Delaware
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26-2593535
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(State or other jurisdiction of Incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, $0.0001 par value per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
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o |
Accelerated filer
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o |
Non-accelerated filer
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o |
Smaller reporting company
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þ |
(Do not check if a smaller reporting company)
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PART I
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3 | |||
ITEM 1—BUSINESS
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8 | |||
ITEM 1A—RISK FACTORS
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21 | |||
ITEM 1B—UNRESOLVED STAFF COMMENTS
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21 | |||
ITEM 2—PROPERTIES
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22 | |||
ITEM 3—LEGAL PROCEEDINGS
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22 | |||
ITEM 4— MINE SAFETY DISCLOSURES
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23 | |||
PART II
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23 | |||
ITEM 5—MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
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23 | |||
ITEM 6—SELECTED FINANCIAL DATA
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24 | |||
ITEM 7—MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
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24 | |||
ITEM 7A—QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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31 | |||
ITEM 8—CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
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31 | |||
ITEM 9—CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
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65 | |||
ITEM 9A—CONTROLS AND PROCEDURES
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65 | |||
I
TEM 9B— OTHER INFORMATION
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66 | |||
PART III
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66 | |||
ITEM 10— DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
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66 | |||
ITEM 11— EXECUTIVE COMPENSATION
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66 | |||
ITEM 12— SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS
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66 | |||
ITEM 13— CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
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66 | |||
ITEM 14— PRINCIPAL ACCOUNTANT FEES AND SERVICES
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66 | |||
PART IV
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67 | |||
ITEM 15— EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
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67 |
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increased cardiac contractility by calcium sensitization of troponin C;
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-
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vasodilation through the opening of potassium channels; and
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cardioprotection and antiapoptopic effect through the opening of mitochondrial potassium channel.
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sustained hemodynamic improvement;
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diminished myocardial injury;
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improved tissue perfusion;
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better outcomes and fewer hospital days;
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effects most favorable in patients with low left ventricular ejection fraction (LVEF) (< 40%); and
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opportunity to initiate therapy pre-operatively due to increased cardiac contractility without increasing intracellular calcium, without increasing oxygen consumption, or affecting cardiac rhythm and relaxation.
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three U.S. patents (5,824,703; 5,840,767; 6,167,887), three Australian patents (690,277; 722,417; 759,557), and two Canadian patents (2,239,170; 2,311,122) pertaining to the use and application of PFCs as gas transport agents in blood substitutes and liquid ventilation with an average remaining life of approximately 3 years;
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exclusive in-licenses to three fundamental gas transport patent applications that represent the core technology used in our products and product candidates
(other than levosimendan)
with an average remaining life of approximately 15 years; and
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one U.S. patent (8,513,309) and numerous patent applications for treatment of several medical and dermatological conditions such as TBI, acne, burns and wounds with an average remaining life of approximately 16 years.
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methods to treat certain diseases and conditions and for biological gas exchange;
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therapies for burn and wound victims;
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delivery of oxygenated PFC;
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various formulations containing PFC; and
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methods and compositions for controlled and sustained production and delivery of peroxide and/or oxygen for biological and industrial applications.
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our ability to obtain additional funding to develop our product candidates;
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the need to obtain regulatory approval of our most advanced product candidates;
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potential risks related to any collaborations we may enter into for our product candidates;
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delays in the commencement, enrollment and completion of clinical testing, as well as the analysis and reporting of results from such clinical testing;
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the success of clinical trials of our Oxycyte and levosimendan product candidates or future product candidates;
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any delays in regulatory review and approval of product candidates in development;
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our ability to establish an effective sales and marketing infrastructure;
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competition from existing products or new products that may emerge;
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the ability to receive regulatory approval or commercialize our products;
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potential side effects of our product candidates that could delay or prevent commercialization;
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potential product liability claims and adverse events;
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potential liabilities associated with hazardous materials;
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our ability to maintain adequate insurance policies;
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our dependency on third-party manufacturers to supply or manufacture our products;
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our ability to establish or maintain collaborations, licensing or other arrangements;
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our ability, our partners’ abilities, and third parties’ abilities to protect and assert intellectual property rights;
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costs related to and outcomes of potential litigation;
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compliance with obligations under intellectual property licenses with third parties;
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our ability to adequately support future growth; and
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our ability to attract and retain key personnel to manage our business effectively.
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the scope, rate of progress and cost of our clinical trials and other research and development activities;
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the costs and timing of regulatory approval;
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the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
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the effect of competing technological and market developments;
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the terms and timing of any collaboration, licensing or other arrangements that we may establish;
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the cost and timing of completion of clinical and commercial-scale manufacturing activities; and
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the costs of establishing sales, marketing and distribution capabilities for our cosmetic products and any product candidates for which we may receive regulatory approval.
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we may not be able to control the amount and timing of resources that our partners may devote to the development or commercialization of our product candidates or to their marketing and distribution;
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partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
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disputes may arise between us and our partners that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and resources;
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partners may experience financial difficulties;
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partners may not properly maintain or defend our intellectual property rights, or may use our proprietary information, in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potential litigation;
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business combinations or significant changes in a partner’s business strategy may adversely affect a partner’s willingness or ability to meet its obligations under any arrangement;
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a partner could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and
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the collaborations with our partners may be terminated or allowed to expire, which would delay the development and may increase the cost of developing our product candidates.
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reaching agreements on acceptable terms with prospective contract research organizations, or CROs, and 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 regulatory approval to commence a clinical trial;
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obtaining institutional review board, or IRB, approval to conduct a clinical trial at numerous prospective sites;
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recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as our product candidates;
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retaining patients who have initiated a clinical trial but may be prone to withdraw due to the treatment protocol, lack of efficacy, personal issues or side effects from the therapy or who are lost to further follow-up;
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maintaining and supplying clinical trial material on a timely basis; and
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collecting, analyzing and reporting final data from the clinical trials.
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
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inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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unforeseen safety issues or any determination that a trial presents unacceptable health risks; and
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lack of adequate funding to continue the clinical trial, including unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties.
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The data obtained from laboratory testing and clinical trials are susceptible to varying interpretations, which could delay, limit or prevent FDA and other regulatory approvals;
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Adverse events could cause the FDA and other regulatory authorities to halt trials;
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At any time the FDA and other regulatory agencies could change policies and regulations that could result in delay and perhaps rejection of our products; and
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Even after extensive testing and clinical trials, there is no assurance that regulatory approval will ever be obtained for any of our products.
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The federal anti-kickback statute is a criminal statute that makes it a felony for individuals or entities knowingly and willfully to offer or pay, or to solicit or receive, direct or indirect remuneration, in order to induce the purchase, order, lease, or recommending of items or services, or the referral of patients for services, that are reimbursed under a federal health care program, including Medicare and Medicaid;
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The federal False Claims Act imposes liability on any person who knowingly submits, or causes another person or entity to submit, a false claim for payment of government funds. Penalties include three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim. In addition, the False Claims Act permits a person with knowledge of fraud, referred to as a qui tam plaintiff, to file a lawsuit on behalf of the government against the person or business that committed the fraud, and, if the action is successful, the qui tam plaintiff is rewarded with a percentage of the recovery;
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Health Insurance Portability and Accountability Act imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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The Social Security Act contains numerous provisions allowing the imposition of a civil money penalty, a monetary assessment, exclusion from the Medicare and Medicaid programs, or some combination of these penalties; and
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Many states have analogous state laws and regulations, such as state anti-kickback and false claims laws. In some cases, these state laws impose more strict requirements than the federal laws. Some state laws also require pharmaceutical companies to comply with certain price reporting and other compliance requirements.
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Our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
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The inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our products;
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The lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
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Unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.
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We may be required to relinquish important rights to our products or product candidates;
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We may not be able to control the amount and timing of resources that our distributors or collaborators may devote to the commercialization of our product candidates;
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Our distributors or collaborators may experience financial difficulties;
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Our distributors or collaborators may not devote sufficient time to the marketing and sales of our products; and
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Business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement.
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others may be able to make compositions or formulations that are similar to our product candidates but that are not covered by the claims of our patents;
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we might not have been the first to make the inventions covered by our issued patents or pending patent applications;
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we might not have been the first to file patent applications for these inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies;
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it is possible that our pending patent applications will not result in issued patents;
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our issued patents may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
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we may not develop additional proprietary technologies that are patentable; or
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the patents of others may have an adverse effect on our business.
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These agreements may be breached;
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These agreements may not provide adequate remedies for the applicable type of breach; or
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Our trade secrets or proprietary know-how will otherwise become known.
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Decreased demand for our products and any product candidates that we may develop;
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Injury to our reputation;
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Withdrawal of clinical trial participants;
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Costs to defend the related litigation;
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Substantial monetary awards to trial participants or patients;
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Loss of revenue; and
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The inability to commercialize any products that we may develop.
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actual or anticipated fluctuations in our financial condition and operating results;
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status and/or results of our clinical trials;
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status of ongoing litigation;
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results of clinical trials of our competitors’ products;
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regulatory actions with respect to our products or our competitors’ products;
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actions and decisions by our collaborators or partners;
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actual or anticipated changes in our growth rate relative to our competitors;
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actual or anticipated fluctuations in our competitors’ operating results or changes in their growth rate;
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competition from existing products or new products that may emerge;
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issuance of new or updated research or reports by securities analysts;
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fluctuations in the valuation of companies perceived by investors to be comparable to us;
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share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
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market conditions for biopharmaceutical stocks in general;
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status of our search and selection of future management and leadership; and
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general economic and market conditions.
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Year-Ended April 30, 2013
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High
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Low
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||||||
First Quarter
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$ | 45.00 | $ | 21.40 | ||||
Second Quarter
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$ | 24.20 | $ | 10.40 | ||||
Third Quarter
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$ | 22.00 | $ | 10.40 | ||||
Fourth Quarter
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$ | 15.80 | $ | 3.60 |
Year-Ended April 30, 2014
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High
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Low
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||||||
First Quarter
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$ | 5.69 | $ | 1.40 | ||||
Second Quarter
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$ | 3.46 | $ | 1.19 | ||||
Third Quarter
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$ | 11.40 | $ | 3.04 | ||||
Fourth Quarter
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$ | 8.35 | $ | 4.46 |
Issuer Purchases of Equity Securities
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Total Number of Shares Purchased (1)
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Average Price Paid per Share (2)
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Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
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Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs
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||||||||||||
Period
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||||||||||||||||
February 1, 2014 - February 28, 2014
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20 | $ | 6.18 | - | $ | - | ||||||||||
March 1, 2014 - March 31, 2014
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20 | 6.47 | - | - | ||||||||||||
April 1, 2014 - April 30, 2014
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19 | 5.55 | - | - | ||||||||||||
Total
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59 | $ | 6.08 | - | $ | - |
(1)
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Represents shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
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(2)
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Represents the average price paid per share for the shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
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Year ended April 30,
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Increase/ (Decrease)
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% Increase/ (Decrease)
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||||||||||||||
2014
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2013
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|||||||||||||||
Product revenue
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$ | 25,731 | $ | 92,683 | $ | (66,952 | ) | (72 | ) % | |||||||
Cost of sales
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129,800 | 43,111 | 86,689 | 201 | % | |||||||||||
Gross profit
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$ | (104,069 | ) | $ | 49,572 | $ | (153,641 | ) | (310 | ) % |
Year ended April 30,
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Increase/ (Decrease)
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% Increase/ (Decrease)
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||||||||||||||
2014
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2013
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|||||||||||||||
Government grant revenue
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$ | 262,995 | $ | 1,141,356 | $ | (878,361 | ) | (77 | ) % |
Year ended April 30,
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Increase/ (Decrease)
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% Increase/ (Decrease)
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||||||||||||||
2014
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2013
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|||||||||||||||
Marketing and sales expense
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$ | 102 | $ | 108,165 | $ | (108,063 | ) | (100 | ) % |
Year ended April 30,
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Increase/ (Decrease)
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% Increase/ (Decrease)
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||||||||||||||
2014
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2013
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|||||||||||||||
Personnel costs
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$ | 10,593,234 | $ | 1,490,752 | $ | 9,102,482 | 611 | % | ||||||||
Legal and professional fees
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2,556,643 | 2,005,311 | 551,332 | 27 | % | |||||||||||
Other costs
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350,855 | (206,788 | ) | 557,643 | 270 | % | ||||||||||
Facilities
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157,449 | 167,693 | (10,244 | ) | (6 | ) % | ||||||||||
Depreciation and amortization
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115,042 | 111,012 | 4,030 | 4 | % |
-
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Audit and accounting fees increased approximately $55,000 due to the costs incurred for valuation services related to the Phyxius acquisition and the filing of registration statements in the current year.
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-
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Investor relation fees increased approximately $560,000 for the costs of outsourced corporate communications firms, road shows and attending investor conferences.
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Legal fees decreased approximately $40,000 due primarily to approximately $285,000 in fees incurred in the prior year for litigation defense costs, partially offset by an increase of approximately $245,000 in fees related to the Phyxius acquisition and the filing of registration statements in the current year.
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Recruiting fees decreased approximately $25,000 due to headcount additions in the prior year.
