Conduct of Development Plans Sample Clauses

Conduct of Development Plans. Each Party shall undertake the tasks allotted to it in the Development Plan with reasonable skill and care and in a timely manner. All such development activities shall be performed in compliance with all applicable Laws, including, without limitation, current good laboratory practices and Good Clinical Practice. The Development Plan shall be reviewed by the JSC at each meeting and at least once in each twelve (12) month period, Licensee shall provide an amended or up-dated Development Plan to the JSC to reflect progress in the development of Licensed Product. Licensee shall submit to the JSC for review any protocols (and any substantive changes thereto) for any Clinical Studies which it proposes to undertake pursuant to the Development Plan in relation to Licensed Product within the Territory (including without limitation, any Phase IV Study), and shall not commence any such study until the JSC has approved the final protocol. Either Party may, as far as is expressly set out in the Development Plan, fulfill its obligations under the Development Plan through sub-contractors, provided always that the subcontracting Party shall remain responsible for such obligations and further provided that the sub-contractor agrees in writing to adopt and implement suitable quality assurance policies and procedures to ensure such compliance.
Sample 1
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Conduct of Development Plans. Each Party shall undertake the tasks allotted to it in each Development Plan with respect to a Development Project with reasonable skill and care and in a timely manner. All such activities shall be performed in compliance with all applicable Laws, including current good laboratory practices and Good Clinical Practice. If a Party’s activities require the receipt of compounds, prototypes, data, Licensed Products and any other materials and items set forth in the Development Plan from the other Party, such other Party shall provide such items without undue delay and in the required quantity and quality. Each Development Plan shall be reviewed by the JSC at each meeting and at least once in each Quarter, the Alliance Managers shall submit to the JSC for review updates (progress reports) to each on-going Development Plan to reflect progress in the development of each Licensed Product, and if applicable, amendments to the Development Plans for approval. Each Party shall, if so requested by the other Party, in a timely manner provide updates or amendments to a Development Project or Development Plan. It is acknowledged that each Party has a significant impact upon the progress of a Development Project and hence shall always allocate sufficient qualified resources and competences to a Development Project and shall support continuation of such resources unless otherwise requested by the other Party. Either Party may fulfil its obligations under a Development Plan through sub-contractors, provided always that such obligations are provided by the sub-contractor in 57/169 “[***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 under the Securities Act of 1933, as amended” accordance with this Agreement and the Related Agreements, as applicable. The sub-contracting Party shall remain fully responsible for the activities performed by sub-contractors and shall be responsible for the sub-contractors’ actions and omissions as if such were performed by the sub-contracting Party itself. In case that KTI is using sub-contractors it is the responsibility of KTI to ensure that the costs for such sub-contracting remain within the agreed Development Budget and that payment is subject to proper delivery of the requested activities and results and timely invoiced.
Sample 1
Conduct of Development Plans. 2.3.1. During the applicable Research Term, Exicure shall use Commercially Reasonable Efforts to perform all activities set forth in the Development Plan for each Collaboration Program through completion thereof, provided that Exicure shall have no obligation to conduct (or report on) (i) the IND-Enabling Activities under such Development Plan unless Allergan has made an Extension Exercise for such Collaboration Program or (ii) the Allergan-Conducted Activities; THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”. and provided, further, that any inability to perform, or delay in the performance of, any of Exicure’s activities under the Development Plan to the extent attributable to a delay by Allergan in conducting any Allergan-Conducted Activities or delivering any results or data related to Allergan-Conducted Activities, where such performance or such delivery of results or data are necessary to enable Exicure to perform such activities, shall not be considered a failure of Exicure to use Commercially Reasonable Efforts to perform its activities under the Development Plan. Without limiting the foregoing, Exicure shall devote FTEs sufficient to perform the activities set forth in each Development Plan, which FTEs shall be appropriately qualified research and development personnel possessing at least the level of skill and experience that Exicure’s personnel engaged in discovery, research and other Development activities for Exicure’s other programs possess. Exicure will conduct its activities under each Development Plan in accordance with good scientific standards and practices and in compliance in all material respects with all applicable Laws, including those regarding environmental, safety and industrial hygiene, quality assurance and quality control (including data integrity), and, solely to the extent stated in the applicable Development Plan, the applicable requirements of GLP and GMP. Exicure shall maintain (either directly or through its subcontractors) laboratories, offices and all other facilities reasonably necessary to carry out the activities to be performed by it pursuant to each Development P...
Sample 1

Related to Conduct of Development Plans

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Development Plan As defined in Section 3.2(a).

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

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