1.15 “Executives” shall have the meaning provided in Section 10.2.
1.16 “Exploit” shall mean the making, having made, importation, use, sale, offering for sale of a product or
process, including, without limitation, the research, development, registration, modification, improvement, manufacture, storage, optimization, import, export, transport, distribution, promotion, marketing, sale or other disposition of a product.
The term “Exploitation” shall have a corresponding meaning.
1.17 “FDA” shall mean the
United States Food and Drug Administration, or any successor agency or agencies thereto, responsible for the evaluation and approval of pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States.
1.18 “Improvement” shall mean any modification, variation or revision to an apparatus, method, formulation,
process, product or technology, or any discovery, technology, process, method or formulation related to an apparatus, method, process, product or technology, whether or not patented or patentable, including any enhancement in the manufacture or
steps or processes thereof, ingredients, preparation, presentation, formulation, means of delivery, packaging or dosage of an apparatus, method, process, product or technology, any discovery or development of any new or expanded indications for an
apparatus, method, process, product or technology, or any discovery or development that improves the stability, safety or efficacy of an apparatus, method, product or technology.
1.19 “Indemnification Claim Notice” shall have the meaning set forth in Section 9.3(a).
1.20 “Indemnified Party” shall have the meaning set forth in Section 9.3(a).
1.21 “Information” shall mean all technical, scientific and other know-how and information, trade secrets, knowledge,
technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, algorithms, apparatuses, compositions of
matter, cells, cell lines, assays, animal models, physical, biological or chemical material, specifications, data, results and other material, including pre-clinical and clinical trial results, manufacturing procedures and test procedures and
techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all Improvements to any of the foregoing, and other discoveries, developments, inventions,
and other intellectual property (whether or not confidential, proprietary, patented or patentable).
1.22
“LICA” shall have the meaning set forth in Section 10.3.
1.23 “Licensed Product” shall
mean any oral spray product that contains, as the sole active ingredient, zolpidem tartrate, for any human uses.
1.24
“Losses” shall have the meaning set forth in Section 9.1.
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