Examples of Bulk Drug Substance Specifications in a sentence
If changes occur in the Project or Bulk Drug Substance Specifications, or if technical difficulties require that Abbott perform either additional work or repeat work, and provided such work is unrelated to Xxxxxx’x fault or negligence, in advance of incorporating such changes or performing any work associated therewith, Abbott shall consult with ZymoGenetics and thereafter provide ZymoGenetics with a new or revised written test protocol with cost estimates for such work.
Such evaluation shall be binding on the Parties, and if such evaluation certifies that the Bulk Drug Substance deviates from any Bulk Drug Substance Specifications, ZymoGenetics may reject those Bulk Drug Substance in the manner contemplated by Section 9.8(c).
In addition, Abbott will test and release Bulk Drug Substance to ZymoGenetics in accordance with the Bulk Drug Substance Specifications described in Exhibit B.
In such event, Xxxxxx at its cost shall promptly replace such rejected amounts with Bulk Drug Substance that conforms with the Bulk Drug Substance Specifications.
If ZymoGenetics and Xxxxxx fail to agree within [ * ] days after ZymoGenetics’ receipt of Xxxxxx’x Response Notice, then the Parties shall promptly mutually select an independent laboratory to evaluate (using the test methods described in the Bulk Drug Substance Specifications) if the Bulk Drug Substance deviates from any Bulk Drug Substance Specifications.
For (a) work performed in conducting the Project in accordance with this Agreement, (b) Deliverables to ZymoGenetics as specified in Exhibit C, and (c) Bulk Drug Substance that is manufactured and delivered in accordance with this Agreement and meets the Bulk Drug Substance Specifications, Xxxxxx shall invoice ZymoGenetics according to the Payment Schedule in Exhibit C and Bulk Drug Pricing in Exhibit D.
Abbott shall manufacture Bulk Drug Substance in accordance with the Bulk Drug Substance Specifications that the Parties shall mutually develop.
Subject to the provisions of Sections 9.8, ZymoGenetics has the right to reject and return, at the expense of Xxxxxx, any portion of any shipment of Bulk Drug Substance that deviates from any Bulk Drug Substance Specifications, without invalidating any remainder of such shipment, to the extent that such deviation arises from Xxxxxx’x failure to manufacture and supply the Bulk Drug Substance in accordance with this Agreement (including, without limitation, the Bulk Drug Substance Specifications).
The Parties may alter from time to time the Bulk Drug Substance Specifications by mutual written agreement without amending this Agreement in accordance with Section 7.5. CONFIDENTIAL AGREEMENT 8 Abbott-ZymoGenetics [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission.
Abbott warrants to ZymoGenetics that Bulk Drug Substance delivered to ZymoGenetics pursuant to Section 6.2 (as “Registration Batches”) or Articles 8 and 9 of this Agreement shall conform with the Bulk Drug Substance Specifications and shall have been manufactured in compliance with this Agreement and all applicable laws and regulations.