firm Orders shall be received by DAEWOONG at least 90 days before the requested date of delivery.
(iv)Each Firm Order for Product shall (unless otherwise agreed between the Parties) be for a quantity that is equal to either (a) the MOQ for that Product or (b) that MOQ together with a multiple of the IOQ for that Product.
(v)Without prejudice to (3)(ii)(d), DAEWOONG shall use its reasonable endeavours to ensure that it has at all times sufficient Manufacturing capacity at each Manufacturing Site to satisfy the Products requirements set out in the Forecast Schedule.
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(8)Samples and stability studies
|
(i)DAEWOONG shall retain samples of each batch of Materials and each batch of Product in accordance with the Quality Agreement and cGMP.
(ii)DAEWOONG shall be responsible for performing (at its own cost) such stability testing on the Product supplied to STOCOSIL pursuant to the MSA as may be required by the Quality Agreement, any relevant Marketing Authorisation, cGMP or as reasonably required by STOCOSIL. If DAEWOONG wishes to outsource the performance of stability testing to a Third Party, STOCOSIL must first approve the use of such Third Party (such approval not to be unreasonably withheld). In addition, the Parties shall discuss whether such work can be performed more effectively and efficiently by STOCOSIL or any Third Party performing primary or secondary packaging for STOCOSIL in relation to the Products. If the Parties agree that DAEWOONG shall outsource stability testing to a Third Party, DAEWOONG shall remain primarily liable to STOCOSIL for the performance of such work and shall remain responsible for the costs of that work. Such costs will be part of DAEWOONG’s COGS.
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(9)Storage and Delivery of Products
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(i)DAEWOONG shall store Materials (and, pending Delivery. Products) in accordance with cGMP and the Quality Agreement.
(ii)Product shall be delivered on FOB Incheon Airport.
(iii)Each Delivery of the Product shall be accompanied by a corresponding Certificate of Analysis and any other documentation specified in the Quality Agreement.
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(10)Shelf life
|
Unless otherwise agreed between the Parties, each Product Manufactured by (or on behalf of) DAEWOONG pursuant to the MSA shall upon Delivery:
(i)if the registered shelf life of such product is more than two (2) years, have at least eithty per cent. (80%) of that registered shelf life remaining; and
(ii)if the registered shelf life of such product is two (2) years or less, have at least eighty five per cent. (85%) of that registered shelf life remaining.
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(11)Inspection and analysis of Products
|
(i)STOCOSIL shall upon receipt conduct such inspections and analysis of Product as may be specified in the Quality Agreement to determine whether the Product complies with the relevant specification.
(ii)If STOCOSIL considers that any of the Product is defective, it will notify DAEWOONG and the Parties will endeavour to agree whether or not that Product is defective. Any payment obligations in respect of the allegedly defective Product will be suspended pending the resolution of this issue.
(iii)At STOCOSIL’s request, DAEWOONG will Manufacture and supply a replacement batch of Product as soon as practicable following notification of the alleged defect.
(iv)If the Parties are unable to agree whether Product is defective, the matter will be referred to an independent third party laboratory to determine whether the Product is conforming (acting as an expert, not as an arbitrator). Except in the case of fraud or manifest error on the part of such independent expert,the decision of such independent expert will be binding upon the Parties. If the independent expert decides that the Product was not defective, the cost of the independent expert will be borne by STOCOSIL. In all other circumstances, the costs of the independent expert will be borne by DAEWOONG.
(v)If Product is agreed (or found) to be defective, DAEWOONG shall dispose of that Product at its own cost and (if no replacement batch has already been provided as contemplated by (11)(iii) above) promptly Manufacture and supply replacement Product as soon as possible but in any event no later than 30 days.
(vi)If Product is agreed (or found) not to be defective, STOCOSIL shall pay for that Product in accordance with the MSA.
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(12)Price
|
(i)Subject to (12)(ii) below, the Supply Price charged by DAEWOONG for the Manufacture and supply of the Product for the Development shall be DAEWOONG’s actual cost of Manufacture (actual COGS of DAEWOONG, which is defined in the PRODUCT DEVELOPMENT, LICENCE AND COMMERCIALIZATION AGREEMENT. Subject to (12)(ii) below, the Supply Price charged by DAEWOONG for the Manufacture and supply of the Product for the Commercial Sales in the Territory shall be DAEWOONG’s actual cost of Manufacture (actual COGS of DAEWOONG, which is defined in the PRODUCT DEVELOPMENT, LICENCE AND COMMERCIALIZATION AGREEMENT plus 50%. For the avoidance of doubt, the Manufacture of a Product shall include stability testing unless the Parties agree that STOCOSIL shall perform (or have performed) such stability tests as contemplated in (8)(ii) above.
(ii)The Supply Price applicable for the Product shall be reviewed by both Parties during the 1st Calendar Quarter of every Calendar Year. Both Parties reveiw the market price of each API for the Product and calculate the average price of 3 suppliers registered in the US-DMF for each API. That average price shall become effective on the last day of the 1st Calendar Quarter of every Calendar Year and shall be applied to calculate a new COGS after such date.
(iii)Notwithstanding (12)(ii) above, DAEWOONG shall keep STOCOSIL promptly informed of any variation in the actual Supply Price (including reductions achieved by means of the Continuous Improvement programme and fluctuations caused by variations in the cost of Materials, labour, overheads or other inputs to the Manufacturing process).
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(13)Title and risk
|
(i)Title to and risk in Product shall pass to STOCOSIL upon Delivery on FOB Incheon Airport.
(ii)To the extent any Materials are supplied to DAEWOONG by STOCOSIL, DAEWOONG shall store such Materials in accordance with instruction for such Materials at no cost to STOCOSIL, DAEWOONG shall only use the Materials to manufacture Product for STOCOSIL, title to those Materials shall remain with STOCOSIL at all times, but DAEWOONG shall bear all risk of loss in those Materials for so long as those Materials (or Products containing those Materials) are in DAEWOONG’s possession or control. DAEWOONG will maintain insurance to provide appropriate coverage of Materials against theft or damage.
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(14)Continuous Improvement
|
The MSA shall include provisions dealing with the establishment and implementation of a continuous improvement programme intended to reduce the costs of Manufacture and/or improve the efficiency, environmental impact and quality of the Manufacturing process. The MSA shall include provisions allocating between the Parties the benefit of any costs savings achieved by means of this continuous improvement programme and determining the ownership of any IP or Know-How created or reduced to practice in the course of that programme.
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(15)Marketing Authorizations
|
STOCOSIL shall be responsible for obtaining and maintaining any Marketing Authorization required to allow it to Commercialize Product supplied pursuant to the MSA. DAEWOONG shall provide STOCOSIL with such reasonable assistance as it may require in connection with obtaining or maintaining such Marketing Authorizations.
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(16)Premises and insurance
|
DAEWOONG shall maintain appropriate insurance for its manufacturing site(s).
|
(17)Know-How, IP and Technical Assistance
|
(i)STOCOSIL shall grant DAEWOONG such licences of its IP and Know-How as DAEWOONG may require to Manufacture the Product.
(ii)DAEWOONG shall grant STOCOSIL such licences of its IP and Know-How as STOCOSIL may require to Commercialize the Product in the Territory.
|
(18)Regulatory, compliance and environmental
|
(i)DAEWOONG shall co-operate with Regulatory Authorities and provide any information and documentation that a Regulatory Authority may require. STOCOSIL will be the primary interface with all regulatory authorities in the Territory and DAEWOONG will immediately inform STOCOSIL if it is contacted by a regulatory authority within the Territory with regard to any submission to a Regulatory Authority and in relation to any anticipated inspection by a Regulatory Authority of a manufacturing site.
(ii)In the event of any inspection by regulatory authorities inside the Territory (including cGMP inspections), STOCOSIL will provide reasonable assistance to DAEWOONG in preparing for such inspections. Notwithstanding this, DAEWOONG shall be responsible for ensuring that its Manufacturing Sites meet all applicable cGMP standards, Production Standards, and the requirements of the MSA (including the Quality Agreement).
(iii)DAEWOONG shall be responsible for preparing and submitting the Regulatory Dossiers to STOCOSIL for the Product as a CMO for inclusion into any Product Registration of STOCOSIL. DAEWOONG shall provide all submissions to regulatory authorities including (whether or not submitted) CTD files, data and documentation from clinical studies and CMC documentation, relating to the Product, as well as all correspondence with regulatory authorities (such as registration and licenses, regulatory drug lists, regulatory dossier, advertising and promotion documents), adverse event files, complaint files, manufacturing records and inspection reports as well as all relating intellectual property rights protecting the same and any invention embodied in such documentation ("Regulatory Documentation") to STOCOSIL for its use for seeking Product Registration of the the Product in any country in the Territory. DAEWOONG hereby grants a perpetual, irrevocable, fully paid up right on a non-exclusive basis to reference to any data contained in all Regulatory Documentation, Product Registrations, post marketing studies, regulatory dossiers and any other data with respect to the Product, for use in STOCOSIL's Product Registration in any country in the Territory.
(iv)DAEWOONG shall be responsible for all waste disposal, and all costs related thereto, connected with the Manufacture of the Product and for compliance with Applicable Law in relation to such disposal.
|
(19)Quality assurance and pharmacovilgilane
|
(i)The Parties agree to enter into a quality agreement within 90 days of the Effective Date which sets forth (a) the roles and responsibilities of the Parties with respect to cGMP and other quality regulations for the Product as required under Applicable Laws, and (b) how the Parties shall interact with each other in connection with the same (the "Quality Agreement"). In the event a conflict arises between any term in this Agreement and a term in the Quality Agreement, the term contained in this Agreement shall prevail.
(ii)The Parties agree to enter into a global pharmacovilgilance agreement, within 120 days of the Effective Date, which sets forth the global safety data exchange procedures to be followed by th Parties for the collection, investigation, reporting, and exchange of information concerning adverse events.
(iii)DAEWOONG shall comply with the Quality Agreement and shall institute and maintain appropriate process controls for the Manufacture of the Product and shall maintain suitable records of such controls which shall be made available to STOCOSIL on request.
(iv)DAEWOONG shall (at STOCOSIL’s request and cost) supply such samples of the Product or Materials as STOCOSIL may reasonably require.
(v)DAEWOONG shall promptly report any adverse trends that arise during the normal or stability testing of any of the Product, provided that DAEWOONG shall not be responsible for doing so if STOCOSIL or STOCOSIL’s Third Party contract manufacturer undertake responsibility for stability testing as contemplated in 8(ii).
(vi)DAEWOONG shall appoint a Senior Quality Manager who shall be responsible for signing each Batch Record and Certificate of Analysis and for the release of the Product.
|
(20)Access to premises and audits
|
(i)STOCOSIL shall be permitted to enter DAEWOONG’s manufacturing site(s) to conduct technical, cGMP and/or environmental inspections and audits on an annual basis (or more frequently for cause).
(ii)DAEWOONG shall ensure that any permitted sub-contractor also allows STOCOSIL to conduct such audits and inspections of any manufacturing site operated by such sub-contractor.
|
(21)Customer complaints and recalls
|
(i)DAEWOONG will maintain complete and accurate records with respect to the Products, including without limitation, the manufacturing and adequate despatch and analytical records to allow quality and destination of Products to be assessed in the event of a complaint. STOCOSIL will be permitted to access these records as necessary.
