“Effective Date” has the meaning set forth in the first paragraph hereof.
“FDA” means the United States Food and Drug Administration, or any successor federal agency having responsibility over Regulatory Approval. “FDA” shall also be deemed to include the applicable governmental or regulatory authority having jurisdiction over Licensed Products in any particular country or region in the Territory (for example, the European Medicines Evaluation Agency for the European Union).
“Field” means the diagnosis, treatment, prevention, mitigation and cure of any and all human diseases and disorders.
“Financing” means the next sale after the Effective Date of shares of Licensee’s capital stock in one transaction or a series of related transactions which is a bona fide financing transaction and in which the proceeds to be received by Licensee are principally from investors who are venture capital, private equity, institutional, corporate or similar investors, on terms and conditions negotiated among Licensee and such investors, but which is not structured on terms and conditions for the purpose of reducing the number of shares of SeriesA-1 Shares to be received by Satiogen pursuant to Section 3.1.
“First Commercial Sale” means the first arm’s length sale of a Licensed Product in a country by Licensee or its Affiliate to a Third Party that is not an Affiliate or sublicensee of the selling party following Regulatory Approval in such country.
“Full Allocation of Common Shares” means 690,000 shares of common stock of Licensee.
“Full Allocation of SeriesA-1 Shares” means 1,380,000 shares of SeriesA-1 Shares.
“GAAP” means United States Generally Accepted Accounting Principles, consistently applied.
“Initiation” means, in any clinical trial, the first dosing of the first patient in such clinical trial.
“Investors” has the meaning set forth in Section 3.1(a).
“Joint Inventions” means inventions or discoveries in which one or more employees, officers, directors, contractors or agents of Satiogen and one or more employees, officers, directors, contractors or agents of Licensee have contributed in a significant manner to the conception of such invention or discovery.
“Know-How” means all data, knowledge and information, including all tangible and intangible techniques, technology, practices, inventions (whether patentable or not), trade secrets, methods, knowledge,know-how, skill, experience, works of authorship and related copyrights, analytical and quality control data, results, descriptions and compositions of matter, chemical manufacturing data, data from toxicological, pharmacological, preclinical and clinical testing and studies, assays, platforms, materials, samples, cell lines, DNA constructs, formulations and specifications.
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