Required Development Sample Clauses

Required Development. With regards to Territory Development that is Required Development, Eisai shall be responsible for fifty percent (50%) and Company -48- 132539616_1 shall be responsible for fifty percent (50%) of all Development Costs incurred by the Parties with respect to each Eisai Collaboration Product.
Sample 1
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Required Development. If (i) the FDA requires that additional clinical trials or other development work be conducted on the Initial Product as a condition of and prior to approving the Initial Product NDA (such required clinical trials or other development work, “Pre-Approval Required Development”) or (ii) the FDA requires additional clinical trials or other development work on the Initial Product after approval of the Initial Product NDA to obtain or maintain such Regulatory Approval in the Territory (such required clinical trials or other development work, “Post-Approval Required Development”), the holder of the Initial Product NDA (or one of its Affiliates) shall notify the other Party of such Pre-Approval Required Development or Post-Approval Required Development, as applicable, and the Parties shall, through the JDC, promptly meet to discuss in good faith and seek to agree on the Development Plan (consistent with Section 3.4) for such Pre-Approval Required Development or Post-Approval Required Development, as applicable; provided, that, unless the Parties otherwise agree in writing: (W) Arena shall be obligated to conduct, or cause one of its Affiliates to conduct, such Pre-Approval Required Development or Post-Approval Required Development, as applicable; (X) subject to Section 4.4(b), Arena shall have final decision-making authority with respect to the Development Plan for such Pre-Approval Required Development or Post-Approval Required Development, as applicable, if the Senior Executives are any unable to resolve any dispute with respect thereto pursuant to Section 4.4(b), except that the Development Expenses with respect to such Pre-Approval Required Development or Post-Approval Required Development, as applicable, shall be allocated between the Parties as set forth in clause (Y) or clause (Z) below, as applicable, and except that if Eisai does not approve the use of Arena FTEs (such approval not to be unreasonably conditioned, withheld or delayed), Arena shall have the right to use such FTEs at its own expense in conducting such development work, with the costs of such FTEs not included in Development Expenses; (Y) the Parties shall share equally the Development Expenses with respect to any Pre-Approval Required Development; and (Z) Eisai shall bear 90% and Arena shall bear 10% of the Development Expenses with respect to any Post-Approval Required Development (including any required Phase 4 clinical trial or outcomes studies), except that the Parties shall share equal...
Sample 1
Required Development. The Owner shall commence the construction of improvements on the Lot in accordance with approved plans and specifications within one year of his purchase of the Lot from the Developer. If the construction is not timely commenced, or once commended, not diligently pursued to completion, the Owner shall nonetheless be required to install acceptable landscaping on the entire Lot. Such landscaping shall comply with the requirements of paragraph 7 and shall include the sodding of the entire ground surface of the Lot. If the Owner fails to either install or maintain the landscaping, Developer shall have the right, privilege and license (but not the obligation) to do so, and all amounts expended by Developer, together with a surcharge of ten percent of cost for overhead shall be, upon written demand of Developer, immediately due and payable by the Owner. If not paid by the Owner with thirty days of demand, the charges shall bear interest at the rate of ten percent per annum and shall be collectible by all lawful means. The charges, together with interest thereon, shall also constitute a lien against the Lot on or for which the work was performed.
Sample 1

Related to Required Development

  • 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.

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

  • Independent Development The Disclosing Party acknowledges that the Receiving Party may currently or in the future be developing information internally, or receiving information from other parties, that is similar to the Confidential Information. Accordingly, nothing in this Agreement will be construed as a representation or agreement that the Receiving Party will not develop or have developed for it products, concepts, systems or techniques that are similar to or compete with the products, concepts, systems or techniques contemplated by or embodied in the Confidential Information, provided that the Receiving Party does not violate any of its obligations under this Agreement in connection with such development.

  • Status as Business Development Company The Borrower is an “investment company” that has elected to be regulated as a “business development company” within the meaning of the Investment Company Act and qualifies as a RIC.

  • Joint Development All inventions, know-how, trade secrets, data or information which result from joint development by the Parties hereto shall be jointly owned by the Parties. The Parties hereby agree to cooperate in good faith in the filing of any and all patent applications in all jurisdictions.

  • Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。

  • Regulatory Affairs Each Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any country of the Territory.

  • Business Development Company Buyer is a business development company as defined in Section 202(a)(22) of the Investment Advisors Act of 1940.

  • Research Independence The Company acknowledges that each Underwriter’s research analysts and research departments, if any, are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriter’s research analysts may hold and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of its investment bankers. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against such Underwriter with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriter’s investment banking divisions. The Company acknowledges that the Representative is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short position in debt or equity securities of the Company.

  • 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.

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