Common use of Xxxxxx Warranty Clause in Contracts

Xxxxxx Warranty. (a) Product Warranty: Xxxxxx represents and warrants that Client Product shall be Produced in accordance with Specifications and cGMP and shall not have become adulterated or misbranded due to the negligence of Xxxxxx or Althea’s failure to comply with the terms of this Agreement. (b) Xxxxxx warrants and covenants that has no knowledge of any patents or other Intellectual Property that would be infringed or misappropriated by Althea’s Production of Client Product hereunder. (c) Xxxxxx warrants and covenants that it will not use any employee or consultant that has been debarred by a regulatory authority, excluded from a federal health care program, or convicted of or pled nolo contendere to any felony or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud, or, to the best of its knowledge, is the subject of debarment proceedings by a regulatory authority. (d) Xxxxxx warrants and covenants that it will not enter into any agreement or arrangement with any other entity that would prevent or in any way interfere with Althea’s ability to perform its obligations hereunder (other than resource allocation and scheduling issues inherent in its business). (e) Xxxxxx represents and warrants that it has obtained (or will obtain prior to Producing Client Product), and will remain in compliance with during the Term, all permits, licenses and other authorizations which are required under federal, state and local laws, rules and regulations generally applicable to its operations and the Facility; provided, however, Xxxxxx shall have no obligation to obtain permits specific to the manufacture of Client Product or relating to the sale, marketing, distribution or use of Bulk Compound or Client Product or with respect to the Labeling of Client Product. (f) Xxxxxx makes no representation or warranty with respect to the sale, marketing, Labeling, distribution or use of the Bulk Compound or, except as expressly set forth in this Section 11.2, the Client Product.

Appears in 3 contracts

Samples: Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc)

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Xxxxxx Warranty. (a) Product Warranty: Xxxxxx XXXXXX represents and warrants that Client Drug Product shall be Produced in accordance with Specifications and cGMP and shall not have become adulterated or misbranded due to the negligence of Xxxxxx or Althea’s failure to comply with the terms of this Agreement. (b) Xxxxxx warrants and covenants that has no knowledge of any patents or other Intellectual Property that would be infringed or misappropriated by Althea’s Production of Client Product hereunder. (c) Xxxxxx warrants and covenants that it will not use any employee or consultant that has been debarred by a regulatory authority, excluded from a federal health care program, or convicted of or pled nolo contendere to any felony or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud, or, to the best of its knowledge, is the subject of debarment proceedings by a regulatory authority. (d) Xxxxxx warrants and covenants that it will not enter into any agreement or arrangement with any other entity that would prevent or in any way interfere with Althea’s ability to perform its obligations hereunder (other than resource allocation and scheduling issues inherent in its business). (e) Xxxxxx cGMP. XXXXXX further represents and warrants that it has obtained (or will obtain prior to Producing Client Drug Product), and will remain in compliance with during the Termterm of this Agreement, all permits, licenses and other authorizations (the “Permits”) which are required under federalApplicable Legal Requirements or as specified in the Project Plan, state and local lawsthe Master Batch Records, rules and regulations generally applicable to its operations and the FacilitySpecifications or the XXXXXX SOPs; provided, however, Xxxxxx XXXXXX shall have no obligation to obtain permits specific to the manufacture of Client Product or Permits relating to the sale, marketing, commercial distribution or use of Bulk Compound APIs or Client Drug Product or with respect to the Labeling of Client Drug Product. (f) Xxxxxx . XXXXXX further represents and warrants that the Drug Product supplied hereunder shall not be adulterated or misbranded within the meaning of the FD&C Act or comparable law, provided, however, that the warranty in this sentence shall not apply to any such adulteration or misbranding that occurred due to information provided by CLIENT or that occurred after the Drug Product leaves ALTHEA’s control. XXXXXX further represents and warrants that it shall perform all Development, Production, and other services hereunder in full compliance with all Applicable Legal Requirements and all other requirements of this Agreement. XXXXXX makes no representation or warranty with respect to the sale, marketing, Labeling, commercial distribution or use of the Bulk Compound or, except APIs or as expressly set forth in this Section 11.2, the Client Productto printed materials supplied by CLIENT or its consignee. XXXXXX further represents and warrants that all Drug Product supplied hereunder shall be transferred free and clear of any liens or encumbrances of any kind arising through XXXXXX or its Affiliates or their respective agents. XXXXXX further represents and warrants that it has no knowledge of any patents or other Intellectual Property rights that would be violated by ALTHEA’s performance hereunder.

Appears in 1 contract

Samples: Drug Product Development and Clinical Supply Agreement (Omeros Corp)

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