Licensure, Registration and Accreditation. Opthea is licensed, registered, or otherwise qualified under all Applicable Laws to do business in each jurisdiction where such licenses, registrations or other qualifications are required.
Licensure, Registration and Accreditation. CymaBay hereby represents and warrants that it is licensed, registered, or otherwise qualified under all Applicable Laws to do business (a) in each jurisdiction where such licenses, registrations or other qualifications are required for the Development and Commercialization of the Product and (b) in each other jurisdiction where such licenses, registrations or other qualifications are required, except as would not reasonably be expected to cause a Material Adverse Event.
Licensure, Registration and Accreditation. Subcontractor represents and warrants that it has, to the extent required by Applicable Law, obtained any licenses, registrations, accreditations, certifications, permits, or authorizations required to do business and provide the Services. Subcontractor will notify Penta immediately if any part of this representation requires amendment during the term of this Subcontractor Agreement.
Licensure, Registration and Accreditation. Reata hereby represents and warrants that, as of the Effective Date, it is licensed, registered, or otherwise qualified under all Applicable Laws in all material respects to do business in each jurisdiction where such licenses, registrations or other qualifications are required and where failure to so qualify would cause a Material Adverse Event.
Licensure, Registration and Accreditation. PB hereby represents and warrants that it is licensed, registered, or otherwise qualified in all material respects under all Applicable Laws to do business in each jurisdiction where such licenses, registrations or other qualifications are required. PB further represents and warrants that there has not been and covenants that there will not be during the Term any breach or default by PB under AZ License which has not been or will not be, as applicable, timely cured as permitted thereunder, and that the AZ License is and shall continue to be in full force and effect during the Term, except to the extent that such a breach, default or failure as to the AZ License would not have a material adverse effect on PB’s ability to satisfy its obligations under this Agreement. During the Term, PB shall: (a) not take any action that would entitle MedImmune to terminate the AZ License pursuant to Section 9.2.3 thereof (b) take such actions as are necessary to cure any action by a Sublicensee (as defined in the AZ License) that would entitle MedImmune to terminate the AZ License; and (c) not mutually agree with MedImmune to terminate the AZ License, without the prior written consent of SFJ, to be given or withheld in its sole discretion. In addition, during the Term, PB shall not take any action to terminate the AZ License without providing [***] prior written notice to SFJ of PB’s intent to terminate so that SFJ may, in its sole discretion, elect to obtain the Program Transfer, and if SFJ elects in writing within such [***] period to obtain the Program Transfer, then PB shall not terminate the AZ License but shall assign it to SFJ in accordance with the Program Transfer Agreement and in such event PB shall not be entitled to any royalty payments as set forth in Section 3 of the Program Transfer Agreement.
Licensure, Registration and Accreditation. 13.2.1.1 Apellis hereby represents and warrants that it is licensed, registered, or otherwise qualified in all material respects under all Applicable Laws to do business in each jurisdiction where such licenses, registrations or other qualifications are required. Apellis further represents and warrants that there has not been and covenants that there will not be during the Term any breach or default by Apellis under the Penn Other Fields License which has not been or will not be, as applicable, timely cured as permitted thereunder, and that the Penn Other Fields License is and shall continue to be in full force and effect during the Term, except to the extent that such a breach, default or failure as to the Penn Other Fields License would not have a material adverse effect on Apellis’ ability to satisfy its obligations under this Agreement. Apellis further covenants that it and its Permitted Third Parties have, or will have at the required times, such certifications, permits, and authorizations as are required to conduct the Trial and perform any and all of their obligations in connection with the Trial.
Licensure, Registration and Accreditation. 13.2.3.1 Reata hereby represents and warrants that, as of the Effective Date, it is licensed, registered, or otherwise qualified under all Applicable Laws in all material respects to do business in each jurisdiction where such licenses, registrations or other qualifications are required and where failure to so qualify would cause a Material Adverse Event. Reata further represents and warrants that, to its knowledge as of the Effective Date, there has not been any breach or default by Reata under the Third Party Licenses, and that it shall not knowingly take any action that would permit the termination by any counter party to a Third Party License for the material breach thereof. Reata further covenants that it shall, and it shall obligate any Permitted Third Parties to, have at the required times, such certifications, permits, and authorizations as are required to conduct the Product Trials and perform any and all of their obligations in connection with the Product Trials.
13.2.3.2 Reata hereby represents and warrants that, prior to the Effective Date, (a) it and its Affiliates have conducted all preclinical and clinical activities related to the Development of the Product in material compliance with Applicable Laws, and (b) to Reata’s knowledge, all Third Parties utilized by Reata to perform any portion of the preclinical and clinical activities have conducted such portion of such preclinical activities in material compliance with Applicable Laws.
13.2.3.3 Reata certifies that, as of the Effective Date, neither it, nor its Affiliates, nor to its knowledge any Permitted Third Parties engaged by it to perform activities in relation to the Product are debarred under subsections 306(a) or (b) of the US Federal Food, Drug, and Cosmetic Act (US Generic Drug Enforcement Act of 1992; 21 USC 335a (a) or (b)), and that it has not knowingly used, and will not knowingly use in any capacity the services of any Person or Permitted Third Party debarred under this law to conduct the Product Trials. Reata further certifies that, as of the Effective Date, neither it, nor any of its Affiliates are excluded from any US health care program, including to Medicare and Medicaid. Reata will notify the AC immediately if either of these certifications needs to be amended in light of new information.
Licensure, Registration and Accreditation. Alnylam hereby represents and warrants that it is licensed, registered, or otherwise qualified under all Applicable Laws to do business in each jurisdiction where such licenses, registrations or other qualifications are required, except as would not be reasonably expected to have a Material Adverse Effect.
Licensure, Registration and Accreditation. It is licensed, registered, or otherwise qualified under all Applicable Laws to do business in each jurisdiction where such licenses, registrations or other qualifications are required except where the lack of which or the failure to be in compliance thereunder would not reasonably be expected to have a Material Adverse Effect.
Licensure, Registration and Accreditation. Contractor warrants that it is licensed, registered, or otherwise qualified under local law, regulations, policies and administrative requirements (collectively, “Applicable Law”) to perform Services as per this Agreement. Contractor further warrants that it has, to the extent required by Applicable Law, obtained any licenses, registrations, accreditations, certifications, permits, or authorizations required to provide the Services that are the subject of this Agreement.
