Development and Commercialization Plans Clause Samples

Development and Commercialization Plans. KHK shall prepare, and submit to DICERNA for its review, a development and commercialization plan for each Licensed Product to be developed and/or commercialized by KHK under this Agreement (each, a “Development and Commercialization Plan”) within [***] after the designation by KHK of such Licensed Product and, in any event, prior to the initiation of development activities with respect to such Licensed Product. Thereafter, for each [***] during the Term, KHK shall provide DICERNA with updates with respect to all significant development decisions made and actions taken by KHK with respect to such Development and Commercialization Plan.

Development and Commercialization Plans. (a) Consistent with Section 4.1: (i) Licensee shall prepare and provide ▇▇▇▇▇ with a development plan (“Development Plan”) for each Specified Disease within the Field. Each Development Plan shall set forth anticipated activities, plans and timelines for the development of Licensed Products targeting the relevant Specified Disease (including regulatory timelines for each Major Country). Following initial submission, each Development Plan shall be updated by Licensee at least annually for each Specified Disease in the Field. Annual updates shall include a description of all significant activities and results since the date of the most recent Development Plan. An initial Development Plans for each Specified Disease included in the Field shall be delivered not later than one hundred eighty (180) days prior to the date upon which Licensee in good faith anticipates Phase I Clinical Trials will begin for the Specified Disease. (ii) Licensee shall provide ▇▇▇▇▇ with a commercialization plan (“Commercialization Plan”) for each Licensed Product no later than one (1) year prior to the anticipated First Commercial Sale of the Licensed Product in a Major Country. Each Commercialization Plan shall set forth projected annual Net Sales and anticipated activities, plans and timelines for the commercialization of the relevant Licensed Product. Each Development Plan and Commercialization Plan shall be prepared by Licensee in good faith and shall reflect Licensee’s intentions and projection as of the date of its delivery to ▇▇▇▇▇.

Development and Commercialization Plans. D.3.1 The Ex-U.S. Planning Subcommittee shall work together in good faith after the [***] of the Effective Date to commence the negotiation and formulation of a detailed plan and budget for the development and Commercialization of the Products in each country in the Ex-U.S. Territory (with respect to each such country, the “D&C Plan”). Any country for which the Ex-U.S. Planning Subcommittee does not prepare a preliminary D&C Plan in accordance with the provisions of this Exhibit D shall, as of the [***] of the Effective Date, no longer be part of the Ex-U.S. Territory; provided that such period shall be tolled in the event of a bona fide dispute between the Parties with respect to a proposed D&C Plan for any Ex-U.S. Country that has been submitted to the Executive Committee (or thereafter to arbitration pursuant to Section 17.2.2) for resolution. D.3.2 The Ex-U.S. Planning Subcommittee shall submit a preliminary D&C Plan to the Executive Committee for approval no later than the third anniversary of the Effective Date. Upon receipt of such preliminary D&C Plan, the Executive Committee shall negotiate in good faith and take such other steps as may be necessary to adopt a final approved D&C Plan not later than [***] thereafter. Changes to the approved D&C Plan may be made at any time and from time to time upon prior written agreement of both Parties or prior approval of the Executive Committee. Any country for which the Executive Committee does not approve a D&C Plan in [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. accordance with the provisions of this Exhibit D shall, as of the date that is [***] after the [***] of the Effective Date, no longer be part of the Ex-U.S. Territory; provided that such period shall be tolled in the event of a bona fide dispute between the Parties with respect to a proposed D&C Plan for any Ex-U.S. Country and such dispute is being resolved by the chief executive officers of the Parties pursuant to Section 17.1 and, thereafter, by arbitration in accordance with Section 17.2.2. D.3.3 Each D&C Plan shall provide that: (a) Par shall be solely responsible for all costs of development, including obtaining MAA Regulatory Approval in the subject country; (b) Par shall have the sole right to book sales of the Products in ...

Development and Commercialization Plans. Copies of InterMune's Product development plan (the "Development Plan") and Product commercialization plan (the "Commercialization Plan") are attached hereto as Exhibits D and E, respectively.

Development and Commercialization Plans. (a) Initial Development Plan. An initial Development plan for the Licensed Product in the Field in the Territory is attached hereto as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the "Development Plan"). Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2. The confidential portions of this exhibit have been omitted and are marked accordingly. The confidential portions will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.

Development and Commercialization Plans. Within [* * *] of the Effective Date with respect to Existing Vaccine Products and prior to beginning any Development or Commercialization activities with respect to an Additional Vaccine Candidate or CPLB Discovered Candidate, CPLB shall present to the Steering Committee for its written approval a Development Plan or Commercialization Plan, as applicable, for each such Licensed Product. The Steering Committee may reasonably request adjustments to activities described in such Development Plan or Commercialization Plan as a condition to granting its approval. In no event shall CPLB materially alter a Development Plan or Commercialization Plan without the Steering Committee’s prior written consent. CPLB shall conduct Development or Commercialization of each Licensed Product in a manner that is materially consistent with the applicable Development Plan or Commercialization Plan. All clinical trial protocols for Licensed Products conducted shall require the prior written approval of Novavax.

Development and Commercialization Plans