Specifications

Specifications. Means the list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which Product at any stage of Manufacture should conform to be considered acceptable for its intended use that are provided by or approved by Rhythm, as such specifications are amended or supplemented from time to time by the parties in writing.

Specifications. Means the specifications for the Product set forth in Attachment 1, as they may be amended or supplemented by the parties pursuant to Section 2.4.

Specifications. Of Product means the specifications for the Product as approved by the FDA. The Specifications may be amended from time to time by written agreement between the Parties and as specifically requested by applicable Regulatory Authorities.

Specifications. Means the specifications for the Product in finished pack form as approved by the Regulatory Authority in the Territory and as set forth in the Marketing Authorization and the form of Certificate of Analysis and Compliance.

Specifications. Shall mean the engineering, operational and/or functional description of the Product(s) as set forth in the specifications contained in Exhibits B, B1, C, C1, and D, as the same may be amended by mutual agreement of the parties.

Specifications. Shall mean the regulatory, manufacturing, quality control and quality assurance procedures, processes, practices, standards, instructions and any other attributes that the parties agree upon, or that are otherwise required, in connection with the manufacture of Product, as set forth on Exhibit B, as amended from time to time by written agreement of the parties pursuant to Section 4.3.

Specifications. Means the written specifications for the Product described in Exhibit 1.1, as the same may be amended from time-to-time pursuant to the provisions of Section 2.7, and the quality standards, including tests, analytical procedures and acceptance criteria, that are established to confirm the quality of the Product which are mutually agreed to in writing and contained or referenced in the Master Batch Record for the Product or as otherwise mutually agreed to in writing by the Parties.

Specifications. Means the specifications for CAPTISOL set forth in EXHIBIT B hereto, as such may be amended from time to time pursuant to SECTION 3.4.

Specifications. The functional and performance specifications (including, without limitation, bills of materials, schematic diagrams, parts and assembly drawings, and test specifications and work/assembly instructions) relating to the testing and manufacturing of each Product as provided by Brocade

Specifications. The applicable release specifications for QS-21 agreed to by the Parties and set out in Exhibit A attached hereto and incorporated herein, as may be amended from time to time by mutual agreement of the Parties.