Compound Specifications definition

Compound Specifications means the specifications for the Compound agreed upon by the Parties, in accordance with Section 8.1(c), in consideration of the regulatory requirements in each country in the Territory, as may be amended from time to time.
Compound Specifications shall have the meaning set forth in Section 4.1.1.

Examples of Compound Specifications in a sentence

  • Schedule 1.32 Compound Specifications [***] Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

  • Compound supplied to Novartis as part of the Nonclinical Evaluation Materials will consist of the supplies of Compound which Xxxxx currently has available to it and shall meet the applicable Compound Specifications for the intended use.

  • Santen or its designee shall have the right to reject any shipment of Compound made to it under this Agreement that does not meet the Compound Specifications and applicable Manufacturing Standards when received by it at such destination when tested in accordance with the Testing Methods.

  • Appendix A to Services Agreement (Compound Data and Compound Specification Guidelines) Unless otherwise specified by the Foundation Services Manager (any such request to be documented in the applicable Steering Committee meeting minutes), the Parties hereby agree that the following Compound Data and Compound Specifications shall be applicable to each Compound that is the subject of a Project under this Agreement.

  • XOMA(US) represents and warrants that all Compound supplied to ALLERGAN hereunder shall (i) meet the applicable Compound Specifications as of the time the Compound is received by ALLERGAN and (ii) will not be adulterated or misbranded within the meaning of the U.S. Food, Drug and Cosmetic Act and the regulations thereunder.


More Definitions of Compound Specifications

Compound Specifications means, with respect to the research grade Compound provided for the Evaluation Studies, those specifications set forth on Schedule 1.32 hereto.
Compound Specifications means, with respect to each Services Compound, the specifications relating to such Services Compound as described in Appendix A or as otherwise specified by the Foundation’s Services Manager and set forth in the applicable Steering Committee meeting minutes.
Compound Specifications will mean the lot clearance specifications for Compound to be provided by Ardent hereunder, as agreed in writing by the parties and as may be revised from time to time by mutual agreement of the parties.
Compound Specifications means the specifications of Compound attached hereto as Schedule 1.1.
Compound Specifications means specifications of the Compound set forth in Exhibit D.
Compound Specifications means (a) with respect to Compound supplied by Xxxxxx Xxxxx hereunder for use by Forest in the United States, those specifications pertaining to the Compound described in Exhibit I hereto and made a part hereof, and any specifications set forth in the IND for the Product to be filed by Forest with the FDA and in the DMF to be filed by Xxxxxx Xxxxx with the FDA, as modified to comply with the NDA for the Products and (b) with respect to Compound supplied by Xxxxxx Xxxxx hereunder for use by Forest in a country of the Territory outside of the United States, those specifications pertaining to the Compound described in Exhibit I hereto, as modified to comply with the specifications contained in the Regulatory Approval for such country, in each case as otherwise modified from time to time in accordance with Section 7.3.
Compound Specifications means the specifications for Compound which shall be reasonably agreed upon from time to time by ALLERGAN and XOMA(US) after consultation and which shall be comparable in scope to the specifications for Compound provided by XOMA(US) to ALLERGAN on the date hereof and identified as "Master Report of Xxxx of Testing (BOT) for rBPI , Effective Date: 4/13/99 R05."