and sculptured works; (c) trade secrets, technology, developments, discoveries and improvements, know-how, proprietary rights, formulae, confidential and proprietary information, technical information, techniques, inventions, designs, drawings, procedures, processes, models, formulations, manuals and systems, whether or not patentable or copyrightable, including all biological, chemical, biochemical, toxicological, pharmacological and metabolic material and information and data relating thereto and formulation, clinical, analytical and stability information and data which have actual or potential commercial value and are not available in the public domain; (d) trademarks, trademark registrations, trademark applications, service marks, service mark registrations, service mark applications, business marks, brand names, trade names, trade dress, names, logos and slogans, Internet domain names, and all goodwill associated therewith; and (e) all other intellectual property or proprietary rights worldwide, in each case whether or not subject to statutory registration or protection.
Section 1.36“Lead-time” means the specified number of months set forth in Appendix 4 of this Agreement, which is the minimum amount of time required between the date Polypeptide receives a Purchase Order hereunder until the API covered by such order must be ready for shipment to CARA (or its designee). .
Section 1.37“Legal Requirements” means, concerning PolyPeptide and its activities and obligations hereunder, any and all French national, local, municipal, state or provincial laws, statutes, ordinances, rules or regulations now or hereafter enacted or promulgated by any French Governmental Body, and, to the extent directly applicable to the manufacture of API by PolyPeptide pursuant to this Agreement, any and all laws and regulations now or hereafter enacted or promulgated by a relevant Governmental Body, in each case as applicable to the development, manufacture, supply and/or sale of the API by Polypeptide or to any aspect thereof. “Legal Requirements” means, concerning CARA and its activities and obligations hereunder, any and all national, local, municipal, state or provincial laws, statutes, ordinances, rules or regulations now or hereafter enacted or promulgated by any United States or other applicable relevant Governmental Body applicable to ordering, purchase, use, marketing and/or sale of the API supplied hereunder to CARA.
Section 1.38“Losses” means, collectively, any and all liabilities, damages, losses, costs, expenses, including obligations, liens, judgments, fines and penalties imposed upon or incurred by an Indemnified Party.
Section 1.39“Manufacturing SOPs” means the specific methods, techniques, processes and standard operating procedures that are to be used by PolyPeptide to manufacture API, including the applicable Quality Control Procedures applicable to the API.
Section 1.40“Master Batch Records” means the master batch records for the API as established by the Parties under Section 2.08, including the applicable Manufacturing SOPs, the in-process testing and QA/QC testing for such API, which are to be used in the manufacture by PolyPeptide of the API hereunder.
Section 1.41“Nonconforming API” means API delivered by PolyPeptide that breaches or otherwise does not meet or conform to the warranty in Section 9.01(b), other than due to defects that are shown to have been caused by damage or mishandling occurring after delivery by PolyPeptide of such API to the carrier under Section 3.05(a).
Section 1.42“Party” and “Parties” have the meanings given such terms, respectively, in the preamble of this Agreement.
Section 1.43“Person” means any individual, corporation, company, partnership, trust, incorporated or unincorporated association, joint venture or other entity of any kind.
Section 1.44“PolyPeptide” has the meaning in the preamble of this Agreement.
Section 1.45“PolyPeptide Approval(s)” means the approval(s) of the Facility as a (c)GMP facility for the manufacture of the API by the FDA and, as applicable, by any other applicable Governmental Body having jurisdiction to approve the Facility.