Development Efforts Sample Clauses
Development Efforts. 4.2.1 Hana shall use Commercially Reasonable Efforts to Develop each Product in the Territory (including carrying out its responsibilities under the Development Plan) to:
(a) conduct or cause to be conducted the necessary and appropriate clinical trials as necessary to obtain and maintain Regulatory Approvals for each Product; and
(b) prepare, file and prosecute or cause to be prepared, filed and prosecuted the Regulatory Submission for each Product.
4.2.2 Hana will provide INEX with written reports to keep INEX fully informed of the progress of the Development of each Product as follows:
(a) at the close of each Calendar Quarter during the first twenty-four (24) months following the Effective Date of the Definitive Agreements; and
(b) on or before June 31 and December 31 of each and every calendar year thereafter.
Development Efforts. (a) During the applicable Development Term with respect to each Product, Alvotech shall (i) use commercially reasonable efforts to develop such Product for the uses of such Product set forth in the Product Data Sheet for such Product in accordance with the Research Plan and (ii) use commercially reasonable efforts (taking into account the commercial potential of such Product in each Alvogen Territory) to obtain, in its own name (or the name of one of its Affiliates) and at its own cost, Regulatory Approvals for such Product in the Alvogen Territories. Alvotech shall use commercially reasonable efforts to conduct the Research Program in good scientific manner and using cGxP of the applicable Territory or other applicable jurisdiction where the Research Program is being conducted, to achieve the objectives of the Research Program efficiently and expeditiously, in compliance with all Applicable Laws. Alvotech shall complete all Phase 4 and post-marketing surveillance studies required to be completed by any Regulatory Agency with respect to a Product as a condition to Regulatory Approval of such Product. Notwithstanding anything in this Agreement to the contrary, Alvotech shall be responsible for taking any and all actions required to support all Product dossiers that may be necessary for any Registration or other Regulatory Approvals with respect to any Product, regardless of whether such actions are required to be taken prior to or following receipt of Regulatory Approval with respect to the applicable Product.
(b) Following Successful Completion of a Phase 3 Clinical Trial with respect to each Product, Alvotech shall use commercially reasonable efforts (taking into account the commercial potential of such Product in each Alvogen Territory) to obtain and maintain, solely in its own name (or the name of one of its Affiliates), and at its own cost, all Regulatory Approvals for such Product in the Alvogen Territories, which, for the avoidance of doubt, shall include the Regulatory Approval of the EMA (if applicable); provided, that Alvotech shall be responsible for obtaining and maintaining all Regulatory Approvals, if any, required to be obtained from each individual country that is included in such Party’s Territories and is also covered by the Regulatory Approval of the EMA.
(c) Alvotech shall solely own all Regulatory Approvals that it obtains in accordance with this Section 2.1, and shall be fully responsible for all regulatory activities and requirements ...
Development Efforts. Genentech will use commercially reasonable and diligent efforts to develop C2B8, including pursuing preclinical development and clinical development of C2B8 and obtaining Regulatory Approvals therefor in all countries in the Licensed Territory, taking into account the scientific and commercial potential of C2B8, including, without limitation, each of the potential indications in the Field for C2B8. Within ninety (90) days of the Original Effective Date, Genentech agrees to provide IDEC with a written development strategy for C2B8 in the Licensed Territory indicating (i) whether Genentech will develop C2B8 alone or with a partner in Europe, (ii) the identity of its European partner (if any), and (iii) a list of clinical trials which Genentech would conduct for C2B8 approval in Europe assuming adequate quantities of C2B8 are available.
Development Efforts. [*]. Table 1: NPI Phase Description D.4 Development Samples. [*].
Development Efforts. Promptly after the Effective Date, Virobay will use Commercially Reasonable Efforts to develop and seek Regulatory Approval for at least one Assigned Product or a Combination Product in the United States, Japan or a Major EU Country.
Development Efforts. (i) Fujisawa shall use Diligent Efforts to carry out development of the Licensed Product for the treatment of the Primary Indications in accordance with the Development Plan. If Fujisawa determines that it will be unable to meet any of the Critical Target Dates identified in the Development Plan within six (6) months after the date specified in such Development Plan, it shall notify the JMC within thirty (30) days of such determination. The JMC shall develop a revised Development Plan for the Licensed Product which shall include new Critical Target Dates, provided however, that DTI's JMC representatives must agree to the new Critical Target Dates. In the event DTI's voting representatives do not agree to the Critical Target Dates set forth in the revised Development Plan, then either Party may, at its election, proceed under Section 3.5(c).
(ii) DTI shall use Diligent Efforts to carry out the Phase I Trial in accordance with the Development Plan. If DTI fails to, or expects that it will fail to, meet any DTI Target Date, by more than three (3) months, Fujisawa may, at its option, assume control of and complete the Phase I Trial. In such event, the Parties shall cooperate fully and take all necessary steps to obtain the necessary Regulatory Approvals to effectuate the transfer of the Phase I Trial.
Development Efforts. In the Shared Territory, each Party shall use Commercially Reasonable Efforts to Develop the Jointly Funded Product/Indications in accordance with the Development Plan and the terms of this Agreement. In the Royalty Territory, Roche shall use Commercially Reasonable Efforts to Develop at least one Licensed Product in accordance with the terms of this Agreement.
Development Efforts. Xxxxxxx shall use commercially reasonable efforts to carry out development of the Initial Product in accordance with the Development Plan, and the Additional Products, if any, in accordance with the Additional Product Development Plan. If Xxxxxxx determines that it will be unable to accomplish any of the key clinical events identified in the relevant Development Plan within 6 months of the date specified in such Development Plan, it shall promptly notify the Development Committee, and it shall develop a revised Development Plan for the relevant Licensed Product. This revised plan shall set new Critical Target Dates. As per Section 3.1, Xxxxxxx shall have the final decision making authority with respect to all aspects of any revised Development Plan, except that DTI must agree to any change in the Critical Target Dates, such agreement not to be unreasonably withheld. In the event DTI does not agree to the Critical Target Dates set forth in the revised plan, then the most recently approved Critical Target Dates shall apply and Xxxxxxx may, at its election, proceed under Section 3.5(c).
Development Efforts. Once a Clinical Candidate has been designated by Tanabe, Tanabe shall use its good faith efforts in proceeding with (i) the development, testing and, where applicable, manufacturing of a Product based on such Clinical Candidate or Chemical Modification thereof, including, without limitation, pre-clinical and clinical development, (ii) obtaining Regulatory and Pricing Approvals in the Territory and (iii) the subsequent manufacturing, marketing and sale of that Product in the Territory. Tanabe shall exercise its reasonable efforts and diligence in conducting such activities with respect to any Compound, Clinical Candidate or Product in accordance with Tanabe's business, legal, medical and scientific judgment and Tanabe's normal practices and procedures for compositions having similar technical and commercial potential for similar uses.
Development Efforts. Seller shall use commercially reasonable efforts to maintain the current results of its development activities for the Development Sites set forth on Schedule 4.7 for the benefit of Purchaser until Purchaser's election pursuant to Section 6.5 hereto.