Catalent. Catalent represents, warrants and undertakes to Client that:
A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity;
B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement;
C. at the time of delivery by Catalent to the designated carrier hereunder, the Supplies shall have been manufactured in accordance with Applicable Laws 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 Drug or other Client-supplied Materials (including artwork, advertising, packaging and labeling) provided to Catalent by Client or its Affiliates;
(i) to Catalent’s knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that would be infringed or misused by Catalent’s performance of this Agreement;
E. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America; and
F. Catalent will not in the performance of its obligations under this Agreement use the services of any person ...
Catalent. Catalent represents, warrants and undertakes to Client that: Catalent represents, warrants and undertakes to Client that unless otherwise agreed to by the parties in a Quotation:
A. At the time of delivery by Catalent to the designated carrier hereunder, (i) the Product shall have been manufactured in accordance with all Applicable Laws, (ii) the Product shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, however, that Catalent shall not be liable any misbranding or mislabeling due to any labeling, instructions or package insert text provided to Catalent by Client or its Affiliates in writing, (iii) the API or other materials if applicable that are provided by Client, (iv) the Product is accompanied by all documentation required under the terms of this Agreement, and (v) the Product will be conveyed to Client will good title and free of all security interests, liens and encumbrances; and
B. It has obtained or will obtain and will maintain in effect through the term of this Agreement, at its sole cost and expense, all necessary licenses, permits, certifications and approvals legally required to operate the Facility and provide the Processing services as required herein; and
C. Catalent is and has not been debarred and, to the best of Catalent’s knowledge, is not subject to any pending debarment. Catalent further represents and warrants that it will not use, in connection with the performance of any services under this Agreement, any person or entity that it knows has been debarred pursuant to any Applicable Laws or which is subject to any pending debarment proceedings; and
D. Catalent has the right to enter into this Agreement.
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 primarily attributable to API or other Client-supplied Materials (including artwork, packaging and labeling); and
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 mean Catalent Pharma Solutions, Inc. together with its successors and assigns.
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 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) 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 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.
