Xxxxxx Warranty. Xxxxxx represents and warrants that it shall Produce all Product in accordance with cGMP and, that all Commercial Product shall meet Product Specifications. Xxxxxx represents and warrants that it has obtained (or will obtain prior to Producing Product), and will remain in compliance with during the Term of this Agreement, all permits, licenses and other authorizations (the “Permits”) which are required under laws and regulations applicable to the Production only of Product as specified in the Product Master Plan; provided, however, Xxxxxx shall have no obligation to obtain Permits relating to the sale, marketing, distribution or use of Product or with respect to the labeling of Product. Xxxxxx makes no representation or warranty with respect to the sale, marketing, distribution or use of API, Product or to printed materials specified by Celator or its consignee.
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.
Xxxxxx Warranty. 11.2.1 [Reserved]
11.2.2 Xxxxxx represents and warrants as follows:
(a) Client Product shall be and has been Produced in accordance with the Specifications (including in- process Specifications) and cGMP, subject to Section 5.1(d);
(b) the Production activities performed by Xxxxxx shall be and have been performed in compliance with the requirements of all applicable material Legal Requirements; [***]; and provided, further, that this Section 11.2.2(b) shall not imply and Xxxxxx expressly disclaims any warranty from Xxxxxx regarding the activities performed by Alder (or performed by third parties on behalf of Alder), including Alder’s or such third party’s designs, formulations, Specifications, clinical or preclinical testing, use, marketing, packaging or labeling of Client Product or any claims made by Alder or such third party regarding safety or efficacy of Client Product; and
(c) when delivered to Client, Client Product shall and does conform to the Specifications. provided, however, that, with respect to Client Product resulting from development or engineering runs, [***] and, with respect to Client Product resulting from development or engineering runs, Xxxxxx represents and warrants [***] that Client Product shall be and has been Produced in accordance with agreed initial target process Specifications and those portions of cGMP which are expressly made applicable in the PWA to the development or engineering runs. XXXXXX & ALDER CONFIDENTIAL 19 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
11.2.3 Except for any liens or encumbrances, if any, of Xxxxxx, securing Client’s payment obligations under this Agreement, Client Product shall be and has been transferred free and clear of any liens or encumbrances of any kind arising through Xxxxxx or its Affiliates or their respective agents or subcontractors.
11.2.4 Xxxxxx represents and warrants that it has obtained (or will obtain prior to Producing Client Product) and will maintain, and will remain in compliance with during the Term, all permits, licenses and other authorizations (the “Permits”) which are required under federal, state and local Legal Requirements applicable to the Production services; provided, however, for clarity, the parties acknowledge that Xxxxxx shall have no obligation to obtain Permits relating to the sale (except any that ...
Xxxxxx Warranty. Xxxxxx represents and warrants that Client Product shall be Produced in accordance with Specifications and cGMP. 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 (the “Permits”) which are required under Applicable Laws for the Production of Client Product; provided, however, Xxxxxx shall have no obligation to obtain Permits relating to the sale, marketing, distribution or use of Bulk Compound or Client Product or with respect to the Labeling of Client Product. Xxxxxx makes no representation or warranty with respect to the sale, marketing, distribution or use of the Bulk Compound or, except as expressly set forth in this Section 11.2, the Client Product, or as to printed materials supplied by Client or its consignee
Xxxxxx Warranty. XXXXXX warrants to TIMET that the Titanium Conversion Services rendered to TIMET by XXXXXX shall be performed in a good and workmanlike fashion in accordance with industry standards and TIMET’s specified process practice, operating procedures and product specifications consistent with the terms set forth in the Submission Sheet.
Xxxxxx Warranty. Xxxxxx represents and warrants that Product shall be Produced in accordance with applicable cGMPs and all other Product Requirements, including without limitation, sterility and endotoxin (with no warranty that Product shall meet the Product Specifications). Except as provided in this Agreement, Xxxxxx makes no representation or warranty with respect to the sale, marketing, distribution or use of the BDS, Product or to printed materials specified by Client or its consignee. Xxxxxx further represents and warrants that (a) it has the right to give Client any information and materials provided by Xxxxxx hereunder, and that Client has the right to use such information and materials for the Production of Product, and (b) Xxxxxx has no knowledge of any (i) patents or other intellectual property rights that would be infringed by Xxxxxx’x Production of Product under this Agreement, or (ii) proprietary rights of third parties which would be violated by Xxxxxx’x performance hereunder, and (c) Xxxxxx will Produce the Product and perform the Process Services in accordance with applicable laws, rules and regulations.
Xxxxxx Warranty. Xxxxxx represents and warrants that Client Product shall be Produced in accordance with and will comply with the Specifications, and cGMP, subject to the provisions of Article 5. Xxxxxx represents and warrants that (a) 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 Regulations generally applicable to its operations and the Facility; provided, however, Xxxxxx makes no representation or warranty with respect to compliance or permits specific to Client Product or Bulk Compound or their manufacture, nor related to the sale, marketing, distribution, use or Labeling of Bulk Compound or Client Product except as expressly set forth in the preceding sentence, and (b) Xxxxxx has no knowledge of any patents or other Intellectual Property that would be infringed or misappropriated by Althea’s Production of Client Product or performance of any other of its obligations under this Agreement.
Xxxxxx Warranty. Xxxxxx represents and warrants that each: (a) Batch of Clinical Product, process validation Batch or registration Batch of Product shall be Produced in accordance with Product Specifications and cGMP, and (b) Batch of Commercial Product shall conform to the Product Specifications and cGMP (the “Product Warranties”). Xxxxxx represents and warrants that it has obtained (or will obtain prior to Producing Product), and will remain in compliance with during the term of this Agreement, all permits, licenses and other authorizations (the “Permits”) which are required under laws and regulations applicable to the Production only of Product as specified in the Product Master Plan; provided, however, Xxxxxx shall have no obligation to obtain Permits relating to the sale, marketing, distribution or use of Product or with respect to the labeling of Product. Xxxxxx makes no representation or warranty with respect to the sale, marketing, distribution or use of printed materials specified by Client or its consignee. For clarification purposes, the Product Warranties shall not apply to a Feasibility Batch of Product.
Xxxxxx Warranty. Xxxxxx represents and warrants to DuPont that (i) execution and performance of this Agreement by Xxxxxx does not and will not constitute a breach of any existing contract to which Xxxxxx is a party (ii) it has received an offer to purchase products of like grade and quality from another supplier and (iii) DuPont has offered the terms and conditions set forth in this Agreement in order to meet such competitive offer.
Xxxxxx Warranty. XXXXXX represents and warrants that Drug Product shall be Produced in accordance with cGMP and the Drug Product Specifications at the time of release. XXXXXX represents and warrants that it has obtained (or will obtain prior to Producing Drug Product), and will remain in compliance with during the term of this Agreement, all permits, licenses and other