(ii)DAEWOONG will notify STOCOSIL of any quality issue or complaint it becomes aware of and will investigate any such issue at STOCOSIL’s request but at DAEWOONG’s own cost.
(iii)STOCOSIL will have control over any recall of Product and will devise the recall strategy in the Territory. DAEWOONG will assist in that strategy as needed. STOCOSIL shall (if lawful and practical to do so) give DAEWOONG prior written notice of any recall that STOCOSIL proposes to make of the Product outside of the Territory. The final decision of any recall of Product outside of the Territory will be DAEWOONG’s.
(iv)The costs of a Product recall will be borne by DAEWOONG if it results from DAEWOONG’s failure to comply with the MSA or DAEWOONG’s negligence. Otherwise, STOCOSIL will be bear the costs of recall.
|
(22)Warranties and indemnities
|
(i)DAEWOONG will warrant (a) compliance as regards Products, processes and waste disposal with Specifications, Quality Agreement, Manufacturing Licence, Marketing Authorisations, GMP and Applicable Laws (including environmental laws), (b) conveyance of good title to Products, (c) that it holds all necessary consents and licences, (d) that there is no active or pending litigation or investigation involving DAEWOONG.
(ii)DAEWOONG will indemnify STOCOSIL against loss and damage caused by (a) breach of DAEWOONG’s warranties, (b) third party death or personal injury arising from a failure to Manufacture a Product in accordance with the MSA, (c) gross negligence or wilful misconduct by DAEWOONG or its employees and (d) costs of Product recalls that DAEWOONG is responsible for under (21) above, in each case unless caused by the gross negligence or wilful misconduct of STOCOSIL or its employees.
(iii)STOCOSIL will indemnify DAEWOONG against loss and damage caused by (a) third party death or personal injury arising from a Product that was fully compliant with the MSA upon delivery, (b) gross negligence or wilful misconduct by STOCOSIL or its employees and (c) costs of Product recalls that STOCOSIL is responsible for under (21) above, in each case unless caused by the gross negligence or wilful misconduct of DAEWOONG or its employees.
|
(23)Ethical standards and human rights
|
The MSA will contain warranties and undertakings in the standard form required by STOCOSIL of all suppliers in relation to ethical standards, human rights and anti-bribery and corruption procedures.
|
(24)Documentation and reports
|
(i)DAEWOONG shall prepare and retain complete and systematic documentation relating to the Manufacture of Products (including Batch Records, Certificates of Analysis, quality records and any reports that the Parties agree DAEWOONG should prepare).
(ii)DAEWOONG will retain such documentation in accordance to applicable law (which shall not be less than three (3) years) and shall allow STOCOSIL to view and copy such records on reasonable notice during the term of this MSA and three (3) years after termination.
|
(25)Labelling and Artwork
|
To the extent relevant, DAEWOONG shall Manufacture each Product using such labelling and artwork as STOCOSIL may specify. The MSA shall include change control provisions covering any proposed alteration of the labelling and artwork required to be affixed to (or embossed on) any of the Product.
|
(26)Term
|
The term of the MSA shall be the same as the PRODUCT DEVELOPMENT, LICENCE AND COMMERCIALIZATION AGREEMENT.
|
(27)Expiry and termination
|
(i)The MSA shall expire at the end of the term unless renewed or terminated earlier in accordance with the MSA.
(ii)The MSA shall contain provision for STOCOSIL to terminate if (a) STOCOSIL ceases to Commercialize the Products, (b) STOCOSIL elects to move Manufacture of Products to a third party where permitted to do so, (c) DAEWOONG is in uncured material or persistent breach of the MSA, (d) DAEWOONG becomes insolvent, (e) DAEWOONG undergoes a change of control or (f) new or unknown impurities are found in Products. Termination for reasons (a), (b) and (f) shall occur on a Product-by-Product basis. Termination for reasons (c), (d) and (e) shall affect the MSA as a whole.
(iii)The MSA shall contain provision for DAEWOONG to terminate if the MSA as a whole if (a) STOCOSIL is in uncured material or persistent breach of the MSA, (b) STOCOSIL becomes insolventSTOCOSIL.
|
(28)Consequences of expiry or termination
|
(i)Certain provisions – e.g. those relating to retention of samples and documentation for a specified number of years, confidentiality and providing assistance in the event of a regulatory investigation – will survive expiry or termination.
(ii)DAEWOONG shall provide technical transfer assistance (and licences of Know-How and IP) as contemplated in (3)(iii) above to permit STOCOSIL, its Affiliates or its nominated Third Parties to Manufacture Products.
(iii)Accrued rights and obligations will survive termination.
|
(29)Confidentiality
|
The MSA shall include customary provisions protecting the confidentiality of any confidential information (including Know-How) that may be disclosed by one Party to the other Party. The provisions shall include customary restrictions on the use and disclosure by a Party of the other Party’s confidential information, subject to the usual exceptions and DAEWOONG’s obligations to license Know-How in circumstances contemplated by (3)(iii) and (29).
|
(30)Assignment and sub-contracting
|
(i)STOCOSIL shall be permitted to assign or otherwise transfer, or to sub-contract, any of its rights and obligations to any Affiliate or a successor in title to the business in relation to one or more of the Products and DAEWOONG shall enter into a novation agreement upon request to give effect to any such transfer.
(ii)Save as permitted by (31)(i), STOCOSIL shall not be permitted to assign or otherwise transfer any of its rights or obligations under the MSA without DAEWOONG’s prior written consent (not to be unreasonably withheld).
(iii)DAEWOONG shall not be permitted to assign or otherwise transfer any of its rights or obligations under the MSA without STOCOSIL’s prior written consent (not to be unreasonably withheld by STOCOSIL).
(iv)DAEWOONG shall not be permitted to sub-contract the performance of any of its obligations under the MSA (including the Manufacture of any Product) without STOCOSIL’s prior written consent (not to be unreasonably withheld).
|
(31)Force Majeure
|
The MSA shall contain customary provisions excusing non-performance by a Party of its obligations to the extent caused by force majeure. The MSA shall also permit a Party to terminate the MSA if the other Party is prevented by force majeure from performing its obligations for an extended period.
|
(32)Governing Law
|
Law of Singapore.
|
(33)Jurisdiction
|
(i)Subject to (34)(ii) and (34)(iii), the Singaperean courts shall have exclusive jurisdiction.
(ii)Subject to (34)(iii), if any dispute arising under the MSA is connected with a dispute arising under the PDLCA, the dispute under the MSA shall be referred to arbitration in accordance with the dispute resolution provisions of the PDLCA.
(iii)Disputes covered by (11) above shall be determined as provided in (11) above.
|
(34)Other customary terms
|
The MSA will include customary terms regarding such matters as (i) waiver, (ii) notices, (iii) entire agreement, (iv) relationship of the Parties, (v) severability, (vi) amendment, (vii) counterparts and (viii) any other relevant matters not covered in this term sheet.
|
(35)Schedules
|
The MSA will have scheduled to it:
(i)a Quality Agreement signed by DAEWOONG (or an appropriate Affiliate) and STOCOSIL (or an appropriate Affiliate);
(ii)the Specification(s) for each Product;
(iii)details of the lead time, MOQ and IOQ for each Product;
(iv)records retention requirements (to the extent not covered by the Quality Agreement);
(v)key performance indicators (if applicable and agreed);
(vi)EHS guidelines; and
(vii)STOCOSIL’s ABAC requirements.
|
(36)Adjustments
|
The Parties acknowledge that certain terms of the MSA contemplated above may need to be adjusted to reflect the nature or characteristics of the Product. If either Party reasonably considers that, in respect of the Product, the terms of the MSA require such adjustment, the Parties shall discuss the matter in good faith (each acting reasonably).
|
Year 1
|
Year 2
|
Year 3
|
Year 4
|
Year 5
|
Year 6
|
Year 7
|
Year 8
|
Year 9
|
Year 10
|
0.5 M
|
1.0 M
|
2.5 M
|
3.35 M
|
4.35 M
|
4.35 M
|
4.35 M
|
4.35 M
|
4.35 M
|
4.35 M
|
|
it gives 1.38B * 0.06 * 0.22 * 0.5 * 0.04 = 0.35M targeting population in US and Japan
|
|
A.
|
Company is in the business of commercializing certain candidate drugs and associated medical devices for monitoring drug levels in patients (collectively, “Products”).
|
|
B.
|
Autotelic is an affiliate of Company, which is in the business of developing personalized Therapeutic Drug Monitoring (TDM) devices and provides “Services,” as defined below, to the Company.
|
|
C.
|
Company desires to engage Autotelic to provide certain services upon the terms and conditions set forth in this Agreement. Autotelic shall use its own personnel, furnishings, equipment and other assets to provide such Services upon the terms and conditions set forth in this Agreement.
|
|
D.
|
Company and Autotelic desire to enter into a written agreement to provide a full statement of their respective rights, duties and obligations with respect to the Services provided for hereunder.
|
|
(a)
|
Chemistry, Manufacturing and Controls services to define and document the nature of the drug substance and drug product, the manner in which both are made, and the manner in which the manufacturing process is controlled as such relate to the Products;
|
|
(b)
|
Regulatory planning, submission, and meeting with regulatory agencies globally to obtain regulatory guidance, concurrence, and approval for clinical trial, regulatory approval path way and ultimately marketing approval. Some examples of regulatory services include submission of new drug application, labeling and marketing to FDA or any drug administration agency worldwide related to the Products;
|
|
(c)
|
Nonclinical services to support the design, execution and submission of nonclinical studies to support IND/NDA approval. These include mechanism of action studies, PK/ADME, Pharmacology, Safety Pharmacology and Toxicology;
|
|
(d)
|
Clinical services to support the NDA. These include protocol design, submission, and approval as SPA. Interaction with KOLs and CROs to arrive at the appropriate protocol designs. The conduct and operation of the clinical trials including budget negotiation, site selection, site activation, data collection, data management, datalock, data cleaning, report writing, safety monitoring.
|
|
(e)
|
Human resources function for Company’s employees, including employee training, development & discipline, insurances, 401k, stock options, candidate search, section, hiring and termination;
|
|
(f)
|
Accounting, forecasting and finance functions to include vendor selection, purchasing, AP/AR, budgeting and financial projection, bookkeeping and auditing, fund raising through loan or stock sales;
|
|
(g)
|
corporate compliance functions to include all SEC filings, K and Q, M&A support and due diligence, legal document reviews including CDA, contracts, corporate docs, all relevant corporate document filings with relevant governmental agencies such as EDD, EIN, Federal, State, and Local Registration; prosecution and defense;
|
|
(h)
|
Business commercialization services including but not limited to generating leads, attending scientific/investor/partnering meetings, identification of potential partners, evaluation of potential drug candidates, term sheet negotiation, due diligence and licensing-in, licensing-out services;
|
|
(i)
|
IP services to include planning, drafting, submission of patent application, responses to government agencies, prosecution, and defense; and
|
|
(j)
|
Such other services as Company may request that Autotelic agrees to provide (which request and agreement shall be in writing).
|
|
i.
