[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.15 Discloser means the Party that discloses its own Confidential Information.
1.16 Disclosure Schedules means the disclosure schedules attached to this Agreement.
1.17 FDA means the United States Food and Drug Administration, including all agencies under its control, and any successor agency thereto.
1.18 First Commercial Sale means, with respect to a country, the first commercial sale of a Product to a Third Party for use, consumption or resale in that country after obtaining regulatory approval in that country.
1.19 Fusion Protein Patent Rights means all Patents related to Provisional Applications or the Research Services Inventions.
1.20 Fusion Protein Research means all ideas and research directly related to the fusion proteins described in the Provisional Applications, and all IP Rights included in, related to, or covering such ideas and research as of the Effective Date.
1.21 Heat Existing Programs means Heats existing research programs related to the gp96-Ig secreting, cell-based therapy known as ImPACT and the secreting, cell-based therapy having a combination of various ligand fusion proteins targeting co-stimulatory receptors (e.g. OX40, ICOS, 4-1BB, and the like) and gp96-Ig known as ComPACT.
1.22 Heat Indemnities has the meaning ascribed to it in Section 7.2.
1.23 IND means an Investigational New Drug application, as defined in 21 Code of Federal Regulations § 312.23, in accordance with the requirements of the United States Food, Drug, and Cosmetic Act of 1938, as amended, and the regulations promulgated thereunder, including all supplements and amendments thereto, filed with the FDA.
1.24 Indemnitee has the meaning ascribed to it in Section 7.3.
1.25 Indemnitor has the meaning ascribed to it in Section 7.3.
1.26 Invention means any and all inventions, discoveries, improvements, processes, know-how and techniques discovered, conceived or reduced to practice in the course of or as a result of activities of the Research Services under this Agreement, whether or not patentable or included in any claim of Patents, together with all IP Rights therein.
1.27 IP Rights means all vested, contingent and future intellectual property rights including: (i) all inventions, compounds, compositions, substances, methods, processes, techniques, know-how, technology, data, information, discoveries, and materials including ideas, concepts, formulas, assays, practices, software, devices, procedures, designs, constructs, plans, applications, research, preclinical and clinical data, regulatory information, manufacturing process, scale-up and other technical data, reports, documentation and samples, including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical,