Active Pharmaceutical Ingredient Sample Clauses

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. For some patients, preparing from APIs can be necessary[21]. Examples of these products are polymyxin-neomycin tablets and isoniazid injections[22]. As described in section 2.6, for these unlicensed APIs, a concise product dossier to ensure safety is necessary. Results from studies investigating efficacy and safety can improve such dossier[15]. Moreover, risk assessment will decide whether GPP is enough or if preparation conform to GMP is necessary. Upon upscaling of these individual active ingredients, expansion of the dossier and QC is necessary[8].

Active Pharmaceutical Ingredient. Hals▇▇ ▇▇▇ll use as the active pharmaceutical ingredients as instructed by Wats▇▇ ▇▇▇ may be either such ingredient manufactured by Hals▇▇ ▇▇ supplied by a third party.

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. “Active Pharmaceutical Ingredient” or “API” shall mean bulk Vancomycin Hydrochloride.

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. 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. (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. (b) Subject to the terms of a commercial supply agreement to be entered into between the Parties, Kissei shall also have the sole right to manufacture and supply Active Pharmaceutical Ingredient for commercial use by MediciNova or its designees in the MediciNova Territory. MediciNova or its designees shall have the right free of charge to cross reference any Drug Master File, if any, owned or controlled by Kissei or its designee and relating to Compound necessary to obtain Regulatory Approval in any jurisdiction in the MediciNova Territory. No later than the date of the End of Phase 2 Meeting (the date of which shall be provided to Kissei at least thirty (30) days in advance by MediciNova), the Parties or their respective designees shall negotiate in good faith to enter into a commercial supply agreement containing commercially reasonable terms applicable to similar types of supply agreements, including provisions for MediciNova to provide Kissei with forecasts of its requirements of Product. In the case of Active Pharmaceutical Ingredient manufactured by Third Parties, the supply price for commercial use means the price paid by Kissei ** CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED WITH THE SECURITIES AND EXCHAN...