Specifications

Specifications. All manufacturing and quality control and assurance procedures, processes, practices, standards, instructions and specifications applicable to the manufacture, packaging, storage and shipment of the Product mutually agreed to in writing by Nastech and LICENSEE, as the same are amended by mutual written agreement of the Parties to meet applicable regulatory requirements, obtain applicable Regulatory Approval, or otherwise and as included in an approved ANDA for the Product, as the ANDA is... amended from time to time. Neither Party shall unreasonably withhold its agreement with respect to the establishment or amendment of the Specifications. View More

Specifications. Means: (a) the product, formula, processing, testing, storage, packaging, handling, and shipping specifications, including, without limitation, the master batch record, that will be supplied by ViroPharma to PCAS; (b) the quality assurance and quality control specifications and analytical methods that will be supplied by ViroPharma to PCAS; and (c) the requirements of cGMP, in each case as may be amended to meet the requests or requirements of FDA or another Regulatory Authority. The complete... and comprehensive Specifications to be supplied by ViroPharma to PCAS under Sections 1.16(a-b) shall be substantially similar to the summary specifications set forth in Exhibit 1.16(a-b) attached to and included in this Agreement. View More

Specifications. Means the specifications for Feedstock set forth on Exhibit A, as such may be adjusted from time to time as set forth in this Supply Agreement.

Specifications. Shall mean the required specifications attached as Schedule 3.

Specifications. Means the quality standards and specifications set forth on Exhibit D, as the same may be amended, modified or supplemented according to Section 24.

Specifications. Shall mean the specifications for the Products as set forth in the Device Master Record, as provided by Customer and accepted by Manufacturer, and as revised from time to time upon mutual agreement of the parties.

Specifications. Means the specifications for the Materials as described in Exhibit A attached hereto.

Specifications. Means the terms, requirements and conditions applicable to the Product and described in the applicable ANDA, as the same may be supplemented and/or amended from time to time, and as required by United States Pharmacopeia.

Specifications. The specifications, bills of materials, part numbers used, design, source and vendor information for the Hardware, and all modifications or developments thereto. Specifications shall be further described on the Statement of Work, attached hereto as Exhibit A. "Specifications" shall specifically exclude any modifications, augmentations, derivations or developments thereto made by or for Larscom.

Specifications. Means the functional specifications for the Developed Applications set forth in the Statement of Work.