Additional Development Proposal definition

Additional Development Proposal has the meaning set forth in Section 5.2.5.1 (Additional Development Proposals).
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Additional Development Proposal has the meaning set forth in Section 3.3.2 (Additional Indications Development).
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Examples of Additional Development Proposal in a sentence

  • If the JSC approves an Additional Development Proposal, the Development Plan shall be deemed to be amended to include the Additional Development Activities and associated budget upon approval of such Additional Development Proposal by the JSC.

  • Each Additional Development Proposal shall describe in reasonable detail the Secondary Indication Study(ies) that the Proposing Party desires to conduct, including a synopsis of the trial, the proposed enrollment criteria, number of patients to be included, endpoints to be measured, and statistical design and powering (the “Additional Development Activities”), as CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • The PSC shall vote on whether to approve an Additional Development Proposal within [***] after receipt thereof from the Proposing Party as set forth in this Section 5.2.5.2 (PSC Decision Regarding Additional Development Activities).

  • The JDC will approve or reject an Additional Development Proposal within [***] days after receipt thereof from the Proposing Party as set forth in this Section 5.2.2.4.

  • The JPT shall review and decide on such Additional Development Proposal within [***] days after its receipt of such Additional Development Proposal; provided that such time shall be extended if the Proposing Party has not provided all available Information reasonably requested by the JPT.

  • The Proposing Party shall provide the JPT with any additional Information related to the Additional Development Proposal reasonably requested by the JPT.

  • The Additional Development Proposal shall be prepared in a similar scope and format of a Development Plan.

  • If the JPT approves an Additional Development Proposal, such Additional Development Proposal shall be submitted promptly to the JSC for review.

  • If the JPT and JSC do not timely approve an Additional Development Proposal within the time periods set forth in Section 4.2.4(b), the other Party (the “Declining Party”) may, within [***] Business Days of the JSC’s final vote with respect to the Additional Development Proposal, initiate the dispute resolution arbitration procedures set forth in Section 16.6.4, if, and only if, the Declining Party determines reasonably and in good faith that (i) [***] or (ii) [***].

  • Each Additional Development Proposal for Additional Development Activities shall include a general description of the Development activities including, as applicable, study design, clinical study endpoints, clinical methodology and monitoring requirements, and the funding budget.

Related to Additional Development Proposal

  • Project Proposal has the meaning set forth in Section 2.2(b).

  • continuing professional development means the continuing professional development contemplated in section 32;

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

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

  • Acquisition Proposal has the meaning set forth in Section 5.03(a).

  • Superior Acquisition Proposal means a bona fide Acquisition Proposal made by a third party for one or more of the McNeil Partnerships which the general partner of each such McNeil Partnership determines in good faith to be more favorable to the limited partners of such McNeil Partnership from a financial point of view than the Mergers and the other transactions contemplated by this Agreement with respect to such McNeil Partnership, and which such general partner determines in good faith is reasonably likely to be consummated.

  • Notice of Superior Proposal has the meaning set forth in Section 5.09(e).

  • Competing Proposal shall have the meaning set forth in Section 6.6(f)(i).

  • Company Acquisition Proposal means any proposal for a merger or other business combination involving the Company or the acquisition of any equity interest in, or a substantial portion of the assets of, the Company, other than the transactions contemplated by this Agreement.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Superior Proposal Notice has the meaning specified in Section 5.4(1)(c).

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

  • Professional development means training programs for

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Technical Proposal means the Contractor’s Technical Proposal dated (Technical Proposal date).

  • Superior Proposal has the meaning set forth in Section 5.09(a).

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

  • Company Superior Proposal shall have the meaning set forth in Section 7.4(b).

  • approved proposal means a proposal approved or deemed to be approved under this Agreement;

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • 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;

  • Responsive Proposal means a Proposal that complies with the material provisions of this RFP.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Project Proponent means the individual or organization that has overall control and responsibility for the Project, or an individual or organization that together with others, each of which is also a Project Proponent, has overall control or responsibility for the Project. The entity(s) that can demonstrate Project Ownership in respect of the Project. For the avoidance of doubt where an individual executes this Representation in their capacity as an authorized office holder of the company who is the Project Proponent, this Representation is made by the company, not the authorized office holder;

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;