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Year ended April 30,
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Increase/ (Decrease)
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% Increase/ (Decrease)
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||||||||||||||
2014
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2013
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|||||||||||||||
Clinical and preclinical development
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$ | 1,947,461 | $ | 1,569,594 | $ | 377,867 | 24 | % | ||||||||
Personnel costs
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818,264 | 637,685 | 180,579 | 28 | % | |||||||||||
Consulting
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153,506 | 117,211 | 36,295 | 31 | % | |||||||||||
Depreciation
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41,199 | 42,968 | (1,769 | ) | (4 | ) % | ||||||||||
Other costs
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26,028 | 32,652 | (6,624 | ) | (20 | ) % | ||||||||||
Facilities
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10,263 | 55,706 | (45,443 | ) | (82 | ) % |
Year ended April 30,
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Increase/ (Decrease)
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% Increase/ (Decrease)
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||||||||||||||
2014
|
2013
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|||||||||||||||
Restructuring expense
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$ | - | $ | 220,715 | $ | (220,715 | ) | — | % |
Year ended April 30,
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Increase/ (Decrease)
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% Increase/ (Decrease)
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||||||||||||||
2014
|
2013
|
|||||||||||||||
Interest expense
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$ | 2,212,283 | $ | 4,238,456 | $ | (2,026,173 | ) | (48 | ) % |
Year ended April 30,
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Increase/ (Decrease)
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|||||||||||
2014
|
2013
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|||||||||||
Other expense (income), net
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$ | 718,436 | $ | (11,683 | ) | $ | 730,119 |
Year ended April 30,
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2014
|
2013
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|||||||
Net cash used in operating activities
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$ | (9,261,571 | ) | $ | (4,921,283 | ) | ||
Net cash used in investing activities
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(147,038 | ) | (147,987 | ) | ||||
Net cash provided by financing activities
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66,945,636 | 3,972,926 |
-
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The initiation, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
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-
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The outcome, timing and cost of regulatory approvals and the regulatory approval process;
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Delays that may be caused by changing regulatory requirements;
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-
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The number of product candidates that we pursue;
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-
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The costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
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The timing and terms of future in-licensing and out-licensing transactions;
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The cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
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-
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The cost of procuring clinical and commercial supplies of our product candidates;
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-
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The extent to which we acquire or invest in businesses, products or technologies; and
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-
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The possible costs of litigation.
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-
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Fees paid to CROs in connection with clinical trials,
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-
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Fees paid to research institutions in conjunction with preclinical research studies, and
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-
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Fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials.
|
CONSOLIDATED BALANCE SHEETS
|
33
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CONSOLIDATED STATEMENTS OF OPERATIONS
|
34
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CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
|
35
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CONSOLIDATED STATEMENTS OF CASH FLOWS
|
36
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CONSOLIDATED STATEMENTS OF CASH FLOWS, continued
|
37
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
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38
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April 30,
2014
|
April 30,
2013
|
|||||||
ASSETS
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||||||||
Current assets
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||||||||
Cash and cash equivalents
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$ | 58,320,555 | $ | 783,528 | ||||
Accounts receivable
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36,358 | 445,237 | ||||||
Government grant receivable
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29,750 | 96,226 | ||||||
Inventory
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- | 99,204 | ||||||
Prepaid expenses
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401,964 | 247,646 | ||||||
Other current assets
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177,406 | 170,410 | ||||||
Total current assets
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58,966,033 | 1,842,251 | ||||||
Property and equipment, net
|
124,374 | 205,389 | ||||||
Debt issuance costs, net
|
21,427 | 150,043 | ||||||
Intangible assets, net
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22,999,744 | 924,698 | ||||||
Goodwill
|
11,265,100 | - | ||||||
Other assets
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52,762 | 58,262 | ||||||
Total assets
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$ | 93,429,440 | $ | 3,180,643 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current liabilities
|
||||||||
Accounts payable
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$ | 411,145 | $ | 977,162 | ||||
Accrued liabilities
|
858,136 | 874,876 | ||||||
Warrant liabilities
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954,876 | - | ||||||
Current portion of notes payable, net
|
346,890 | 57,539 | ||||||
Total current liabilities
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2,571,047 | 1,909,577 | ||||||
Other liabilities
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10,932 | 54,660 | ||||||
Deferred tax liability
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7,962,100 | - | ||||||
Long-term portion of notes payable, net
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- | 2,994,442 | ||||||
Total liabilities
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10,544,079 | 4,958,679 | ||||||
Commitments and contingencies; see Note I.
|
||||||||
Stockholders' equity (deficit)
|
||||||||
Preferred stock, undesignated, authorized 9,947,439 and 9,990,400 shares; respectively. See Note G.
|
||||||||
Series B Preferred stock, par value $.0001, issued 2,100 shares; outstanding 0 and 987, respectively.
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- | 1 | ||||||
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 27,858,000 and 1,930,078, respectively
|
2,786 | 193 | ||||||
Additional paid-in capital
|
219,468,498 | 115,265,854 | ||||||
Accumulated deficit
|
(136,585,923 | ) | (117,044,084 | ) | ||||
Total stockholders’ equity (deficit)
|
82,885,361 | (1,778,036 | ) | |||||
Total liabilities and stockholders' equity (deficit)
|
$ | 93,429,440 | $ | 3,180,643 |
Year ended April 30,
|
||||||||
2014
|
2013
|
|||||||
Product revenue
|
$ | 25,731 | $ | 92,683 | ||||
Cost of sales
|
129,800 | 43,111 | ||||||
Net product revenue
|
(104,069 | ) | 49,572 | |||||
Government grant revenue
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262,995 | 1,141,356 | ||||||
Total net revenue
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158,926 | 1,190,928 | ||||||
Operating expenses
|
||||||||
Selling, general, and administrative
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13,773,325 | 3,676,145 | ||||||
Research and development
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2,996,721 | 2,455,816 | ||||||
Restructuring expense
|
- | 220,715 | ||||||
Loss on impairment of long-lived assets
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- | 27,279 | ||||||
Total operating expenses
|
16,770,046 | 6,379,955 | ||||||
Net operating loss
|
16,611,120 | 5,189,027 | ||||||
Interest expense
|
2,212,283 | 4,238,456 | ||||||
Other expense (income)
|
718,436 | (11,683 | ) | |||||
Net loss
|
$ | 19,541,839 | $ | 9,415,800 | ||||
Preferred stock dividend
|
5,803,362 | 958,071 | ||||||
Net loss attributable to common stockholders
|
$ | 25,345,201 | $ | 10,373,871 | ||||
Net loss per share, basic
|
$ | (2.71 | ) | $ | (6.29 | ) | ||
Weighted average number of common shares outstanding, basic
|
9,362,031 | 1,650,280 | ||||||
Net loss per share, diluted
|
$ | (2.71 | ) | $ | (6.68 | ) | ||
Weighted average number of common shares outstanding, diluted
|
9,362,031 | 1,759,025 |
Preferred Stock
|
Common Stock
|
|||||||||||||||||||||||||||
Number of Shares
|
Amount
|
Number of Shares
|
Amount
|
Additional paid-in capital
|
Accumulated deficit |
Total stockholders' equity (deficit)
|
||||||||||||||||||||||
Balance at April 30, 2012
|
- | $ | - | 1,470,890 | $ | 2,942 | $ | 107,279,296 | $ | (107,628,284 | ) | $ | (346,046 | ) | ||||||||||||||
Preferred stock sold, net of offering costs
|
2,100 | 1 | 1,851,149 | 1,851,150 | ||||||||||||||||||||||||
Common stock sold, net of offering costs
|
- | |||||||||||||||||||||||||||
Common stock issued for convertible preferred stock
|
(1,113 | ) | 400,708 | 804 | 4,509,184 | 4,509,988 | ||||||||||||||||||||||
Common stock issued as interest on convertible debt
|
16,524 | 33 | 745,175 | 745,208 | ||||||||||||||||||||||||
Common stock issued as dividend on convertible preferred stock
|
17,409 | 32 | 331,366 | 331,398 | ||||||||||||||||||||||||
Compensation on options and restricted stock issued
|
4,465 | 9 | 269,522 | 269,531 | ||||||||||||||||||||||||
Issuance of warrants
|
656,535 | 656,535 | ||||||||||||||||||||||||||
Exchange of warrants
|
20,000 | 40 | (380,040 | ) | (380,000 | ) | ||||||||||||||||||||||
Beneficial conversion feature of convertible debt
|
- | |||||||||||||||||||||||||||
Fractional shares of common stock due to reverse stock split
|
82 | (3,667 | ) | 3,667 | - | |||||||||||||||||||||||
Net loss
|
(9,415,800 | ) | (9,415,800 | ) | ||||||||||||||||||||||||
Balance at April 30, 2013
|
987 | $ | 1 | 1,930,078 | $ | 193 | $ | 115,265,854 | $ | (117,044,084 | ) | $ | (1,778,036 | ) | ||||||||||||||
Preferred stock sold, net of offering costs
|
5,369 | 1 | 4,895,187 | 4,895,188 | ||||||||||||||||||||||||
Preferred stock issued for convertible debt
|
4,600 | 3 | 4,599,997 | 4,600,000 | ||||||||||||||||||||||||
Common and preferred stock issued for asset purchase
|
32,992 | 3 | 1,366,844 | 137 | 24,046,860 | 24,047,000 | ||||||||||||||||||||||
Common stock sold, net of offering costs
|
10,678,571 | 1,068 | 54,907,282 | 54,908,350 | ||||||||||||||||||||||||
Common stock issued for convertible preferred stock
|
(43,948 | ) | (8 | ) | 9,056,415 | 906 | (898 | ) | - | |||||||||||||||||||
Common stock issued as interest on convertible debt
|
4,881 | 1 | 220,040 | 220,041 | ||||||||||||||||||||||||
Common stock issued as dividend on convertible preferred stock
|
1,407,485 | 140 | (140 | ) | - | |||||||||||||||||||||||
Compensation on options and restricted stock issued
|
50,144 | 5 | 8,131,619 | 8,131,624 | ||||||||||||||||||||||||
Common stock issued for services rendered
|
198,668 | 20 | 499,980 | 500,000 | ||||||||||||||||||||||||
Exercise of warrants
|
3,161,145 | 316 | 7,135,753 | 7,136,069 | ||||||||||||||||||||||||
Reclassification of warrants from equity to derivative liability
|
(233,036 | ) | (233,036 | ) | ||||||||||||||||||||||||
Fractional shares of common stock due to reverse stock split
|
3,769 | - | ||||||||||||||||||||||||||
Net loss
|
(19,541,839 | ) | (19,541,839 | ) | ||||||||||||||||||||||||
Balance at April 30, 2014
|
- | $ | - | 27,858,000 | $ | 2,786 | $ | 219,468,498 | $ | (136,585,923 | ) | $ | 82,885,361 |
Year ended April 30,
|
||||||||
2014
|
2013
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net Loss
|
$ | (19,541,839 | ) | $ | (9,415,800 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||
Depreciation and amortization
|
150,489 | 148,804 | ||||||
Interest on debt instruments
|
2,181,955 | 4,236,332 | ||||||
Loss on impairment, disposal and write down of long-lived assets
|
2,519 | 35,673 | ||||||
Issuance and vesting of compensatory stock options and warrants
|
8,042,662 | 84,267 | ||||||
Issuance of common stock as compensation
|
651,460 | 185,264 | ||||||
Change in the fair value of warrants
|
721,840 | - | ||||||
Changes in operating assets and liabilities
|
||||||||
Accounts receivable, prepaid expenses and other assets
|
519,255 | (245,747 | ) | |||||
Inventory
|
99,204 | (20,228 | ) | |||||
Accounts payable and accrued liabilities
|
(2,089,116 | ) | 70,152 | |||||
Net cash used in operating activities
|
(9,261,571 | ) | (4,921,283 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Purchase of property and equipment
|
(9,804 | ) | (17,199 | ) | ||||
Proceeds from the sale of property and equipment
|
- | 4,064 | ||||||
Capitalization of patent costs and license rights
|
(137,234 | ) | (134,852 | ) | ||||
Net cash used in investing activities
|
(147,038 | ) | (147,987 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
|
62,044,419 | - | ||||||
Repurchase of outstanding warrants
|
- | (380,000 | ) | |||||
Proceeds from issuance of notes payable, net of issuance costs
|
141,320 | 102,671 | ||||||
Proceeds for issuance of convertible preferred stock, net of issuance costs
|
4,895,188 | 4,351,150 | ||||||
Payments on notes - short-term
|
(135,291 | ) | (100,895 | ) | ||||
Net cash provided by financing activities
|
66,945,636 | 3,972,926 | ||||||
Net change in cash and cash equivalents
|
57,537,027 | (1,096,344 | ) | |||||
Cash and cash equivalents, beginning of period
|
783,528 | 1,879,872 | ||||||
Cash and cash equivalents, end of period
|
$ | 58,320,555 | $ | 783,528 | ||||
Cash paid for:
|
||||||||
Interest
|
$ | 30,328 | $ | 2,123 | ||||
Income taxes
|
$ | - | $ | - |
-
The Company issued 4,881 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $45.10 for the payment of $220,041 interest payable on convertible notes with a gross carrying value of $4,900,000.
|
-
The Company issued 831,401 shares of its common stock for the payment of $
1,300,204
as dividends on the Series C 8% Convertible Preferred stock.
-
The Company issued 4,600 shares of Series D 8% Convertible Preferred Stock as consideration for cancellation of $4.6 million in outstanding principal amount of a convertible promissory note issued by the Company on July 1, 2011.
-
The Company issued 576,084 shares of its common stock for the payment of $1,104,000 as dividends on the Series D 8% Convertible Preferred stock.
