Catalent Sample Clauses
Catalent. Catalent represents, warrants and undertakes to Client that:
A. at the time of delivery by Catalent as provided in Section 6.1, Product shall meet all Specifications, shall have been Processed in accordance with Applicable Laws and the Quality Agreement and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Client-supplied Materials which are not the result of Catalent’s negligence or misconduct or otherwise under Catalent’s reasonable control (including artwork, advertising and labeling);
B. during the Term, the Facility, all equipment used for the Processing of Product (and the Validation Services or Product Maintenance Services) within such Facility, and the Processing, Validation Services, and Product Maintenance Services activities contemplated herein will conform to all Applicable Laws;
C. title to all Product supplied under this Agreement will pass as provided in this Agreement, free and clear of any security interest, lien, or other encumbrance;
D. neither Catalent nor any of its employees or subcontractors performing or involved with its performance under this Agreement have been “debarred” under 21 U.S.C. §335(a) or (b) or otherwise by any Regulatory Authority, nor to Catalent’s knowledge have debarment proceedings against Catalent or any of its employees or subcontractors been commenced. Catalent will promptly notify Client in writing if any such proceedings have commenced or if Catalent or any of its employees or subcontractors are debarred by any Regulatory Authority; and
E. all Validation Services and Product Maintenance Services shall be carried out in a diligent, professional manner in accordance with Catalent’s standard operating procedures and cGMP, if applicable.
Catalent. Catalent represents and warrants to Client that:
A. at the time of delivery of the Product as provided in Section 6.1, such Product will conform to and will have been Processed and/or Packaged in conformance with the Product Specifications and Applicable Laws; provided that Catalent shall not be liable for defects attributable to API or other Client supplied materials (including artwork, packaging, and labeling);
B. it has, and shall have, good, complete and valid rights to utilize the Catalent Technology utilized in connection with the Product and as contemplated by this Agreement. To its knowledge, there are no patents owned by others related to the Catalent Technology used with 14 ***Confidential Treatment Requested the Product which would be infringed or misused by Catalent’s performance of the Agreement and, to its knowledge, there are no trade secrets or other proprietary rights of others related to the Catalent Technology used with the Product which would be infringed or misused by Catalent’s performance of this Agreement;
C. All Products will be Processed and Packaged at the Facilities; and
D. Catalent will comply with all Applicable Laws relative to Catalent’s performance under this Agreement.
E. THE LIMITED WARRANTY SET FORTH IN THIS SECTION 12.1 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSED IN THIS SECTION 12.1, CATALENT MAKES NO OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PROCESSING OR THE PRODUCT. IN ADDITION, CATALENT HEREBY DISCLAIMS LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY AND ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO PRODUCT.
Catalent. Catalent shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement:
(A) Commercial General Liability insurance with a per-occurrence limit of not less than […***…];
(B) Products and Completed Operations Liability Insurance with per-occurrence limit of not less than […***…];
(C) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than […***…] per accident; and
(D) Professional Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than […***…]. The parties hereby acknowledge and agree that Catalent may self-insure all or any portion of the above-required insurance. In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than […***…] years following the termination or expiration of this Agreement. Catalent shall obtain a waiver from any insurance carrier with whom Catalent carries Workers’ Compensation insurance releasing its subrogation rights against Client. Catalent shall furnish to Customer a certificate of insurance or other evidence of the required insurance and additional insured status as soon as practicable after the Effective Date and within […***…] days after renewal of such policies, and such certificate shall provide that the insurer will give Client at least […***…] days’ written notice of any material change in or cancellation of such insurance. Each insurance policy which is required under this Agreement, other 18 ***Confidential Treatment Requested than self-insurance, shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.
Catalent. Catalent represents, warrants and undertakes to Client that A. at the time of delivery by Catalent as provided in Section 6.1, Product shall have been Processed in accordance with Applicable Laws and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to API or other Client supplied Materials (including artwork, packaging and labeling); and
Catalent. “Catalent” shall mean Catalent Pharma Solutions, Inc. together with its successors and assigns.
Catalent. Catalent represents and warrants to Client that:
A. at the time of delivery, Product will have been manufactured in accordance with all Applicable Laws and the Specifications, and will not be adulterated, misbranded or mislabeled according to Applicable Laws; excluding any defects attributable to API or other materials supplied by Client;
B. Catalent’s use and application of any intellectual property, other than that provided to Catalent by Client, in the manufacturing of the Product and the performance of this Agreement does not violate or infringe on any third-party intellectual property rights;
C. Catalent has obtained (or will obtain prior to manufacturing the Product), and will remain in material compliance with all authorizations which are required under Applicable Laws; and
D. Catalent and its employees, affiliates, contractors, and agents have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 335(a) or 335(b) of the Federal Food, Drug, and Cosmetic Act.
Catalent. Catalent shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement:
(A) Commercial General Liability insurance with a per-occurrence limit of not less than $1,000,000; PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS.
(B) Products and Completed Operations Liability Insurance with per-occurrence limit of not less than $5,000,000;
(C) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than $1,000,000 per accident; and
(D) Professional Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than $1,000,000. The parties hereby acknowledge and agree that Catalent may self-insure all or any portion of the above-required insurance. In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than three (3) years following the termination or expiration of this Agreement. Catalent shall obtain a waiver from any insurance carrier with whom Catalent carries Workers’ Compensation insurance releasing its subrogation rights against Client. Catalent shall furnish to Customer a certificate of insurance or other evidence of the required insurance and additional insured status as soon as practicable after the Effective Date and within thirty (30) days after renewal of such policies. Each insurance policy which is required under this Agreement, other than self-insurance, shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.
Catalent. Catalent represents, warrants and undertakes to Client that (A) at the time of delivery by Catalent as provided in Section 6.1, Product shall have been Processed in accordance with Applicable Laws and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Client-supplied Materials (including artwork, advertising and labeling); and (B) it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b)].
Catalent. Catalent represents, warrants and undertakes to Palatin that:
A. at the time of delivery by Catalent as provided in Clause 6.1, all Product shall have been Processed in accordance with Applicable Laws and in conformance with the Specifications and the Quality Agreement and will not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Palatin-supplied Materials (including artwork, advertising and labeling);
B. Catalent will comply with all Applicable Laws applicable to Catalent’s performance under this Agreement and its use of any Palatin-supplied Materials;
C. To Catalent’s knowledge, there are no patents owned by others, or trade secrets or other proprietary rights of others, that would be infringed by the Catalent IP in Catalent’s performance of the Agreement;
D. Catalent and its employees, affiliates, contractors, and agents have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 335(a) or 335(b) of the Federal Food, Drug, and Cosmetic Act; and
E. Catalent will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications.
Catalent. Catalent represents, warrants and undertakes to Client that:
A. The regulatory documents and other data and information provided by Catalent to Client under the Project Documents in connection with the GPEx Cell Line is sufficient for Client to file for regulatory approval for the Expression Product;
B. To the best of Catalent’s knowledge, GPEx Technology that is provided to Client (including, to its knowledge, in combination with the Product) for the purposes anticipated by this Agreement, will not infringe, misappropriate or violate any patent, trademark, trade secret, copyright or other intellectual property or other proprietary rights of any third party;
C. to its knowledge, it has all necessary ownership or rights to use the GPEx Technology the purposes of fulfilling its obligations under this Agreement and no additional licenses for third party intellectual property are required to use the GPEx Technology for the purposes anticipated by this Agreement; and
D. it has the lawful right to sell the GPEx Cell Line to Client for all purposes contemplated hereunder.