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Of FRESENIUS Sample Clauses

Of FRESENIUS. FRESENIUS warrants and represents that as of the Effective Date and at all times during the term of this Agreement that: 17.2.1 FRESENIUS has received all approvals required by all applicable Regulatory Agencies for the operation of the Facility as a cGMP manufacturing facility and necessary to operate the Facility in compliance with all applicable local laws, rules and regulations in Sweden. 17.2.2 All quantities of the Products supplied hereunder (i) shall meet the Product Specifications, (ii) shall be manufactured in accordance with Production Standards, and (iii) shall not be adulterated, misbranded or otherwise in violation of the U.S. Federal Food, Drug, and Cosmetic Act, and its foreign equivalents, as such laws exist at the time of shipment of such Product; 17.2.3 FRESENIUS’ manufacture of the Products shall adhere to all applicable governmental laws, rules and regulations relating to the manufacture of the Products in the United States and Europe; 17.2.4 All Products delivered to TRANSMEDICS shall be free and clear of any liens and/or encumbrances by any third party; 17.2.5 To the best of FRESENIUS’ knowledge, the manufacturing processes used to manufacture of the Products hereunder to the extent such process does not involve TRANSMEDICS Know-How does not infringe on any third party’s intellectual property rights.
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