Product Development Plan. Subject to Section 4.3.2(i), all Development activities to be conducted during the Collaboration Period in connection with any Compound or Licensed Product will be performed by the Parties in accordance with the terms and conditions set forth in this Section 4 and the Licensed Product development plan as set forth in Exhibit A (as such plan may be amended from time to time by mutual agreement of the Parties, the “Product Development Plan”). The Product Development Plan shall include, among other things (a) all Development activities reasonably anticipated to be undertaken by each Party to advance Development activities with respect to the first Licensed Product, including the planning, design and implementation of the Phase I/II Clinical Trial, (b) all pre-clinical, Phase I/II Clinical Trial and other development activities reasonably anticipated to be required to be performed by or on behalf of Spark, (c) the reasonably anticipated technical and Manufacturing activities to be undertaken by the Parties to support the Phase I/II Clinical Trial, (d) a reasonably detailed budget for each of the activities to be performed by Spark and Pfizer under the Product Development Plan (the “Budget”) and (e) particular personnel and other resources that each Party will be required to contribute to the performance of Product Development Plan activities. The Parties agree that by consensus, the JSC may add one or more additional Product Development Plans with respect to additional Compounds and Licensed Products. For the opening of Clinical Trial sites in jurisdictions outside the United States, Pfizer shall provide an appropriate representative who will join Spark study team meetings and provide reasonable assistance and advice.
Product Development Plan. The initial Development Plan for the Product in the Field is set forth in Exhibit 1.30 (the “Initial Development Plan”). The JDC will direct, coordinate and manage the Development of the Product in the Field, according to the Development Plan. The following provisions shall apply with respect to the Development of Products:
(a) The Development Plan for the Product will include, among other things, the indications in the Field for which the Product is to be Developed and other exploratory indications in the Field for which the Product may be developed, critical activities to be undertaken, certain timelines, Go/No Go decision points and relevant decision criteria and certain allocations of responsibilities between the Parties for the various activities to be undertaken under the Development Plan. The Development Plan will also include a Development Budget, as mutually agreed by the Parties. Neither Party will be required, in any Calendar Quarter, to make any Development investment in excess of the [**] of the amount designated to such Party in the Development Budget for such Calendar Quarter. During the Term, the JDC will amend the Development Plan on an ongoing basis as necessary.
(b) The JDC will oversee the allocation and assignment of Development activities in the Development Plan between the Parties. Such allocations and assignments shall be consistent with the more specific provisions set forth in Schedule 4.1.1.
(c) The Parties will use Commercially Reasonable Efforts to implement and conduct the Development activities assigned to them pursuant to the Development Plan, in accordance with Applicable Laws.
Product Development Plan. Commencing on the date that Company exercises an Option and Consultant licenses the Licensed Rights, a product development plan (“Product Development Plan”) with estimated costs and timelines will be completed within sixty (60) days by Company for the development and commercialization of each product. Subject to the R&D Chargeback, Company agrees to solely bear the full cost and responsibility for all evaluation expenses, product development, clinical assessments, commercial preparation, patent protection and related patent expenses, consulting costs. THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
Product Development Plan. The Design & Development Program will be conducted in accordance with the Product Development Plan that describes the work to be pursued by Ambrx and Elanco during each Program Year. Except for the first Program Year, the Product Development Plan may be updated and approved by the Steering Committee at any time, but no later than sixty (60) days prior to the start of each Program Year. The Product Development Plan in effect at any time may not be amended except as agreed in writing by the Steering Committee. If at any time during the Program Year, either Party determines that a change to the Product Development Plan would benefit the Design & Development Program, such Party will prepare and submit to the Steering Committee a written proposal detailing its proposed changes to the Product Development Plan. Any proposed change to the Product Development Plan that would increase Ambrx’ scope of responsibility or require the commitment of additional resources, whether personnel or monetary, by Ambrx are subject to (a) the prior approval via Notice of the President and CEO of Ambrx; and (b) full reimbursement by Elanco. Proposed change(s) shall be submitted to the Steering Committee at least fifteen (15) days prior to its next regular meeting or communicated by means of such other notice as agreed by the Parties.
Product Development Plan. The Steering Committee will approve a detailed Product Development Plan which will be prepared by Senomyx within [***] of the selection of a Selected Compound under the applicable Phase of the Collaborative Program. The Product Development Plan, which will outline the responsibilities of the parties, will be attached as Appendix D to the Agreement, and incorporated into the Agreement by reference.
