Common use of Quality Assurance Representations, Warranties and Covenants Clause in Contracts

Quality Assurance Representations, Warranties and Covenants. (a) Cipher, in its own name and on behalf of any of its Approved Manufacturers, Contract Finishers and Affiliates engaged in the performance of the actions contemplated hereby, including the Manufacture, sale and delivery of Product hereunder, hereby represents, warrants and covenants to Distributor that all Product or Authorized Generic that Cipher or any of Cipher’s Approved Manufacturers or Affiliates Manufactures, supplies and delivers under and pursuant to this Agreement will: (i) conform in all material respects to the Specifications at time of release; (ii) be free and clear from all material liens, encumbrances and defects of title, other than those that arise directly as a result of actions taken by Distributor; and (iii) comply with the requirements under the GMP standards, the Regulatory Approvals and the Other Approvals, as applicable, the Act and any other applicable Law in the Territory, and will not, at the time of such delivery, (i) be adulterated or misbranded within the meaning of the Act, or (ii) be an article which may not, under the provisions of the Act, be introduced into interstate commerce. (iv) shall furnish to Distributor a certificate of analysis for each lot of the Product shipped to Distributor, and a certificate that such lot meets the quality control standards set forth in the relevant approved application for Regulatory Approval all well as the annual certificate of compliance. (b) Distributor shall be responsible for storing Product under appropriate conditions as specified in labelling and for Marketing, Testing, Distribution and sale in full compliance with the applicable GMP standards, the Regulatory Approvals, the Other Approvals, the Act and the applicable Law. Distributor shall have received and shall be in current compliance with all Approvals of any Authority as may be required to Market the Product pursuant to this Agreement. (c) None of Distributor, Distributor’s Affiliates or SubDistributors shall, in bad faith, disrupt or cause the disruption of the supply of the Product into the marketplace in the Territory. (d) Cipher or its Approved Manufacturer(s) shall have received, and shall be in current compliance with, all Approvals of any Regulatory Authority as may be required to Manufacture and/or to supply the Product pursuant to this Agreement, and, as of the Effective Date, Cipher or, to its knowledge, any Approved Manufacturer has not received any warning letters or similar regulatory letters from any Regulatory Authority within the last three years with respect to the Product which Cipher has not disclosed to Distributor or which prevents the Manufacture and supply of the Product. The NDA has been approved and such approval is currently in full force and effect. (e) Each Party represents and warrants to the other Party that it has not engaged in any conduct or activity which could justify a Regulatory Authority debarment action, and no disbarment proceedings are currently underway or, to its knowledge, contemplated against it or any of its employees and, to its knowledge, neither its Approved Manufacturer nor any of its Contract Finishers has engaged in conduct that would justify a Regulatory Authority disbarment action and no proceedings are currently underway or contemplated against any of its Approved Manufacturers or Contract Finishers or any of their employees.

Quality Assurance Representations, Warranties and Covenants. (a) CipherCytoDyn, in and its own name and on behalf of any of its Approved Manufacturers, Contract Finishers and Affiliates engaged in the performance of the actions contemplated hereby, including the Manufacture, sale and delivery of Product hereunder, hereby represents, warrants and covenants to Distributor American Regent that all Product that CytoDyn or Authorized Generic that Cipher or any of Cipher’s Approved Manufacturers or its Affiliates Manufactures, supplies and delivers under and pursuant to this Agreement will: (i) conform in all material respects to the Specifications at time of releaseshipment to American Regent; (ii) be free and clear from all material liens, encumbrances and defects of title, other than those that arise directly as a result of actions taken by DistributorAmerican Regent; and (iii) comply with the requirements under the GMP cGMP standards, the Regulatory Approvals and the Other Approvals, as applicable, the Act and any other applicable Applicable Law in the Territory, and will not, at the time of such delivery, (iA) be adulterated or misbranded within the meaning of the Actmisbranded, or (iiB) be an article which may not, under the provisions of the Act, be introduced into interstate commerce. (iv) shall furnish to Distributor a certificate of analysis for each lot of the Product shipped to Distributor, and a certificate that such lot meets the quality control standards set forth in the relevant approved application for Regulatory Approval all well as the annual certificate of compliance. (b) Distributor American Regent shall be responsible for storing Product under appropriate conditions as specified in labelling labeling and for Marketing, Testing, Distribution and sale distribution in full compliance with the applicable GMP cGMP standards, the Regulatory Approvals, the Other Approvals, the Act Approvals and the applicable Applicable Law. Distributor shall have received and shall be in current compliance with all Approvals of any Authority as may be required to Market the Product pursuant to this Agreement. (c) None of Distributor, Distributor’s Affiliates or SubDistributors shallAmerican Regent shall not, in bad faith, disrupt or cause the disruption of the supply of the Product into the marketplace in the Territory. (d) Cipher or its Approved Manufacturer(s) CytoDyn shall have receivedat all times during the Term, and shall be in current compliance with, all Regulatory Approvals of any Regulatory Authority as may be required to Manufacture and/or to supply the Product pursuant to this Agreement, and, as of the Effective Date, Cipher or, to its knowledge, any Approved Manufacturer has not received any warning letters or similar regulatory letters from any Regulatory Authority within the last three years with respect to the Product which Cipher has not disclosed to Distributor or which prevents the Manufacture and supply of the Product. The NDA has been approved and such approval is currently in full force and effect. (e) Each Party represents and warrants that neither it nor any of its Affiliates, directly involved with the performance of this Agreement has been debarred under subsections (a) or (b) of Section 306 of the Act, as amended, 21 U.S.C. Section 335a(a) and (b) or comparable foreign regulation, has been excluded, debarred, suspended or otherwise ineligible to the other participate in a federal, provincial, or state health care program, (e.g., Medicare or Medicaid) or government procurement or non-procurement program or comparable foreign programs (a “Program”). Moreover, if any Party that it has not engaged in any conduct or activity which could justify a Regulatory Authority debarment action, and no disbarment proceedings are currently underway or, to its knowledge, contemplated against it or any of its employees andAffiliates, directly involved with the performance of this Agreement is subsequently excluded, debarred or otherwise ruled ineligible to its knowledgeparticipate in a Program, neither its Approved Manufacturer nor such Party agrees to immediately notify the other Party of such debarment, exclusion or suspension. Each Party shall also immediately notify the other Party in the event the notifying Party or any of its Contract Finishers Affiliates, directly involved with the performance of this Agreement has engaged been proposed for exclusion from participation in conduct any Program or charged with a criminal offense which, if convicted, would result in mandatory or discretionary exclusion in any such Program. (f) Each Party represents and warrants that would justify a Regulatory Authority disbarment action it did not and no proceedings are currently underway will not knowingly use in any capacity the services of any person debarred under the Act or contemplated against comparable foreign regulation or excluded, debarred, or otherwise ineligible to participate in any Program in connection with its performance of its Approved Manufacturers or Contract Finishers or any of their employeesthis Agreement.

