Release Specifications definition

Release Specifications means the tests and limits against which raw material, intermediate and final product are measured prior to use and/or release.

Release Specifications means the written release specifications dated March 8, 1993, and attached as Exhibit 1.7.3 and which shall in no event be inconsistent with the ELA/PLA Specifications or Manufacturing Specifications. .4 With respect to jurisdictions other than the United States, the Beta Specifications shall be deemed to be the product specifications and manufacturing processes and in-process specifications established under applicable licenses or regulations in such jurisdictions, together with the release specifications for such jurisdictions as are reasonably agreed to by the Parties.

Release Specifications is defined in Section 15.

Examples of Release Specifications in a sentence

• Release Specifications (1) Copies of, and information with respect to, any disciplinary complaint released to the public pursuant to paragraph (a) of this Rule shall indicate that a disciplinary complaint represents the initiation of a formal proceeding by the Exchange in which findings as to the allegations in the complaint have not been made and does not represent a decision as to any of the allegations contained in the complaint.

• EXHIBIT A DENDREON KNOW-HOW Dendreon "Know-How" would also relate to information (clinical protocols, Batch Record, SOP's, Release Specifications, minutes from meetings, and other Dendreon documents) that was discussed and memorialized at previous Kirin-Dendreon Meetings.

• In the event of a dispute between the parties as to whether Product meets the Release Specifications or the Specifications, final determination that a Product does or does not meet the Release Specifications or the Specifications shall be made only in accordance with the dispute resolution procedure set forth in Article 6.5 of this Agreement.

• Sandoz Release Specifications Table set forth in Schedule 2 of the Agreement, as amended and replaced by Clause 7 of the First Amendment to the Agreement and clause 2.1 of the Third Amendment to the Agreement, is hereby amended and entirely replaced by the document CP-No. / CP-Version 7206.4 (Exhibit A), which is incorporated herein by reference.

• Stellar or Xxxxxx will be permitted to renegotiate the per vial price, acting reasonably, if the failure rate under the Release Specifications for Finished Product exceeds 20% of the batches produced in a 12-month period.

More Definitions of Release Specifications

Release Specifications means the set of analytical tests, methods, and acceptance criteria for Product attributes which must be met in order to prove the Product meets the standards of quality, purity, identity and strength filed with the FDA for this substance. Release Specifications are a critical part of the Process and are filed with the FDA as part of an IND, MF or an NDA. All Release Specifications are set forth on Exhibit A attached hereto, which were established initially by NeoRx in consultation with University and which may be amended from time to time by written agreement of the Parties and to conform with all requirements of the FDA and applicable laws and regulations. Upon such amendment, University will implement any modified documents and/or procedures pertinent to the revised Release Specifications.

Release Specifications means the written methods, formulae, standards, making and packing standards, procedures, tests and/or test protocols for Products provided by P&G to OSGP, which shall at all times conform with the health registrations, as applicable.

Release Specifications means certain physical characteristics of a Raw Material.

Release Specifications means the set of analytical tests, methods, and acceptance criteria for Product attributes which must be met in order to prove the Product meets the standards of quality, purity, identity and strength for this substance. Release Specifications are a critical part of the Process and are filed with the FDA as part of an IND, MF or an NDA. All Release Specifications are set forth on Exhibit A attached hereto, which were established initially by NeoRx in consultation with University and which may be amended from time to time by written agreement of the Parties and which are to conform with all requirements of the FDA and applicable laws and regulations. Upon such amendment, University will implement any modified documents and/or procedures pertinent to the revised Release Specifications. Both parties have the right to propose process and specification improvements that are mutually beneficial, provided that no such improvements shall be implemented without the written approval of the other party.

Release Specifications means the Product Specifications mutually agreed by the Parties with which the Product shall comply at the time of release.

Release Specifications means, the set of analytical tests, methods, and acceptance criteria required to determine Gemstones radio analytical attributes that must be met in order to prove that the Gemstones meet the applicable international or domestic standards for “Exempt Material”. Release Specifications may be amended from time to time by written agreement of the parties and as dictated by applicable laws and regulations.

Release Specifications means the detailed product requirements, functional specifications and testing methodologies for the final BNP Assay or BNP Calibrator and Control, as such requirements, specifications and methodologies shall be developed by the parties in accordance with Section 3.5 and as may be modified from time to time upon mutual written agreement of the parties.