Specifications

Specifications. Are the final Product release specifications as defined in Exhibit A, as amended by the Parties in accordance with this Agreement.

Specifications. Means the specifications of the Product as set out in Appendix 1 (as may be amended from time to time pursuant to Section 2.4 below) and as filed with and approved by the Relevant Authorities;

Specifications. The specifications of the Product as set out in Appendix 1 (as may be amended from time to time pursuant to Section 2.4 below) and as filed with and approved by the FDA and/or any other Relevant Authorities, together with the manner of performance of the Manufacturing Services and specification of the related Raw Materials, components, methods and stability protocols and procedures as set forth in and in accordance with (a) the relevant Marketing Authorization, (b) the master control documents... and change control documents utilized as of the Effective Date, as may be amended from time to time upon written agreement of the Parties, and (c) cGMPs View More

Specifications. Means the specifications for the Crude Oil set forth on Exhibit A attached hereto 2

Specifications. Written specifications of the Glass Capsule and of the processes to be used to produce and control the Glass Capsule, agreed between the parties, and as further defined in Schedule 1. Specifications concerning the processes are only applicable in respect to the Initial Equipment and Tooling.

Specifications. Means the specifications set forth in the applicable United States Pharmacopoeia monograph (should such a monograph be published), the applicable European Pharmacopoeia monograph (should such monograph be published), the DMF, the specifications set forth in this Agreement, including without limitation, those set forth on Exhibit B hereto which Exhibit B shall be supplemented from time to time as additional Drug Substances are added to this Agreement and as mutually agreed upon by the parties... hereto. View More

Specifications. With respect to any Deliverable under a Work Statement, the specifications set forth in such Work Statement.

Specifications. The specifications attached as Schedule G. The Specifications may be changed from time to time upon the mutual written agreement of the parties

Specifications. The specification for the Integrated Products set forth in Exhibit A (or as otherwise agreed to by the parties in writing)

Specifications. The composition, quality, purity, identity and strength of a Product and any chemistry, manufacturing and controls requirements for the manufacture of Product: (a) as appended hereto at Schedule 1,; or (b) as approved and provided by Synergy to Contractor and accepted by Contractor prior to the commencement of the Services and included in the applicable Work Order, as applicable