-
The Company issued 1,366,844 shares of its common stock that had a fair value of approximately $8.7 million and 32,992 shares of its Series E Convertible Preferred Stock, which are convertible into an aggregate of 3,299,200 shares of common stock, that had a fair value of approximately $15.3 million in exchange for the assets of Phyxius Pharma, Inc., as further discussed in Note D to these consolidated financial statements. The Company recorded Goodwill of
$11,265,100
as a result of this issuance.
|
-
The Company issued 16,524 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $45.11 for the payment of $745,208 interest payable on convertible notes with a gross carrying value of $4,900,000.
|
-
The Company issued 191,934 shares of its common stock upon the conversion of 3,668 shares of Series A convertible preferred stock with a fair value of $4,509,987.
|
-
|
Fees paid to CROs in connection with clinical trials,
|
-
|
Fees paid to research institutions in conjunction with preclinical research studies, and
|
-
|
Fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials.
|
Laboratory equipment
|
3 – 5 years
|
Office equipment
|
5 years
|
Office furniture and fixtures
|
7 years
|
Computer equipment and software
|
3 years
|
Leasehold improvements
|
Shorter of useful life or remaining lease term
|
Year ended April 30,
|
||||||||
2014
|
2013
|
|||||||
Historical net loss per share:
|
||||||||
Numerator
|
||||||||
Net loss, attributable to common stockholders
|
$ | (25,345,201 | ) | $ | (10,373,871 | ) | ||
Less: Effect of amortization of interest expense on convertible notes
|
- | (1,382,537 | ) | |||||
Net loss attributable to common stockholders (diluted)
|
(25,345,201 | ) | (11,756,408 | ) | ||||
Denominator
|
||||||||
Weighted-average common shares outstanding
|
9,362,031 | 1,650,280 | ||||||
Effect of dilutive securities
|
- | 108,745 | ||||||
Denominator for diluted net loss per share
|
9,362,031 | 1,759,025 | ||||||
Basic net loss per share
|
$ | (2.71 | ) | $ | (6.29 | ) | ||
Diluted net loss per share
|
$ | (2.71 | ) | $ | (6.68 | ) |
Year ended April 30,
|
||||||||
2014
|
2013
|
|||||||
Options to purchase common stock
|
3,647,858 | 11,336 | ||||||
Warrants to purchase common stock
|
2,762,466 | 759,410 | ||||||
Restricted stock grants
|
42,478 | 1,917 | ||||||
Convertible note shares outstanding
|
6,652 | 98 | ||||||
Convertible preferred shares outstanding
|
- | 97,400 |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Balance as of April 30, 2014
|
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|||||||||||||
Current Assets
|
||||||||||||||||
Cash and cash equivalents
|
$ | 58,320,555 | $ | 58,320,555 | $ | - | $ | - | ||||||||
Current Liabilities
|
||||||||||||||||
Warrant liabilities
|
$ | 954,876 | $ | - | $ | - | $ | 954,876 |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Balance as of April 30, 2013
|
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|||||||||||||
Current Assets
|
||||||||||||||||
Cash and cash equivalents
|
$ | 783,528 | $ | 783,528 | $ | - | $ | - | ||||||||
Current Liabilities
|
||||||||||||||||
Warrant liabilities
|
$ | - | $ | - | $ | - | $ | - |
Series C Warrants
|
April 30,
2014
|
April 30,
2013
|
||||||
Closing stock price
|
$ | 4.88 | $ | - | ||||
Expected dividend rate
|
0 | % | - | % | ||||
Expected stock price volatility
|
90.32 | % | - | % | ||||
Risk-free interest rate
|
1.75 | % | - | % | ||||
Expected life (years)
|
5.23 | - |
April 30,
2014
|
April 30,
2013
|
|||||||
Raw materials
|
$ | - | $ | 28,779 | ||||
Finished goods
|
- | 70,425 | ||||||
$ | - | $ | 99,204 |
April 30,
2014
|
April 30,
2013
|
|||||||
R&D materials
|
$ | 177,406 | $ | 159,892 | ||||
Other
|
- | 7,090 | ||||||
Dermacyte samples
|
- | 3,428 | ||||||
$ | 177,406 | $ | 170,410 |
April 30,
2014
|
April 30,
2013
|
|||||||
Laboratory equipment
|
$ | 683,632 | $ | 768,252 | ||||
Computer equipment and software
|
142,380 | 135,697 | ||||||
Office furniture and fixtures
|
130,192 | 130,192 | ||||||
956,204 | 1,034,141 | |||||||
Less: Accumulated depreciation and amortization
|
(831,830 | ) | (828,752 | ) | ||||
$ | 124,374 | $ | 205,389 |
April 30,
2014
|
April 30,
2013
|
|||||||
Employee related
|
$ | 609,130 | $ | 66,632 | ||||
Deferred revenue
|
124,521 | 185,068 | ||||||
Operating costs
|
76,632 | 19,865 | ||||||
Restructuring liability
|
43,728 | 43,728 | ||||||
Convertible note interest payable
|
4,125 | 59,583 | ||||||
Accrued settlement costs
|
- | 500,000 | ||||||
$ | 858,136 | $ | 874,876 |
April 30,
2014
|
April 30,
2013
|
|||||||
Net non-cancelable operating lease obligation
|
$ | 54,660 | $ | 98,388 | ||||
Less: current portion
|
(43,728 | ) | (43,728 | ) | ||||
Long-term portion of net non-cancelable operating lease obligation
|
$ | 10,932 | $ | 54,660 |
Common stock
|
8,747,802 | |||
Series E convertible preferred stock
|
15,299,198 | |||
Total
|
24,047,000 |
-
|
Exercise price equal to the common stock price as of the Valuation Date.
|
-
|
Term based on management’s risk-adjusted expected time to meeting the vesting condition, which was further increased by 6 months to reflect the marketability restriction of the unregistered stock, consistent with SEC Rule 144 of the Securities Act.
|
-
|
Volatility was consistent with the term for the individual milestone payments derived from the median historical asset volatility for a set of comparable guideline companies. The volatility was then relevered to estimate the equity volatility of the Company.
|
November 13,
2013
|
Measurement
|
November 13,
2013
|
||||||||||
(As initially reported)
|
Period Adjustments (1)
|
(As adjusted)
|
||||||||||
IPR&D
|
$ | 22,000,000 | $ | - | $ | 22,000,000 | ||||||
Trade and other payables
|
(256,000 | ) | - | (256,000 | ) | |||||||
Liabilities arising from a contingency
|
(1,000,000 | ) | - | (1,000,000 | ) | |||||||
Deferred tax liability related to intangibles acquired
|
- | (7,962,100 | ) | (7,962,100 | ) | |||||||
Total identifiable net assets
|
20,744,000 | (7,962,100 | ) | 12,781,900 | ||||||||
Goodwill
|
3,303,000 | 7,962,100 | 11,265,100 | |||||||||
Total fair value of consideration
|
$ | 24,047,000 | $ | - | $ | 24,047,000 |
(1)
|
The measurement period adjustments primarily reflect the recording of a deferred tax liability and resulting goodwill. The measurement period adjustments were made to reflect facts and circumstances existing as of the acquisition date and did not result from intervening events subsequent to the acquisition date.
|
Year ended April 30,
|
||||||||
2014
|
2013
|
|||||||
Total net revenue
|
158,926 | 1,190,928 | ||||||
Net loss
|
$ | 19,560,030 | $ | 9,418,395 | ||||
Net loss attributable to common stockholders
|
$ | 25,363,392 | $ | 10,376,466 | ||||
Net loss per share, basic
|
$ | (2.37 | ) | $ | (3.44 | ) | ||
Weighted average number of common shares outstanding, basic
|
10,717,037 | 3,017,124 | ||||||
Net loss per share, diluted
|
$ | (2.37 | ) | $ | (3.76 | ) | ||
Weighted average number of common shares outstanding, diluted
|
10,717,037 | 3,125,869 |
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
||||||||||||||
IPR&D
|
$ | 22,000,000 | N/A | $ | - | $ | - | $ | 22,000,000 | ||||||||||
Patents
|
724,067 | 10.8 | - | (289,943 | ) | 434,124 | |||||||||||||
License Rights
|
607,947 | 14.6 | - | (148,713 | ) | 459,234 | |||||||||||||
Trademarks
|
106,386 | N/A | - | - | 106,386 | ||||||||||||||
Total
|
$ | 23,438,400 | $ | - | $ | (438,656 | ) | $ | 22,999,744 |
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
||||||||||||||
Patents
|
$ | 645,918 | 11.2 | $ | (27,279 | ) | $ | (258,499 | ) | $ | 360,140 | ||||||||
License Rights
|
572,370 | 15.6 | - | (117,969 | ) | 454,401 | |||||||||||||
Trademarks
|
110,157 | N/A | - | - | 110,157 | ||||||||||||||
Total
|
$ | 1,328,445 | $ | (27,279 | ) | $ | (376,468 | ) | $ | 924,698 |
Year ending April 30,
|
Amount
|
|||
2015
|
$ | 66,525 | ||
2016
|
65,949 | |||
2017
|
62,032 | |||
2018
|
61,239 | |||
2019
|
61,111 | |||
Therafter
|
576,502 | |||
$ | 893,358 |
April 30,
2014
|
April 30,
2013
|
|||||||
Current portion of notes payable, net
|
$ | 63,568 | $ | 57,539 | ||||
Current portion of convertible notes payable
|
300,000 | - | ||||||
Less: Unamortized discount
|
(16,678 | ) | ||||||
Current portion of notes payable, net
|
$ | 346,890 | $ | 57,539 | ||||
Long-term portion of convertible notes payable
|
$ | - | $ | 4,900,001 | ||||
Less: Unamortized discount
|
- | (1,905,559 | ) | |||||
Long-term portion of notes payable, net
|
$ | - | $ | 2,994,442 |
Conversion
|
Subject to certain ownership limitations, the Series D Stock is convertible at any time at the option of the holder into shares of the Company’s common stock at a conversion ratio determined by dividing the stated value of the Series C Stock (or $1,000) by a conversion price of $1.95 per share. The conversion price is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.
Until such time that for at least 25 trading days during any 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 250% of the initial conversion price, if the Company sells or grants any option to purchase or sell any common stock or common stock equivalents entitling any person to acquire shares of common stock at an effective price per share that is lower than the then conversion price, or the Base Conversion Price, then the conversion price shall be reduced to equal the Base Conversion Price
|
|
Dividends and Make-Whole Payment
|
Until the third anniversary of the date of issuance of the Series D Stock, the holder of the Series D Stock is entitled to receive dividends at the rate of 8% per annum of the stated value for each share of Series D Stock held by such holder payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the original issue date, and on each dividend payment date. The Company can elect to pay the dividends in cash or in duly authorized, validly issued, fully paid and non-assessable shares of common stock, or a combination thereof. If the Company pays the dividends in shares of common stock, the shares used to pay the dividends will be valued at 90% of the average volume weighted average price for the 20 consecutive trading days ending on the trading day immediately prior to the applicable dividend payment date. From and after the third anniversary of the date of issuance of the Series D Stock, the holder of Series D Stock will be entitled to receive dividends equal, on an as-if-converted to common stock basis, to and in the same form as dividends actually paid on shares of common stock when, as, and if such dividends are paid on shares of common stock. The Company has never paid dividends on its common stock and the Company does not intend to do so for the foreseeable future.
In the event OXBT Fund converts its Series D Stock prior to the third anniversary of the date of issuance of the Series D Stock, the Company must also pay to OXBT Fund in cash, or at the Company’s option in common stock valued as described above, or a combination of cash and shares of common stock, with respect to the Series D Stock so converted, an amount equal to $240 per $1,000 of the stated value of the Series D Stock, less the amount of any dividends paid in cash or in common stock on such Series D Stock on or before the date of conversion.
|
Liquidation
|
Upon any liquidation, dissolution or winding up of the Company after payment or provision for payment of debts and other liabilities of the Company, but before any distribution or payment is made to the holders of any junior securities, the holder of Series D Stock shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders an amount equal to $1,000 per share, after which any remaining assets of the Company shall be distributed among the holders of the other class or series of stock in accordance with the Company’s Certificate of Incorporation.
|
|
Voting rights
|
Shares of Series D Stock will generally have no voting rights, except as required by law and except that the consent of the holder of the outstanding Series D Stock will, among other things, be required to amend the terms of the Series D Stock.
|
Conversion
|
Subject to certain ownership limitations, the Series C Stock is convertible at any time at the option of the holder into shares of the Company’s common stock at a conversion ratio determined by dividing the stated value of the Series C Stock (or $1,000) by a conversion price of $1.95 per share. The conversion price is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions.
Until such time that for at least 25 trading days during any 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 250% of the initial conversion price, if the Company sells or grants any option to purchase or sell any common stock or common stock equivalents entitling any person to acquire shares of common stock at an effective price per share that is lower than the then conversion price, or the Base Conversion Price, then the conversion price shall be reduced to equal the Base Conversion Price
|
Dividends and Make-Whole Payment
|
Until the third anniversary of the date of issuance of the Series C Stock, each holder of the Series C Stock is entitled to receive dividends at the rate of 8% per annum of the stated value for each share of Series C Stock held by such holder payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the original issue date, and on each dividend payment date. The Company can elect to pay the dividends in cash or in duly authorized, validly issued, fully paid and non-assessable shares of common stock, or a combination thereof. If the Company pays the dividends in shares of common stock, the shares used to pay the dividends will be valued at 90% of the average volume weighted average price for the 20 consecutive trading days ending on the trading day immediately prior to the applicable dividend payment date. From and after the third anniversary of the date of issuance of the Series C Stock, each holder of Series C Stock will be entitled to receive dividends equal, on an as-if-converted to common stock basis, to and in the same form as dividends actually paid on shares of common stock when, as, and if such dividends are paid on shares of common stock. The Company has never paid dividends on its common stock and the Company does not intend to do so for the foreseeable future.
