SAFC Representations and Warranties. SAFC hereby represents and warrants as follows: (a) The execution, delivery and performance of this Agreement does not conflict with, violate or breach any agreement to which SAFC is a party or SAFC’s constituent documents, and SAFC is not prohibited or limited by any law or agreement (to which it is a party) from entering into this Agreement and the performance of this Agreement will not create any conflict of interest with any other business or activity engaged in by SAFC; (b) Vector Product shall be Manufactured and shipped in compliance with cGMP, the Master Batch Record, the Specifications, the Quality Agreement and all other applicable laws, rules and regulations; (c) SAFC and its Affiliates, approved subcontractors and any person used by SAFC and its Affiliates and subcontractors to perform services under this Agreement (i) have not been debarred and are not the subject of a conviction described in Section 306 of the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 335a; (ii) are not subject to any similar sanction by any government regulatory authority; and (iii) SAFC shall notify Company immediately in writing if SAFC, its Affiliates or any subcontractor or any person used to perform services hereunder, as applicable, is subject to the foregoing, or of any action, suit, claim, investigation or proceeding; (d) All Vector Product delivered by SAFC hereunder will conform to the Quality Agreement and the Specifications; and (e) SAFC will have obtained and maintained in effect all such approvals and permits as may be required under applicable laws, rules, regulations and requirements to operate the Manufacturing Facility for the purposes of Manufacturing Vector Product under the Quality Agreement and under this Agreement. SAFC shall make copies of such registrations and all related documents available for viewing by Company and its designees for inspection, upon prior reasonable request from Company.
Appears in 2 contracts
Samples: Clinical and Commercial Supply Agreement (Bluebird Bio, Inc.), Clinical and Commercial Supply Agreement (Bluebird Bio, Inc.)
SAFC Representations and Warranties. SAFC hereby represents represents, warrants and warrants covenants as follows:
(ai) The execution, delivery and performance of this Agreement does not conflict with, violate or breach any agreement to which SAFC is a party or SAFC’s constituent documents, and (ii) SAFC is not prohibited or limited by any law or agreement (to which it is a party) from entering into this Agreement and (iii) the performance of this Agreement will not create any legal conflict of interest with any other business or activity engaged in by SAFC;
(b) Vector Product The API at the time of delivery shall be (i) have been Manufactured and shipped delivered in compliance with cGMPwith, the Master Batch Recordand shall meet, the Specifications, the Quality Agreement and all other applicable laws, rules and regulations;
(c) SAFC and its Affiliates, approved subcontractors and any person used by SAFC and its Affiliates and subcontractors to perform services under this Agreement (i) have not been debarred and are not the subject of a conviction described in Section 306 of the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 335a; (ii) are not subject to any similar sanction by any government regulatory authority; and be Manufactured in accordance with all Laws (including cGMPs) in effect on the day of delivery, (iii) SAFC shall notify Company immediately in writing if SAFC, its Affiliates or any subcontractor or any person used to perform services hereunder, as applicable, is subject to the foregoing, or of any action, suit, claim, investigation or proceeding;
(d) All Vector Product delivered by SAFC hereunder will conform to the Quality Agreement and the Specifications; and(iv) not be adulterated or misbranded within the meaning of the U.S. Federal Food, Drug and Cosmetic Act (the “Act”), or any similar Law of any other jurisdiction, and (v) not be an article that may not, under the provisions of the Act, or any similar Law of any other jurisdiction, be introduced into stream of commerce;
(ec) SAFC will have obtained and maintained in effect all such approvals and permits as may be required under applicable laws, rules, regulations and requirements to operate the Manufacturing Facility facility for the API for the purposes of Manufacturing Vector Product API under the Quality Agreement and under this Agreement. ;
(d) SAFC will not in the course of performing the Manufacturing obligations hereunder, infringe or misappropriate any intellectual property of any other person, provided, however, that this warranty does not apply to SAFC’s use of any Company Confidential Information used solely in accordance with the terms of this Agreement or the Quality Agreement or other written instructions provided by Company in accordance with the Quality Agreement and used by SAFC in Manufacturing API hereunder.
(e) SAFC shall make copies not disclose to Company any trade secrets or confidential or proprietary information of any third party without the consent of such registrations and all related documents available for viewing by Company third party.
(f) SAFC agrees that federal securities law may prohibit it, its affiliates and its designees representatives from purchasing or selling any securities of the Company while it is in possession of material, non-public information of the Company, and that it will not disclose any material, non-public information, directly or indirectly, to any party for inspection, upon prior reasonable request from the purpose of encouraging such party to trade in the Company’s securities and that it will comply at all times with the applicable Federal Securities Laws and regulations.
Appears in 1 contract
Samples: Commercial Supply Agreement (Amag Pharmaceuticals Inc.)
SAFC Representations and Warranties. SAFC hereby represents and warrants as follows:
(ai) The execution, delivery and performance of this Agreement does not conflict with, violate or breach any agreement to which SAFC is a party or SAFC’s constituent documents, and (ii) SAFC is not prohibited or limited by any law or agreement (to which it is a party) from entering into this Agreement and (iii) the performance of this Agreement will not create any conflict of interest with any other business or activity engaged in by SAFC;
(b) Vector The Product shall be Manufactured and shipped in compliance with cGMP, the Master Batch Record, the Specifications, the Quality Agreement and all other applicable laws, rules and regulations;
(c) SAFC and its Affiliates, approved subcontractors and any person used by SAFC and its Affiliates and subcontractors to perform services under this Agreement (i) have not been debarred and are not the subject of a conviction described in Section 306 of the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 335a; (ii) are not subject to any similar sanction by any government regulatory authority; and (iii) SAFC shall notify Company immediately in writing if SAFC, its Affiliates or any subcontractor or any person used to perform services hereunder, as applicable, is subject to the foregoing, or of any action, suit, claim, investigation or proceeding;
(d) All Vector Product delivered by SAFC hereunder will conform to the Quality Agreement and Agreement, the Specifications, and cGMP; and
(ed) SAFC will have obtained and maintained in effect all such approvals and permits as may be required under applicable laws, rules, regulations and requirements to operate the Manufacturing Facility facility for Product for the purposes of Manufacturing Vector Product under the Quality Agreement and under this Agreement
(e) SAFC warrants and covenants that it will not use any employee, subcontractor, or consultant that has been debarred or suspended under 21 U.S.C. § 335(a) or (b). SAFC shall make copies represents that it does not currently have and will not hire, as an officer or an employee, or subcontractor any person who has been convicted of such registrations a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Federal Food, Drug, and all related documents available for viewing by Cosmetic Act.
(f) SAFC warrants and covenants to Company and its designees for inspectionthat SAFC will not in the course of performing the manufacturing obligations hereunder, upon prior reasonable request from Companyinfringe or misappropriate any intellectual property of any other person.
Appears in 1 contract
Samples: Commercial Supply Agreement (Amag Pharmaceuticals Inc.)