Active Pharmaceutical Ingredient Specifications definition
Examples of Active Pharmaceutical Ingredient Specifications in a sentence
All shipments of Active Pharmaceutical Ingredient shall be accompanied by a certificate of analysis from the Active Pharmaceutical Ingredient manufacturer confirming the identity, purity and compliance with the Active Pharmaceutical Ingredient Specifications covering such Active Pharmaceutical Ingredient.
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.
Serendex reserves the right to reject any Lot of Active Pharmaceutical Ingredient or subdivision thereof by reason of the failure of such Lot to meet any applicable specification or standard as set forth in the this Agreement, including but not limited to the Active Pharmaceutical Ingredient Specifications.
In the event Hospira notifies Cempra that the API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, Cempra shall have the right to confirm such findings at the Facility.
Each Obligor will not, nor will it permit any of its Subsidiaries to, engage to any material extent in any business other than the business of the type conducted by the Obligors and their Subsidiaries on the Amendment Effective Date and businesses reasonably related thereto and reasonable extensions thereof.
If Cempra or such independent expert confirms that such shipment does not meet the Active Pharmaceutical Ingredient Specifications, Cempra 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 reasonable, documented expenses of shipping and testing the shipment samples.
In the event Pfizer notifies ▇▇▇▇▇▇▇ that the API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, ▇▇▇▇▇▇▇ will have the right to confirm such findings at the Facility.
With respect to the failure of the Product to meet Product Specifications (solely where such failure is not as a result of a failure of the API to meet the Active Pharmaceutical Ingredient Specifications), Hospira may, at its option, in place of reimbursing the replacement cost of such API as set forth in Section 5.3 above, provide Company with replacement Product and waive the Product price with respect to (i) the initial non-conforming Product and (ii) the replacement Product.
In the event Hospira notifies Kythera that the API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, Kythera shall have the right to confirm such findings at Hospira’s manufacturing location.
In the event Hospira notifies Durata that the API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, Durata shall have the right to confirm such findings at Hospira’s manufacturing location.