Diligence and Responsibilities. Zai shall be primarily responsible for, and shall use Commercially Reasonable Efforts to conduct, all Development activities of the Products in the Field in the Territory in accordance with the Clinical Development Plan at Zai’s sole cost subject to Section 5.4(b). Zai shall perform such obligations under the Clinical Development Plan in a professional manner, and in compliance in all respects with the Clinical Development Plan and the requirements of Applicable Laws, GCP and cGMP. Changes in the scope or direction of the Development work under this Agreement that would be a material deviation from the Clinical Development Plan must be approved by the JSC as set forth in Section 3.2(b); provided that any change with respect to Joint Global Studies shall be consistent with the Joint Global Studies as set forth in the Global Development Plan.
Diligence and Responsibilities. (a) Zai shall be responsible for and use Commercially Reasonable Efforts to (i) Develop Licensed Products in the Field in the Territory in accordance with the Territory Development Plan, (ii) perform the Development activities assigned to Zai under the Global Development Plan [***], and (iii) Commercialize Licensed Products in the Field in the Territory.
(b) Zai shall use Commercially Reasonable Efforts to conduct the tasks assigned to it in the Territory Development Plan, and the tasks assigned to it in the Global Development Plan and achieve the objectives set forth therein. Zai shall conduct such tasks in a timely, professional manner and in compliance with the Territory Development Plan and Global Development Plan, as applicable, and all Applicable Laws, including GLP, GCP and cGMP. NVCR may conduct such tasks assigned to it, and any other activities assigned to it under this Agreement, through one or more Affiliate or Third Party designees.
(c) No later than [***] days following the Effective Date, the Parties will cooperate to finalize, and shall mutually agree upon prior to attachment to this Agreement in Exhibit B, a written timeline (the “NMPA Submission Timeline”) for Regulatory Submissions to the NMPA, which NMPA Submission Timeline may be amended upon mutual agreement by the Parties from time to time. Zai will develop the timelines for other indications within [***] days after the Effective Date.
Diligence and Responsibilities. […***…] BeiGene shall be responsible for the Development of the Licensed Products in the Field in the Territory in accordance with this Article 5. BeiGene shall use Commercially Reasonable Efforts to (i) […***…], and (ii) […***…]. BeiGene shall conduct such tasks in a timely, professional manner and in compliance with the Territory Development Plan and Global Development Plan, as applicable, and all Applicable Laws, including GLP, GCP and cGMP.41
Diligence and Responsibilities. (a) Except for the Zymeworks Ongoing Studies, Jazz shall be responsible for the Development of the Licensed Products in the Field in the Territory in accordance with this Article 5. Jazz shall use Commercially Reasonable Efforts to (i) Develop a Licensed Product in the Field in each of the Major Market Countries, and (ii) seek to obtain Regulatory Approval for a Licensed Product in the Field in each of the Major Market Countries, in each case of (i) and (ii) for the treatment of [***]. Jazz shall conduct such tasks in a timely, professional manner and in compliance with the Territory Development Plan, as applicable, and all Applicable Laws, including GLP and GCP.
(b) Zymeworks shall be responsible for conducting the Zymeworks Ongoing Studies and the Zymeworks Korean Studies in accordance with this Article 5, at Jazz’s cost and expense as specified in Sections 5.5 and 9.2. Zymeworks shall complete the Zymeworks Ongoing Studies and Zymeworks Korean Studies in accordance with the Zymeworks Development Plan[***]. [***] Zymeworks shall conduct such tasks in a timely, professional manner and in compliance with the Zymeworks Development Plan and all Applicable Laws, including GCP and cGMP. Jazz shall not amend the Zymeworks Development Plan to remove any of the Zymeworks Ongoing Studies or Zymeworks Korean Studies[***].
Diligence and Responsibilities. Zai shall be primarily responsible for, and shall use Commercially Reasonable Efforts to Develop the Products in the Field in the Territory, including the conduct of all Development activities of the Products in the Field in the Territory in accordance with the Development Plan at Zai’s sole cost subject to Section 5.5(b). [***]. Zai shall perform such obligations under the Development Plan in a professional manner, and in compliance in all respects with the Development Plan and the requirements of Applicable Laws, GCP and cGMP. Changes in the scope or direction of the Development work under this Agreement that would be a material deviation from the Development Plan must be approved by the JSC as set forth in Section 3.2(b); provided that any change with respect to Joint Global Studies shall be consistent with the Joint Global Studies as set forth in the Global Development Plan.