|
In the case of Autotelic’s personnel who provide Services to Company, to the product of (i) the “Average Percentage”, defined below, of such personnel multiplied by (ii) the actual gross payroll in the corresponding month of such personnel. The “Average Percentage” shall mean the total percentage, based on the employee daily working time sheet, of the personnel worked on each project divided by actual working days of each month. Upon request, Autotelic shall provide Company with weekly time sheet to substantiate percentage of services performed.
|
|
ii.
|
In the case of space used at Autotelic’s facilities, a pro-rata portion of all occupancy costs of each such facility, including, without limitation, rent, utilities, maintenance and taxes, pro-rated based upon the amount of space of such facility devoted solely to Company’s use compared to the total space of such facility. In the case of any facility owned by Autotelic, rent shall be imputed based on the fair market value of comparable space similarly located and comparably equipped, as agreed upon in writing by the parties.
|
|
iii.
|
In the case of expenses paid by Autotelic to third party contractors or material used in connection with the performance of the contracts, including but not limited to clinical trial, non-clinical trial, CMO, FDA regulatory process, CRO and CMC, Company shall pay Autotelic an amount equal to the actual invoice amount plus 20% mark up of providing the Services. Upon request, Autotelic shall provide Company with actual invoice received from the third party contractors or vendors.
|
|
iv.
|
In the case of acquiring other assets by Autotelic in providing the Services such as equipment, software or databases, Company shall pay Autotelic an amount equals to the actual invoice amount times “estimated usage percentage”, without additional mark up. The “estimated usage percentage” shall be determined, based on the annual projected usage percentage, estimated by the Autotelic’s project manager at the time of the acquisition, which shall be reviewed on an annual basis.
|
$25,000
|
Effective Date April 1, 2016
City of Industry, California
|
|
1.
|
Term of Warrant. Subject to the terms and conditions set forth herein, One Third (1/3) of the Warrant shall be exercisable on each anniversary date from the Effective Date of the Agreement for three year period and the Warrant shall be expired and voided eight (8) years after the Effective Date (the “Warrant Expiration Date”)of the Agreement.
|
|
a.
|
Exercise Price. This Common Stock Warrant shall be exercisable to purchase the Company’s common stock at an exercise price of $0.0008 per share for an aggregate purchase price of two hundred dollars ($200.00) for two hundred fifty thousand (250,000) shares of the Common Stock (“Founders Shares”) of the Company or five percent (5%) of the total Founders Shares already issued or to be issued by the Company. The Company represents and warrants that the Company is authorized to issue only five million (5,000,000) shares of the Founders Shares of the Company in total. However, the Company is not prohibited to issue additional shares for other purposes, including but not limited to convertible notes and private placement funding.
|
|
12.
|
Piggyback Registration Rights
|
|
13.
|
Miscellaneous.
|
|
a.
|
Issue Date. The provisions of this Warrant shall be construed and shall be given effect in all respect as if it had been issued and delivered by the Company on the date hereof. This Warrant shall be binding upon any successors or assigns of the Company. This Warrant shall constitute a contract under the laws of the State of California and for all purposes shall be construed in accordance with and governed by the laws of said state.
|
|
b.
|
Restrictions. The Holder hereof acknowledges that the Common Stock acquired upon the exercise of this Warrant may have restrictions upon its resale imposed by state and federal securities laws.
|
|
c.
|
Holding Period: Holder shall not transfer sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of this Warrant or any Warrants Shares hereunder for a period of one year from the Effective Date (the “Lock-Up Period”). In addition to the Lock-Up Period, in connection with any public registration by the Company of its securities, and upon request of the Company or any of its underwriters managing such offering of the Company’s securities, Holder (and any assignee) hereby agrees not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company (other than those included in the registration) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed 180 days (or such longer period if the Lock-Up Period has more than 180 days before its expiration) from the effective date of such registration as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the Company’s offering (the “Public Registration Lock-Up). Notwithstanding the foregoing, if during the last 17 days of such restricted period, the Company issues an earnings release or material news or a material event relating to the Company occurs, or prior to the expiration of the restricted period the Company announces that it will release earnings results during the 16-day period beginning on the last day of the restricted period, then, upon the request of the managing underwriter, to the extent required by any FINRA rules, the restrictions imposed by this subsection shall continue to apply until the end of the third trading day following the expiration of the 15-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. Notwithstanding anything to the contrary provided herein, the Public Registration Lock-Up shall only apply to the Warrant Shares if all officers and directors of the Company with respect to all shares of Common Stock owned beneficially and/or of record by all such persons are subject to substantially identical restrictions with respect to all shares of Common Stock owned beneficially and/or of record by such persons.
|
|
d.
|
Waivers and Amendments. Any term of this Warrant may be amended with the written consent of the Company and the Holder. Any amendment effected in accordance with this Section 13 shall be binding upon the Holder and the Company; provided, however, that such amendment must apply to all such Holders equally and ratably in accordance with the number of shares of Common Stock issuable upon exercise of their Common Stock Warrants. The Company shall promptly give notice to all Holders of Common Stock Warrants of any amendment effected in accordance with this Section 13.
|
|
e.
|
All notices and other communications provided for or permitted hereunder shall be made by hand-delivery, telecopier, or overnight air courier guaranteeing next day delivery at the address set forth on the signature page hereof to the Purchaser and with respect to the Corporation at its principal place of business. All such notices and communications shall be deemed to have been duly given at the time delivered by hand, if personally delivered; when receipt acknowledged, if telecopied; and the next business day after timely delivery to the courier, if sent by overnight air courier guaranteeing next day delivery. The parties may change the addresses to which notices are to be given by giving five days prior written notice of such change in accordance herewith.
|
STOCOSIL Inc.
_____________________________________
Signed
Name:
Position:
|
Tae Hun Kim
_____________________________________
Signed
Name: Tae Hun Kim
Address: _____________________________
|
|
a.
|
Exercise Price. The Exercise Price at which this Warrant may be exercised shall be $400 for five hundred thousand (500,000) shares of the Common Stock (“Founders Shares”) of the Company or ten percent (10%) of the total Founders Shares already issued or to be issued by the Company. The Company represents and warrants that the Company is authorized to issue only five million (5,000,000) shares of the Founders Shares of the Company in total.
|
|
12.
|
Registration Rights.
|
|
13.
|
Miscellaneous.
|
|
a.
|
Issue Date. The provisions of this Warrant shall be construed and shall be given effect in all respect as if it had been issued and delivered by the Company on the date hereof. This Warrant shall be binding upon any successors or assigns of the Company. This Warrant shall constitute a contract under the laws of the State of California and for all purposes shall be construed in accordance with and governed by the laws of said state.
|
|
b.
|
Restrictions. The Holder hereof acknowledges that the Common Stock acquired upon the exercise of this Warrant may have restrictions upon its resale imposed by state and federal securities laws.
|
|
c.
|
Holding Period: The Holder agrees that the Common Stock acquired upon the exercise of the Warrant may not be traded prior to 365 days after the effective date of the registration statement filed by the Company.
|
|
d.
|
Waivers and Amendments. Any term of this Warrant may be amended with the written consent of the Company and the Holder. Any amendment effected in accordance with this Section 13 shall be binding upon the Holder, any transferee thereof and the Company; provided, however, that such amendment must apply to all such Holders equally and ratably in accordance with the number of shares of Common Stock issuable upon exercise of their Common Stock Warrants. The Company shall promptly give notice to all Holders of Common Stock Warrants of any amendment effected in accordance with this Section 13.
|
|
12.
|
Registration Rights. The Company has granted Holder certain “piggyback” registration rights with respect to the Warrant Shares as set forth on Exhibit A attached hereto.
|
|
13.
|
Miscellaneous.
|
|
a.
|
Issue Date. The provisions of this Warrant shall be construed and shall be given effect in all respect as if it had been issued and delivered by the Company on the date hereof. This Warrant shall be binding upon any successors or assigns of the Company. This Warrant shall constitute a contract under the laws of the State of Delaware and for all purposes shall be construed in accordance with and governed by the laws of said state.
|
|
b.
|
Restrictions. The Holder hereof acknowledges that the Common Stock acquired upon the exercise of this Warrant may have restrictions upon its resale imposed by state and federal securities laws.
|
|
c.
|
Holding Period: Holder shall not transfer sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of this Warrant or any Warrants Shares hereunder for a period of one year from the Effective Date (the “Lock-Up Period”). In addition to the Lock-Up Period, in connection with any public registration by the Company of its securities, and upon request of the Company or any of its underwriters managing such offering of the Company’s securities, Holder (and any assignee) hereby agrees not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company (other than those included in the registration) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed 180 days (or such longer period if the Lock-Up Period has more than 180 days before its expiration) from the effective date of such registration as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the Company’s offering (the “Public Registration Lock-Up). Notwithstanding the foregoing, if during the last 17 days of such restricted period, the Company issues an earnings release or material news or a material event relating to the Company occurs, or prior to the expiration of the restricted period the Company announces that it will release earnings results during the 16-day period beginning on the last day of the restricted period, then, upon the request of the managing underwriter, to the extent required by any FINRA rules, the restrictions imposed by this subsection shall continue to apply until the end of the third trading day following the expiration of the 15-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. Notwithstanding anything to the contrary provided herein, the Public Registration Lock-Up shall only apply to the Warrant Shares if all officers and directors of the Company with respect to all shares of Common Stock owned beneficially and/or of record by all such persons are subject to substantially identical restrictions with respect to all shares of Common Stock owned beneficially and/or of record by such persons.
|
|
d.
|
Waivers and Amendments. Any term of this Warrant may be amended with the written consent of the Company and the Holder. Any amendment effected in accordance with this Section 13 shall be binding upon the Holder, any transferee thereof and the Company.
|
|
e.
|
All notices, requests, consents and other communications under this Warrant shall be in writing and shall be deemed to have been duly made when made in accordance with the notice provisions under the Product Development Agreement.
|
|
PURCHASER
|
:
|
AUTOTELIC, INC.
|
|
COMPANY
|
:
|
STOCOSIL, INC.
|
|
SECURITY
|
:
|
WARRANT AND COMMON STOCK ISSUED UPON EXERCISE OF WARRANT
|
|
AMOUNT
|
:
|
116,757 SHARES
|
|
DATE
|
:
|
June 18, 2015
|
|
12.
|
Registration Rights. The Company has granted Holder certain “piggyback” registration rights with respect to the Warrant Shares as set forth on Exhibit A attached hereto.
|
|
13.
|
Miscellaneous.
|
|
a.
|
Issue Date. The provisions of this Warrant shall be construed and shall be given effect in all respect as if it had been issued and delivered by the Company on the date hereof. This Warrant shall be binding upon any successors or assigns of the Company. This Warrant shall constitute a contract under the laws of the State of Delaware and for all purposes shall be construed in accordance with and governed by the laws of said state.
|
|
b.
|
Restrictions. The Holder hereof acknowledges that the Common Stock acquired upon the exercise of this Warrant may have restrictions upon its resale imposed by state and federal securities laws.
|
|
c.
