Specifications and Supply Sample Clauses

Specifications and Supply. GSK hereby represents, warrants and covenants that all GSK Supplied Product shall, with the exception of information provided to GSK by PAR: (i) not be misbranded or adulterated under Applicable Law, (ii) be in fully finished form, labeled and packaged for supply to the ultimate consumer in accordance with Applicable Law, (iii) meet the applicable specifications and requirements set forth in Schedule 4.2(b)(iii), (iv) be manufactured, labeled, packaged and stored in accordance with specifications in the applicable NDA, cGMP, and Applicable Law and (v) be capable of maintaining conformity to said specifications and requirements when handled and stored in accordance with the Labeling until the applicable expiry date of such GSK Supplied Product. GSK (or its Affiliate) may have manufactured, and supplied to PAR, GSK Supplied Product from any of GSK’s (or its Affiliates or its or their supplier’s or subcontractor’s) FDA approved and registered manufacturing facilities. All GSK Supplied Product shall be supplied to PAR and its Affiliates in compliance with Applicable Law, including cGMP and the Quality Agreement (“Quality Agreement”), which shall be entered into by the Parties within thirty (30) days after the Execution Date (but in any event prior to the release of the Initial Quantity to PAR) and shall be substantially in the form set forth in Schedule 4.2(b). GSK shall use commercially reasonable efforts to promptly respond to any reasonable inquiries from PAR regarding the supply of GSK Supplied Product.