In the event a holder converts his, her or its Series C Stock prior to the third anniversary of the date of issuance of the Series C Stock, the Company must also pay to the holder in cash, or at the Company’s option in common stock valued as described above, or a combination of cash and shares of common stock, with respect to the Series C Stock so converted, an amount equal to $240 per $1,000 of the stated value of the Series C Stock, less the amount of any dividends paid in cash or in common stock on such Series C Stock on or before the date of conversion.
|
|
Liquidation
|
Upon any liquidation, dissolution or winding up of the Company after payment or provision for payment of debts and other liabilities of the Company, but before any distribution or payment is made to the holders of any junior securities, the holders of Series C Stock shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders an amount equal to $1,000 per share, after which any remaining assets of the Company shall be distributed among the holders of the other class or series of stock in accordance with the Company’s Certificate of Incorporation.
|
|
Voting rights
|
Shares of Series C Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series C Stock will, among other things, be required to amend the terms of the Series C Stock.
|
Dividends
|
No dividends shall be paid on shares of Preferred Stock.
|
|
Conversion
|
Holders may elect to convert shares of Series B Stock into shares of common stock at the then-existing conversion price at any time. The initial conversion price is $5.00 per share of common stock, and is subject to certain adjustments, including an anti-dilution provision that reduces the conversion price upon the issuance of any common stock or securities convertible into common stock at an effective price per share less than the conversion price and a one-time price reset following the effectiveness of a reverse split of the Company’s outstanding common stock.
|
|
Liquidation preference
|
In the event of the Company’s voluntary or involuntary dissolution, liquidation or winding up, each holder of Series B Stock will be entitled to be paid a liquidation preference equal to the initial stated value of such holder’s Series B Stock of $1,000 per share, plus accrued and unpaid dividends and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Series B Stock.
|
|
Voting rights
|
Shares of Series B Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series B Stock will among other things, be required to amend the terms of the Series B Stock.
|
Warrants
|
Weighted Average Exercise Price
|
|||||||
Outstanding at April 30, 2012
|
261,999 | $ | 41.60 | |||||
Issued
|
658,154 | 6.69 | ||||||
Cancelled
|
(67,568 | ) | 44.40 | |||||
Forfeited
|
(93,175 | ) | 38.40 | |||||
Outstanding at April 30, 2013
|
759,410 | $ | 11.00 | |||||
Issued
|
5,165,862 | 2.60 | ||||||
Exercised
|
(3,161,145 | ) | 2.26 | |||||
Forfeited
|
(1,661 | ) | 126.00 | |||||
Outstanding at April 30, 2014
|
2,762,466 | $ | 4.28 |
Shares Available for Grant
|
||||
Balances, at April 30, 2012
|
276,582 | |||
Options granted
|
(1,595 | ) | ||
Options cancelled/forfeited
|
7,851 | |||
Restricted stock granted
|
(5,318 | ) | ||
Restricted stock cancelled/forfeited
|
5,206 | |||
Balances, at April 30, 2013
|
282,726 | |||
additional shares reserved
|
3,600,000 | |||
Options granted
|
(3,637,822 | ) | ||
Options cancelled/forfeited
|
1,300 | |||
Restricted stock granted
|
(135,662 | ) | ||
Restricted stock cancelled/forfeited
|
44,866 | |||
Balances, at April 30, 2014
|
155,408 |
Outstanding Options
|
||||||||||||
Number of Shares
|
Weighted Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||
Balances, at April 30, 2012
|
17,592 | $ | 81.20 | |||||||||
Options granted
|
1,595 | $ | 32.60 | |||||||||
Options cancelled
|
(7,851 | ) | $ | 106.40 | ||||||||
Balances, at April 30, 2013
|
11,336 | $ | 57.00 | |||||||||
Options granted
|
3,637,822 | $ | 5.64 | |||||||||
Options cancelled
|
(1,300 | ) | $ | 43.90 | ||||||||
Balances, at April 30, 2014
|
3,647,858 | $ | 5.79 | $ | 8,736 | ( 1) |
(1)
|
Amount represents the difference between the exercise price and $4.88, the closing price of Oxygen Biotherapeutics’ stock on April 30, 2014, as reported on The NASDAQ Capital Market, for all in-the-money options outstanding.
|
Options Outstanding at April 30, 2014
|
Options Exercisable and Vested at April 30, 2014
|
|||||||||||||||||
Exercise Price
|
Number of Options
|
Weighted Average Remaining Contractual Life (Years)
|
Number of Options
|
Weighted Average Exercise Price
|
||||||||||||||
$ | 1.61 to $5.65 | 3,637,843 | 9.9 | 1,826,145 | $ | 5.63 | ||||||||||||
$ | 14.80 to $59.80 | 6,455 | 7.0 | 5,979 | $ | 39.82 | ||||||||||||
$ | 60.80 to $102.00 | 2,351 | 4.4 | 2,351 | $ | 80.65 | ||||||||||||
$ | 111.60 to $138.00 | 1,209 | 5.4 | 1,209 | $ | 121.81 | ||||||||||||
3,647,858 | 9.9 | 1,835,684 | $ | 5.91 |
Number of Option Shares
|
Weighted Average Exercise Price
|
Aggregate Intrinsic Value (1)
|
Weighted Average Remaining Contractual Life (Years)
|
|||||||||||||
Vested
|
1,835,684 | $ | 5.91 | $ | 8,736 | 9.9 | ||||||||||
Vested and expected to vest
|
3,645,025 | $ | 5.79 | $ | 9,237 | 9.9 |
(1)
|
Amount represents the difference between the exercise price and $4.88, the closing price of Oxygen Biotherapeutics’ stock on April 30, 2014, as reported on The NASDAQ Capital Market, for all in-the-money options outstanding.
|
For the year ended April 30
|
||||||||
2014
|
2013
|
|||||||
Risk-free interest rate (weighted average)
|
1.80 | % | 1.29 | % | ||||
Expected volatility (weighted average)
|
98.20 | % | 79.62 | % | ||||
Expected term (in years)
|
6 | 7 | ||||||
Expected dividend yield
|
0.00 | % | 0.00 | % |
Risk-Free Interest Rate
|
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
|
Expected Volatility
|
The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
|
Expected Term
|
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the historical experience that the Company has had with its stock option grants.
|
Expected Dividend Yield
|
The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and do not anticipate paying any dividends in the near future.
|
Forfeitures
|
As stock-based compensation expense recognized in the statement of operations for the years ended April 30, 2014 and 2013 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.
|
Outstanding Restricted Stock Grants
|
||||||||
Number of Shares
|
Weighted Average Grant Date Fair Value
|
|||||||
Balances, at April 30, 2012
|
1,805 | $ | 43.80 | |||||
Restricted stock granted
|
5,318 | $ | 35.00 | |||||
Restricted stock vested
|
(4,465 | ) | $ | 32.60 | ||||
Restricted stock cancelled
|
(741 | ) | $ | 36.20 | ||||
Balances, at April 30, 2013
|
1,917 | $ | 48.40 | |||||
Restricted stock granted
|
135,662 | $ | 3.00 | |||||
Restricted stock vested
|
(50,235 | ) | $ | 2.30 | ||||
Restricted stock cancelled
|
(31,503 | ) | $ | 1.67 | ||||
Restricted stock forfeited
|
(13,363 | ) | $ | 4.49 | ||||
Balances, at April 30, 2014
|
42,478 | $ | 6.39 |
Charges Incurred During the Year Ended April 30, 2014
|
Amounts Paid Through April 30, 2014
|
Amounts Accrued at April 30, 2014
|
||||||||||
Future lease obligations, net of sublease revenue
|
$ | - | $ | 87,224 | $ | 54,660 |
Year ending April 30,
|
||||
2015
|
111,171 | |||
2016
|
94,917 | |||
$ | 206,088 |
2014
|
2013
|
|||||||
U.S. federal taxes (benefit) at statutory rate
|
$ | (6,644,225 | ) | $ | (3,201,372 | ) | ||
State income tax benefit, net of federal benefit
|
(765,026 | ) | (356,452 | ) | ||||
Stock compensation
|
3,099,270 | |||||||
Nondeductible interest
|
827,284 | 1,592,027 | ||||||
Other nondeductible
|
292,355 | 47,652 | ||||||
Other, including effect of tax rate brackets
|
53,621 | 132,806 | ||||||
Change in state tax rate
|
(8,377 | ) | - | |||||
Change in valuation allowance
|
3,145,098 | 1,785,339 | ||||||
$ | - | $ | - |
Deferred Tax Assets
|
2014
|
2013
|
||||||
Net operating Loss Carryforwards
|
$ | 30,748,100 | $ | 27,446,605 | ||||
Accruals and other
|
230,900 | 336,631 | ||||||
Depreciation and amortization
|
- | 16,766 | ||||||
Net deferred tax assets
|
30,979,000 | 27,800,002 | ||||||
Deferred Tax Liabilities
|
||||||||
IPR&D
|
(7,962,100 | ) | - | |||||
Other liabilities
|
(33,900 | ) | - | |||||
Valuation allowance
|
(30,945,100 | ) | (27,800,002 | ) | ||||
Net Deferred Tax Liabilities
|
$ | (7,962,100 | ) | $ | - |
-
|
Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
|
-
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of Consolidated Financial Statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and our Board of Directors; and
|
-
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our Consolidated Financial Statements.
|
-
|
Reports of Independent Registered Public Accounting Firm.
|
-
|
Consolidated Balance Sheets as of April 30, 2014 and 2013.
|
-
|
Consolidated Statements of Operations for each of the two years ended April 30, 2014 and April 30, 2013.
|
-
|
Consolidated Statements of Stockholders’ Equity (Deficit) for each of the two years ended April 30, 2014 and April 30, 2013.
|
-
|
Consolidated Statements of Cash Flows for each of the two years ended April 30, 2014 and April 30, 2013.
|
-
|
Notes to the Consolidated Financial Statements.
|
OXYGEN BIOTHERAPEUTICS, INC.
|
|||
Date: July 29, 2014
|
By:
|
/s/ John P. Kelley | |
John P. Kelley
|
|||
Chief
Executive
Officer
(Principal
Executive
Officer)
|
|||
Name
|
Title
|
Date
|
||
/s/ John P. Kelley |
Chief Executive Officer
|
July 29, 2014
|
||
John P. Kelley
|
(Principal Executive Officer) | |||
/s/ Michael B. Jebsen
|
Chief Financial Officer
|
July 29, 2014
|
||
Michael B. Jebsen | (Principal Financial Officer and Principal Accounting Officer) | |||
/s/ Ronald R. Blanck
|
Director
|
July 29, 2014
|
||
Ronald R. Blanck, DO | ||||
/s/ Gregory Pepin
|
Director
|
July 29, 2014
|
||
Gregory Pepin | ||||
/s/ William A. Chatfield
|
Director
|
July 29, 2014
|
||
William A. Chatfield | ||||
/s/ Chris A. Rallis
|
Director
|
July 29, 2014
|
||
Chris A. Rallis | ||||
/s/ Anthony DiTonno
|
Director
|
July 29, 2014
|
||
Anthony DiTonno | ||||
/s/ Gerald Proehl
|
Director
|
July 29, 2014
|
||
Gerald Proehl |
Exhibit No.
