IND means an investigational new drug application, as defined in the FD&C Act, filed with the FDA and necessary for beginning clinical trials of any product in humans or any equivalent application or other documentation filed with any Regulatory Authority of a country other than the U.S. required to begin clinical trials of any product in humans in that country.
Indemnified Party shall have the meaning specified in Section 12.2.
Indemnifying Party shall have the meaning specified in Section 12.2.
Inflammatory Bowel Disease or IBD means (a) Crohns Disease or (b) ulcerative colitis [***].
Initial Product Development means, with respect to a Licensed Product, Development activities to be undertaken until such time as a strain-level composition such Licensed Product candidate is finalized and is eligible for classification by the FDA Center for Biologics Evaluation and Research (CBER) as a new biological entity for purposes of FDA review. Initial Product Development does not include CMC Development.
Joint Development Committee shall have the meaning specified in Section 3.1(a).
Joint Manufacturing Committee shall have the meaning specified in Section 3.3(a).
Joint Patent Rights means those Patent Rights that Cover Joint Program Intellectual Property.
Joint Program Data and Results means Program Data and Results that is owned jointly by the parties pursuant to Section 2.2(b).
Joint Program Intellectual Property means Program Intellectual Property that is owned jointly by the parties pursuant to Section 2.2(b).
Joint Steering Committee shall have the meaning specified in Section 3.2(a).
Know-How means discoveries, observations, inventions, know-how, knowledge, trade secrets, techniques, technology, skill, experience, specification, methodologies, modifications, improvements, works of authorship, designs and data (including pharmacological, biological, chemical, biochemical, toxicological, regulatory, analytical, quality control and stability data) (whether or not protectable under patent, copyright, trade secrecy or other laws).
Licensed Product Clinical Data means (a) FIN-524 Clinical Data and (b) FIN-525 Clinical Data.
Licensed Product(s) means (a) any FIN-524 Licensed Products and (b) any FIN-525 Licensed Products.
Licensed Technology means (a) Finch Patent Rights and (b) Finch Intellectual Property.
Losses shall have the meaning specified in Section 12.2.
MAA means: (a) a Marketing Authorization Application, or a New Drug Application (NDA), submitted pursuant to the requirements of the FDA, as more fully defined in 21 U.S. C.F.R. §314.3 et seq.; (b) a Biologics License Application submitted pursuant to the requirements of the FDA, as more fully defined in 21 U.S. C.F.R. §601; and (c) any equivalent application submitted in any country in the Territory, including a European Marketing Authorization Application, together, in each case, with all additions, deletions or supplements thereto, and as any and all such requirements may be amended, or supplanted, at any time.