Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws;
(b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights;
(c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b);
(d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act;
(e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval);
(f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs;
(g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs;
(h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a);
(i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights;
(j) all employees, consultants, subcontractors and agents perfo...
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws; and
(b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate’s unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights.
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Manufacturing Services in a professional and workmanlike manner and in accordance with the Specifications, cGMPs, and Applicable Laws,
(b) Patheon and its personnel performing the Manufacturing Services have the requisite experience, skills, knowledge, and expertise necessary to perform the Manufacturing Services in a competent manner;
(c) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliates unencumbered property, (ii) may be lawfully used by Patheon, and (iii) to the knowledge of Patheon, does not infringe and will not infringe any Third Party Rights; and
(d) the Products will be delivered free of all liens and encumbrances
Patheon Warranties. Patheon covenants, represents and warrants that (a) it shall perform the Manufacturing Services in accordance with the Specifications, cGMPs and all applicable Laws and that any Product supplied by it hereunder at the time of shipment, shall comply with the Specifications, (b) Patheon is not aware of any Intellectual Property of any third party that is necessary for Patheon to manufacture the Product as contemplated hereby and (c) the Active Material will not be used for any purpose beyond or different from the scope of the Manufacturing Services or otherwise in violation of the terms and conditions of this Agreement. Patheon acknowledges that the Product is controlled under Schedule III of the Controlled Substances Act and, as such, is subject to regulations and restrictions concerning its sale and distribution. Patheon agrees to comply with all such regulations and restrictions, as well as any reasonable instructions from the Client with respect to the use and storage of the Product. Without limiting the foregoing, (a) Patheon will obtain and/or maintain in force during the term of the Agreement all licenses and authorizations from the Drug Enforcement Administration or any other regulatory or governmental agency which are necessary for it to manufacture and possess the Product; and (b) Patheon will keep the Product in a secure location with access limited to authorized employees.
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) all Product delivered hereunder shall (i) conform to the applicable Specifications; (ii) be free and clear of any and all encumbrances, liens, or other third party claims; (iii) be manufactured, packaged, labelled and delivered in compliance with the Quality Agreement and applicable cGMP, all regulatory approvals for the Product, and Applicable Laws and in accordance with manufacturing procedures described in the applicable master batch records for such Product; (iv) not be adulterated or misbranded within the meaning of the United States Food, Drug and Cosmetic Act, as amended, and any regulations promulgated thereunder, or any analogous law or regulation in the applicable jurisdiction (the “Act”); (v) not be articles that, under the provisions of the Act, may not be introduced into interstate commerce and (vi) subject to Client’s representation in Section 9.2(a)(ii)(C), the manufacture of the Product in accordance with this Agreement will not infringe any Third Party Rights;
(i) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, all regulatory approvals for the Product and Applicable Laws, and (ii) the Components, Active Materials and the Xxxx Back Items will at all times be free and clear of any and all encumbrances, liens, or other third party claims; and
(c) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate’s unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights.
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Manufacturing Services in accordance with the Processing Instructions, cGMPs, and Applicable Laws;
(b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights;
(c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); and
(d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act.
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Manufacturing Services in accordance with this Agreement, the Specifications, Master Batch Record, cGMPs, and Applicable Laws;
(b) all Product Patheon delivers to Client pursuant to this Agreement shall be transferred to Client free and clear of any liens or encumbrances of any kind provided that Client pays all invoices in accordance with Section 5.5;
(c) all Product Patheon delivers to Client pursuant to this Agreement shall, at the time of delivery, not be adulterated or misbranded as a result of a failure by Patheon to perform the Manufacturing Services in accordance with this Agreement, the Specifications, cGMPs and Applicable Laws within the meaning of adulterated or misbranded as set out in the United States Federal Food, Drug, and Cosmetic Act or within the meaning of all Applicable Law in which the definitions of adulteration and misbranding are substantially the same as those contained in United States Federal Food, Drug, and Cosmetic Act, as such act and such laws are constituted and effective at the time of delivery, and will not be an article which may not under the provisions of Sections 404 and 505 of the United States Federal Food, Drug, and Cosmetic Act be introduced into interstate commerce as a result of a failure by Patheon to perform the Manufacturing Services in accordance with this Agreement, the Specifications, cGMPs and Applicable Laws;
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Manufacturing Services in accordance with the Manufacturing Requirements;
(b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate’s unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; and
(c) the Product will, on delivery, conform to the Specifications, have been manufactured in accordance with the Manufacturing Requirements, and not be adulterated.