|
|
Exhibits Required by Item 601 of Regulation S-K
|
2.1
|
|
Agreement and Plan of Merger dated April 28, 2008 (1)
|
2.2
|
|
Asset Purchase Agreement by and between Oxygen Biotherapeutics, Inc., Life Newco, Inc., Phyxius Pharma, Inc., and the stockholders of Phyxius Pharma, Inc. dated October 21, 2013 (34)
|
3.1
|
|
Certificate of Incorporation (1)
|
3.2
|
Certificate of Amendment of the Certificate of Incorporation (14)
|
|
3.3
|
Certificate of Amendment of the Certificate of Incorporation (30)
|
|
3.4
|
Certificate of Designations of Series A Convertible Preferred Stock (28)
|
|
3.5
|
Certificate of Designations of Series B-1 Convertible Preferred Stock (31)
|
|
3.6
|
Certificate of Designations of Series B-2 Convertible Preferred Stock (31)
|
|
3.7
|
Certificate of Designations of Series C 8% Convertible Preferred Stock (32)
|
|
3.8
|
Certificate of Designations of Series D 8% Convertible Preferred Stock (33)
|
|
3.9
|
Certificate of Designations of Series E Convertible Preferred Stock (34)
|
|
3.10
|
|
Amended and Restated Bylaws (22)
|
4.1
|
|
Specimen Stock Certificate (19)
|
10.1
|
|
Agreement with Leland C. Clark, Jr., Ph.D. dated November 20, 1992 with amendments, Assignment of Intellectual Property/ Employment (2)
|
10.2
|
|
Agreement between the Registrant and Keith R. Watson, Ph.D. Assignment of Invention (2)
|
10.3
|
|
Children’s Hospital Research Foundation License Agreement dated February 28, 2001 (2)
|
10.4
|
Exclusive License Agreement with Virginia Commonwealth University dated May 22, 2008 (9)
|
|
10.5
|
Amendment no. 1 to the Exclusive License Agreement with Virginia Commonwealth University Intellectual Property Foundation (10)
|
|
10.6
|
Amendment no. 2 to the Exclusive License Agreement with Virginia Commonwealth University Intellectual Property Foundation (10)
|
|
10.7
|
|
Form of Option issued to Executive Officers and Directors (2)
|
10.8
|
|
Form of Option issued to Employees (2)
|
10.9
|
|
Restricted Stock Award Agreement (22)
|
10.10
|
|
Form of Warrant issued to Unsecured Note Holders 2006-2007 (3)
|
10.11
|
|
Form of Convertible Note – 2008 (4)
|
10.12
|
|
Form of Warrant issued to Convertible Note Holders (4)
|
10.13
|
|
Form of Purchase Agreement – US Purchase (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.14
|
|
Form of Purchase Agreement – Non-US Purchase (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.15
|
|
Form of Purchase Agreement – US Note Exchange (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.16
|
|
Form of Purchase Agreement – Non-US Note Exchange (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.17
|
|
Form of Warrant issued to Financing Consultants (5)
|
10.18
|
|
1999 Amended Stock Plan (amended 2008) (5)
|
|
Amendment No. 1 to Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan*
|
|
|
Amendment No. 2 to Oxygen Biotherapeutics, Inc. 1999 Amended Stock Plan*
|
|
10.21
|
|
Employment Agreement with Richard Kiral, restated February 1, 2009 (8)
|
10.22
|
Resignation of Employment and Consulting Agreement with Richard Kiral (20)
|
|
10.23
|
Employment Agreement with John Kelley dated November 13, 2013 (35)
|
|
10.24
|
Employment Agreement with Michael B. Jebsen dated December 1, 2010 (16)
|
|
10.25
|
Amended and Restated Employment Agreement with Michael B. Jebsen dated May 19, 2011 (20)
|
|
10.26
|
Second Amended and Restated Employment Agreement with Michael Jebsen dated November 13, 2013 (35)
|
|
10.27
|
Form of Indemnification Agreement (20)
|
|
10.28
|
|
Description of Non-Employee Director Compensation (25)
|
10.29
|
|
Securities Purchase Agreement (including exhibits) between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio dated June 8, 2009 (6)
|
10.30
|
|
Amendment no. 1 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (11)
|
10.31
|
|
Amendment no. 2 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (12)
|
10.32
|
|
Amendment no. 3 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (23)
|
10.33
|
Form of Exchange Agreement dated July 20, 2009 (7)
|
|
10.34
|
Waiver—Convertible Note (10)
|
|
10.35
|
Amendment—Common Stock Purchase Warrant (10)
|
|
10.36
|
Form of Warrant for May 2010 offering (13)
|
|
10.37
|
Form of Subscription Agreement for May 2010 offering (13)
|
|
10.38
|
Warrant issued to Blaise Group International, Inc. (14)
|
|
10.39
|
Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (15)
|
|
10.40
|
Form of Promissory Note under Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (15)
|
|
10.41
|
First Amendment to Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (17)
|
|
10.42
|
Lease Agreement for North Carolina corporate office (18)
|
|
10.43
|
Standard Industrial Lease relating to OBI’s California facility (12)
|
|
10.44
|
Task Order between the Company and NextPharma, dated November 15, 2011 (23)
|
|
10.45
|
Form of Convertible Note for July 2011 offering (included in exhibit 10.56)
|
|
10.46
|
Form of Warrant for July 2011 offering (included in exhibit 10.56)
|
|
10.47
|
Form of Convertible Note and Warrant Purchase Agreement for July 2011 offering (21)
|
|
10.48
|
Placement Agency Agreement, dated December 8, 2011, between Oxygen Biotherapeutics, Inc. and William Blair & Company, L.L.C., as placement agent (24)
|
|
10.49
|
Form of Warrant for December 2011 offering (24)
|
|
10.50
|
Form of Securities Purchase Agreement for December 2011 offering (24)
|
|
10.51
|
Form of Amendment Agreement for December 2011 offering (26)
|
|
10.52
|
Form of Lock-up Agreement for December 2011 offering (24)
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
|
|
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350*
|
|
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350*
|
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
(1)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 30, 2008, and are incorporated herein by this reference.
|
(2)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 13, 2004, and are incorporated herein by this reference.
|
(3)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on September 6, 2006, and are incorporated herein by this reference.
|
(4)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 21, 2008, and are incorporated herein by this reference.
|
(5)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 13, 2008, and are incorporated herein by this reference.
|
(6)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 8, 2009, and is incorporated herein by this reference.
|
(7)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on July 21, 2009, and is incorporated herein by this reference.
|
(8)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 12, 2009, and are incorporated herein by this reference.
|
(9)
|
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on September 22, 2008, and is incorporated herein by this reference.
|
(10)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 19, 2010, and are incorporated herein by this reference.
|
(11)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on September 2, 2009, and is incorporated herein by this reference.
|
(12)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on April 28, 2010, and are incorporated herein by this reference.
|
(13)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on May 4, 2010, and are incorporated herein by this reference.
|
(14)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 13, 2009, and are incorporated herein by reference.
|
(15)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on October 13, 2010, and are incorporated herein by this reference.
|
(16)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on December 9, 2010, and are incorporated herein by this reference.
|
(17)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 30, 2010, and is incorporated herein by this reference.
|
(18)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 21, 2011, and are incorporated herein by this reference.
|
(19)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 23, 2010, and are incorporated herein by this reference.
|
(20)
|
This document was filed as an exhibit to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 15, 2011, and is incorporated herein by this reference.
|
(21)
|
This document was filed as an exhibit to the current report on Form 8-K/A filed by Oxygen Biotherapeutics with the SEC on July 1, 2011, and is incorporated herein by this reference.
|
(22)
|
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on December 15, 2011, and is incorporated herein by this reference.
|
(23)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 16, 2011, and are incorporated herein by this reference.
|
(24)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 9, 2011, and are incorporated herein by this reference.
|
(25)
|
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 15, 2012, and is incorporated herein by this reference.
|
(26)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 15, 2012, and is incorporated herein by this reference.
|
(27)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 15, 2012, and is incorporated herein by reference.
|
(28)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 25, 2012, and are incorporated herein by this reference.
|
(29)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on February 25, 2013, and are incorporated herein by this reference.
|
(30)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on May 15, 2013, and is incorporated herein by this reference.
|
(31)
|
These documents were filed as exhibits to the registration statement on Form S-1 filed by Oxygen Biotherapeutics with the SEC on March 22, 2013, and are incorporated herein by this reference.
|
(32)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on July 25, 2013, and are incorporated herein by reference.
|
(33)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on August 26, 2013, and are incorporated herein by reference.
|
(34)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on October 25, 2013, and is incorporated herein by reference.
|
(35)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 19, 2013, and are incorporated herein by reference
|
(36)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 17, 2014, and are incorporated herein by this reference.
|
*
|
Filed herewith.
|
1.0
|
CONDITIONS PRECEDENT
|
2.0
|
DEFINITIONS
|
2.1
|
"Affiliate"
of a Party means a Person that, directly or indirectly, through one or more intermediaries, Controls, is Controlled by or is under common Control with the first mentioned Person. A Person shall be deemed to control another Person if such first Person possesses, directly or indirectly, the power to direct, or cause the direction of, the management and policies of the second Person, whether through the ownership of voting securities, by contract or otherwise.
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2.2
|
"Control”
means, with respect to any Person, the possession, directly or indirectly, of the power to direct or cause the direction of management of a Person, whether through ownership of voting securities, by contract or otherwise.
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2.3
|
“Cosmetic Product”
means articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, expressly excluding any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
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2.4
|
“Dermacyte”
means the Cosmetic Product containing PFCs manufactured and distributed by OBI.
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2.5
|
"FDA"
shall
mean the U.S. Food and Drug Administration and any successor agency.
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2.6
|
"Field"
mean
s,
and is limited to, applications involving the use of Cosmetic Products and expressly excluding dermatological products or claims.
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2.7
|
"Licensor Patent Rights"
means those domestic and foreign Patent Rights that are owned or Controlled by Licensor as of January 1, 2013 as set forth on Schedule A, attached hereto and incorporated herein by reference, and which are subject to change without VCD prior approval, any such change to be automatically incorporated into this agreement upon receipt of written notification of such changes to VCD.
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2.8
|
"Licensed Products"
means any Cosmetic Product the packaging, labeling, use or sale of which relies in whole or in part on some or all of the Licensor Patent Rights or OBI Know-How. For clarification, any Product purchased by VCD from OBI is Licensed Product, and includes Product in any package and under any label which VCD may utilize for commercialization.
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2.9
|
"Net Sales"
means the gross amount invoiced by Licensee (and/or any sublicensees) for sales of Licensed Products less:
|
(a)
|
Transportation charges or allowances actually paid or granted;
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(b)
|
Trade, quantity, cash or other discounts, if any, allowed and paid by Licensee independent parties in arms-length transactions;
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(c)
|
Credits or allowances made or given on account of rejec
ts, returns,
recalls or retroactive price reductions for any amount not collected;
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(d)
|
Any tax or governmental charge directly on sale or transportation, use or delivery or services paid by Licensee and not recovered from the purchaser.
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2.10
|
"OBI Know-How"
means all information, data, or materials, whether in hard copy or electronic form, that are necessary or useful for the sale, packaging, labeling or other commercialization of Licensed Product(s), which OBI controls as of the Effective Date.
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2.11
|
"Patent Rights"
means any and all patent applications and any patents issuing therefrom, worldwide, together with any extensions, registrations, confirmations, supplemental protection certificates and other like forms of patent term extensions, reissues, continuations, divisions, continuations-in-part, reexaminations, corrections, substitutions or renewals thereof, and all foreign counterparts thereof. Where applicable, it shall also mean Trademarks and copyrights.
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2.12
|
"Person"
means any natural person, entity, corporation, partnership, firm, organization, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, any government or agency or political subdivision thereof, or any other entity.
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2.13
|
“Product”
means a specific formulation of Cosmetic Product containing one or more PFCs, manufactured in bulk quantities by OBI, for purchase by VCD.
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2.14
|
“Territory
” means worldwide.
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2.15
|
"Third Party"
means any Person other than OBI or Licensee.
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3.0
|
LICENSES
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3.1
|
Licenses:
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3.2
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Sublicenses:
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4.0
|
CONSIDERATION
|
4.1
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Annual License Fee
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4.2
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Royalties
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(a)
|
Licensee agrees to make quarterly written reports to OBI within thirty (30) days after the first days of each January, April, July, and October during the life of this Agreement and as of such dates, stating in each such report the number, description, and aggregate selling prices of Licensed Products sold or otherwise disposed of during the preceding three calendar months and upon which royalty is payable as provided in Section 4.2 hereof. The first such report shall include all such Licensed Products so sold or otherwise disposed of prior to the date of such report.
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(b)
|
With each such report, Licensee shall remit to OBI the total amount of royalty payments due. All amounts payable to OBI hereunder shall be payable in United States funds, subject to deduction for any taxes, assessments, fees or charges of any kind withheld or imposed by any country on any royalty or other payment payable to OBI hereunder. Payments of royalties that are not made when due shall accrue interest at the rate of one percent (1 %) over the prime rate in effect at the Chase Manhattan Bank (N.A.) on the due date.
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(c)
|
Licensee will keep complete, true and accurate books of account and records for the purpose of showing the derivation of all amounts payable to OBI under this Agreement. Such books and records will be kept at Licensee's principal place of business for at least three (3) years following the end of the calendar quarter to which they pertain, and will be available no more than once during any calendar year, during normal business hours, upon seven (7) days prior written notice, for inspection by a representative of OBI for the purpose of verifying Licensee's royalty statements or Licensee's compliance in other respects with this Agreement. The representative will be obliged to treat such books and records as Confidential Information.
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(d)
|
Inspections made under this section shall be at the expense of OBI, unless a variation or error in any amount payable to OBI under this Agreement is identified, in which case the expenses of the Inspection shall be paid by Licensee.
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5.0
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TECHNOLOGY TRANSFER AND DILIGENCE
|
5.1
|
Technology Transfers
.
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5.2
|
Diligence Requirements
.
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6.0
|
WARRANTIES; ASSUMPTION OF RISK; INDEMNIFICATION; AND INSURANCE
|
6.1
|
OBI's
Warranties
.
|
(a)
|
it is the good faith belief that it holds all rights necessary to grant to Licensee the licenses granted under this Agreement with respect to the Licensor Patent Rights;
|
(b)
|
it has received no notification that the Licensor Patent Rights are invalid and has not received written notification from a Third Party claiming that the rights granted hereunder will infringe on any patent or other proprietary right of such Third Party;
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(c)
|
it has not assigned or conveyed, and has not promised to assign or convey, any interest in any Patent Rights inconsistent with the rights granted under this Agreement;
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(d)
|
it has the good faith belief that it holds all rights necessary to grant to Licensee the licenses granted under this Agreement with respect to the OBI Know-How; and
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(e)
|
it has not assigned or conveyed, and has not promised to assign or convey, any interest in any OBI Know-How inconsistent with the rights granted under this Agreement.
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6.2
|
Licensee's Warranties
.
|
(a)
|
to its knowledge, the execution, delivery and performance by Licensee of this Agreement do not contravene or constitute a default under any provision of applicable law or any agreement, judgment, injunction, order, decree or other instrument binding upon Licensee; and
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(b)
|
Licensee has no agreement with any Third Party that, by its terms and without a material breach of the terms of such agreement, materially and adversely affects the rights of Licensor or the obligations of Licensee under this Agreement.
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6.3
|
Injunctive Relief:
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6.4
|
Assumption of Risk
.
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(a)
|
Except as otherwise noted below, as between Licensee and OBI, Licensee assumes all responsibility for and all risk of damage or injury that may occur as a result of its, or its sublicensees', storing, filling and finishing, using, marketing, selling, offering to sell, importing, exporting or distributing Licensed Products. Licensee shall indemnify, defend, and hold OBI and its directors, officers, equityholders, agents, employees, Affiliates and representatives (each, an
"Licensor Indemnified Party,"
and collectively,
"Licensor Indemnified Parties")
harmless for any and all Third Party claims, suits, demands, proceedings, actions, damages, judgments, costs, liabilities, settlement costs or losses, including, without limitation, attorneys' fees, legal expenses, and costs arising from the actions of Licensee with respect to any Licensed Product used, sold, offered for sale, imported, exported, distributed, received or provided as a result of its licensing the OBI Patent Rights or the OBI Know-How under this Agreement, including without limitation (i) any products liability or similar claim for personal injury or property damage; (ii) claims or actions arising from or based on a breach of Licensee's representations and warranties set forth in this Agreement; (iii) claims or actions by Licensee's sublicensees arising from or based on a breach of Licensee's obligations under a sublicense agreement; and (iv) claims arising from clinical trial studies conducted by or on behalf of Licensee related to the Licensed Products, insofar as any such claims do not arise out of the negligence or willful misconduct of Licensor or Licensor Indemnified Party, as applicable. The foregoing right of indemnity for claims shall not be subject to the limitations of liability described in Article 7
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6.5
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Indemnification
.
