Examples of Product Master Plan in a sentence
In general, Baxter is responsible for performing tests and assays directly related to the filling operation; i.e., identity testing, uniformity by unit weight variation, pre-filtration bioburden, bulk and finished Product sterility, etc., or as otherwise determined by agreement between Halozyme and Baxter in the Product Master Plan.
In the event that the terms of the Product Master Plan or Quality Agreement are inconsistent with the terms of this Agreement, this Agreement shall control, unless otherwise explicitly agreed to in writing by the parties.
None of the provisions of this Agreement (including the Exhibits hereto) or the Product Master Plan shall be considered waived by any party hereto unless such waiver is agreed to, in writing, by authorized agents of such party.
The Steering Committee shall have the oversight and responsibility to review and propose changes to the Product Master Plan, to propose and plan clinical programs for the Product, and to propose Other Products in accordance with the terms and conditions of this Agreement.
Prior to the Agreement Date, the parties have mutually agreed upon each of the exhibits attached to this Agreement comprising the Product Master Plan.
In accordance with the Product Master Plan, Halozyme shall pursue regulatory approval of marketing licenses for Products Produced by Baxter for Halozyme hereunder.
The Product Master Plan and Quality Agreement shall be incorporated herein and by reference and made a part of this Agreement.
Halozyme further warrants that the API provided to Baxter hereunder (1) conforms to the API Specifications, (2) has been produced in accordance with cGMP and all applicable laws and regulations set forth in the Product Master Plan as relating to the API and in accordance with the applicable Certificates of Analysis (provided in accordance with the Quality Agreement) accompanying each Lot of API and (3) is not adulterated or misbranded within the meaning of the FD&C Act.
The parties hereto acknowledge that this Agreement, together with the Product Master Plan, the Confidentiality Agreement, the Quality Agreement and the Exclusive Distribution Agreement sets forth the entire agreement and understanding of the parties and supersedes all prior written or oral agreements or understandings with respect to the subject matter hereof.
Except as otherwise set forth in Sections 2.2.2 and 2.4, the Product Master Plan may be amended from time to time, as the parties experience with the Production, testing and use of the Product warrants, only upon recommendation of the Steering Committee and upon mutual written agreement of Halozyme and Baxter.