|
Holding Period: Holder shall not transfer sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of this Warrant or any Warrants Shares hereunder for a period of one year from the Effective Date (the “Lock-Up Period”). In addition to the Lock-Up Period, in connection with any public registration by the Company of its securities, and upon request of the Company or any of its underwriters managing such offering of the Company’s securities, Holder (and any assignee) hereby agrees not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company (other than those included in the registration) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed 180 days (or such longer period if the Lock-Up Period has more than 180 days before its expiration) from the effective date of such registration as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the Company’s offering (the “Public Registration Lock-Up). Notwithstanding the foregoing, if during the last 17 days of such restricted period, the Company issues an earnings release or material news or a material event relating to the Company occurs, or prior to the expiration of the restricted period the Company announces that it will release earnings results during the 16-day period beginning on the last day of the restricted period, then, upon the request of the managing underwriter, to the extent required by any FINRA rules, the restrictions imposed by this subsection shall continue to apply until the end of the third trading day following the expiration of the 15-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. Notwithstanding anything to the contrary provided herein, the Public Registration Lock-Up shall only apply to the Warrant Shares if all officers and directors of the Company with respect to all shares of Common Stock owned beneficially and/or of record by all such persons are subject to substantially identical restrictions with respect to all shares of Common Stock owned beneficially and/or of record by such persons.
|
|
d.
|
Waivers and Amendments. Any term of this Warrant may be amended with the written consent of the Company and the Holder. Any amendment effected in accordance with this Section 13 shall be binding upon the Holder, any transferee thereof and the Company.
|
|
e.
|
All notices, requests, consents and other communications under this Warrant shall be in writing and shall be deemed to have been duly made when made in accordance with the notice provisions under the Product Development Agreement.
|
|
PURCHASER
|
:
|
AUTOTELIC, INC.
|
|
COMPANY
|
:
|
STOCOSIL, INC.
|
|
SECURITY
|
:
|
WARRANT AND COMMON STOCK ISSUED UPON EXERCISE OF WARRANT
|
|
AMOUNT
|
:
|
33,621 SHARES
|
|
DATE
|
:
|
August 31, 2015
|
|
12.
|
Registration Rights. The Company has granted Holder certain “piggyback” registration rights with respect to the Warrant Shares as set forth on Exhibit A attached hereto.
|
|
13.
|
Miscellaneous.
|
|
a.
|
Issue Date. The provisions of this Warrant shall be construed and shall be given effect in all respect as if it had been issued and delivered by the Company on the date hereof. This Warrant shall be binding upon any successors or assigns of the Company. This Warrant shall constitute a contract under the laws of the State of Delaware and for all purposes shall be construed in accordance with and governed by the laws of said state.
|
|
b.
|
Restrictions. The Holder hereof acknowledges that the Common Stock acquired upon the exercise of this Warrant may have restrictions upon its resale imposed by state and federal securities laws.
|
|
c.
|
Holding Period: Holder shall not transfer sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of this Warrant or any Warrants Shares hereunder for a period of one year from the Effective Date (the “Lock-Up Period”). In addition to the Lock-Up Period, in connection with any public registration by the Company of its securities, and upon request of the Company or any of its underwriters managing such offering of the Company’s securities, Holder (and any assignee) hereby agrees not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company (other than those included in the registration) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed 180 days (or such longer period if the Lock-Up Period has more than 180 days before its expiration) from the effective date of such registration as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the Company’s offering (the “Public Registration Lock-Up). Notwithstanding the foregoing, if during the last 17 days of such restricted period, the Company issues an earnings release or material news or a material event relating to the Company occurs, or prior to the expiration of the restricted period the Company announces that it will release earnings results during the 16-day period beginning on the last day of the restricted period, then, upon the request of the managing underwriter, to the extent required by any FINRA rules, the restrictions imposed by this subsection shall continue to apply until the end of the third trading day following the expiration of the 15-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. Notwithstanding anything to the contrary provided herein, the Public Registration Lock-Up shall only apply to the Warrant Shares if all officers and directors of the Company with respect to all shares of Common Stock owned beneficially and/or of record by all such persons are subject to substantially identical restrictions with respect to all shares of Common Stock owned beneficially and/or of record by such persons.
|
|
d.
|
Waivers and Amendments. Any term of this Warrant may be amended with the written consent of the Company and the Holder. Any amendment effected in accordance with this Section 13 shall be binding upon the Holder, any transferee thereof and the Company.
|
|
e.
|
All notices, requests, consents and other communications under this Warrant shall be in writing and shall be deemed to have been duly made when made in accordance with the notice provisions under the Product Development Agreement.
|
|
PURCHASER
|
:
|
AUTOTELIC, INC.
|
|
COMPANY
|
:
|
STOCOSIL, INC.
|
|
SECURITY
|
:
|
WARRANT AND COMMON STOCK ISSUED UPON EXERCISE OF WARRANT
|
|
AMOUNT
|
:
|
69,559 SHARES
|
|
DATE
|
:
|
October 31, 2015
|
|
12.
|
Registration Rights. The Company has granted Holder certain “piggyback” registration rights with respect to the Warrant Shares as set forth on Exhibit A attached hereto.
|
|
13.
|
Miscellaneous.
|
|
a.
|
Issue Date. The provisions of this Warrant shall be construed and shall be given effect in all respect as if it had been issued and delivered by the Company on the date hereof. This Warrant shall be binding upon any successors or assigns of the Company. This Warrant shall constitute a contract under the laws of the State of Delaware and for all purposes shall be construed in accordance with and governed by the laws of said state.
|
|
b.
|
Restrictions. The Holder hereof acknowledges that the Common Stock acquired upon the exercise of this Warrant may have restrictions upon its resale imposed by state and federal securities laws.
|
|
c.
|
Holding Period: Holder shall not transfer sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of this Warrant or any Warrants Shares hereunder for a period of one year from the Effective Date (the “Lock-Up Period”). In addition to the Lock-Up Period, in connection with any public registration by the Company of its securities, and upon request of the Company or any of its underwriters managing such offering of the Company’s securities, Holder (and any assignee) hereby agrees not to sell, make any short sale of, loan, grant any option for the purchase of, or otherwise dispose of any securities of the Company (other than those included in the registration) without the prior written consent of the Company or such underwriters, as the case may be, for such period of time (not to exceed 180 days (or such longer period if the Lock-Up Period has more than 180 days before its expiration) from the effective date of such registration as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the Company’s offering (the “Public Registration Lock-Up). Notwithstanding the foregoing, if during the last 17 days of such restricted period, the Company issues an earnings release or material news or a material event relating to the Company occurs, or prior to the expiration of the restricted period the Company announces that it will release earnings results during the 16-day period beginning on the last day of the restricted period, then, upon the request of the managing underwriter, to the extent required by any FINRA rules, the restrictions imposed by this subsection shall continue to apply until the end of the third trading day following the expiration of the 15-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. Notwithstanding anything to the contrary provided herein, the Public Registration Lock-Up shall only apply to the Warrant Shares if all officers and directors of the Company with respect to all shares of Common Stock owned beneficially and/or of record by all such persons are subject to substantially identical restrictions with respect to all shares of Common Stock owned beneficially and/or of record by such persons.
|
|
d.
|
Waivers and Amendments. Any term of this Warrant may be amended with the written consent of the Company and the Holder. Any amendment effected in accordance with this Section 13 shall be binding upon the Holder, any transferee thereof and the Company.
|
|
e.
|
All notices, requests, consents and other communications under this Warrant shall be in writing and shall be deemed to have been duly made when made in accordance with the notice provisions under the Product Development Agreement.
|
|
PURCHASER
|
:
|
AUTOTELIC, INC.
|
|
COMPANY
|
:
|
STOCOSIL, INC.
|
|
SECURITY
|
:
|
WARRANT AND COMMON STOCK ISSUED UPON EXERCISE OF WARRANT
|
|
AMOUNT
|
:
|
63,484 SHARES
|
|
DATE
|
:
|
January 31, 2016
|
STOCOSIL INC.
By:_____________________________________
Name: PYNG SOON
Title: CEO
INDEMNITEE
_______________________________________
(Signature)
_______________________________________
Print Name_______________________________________
_______________________________________
Address:
|
STOCOSIL INC.
By:____________________________________
Name: Vuong Trieu
Title: President
INDEMNITEE
_______________________________________
(Signature) _______________________________________
Print Name
_______________________________________
_______________________________________
Address:
|
STOCOSIL INC.
By:
Name: Pyng Soon
Title: CEO
INDEMNITEE
_______________________________________
(Signature)
_______________________________________
Print Name
_______________________________________
_______________________________________
Address:
|
STOCOSIL INC.
By:____________________________________
Name: Pyng Soon
Title: CEO
INDEMNITEE
_______________________________________
(Signature)
_______________________________________
Print Name
_______________________________________
_______________________________________
Address: |
1
|
DEFINITIONS
|
|
1.1
|
“Action” shall have the meaning set forth in Section 7.2 of this Agreement.
|
|
1.2
|
“ACH” means Automated Clearing House.
|
|
1.3
|
“Affiliate” means any person that is directly or indirectly, through one or more intermediaries, Controlling, Controlled by, or under common Control with, one of the Parties. For purposes of this definition, “Control” shall mean possessing, directly or indirectly, the power to direct or cause the direction of the management, policies and operations of a person, whether through ownership of voting securities, by contract or otherwise.
|
|
1.4
|
“Books and Records” shall have the meaning set forth in Schedule B-1 attached to this Agreement.
|
|
1.5
|
“Branding” means trademarks, service marks, domain names, logos, links, navigation and other indicators of origin.
|
|
1.6
|
“Content” means any or all text, images, video, audio, graphics, and other data, products, materials, services, text, pointers, technology, code, language, functions and software, including Branding.
|
|
1.7
|
“Exchange Act” means the Securities Exchange Act of 1934, as amended.
|
|
1.8
|
“Fees” shall have the meaning set forth in Section 3.1 of this Agreement.
|
|
1.9
|
“FINRA” means the Financial Industry Regulatory Authority, Inc. or any successor thereto.
|
|
1.10
|
“Folio Branding” means all Branding (other than from Issuer) used by Folio and includes any Branding provided by Folio to Issuer for use on the Issuer Site.
|
|
1.11
|
“Folio Content” means the Content owned by, licensed for use by, or otherwise permitted to be used by Folio in any manner, which for the avoidance of doubt shall in no event include Issuer Content.
|
|
1.12
|
“Folio Customer” means a person that has executed a customer account agreement with Folio and maintains a brokerage account with Folio, whether or not they have purchased the Private Securities.
|
|
1.13
|
“Folio Indemnified Parties” shall have the meaning set forth in Section 7.2 of this Agreement.
|
|
1.14
|
“Folio Name” means, and includes, the name of Folio or any of its Affiliates, or the name of any member, stockholder, partner, manager or employee of Folio or any of its Affiliates, or any trade name, trademark, logo, service mark, symbol or any abbreviation, contraction or simulation thereof owned or used by Folio or any of its Affiliates.
|
|
1.15
|
“Folio Site” means those internet sites, including, but not limited, to www.folioinvesting.com, www.folioclient.com and www.folioinstitutional.com, maintained by Folio for the purpose of offering its services.
|
|
1.16
|
“Investor(s)” means a Folio Customer who holds the Private Securities in a brokerage account with Folio, excluding Issuer.
|
|
1.17
|
“Issuer Branding” means all Branding (other than from Folio) used by Issuer and includes any Branding provided by Issuer to Folio for use on the Folio Site.
|
|
1.18
|
“Issuer Content” means the Content owned by, licensed for use by, or otherwise permitted to be used by Issuer in any manner, which for the avoidance of doubt shall in no event include Folio Content.