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6.6
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Notice and Cooperation Requirements.
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6.7
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Infringement Claims
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6.8
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Insurance
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(a)
|
Licensee shall maintain at all times during the Term of the Agreement, and until the date that all statutes of limitation covering claims, actions or suits that may be brought for personal injury based on the packaging, labeling, sale, distribution or use of such Licensed Product have expired in all countries in the Territory., commercial general liability insurance from a recognized, creditworthy insurance company, on a claims-made basis, with endorsements for contractual liability and product liability, and with coverage limits of not less than $5,000,000 per occurrence, and which shall name Licensor as an "additional insured" thereunder. The minimum level of insurance set forth herein shall not be construed to create a limit on Licensee's liability hereunder.
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(b)
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Notwithstanding the obligation set forth in Section 6.8(a) above, each Party shall at all times maintain in force at its sole cost and expense, with reputable insurance companies, general liability insurance and products liability insurance coverage in an amount reasonably sufficient to insure against liability. Within 10 days following written request of a Party, the other Party shall furnish a certificate of insurance evidencing such coverage as of such date, and, in the case of a modification or cancellation of such coverage, a new certificate of insurance evidencing coverage that meets the requirements in the first sentence of this Section 6.8.
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7.0
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LIMITATION OF LIABILITY
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8.0
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CONFIDENTIALITY
|
8.1
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Obligations Regarding Confidential Information
|
(a)
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The Parties have entered into a Confidential Disclosure Agreement (“CDA”) effective October 15, 2012 which is hereby incorporated by reference. The maintenance of confidential treatment to disclosed information shall continue for at least five (5) years after termination of this Agreement.
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(b)
|
Licensee and Licensor (as applicable, each a
"Receiver")
shall each use all reasonable steps to keep confidential, for the term of this Agreement and for five (5) years thereafter, and with respect to trade secrets, for so long as such trade secrets are protected, any Licensee know-how and Licensor know-how, as the case may be, and any other proprietary or business information provided or made available by the other Party (as applicable, each a
"Discloser")
hereunder
("Confidential Information"),
which steps shall include, without limitation, steps no less stringent than the Receiver employs to protect its own Confidential Information. Without the prior written consent of Discloser, Receiver shall not use (except as contemplated by this Agreement), or disclose to any Third Party, any Confidential Information of Discloser; provided, however, that the foregoing shall not apply to Confidential Information that Receiver can establish by written documentation:
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(i)
|
was publicly known at the time of disclosure by Receiver;
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(ii)
|
becomes publicly known, without Receiver's breach of this confidentiality restriction subsequent to such disclosure to Receiver hereunder;
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(iii)
|
was otherwise known by Receiver from a source (other than Discloser) lawfully having the right to possess and disclose such information without restriction;
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(iv)
|
was developed by Receiver independently of the disclosure by Discloser; or
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(v)
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was known by Receiver without obligation to Discloser prior to receiving such information from Discloser.
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8.2
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Permitted Disclosures of Confidential Information
|
(a)
|
to its legal representatives, Affiliates, agents, consultants, directors, outside subcontractors, sublicensees, development partners, and prospective investors under like confidentiality obligations on the part of the recipients and solely for the purposes of the Receiver fulfilling its obligations under this Agreement;
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(b)
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to the extent required by law or regulation, provided that to the extent reasonably possible, Receiver shall give prompt written notice of the proposed disclosure to Discloser so as to allow Discloser an opportunity, at its own cost and expense, to object to such requirement and, if applicable, assure that confidential treatment will be accorded to such Confidential Information;
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(c)
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to Regulatory Authorities, to the extent that such Confidential Information is reasonably required to be disclosed for the purpose of securing necessary governmental authorization for the clinical testing or marketing of Licensed Products or for the purpose of conducting clinical testing; or
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(d)
|
to the extent that such Confidential Information is reasonably required to be disclosed for the purpose of prosecuting or defending litigation; provided, however, the Receiver shall promptly notify the Discloser of such request and cooperate with the Discloser to obtain any and all possible protection for such Confidential Information prior to providing same to requestor, if such is ultimately required.
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8.3
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Confidentiality of This Agreement
.
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8.4
|
Extension of Obligation
s.
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9.0
|
PATENTS
|
9.1
|
Patent Prosecution and Maintenance
.
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9.2
|
Further Assurances
.
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9.3
|
Patent Marking
.
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10.0
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ENFORCEMENT OF INTELLECUAL PROPERTY RIGHTS
|
10.1
|
Infringement Notice.
|
(a)
|
If OBI becomes aware of any infringement or threatened infringement of any Licensor Patent Rights in the Field, then OBI shall give notice to Licensee within ten (10) business days of becoming aware of such infringement or threat.
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(b)
|
If Licensee becomes aware of any infringement or threatened infringement of any OBI Patent Rights in the Field, then Licensee shall give notice to OBI within ten (10) business days of becoming aware of such infringement or threat.
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10.2
|
Enforcement Actions
.
|
(a)
|
In the case of any infringement of any OBI Patent Right by any Third Party (an "Infringer") in the Field during the Term, Licensee shall have the right and the obligation, at Licensee's expense, to cause such Third Party to cease such infringement and to otherwise enforce such Licensor Patent Right. Licensor shall assist Licensee as reasonably requested, at Licensee's expense, in taking any such action against any such Infringer. Any amount recovered as a result of any action taken by Licensee hereunder shall be retained by Licensee. If, following reasonable notice from the OBI, Licensee shall fail to take any action against any Infringer which Licensor may reasonably deem necessary or desirable to prevent such infringement or violation, or to recover damages therefore, in addition to any other remedy available to it, Licensor may, upon notice to Licensee, take any steps OBI may deem appropriate against such Infringer at OBI's own expense. Licensee shall assist OBI, at OBI's expense, as reasonably requested in taking any such action against any such Infringer. Any amount recovered as a result of any such action taken by OBI shall be retained solely by OBI. This paragraph shall survive the termination or expiration of this Agreement.
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(b)
|
No settlement, compromise, consent judgment or any voluntary final disposition of the suit may be entered into by Licensee without the prior written consent of OBI, which consent shall not be unreasonably withheld or delayed.
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10.3
|
Patent Actions
.
|
(a)
|
In the event that Licensee files an action for a declaratory judgment of patent invalidity, initiates a re-examination or opposition proceeding, interference, or otherwise challenges the validity or enforceability of any of OBI’s Patent Rights (each a "Patent Action"):
|
(b)
|
Such Patent Action will be resolved, upon written notice of its demand for arbitration ("Demand") to OBI, by arbitration under 35 U.S.C. 294 (and, in the event of an interference action, under 35 U.S.C. l35) and the United States Arbitration Act 9 U.S.C. ss. 1 et seq., to the extent not inconsistent with 35 U.S.C. 294 or 35 U.S.C. 135. The arbitration shall be administered by the American Arbitration Association ("AAA") under its Supplementary Rules for the Resolution of Patent Disputes and judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof. The arbitrator shall be appointed within thirty (30) days of the filing of a Demand and discovery shall be limited to a period of sixty (60) days. The written decision and award shall be rendered within six (6) months of the filing of the Demand. All arbitrator(s) eligible to conduct the arbitration must undertake in writing as a condition of service to render their opinion(s) promptly after the final arbitration hearing and to provide a reasoned written opinion setting forth the findings of fact and conclusions of law. Except to the extent entry of judgment and any subsequent enforcement may require disclosure, or except as required by law, all matters relating to the arbitration, including the award, shall be held in confidence by the parties.
|
(c)
|
Licensee shall continue to pay all Annual Licensing Fees and other payment obligations due under this Agreement during the pendency of any Patent Action, without the right to recoup any amounts paid under this Agreement in the event that the Patent Action is upheld.
|
(d)
|
In the event there is no judgment of invalidity or infringement with respect to the Licensor Patent Rights, Licensee shall reimburse all of Licensor's costs and expenses (including without limitation, attorneys' and experts' fees) arising from its defense of such action.
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11.0
|
TERM & TERMINATION
|
11.1
|
Term.
|
(a)
|
Unless terminated earlier, according to the provisions of sections 11.2 or 11.3, the premises and promises and this Agreement are in effect for five (5) years from the Effective Date.
|
(b)
|
Either Party may terminate this Agreement in the event of breach of a material obligation of the other Party if such breach remains uncured thirty (30) days after written notice of such breach is delivered to such breaching Party.
|
(c)
|
OBI may cancel this Agreement with ten (10) business days notice in the event of a failure to pay Annual License Fees or Royalty Fees when due.
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11.2
|
Termination for Cause
|
(a)
|
OBI shall have the right to terminate this Agreement immediately upon notice in the event VCD ceases to conduct its operations in the normal course of business, including inability to meet its obligations as they mature, or if any proceeding under the bankruptcy or insolvency laws is brought by or against VCD, or a receiver is appointed for VCD.
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(b)
|
OBI may terminate this Agreement without penalty immediately following written notice if Licensee (i) is the subject of any proceeding related to its liquidation or insolvency (whether voluntary or involuntary) which is not dismissed within ninety (90) calendar days or (ii) makes or attempts to make an assignment for the benefit of its creditors.
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11.3
|
Effect of Termination
|
(a)
|
Except as expressly set forth herein, all licenses, rights and obligations under this Agreement shall immediately end upon termination of this Agreement for any reason; provided, however, that termination of this Agreement shall not release any Party from any payment obligation that has accrued as of the effective date of the termination. Without limiting the foregoing, Licensee shall pay OBI, within thirty (30) days after such termination, amounts equal to all reimbursable expenses payments and all other payments which were owed by Licensee. In addition, for a termination other than expiration as set forth in Section 12.1, Licensee, its Affiliates, and sublicensees, as applicable, shall return to OBI within sixty (60) days of termination all tangible OBI Know-How and Confidential Information provided to Licensee by Licensor pursuant to this Agreement.
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(b)
|
Upon termination of this Agreement VCD shall pay to OBI all undisputed amounts then due and payable, including any due but unpaid Annual License Fees and Development Costs. VCD shall be responsible for the purchase of Product which constitute Firm Orders as of the effective date of termination; and OBI shall not otherwise be responsible for any material ordered by VCD in anticipation of forecasts or future orders or for costs or profits on Products not supplied.
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(c)
|
The respective rights and obligations of the Parties hereunder shall survive the termination or expiration of this Agreement to the extent necessary for the intended preservation of such rights and obligations including, but not limited to, insurance, indemnification, confidentiality, regulatory compliance, records retention, audit rights, and recall responsibilities.
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(d)
|
VCD shall pay Royalty Fees as they become due on any Product purchased prior to termination.
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12.0
|
PRODUCT DEVELOPMENT
|
12.1
|
Product Development
|
(a)
|
At the request of VCD, OBI shall use reasonable efforts to develop Product to meet VCD’s needs.
|
(b)
|
VCD has requested OBI to develop the following Products:
|
(i)
|
Dermacyte Concentrate with a PFC content of fifty percent (50%) or greater
|
(ii)
|
Dermacyte Eye Complex with a PFC content of twenty-five percent (25%) or greater
|
(iii)
|
Dermacyte Day cream with a PFC content of one percent (1%) or greater
|
(iv)
|
Dermacyte Night cream with a PFC content of percent (3%) or greater
|
12.2
|
Product Development Costs
|
(a)
|
VCD shall be responsible for the payment of all costs for Product development (“Product Development Costs”).
|
(b)
|
OBI shall provide VCD with estimates for costs to be incurred and no costs shall be incurred by OBI until they have received seventy-five percent (75%) of the estimated costs.
|
(c)
|
VCD shall reimburse OBI for the actual costs incurred within thirty (30) days of VCD’s receipt of a final expense report from OBI,which will include a 10% markup for administrative overhead..
|
(d)
|
All intellectual property and Know-How generated from or in connection with Product Development shall be owned exclusively by OBI and shall be incorporated as part of the License granted to Licensee hereunder.