(d) neither it nor any of its Affiliates, personnel or contractors performing any Manufacturing Services will make any payments or gifts to foreign governments or related persons for the purpose of obtaining or retaining business for or with, or directing business to, any person in connection with the performance of Manufacturing Services. Accordingly, Patheon agrees that no portion of monies paid or payable in connection with this Agreement, nor any other item of value, will, directly or indirectly, be paid, received, transferred, loaned, offered, promised or furnished to, or for the use of, any officer or employee of any foreign government department, agency, instrumentality or corporation thereof, or any political party or any official of such party or candidate for office, or any person acting for or on behalf of any of the foregoing, for the purpose of (i) inducing the recipient to misuse his or her official position to direct business wrongfully to Client, Patheon, or any other person, (ii) influencing any act or decision of an official in his or her official capacity, including to obtain regulatory approvals for Product, (iii) inducing an official to do or omit to do any act in violation of his or her lawful duty, (iv) obtaining any improper advantage, or (v) inducing a foreign official to use his or her influence improperly to affect or influence any act or decision.
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Services in accordance with the Specifications, cGMPs, the Quality Agreement, and Applicable Laws;
(b) all Product, upon delivery EXW at the Facility to Client or to a party of Client’s designation, shall (i) fully conform to the applicable Specifications and release information; (ii) have been manufactured in compliance with the applicable regulatory requirements, cGMPs, the Specifications, the Quality Agreement, and all Applicable Laws; and (iii) not be adulterated or misbranded within the meaning of any Applicable Law;
(c) Patheon has, and shall use commercially reasonable efforts to maintain the resources and personnel necessary to fully perform its obligations under this Agreement in a timely manner; and without limiting Patheon’s personnel training and qualification obligations under the Quality Agreement (as applicable), any individual used by Patheon to perform the Services are, and will continue to be, qualified and have, and will continue to have, sufficient technical expertise to perform Patheon’s obligations under this Agreement;
(d) to the best of Patheon’s knowledge and belief, any Patheon Intellectual Property used by Patheon or its Affiliates to perform the Services (i) is Patheon’s or its Affiliate’s unencumbered property, (ii) may be lawfully used by Patheon and its Affiliates, and (iii) does not infringe and will not infringe any third party rights in the Territory.
Patheon Warranties. Patheon covenants, represents, and warrants that:
(a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws and that any Product supplied by it hereunder at the time of shipment, will comply with the Specifications;
(b) Patheon is not aware of any Intellectual Property of any third party that is necessary for Patheon to manufacture any Product as contemplated hereby;
(c) The Active Material will not be used for any purposes beyond or different from the scope of the Manufacturing Services or otherwise in violation of the terms and conditions of this Agreement. Patheon acknowledges that certain of the Products are controlled under the Controlled Substances Act and, as such, are subject to regulations and restrictions concerning sale and distribution. Patheon agrees to comply with these regulations and restrictions, as well as any reasonable instructions from Client with respect to the use and storage of the Products. Without limiting the foregoing, (a) Patheon will obtain and/or maintain in force during the term of the Agreement all licenses and authorizations from the Drug Enforcement Administration or any other regulatory or governmental agency which are necessary for it to manufacture and possess these Products; and (b) Patheon will keep these Products in a secure location with access limited to authorized employees; and (d) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights.