|
|
1.19
|
“Issuer Indemnified Parties” shall have the meaning set forth in Section 7.3 of this Agreement.
|
|
1.20
|
“Issuer Site” means those internet sites as set forth on Schedule A maintained by the Issuer or an Affiliate of Issuer for the purpose of offering the Private Securities.
|
|
1.21
|
“Law” or “Legal Requirement” means any statute, law, ordinance, rule or regulation, or any order, judgment, or plan, of any court, arbitrator, department, agency, authority, instrumentality or other body, whether federal, state, municipal, foreign, self-regulatory or other that governs the activities of either of the Parties.
|
|
1.22
|
“Losses” shall have the meaning set forth in Section 7.2 of this Agreement.
|
|
1.23
|
“Offering” means the offering, pursuant to a registration statement under the Securities Act or an exemption therefrom, of Private Securities to Investors.
|
|
1.24
|
“Private Placements Platform” means such technology owned, operated or made available by Folio or an Affiliate of Folio for Issuer’s use in making the Private Securities available in a direct Offering.
|
|
1.25
|
“Private Security(ies)” shall have the meaning set forth in the recitals.
|
|
1.26
|
“SEC” means the U.S. Securities and Exchange Commission.
|
|
1.27
|
“Securities Act” means the Securities Act of 1933, as amended.
|
|
1.28
|
“Services” shall have the meaning set forth in Section 2.1 and 2.2 of this Agreement.
|
|
1.29
|
“Term” shall have the meaning set forth in Section 8.1 of this Agreement.
|
2
|
ESCROW AND RELATED CUSTODIAL SERVICES
|
|
2.1
|
Escrow and Related Closing Services. Folio shall provide its escrow-less private offering closing services, and perform related services, as described by the provisions of Schedule B-1 of this Agreement for the Private Securities.
|
|
2.2
|
Custodial and Related Services. Folio shall hold, as nominee custodian, the Private Securities and perform related services with respect to Issuer to the extent explicitly required by specific provisions contained in Schedule B-1 of this Agreement and shall not be responsible for any duties or obligations not specifically allocated to Folio pursuant to this Agreement, which services shall be contingent upon Issuer meeting its obligations as outlined herein and in Schedule B-2, and as limited by Schedule C of this Agreement (the “Services”). Folio may also, in its sole discretion, take such actions as it reasonably deems necessary to perform due diligence or investigation with respect to Issuer and/or any Offering at any time and from time to time.
|
|
2.3
|
Exclusivity. Because confusion and inconsistencies may arise from the use of multiple recordkeeping and custody systems to hold the Private Securities in the U.S., unless otherwise agreed to between the Parties, Issuer shall not, during the Term, establish, maintain or permit any other person to establish or maintain on its behalf a similar relationship with a custodian, clearing broker or transfer agent to perform the Services with respect to the Private Securities.
|
|
2.4
|
Modifications to Folio Systems, Platforms and Operations. Folio upgrades and enhances its platform and amends, modifies and changes its operations and procedures on a consistent basis. Folio reserves the right, therefore, in its sole discretion, to change or modify the Private Placements Platform at any time and from time to time.
|
|
2.5
|
No Discretionary Authority. Unless and only to the extent specifically described in any separate agreement between Folio and Issuer: (a) Folio shall, at all times, act solely in a passive, non-discretionary capacity with respect to Issuer and each Investor and each brokerage account with Folio maintained by Issuer or each Investor and shall not be responsible or liable for any investment decisions or recommendations with respect to the purchase or disposition of any Private Security or other assets; (b) Folio shall not be responsible for questioning, investigating, analyzing, monitoring, or otherwise evaluating any of the investment decisions of any Investor or reviewing the prudence, merits, viability or suitability of any investment decision made by any Investor, including the decision to purchase or hold the Private Securities or such other investment decisions or direction that may be provided by any individual or entity with authority over the relevant Investor; and (c) Folio shall not be responsible for directing investments or determining whether any investment by an Investor or any person or entity with authority to make investment decisions on Investor’s behalf is acceptable under applicable Law.
|
|
2.6
|
Book Entry Securities. The Private Securities will be book entry securities on Folio’s Books and Records and held for the benefit of the Investors. Folio will maintain, as part of the Services, information as to amounts owed and paid with respect to the Private Securities to the individual Investors. Accordingly, Folio agrees to accurately maintain its Books and Records and to provide Issuer information from its Books and Records as reasonably requested by Issuer. Issuer shall maintain on its books and records the amount owed and paid to Investors with respect to the Private Securities, which may be in aggregate if permitted by Law and include an omnibus position in the Private Securities at Folio, held and maintained for the benefit of the Investors. Issuer will notify Folio immediately if the amount owed or paid with respect to the Private Securities to Investors or the position held on Issuer’s books and records is different from the amount that Folio reports to Issuer.
|
3
|
FEES
|
|
3.1
|
Fees. The fees payable by Issuer to Folio are specified in Schedule D to this Agreement (collectively, “Fees”). Folio is authorized to debit the Fees or any other obligation of Issuer to Folio automatically from Issuer’s account with Folio as such becomes due. Issuer will maintain sufficient cash in, and from time to time deposit sufficient funds in, such account to ensure payment of its obligations, including the Fees, to Folio.
|
|
3.2
|
Required Fee Changes. Subject to Section 8, Folio reserves the right to increase, amend or change the Fees as a result of: (a) changes in Law; (b) increased costs or fees charged by vendors or non-affiliated third party service providers, that in Folio’s sole reasonable judgment requires Folio to incur new or increased costs to provide the Services; or (c) changes in the Services that result in the performance of additional, duplicative or amended activities by Folio under this Agreement, which, in Folio’s sole reasonable judgment cause Folio to incur new or increased costs.
|
|
3.3
|
Discretionary Fee Changes. Subject to Sections 3.4 and 8, if Folio needs to, and does, reserve the right to increase, amend or change the Fees as a result of changes in the business environment, internal procedural changes, its determination to increase the profitability of providing the Services, or other matters foreseen or unforeseen.
|
|
3.4
|
Fee Change Procedure. Prior to debiting Issuer’s account for Fees that have changed pursuant to this Section 3, Folio promptly will provide Issuer with an amended Schedule D or such other documentation necessary to describe the Fee changes, along with an explanation of any changes. Any amendments or updates to the Fees in Schedule D or otherwise shall become effective upon the expiration of the earlier of thirty (30) days after the date of such notice or, should the Fee change be due to costs or fees from a third party, , then the date on which such third party costs or fees become effective.
|
4
|
NAMES, BRANDS, WEBSITES AND CONTENT
|
|
4.1
|
Use of Folio Name, Folio Brand and Folio Content. Issuer shall not, and shall cause its representatives not to, without the prior written consent of Folio: (a) use in advertising, publicity, or otherwise any Folio Name, Brand or Content, or (b) represent, directly or indirectly, that Issuer, any Affiliate of Issuer, or any representative of Issuer or the Private Securities have been approved, endorsed, or recommended by Folio or any of its Affiliates. In addition, all use of the Folio Name, Branding or Content and all descriptive materials about the Services used by Issuer on the Issuer Site or elsewhere, must be reviewed and approved by Folio, as to appearance, substance and placement, prior to use by Issuer. Folio may also require a “jump” or other interstitial page in connection with any links or references to Folio or any of its websites or otherwise if deemed necessary by Folio to ensure clear demarcation between any websites or content of Folio and any websites or content of Issuer. Issuer understands that any breach hereof may also cause a breach of Law, and Issuer will be liable hereunder for any failure to obtain such prior approval or otherwise comply with these provisions.
|
|
4.2
|
Use of Issuer Name, Issuer Brand and Issuer Content. Folio shall not, and shall cause its representatives not to, without the prior written consent of Issuer use in advertising, publicity, or otherwise any Issuer Name, Brand or Content. In addition, all use of the Issuer Name, Branding or Content on the Folio Site must be reviewed and approved by Issuer, as to appearance, substance and placement, prior to use by Folio. Issuer may also require a “jump” or other interstitial page in connection with any links or references to Issuer or any of its websites or otherwise to ensure clear demarcation between any websites or content of Issuer and any websites or content of Folio. Folio understands that any breach hereof may also cause a breach of Law, and Folio will be liable hereunder for any failure to obtain such prior approval or otherwise comply with these provisions.
|
|
4.3
|
No Responsibility for Issuer Site or Issuer Content. Folio is not preparing, endorsing, adopting, reviewing or approving in any way the Issuer Site or Issuer Content or any offering material, including any offering memorandum, or any other materials of any kind prepared by Issuer or on behalf of Issuer (even if prepared by Folio on behalf of Issuer) wherever it may appear, except to the extent that the Issuer Site, Issuer Content or other material specifically references Folio, and then only to the limited extent of such reference.
|
|
4.4
|
No License of Intellectual Property. No license or grant of any intellectual property of any nature whatsoever, including any Branding or Content, or any data, business method, patents or applications thereof or similar material shall be deemed granted, licensed or otherwise from either Party (or any Affiliate thereof) to the other (or any Affiliate thereof) under this Agreement.
|
5
|
CONFIDENTIAL INFORMATION
|
|
5.1
|
Either Party or any Affiliate thereof may disclose to the other or an Affiliate thereof (the recipient being the “Receiving Party”) certain technical or other business information that is not generally available to the public, the specific terms of this Agreement, and/or personal information relating to any person (specifically including in the case of Folio, information relating to a Folio Customer). All such information is referred to herein as “Confidential Information”. Notwithstanding the foregoing, the Books and Records as they pertain to the Private Securities (and with the permission of the Investors with respect to any personally identifying information), will be made available to Issuer, and shall be Confidential Information as to Folio, and may only be used by Issuer in accordance with Law or as otherwise authorized by the Folio Customer to whom the information pertains by affirmative or negative consent, as permitted.
|
|
5.2
|
The Receiving Party agrees to use Confidential Information solely in conjunction with its performance under this Agreement, in conducting an Offering, and or as otherwise authorized by the Folio Customer to whom the information pertains by affirmative or negative consent, as permitted, and not to disclose or otherwise use such information in any other fashion and to maintain such information with at least the standard of care it uses to protect its own Confidential Information, but in no event less than a reasonable standard of care.
|
|
5.3
|
The Receiving Party will not be required to keep confidential such Confidential Information to the extent that it: (a) becomes generally available without fault on its part; (b) is already rightfully in the Receiving Party’s possession prior to its receipt from the disclosing Party; (c) is independently developed by the Receiving Party; (d) is rightfully obtained by the Receiving Party from third parties; or (e) is otherwise required to be disclosed by law or judicial process.
|
|
5.4
|
Information related to this Agreement shall be deemed Confidential Information, but in the event either Party wishes to disclose such information, such Party shall seek the prior written consent of the other, and such consent shall not be unreasonably withheld.
|
|
5.5
|
Unless required by Law, including, but not limited to, regulatory or judicial requests for information (whether formal or informal), or to assert its rights under this Agreement, and except for disclosure on a “need to know basis” to its own employees, and its legal, investment and financial advisers, other professional advisers or others as authorized by the Folio Customer to whom the information pertains by affirmative or negative consent, as permitted, on a confidential basis (in each case pursuant to written agreements with each such person requiring it to maintain such information as confidential to the same extent as if it were a party to this Agreement), each Party agrees not to disclose the Confidential Information without the prior written consent of the other Party, which consent shall not be unreasonably withheld.
