“Invoice Currency” means USD.
“Joint Manufacturing Team” or “JMT” has the meaning give to such term in Section 11.2.
“Joint Supply Team” or “JST” has the meaning given to such term in Section 11.4.
“Know-How” means any and all commercial, technical, scientific and other types of (a) data (including datasets), documents, information, conclusions, inventions (whether patentable or not), discoveries, know-how, technology, protocols, assays, methods, processes, formulae, instructions, techniques, designs, drawings or specifications (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, preclinical, clinical, safety, manufacturing and quality control data and information).
“Latent Defect” means a Defect other than an Obvious Defect.
“License Agreement” means the License Agreement dated on or around the date hereof by and among Metsera, Metsera’s Affiliate and Amneal.
“Major European Markets” means [***].
“Manufacture” or “Manufacturing” means activities related to the manufacturing of a product or any component or ingredient thereof, including producing, synthesizing, manufacturing, processing, compounding, storing, filling, finishing, packaging, sterilization, labelling, serializing, supplying, disposing of waste, releasing and sample retention of Product, leafleting, shipping, and holding of product or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial manufacture and analytic development, formulation development, product characterization, stability studies and testing, quality assurance, and quality control.
“Manufacturer’s Release” means [***].
“Manufacturing Licenses” means all licenses, permits, approvals, authorizations and consents necessary for, or required in connection with, the lawful Manufacture and supply of the Products at the Facilities.
“Manufacturing TT” has the meaning given to such term in Section 26.
“Marketing Authorization” means, in respect of a Product, such marketing authorization, biologics license application, approval, license, registration or other authorization issued by the FDA, EMA, or any equivalent filing in a country or regulatory jurisdiction other than the United States or the European Union with the applicable Regulatory Authority, in connection with obtaining marketing approval of that Product on the market in the relevant Territory, (or, as applicable, a finished product Manufactured using that Product), including a New Drug Application (NDA), Biologics License Application (BLA), Investigational New Drug application (IND) or Investigational Medicinal Product Dossier (IMPD), or any equivalent filing in any country or jurisdiction.
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