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 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),—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. 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. The Client shall, at its sole cost and expense, deliver the API to Patheon in sufficient quantities to meet each Firm Order not later than the date of submission of the relevant Firm Order pursuant to Section 5.1(b), which API shall be held by Patheon on behalf of the Client on the terms and subject to the conditions herein contained. Client’s failure to supply Patheon with API in accordance with the timeframes set forth in this Section 3.2 shall not be deemed a breach of this Agreement but shall release Patheon from strict compliance with the Delivery Date(s) specified in a particular Firm Order, provided however, Patheon shall use all commercially reasonable efforts to meet the Delivery Dates specified in a Firm Order once the Client supplies Patheon with API. The parties acknowledge and agree that title to the API shall at all times belong to and remain the property of the Client. Patheon agrees that any API received by it shall only be used by Patheon to provide the Manufacturing Services. Patheon’s liability with respect to any lost or damaged Active Pharmaceutical Ingredient shall be as set forth in Section 9.2.
Active Pharmaceutical Ingredient. Patheon shall act as the Client’s depositary for the API. As such, Patheon shall be liable for any loss or damage to the API, provided that: such loss or damage (i) occurs while such API are in Patheon’s possession and control; or (ii) is otherwise due to Patheon’s gross negligence or intentional misconduct. Notwithstanding the foregoing, any liability that results from a breach by Patheon of the Manufacturing Requirements shall be limited to the API value as listed in Schedule B (the “API Value”) attributable to the relevant API lost or damaged and, in any event, Patheon’s liability for loss or damage to API resulting from a breach by Patheon of the Manufacturing Requirements shall not exceed the applicable maximum API Value listed in Schedule B (the “Maximum API Value”), in the aggregate, in any Year.
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. (a) Subject to the terms of a clinical supply agreement to be entered into between the Parties, Kissei shall have the sole right to manufacture and supply to MediciNova in accordance with cGMP and other applicable regulatory requirements the Active Pharmaceutical Ingredient and MediciNova shall purchase such Active Pharmaceutical Ingredient from Kissei, for use in preclinical and clinical trials. The supply price of such Active Pharmaceutical Ingredient shall be the Cost of Goods Sold. Notwithstanding the stipulation in Section 3.01, Kissei shall disclose or make available to MediciNova the Kissei Intellectual Property relating to manufacturing Active Pharmaceutical Ingredient to the extent that such information is required by Regulatory Authorities to obtain Regulatory Approval or Kissei or its designee shall file a Drug Master File relating to the Active Pharmaceutical Ingredient. In the event that Kissei or its designee files a Drug Master File relating to Active Pharmaceutical Ingredient, Kissei or such designee will allow MediciNova or its designees to cross reference any such Drug Master File free of charge.
Active Pharmaceutical Ingredient. API shall mean the active pharmaceutical ingredient(s) set forth in Annex 1.1. /s/ Xxxx /s/ KG 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.