|
|
5.6
|
This Section 5 shall survive for a period of three (3) years beyond the Term, except with respect to Confidential Information that is personal or identifying information regarding or relating to a Folio Customer, in which case this Section 5 shall be indefinite, unless in the case of Issuer such disclosure is authorized by the relevant Folio Customer in connection with the Private Securities and in the case of Folio, is otherwise permitted by Law.
|
6
|
REPRESENTATIONS, WARRANTIES AND COVENANTS
|
|
6.1
|
Mutual Representations and Warranties. Each Party represents and warrants to the other Party that:
|
|
a.
|
it is duly organized and validly existing under the laws of the jurisdiction of its establishment;
|
|
b.
|
it has the full power and authority to enter into this Agreement and to perform its obligations under this Agreement;
|
|
c.
|
it has obtained all material consents and approvals and taken all actions necessary for it to validly enter into and give effect to this Agreement and to engage in the activities contemplated and perform its obligations under this Agreement;
|
|
d.
|
this Agreement will, when executed, constitute lawful, valid and binding obligations on it, enforceable in accordance with its terms; and
|
|
e.
|
neither the execution and delivery of this Agreement, nor the performance by such Party of its obligations hereunder will (i) violate any Legal Requirement, (ii) require any authorization, consent, approval, exemption or other action by or notice to any government entity, or (iii) violate or conflict with, or constitute a default (or an event which, with notice or lapse of time, or both, would constitute a default) under the governing documents of such Party or any contract, commitment, understanding, arrangement, agreement or restriction of any kind or character to which such Party is a party or by which such Party or any of its assets or properties may be bound or affected.
|
|
6.2
|
Issuer Representations, Warranties and Covenants. Issuer represents, warrants and covenants to Folio that:
|
|
a.
|
the Private Securities are registered or exempt from the registration requirements of the Securities Act, and the rules and regulations promulgated thereunder, and are registered or exempt from the registration requirements of any state where Issuer from time to time will offer such securities;
|
|
b.
|
it will not, during the Term, either (i) act as a “broker” or “dealer” as those terms are defined under the Exchange Act or otherwise in a capacity under any other Law that is not permitted, unless pursuant to an applicable exemption, or provide investment advice with respect to any Folio Customer or (ii), with respect to any Folio Customer, hold or have access to any funds or securities, or extend credit for the purpose of purchasing securities through Folio, including specifically the Private Securities; and
|
|
c.
|
Issuer owns the Issuer Brand, Issuer Site and Issuer Content and/or has the right to grant the licenses and/or rights of use as contemplated by this Agreement.
|
|
6.3
|
Folio Representations, Warranties and Covenants. Folio represents, warrants and covenants to Issuer that:
|
|
a.
|
it is, and during the Term will remain, duly registered and in good standing as a broker-dealer with the SEC and is a member firm in good standing with FINRA; and
|
|
b.
|
Folio owns the Folio Brand, Folio Site and Folio Content and/or has the right to grant the licenses and/or rights of use as contemplated by this Agreement.
|
|
6.4
|
Disclaimer of Warranties. THE SERVICES ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. FOLIO SPECIFICALLY DISCLAIMS ALL WARRANTIES FOR THE SERVICES, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NEITHER FOLIO NOR ANY AFFILIATE OF FOLIO WARRANTS THAT THE SERVICE WILL MEET ISSUER’S OR ANY INVESTOR’S REQUIREMENTS OR THAT THE SERVICES WILL BE UNINTERRUPTED OR ERROR-FREE. NO ORAL OR WRITTEN INFORMATION GIVEN BY FOLIO OR ITS AFFILIATES SHALL CREATE ANY WARRANTIES OR IN ANY WAY INCREASE THE SCOPE OF FOLIO’S OBLIGATIONS HEREUNDER.
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7
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LIMITATIONS OF LIABILITY; INDEMNIFICATION
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7.1
|
Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO ANOTHER PARTY FOR ANY SPECIAL, INDIRECT, CONSEQUENTIAL, PUNITIVE OR EXEMPLARY DAMAGES OF ANY NATURE, EVEN IF SUCH PARTY SHALL HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING SHALL APPLY REGARDLESS OF THE NEGLIGENCE OR OTHER FAULT OF ANY PARTY AND REGARDLESS OF WHETHER SUCH LIABILITY SOUNDS IN CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR ANY OTHER THEORY OF LIABILITY.
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7.2
|
Folio Indemnification. Issuer agrees to indemnify, defend and hold Folio and its Affiliates and their respective officers, directors, agents and employees (each a “Folio Indemnified Party” or, collectively, “Folio Indemnified Parties”) harmless against any investigation, claim, action, or proceeding (including a regulatory inquiry, whether formal or informal or any arbitration or court action) (“Action”) brought by a Folio Customer, court, regulator or self-regulatory organization asserting jurisdiction over the Folio Indemnified Party or by any other party against any Folio Indemnified Party if such Action relates to Issuer, any Affiliate of Issuer, the Securities, the Offering, the marketing and advertising thereof, or that results from any action, inaction, omission, misstatement or statement of Issuer or any person acting in connection with Issuer or on Issuer’s behalf (other than any misstatement or statement about Folio provided by Folio) arising out of or based upon (a) the Issuer Site or the offering circular, including any amended versions thereof; (b) any breach or alleged breach of any of Issuer’s representations, warranties, covenants or agreements hereunder and including any representations, warranties, covenants or agreements contained in the Schedules to this Agreement; (c) any breach or alleged breach of confidentiality or privacy relating to Issuer’s failure or alleged failure to treat any Folio Customer’s personal or identifying information as confidential pursuant to Section 5; and (d) infringement or misappropriation by Issuer of any third party’s property and/or intellectual property rights, including, but not limited to, patents, trademarks, copyrights, trade secrets and publicity rights. Further, Issuer shall indemnify the Folio Indemnified Parties against all expenses, fees (including reasonable attorney’s fees and other legal expenses), losses, claims, damages, demands, liabilities, judgments (including fines and settlements), costs of investigation or responding to inquiries or otherwise (“Losses”) incurred by or levied or brought against the Folio Indemnified Parties arising out of, or related to, Actions warranting indemnification pursuant to this Section 7.2 as such Losses arise.
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7.3
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Issuer Indemnification. Folio agrees to indemnify, defend and hold Issuer and its Affiliates and their respective officers, directors, agents and employees (each an “Issuer Indemnified Party” and, collectively, “Issuer Indemnified Parties”) harmless against any Action brought by an Investor, Folio Customer, court, or regulator asserting jurisdiction over the Issuer Indemnified Party or by any other party against any Issuer Indemnified Party relating to Folio, any Affiliate of Folio or the Services, insofar as the Action arises out of or is based upon (a) the Folio Site; (b) any misstatement or statement about Folio provided by Folio to Issuer; (c) any breach or alleged breach of any of Folio’s representations, warranties, covenants or agreements hereunder and including any representations, warranties, covenants or agreements contained in the Schedules to this Agreement; (d) any and all commitments, representations, warranties or statements of any kind by Folio to any third party regarding the use of the Folio Site; and (e) infringement or misappropriation by Folio of any third party’s property and/or intellectual property rights, including, but not limited to, patents, trademarks, copyrights, trade secrets and publicity rights. Further, Folio shall indemnify the Issuer Indemnified Parties against all Losses incurred by or levied or brought against the Issuer Indemnified Parties arising out of, or related to, Actions warranting indemnification pursuant to this Section 7.3 as such Losses arise.
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7.4
|
No Claim Preclusion. Nothing in this Section shall be construed to preclude either Party from making any claim against the other arising out of a failure to perform obligations under this Agreement. Neither Party shall be precluded from claiming or commencing an action for contribution to any amounts the other may be required or otherwise agree to pay to an Investor or other third party, including a regulator, with jurisdiction over the Services.
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8
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TERM AND TERMINATION
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8.1
|
Term. This Agreement shall be effective on the Effective Date, and continue in force for so long as the Private Securities remain on the Private Placements Platform (the “Term”), unless otherwise terminated pursuant to the provisions of this Section 8.
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8.2
|
Termination Without Cause. This Agreement may be terminated without cause:
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8.3
|
Termination for Regulatory, Legal, Reputational or Other Risks.
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a.
|
In the event that any due diligence or investigation results in findings that would pose regulatory, legal, reputational or other risks to Folio, Folio shall provide Issuer notice of such risks and a reasonable opportunity to cure them. If the risks are not addressed or cured to Folio’s reasonable satisfaction, Folio may terminate this Agreement. Folio will facilitate the orderly transition of the custody of the Private Securities to such person designated by the Issuer in accordance with Section 8.9.
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b.
|
In Folio’s sole discretion, if the risks described in 8.3.a are of sufficient size, significance or immediacy that a delay in termination of this Agreement would be inappropriate, Folio may terminate this Agreement immediately.
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8.4
|
Termination for Cause or Insolvency. Either Party may terminate this Agreement immediately if the other Party:
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8.5
|
Termination for Force Majeure. In the event of a force majeure that lasts longer than thirty (30) days, the Party not experiencing the force majeure event may terminate this Agreement upon written notice to the other Party.
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8.6
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Compliance with Laws. If at any point during the Term, either Party’s performance under this Agreement conflicts or threatens to conflict with any Legal Requirement, such Party may suspend performance under this Agreement and negotiate in good faith to amend this Agreement so that each Party’s performance hereunder complies with such Legal Requirement. If after thirty (30) days, the Parties are unable to agree on a mutually acceptable amendment, either Party may immediately terminate this Agreement upon written notice to the other Party.
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8.7
|
Actions Upon Termination. Upon the termination of this Agreement, Issuer shall remove all references to any Folio Name, Branding and Content from the Issuer Site or Issuer Content and terminate all links on the Issuer Site to any Folio Site. Folio shall remove all references to Issuer Name, Branding and Content and terminate all links on the Folio Site to any Issuer Site. Each Party shall promptly return all Confidential Information, documents, manuals and other materials stored in any form or media (including but not limited to electronic copies) belonging to the other Party, except as may be otherwise provided in this Agreement or required by Law.
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8.8
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Termination Fee. Termination Fees are set forth in Schedule D.
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8.9
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Cooperation. In all events, if there are one or more Investors at the time of termination, the Parties will cooperate in planning and implementing an orderly transition of the custody of the Private Securities to such person designated by Issuer authorized under applicable Law to assume custody of the securities, or to Issuer itself if it is authorized to hold such securities in custody, or to such other person selected by Folio if Issuer does not so select such person within a reasonable period not to exceed ninety (90) days. In all events, Issuer shall pay the reasonable costs of such transition. As part of such a transition, the Parties agree to seek the affirmative or negative consent of Investors to the sharing of Confidential Information necessary for their transition.
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9
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ARBITRATION
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9.1
|
Arbitration Proceedings Disclosure. The Parties hereby agree to arbitration and agree and acknowledge the following with respect to arbitration proceedings:
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a.
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Arbitration is final and binding on the Parties;
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b.
|
The Parties are waiving their right to seek remedies in court, including the right to a jury trial;
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c.
|
Pre-arbitration discovery generally is more limited than and different from court proceedings;
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d.