Product Development Plan. Within three (3) months after the Effective Date of this Agreement Licensee shall submit a confidential product development plan (“Plan”) to University. The Plan shall set forth Licensee’s best estimate and forecasts of the primary tasks and schedule of milestones for the identification and development of Licensed Product(s) and Licensed Services. The Plan and any updates thereto shall contain the following minimum information:
7.2.1 Identification of Licensed Products and Licensed Services planned for commercial development;
7.2.2 Tasks to be performed by Licensee and its Sublicensees to commercially develop Licensed Products and Licensed Services including estimated time frames for pre-clinical studies, clinical trials, product development, market testing;
7.2.3 Tasks to be performed to achieve United States (and, as appropriate, foreign) regulatory approvals (including any IND applications, drug testing (Phases I, II, III), NDA filings or other certification for each Licensed Product and Licensed Service which requires such approvals, including time schedule; and,
7.2.4 Estimated time of First Commercial Sale of each Licensed Product and Licensed Service;
Product Development Plan. The Product Development Plan is targeted for completion on September 17, 1999.
Product Development Plan. The initial Development Plan for the Product in the Field is set forth in Exhibit C (the “Initial Development Plan”). The JDC will direct, coordinate, and manage the Development of the Product in the Field, according to the Development Plan. The Development Plan for the Product will include, among other things, the indications in the Field for which the Product is to be Developed and other exploratory indications in the Field for which the Product may be developed, critical activities to be undertaken, certain timelines, go/no go decision points and relevant decision criteria and certain allocations of responsibilities between the Parties for the various activities to be undertaken under the Development Plan. During the Term, the JDC will amend the Development Plan on an ongoing basis as necessary.
Product Development Plan. After the Effective Date, BMS developed a proposed overall, continuing plan for the development, regulatory approval and continuing study of Product in the Territory. BMS submitted a draft of the plan (the Full Development and Commercialization Plan) to the PDC for its consideration, modification as it deemed appropriate, finalization and approval. After such consideration and modification, the PDC approved the plan (as indicated by the written approval of the Co-Chairs of the PDC). The Full Development and Commercialization Plan approved by the PDC is set forth or incorporated by reference in Appendix D and is hereby incorporated into this Agreement (such plan, as it is approved and as it may hereafter be modified and updated by the PDC, is referred to as the “Product Development Plan”). Each party shall use all commercially reasonable efforts to carry out its respective obligations under the Product Development Plan. The Product Development Plan sets forth, and shall continue to set forth, the detailed outlines and timelines of the scientific, medical, clinical, regulatory and other activities to be * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION undertaken for the purpose of obtaining, as soon as reasonably practicable, initial and subsequent marketing approvals, providing market support, and developing any and all indications, formulations, dosage and dosing regimes for Product, all of which activities shall be undertaken by BMS and Otsuka at their respective risk and expense in accordance with the delineation of obligations set forth in Sections 4.3.2 and 4.3.3 (unless the parties mutually agree otherwise in writing). Such timelines shall include, without limitation, projected fling dates for the NDA in the United States and an MAA in the European Union. In developing and modifying the proposed Product Development Plan, and during the course of its implementation, BMS shall take into consideration such of Otsuka’s clinical, regulatory, commercial and scheduling requirements for the development, regulatory approval and marketing of Product in the Reserved Territory as Otsuka communicates to the PDC from time to time. Without limiting the above, BMS recognizes that there will be certain clinical studies, identified in Appendix E, that are essential to regulatory approval of Product in Japan (part of the Reserved Territory), and that may also be required or desirable for the r...
Product Development Plan. It is the intention of the Parties to develop new Products, in addition to the existing Products provided for in Section III of this Agreement, at various times during the Term of this Agreement and to add these new Products to Table 3.2-1 for purchase by SpectraPoint. The Product Development Team (as defined in Paragraph 6.1) is responsible for defining the requirements for all new Products ("Product Definition"). After completion of the Product Definition for each new Product, the Product Development Team shall prepare a schedule and a work breakdown structure ("Product Development Plan") setting forth, at minimum, the following milestones: detailed design requirements for the Product; detailed preliminary design specifications for the Product ("Preliminary Design Specifications"); development of the testing protocol to verify the design specifications; verification testing for the design specifications; final design review; development of final acceptance test; production of engineering evaluation units; development of production tooling; testing for the engineering evaluation units; and a mutually agreeable delivery schedule for SpectraPoint property, if any. For each milestone, the Plan shall provide: a target begin date; target end date; the target price; the responsibilities of each Party; the price for the engineering evaluation units and the total target price for the application design on each Product ("Target Design Price"). SpectraPoint and REMEC shall each bear the full cost of their respective Product Development Team members, inclusive of all support costs, in conjunction with new Product development efforts. Neither Party shall be obligated to implement a Product Development Plan until it has been approved by an authorized representative of each Party.
