Conformity; Specifications; Quality Control. (a) All quantities of API supplied by the Company pursuant to this Section 8 will comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of API at the time it is shipped by the Company hereunder.
Conformity; Specifications; Quality Control. All Finished Product manufactured, supplied, distributed and sold by or on behalf of Valera shall (i) be manufactured, packaged and labeled in accordance with cGMPs and with applicable laws; (ii) not be adulterated or misbranded; and (iii) meet and comply with VANTAS Specifications contained in the NDA for VANTAS. Valera shall conduct, or cause to be conducted, quality control testing of VANTAS, in accordance with such specifications, prior to shipment and prepare and retain records pertaining to such testing in accordance with the NDA, applicable laws and Valera’s internal standard operating procedures.
Conformity; Specifications; Quality Control. (a) All quantities of Finished Products and/or Samples supplied by Indevus pursuant to this Article 14 will conform in all material respects to the Specifications. * CONFIDENTIAL TREATMENT REQUESTED 72
Conformity; Specifications; Quality Control. (a) All Product, Finished Product and Implanters supplied by DURECT pursuant to this Agreement shall comply in all material respects with the Specifications and applicable Manufacturing Standards and shall adhere to all applicable laws and regulations relating to the manufacture, sale and shipment of each shipment of Product, Finished Product and Implanters at the time it is shipped by DURECT hereunder.
Conformity; Specifications; Quality Control. (a) All quantities of Compound supplied by Inspire pursuant to this Section 8 will comply with the Compound Specifications and applicable Manufacturing Standards and shall adhere to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of each shipment of Compound at the time it is shipped by Inspire hereunder.
Conformity; Specifications; Quality Control. (a) All quantities of Product supplied by SANQUIN pursuant to this Section 4 will comply in all material respects with the Specifications and Manufacturing Standards and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, packaging, sale, storage, and shipment of each shipment of Product at the time it is shipped by SANQUIN hereunder.
Conformity; Specifications; Quality Control a. All quantities of the Product supplied by Omrix pursuant to this Agreement will comply in all material respects with the Specifications and shall adhere in all material respects to all applicable governmental laws and regulations relating to the manufacture, packaging, sale, storage, and shipment of each shipment of the Product at the time it is shipped by Omrix hereunder.
Conformity; Specifications; Quality Control. (a) All quantities of Supplied Goods supplied by Inspire pursuant to the Supply Agreement will comply with all applicable Specifications and applicable Manufacturing Standards and shall adhere to all applicable governmental laws and regulations relating to the manufacture, sale and shipment of the respective Supplied Goods at the time they arrive at the point designated by Kissei.
Conformity; Specifications; Quality Control. All Finished Product and Product Samples supplied, distributed and sold by or on behalf of CRTX in the Territory during the Term shall (i) be manufactured, packaged and labeled in accordance with cGMPs and with Applicable Laws; (ii) not be adulterated or misbranded; and (iii) meet and comply with each Product's Specifications contained in the applicable NDA. CRTX shall conduct, or cause to be conducted, quality control testing of Product, in accordance with such specifications, prior to shipment and prepare and retain records pertaining to such testing in accordance with the NDA, Applicable Laws and CRTX's internal standard operating procedures. In the event of any failure to comply with this Section 10.5 (other than a failure due to CRTX's gross negligence or intentional misconduct), CRTX's sole and exclusive liability under this Agreement, and DEY's sole and exclusive remedy, shall be that CRTX shall replace the non-conforming Product.
Conformity; Specifications; Quality Control. 5.8.1. All quantities of the Product supplied by Kamada pursuant to this Agreement will comply in all material respects with the Manufacturing Specifications and shall adhere in all material respects to all Applicable Laws relating to the manufacture, packaging, sale, storage, and shipment of each shipment of the Product at the time such shipment is delivered to Kedrion's Facility.
