Diligence; Standards of Conduct. (a) Each Party shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for the Products throughout the Territory (i) in the CKD Indications and (ii) in each [*], other indication in the Field and Designated Indication that [*] in the Development Plan. If at any time there is only one Collaboration Compound (either because no additional Collaboration Compounds have been developed or because development of all other Collaboration Compounds have been terminated), then the foregoing obligation shall be for one Product only. (b) Each Party shall use Commercially Reasonable Efforts to carry out the tasks assigned to it under the Development Plan in a timely and effective manner. Each Party shall conduct its activities under the Development Plan in a good scientific manner and in compliance in all material respects with all applicable laws and regulations. Without prejudice to the aforesaid, the Party responsible for the conduct of any Clinical Trials hereunder shall perform such Clinical Trials in a good scientific manner, in compliance with all applicable laws and regulations, GCP, this Agreement and the Development Plan as well as the relevant protocol and investigator’s brochure. Such Party shall further require the principal investigators, study sites and any contractors involved in the performance of such Clinical Trials to comply with all safety reporting procedures set forth in the Pharmacovigilance Agreement in connection with their performance of such Clinical Trials.
Appears in 2 contracts
Samples: License, Development and Commercialization Agreement (Fibrogen Inc), License, Development and Commercialization Agreement (Fibrogen Inc)
Diligence; Standards of Conduct. (a) Each Party shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for the Products throughout the Territory (i) in the CKD Indications and (ii) in each [*[ * ], other indication in the Field and Designated Indication that [*[ * ] in the Development Plan. If at any time there is only one Collaboration Compound (either because no additional Collaboration Compounds have been developed or because development of all other Collaboration Compounds have been terminated), then the foregoing obligation shall be for one Product only.
(b) Each Party shall use Commercially Reasonable Efforts to carry out the tasks assigned to it under the Development Plan in a timely and effective manner. Each Party shall conduct its activities under the Development Plan in a good scientific manner and in compliance in all material respects with all applicable laws and regulations. Without prejudice to the aforesaid, the Party responsible for the conduct of any Clinical Trials hereunder shall perform such Clinical Trials in a good scientific manner, in compliance with all applicable laws and regulations, GCP, this Agreement and the Development Plan as well as the relevant protocol and investigator’s brochure. Such Party shall further require the principal investigators, study sites and any contractors involved in the performance of such Clinical Trials to comply with all safety reporting procedures set forth in the Pharmacovigilance Agreement in connection with their performance of such Clinical Trials.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Fibrogen Inc)
Diligence; Standards of Conduct. (a) Each Party shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for the Products throughout the Territory (i) in the CKD Indications and (ii) in each [*[ * ], other indication in the Field and Designated Indication that [*[ * ] in the Development Plan. If at any time there is only one Collaboration Compound (either because no additional Collaboration Compounds have been developed or because development of all other Collaboration Compounds have been terminated), then the foregoing obligation shall be for one Product only.or
(b) Each Party shall use Commercially Reasonable Efforts to carry out the tasks assigned to it under the Development Plan in a timely and effective manner. Each Party shall conduct its activities under the Development Plan in a good scientific manner and in compliance in all material respects with all applicable laws and regulations. Without prejudice to the aforesaid, the Party responsible for the conduct of any Clinical Trials hereunder shall perform such Clinical Trials in a good scientific manner, in compliance with all applicable laws and regulations, GCP, this Agreement and the Development Plan as well as the relevant protocol and investigator’s brochure. Such Party shall further require the principal investigators, study sites and any contractors involved in the performance of such Clinical Trials to comply with all safety reporting procedures set forth in the Pharmacovigilance Agreement in connection with their performance of such Clinical Trials.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement