Example ContractsClausesIndependent Development Activities
Independent Development Activities
Independent Development Activities contract clause examples

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.

Independent Activities. Except as otherwise provided herein, the General Partner and its affiliates, and its (and its affiliates’), officers, directors, shareholders and employees, and each Limited Partner may, notwithstanding the existence of this Agreement, engage in whatever activities they choose, whether the same be competitive with the Business of the Partnership or otherwise, without having or incurring any obligation to offer any interest in such activities to any party hereto. Neither this Agreement nor any activity undertaken pursuant hereto shall prevent such persons from engaging in such activities, and as a material part of the consideration for the General Partner’s execution hereof, each Limited Partner hereby waives, relinquishes and renounces any such right or claim of participation. Nothing in the foregoing, however, shall be deemed to reduce any of the liabilities of the General Partner under this Agreement.

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.

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.

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 Costs Relating to Initial Development Activities. […​…]

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.

“Development Plan” means a development plan (other than the Initial Development Plan and Budget) setting forth in reasonable detail specific Clinical Studies and other Development activities (other than the Initial Development Activities) to be performed with respect to the Licensed Compound or a Licensed Product, which plan shall set forth Clinical Studies and Development activities subsequent to those of the Initial Development Plan and Budget.

“Develop” or “Development” means the conduct of clinical drug development activities pertaining to a Development Candidate or Product, including toxicology, pharmacology, test method development, stability testing, process development, technology transfer, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including investigator-sponsored clinical trials, Supplemental Trials, Required Phase 4 Clinical Trials and any post-approval studies required by the relevant Regulatory Authority), regulatory affairs, pharmacovigilance, Regulatory Approval and Pricing Approval, and clinical study regulatory activities (including regulatory activities directed to obtaining pricing and reimbursement approvals). For clarity, Development will exclude any Research, Commercialization and Manufacturing activities.

Development Reports. Licensee shall provide Merck with reasonably detailed reports describing its progress with respect to its Development efforts under this Agreement (hereinafter “Development Reports”). Such Development Reports shall be furnished annually until the First Commercial Sale. Each Development Report shall include the following information for the Licensed Product: a description of the Development work conducted during the year in reasonable detail, including clinical studies, formulation work, manufacturing work, and other testing work and regulatory activity; timelines for such work; and key decision gates and milestones anticipated for such work. All Development Reports created by Licensee shall be deemed the Proprietary Information of Licensee and are subject to the confidentiality obligations of Article IX.

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