Active Pharmaceutical Ingredients Sample Clauses
The 'active pharmaceutical ingredients' clause defines the substances within a pharmaceutical product that are responsible for its therapeutic effect. This clause typically specifies the standards, quality requirements, and sources for these ingredients, ensuring that only approved and compliant materials are used in manufacturing. By clearly outlining these parameters, the clause helps maintain product safety and efficacy, and reduces the risk of regulatory or quality issues related to the core components of the drug.
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Active Pharmaceutical Ingredients. For the Product, Insys make certain that the Third Party Manufacturer uses Commercially Reasonable Efforts to maintain a rotating inventory of the required active pharmaceutical ingredients (“API”) and inactive pharmaceutical ingredients (“IPI”) in sufficient quantities to satisfy binding purchase orders provided by Mylan to Insys (the “API and IPI Rotating Inventory”). Insys will also make certain that the Third Party Manufacturer manages the API and IPI Rotating Inventory on a “First-In First-Out” (FIFO) basis, in accordance with cGMPs. Insys, as the API supplier, shall perform an audit of its facility supplying the API, and shall certify the results to Mylan, and shall supply Mylan with a copy of the certified audit report within five (5) calendar days of its completion. Insys shall be responsible for the performance of the Third Party Manufacturer under this Section 4.6, and shall provide reports regarding the regular and successful completion of all of these obligations regarding API to Mylan on a timely basis.
Active Pharmaceutical Ingredients. (APIs) of all approved drugs: 6000+
Active Pharmaceutical Ingredients. Schedule 1 of the Agreement shall be replaced with new Schedule 1 attached hereto.
Active Pharmaceutical Ingredients. (i) Patheon shall not be responsible for any loss or damage to any quantity of API, except where such loss or damage occurs while such materials are located on Patheon’s premises and results from Patheon’s negligence or intentional misconduct or failure by Patheon to provide the Processing services in accordance with the Patheon Manufacturing Responsibilities, or where Patheon [*] on a [*] basis as provided in Section 5.6(a). In such circumstances, Patheon’s maximum liability shall be as outlined in Section 7.3(a)(iii).
(ii) For greater certainty, Gilead acknowledges that loss or damage of API in the course of technology transfer from Gilead to Patheon, or as part of failed regulatory, stability or test batches, shall not be regarded as lost due to the negligence or intentional misconduct of Patheon unless and to the extent that Patheon did not provide the Processing services in accordance with Patheon Manufacturing Responsibilities. Further, Patheon shall not be responsible for any loss or damage to any API where such loss or damage occurs during a batch implementing a new process or procedure (a “Development Batch”); provided, however, that both Parties shall agree, prior to commencement of manufacture of a batch, whether such batch shall be deemed a Development Batch. If the Parties do not agree in advance in writing that a given batch is a Development batch, then such batch shall not be deemed to be a Development Batch.
(iii) Patheon’s maximum liability for loss or damage to any quantity of API for any reason whatsoever including, without limitation, those referred to in Section 7.3(a) (i) and (ii) shall be limited to the [*].
Active Pharmaceutical Ingredients. API will be tested by Client’s third party laboratory prior to delivery to Patheon. Upon delivery of the API at the Facility, Patheon shall rely on the certificate of analysis that is supplied with the incoming API and shall only conduct identity testing on such API. To the extent that Patheon discovers defective API during such review, Patheon shall promptly give the Client written notice of any API that are not in compliance with the Specifications. Patheon’s liability with respect to any lost or damaged API shall be as set forth in Section 9.2.