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12.3
|
Product Formulation
|
(a)
|
OBI shall develop formulations for each Product requested by VCD. VCD shall have no right to independently develop formulations for Product. VCD shall approve all formulations prior to OBI’s manufacture of Product.
|
(b)
|
Product formulation costs will be considered Product Development Costs.
|
12.4
|
Safety Testing
|
(a)
|
OBI shall conduct toxicology, stability and other safety tests (“Safety Testing”) on all Product(s) prior to making such Product(s) available for purchase by VCD.
|
(b)
|
All Safety Testing shall be considered Product Development Costs.
|
12.5
|
Cosmetic Clinical Trials
|
(a)
|
Upon mutual agreement of the Parties, OBI shall conduct cosmetic clinical trials on Product(s).
|
(b)
|
Such cosmetic clinical trials will be considered Product Development Costs.
|
(c)
|
VCD shall have the right to review and approve all study protocols prior to implementation.
|
12.6
|
Packaging and Labeling
|
(a)
|
OBI’s obligations for packaging and labeling are limited to the packaging of bulk Product in a container that is appropriately labeled for shipment to VCD or VCD’s designee.
|
(b)
|
VCD shall be solely responsible for, and shall bear all costs of, the final packaging and labeling of all Licensed Product.
|
(c)
|
OBI packaging, labeling and shipping shall be considered manufacturing costs.
|
13.0
|
PRODUCT SUPPLY
|
13.1
|
Delivery
.
|
(a)
|
VCD shall provide forecasts of the quantity of Product required for the next quarter (“Forecasted Orders”) as part of their quarterly reports in accordance with section 5.2(b) above.
|
(b)
|
VCD shall provide a Purchase Order for each Product sixty (60) days prior to delivery date (“Firm Order”). OBI shall furnish Products within the timeframe established at the time VCD requests the shipment. OBI agrees to use its best efforts to meet any request by VCD for delivery of Products prior to a delivery date stated in the applicable Purchase Order. OBI shall notify VCD of any Late Delivery and specify the estimated delivery date and the circumstances causing the delay, keeping VCD informed about the status of the Late Delivery.
|
(c)
|
VCD shall be solely responsible for all transportation expenses and risk of loss or damage to Products. OBI shall ship Products in compliance with all Applicable Laws.
|
(d)
|
OBI shall pack and ship all Products in accordance with the VCD shipping specifications given at the time the shipping request is made to ensure that no damage shall result during shipping.
|
(e)
|
All shipments of Product delivered by OBI shall be accompanied by the appropriate Material Safety Data Sheet (“MSDS”).
|
13.2
|
Pricing/Payment
.
|
(a)
|
Purchase price of Product will be OBI’s actual manufacturing costs plus twenty-five percent (25%) for administrative overhead.
|
(b)
|
Upon receipt of a Purchase Order signed by both parties, VCD will issue a payment equal to fifty percent (50%) of the total Purchase Order amount. All payments will be issued as follows, or in accordance with such other written instructions as OBI shall provide:
|
(c)
|
OBI shall prepare and deliver to VCD an invoice for each lot of released Product purchased hereunder. All invoices shall be submitted in writing issued as follows, or in accordance with such other written instructions as VCD shall provide:
|
(d)
|
All invoices shall be submitted contemporaneously with or subsequent to the release of Product under the Purchase Order. The invoices shall specify the price of the Product, the Purchase Order number, the quantity of Product actually released, and any prior amount paid by VCD to OBI against the applicable Purchase Order as provided for in section 12.2(a). In no event shall any invoice be dated prior to the date of release.
|
(e)
|
Payment terms for each undisputed shipment of Products shall be net thirty (30) days from the date of invoice, provided that no invoice shall be dated prior to the delivery and acceptance of corresponding Products.
|
13.3
|
Specifications; Quality
:
|
(a)
|
OBI shall label and package Product in accordance with the provisions of all Laws, Product Specifications and Purchase Order specifications, as applicable.
|
(b)
|
Product released pursuant to this Agreement shall comply with the Product Specifications. A Certificate of Analysis showing the Product name, lot or batch number, date of manufacture, release date, and the specifications and results of the analysis of all Product properties requested by VCD, will be provided by OBI with each lot of manufactured Product.
|
(c)
|
Subject to Applicable Laws, neither the Product Specifications, nor any change in any Product that may alter its properties, impurities, or any other characteristic of the Products, may be changed without VCD’s prior written consent. OBI shall not unreasonably withhold its agreement to any change in the Product Specifications requested by VCD. OBI shall not make any substitutions for Products ordered without the prior written approval of VCD.
|
(d)
|
OBI is responsible for retaining samples of each lot of Product.
|
13.4
|
Notice of Claim or Rejection.
|
(a)
|
In the event that VCD learns, or should reasonably learn, of any claim with respect to Product, VCD will inform OBI in writing of the claim. OBI’s sole responsibility shall be replacement of Product. OBI will not be responsible for replacing or reimbursing the cost of the packaging, labeling, or other processing costs incurred by VCD.
|
(b)
|
Should the Product fail to meet specifications during its labeled shelf life, VCD is responsible for the recall and disposition of Product
|
(c)
|
In the event that a shipment of Product fails to conform to Purchase Order or to meet any warranty hereunder, VCD shall notify OBI within ten (10) days of receipt of Product. Notification of non-conformity must (1) be in writing, and (2) contain specific details regarding the nature of the defects, and (3) specify the specific Product(s) and Purchase Order the affected product was purchased under. Upon receipt of such notice, OBI shall advise VCD on whether to return such Product(s) to OBI or store them pending instructions from OBI as to their disposal. Issuance of the notice of non-conformity shall be deemed a rejection of that portion of the shipment which was non-conforming and payments made in advance of rejected Product shall be credited to the next Purchase Order or replacement Product will be immediately shipped, at OBIs sole discretion.
|
13.5
|
Audits.
|
13.6
|
Regulatory and Environmental Compliance
:
|
(a)
|
To the extent an Adverse Event of which a Party becomes aware implicates supply of the Product, such Party shall promptly inform the other Party of such Adverse Event and shall disclose to the other Party any information it has regarding that Adverse Event.
|
(b)
|
If any Governmental Authority shall take any action which shall require a response or action by either Party with respect to Products, Product Specifications, or any operating procedure affecting the Products, the Parties shall immediately notify each other of the required response or action. This specifically includes receiving and responding to 483s and/or Warning Letters or items of a similar nature issued by an inspecting authority.
|
(c)
|
In carrying out its obligations under this Agreement, the Parties shall comply in all respects with Applicable Laws in effect.
|
14.0
|
MISCELLANEOUS
|
14.1
|
Information Exchange
.
|
14.2
|
Subcontracting
.
|
14.3
|
Force Majeure
.
|
14.4
|
Independent Contractor
.
|
14.5
|
No Third Party Beneficiaries
:
|
14.6
|
Assignment
.
|
14.7
|
Severability
.
|
14.8
|
Waiver
.
|
14.9
|
Dispute Resolution
.
|
(a)
|
Except as set forth in Section 10.3, all disputes, claims, or controversies arising out of or relating to this Agreement or the negotiation, validity or performance hereof that are not resolved by mutual agreement shall be finally and exclusively settled by binding arbitration to be conducted under the Rules of Arbitration of the International Chamber of Commerce ("ICC Rules") or its successor in accordance with the procedure set forth in this Section.
|
(b)
|
The arbitration shall be held in Raleigh, North Carolina before a single arbitrator appointed in accordance with the ICC Rules.
|
(c)
|
The Parties covenant and agree that the arbitration shall commence within ninety (90) days of the date on which a written demand for arbitration is filed by any Party hereto and shall proceed and be completed expeditiously thereafter. Each Party agrees to select one arbitrator within thirty (30) days of the commencement of the arbitration and the arbitrators selected by the Parties will select the arbitrator who will preside over the dispute. The arbitrator shall have the power to order the production of documents by each Party and any Third-Party witness that the arbitrator deems to be relevant to the issues in dispute. The arbitrator's decision and award shall be made and delivered within ninety (90) days of the conclusion of the arbitration proceeding. The arbitrator's decision shall set forth in writing a reasoned basis for any award of damages or finding of liability. It is the intent of the Parties that the arbitration proceed in a manner that is efficient and cost-effective.
|
(d)
|
The Parties covenant and agree that they will participate in the arbitration in good faith and that they will share equally its costs, except as otherwise provided herein. The arbitrator may in his or her discretion assess costs and expenses (including the reasonable legal fees and expenses of the prevailing Party) against any Party to a proceeding. Any Party unsuccessfully refusing to comply with an order of the arbitrator shall be liable for costs and expenses, including attorneys' fees, incurred by the other Party in enforcing the award. This Section applies equally to requests for temporary, preliminary or permanent injunctive relief, except that in the case of temporary or preliminary injunctive relief any Party may proceed in court without prior arbitration for the limited purpose of avoiding immediate and irreparable harm. The provisions of this Section shall be enforceable in any court of competent jurisdiction.
|
14.10
|
Consent to Jurisdiction
.
|
14.11
|
Joint Drafting
.
|
14.12
|
Governing Law
.
|
14.13
|
Bankruptcy/Insolvency.
|
(a)
|
All licenses granted under this Agreement by either Party to the other Party including, without limitation, licenses of any interests in the (i) the Licensor Patent Rights, (ii) the OBI Know-How, (iii) the Licensed Products, and any embodiments of any such intellectual property and all other intellectual property in which Licensor has any interest (collectively, the "Intellectual Property"), for all purposes of Section 365 of Title 11 of the United States Code ("Title 11"), constitute "intellectual property" as defined in Title 11. During the term of this Agreement, each Party shall create and maintain current copies to the extent practicable of all such Intellectual Property. If a bankruptcy proceeding is commenced by or against OBI under Title 11 (a “Bankrupcy Proceeding”), the Licensee shall be entitled to obtain and retain a copy of any and all such Intellectual Property, and the same, if not already in the possession of Licensee at the commencement of the Bankruptcy Proceeding, shall be promptly delivered by the Party which commenced the Bankruptcy Proceeding or its duly appointed Trustee in the Bankruptcy Proceeding (the "Trustee") to Licensee upon the written request of Licensee. If Licensor or OBI commences a Bankruptcy Proceeding and that Party or its Trustee rejects this Agreement pursuant to Section 365 of Title 11, Licensee may, in its sole and absolute discretion, elect pursuant to Section 365(n) of Title 11 to either (i) retain all rights granted to Licensee under this Agreement to the extent permitted by law, including, without limitation, all rights to enforce all exclusivity provisions with respect to the Intellectual Property and any agreements supplementary to this Agreement to the Intellectual Property and any embodiments of the Intellectual Property or (ii) treat this Agreement as terminated.
|
(b)
|
In the event that (i) a Bankruptcy Proceeding is commenced by OBI or (ii) this Agreement is rejected in a Bankruptcy Proceeding of OBI pursuant to Section 365 of Title 11, Licensee retains all rights, in its sole and absolute discretion, to enforce its exclusive license, in the Territory to all of the Intellectual Property as set forth in this Agreement, with the right to sublicense (subject to the terms of this Agreement) under the Licensor Patent Rights, to develop, make, have made, use, sell, offer to sell, import, export, distribute, manufacture and otherwise commercialize the Licensed Products in the Field; provided, however, that Licensee shall continue to fulfill its royalty obligations under this Agreement. Licensee agrees to pay Licensor, or any Trustee in such Bankruptcy Proceeding of Licensor, a royalty for such a license equivalent to the license royalty provision provided in this Agreement and these rights shall survive termination or expiration of this Agreement pursuant to a Bankruptcy Proceeding.
|
14.14
|
Remedies
.
|
14.15
|
Export Law
.
|
14.16
|
Ownership of Enhancements.
|
14.17
|
Entire Agreement
.
|
14.18
|
Headings
.
|
14.19
|
Counterparts
.
|
14.20
|
Survival
.
|
OXYGEN BIOTHERAPEUTICS, INC.
|
VALOR SA
|
|
By/Signature: /s/ Michael Jebsen
Name: Michael Jebsen
Title: President, Chief Financial Officer
|
|
By/Signature: /s/ Andre Valentin
Name: Andre Valentin
Title: Administrator
|
Date: 2/5/2013
|
Date: 2/5/2013
|
1.
|
RECITALS
|
a.
|
Tenor is a Plaintiff and OBI is the Defendant in the following litigation (the "Litigation") pending in the United States District Court for the Southern District of New York:
Tenor Opportunity Master Fund, Ltd., Aria Opportunity Fund, Ltd. and Parsoon Opportunity Fund, Ltd. v. Oxygen Biotherapeutics, Inc.
, Case No. 11 Cv 6067( KBF).
|
b.
|
Tenor and OBI were Parties to a Subscription Agreement dated May 4, 2010, which was the subject of the Litigation (the “Subscription Agreement”).
|
c.
|
Each of the Parties to this Settlement Agreement desire to permanently settle and resolve any and all claims, disputes, issues or matters that exist between them as of the date of this Settlement Agreement and to dismiss with prejudice the Litigation.
|
2.
|
SETTLEMENT TERMS
|
a.
|
Beginning on the first day of each calendar quarter following the Initial Payment, OBI will pay to Tenor by wire transfer five additional payments in the amount of one hundred thousand dollars ($100,000) plus interest accrued thereon from the date of this Settlement Agreement to the date of payment at the rate of fifteen percent (15%) per year (“Quarterly Payments”). For the sake of clarity, the first such Quarterly Payment shall be due on July 1, 2013.
|
b.
|
Should OBI enter into a transaction whereby cash proceeds are paid to OBI (“Financing”) or OBI receives assets of value or the aggregate sum of cash proceeds and assets received from a series of transactions during a trailing twelve (12) month period exceeds one million dollars ($1,000,000) prior to the last Quarterly Payment being made, OBI shall pay to Tenor an Escalated Payment on a pro-rata basis as follows, with the Quarterly Payments thereafter adjusted so that the aggregate of sums paid to Tenor under this Settlement Agreement equals six hundred thousand dollars ($600,000) in aggregate plus any interest accrued thereon as provided for in this Settlement Agreement (“Total Settlement Amount”) :
|
i.
|
Financing of five million dollars ($5,000,000) or greater: the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing.
|
ii.
|
Financing of four million dollars ($4,000,000) or greater: eighty percent (80%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing. Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(a) above.
|
iii.
|
Financing of three million dollars ($3,000,000) or greater: sixty percent (60%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing. Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(a) above.
|
iv.
|
Financing of two million dollars ($2,000,000) or greater: forty percent (40%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing. Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(a) above.
|
v.