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The arbitrators’ award is not required to include factual findings or legal reasoning;
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e.
|
A Party’s right to appeal or to seek modification of rulings by the arbitrators is strictly limited; and
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f.
|
The panel of arbitrators may include a minority of arbitrators who were or are affiliated with the securities industry.
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9.2
|
Arbitration Agreement. Any controversy between the Parties arising out of this Agreement shall be submitted to arbitration conducted before FINRA Dispute Resolution, and in accordance with FINRA rules. Arbitration must be commenced by service upon the other Party of a written demand for arbitration or a written notice of intention to arbitrate. Proceedings and hearings will take place in New York, New York. Both Parties waive any right either of them may have to institute or conduct litigation or arbitration in any other forum or location, or before any other body. Arbitration is final and binding on both Parties. An award rendered by the arbitrator(s) may be entered in any court of applicable jurisdiction over the Parties.
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10
|
GENERAL TERMS AND CONDITIONS
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10.1
|
Compliance with Law. Each Party agrees to comply with any Legal Requirement applicable to the performance of its obligations hereunder.
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10.2
|
Non-exclusive Folio Relationship. Folio reserves the right, without obligation or liability to Issuer, to market and provide either directly, through other Parties, or through any other type of distribution channel, services to others that are the same as or similar to the Services.
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10.3
|
No Agency. Neither Party is an agent, representative or partner of the other Party. Neither Party shall have any right, power or authority to enter into any agreement for or on behalf of, or to incur any obligation or liability for, or to otherwise bind, the other Party. This Agreement shall not be interpreted or construed to create an association, joint venture, co-ownership, co-authorship, or partnership between the Parties or to impose any partnership obligation or liability upon either Party.
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10.4
|
Amendments and Modifications. No change, amendment or modification of any provision of this Agreement will be valid unless set forth in writing and signed by the Parties.
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10.5
|
Assignment. Issuer shall not assign, sublicense or otherwise transfer this Agreement or any right, interest or benefit hereunder, except by operation of law, without the prior written consent of Folio, which consent may be withheld in Folio’s sole discretion. Folio shall have the right to assign, sublicense or otherwise transfer this Agreement or any right, interest or benefit hereunder, including an assignment by operation of law, to any Affiliate of Folio that is properly authorized under applicable Law to provide the Services by giving notice to Issuer within thirty (30) days of any of the actions listed herein.
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10.6
|
Governing Law. This Agreement shall be interpreted, construed and enforced in all respects in accordance with the laws of the Commonwealth of Virginia, except with respect to the choice of law provisions therein or to the extent inconsistent with FINRA Rules applicable to an arbitration proceeding under Section 9.
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10.7
|
No Waiver. The failure of either Party to insist upon or enforce strict performance by the other Party of any provision of this Agreement or to exercise any right under this Agreement shall not be construed as a waiver or relinquishment to any extent of such Party’s right to assert or rely upon any such provision or right in that or any other instance; rather the same shall be and remain in full force and effect.
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10.8
|
Notice. Any notice required or permitted under this Agreement shall be in writing and delivered to the receiving Party’s principal place of business as set forth on the signature block to this Agreement in a manner contemplated in this Section and addressed to the attention of its General Counsel. Notice shall be deemed duly given (a) if delivered by hand, when received, (b) if transmitted by email, upon confirmation that the entire document has been successfully received, (c) if sent by recognized overnight courier service, on the business day following the date of deposit with such courier service so long as the deposit was made by that overnight courier service’s deadline or on the second business day following the date of deposit if after that overnight courier service’s deadline, or (d) if sent by certified mail, return receipt requested, on the third business day following the date of deposit in the United States mail.
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10.9
|
Entire Agreement. This Agreement and the Schedules hereto and incorporated herein by reference constitute the entire agreement between the Parties and supersede any and all prior agreements or understandings between the Parties with respect to the subject matter hereof. Neither Party shall be bound by, and each Party specifically objects to, any term, condition or other provision or other condition which is different from or in addition to the provisions of this Agreement (whether or not it would materially alter this Agreement) and which is proffered by the other Party in any purchase order, correspondence or other document, unless the Party to be bound thereby specifically agrees to such provision in writing.
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10.10
|
Severability; Survival. In the event that any provision of this Agreement conflicts with the law under which this Agreement is to be construed or if any such provision is held invalid by a court with jurisdiction over the Parties to this Agreement, such provision shall be deemed to be restated to reflect as nearly as possible the original intentions of the Parties in accordance with applicable Law, and the remainder of this Agreement shall remain in full force and effect. All provisions herein that by their terms or intent are to survive the termination of this Agreement shall so survive, specifically including Sections 3, 5, 6, 7, 9 and 10.
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10.11
|
Headings. The headings used in this Agreement are for convenience only and are not to be construed to have legal significance.
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10.12
|
Third Parties. This Agreement is between the Parties hereto and is not intended to confer any benefits on third parties including, but not limited to, Investors.
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10.13
|
Force Majeure. Neither Party will be liable for delay or default in the performance of its obligations under this Agreement if such delay or default is caused by conditions beyond its reasonable control, including, but not limited to, fire, flood, accident, earthquakes, telecommunications line failures, storm, acts of war, riot, acts of terrorism, government interference, strikes and/or walk-outs. In addition, Folio shall not be responsible for downtime or other problems with any website, including the Folio website, caused by any public or third party private network, including the Internet or any communications carrier network, or computer hardware or software problems regardless of whether they arise in the ordinary course of business or constitute extraordinary events.
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1.
|
Escrow-less Closing Services. Folio provides its escrow-less money transfer functions for funding an investment in an Offering through a brokerage account (replacing the function of a bank escrow agent) under an SEC no-action letter received by Folio Investments, Inc. dated July 15th, 2015 regarding Exchange Act Rule 15c2-4(b)(1), subject to the fees specified in Schedule D.1 of this Agreement. This service involves setting up an account for Issuer, setting up customer accounts for the Investors, receiving money into the customer accounts, and conducting closings in which funds in customer accounts are transferred from those accounts to Issuer’s account in amounts equal to subscription requests Issuer has accepted.
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2.
|
Use of the Folio Private Placements Platform. Folio will make tools available to Issuer for Issuer to perform or Folio to perform on behalf of Issuer, the following activities with respect to the Private Placements Platform, subject to the fees specified in Schedule D.2 of this Agreement:
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a.
|
display information regarding the Offering as provided and instructed by Issuer or an agent of Issuer, including, but not limited to the number of units of the Private Securities available, price, and terms;
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|
b.
|
provide the ability for a Folio Customer, through a link to a third party hosting site or otherwise, to view such documents as Issuer has created and determines to make available to potential investors relating to the Securities, including, but not limited to, an offering circular or a private placement memorandum and subscription agreement or other similar offering materials, and to submit a subscription request for an Offering;
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c.
|
provide information provided by Folio Customers relating to their qualifications to purchase the Securities, including presenting Issuers with successfully submitted subscription requests for review;
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|
d.
|
verify that a Folio Customer has the appropriate status to purchase the Private Securities based on the status requirements specified by Issuer on the Private Placement Platform (in connection with such verification, Folio relies solely on the information or documents with respect to net worth or income as provided by such Folio Customer to Folio, on the representation of verified status from a certified public accountant or licensed attorney or other person reasonably capable of providing such attestation, or such other third party services that Folio reasonably believes can provide such verification. Folio cannot represent or warrant that such information or documents are accurate or complete and disclaims liability for any determination by Folio of such status in reliance on such information, documents or representations to the extent that Folio has a reasonable belief that it has relied in good faith on such information or attestation or service). Additional fees apply for Regulation D Rule 506(c) verification of accredited investor status;
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e.
|
provide a mechanism for Issuer to review, accept or reject subscribers to its offering, including enabling investors and issuers to confirm that sufficient cash has been deposited into customer accounts to satisfy subscription requests prior to the cash required by date, and notifying users of the cash required by date for an offering prior to subscription;
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f.
|
provide Investors with a mechanism to view the status of their subscription and the date that the issuer has set for cash required for closing; and
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g.
|
if requested by Issuer, seek, on behalf of Issuer and at Issuer’s expense (additional fees apply), to make available the Private Securities for purchase in Individual Retirement Accounts (in connection with such request, Folio can make no assurances that the Private Securities will be approved for holding in Individual Retirement Accounts, as such accounts are held by a third party custodian who reviews the request and makes a determination in its sole discretion).
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3.
|
Custody and Transfer of Private Securities. After Issuer has executed a Folio Customer Account Agreement, Folio will, in the ordinary course, and consistent with Folio’s policies and procedures as in existence from time to time, maintain an account for the benefit of Issuer to hold the Private Securities, whether in certificated or uncertificated form, for Issuer’s benefit and any other securities or cash as may be purchased and/or deposited or held by Issuer in its account with Folio. As custodian, Folio will also provide the following services, subject to the fees specified in Schedule D.3, D.4, D.5, D.6, and D.7 of this Agreement:
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a.
|
maintain books and records identifying each Investor, each Investor’s address, the terms of the Private Securities in which each Investor invests, and a log of all transactions with each Investor (collectively, “Books and Records) in accordance with Law as it does in the ordinary course with respect to any customer of Folio’s holding securities on the Folio platform.
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b.
|
provide Issuer with a mechanism for Issuer to reconcile with Issuer records Investor holdings of the Private Securities from time to time (at the omnibus level and at the individual beneficial holder level, subject to Issuer maintaining the confidentiality of such information as set forth in Section 5 of this Agreement);
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c.
|
transfer cash and the Private Securities, if permitted, between an Investor account and the account of another Folio Customer, subject to the transaction fees payable for those services at this time, which are not specified in this Agreement;
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d.
|
record and process transactions between Issuer and Investors in the Private Securities such as cash and securities distributions;
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|
e.
|
maintain records of identifying information regarding Investors (subject to Section 5 of this Agreement); and
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f.
|
process communications between Issuer and Investors regarding the offering of the Private Securities, and other corporate actions.
