PFIZER Development Plan definition

PFIZER Development Plan means, with respect to the Product, a strategy and planning document for all research and development activities to be conducted pursuant to this Agreement up to and including filing an NDA, which document shall describe in reasonable detail the Commercially Reasonable Efforts activities to be undertaken by PFIZER (including Clinical Trials, seeking Regulatory Approvals and manufacturing activities) and the expected timing of each activity.

Examples of PFIZER Development Plan in a sentence

  • After the PFIZER Option Date, PSIVIDA shall supply to PFIZER, at PSIVIDA’s Cost of Clinical Supplies, all or a portion of PFIZER’s Clinical Supply Requirements for the Product, in accordance with the PFIZER Development Plan.

  • PFIZER shall also deliver a copy of the then-current PFIZER Development Plan to PSIVIDA promptly after PSIVIDA’s request.

  • PFIZER shall update the PFIZER Development Plan and deliver such updated PFIZER Development Plan to PSIVIDA on each anniversary date of the PFIZER Option Date up to the date of the First Commercial Sale of the Product if PFIZER has made any material changes to such plan during the prior year.

  • Within sixty (60) days after the PFIZER Option Date, PFIZER shall prepare and deliver to PSIVIDA the PFIZER Development Plan.

  • In the event of an inconsistency or discrepancy between the PFIZER Development Plan and this Agreement, the terms of this Agreement shall prevail.

  • After the PFIZER Option Date, PFIZER shall use Commercially Reasonable Efforts to develop the Product in accordance with the PFIZER Development Plan for the Product, and to seek Regulatory Approval for and commercialize the Product in the United States and the Major EU Countries.

Related to PFIZER Development Plan

  • 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;

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

  • Development Program means the implementation of the 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.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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;

  • 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.

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

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

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

  • 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.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • 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).

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Development Budget means the cost categories listed on Pages 8 - 11 in Form 3 that are directly related to the proposed Project as submitted in the Application. Indirect or off-site costs not directly related to the development of the project are not valid or eligible costs.

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

  • Work Plan means a plan that describes each individual activity to be conducted to complete eligible activities and the associated costs of each individual activity.

  • 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 Project means a project for the development of land within a

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Research Budget has the meaning set forth in Section 2.2.