|
Financing of one million dollars ($1,000,000) or greater: twenty percent (20%) of the aggregate of all Quarterly Payments that remain due shall be paid within five (5) business days of OBI’s receipt of proceeds from the Financing. Any remaining balance of the Total Settlement Amount following this Escalated Payment to be paid in regularly scheduled Quarterly Payments as provided for under section 2(b) above.
|
c.
|
If a scheduled payment date falls on a non-business day, the payment shall be made on the first business day following the payment due date. Such delay shall not be deemed a breach of this Settlement Agreement. For purposes of this provision, a non-business day shall be Saturday, Sunday or any day which OBI has designated as a company closure in Exhibit A attached hereto and incorporated herein by reference, or when a state of emergency has been declared for any portion of North Carolina within a fifty (50) mile radius of OBI’s Corporate Headquarters.
|
3.
|
NOTICE AND BREACH
|
a.
|
In the event of any breach of any obligation under this Settlement Agreement, the non-breaching Party shall provide the breaching Party three (3) business days written notice of breach and opportunity to cure, which may be delivered via electronic mail, overnight courier, facsimile or hand delivery service, delivered in accordance with the Notice provision of this Settlement Agreement. If and to the extent any breach is not curable, no such notice shall be required.
|
b.
|
In the event OBI breaches its obligation to make any payment under this Settlement Agreement and such breach is not cured after notice within the period provided for in this section, all amount remaining payable or to come due under this Settlement Agreement shall immediately be accelerated and become due and payable, including interest thereon at the rate provided for in paragraph b of this section from the date of this Settlement Agreement to the date of payment.
|
c.
|
It shall be a breach of this Settlement Agreement and constitute a default of payment obligations in the event that OBI shall (i) have entered involuntarily against it an order for relief under the Bankruptcy Code, as amended; (ii) not pay, or admit in writing its inability to pay, its debts generally as they become due; (iii) make an assignment for the benefit of creditors; (iv) apply for, seek, consent to or acquiesce in, the appointment of a receiver, custodian, trustee, examiner, liquidator or similar official for it or any substantial part of its Property; (v) institute any proceeding seeking to have entered against it an order for relief under the Bankruptcy Code, as amended, to adjudicate it insolvent, or seeking dissolution, winding up, liquidation, reorganization, arrangement, adjustment or composition of it or its debts under any law relating to bankruptcy, insolvency or reorganization or relief of debtors or fail to file an answer or other pleading denying the material allegations of any such proceeding filed against it; (vi) take any action in furtherance of any matter described in parts (i) through (v) above; and (vii) fail to contest in good faith any involuntary bankruptcy proceeding or other attempt of creditors to seek relief for failure of OBI to pay its debts when due.
|
d.
|
If OBI shall default on any payment due under this Settlement Agreement or is in breach pursuant to paragraphc. of this section, in addition to amounts otherwise due and payable, Tenor shall be entitled to recover and receive from OBI its reasonable costs and expenses of collection of such amounts, or enforcement of its rights under this Settlement Agreement, which costs and expenses shall include, but not be limited to reasonable attorneys’ fees.
|
a.
|
Tenor Release
. Tenor, on behalf of its constituent entities and each of their agents, employees, representatives, partners, officers, parents, shareholders, directors, subsidiaries, attorneys, predecessors, successors and assigns does hereby irrevocably release, acquit and forever discharge OBI and each of its respective agents, employees, representatives, parents, shareholders, directors, subsidiaries, officers, directors, attorneys, jointly and severally (the "OBI Releasees"), of and from any and all debts, suits, claims, actions, causes of action, controversies, demands, rights, damages, losses, expenses, costs, attorneys' fees, compensation, liabilities and obligations whatsoever (hereinafter referred to collectively as "Claims"), suspected or unsuspected, known or unknown, foreseen or unforeseen, arising at any time up to and including the date of this Settlement Agreement, which Tenor may now have or at any time heretofore may have had, or which at any time hereafter may have or claim to have against the OBI Releasees, relating to, arising from, or concerning any claim asserted in the Litigation, or any other claim relating to or otherwise arising from the sale of convertible debt securities of OBI consummated on June 30, 2011 and July 1, 2011 (hereinafter "Released Claims"). For avoidance of doubt, except as expressly provided herein, Tenor does not release OBI from any obligations remaining or existing under the Subscription Agreement.
|
b.
|
OBI Release
. OBI, on behalf of itself and its constituent entities and each of their agents, employees, representatives, partners, officers, parents, shareholders, directors, subsidiaries, attorneys, predecessors, successors and assigns does hereby irrevocably release, acquit and forever discharge Tenor and each of its respective agents, employees, representatives, parents, shareholders, directors, subsidiaries, officers, directors, attorneys, jointly and severally (the "Tenor Releasees"), of and from any and all debts, suits, claims, actions, causes of action, controversies, demands, rights, damages, losses, expenses, costs, attorneys' fees, compensation, liabilities and obligations whatsoever (hereinafter referred to collectively as "Claims"), suspected or unsuspected, known or unknown, foreseen or unforeseen, arising at any time up to and including the date of this Settlement Agreement, which OBI may now have or at any time heretofore may have had, or which at any time hereafter may have or claim to have against the Tenor Releasees, relating to, arising from, or concerning the Subscription Agreement, the Litigation or the subject matter thereof (hereinafter "Released Claims")
.
For avoidance of doubt, except as expressly provided herein, OBI does not release Tenor from any obligations remaining or existing under the Subscription Agreement.
|
c.
|
If and to the extent applicable the Parties and their representatives, heirs and assigns expressly waive and release any right or benefit which they have or may have under Section 1542 of the Civil Code of the State of California and any other statute or common law doctrine of like effect, to the fullest extent that they may waive all such rights and benefits pertaining to the matters released herein. It is the intention of the Parties, through this Settlement Agreement and with the advice of counsel, to fully, finally and forever settle and release all such matters and all claims relative thereto, in furtherance of this intention.
|
d.
|
Dismissal With Prejudice
. Tenor, upon execution and delivery of this Settlement Agreement and receipt of the Initial Payment as provided for in section 2(a) above, shall execute and deliver to OBI a Stipulation Of Voluntary Dismissal (“Dismissal”), in the form attached hereto and incorporated herein by reference as Exhibit B.
|
a.
|
Any notice, demand, request, consent, approval, or communication that either party desires or is required to give to the other Party shall be addressed to the other Party at the address set forth below. Any Party may change his/his/its address by notifying the other Parties of their change of address(es) in writing. Any such notice shall be effective three (3) days after dispatch if mailed via First Class Mail, on the day after dispatch if delivered via pre-paid overnight courier and when dispatched if delivered via electronic mail or on the date of delivery if otherwise delivered via hand delivery service to the below addresses.
|
a.
|
In order to carry out the terms and conditions of this Settlement Agreement, the Parties agree to promptly execute upon reasonable request any and all documents and instruments necessary to effectuate the terms of this Settlement Agreement.
|
b.
|
By entering into this Settlement Agreement, no party admits or acknowledges that they committed any wrongdoing on their part or where a court of competent jurisdiction has held or might have held that a wrongdoing was committed, that such wrongdoing damaged the other Party in any manner. The Parties acknowledge and agree that amounts paid by OBI under this Settlement Agreement are being made solely to avoid the costs of defense of further litigation.
|
c.
|
This Settlement Agreement shall be governed by and construed in accordance with the laws of the State of New York without reference to its rules regarding choice or conflict of laws. Any action brought by OBI or Tenor for breach of this Settlement Agreement shall be filed in the United States District Court for the Southern District of New York. Subsequent changes in New York law or federal law through legislation or judicial interpretation that creates or finds additional or different rights and obligations of the Parties shall not affect this Settlement Agreement.
|
d.
|
This Settlement Agreement, along with the Dismissal, is the entire agreement between the Parties with respect to the Released Claims or subject matter of this Settlement Agreement and supersedes all prior and contemporaneous oral and written agreements and discussions pertaining to the Released Claims or subject matter of this Settlement Agreement. Any representations, promise or condition in connection herewith not specifically incorporated herein shall not be binding upon any Party. This Settlement Agreement may not be modified except in a writing signed by authorized representative of all Parties.
|
e.
|
No breach of any provision of this Settlement Agreement can be waived unless in writing signed by the Party to be charged with such a waiver. Waiver of any one breach of any provision hereof, in whole or in part, shall not be deemed to be a waiver of any other breach of the same or any other provision hereof.
|
f.
|
This Settlement Agreement shall be binding upon and inure to the benefit of the successors and assigns of each Party; provided, however, that a Party may not assign this Settlement Agreement in whole or in part without obtaining the prior written approval of the other Party, except that a Party shall have the right to assign this Agreement without the consent of the other Party to any affiliate or to any purchaser of that Party's entire business or of substantially all of that Party's assets relating to the subject matter of this Settlement Agreement.
|
g.
|
The Parties each represent and warrant they have not assigned all or any portion of any claim pertaining to the Released Claims to any person or entity. In the event any claims are made by any third persons or entities based upon any purported assignment or any such liens or claims are asserted in connection with the Released Claims or proceeds of the Settlement Agreement, then the Party who has breached his representation or warranty contained herein agrees to indemnify and hold harmless the other Party from any said claims being made.
|
h.
|
If any one or more of the provisions of this Settlement Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions of this Settlement Agreement shall not in any way be affected or impaired thereby. If such condition, covenant or other provisions shall be deemed invalid due to its scope or breadth, such covenant, condition or other provision shall be deemed valid to the extent of the scope or breadth permitted by law.
|
i.
|
Each of the Parties represent and declare that in executing this Settlement Agreement, they relied solely upon their own judgment, belief and knowledge and on the advice and recommendations of their own independently selected counsel, concerning the nature, extent and duration of their rights and claims and that they have not been influenced to any extent whatsoever in executing the same by any representations or statements covering any matters made by any of the Parties hereto or by any person representing them. The Parties each acknowledge that neither they nor any of their representatives have made any promise, representation or warranty whatsoever, written or oral to any other Party, as any inducement to enter into this Settlement Agreement, except as expressly set forth in this Settlement Agreement.
|
j.
|
This Settlement Agreement is the result of negotiation and compromise among the Parties and no Party shall be prejudiced as having been the drafter of the Settlement Agreement or any related exhibits incorporated therein. Ambiguities shall not be construed against the interest of either Party solely by reason of it having drafted all or any part of this Settlement Agreement. Headings of sections and paragraphs are for convenience of the parties only and are not a part of this Settlement Agreement and shall not be considered in the interpretation or construction of this Settlement Agreement.
|
k.
|
Each Party further represents and warrants that it has carefully read this Settlement Agreement and knows and understands the contents and that it executed this Settlement Agreement freely and voluntarily and having had the benefit of the advice of legal counsel of its choosing.
|
l.
|
This Settlement Agreement may be executed in any number of identical counterparts, each of which shall be an original, which together constitute one and the same instrument, which shall be binding and effective as to all Parties. This Settlement Agreement may be executed via facsimile or other form of electronically transmitted signature, which shall have the same force and effect as if they were original signatures.
|
m.
|
Each Party warrants and represents that it has all necessary right, title and authority to enter into this Settlement Agreement, to grant the rights and interests herein granted and to perform all of its obligations under this Settlement Agreement and that any person executing this Agreement on its behalf is duly authorized to do so.
|
n.
|
The provisions and existence of this Settlement Agreement may not be cited by any Party as an admission of any issue of fact or law, except in an action to enforce or for breach of this Settlement Agreement. It is understood and agreed that if the foregoing provision is breached by either Party, the non-breaching Party may be entitled to injunctive or other equitable relief to prevent such a breach. Any non-breaching Party seeking such injunctive relief will not be obligated to secure any bond or give any security in connection with the application for such relief. The right to seek injunctive relief is in addition to all other rights, remedies and forms of relief which may be available. In furtherance of the foregoing, any and all press releases relating to the subject matter hereof shall be mutually agreed upon.
|
OXYGEN BIOTHERAPEUTICS, INC.
|
TENOR OPPORTUNITY MASTER FUND, LTD., ARIA OPPORTUNITY FUND, LTD. AND PARSOON OPPORTUNITY FUND, LTD.
|
|
By:
/s/ Michael Jebsen
Name:
Michael Jebsen
Title
President
|
|
By:
/s/ Daniel H. Koehar
Name:
Daniel H. Koehar
Title:
Director
|
GUSRAE KAPLAN NUSBAUM PLLC
By: /s/ Martin P. Russo
Martin P. Russo, Esq. (MR-4130)
mrusso@gkblaw.com
120 Wall Street
New York, NY 10005
Phone: 212-269-1400
Fax: 212-804-5449
Attorney for Defendant
|
HOGAN
LOVELLS US LLP
By: /s/ David Dunn
David Dunn, Esq. (DD-1823)
david.dunn@hoganlovells.com
875 Third Avenue
New York, NY 10022
Phone: 212-918-3000
Fax: 212-918-3100
Attorney for Plaintiffs
|
Date: July 29, 2014
|
OXYGEN BIOTHERAPEUTICS, INC.
|
||
By:
|
/s/ John P. Kelley
|
||
John P. Kelley
|
|||
Chief Executive Officer
(Principal Executive Officer)
|
Date: July 29, 2014
|
OXYGEN BIOTHERAPEUTICS, INC.
|
||
By:
|
/s/ Michael B. Jebsen
|
||
Michael B. Jebsen
|
|||
Chief Financial Officer
(Principal Financial Officer)
|
Date: July 29, 2014
|
/s/ John P. Kelley
|
||
John P. Kelley
|
|||
Chief Executive Officer
(Principal Executive Officer)
|
|||
Date: July 29, 2014
|
/s/ Michael B. Jebsen
|
||
Michael B. Jebsen
|
|||
Chief Financial Officer
(Principal Financial Officer)
|
|||