Good Manufacturing Practices. Products shall be manufactured and tested by Seller in accordance with all applicable U.S. laws and United States Food and Drug Administration (FDA) regulations, including but not limited to the FDA's current Good Manufacturing Practice regulations in effect at the time of such manufacture or testing. Seller shall notify Buyer of any FDA inspection of its production facilities used to manufacture any products and shall furnish Buyer with copies of any Form 483 report and Establishment. Inspection Reports to the extent that they apply to any product.
Good Manufacturing Practices. The Technical Agreement contains provisions relating to GMPs. If Allos’ failure to comply with applicable Laws causes a Supply Interruption, Section 4 of this Agreement will apply.
Good Manufacturing Practices. All employees on the site are committed to following Good Manufacturing Practices covering safety, quality, hygiene, housekeeping, cleanliness, appearance, operating procedures, responsibility, identification and maintenance.
Good Manufacturing Practices. (GMP’s). [The United States has clari- fied its interpretation that under the MRA, paragraph (c)(1) of this section has to be understood as the U.S. defini- tion and paragraph (c)(2) as the EC def- inition.]
Good Manufacturing Practices. Products will be manufactured and packaged by Supplier in accordance with current Good Manufacturing Practices (“cGMP”).
Good Manufacturing Practices. Where Seller provides goods or services for Buyer to manufacture medicinal products that require compliance with the principles and guidelines of current good manufacturing practices (“cGMP”) it is the responsibility of Seller to satisfy the following additional requirements.
Good Manufacturing Practices. BioCheck shall manufacture Products for supply hereunder in accordance with applicable current Good Manufacturing Practices, as defined by the United States Food and Drug Administration.
Good Manufacturing Practices. (a) Access shall ensure that all Devices are designed and manufactured in material compliance with (i) FDA’s Good Manufacturing Practices, [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. which are codified in the Quality System Regulation (“QSR”) set forth in 21 C.F.R. Part 820, (ii) the Quality Agreement and (iii) the Supply Agreement.
Good Manufacturing Practices. QUALITY SYSTEMS REGULATIONS. MacroPore shall be responsible for compliance with present and future applicable statutes, laws, ordinances and regulations of national, federal, state and local governments now or hereafter in effect relating to the [design,] manufacture and/or quality of Developed Products. Without limitation of the foregoing, MacroPore represents and warrants to Medtronic that all Developed Products sold and delivered to Medtronic under this Agreement will have been manufactured in accordance with all applicable requirements. MacroPore shall cause Medtronic's regulatory personnel to be provided with reasonable access from time to time to the facilities and records of MacroPore for the purpose of confirming MacroPore's compliance with this Section 4.2.
Good Manufacturing Practices. EDT shall ensure that Contract Manufacturer and any other contractors/affiliates shall manufacture, store and prepare all Product and related raw materials for shipping in accordance with the cGMPs, in a facility to be agreed upon by EDT and SM. EDT may not change manufacturing of the Product to an alternate facility without first obtaining SM’s written approval.
