Active Pharmaceutical Ingredient. (API) — Any API or mixture of APIs, intended to be used in the manufacture of a drug (or: medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such APIs are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the body of man or animals. Business day — Any day of the week, other than Saturday, Sunday, or day on which the party required to take action is regularly closed for business, i.e., Monday to Friday (European working hours) except any official national or regional bank holidays or shut down of the plant. CEP — A certificate issued by the European Directorate for the Quality of Medicines which demonstrates that the Product complies with the requirements of the European Pharmacopoeia monograph and / or Transmissible Spongiform Encephalopathy (TSE) requirements. Also known as “CoS” = Certificate of Suitability. Certificate of Analysis — A document identified as such, provided by the Supplier signed by its Responsible Person, or produced by a computer system which provides a degree of control equivalent to that given by a signature, which sets forth the analytical test results, obtained from testing of a representative sample, against the specifications for the batch to be delivered. Certificate of Conformance — A document identified as such, provided by the Supplier and signed by a nominated representative of its Quality Unit; or produced by a computer system which provides a degree of control equivalent to that given by a signature, which certifies that each batch of Product was produced and -tested in compliance with the agreed specifications, cGMP, and the relevant pharmacopoeial monographs, as applicable. Contract — Business agreement for supply of goods or performance of work at a specified price. Contract Manufacture — Performance of some aspect of manufacture, under a contract, on behalf of the original manufacturer.
Active Pharmaceutical Ingredient. (API) Specifications shall mean the Bulk Formulated Drug Substance Specifications and requirements contained in or made a part of Company’s ANDA/NDA or other regulatory filing for territory.
Active Pharmaceutical Ingredient. (API),—Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the Drug Product as defined in ICH Q 7. Such substances are intended to furnish pharmacological activity or other direct effect on the diagnosis, cure mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
Active Pharmaceutical Ingredient. “Active Pharmaceutical Ingredient” or “API” shall mean bulk Vancomycin Hydrochloride.
Active Pharmaceutical Ingredient. “Active Pharmaceutical Ingredient” or “API” means the active pharmaceutical ingredient, sterile fosfomycin sodium. The API shall meet European Pharmacopoeia 01/2008: 1329 monograph specifications and any other specifications that may be required by the FDA for approval in the Territory.
Active Pharmaceutical Ingredient. Halsxx xxxll use as the active pharmaceutical ingredient [___________________] as instructed by Watsxx xxx may be either such ingredient manufactured by Halsxx xx supplied by a third party.
Active Pharmaceutical Ingredient. Supply. Hospira shall manufacture Product for Company from API that Company shall supply to Hospira at no cost. Company shall supply API to Hospira in quantities sufficient to satisfy Hospira's gross manufacturing requirements of Product. Hospira's use of API received from Company shall be limited to development contemplated by this Agreement and the manufacture of Product for Company. Company shall deliver API [*], at the [*] Site, pursuant to no-cost purchase orders that Hospira issues to Company. [*] Hospira shall (i) perform an identification test on the API and confirm the shipment quantity, and (ii) notify Company of any inaccuracies with respect to quantity or of any claim that any portion of the shipment fails the identification test. In the event Hospira notifies Company of any deficiency in the quantity of API received, Company shall have the right to confirm such findings at Hospira's manufacturing location at Company's cost. If it confirms the deficiency, Company shall promptly ship to Hospira, at Company's own expense, the quantity of API necessary to complete the API shipment. In the event Hospira notifies Company that the API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, Company shall have the right to confirm such findings at Hospira's manufacturing location. If Company determines that such shipment of API conformed to the Active Pharmaceutical Ingredient Specifications, the parties shall submit samples of such shipment to a mutually acceptable independent laboratory for testing. If such independent laboratory determines that the shipment conformed to the Active Pharmaceutical Ingredient Specifications, Hospira shall bear all expenses of shipping and testing such shipment samples. If Company or such independent laboratory confirms that such shipment did not meet the Active Pharmaceutical Ingredient Specifications, Company shall replace, at no cost to Hospira, the portion of the API shipment which does not conform to the Active Pharmaceutical Ingredient Specifications and bear all expenses of shipping and testing the shipment samples. Title. Company shall retain title to the API while it is in the Hospira facility. Subject to the limitation in Section 5.3(c), Hospira shall assume responsibility and risk for the safekeeping, storage and handling for all shipments of API delivered hereunder and accepted by Hospira.
Active Pharmaceutical Ingredient. Only Horizon shall arrange or contract with supplier(s) of Glycopyrrolate to supply Glycopyrro-late for the manufacture of the Product. Mikart shall purchase such Glycopyrrolate from such supplier(s) only pursuant to such contract or arrangement and on behalf of Horizon.
Active Pharmaceutical Ingredient. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes active ingredient of the Finished Animal Drug Product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body of animals.
Active Pharmaceutical Ingredient. API shall mean the active pharmaceutical ingredient(s) set forth in Annex 1.1. Siegfried Jazz 1.2 Affiliate shall mean with respect to any Party any person or entity Controlling, Controlled by, or under common Control with a Party at any time during the Term of this Agreement. For purposes of this definition, the term Control shall mean the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting stock, by contract or otherwise. In the case of a corporation, the term Control shall mean the direct or indirect ownership of at least fifty per cent (50%) of the outstanding voting stock.