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|
1.
|
based upon the Books and Records provided by Folio or an Affiliate of Folio from time to time, maintain an accurate and complete record on its official books and records of the number of units (which may be in aggregate if permitted by Law) of Private Securities and, if permitted by Law, as held by Folio as nominee custodian for Folio Customers noting that such units are held by “Folio Investments, Inc. for the exclusive benefit of its customers”, or if certificated, deliver to Folio an original, duly issued and outstanding unit certificate in the name of “Folio Investments, Inc. for the exclusive benefit of its customers” in an amount equal to the number of units of Private Securities held by Shareholders;
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2.
|
maintain an accurate and complete record on its official books and records of the number of units of Private Securities, if any, held by Folio for Folio’s own benefit, or if certificated, deliver to Folio an original, duly issued and outstanding unit certificate in the name of “Folio Investments, Inc.” in an amount equal to the number of units of Private Securities held by Folio;
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3.
|
provide to Folio a statement and attestation, in the form and at the time that Folio may reasonably require from time to time each calendar quarter, indicating the number of units of the Private Securities recorded in Issuer’s records as being held by “Folio Investments, Inc. for the exclusive benefit of its customers” and as being held by Folio itself for its own benefit, if any, as of the last day of such quarter, and, if certificated, attesting to (A) the authenticity of the certificate(s) in Folio’s possession, (B) that the certificate(s) represent(s) the number of units of Private Securities represented in Issuer’s records, and (C) that the certificate(s) in Folio’s possession is/are recorded on Issuer’s official books and records as “Folio Investments, Inc. for the exclusive benefit of its customers” and “Folio Investments, Inc.”, respectively;
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4.
|
provide Folio with the option and opportunity to audit, or have a third party audit on Folio’s behalf, Issuer’s books and records to confirm any information maintained by Issuer under the Agreement and authorize Folio to contact Issuer’s auditors and request that they provide confirmation of such information, all at Issuer’s sole expense;
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5.
|
provide Folio, no later than January 31st of each year, a written letter of assurance on Issuer’s letterhead (or on the letterhead of Issuer’s counsel on Issuer’s behalf or Issuer’s audit firm) that the Private Securities identified in Issuer’s books and records as held by “Folio Investments, Inc. for the exclusive benefit of its customers” and/or “Folio Investments, Inc.” or that the units evidenced by certificate(s) in such names are not subject to any right, charge, security interest, lien, or claim of any kind in favor of Issuer or any person claiming through Issuer and that all such securities issued and outstanding for the prior year have been validly authorized, duly and validly issued, fully paid and are non-assessable and free of restrictions on transfer other than restrictions on transfer that have been provided to Folio by Issuer;
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6.
|
provide Folio, pursuant to such methods as Folio may reasonably require (e.g., through a designated website or email to Folio’s operations department), by the end of the first day of each calendar quarter, and at any time and from time to time as soon as reasonably practicable if there is a material change in value, a statement of the per unit value of the Private Securities as set by an authorized executive of Issuer or Issuer’s board of directors, which shall constitute an instruction to Folio to communicate to Investors that unit value as the then current value of the Private Securities and to update Investor account values accordingly;
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7.
|
provide Folio, pursuant to such methods as Folio may reasonably require, with the details of, and all monies associated with any dividend, interest, principal or other payment due to Investors and a detailed record of the recipients and amounts to be credited thereto and any tax reporting codes in a manner required by Folio from time to time in order for Folio to credit Investors with such payments on a timely basis and to produce relevant tax documentation therefrom (it is agreed that Issuer shall produce or cause to be produced by third parties on behalf of Issuer, at Issuer’s expense, any Schedule K-1’s or similar documents for delivery by Folio to Shareholders); and; and
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8.
|
provide to Folio, in such form and at such time as Folio may reasonably request, a copy of any documentation, memoranda, agreements or other documents or information that Folio believes is necessary for it to satisfy any filing, reporting or other applicable legal requirements it may have relating to the custody of the Private Securities.
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1.
|
Services Under Separate Agreement. This Agreement does not address nor authorize Folio to provide, investment banking or underwriter services to Issuer, to act as an underwriter or selling group member, to issue the Private Securities, to provide advice or advisory services in connection with the services as set forth in Schedule B, to recommend the Private Securities or the Offering, or to make any suitability determinations with respect to any Folio Customer. Folio is not committing to and does not intend to purchase any of the Private Securities for its own account or that of an Affiliate. However, Issuer and Folio understand and agree that, in addition to the services provided herein and under a separate agreement entitled “Participating Dealer or Selling Agreement” or “Distribution Agreement” or other substantially similar agreement (“Selling Agreement”) which may be entered into between the issuer or sales agent and Folio, Folio may participate in the offering as a dealer in the sale of the Securities. In its capacity as a dealer, Folio shall be entitled to receive a reallowance on commissions in accordance with the Selling Agreement, which shall be compensation for Folio's portion of the commissions as a Dealer and shall be separate and distinct from the fees set forth in Schedule D of this Agreement.
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2.
|
No Approval of Issuer Content. Folio is not preparing, endorsing, adopting, or approving in any way any offering memoranda or other offering documents, SEC, state or other regulatory filings, or any sales or marketing material or Issuer Content, specifically including any Issuer Sites, or any other material or Content of any kind wherever they may appear except to the extent that such websites, material or Content specifically reference the Folio Name, Branding, Content, or descriptive materials about the Services, and then only to the extent of such references and specifically not including other portions of such website or materials.
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3.
|
No Setting, Reviewing or Guaranteeing of Price, Tax or Other Data. Folio is not setting, calculating, creating, approving, endorsing, adopting, reviewing, recommending or guaranteeing any price for the Private Securities, or giving any opinion with respect to the accuracy, reliability or completeness of any data or information about the Private Securities appearing on a Folio Site or elsewhere. Folio is relying on Issuer for all such data and information. Folio is not preparing or calculating any tax statements or documentation on behalf of Issuer, specifically including Schedule K-1s, except for those tax documents normally and usually included as part of a brokerage account (such as 1099s).
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|
|
1.
|
Escrow-less Closing Fees.
|
|
a.
|
Reserved when Folio is compensated by an intermediary broker dealer instead of the issuer, or
|
|
b.
|
Forty-five basis points (45 bps) of the dollar value of the securities issued to Shareholders pursuant to each Offering at the time of closing, with a minimum fee to Folio of the greater of (a) $30 per Shareholder per Offering, or (b) $10,000 per Offering; provided, however, that the aggregate fees payable under Schedule D.1, D.2 and D.3, collectively, shall not exceed $55,000.
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|
2.
|
Private Placement Platform Fees.
|
|
a.
|
Reserved when Folio is compensated by an intermediary broker dealer instead of the issuer, or
|
|
b.
|
Five basis points (5 bps) of the dollar value of the securities issued to Shareholders pursuant to each Offering at the time of closing; provided, however, that the aggregate fees payable under Schedule D.1, D.2 and D.3, collectively, shall not exceed $55,000.
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3.
|
Due Diligence Fees.
|
|
a.
|
Reserved when issuer due diligence is performed an intermediary broker dealer instead of Folio, or
|
|
b.
|
Issuer shall pay Folio fees (whether charged by Folio or by a third party) related to conducting due diligence with respect to the Offering, Issuer or any principal or other person associated with Issuer that Folio deems necessary or appropriate, which will generally be $10,000 per Offering but may be greater if additional efforts are necessary to conduct adequate due diligence; provided, however, that the aggregate fees payable under Schedule D.1, D.2 and D.3, collectively, shall not exceed $55,000. Folio will consult with the issuer before deciding to incur additional costs and will only incur such fees with the agreement of both Parties. Due Diligence Fees are payable even if no securities are issued.
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|
4.
|
Fee for Termination and Transfer of Private Securities Pursuant to Section 8 Not Related to the Failure of an Offering to be Completed. For terminations pursuant to Sections 8.2(a), 8.3(a) or 8.4(a) that are not related to and do not arise from the failure of an Offering to be completed under the terms of this Agreement, and for which there are any Shareholders for Folio to transfer to another firm, Issuer shall pay a termination fee (“Termination Fee”) that is the greater of (a) $25,000, or (b) the current number of Shareholders of Private Securities as established at the time of transition, multiplied by $250; provided, however, that the Termination Fee shall not apply for terminations under Section 8.2(a) if the termination is by Folio. This Termination Fee does not apply if securities are transferred through the DTCC ACAT system to other custodians, though the transfer fees paid by customers in Section 7 below would apply.
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|
5.
|
Administrative Expenses. Issuer shall bear and pay all costs, fees and expenses relating to the preparation, printing, filing and dissemination of information relating to the securities issued to Shareholders pursuant to each Offering and any amendments or supplements thereto, including any federal or state fees imposed on Issuer or on Folio relating to the Offering, including, but not limited to, any costs, fees or expenses incurred by Folio in connection with the filing of documents with regulatory authorities (such as costs for federal and state filings of the Offering under Regulation D (e.g., Form D) or Regulation A of the Securities Act (e.g., Form 1-A and FINRA Rule 5110)), and any fees or expenses relating to the issuance and/or delivery of the securities (such as transfer agent fees, certificate fees, DTCC fees, NSCC fees).
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|
6.
|
Service Fees. Based upon Issuer request and specific requirements provided by Issuer, Issuer may be charged the following service fees as set forth on a fee schedule published from time to time by Folio, that are subject to change at any time in Folio’s sole discretion:
|
|
a.
|
Private Securities Proxy, Corporate Action, and Corporate Communication Fees – to the extent Issuer requests Folio to distribute corporate communications and process Investor voting, Issuer will be charged fees for corporate action and communication process and any resultant tax documents or customer inquiries as published from time to time by Folio on a webpage made available to you, which fees are subject to change at any time in the sole discretion of Folio. Note that such fees are set by securities regulations for publicly traded securities.
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|
b.
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Private Securities Dividend, Interest, Principal Payments, Return of Capital and Other Corporate Cash Flows – to the extent Issuer requests Folio to process and distribute corporate cash flows, Issuer will be charged fees for processing corporate cash flows and any resultant tax documents or customer inquiries per the schedule as published from time to time by Folio on a webpage made available to you, which fees are subject to change at any time in the sole discretion of Folio. Note that such fees only apply to the processing of these actions for Private Securities, not those publicly traded securities for which such actions are processed via DTCC.
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c.
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Private Securities Review for Purchase by IRA Accounts – to the extent Issuer requests that the Private Securities to be available for purchase by IRA accounts, a one-time fee will be charged per Private Security identified on Schedule A for evaluation, which may or may not result in approval. This fee currently is $300 and is subject to change at any time in the sole discretion of Folio.
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d.
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Supplemental Tax Document Processing – to the extent Issuer requests document processing services beyond the activities set forth in Schedule B, including, but not limited to, processing document corrections based on reclassification of disbursements or additional processing of tax documents (e.g., corrected 1099s), additional fees may be charged at the time and at the rate incurred by Folio plus overhead.
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e.
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Private Securities Transfers and Secondary Transactions – to the extent Issuer requests that Folio maintain any restrictions on the transfer of beneficial ownership, or allows for transfers of its securities, Folio will, in good faith, attempt to prevent transfers of the Private Securities without Issuer’s consent, except as required by or pursuant to operation of Law. Issuer will be charged fees for processing such transfers per the schedule as published from time to time by Folio on a webpage made available to you, which fees are subject to change at any time in the sole discretion of Folio.
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f.
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DTCC eligibility filing on UW Source – to the extent Issuer requests that Folio file for DTCC eligibility using the DTCC UW Source application, a one-time fee will be charged per Private Security identified on Schedule A for submission, which may or may not result in DTCC approval. This fee currently is $10,000 and is subject to change at any time in the sole discretion of Folio. For DTCC eligibility applications outside of the UW Source application, this fee will increase to reflect DTCCs higher fee for applications submitted outside of UW Source. Additional fees apply for Folio to refile a DTCC submission. The issuer is responsible for obtaining a CUSIP for its offering prior to the DTCC submission, and providing that CUSIP, finalized offering documents (SEC qualified for Reg A) if applicable, and a legal opinion to Folio for submission to DTCC.
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7.
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Fees to Folio Customers. Folio in its sole discretion may charge fees to Folio Customers that are related to the brokerage account or activities in the brokerage account with Folio, which can generally be accessed here: https://www.folioinvesting.com/folioinvesting/pricing/special-services-fees/ but customers will not be charged any fees for purchasing the Private Securities in the Offering.
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