Conduct of Development and Regulatory Activities Sample Clauses

Conduct of Development and Regulatory Activities. Diligence. Eisai shall, or shall cause the applicable Eisai Related Party (in the applicable country) to (i) conduct all studies related to the Initial Product or the Once-Daily Product required by the FDA as a condition to obtain and maintain Regulatory Approval thereof in the United States (including the FDA Pediatric Studies and the CVOT, but excluding the ▇▇▇▇ Plus Study and the Delay to Onset of Diabetes Study), (ii) conduct the ▇▇▇▇ Plus Study until the earlier of February 1, 2018 and the completion of such study through determination of whether the primary endpoint is achieved, substantially consistent with the current trial objectives as of the Effective Date, (iii) conduct the Delay to Onset of Diabetes Study until the earlier of February 1, 2018 and the completion of such study through determination of whether the primary endpoint is achieved, substantially consistent with the current trial objectives as of the Effective Date and (iv) use Commercially Reasonable Efforts to develop and seek Regulatory Approval for a Product in each of China, Japan and the European Union. Notwithstanding the foregoing, if any Regulatory Authority or independent data safety committee in the Territory requires Eisai to suspend or terminate, or not to commence, the conduct of any study in any of the foregoing clauses (i)-(iii) for safety reasons, then Eisai shall be relieved of its obligation to conduct such study in the applicable regulatory jurisdiction, to the extent and for the duration of such required suspension or termination, but only for so long as Eisai uses Commercially Reasonable Efforts to address any relevant issues raised by the applicable Regulatory Authority or independent data safety committee if it would be commercially reasonable to continue such study after addressing any such issues.
View Source
Conduct of Development and Regulatory Activities. Compliance with the ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Development Plan, the Palatin Development Plan and Applicable Laws. All Development and regulatory activities in connection with the clinical development programs conducted to obtain and maintain Regulatory Approval for the Product in the Territory shall be conducted by and on behalf of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ in accordance with the ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Development Plan and the other provisions of this Agreement, and by and on behalf of Palatin in accordance with the Palatin Development Plan and the other provisions of this Agreement. Each Party shall conduct those activities for which it is the responsible Party under the ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Development Plan or Palatin Development Plan and the other provisions of this Agreement, as applicable, in compliance in all material respects with all applicable laws and in accordance with GLP and GCP and GVP (when applicable) under the applicable laws of the country in which such activities are conducted.
View Source
Conduct of Development and Regulatory Activities 
View SourceView Similar (3)

Related to Conduct of Development and Regulatory Activities

  • Regulatory Activities a) As between the Parties, Xynomic shall have the sole responsibility and discretion for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). All Regulatory Approvals relating to the Licensed Compounds or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Xynomic or its designated Affiliate. Pharmacyclics hereby assigns to Xynomic all of Pharmacyclics’ (or its Affiliates’) right, title, and interest in and to all Regulatory Documentation owned by Pharmacyclics (or its Affiliates) and held in Pharmacyclics’ name (or its Affiliates) as of the Effective Date or generated in the “winding up” activities after the Effective Date and shall deliver all Regulatory Documentation as well as embodiments of all Regulatory Documentation to Xynomic within sixty (60) days after the Effective Date. b) Xynomic shall notify the Pharmacyclics Alliance Manager promptly (but in no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Xynomic (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Xynomic shall consult with Pharmacyclics and shall consider Pharmacyclics’ comments in good faith. If a recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, Xynomic (or its Sublicensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 2.2.1.b), Xynomic (or its Sublicensee) shall be solely responsible for the execution and all costs thereof.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection ▇▇▇▇▇; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Specific Activities Please give detailed information about the specific activities of the Project promoter and the Partner(s), with budget allocations 7.1 The main tasks of [name of the Project Promoter], referred to as the ‘Project Promoter’, are summarized as follows: Name Project activities Project budget 1 .... [mention the budget allocated to Project Promoter for the respective activity] EUR.... Activity 2 .... EUR... 7.2 The main input/responsibilities of [name of the Project Partner(s)], referred to as Partner 1, 2, etc., are summarized as follows: Name Project activities Project budget Partner 1... [briefly present the project activity implemented by Partner]. Activity 1 .... [mention the budget allocated to Partner 1 for the respective activity] EUR.... Activity 2 .... EUR... Name Project activities Project budget

  • Collaboration activities 4.1 The Collaboration Suppliers will perform the Collaboration Activities and all other obligations of this Agreement in accordance with the Detailed Collaboration Plan. 4.2 The Collaboration Suppliers will provide all additional cooperation and assistance as is reasonably required by the Buyer to ensure the continuous delivery of the services under the Call-Off Contract. 4.3 The Collaboration Suppliers will ensure that their respective subcontractors provide all cooperation and assistance as set out in the Detailed Collaboration Plan.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.