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.

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Compound Specifications shall have the meaning set forth in Section 4.1.1.

Compound Specifications means, with respect to the research grade Compound provided for the Evaluation Studies, those specifications set forth on Schedule 1.32 hereto.

Examples of Compound Specifications in a sentence

• 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.

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

• In the event that no such existing lot is fully conforming with Compound Specifications, HMR shall provide Matrix, at HMR's expense, with one (1) lot of twenty (20) kilograms of bulk active ingredient fully conforming with Compound Specifications.

• In the event that any such shipment or batch thereof is ultimately agreed or found not to meet the Compound Specifications or Manufacturing Standards, Inspire agrees to replace such shipment at its expense, including charges incurred by Santen for shipping and/or storage, if applicable.

• Prior to shipment of Product to Matrix, HMR shall test an agreed upon lot of bulk active ingredient for conformance with the Compound Specifications and provide such test data to Matrix.

More Definitions of Compound Specifications

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 means the specifications for the Compound approved by the Joint Development Committee in consideration of the regulatory requirements in the Territory, as may be amended from time to time.

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 ▇▇▇▇ of Testing (BOT) for rBPI , Effective Date: 4/13/99 R05."

Compound Specifications means the specifications of Compound attached hereto as Schedule 1.1.

Compound Specifications means the specifications set forth on Schedule 1.3.

Compound Specifications. - means the written physical and chemical specifications for the Bulk Compound referenced in Appendix 1 hereto as amended from time to time pursuant to Clause 8.5.

Compound Specifications means (a) with respect to Compound supplied by ▇▇▇▇▇▇ ▇▇▇▇▇ 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 ▇▇▇▇▇▇ ▇▇▇▇▇ with the FDA, as modified to comply with the NDA for the Products and (b) with respect to Compound supplied by ▇▇▇▇▇▇ ▇▇▇▇▇ 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.