Diligence; Standards of Conduct. During the Research Term, Surface (itself or through its Affiliates or by permitted subcontracting pursuant to Section 3.1.7) will use Commercially Reasonable Efforts to [***] Surface will conduct its activities under the T1 Research Plan in a good scientific manner and in compliance with applicable Law.”
5. Section 5.1.2 is hereby amended by deleting Section 5.1.2 in its entirety and replacing it with the following:
Diligence; Standards of Conduct. On an Option Target-by-Option Target basis, during the Research Term, Surface (itself or through its Affiliates or by permitted subcontracting pursuant to Section 3.2.6) will use Commercially Reasonable Efforts to [***] Surface will conduct its activities under the Option Target Research Plans in a good scientific manner and in compliance with applicable Law.
Diligence; Standards of Conduct. On a Global Target-by-Global Target basis, Novartis will use Commercially Reasonable Efforts to (a) [***] and (b) perform all Development activities for the Global Antibody Candidates and Global Licensed Products for such Global Target in accordance with the Global Development Plan. On a Global Target-by-Global Target basis, Surface will use Commercially Reasonable Efforts to (x) [***] and (y) perform all Development activities for the Global Antibody Candidates and Global Licensed Products for such Global Target in accordance with the Global Development Plan that Surface agrees to perform at Novartis’ request.
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.
Diligence; Standards of Conduct. During the Licensed Period, Shionogi, itself or with any of its Related Parties, will use Commercially Reasonable Efforts to (a) perform the Development activities specified under each Development Plan approved by the JSC for a specific Licensed Product in the Field throughout the Shionogi Territory; and (b) Develop the TO Products in the Lead Indication and in each Additional Indication throughout the Shionogi Territory. Without limiting the foregoing, Shionogi or any of its Related Parties shall (i) file a request for commencement of Clinical Studies with the PMDA for the TO Products in the Field in Japan within [***] ([***]) months after the Option Exercise Date; (ii) Initiate Clinical Studies for the TO Products in the Field in Japan within [***] ([***]) months after receipt of feedback on the Clinical Study design for the TO Products in the Field from PMDA, (iii) file a request for Regulatory Approval for the TO Products in the Field in Japan within [***] ([***]) months after Completion of the Development Data Set for the TO Products in the Field in Japan as required by PMDA, and (iv) file a request for Regulatory Approval for the TO Products in the Field in Taiwan within [***] ([***]) months after the Regulatory Approval is obtained in Japan on the assumption that the procedure to obtain the Regulatory Approval for the TO Products in Taiwan is substantially the same as that for pharmaceutical products. The Parties shall discuss, in good faith at the JSC, the requirement of item (iv) if the procedure to obtain the Regulatory Approval for the TO Products has been confirmed by the JSC and is substantially different from that for pharmaceutical products in Taiwan.
Diligence; Standards of Conduct. Each of Biogen and Sage will use Commercially Reasonable Efforts to carry out the tasks for which it is responsible for under the applicable corresponding Joint Medical Affairs Plan in accordance with the applicable timelines set forth in such plan.
Diligence; Standards of Conduct. 4.2.2.1 With respect to the Product and Optional Product, the Parties agree to use Commercially Reasonable Efforts to undertake, and to bear the costs associated with, the key Development activities of the countries in the Territory and countries outside of the Territory.
4.2.2.2 Each Party shall use Commercially Reasonable Efforts to develop the Product and/or Optional Product in accordance with timelines set out in the relevant Development Plans.
4.2.2.3 The Parties shall conduct all of their respective activities in connection with this Agreement with reasonable skill and care in a good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws, rules and regulations, and, to the extent applicable, all other requirements of GMP, GLP and current GCP.
4.2.2.4 Both Parties acknowledge the importance of ensuring that the activities under this Agreement are undertaken in accordance with the following good data management practices:
(a) data being generated using sound scientific techniques and processes;
(b) data being accurately and reasonably contemporaneously recorded in accordance with good scientific practices by the persons responsible for conducting the research under this Agreement;
(c) data being analysed appropriately without bias in accordance with good scientific practices; and
(d) data and results being stored securely and in a form which can be easily retrieved.