Quality Assurance Representations, Warranties and Covenants. (a) CipherCan-Xxxx, in its own name and on behalf of any of its Approved Manufacturers, Contract Finishers and Affiliates engaged in the performance of the actions contemplated hereby, including the Manufacture, sale and delivery of Supplied Product hereunder, hereby represents, warrants and covenants to Distributor that all Supplied Product or Authorized Generic that Cipher Can-Xxxx or any of Cipher’s Can-Xxxx’x Approved Manufacturers or Affiliates Manufactures, supplies and delivers under and pursuant to this Agreement will: (i) conform in all material respects to the Specifications at time of releaseshipment to Distributor; (ii) be free and clear from all material liens, encumbrances and defects of title, other than those that arise directly as a result of actions taken by Distributor; and (iii) comply in all material respects with the requirements under the GMP standards, the Regulatory Approvals and the Other Approvals, as applicable, the Act and any other applicable Law in the Territory, and will not, at the time of such delivery, (i) delivery be adulterated or misbranded within the meaning of the Act, or (ii) be an article which may not, under the provisions of the Act, be introduced into interstate commerce. (ivb) Can-Xxxx shall furnish to Distributor a certificate of analysis for each lot of the Supplied Product shipped to Distributor, and a certificate that such lot meets the quality control standards set forth in the relevant approved application for Regulatory Approval all well as the annual certificate of compliance. (bc) Distributor shall be responsible for storing Supplied Product under appropriate conditions as specified in labelling labeling and for Marketing, Testing, Distribution and sale distribution in full compliance with the applicable GMP standards, the Regulatory Approvals, the Other Approvals, the Act and the applicable Law. Distributor shall have received and shall be in current compliance with all Approvals of any Authority as may be required to Market the Supplied Product pursuant to this Agreement. (cd) None of Distributor, Distributor or Distributor’s Affiliates or SubDistributors shall, in bad faith, disrupt or cause the disruption of the supply of the Supplied Product into the marketplace in the Territory. (de) Cipher Can-Xxxx or its Approved Manufacturer(s) shall have received, and shall at all times during the Term, be in current compliance with, all Approvals of any Regulatory Authority as may be required to Manufacture and/or to supply the Supplied Product pursuant to this Agreement, and, as of the Effective Date, Cipher Can-Xxxx or, to its knowledge, any Approved Manufacturer has not received any warning letters or similar regulatory letters from any Regulatory Authority within the last three (3) years with respect to the Product which Cipher Can-Xxxx has not disclosed to Distributor or which prevents the Manufacture and supply of the Product. The NDA has been approved and such approval is currently in full force and effect. (ef) Can-Xxxx shall ensure that each lot of the Supplied Product shipped to Distributor has a shelf-life and expiration date of at least thirty-six (36) months at the date of shipment. (g) Each Party represents and warrants to the other Party that it has not engaged in any conduct or activity which could justify a Regulatory Authority an FDA debarment action, and no disbarment debarment proceedings are currently underway or, to its knowledge, contemplated against it or any of its employees and, to its knowledge, neither its Approved Manufacturer nor or any of its Contract Finishers has engaged in conduct that would justify a Regulatory Authority disbarment an FDA debarment action and no proceedings are currently underway or contemplated against any of its Approved Manufacturers or Contract Finishers or any of their employees.