Pre-Option Development Plan definition

Pre-Option Development Plan means the development plan for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx attached hereto as APPENDIX 2.
Pre-Option Development Plan means the Development plan, as set forth on Exhibit D, which details the Development activities to be conducted pursuant to this Agreement with respect to the Compound and the Product in the Field in the Territory during the Pre-Option Period, and contains the Pre-Option Development Budget, as such Pre-Option Development Plan may be amended or updated from time to time in accordance with Article 3. For the avoidance of doubt, the Pre-Option Development Plan shall be amended to [***] of the Post-Option Interim Development Plan.
Pre-Option Development Plan means the written plan, as it may be amended from time to time by mutual agreement of the Parties, for the conduct by a Party of Pre-Option Development Activities for the other Party’s Collaboration Program in such first Party’s Territory (i.e., Brii Bio’s conduct of Pre-Option Development Activities for a Vir Program in the China Territory or Vir’s conduct of Pre-Option Development Activities for a Brii Bio Program in the United States), setting forth, among other things (a) a description of such Pre-Option Development Activities, including an estimated timeline for performance of such Pre-Option Development Activities, (b) the quantities and timing of supply of Product and Compound for such Pre-Option Development Activities, (c) the protocol for any Clinical Trials, and (d) the Pre-Option Development Budget for such Pre-Option Development Activities.

Examples of Pre-Option Development Plan in a sentence

  • Concerns can be raised anonymously in a number of ways, including through the Company’s online whistleblower reporting system, or by telephone.

  • Akcea will provide reports and analyses at each CSC meeting detailing the current status of each Product under the Pre-Option Development Plan together with a summary of the data generated by Akcea under such plan.

  • If there are additional activities Novartis wishes Akcea to conduct under the Pre-Option Development Plan, the Parties will discuss and mutually agree on any such additional activities through the CSC, and Akcea will use Commercially Reasonable Efforts to conduct such agreed activities under the Pre-Option Development Plan (and such plan will be updated accordingly).

  • Firms also need to cut costs in the face of intense global competition.

  • Neither Party will have any further obligations with respect to the Terminated Product under the Pre-Option Development Plan.

  • Without limiting the foregoing, Akcea may discontinue an activity under the Pre-Option Development Plan if after having consulted, and having given good faith consideration to the recommendations of the CSC, Akcea in good faith believes that continuing such activity would (A) pose an unacceptable risk or threat of harm in humans, or (B) violate any Applicable Law, ethical principles, or principles of scientific integrity.

  • Akcea will promptly disclose to Novartis through the CSC the results of all work performed by Akcea under the Pre-Option Development Plan (including activities under SCHEDULE 1.3.2) in a reasonable manner as such results are obtained.

  • Akcea will use Commercially Reasonable Efforts to develop each of AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx through the completion of a Phase 2 Dose-Ranging Trial in accordance with the Pre-Option Development Plan attached hereto as APPENDIX 2.

  • AuditorsOn 2 May 2008, PricewaterhouseCoopers LLP resigned as auditors of the Company and the Directors appointed KPMG Audit Plc as auditors.

  • MacroGenics shall be solely responsible for supplying, at its own expense, all quantities of Product necessary for completion of the activities contemplated under the Pre-Option Development Plan.


More Definitions of Pre-Option Development Plan

Pre-Option Development Plan means the Development plan, as set forth on Exhibit D, which details the Development activities to be conducted pursuant to this Agreement with respect to the Compound and the Product in the Field in the Territory during the Pre-Option Period, and contains the Pre- Option Development Budget, as such Pre-Option Development Plan may be amended or updated from time to time in accordance with Article 3. For the avoidance of doubt, the Pre-Option Development Plan shall be amended to [***] of the Post-Option Interim Development Plan.

Related to Pre-Option Development Plan

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Development Program means the implementation of the development plan.

  • Share Option Plan means any equity incentive plan of the General Partner, the General Partner Entity, the Partnership and/or any Affiliate of the Partnership.

  • Economic development incentive means a financial incentive,

  • Technology Transfer Plan will have the meaning set forth in Section 4.1.

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Development Phase means the period before a vehicle type is type approved.

  • Stock Option Plan means any stock option plan now or hereafter adopted by the Company or by the Corporation, including the Corporate Incentive Award Plan.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).