Common use of Catalent Clause in Contracts

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 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 at the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, (i) the Product shall meet all Specifications, shall have been manufactured Processed in accordance with all Applicable Laws, (ii) Laws and the Product Quality Agreement and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, however, that Catalent shall not be liable any misbranding for defects attributable to Client-supplied Materials which are not the result of Catalent’s negligence or mislabeling due 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 any labeling, instructions or package insert text all Applicable Laws; C. title to all Product supplied under this Agreement will pass as 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, 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 (vb) the Product 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 be conveyed to promptly notify Client will good title and free in writing if any such proceedings have commenced or if Catalent or any of all security interests, liens and encumbrancesits employees or subcontractors are debarred by any Regulatory Authority; and B. It has obtained or will obtain E. all Validation Services and will maintain Product Maintenance Services shall be carried out in effect through the term of this Agreementa diligent, 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 professional manner in accordance with Catalent’s knowledgestandard operating procedures and cGMP, 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 Agreementif applicable.

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 (A) at the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, (i) the Product shall have been manufactured Processed in a professional xxxxxxx-like manner in accordance with all cGMP, Applicable LawsLaws and the terms and conditions of this Agreement, (ii) and in conformance with the Product Specifications and shall not be adulterated, misbranded misbranded, or mislabeled within the meaning of Applicable Laws; provided, however, that Catalent shall not be liable for defects attributable to Client-supplied Materials (including artwork, advertising and labeling); (B) it will not in the performance of its obligations under this Agreement use the services of any misbranding person debarred or mislabeling due suspended under 21 U.S.C. §335(a) or (b); (C) that none of Catalent’s services hereunder or any part of this Agreement is or will be inconsistent with any obligation Catalent may have to others; (D) all work under this Agreement will be Catalent’s original work and, to the best of its knowledge, none of the Processing or any labelingdevelopment, instructions use, production, distribution or package insert text provided to Catalent by Client exploitation thereof will infringe, misappropriate or its Affiliates in writing, (iii) the API violate any intellectual property or other materials if applicable that are provided right of any person or entity (including, without limitation Catalent or any of its Affiliates); (E) no [*] shall be employed or utilized in the performance of any Services hereunder, nor incorporated into any Product or other deliverables generated by Client, Catalent under this Agreement (ivincluding any Client IP); (F) at the Product is accompanied by all documentation required under the terms time of execution of this Agreement, and no [*] shall be employed or utilized in the performance of any Services hereunder, nor incorporated into any Product or other deliverables generated by Catalent under this Agreement or under the 2013 MSA and; (vG) the Product will be conveyed to Client will good title and free of all security interestsCatalent does not, liens and encumbrances; and B. It has obtained or will obtain and will maintain in effect through not during the term of this Agreement, at its sole cost knowingly manufacture, process or house in inventory penicillin or non-penicillin beta lactam products or products that result in beta lactam-containing derivatives, degradation products or other compounds, unless with prior written approval by Client; 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. (H) Catalent has the full right and authority to enter into provide Client with the assignments, licenses and other rights provided for herein. 22 [*] = Certain confidential information contained in this Agreement.document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL 12.2

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 (A) at the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, (i) the Product shall have been manufactured Processed in a professional xxxxxxx-like manner in accordance with all cGMP, Applicable LawsLaws and the terms and conditions of this Agreement, (ii) and in conformance with the Product Specifications and shall not be adulterated, misbranded misbranded, or mislabeled within the meaning of Applicable Laws; provided, however, that Catalent shall not be liable for defects attributable to Client-supplied Materials (including artwork, advertising and labeling); (B) it will not in the performance of its obligations under this Agreement use the services of any misbranding person debarred or mislabeling due suspended under 21 U.S.C. §335(a) or (b); (C) that none of Catalent’s services hereunder or any part of this Agreement is or will be inconsistent with any obligation Catalent may have to others; (D) all work under this Agreement will be Catalent’s original work and, to the best of its knowledge, none of the Processing or any labelingdevelopment, instructions use, production, distribution or package insert text provided to Catalent by Client exploitation thereof will infringe, misappropriate or its Affiliates in writing, (iii) the API violate any intellectual property or other materials if applicable that are provided right of any person or entity (including, without limitation Catalent or any of its Affiliates); (E) no [*] shall be employed or utilized in the performance of any Services hereunder, nor incorporated into any Product or other deliverables generated by Client, Catalent under this Agreement (ivincluding any Client IP); (F) at the Product is accompanied by all documentation required under the terms time of execution of this Agreement, and no [*] shall be employed or utilized in the performance of any Services hereunder, nor incorporated into any Product or other deliverables generated by Catalent under this Agreement or under the 2013 MSA and; (vG) the Product will be conveyed to Client will good title and free of all security interestsCatalent does not, liens and encumbrances; and B. It has obtained or will obtain and will maintain in effect through not during the term of this Agreement, at its sole cost knowingly manufacture, process or house in inventory penicillin or non-penicillin beta lactam products or products that result in beta lactam-containing derivatives, degradation products or other compounds, unless with prior written approval by Client; 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. (H) Catalent has the full right and authority to enter into provide Client with the assignments, licenses and other rights provided for herein. [*] = Certain confidential information contained in this Agreementdocument, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.