Specifications

Specifications. Means the physical, technical, functional and/or performance requirements for the Products as set forth more specifically in Schedule A.

Specifications. The specifications for the Product contained in the CE Mark file

Specifications. Means the specifications for the Product contained in a regulatory filing or internal quality control documents.

Specifications. The specifications for the supply of the BULK DRUG SUBSTANCE and BULK DRUG TABLETS to VIVUS, a draft of which is attached hereto as Appendix-E, and which shall be amended from time to time as agreed by the Parties and in accordance with the terms of this Agreement.

Specifications. Shall mean the specifications for the API agreed to by the parties in writing and approved by the FDA.

Specifications. The technical and other specifications and quality standards for Software as set forth on Exhibit A1 attached hereto and those set forth in a Statement of Work having been executed by the Parties.

Specifications. The specifications for the Material attached hereto as Exhibit A or such other specifications as are mutually agreed to in writing by the Parties from time to time

Specifications. Specifications, drawings, requirements, performance and/or functions, relating to the Products set forth on Schedule C, which is attached hereto and is incorporated herein by reference. Each Specification is applicable only to those Products identified in the introduction to such Specification.

Specifications. With respect to the PRODUCT, all specifications for Materials, processes, methods, formulae, analyses, instruction, standards, know—how, testing and control procedures, information and other specifications relating to the Manufacture of the PRODUCT as set forth on Annex 6 hereto or in the Quality Assurance Agreement.

Specifications. Means the product, process, or fabrication specifications set forth in the Statement of Work or as modified by the Parties in connection with the production of a particular batch of product(s) hereunder.