1.21 “Facility” means [****].
1.22 “Force Majeure” has the meaning set forth in Section 9.4.
1.23 [INTENTIONALLY LEFT BLANK]
1.24 “FDA” shall mean the U.S. Food and Drug Administration or the equivalent Indian or other global regulatory authorities.
1.25 “FD&C Act” shall mean the United States Food, Drug and Cosmetic Act, as amended, and any regulations promulgated thereunder.
1.26 “Financial Year” means each successive period of twelve (12) consecutive calendar months commencing on April 1 and ending on March 31.
1.27 “Glenmark Indemnitees” has the meaning set forth in Section 7.2.
1.28 “Glenmark Intellectual Property” shall have the meaning set out in Section 3.6F(ii).
1.29 “Governmental Authority” shall mean any court, agency, department, authority or other instrumentality of any national, supranational state, county, city or other political subdivision.
1.30 “Indemnified Party” has the meaning set forth in Section 7.3A.
1.31 “Indemnifying Party” has the meaning set forth in Section 7.3A.
1.32 “Invention” means any discovery, improvement, process, formula, data, invention, know-how, trade secret, technique, procedure, device, or other intellectual property, whether or not patentable, including any enhancement in the manufacture, formulation, ingredients, preparation, presentation, means of delivery, dosage or packaging of Crofelemer Final or any Crofelemer-Based Product or any discovery or development of a new indication for Crofelemer Final or any Crofelemer-Based Product.
1.33 [INTENTIONALLY LEFT BLANK]
1.34 “Losses” has the meaning set forth in Section 7.1.
1.35 “Manufacture” or “Manufactured” or “Manufacturing”, as the context requires, shall mean to process, manufacture, package, label, hold and/or store, warehouse, quality control testing and quality control analysis, release of the Crofelemer Final by Glenmark or by any of its Affiliates on behalf of Glenmark.
1.36 “Manufacturing Instructions” means those documents describing (i) the processing of CPL into Crofelemer Final and (ii) the testing of the materials, intermediates, and products of such processing.
1.37 “Napo Indemnitees” has the meaning set forth in Section 7.1.
1.38 “Napo Intellectual Property” means intellectual property (except Glenmark Intellectual Property) including (i) the Manufacturing IP, all Transferred Information, Transferred Regulatory Documents, and Batch Records (as those terms are defined in the Transfer Agreement), (ii) all Inventions, occurring before or after the Effective Date, that were not included in the Transferred Information and (iii) any other patents, trade secrets, copyrights and other technical information and know-how (whether or not patentable), including without limitation methods, processes, practices, formulae, instructions, skills, techniques, procedures, technical assistance, designs, assembly procedures, specifications, test methods, analytical