API Specifications definition

API Specifications means the specifications for the API set forth in Schedule 1.3.

API Specifications has the meaning set forth in NDA, as amended or supplemented in accordance with this Agreement.

API Specifications mean all specifications set forth on Schedule 5.1 to this Agreement.

Examples of API Specifications in a sentence

• All or any part of any shipment may be held for Halozyme’s disposition, at Halozyme’s expense if found to be not in conformance with the API Specifications.

• You may authorize Developers to access Confidential Information and Your Materials through the Selling Partner APIs and the API Materials only through APIs documented and communicated by us in accordance with any applicable Selling Partner API Specifications.

• However, accounting systems in developing countries have been predominantly imported from developed countries, thus it is important to raise questions about their relevance to the information needs of developing countries, given the obvious differences between the socio-economic systems of developed and developing countries.

• The API Specifications shall not be amended without the prior written consent of both parties.

• The Manufacturer shall use commercially reasonable efforts to assist the Company, during the Term to (i) locate and qualify a new supplier of API that meets cGMP Requirements, the API Specifications and applicable Law (“Compliant API”) for the Products and (ii) provide such documents and take such other actions as are necessary to allow the Company to list and obtain FDA approval for the new supplier as an alternate supplier of API in the NDA.

More Definitions of API Specifications

API Specifications means the Specifications set forth on Exhibit C.

API Specifications is defined in Section 2.2.1(a).

API Specifications means the set of analytical methods and corresponding values and limits for the quality control of the identity, purity and content of the API, as set forth in Schedule A.1 of the Quality Agreement and as approved by the FDA. The Parties may at any time amend, replace or update the API Specifications subject to prior written mutual agreement and subject to Section 5.6.

API Specifications means the specifications for Active Pharmaceutical Ingredient attached hereto as Schedule 1.4.

API Specifications means the detailed description and parameters of the API set forth on Exhibit 1.3.

API Specifications means those specifications for API set forth in Exhibit A attached hereto as may be amended or supplemented from time to time in accordance with Sections 6.1 and 6.2.

API Specifications means the specifications for the API to be Manufactured by PharmaZell and supplied to Intercept hereunder as such specifications are set forth in the Quality Agreement, as the same may be amended from time to time.