Diligence and Responsibilities. Company shall be responsible for the Development of the Licensed Products in the Field in the Territory in accordance with this Article 5. Company, directly or through one or more Affiliates or Third Parties, shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Licensed Products in the Field in the United States, in at least one of the countries from the United Kingdom, France, Germany, Italy and Spain, and at least one of China and Japan (the “Approval Countries”). Company shall conduct such tasks in a timely, professional manner and in compliance with all Applicable Laws, including GLP, GCP and GMP. For avoidance of doubt, Company is not obligated to achieve the Breakthrough Designation Milestone.
Diligence and Responsibilities. (a) Zai will be responsible for, and use Commercially Reasonable Efforts to Develop the Licensed Product in the Field in the Territory in accordance with the Development Plan, at its sole cost and expense.
(b) Zai will use Commercially Reasonable Efforts to conduct its tasks pursuant to the Development Plan and to attempt to achieve the objectives of the Development Plan. Zai will perform such obligations under the Development Plan in a professional manner, and in compliance in all material respects with the Development Plan and the requirements of Applicable Law, GCP and cGMP. Changes in the scope or direction of the Development work under this Agreement that would require a material deviation from the Development Plan must be approved by the JSC as set forth in Section 3.2(b).
Diligence and Responsibilities. (a) Zai shall be responsible for, and shall use Commercially Reasonable Efforts to, Develop the Licensed Product in the Field in the Territory in accordance with the Development Plan. For clarity, Zai shall use Commercially Reasonable Efforts to Develop the Licensed Products pursuant to the Development Plan [***].
(b) Zai shall use Commercially Reasonable Efforts to conduct its tasks pursuant to the Development Plan and to achieve the objectives of the Development Plan. Zai shall perform such obligations under the Development Plan in a professional manner, and in compliance in all respects with the Development Plan and the requirements of Applicable Laws, GCP and cGMP. Changes in the scope or direction of the Development work under this Agreement that would require a material deviation from the Development Plan must be approved by the JSC as set forth in Section 3.2(b).
(c) Zai shall use Commercially Reasonable Efforts to Develop the Licensed Product through the most expeditious available regulatory pathway in the Territory.
Diligence and Responsibilities. (a) Ahon shall be responsible for and use Commercially Reasonable Efforts to Develop the Licensed Product in the Field in each of the Regions in the Territory in accordance with the Development Plan, as defined below.
(b) Ahon shall conduct its tasks set forth in to the Development Plan and to attempt to achieve the objectives set forth therein in a timely manner. Ahon shall perform such obligations in a professional manner, and in compliance with the Development Plan and the requirements of all Applicable Laws, including GLP and GCP.
(c) Without limiting the foregoing, Ahon shall achieve the following Development milestone before the deadline specified in the table below. For each calendar quarter during Development, Ahon shall provide to DiaMedica a report that details the progress and results of the Development Plan with DiaMedica’s assistance especially on the initial Development Plan, which report shall include a summary of the Development activities performed and all results, analysis and conclusions thereof. DiaMedica shall review such report and make recommendations regarding changes to the Development Plan. The initial Development Plan is attached in Exhibit C subject to Section 4.2. [***] Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. Obtain CTA approval or IND filing review results by NMPA [***] months after the Effective Date
(d) DiaMedica shall be responsible for and use Commercially Reasonable Efforts to Develop the Licensed Product in the Field outside the Territory in accordance with DiaMedica’s development plan and assist Ahon to undertake Ahon’s responsibilities pursuant to Development and Regulatory Approval in the Agreement before First Commercial Sale of Licensed Product in the Territory, which assistance shall be provided without further cost through CTA submission. After CTA submission, such assistance shall be provided at no cost for the first [***] FTE hour and at the rate of US$[***] per FTE hours thereafter. In any case Ahon shall reimburse DiaMedica for its out-of-pocket expenses (including travel and accommodation) incurred to provide such assistance. Nevertheless, Ahon’s total payment to DiaMedica for such technical assistance shall not be over than $[***] and the normal project communication shall not be included.
(e) In the event that NMPA requires supplementary non-clinical studies involving CMC (“CM...
Diligence and Responsibilities. Each Party will be responsible for, and will use Commercially Reasonable Efforts to conduct, all Development activities of the Product in the Field to be conducted by such Party in accordance with the Global Development Plan [***]. Each Party will perform such obligations under the Global Development Plan in a professional manner, and in compliance in all respects with the Global Development Plan and the requirements of Applicable Laws, GCP, and cGMP. [***].
