Common use of Active Pharmaceutical Ingredient Supply Clause in Contracts

Active Pharmaceutical Ingredient Supply. Hospira shall manufacture Product for Omeros from APIs that Omeros shall supply at no cost to Hospira. Omeros shall supply APIs to Hospira in quantities sufficient to satisfy Hospira’s gross manufacturing requirements of Product for Omeros. Hospira’s use of APIs received from Omeros shall be limited to Processing of Product for Omeros as contemplated by this Agreement. Omeros shall deliver or cause to be delivered APIs D.D.P. (Incoterms 2000) Hospira’s designated Facility pursuant to no-cost purchase orders that Hospira issues to Omeros. Within thirty (30) days of Hospira’s receipt of any APIs supplied by Omeros hereunder, Hospira shall (a) perform identification, bacterial endotoxin and microbial limit testing on the APIs and confirm the shipment quantity, and (b) notify Omeros 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 Omeros of any deficiency in quantity of APIs received, Omeros shall use reasonable commercial efforts to promptly ship to Hospira, at its own expense, the quantity of APIs necessary to fulfill the original APIs shipment, unless Hospira and Omeros mutually agree to a reduction in Product quantity to be Processed in accordance with Section 3.10.2. Hospira recognizes that the APIs will be procured by Omeros from third parties. In the event that Omeros is unable to make up any shortage of APIs, Hospira shall be excused from any resulting delay in the Processing of Product but Omeros shall be bound to any firm Purchase Orders which have been accepted by Hospira, to be completed once API becomes available. In the event Hospira notifies Omeros that the APIs shipment does not conform to the Specifications, Omeros shall have the right to confirm such findings at Hospira’s manufacturing location. If Omeros determines that such shipment of APIs conformed to the 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 Specifications, Hospira shall bear all expenses of shipping and testing such shipment samples. If Omeros or such independent laboratory confirms that such shipment did not meet the Specifications, Omeros shall replace, at no cost to Hospira, the portion of the APIs which does not conform to the Specifications and bear all expenses of shipping and testing the shipment samples.

Appears in 3 contracts

Samples: Commercial Supply Agreement (Omeros Corp), Commercial Supply Agreement (Omeros Corp), Commercial Supply Agreement (Omeros Corp)

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Active Pharmaceutical Ingredient Supply. Hospira shall manufacture Product for Omeros Company from APIs API that Omeros Company shall supply to Hospira at no cost to Hospiracost. Omeros Company shall supply APIs API to Hospira in quantities sufficient to satisfy Hospira’s gross manufacturing requirements of Product for OmerosProduct. Hospira’s use of APIs API received from Omeros Company shall be limited to Processing development contemplated by this Agreement and the manufacture of Product for Omeros as contemplated by this AgreementCompany. Omeros Company shall deliver or cause to be delivered APIs API FOB Destination for deliveries originating in the United States, and D.D.P. (Incoterms 2000) Hospira’s designated Facility for deliveries originating outside the United States, the Hospira Facility, pursuant to no-cost purchase orders that Hospira issues to OmerosCompany. Within thirty (30) days of Hospira’s receipt of any APIs API supplied by Omeros Company hereunder, Hospira shall (ai) perform identification, bacterial endotoxin and microbial limit testing an identification test on the APIs API and confirm the shipment quantity, and (bii) notify Omeros 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 Omeros Company of any deficiency in the quantity of APIs API received, Omeros Company shall use reasonable commercial efforts to promptly ship to Hospira, at its Company’s own expense, the quantity of APIs API necessary to fulfill complete the original APIs API shipment, unless Hospira and Omeros mutually agree to a reduction in Product quantity to be Processed in accordance with Section 3.10.2. Hospira recognizes that the APIs will be procured by Omeros from third parties. In the event that Omeros is unable to make up any shortage of APIs, Hospira shall be excused from any resulting delay in the Processing of Product but Omeros shall be bound to any firm Purchase Orders which have been accepted by Hospira, to be completed once API becomes available. In the event Hospira notifies Omeros Company that the APIs API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, Omeros Company shall have the right to confirm such findings at Hospira’s manufacturing location. If Omeros Company determines that such shipment of APIs 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 Specifications[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Hospira shall bear all expenses of shipping and testing such shipment samples. If Omeros or such independent laboratory confirms that such shipment did not meet the SpecificationsMARKED BY BRACKETS, Omeros shall replaceHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, at no cost to Hospira, the portion of the APIs which does not conform to the Specifications and bear all expenses of shipping and testing the shipment samplesAS AMENDED.

Appears in 1 contract

Samples: Development and Supply Agreement (Tercica Inc)

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