4.2.2.5 The Parties agree to implement the necessary processes to ensure a close, co-operative working relationship in order to enable both Parties to fulfil their obligations under this Agreement.
4.2.2.6 During the Term of this Agreement, each Party shall provide to the other Party all such Party’s Know-How (i.e., in case of DAEWOONG, DAEWOONG Know-How, and in the case of STOCOSIL, all STOCOSIL Know-How) and that has not previously been provided hereunder, in each case promptly upon request by the other Party. The Party providing such Party’s Know-How shall provide the same in electronic form to the extent the same exists in electronic form, and shall provide copies as reasonably requested and an opportunity for the other Party or its designee to inspect (and copy) all other materials comprising such Know-How (including for example, original patient report forms and other original source data). The Parties will cooperate and reasonably agree upon formats and procedures to facilitate the orderly and efficient exchange of the DAEWOONG Know-How...
Diligence; Standards of Conduct with respect to the Work Plan. Each Party agrees to use Commercially Reasonable Efforts to perform the tasks assigned to such Party under the Work Plan in a timely and effective manner, and each Party further agrees to conduct its activities under the Work Plan in a good scientific manner and in compliance in all material respects with Applicable Law. In the event of any inconsistency between the Work Plan and this Agreement, the terms of this Agreement will prevail. Without limiting the foregoing, in all events, both Parties will provide all resources necessary to support the Development Program, including providing the appropriate technical resources and personnel with the appropriate skill, training and expertise. All disputes regarding the level of efforts and resources dedicated by a Party to the performance of the Development Program will be escalated to the JSC.
Diligence; Standards of Conduct. With respect to each Collaboration Antigen, Unum (itself or through its Affiliates or by permitted subcontracting pursuant to Section 5.9) agrees to use Commercially Reasonable Efforts to Develop Research Candidates in the Territory, and to carry out the tasks specified under the Research Plan, in a timely and effective manner, and agrees to conduct its activities under the Research Plan in a good scientific manner and in compliance in all material respects with Applicable Law. SGI will cooperate with and provide reasonable support to Unum (especially in connection with the SGI Antibodies included in such Research Candidates) in connection with Unum’s performance of its responsibilities under the Research Plan. The Parties acknowledge and agree, however, that no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement (notwithstanding the focus of the Research Program described above).
Diligence; Standards of Conduct. (a) With respect to each Collaboration Antigen, Unum (itself or through its Affiliates or by permitted subcontracting pursuant to Section 6.9) agrees to use Commercially Reasonable Efforts to Develop the applicable Development Candidate in the Shared Territory, and to carry out the tasks specified under the Early Clinical Development Plan, in a timely and effective manner, and agrees to conduct its activities under the Early Clinical Development Plan in a good scientific manner and in compliance in all material respects with Applicable Law. SGI will cooperate with and provide reasonable support to Unum (especially in connection with the SGI Antibodies included in such Development Candidate) in connection with Unum’s performance of its responsibilities under the Early Clinical Development Plan. The Parties acknowledge and agree, however, that no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement (notwithstanding the focus of the Early Clinical Development Plan described above).
(b) On a Development Candidate-by-Development Candidate basis, each Party (itself or through its Affiliates or by permitted subcontracting pursuant to Section 6.9) agrees to use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for the Development Candidate and associated Product in the Shared Territory, and to carry out the tasks specified under the Late Clinical Development Plan, in a timely and effective manner and in a good scientific manner and in compliance in all material respects with Applicable Law. Each Party will cooperate with and provide reasonable support to the other Party (especially in connection with, in the case of support by Unum, the ACTR T-cells, and in the case of support by SGI, the SGI Antibodies, in each case included in such Development Candidate) in connection with the other Party’s performance of its responsibilities under the Late Clinical Development Plan.
(c) On a Development Candidate-by-Development Candidate basis, SGI (itself or through its Affiliates or by permitted subcontracting pursuant to Section 6.9) agrees to use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for the Development Candidate and associated Product in the Licensed Territory, and to carry out the tasks specified under the Late Clinical Development Plan, in a timely and effective manner and in a good scientific ...
