Additional Development Activities in the Territory. Licensee, at its own cost and expense, shall have the right, subject to Axsome’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed, to conduct Development activities of the Licensed Products in the Field in the Territory solely for the purposes of complying with any post-approval requirements imposed or agreed to with any Regulatory Authority in the Territory as a condition of granting or maintaining the Regulatory Approval in the Territory for such Licensed Product in the Field and for otherwise enhancing the label for, or adding additional indications (in the Field) to enable and support the Commercialization of the Licensed Products, in each case for use in the Field in the Territory. Prior to initiating any such Development activity, Licensee shall notify and consult with Axsome with respect thereto and Axsome shall have the right to review, and Licensee shall provide to Axsome for review, the plans and protocols for any such Development activities prior to Axsome providing its written consent to permit Licensee to conduct such Development activities. In the event Axsome provides written consent for such proposed Development activities, Licensee shall consider in good faith, and not unreasonably refuse to address, any of Axsome’s comments and suggestions provided by Axsome to Licensee with respect to the plans and protocols of any such Development activities. For clarity, # it shall be reasonable for Axsome to withhold its consent for Licensee to conduct any particular Development activity with respect to any Licensed Product if Axsome, in good faith, reasonably believes that such Development activity may have an adverse impact on any product containing the Licensed Compound (including on any Regulatory Approval with respect thereto) that Axsome, its Upstream Licensors or its or their Affiliates or licensees is developing or Commercializing or is planning to develop or Commercialize outside of the Territory and # Axsome is hereby deemed to have provided its consent for Licensee to conduct the studies listed on [Schedule 3.3.2]. Licensee shall use reasonable efforts to conduct all such approved Development activities and to conduct them in compliance with all applicable legal and regulatory requirements, good clinical practices, ethical requirements and industry guidelines.
Following the Commencement Date, Neuren and ACADIA shall discuss the Development Plan and coordinate and conduct all Development activities with respect to any Compound and any Product as set out in this clause 5, provided that ACADIA shall be responsible for the day-to-day operations and decision-making for all Development activities under the Development Plan or otherwise with respect to any Compound or any Product in the Territory.
Initial Development Activities. shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan and Budget by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities. shall provide [[Organization A:Organization]] with monthly high-level status reports noting project critical path activities, risks and mitigation plans. If is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within [ ] after written notice thereof from [[Organization A:Organization]], [[Organization A:Organization]] shall have the right, at [[Organization A:Organization]]s sole election, and without limitation to any other right or remedy available to [[Organization A:Organization]], to assume and complete some or all of such Initial Development Activities. The Parties acknowledge and agree that in the event [[Organization A:Organization]] assumes some or all of such Initial CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [......]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
ACADIA will inform and seek the approval of the JSC for any additional development activities it is proposing to undertake in the Territory with respect to any Compound or Product in additional indications. The JSC will review in detail the potential studies and development activities to identify a basis for proceeding, taking into consideration the commercial, scientific and clinical potential for such proposed additional development activities.
Additional Activities. Employee agrees that during the Term of this Agreement she shall not: # engage in other business activities of any kind which would give rise to a conflict of interest for Employee with respect to her duties and obligations to the Company and under this Agreement, # directly or indirectly, engage in any activities which may damage the business of the Company or which may adversely affect the goodwill, reputation or business relations of the Company with its customers, the public generally or with any of its other employees.
The JSC will assess any proposals for further development activities with any Compound or Product in additional indications and decide whether to continue and fund any such further development. For clarity, the JSC shall not be obligated to approve any further development of any Compound or Product in an additional indication that would adversely impact the development or commercialization of any Compound or Product in the Territory.
if the dispute relates to any Regulatory, manufacturing, CMC, Development, or Commercialisation activities for any Compound or Product in the Territory, including any amendment to the Development Plan regarding any Development activities for any Compound or Product in the Territory, ACADIA will have the final decision-making authority;
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Licensed Products. Arcus shall use Commercially Reasonable Efforts to manufacture or otherwise obtain supply of its requirements of packaged and labeled Licensed Products in connection with its Development and Commercialization obligations hereunder, in accordance with all Applicable Laws, GMP (as applicable) and this Agreement. For so long as Arcus is conducting Development activities under this Agreement, Arcus shall provide to WuXi, no later than on June 30 and December 31 of each calendar year, with written summaries of the Development activities it performed, or caused to be performed, in respect of Licensed Products since the preceding report (or, with respect to the first such report, since the Effective Date), and the future Development activities it CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Patented Products in the Field. Notwithstanding the foregoing, Arcus is obligated to file an IND in the United States on a Patented Product no later than months from the Effective Date; provided that Stage 2 Technology Transfer, as defined in Section 3.3.1 below, is completed no later than days following the Effective Date. The deadline for Arcus to file an IND in the United States on a Patented Product shall be extended by one (1) day for each day that Abmuno is late in completing Stage 2 Technology Transfer. Any delay or postponement in the filing of an IND in the United States on a Patented Product beyond the deadline for such filing will be subject to approval by Abmuno, which approval shall not be unreasonably withheld, conditioned or delayed.
Prohibited Activities; Additional Compensation. In exchange for the fixed employment term provided by this Agreement and additional payments by the Company of $750,000 on each of the next two anniversary dates of the Agreement End Date, Executive agrees to comply with the Companys standard post-employment covenants and execute the Companys standard form of release as set forth below. Specifically, Executive agrees:
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