Common use of Hospira Representations and Warranties Clause in Contracts

Hospira Representations and Warranties. Hospira represents and warrants that: (a) it has the full power, right and authority to execute and deliver this Agreement; (b) it shall use commercially reasonable best efforts to perform its obligations hereunder; (c) it will assign professional personnel, qualified to perform the Services in a manner consistent with the technical requirements of the Processing of Product; (d) none of its officers, directors, employees, Affiliates, contractors or agents has been debarred or, to Hospira’s knowledge, threatened with debarment under the Generic Drug Enforcement Act or convicted of a crime which could lead to debarment, and it has not utilized, and will not utilize, the services of any † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION individual or entity in the performance of any Services that has been debarred or threatened with debarment under the Generic Drug Enforcement Act, convicted of a crime that could lead to debarment or subject to any other penalty or sanction by the FDA; (e) it will conduct the Services in conformity with Applicable Laws including applicable cGMP, the procedures and parameters set forth in the Specifications, and generally accepted professional standards, and the event of any conflicts between the foregoing requirements, the most stringent requirement shall be met so long as consistent with all Applicable Laws; (f) each Certificate of Analysis will reflect the results of the tests conducted on the Batch of Product to which it relates, each Certificate of Compliance will be accurate and true, and the Batch Records delivered to Omeros will accurately reflect in all material respects the processes and procedures followed by Hospira in Processing Product as set forth in the Specifications; (g) the Product shall not have been and shall not be adulterated, misbranded, misused, contaminated, tampered with or otherwise altered, mishandled while in the custody and control of Hospira; and (h) it will not transfer to any third party any Product, other than (i) for the purpose of tests at any outside testing laboratory or consultant, as provided under Subsection 3.3.4, (ii) to Omeros’ designee or (iii) to any subcontractor approved in accordance with Subsection 6.1. In the event that Hospira receives notice of the debarment or threatened debarment of any individual or entity utilized by Hospira in connection with the Product, Hospira shall notify Omeros in writing immediately, and Omeros shall have the right to terminate this Agreement upon written notice without further cost or liability, except for payments of accrued and unpaid obligations to the date of termination. Hospira further represents and warrants that it has obtained (or will obtain prior to Processing Product or performance of other Services), and will remain in compliance with during the term of this Agreement, all permits, licenses and other authorizations which are required under Applicable Laws for the Processing of Product or performance of other Services hereunder.

Hospira Representations and Warranties. Hospira represents and warrants that: that (a) it has the full power, right and authority to execute and deliver this Agreement; (b) it shall use all commercially reasonable best efforts to perform its obligations hereunder; (cb) it will assign professional personnel, qualified to perform the Services in a manner consistent with the technical requirements of the Processing of Product; , (d) none of its officers, directors, employees, Affiliates, contractors or agents has been debarred or, to Hospira’s knowledge, threatened with debarment under the Generic Drug Enforcement Act or convicted of a crime which could lead to debarment, and it has not utilized, and will not utilize, the services of any † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION individual or entity in the performance of any Services that has been debarred or threatened with debarment under the Generic Drug Enforcement Act, convicted of a crime that could lead to debarment or subject to any other penalty or sanction by the FDA; (ec) it will conduct the Services in conformity with Applicable Laws including applicable cGMP, the procedures and parameters set forth in the Specifications, and generally accepted professional standardsstandards for the pharmaceutical industry, and the event of any conflicts between the foregoing requirements, the most stringent requirement shall be met so long as consistent with all Applicable Laws; , (fd) each Certificate of Analysis will reflect the results of the tests conducted on the Batch of Product to which it relates, each Certificate of Compliance will be accurate and true, and the Batch Records delivered to Omeros will accurately reflect in all material respects the processes and procedures followed by Hospira in Processing Product as set forth in the Specifications; , (e) all Product that Hospira delivers to Omeros pursuant to this Agreement shall, at the time of Delivery, not be adulterated or misbranded within the meaning of the 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 the Act, as the 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 Act be introduced into interstate commerce, (f) the API used by Hospira to Process Product hereunder shall have been manufactured in accordance with all applicable cGMP (including ICH Q7A) and meets the specification for API set forth in the Specifications of Exhibit B and (g) the Product shall not have been and shall not be adulterated, misbranded, misused, contaminated, tampered with or otherwise altered, mishandled while in the custody and control of Hospira; and (h) it will not transfer to any third party any Product, other than than, (i) for the purpose of tests at any independent expert or outside † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION testing laboratory or consultant, as provided under Subsection 3.3.4Section 3.3.6, (ii) to Omeros’ designee designee, or (iii) to any subcontractor approved in accordance with Subsection Section 6.1. In the event that Hospira receives notice of the debarment or threatened debarment of any individual or entity utilized by Hospira in connection with the Product, Hospira shall notify Omeros in writing immediately, and Omeros shall have the right to terminate this Agreement upon written notice without further cost or liability, except for payments of accrued and unpaid obligations to the date of termination. Hospira further represents and warrants that it has obtained (or will obtain prior to Processing Product or performance of other Services), and will remain in compliance with during the term of this Agreement, all permits, licenses and other authorizations which are required under Applicable Laws for the Processing of Product or performance of other Services hereunder.

Hospira Representations and Warranties. Hospira represents and warrants that: (a) it has the full power, right and authority to execute and deliver this Agreement; (b) it shall use commercially reasonable best efforts to perform its obligations hereunder; (c) it will assign professional personnel, qualified to perform the Services in a manner consistent with the technical requirements of the Processing of Product; (d) none of its officers, directors, employees, Affiliates, contractors or agents has been debarred or, to Hospira’s knowledge, threatened with debarment under the Generic Drug Enforcement Act or convicted of a crime which could lead to debarment, and it has not utilized, and will not utilize, the services of any † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION individual or entity in the performance of any Services that has been debarred or threatened with debarment under the Generic Drug Enforcement Act, convicted of a crime that could lead to debarment or subject to any other penalty or sanction by the FDA; (e) it will conduct the Services in conformity with Applicable Laws including applicable cGMP, the procedures and † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION parameters set forth in the Specifications, and generally accepted professional standards, and the event of any conflicts between the foregoing requirements, the most stringent requirement shall be met so long as consistent with all Applicable Laws; (f) each Certificate of Analysis will reflect the results of the tests conducted on the Batch of Product to which it relates, each Certificate of Compliance will be accurate and true, and the Batch Records delivered to Omeros will accurately reflect in all material respects the processes and procedures followed by Hospira in Processing Product as set forth in the Specifications; (g) the Product shall not have been and shall not be adulterated, misbranded, misused, contaminated, tampered with or otherwise altered, mishandled while in the custody and control of Hospira; and (h) it will not transfer to any third party any Product, other than (i) for the purpose of tests at any outside testing laboratory or consultant, as provided under Subsection 3.3.4, (ii) to Omeros’ designee or (iii) to any subcontractor approved in accordance with Subsection 6.1. In the event that Hospira receives notice of the debarment or threatened debarment of any individual or entity utilized by Hospira in connection with the Product, Hospira shall notify Omeros in writing immediately, and Omeros shall have the right to terminate this Agreement upon written notice without further cost or liability, except for payments of accrued and unpaid obligations to the date of termination. Hospira further represents and warrants that it has obtained (or will obtain prior to Processing Product or performance of other Services), and will remain in compliance with during the term of this Agreement, all permits, licenses and other authorizations which are required under Applicable Laws for the Processing of Product or performance of other Services hereunder.