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. 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. 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 Major Market Countries.
Development Efforts. [*]. Table 1: NPI Phase Description
Development Efforts. 4.1. The Company undertakes, at its own expense, to make commercially reasonable efforts to commercialize Licensed Products in the RPE Field and in the Photoreceptor Field, including bio-testing of the Licensed Materials and the Licensed Products, clinical trials and other steps required for obtaining regulatory approvals from the relevant authorities as are consistent with the commercial efforts generally applied to similar products of similar potential throughout the Term.
4.2. Without derogating from the generality of the foregoing, in order to maintain its license in the Photoreceptor Field the Company shall be required to meet the development milestones listed in Annex G within the time frames specified therein (the “Development Milestones”). If the Company believes that it will not achieve a Development Milestone, it may notify Hadasit in writing in advance of the relevant deadline. The Company will include with such notice (a) reasonable explanations of the reasons for such failure (“Legitimate Reasons”, and lack of funding shall not constitute a Legitimate Reason) and (b) a reasonable detailed written plan for achieving a reasonable extended and/or amended milestone (the “Plan”). If Hadasit in its reasonable discretion accepts the Plan, then Annex G shall be deemed as having been automatically amended accordingly. Hadasit’s failure to accept or reject the Plan within [ * ] business days shall be deemed as approval. If there is a dispute between the parties in relation to the Plan, then they shall collaborate to develop a mutually acceptable Plan within [ * ] days of Hadasit’s notice. Should the Company not provide a Legitimate Reason and/or a Plan accepted by Hadasit within the respective timeframes mentioned above, then Hadasit shall be entitled, by written notice to the Company, to restrict the Field to the RPE Field, and all rights and licenses granted hereunder in the Photoreceptor Field shall revert to Hadasit. Such restriction shall be the only remedy available to Hadasit for the Company failing to reach a Development Milestone. It is understood and agreed that Hadasit shall not unreasonably exercise such right.
4.3. The Company shall be entitled to remove the Photoreceptor Field from the scope of the License at any time by providing [ * ] days prior written notice to Hadasit, in which case the provisions of the preceding Section 4.2 shall not longer have any effect.
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.
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. (a) SG and GNE each agree to use commercially reasonable and diligent efforts to collaborate to develop and bring a Licensed Product to market in the Field. The Parties further agree to cooperate with the other in carrying out the Development Plan. As used in this Agreement, the term commercially reasonable and diligent efforts will mean those efforts consistent with the exercise of prudent scientific and business judgment, as applied to other pharmaceutical products of similar potential and market size by the Party in question.
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).
