Amendments to Development Plan. From time to time during the License Term, either Party may submit to the JRDC any proposed amendment of any Global Development Plan to amend the then-currently approved Development activities (such proposed amendment, a “Proposed Development Plan Amendment”) for the JRDC’s review and approval by the JSC. Any Proposed Development Plan Amendment shall contain, at a minimum, information supporting the rationale for the Proposed Development Plan Amendment related to Licensed Products from a scientific, regulatory and commercial standpoint, as well as an estimated developmental critical path, and an estimate of the cost of such Development. The JRDC shall consider any submitted Proposed Development Plan Amendment during its next scheduled meeting. Once approved by the JSC (or otherwise resolved pursuant to Section 2.9), each amended Global Development Plan (including the Development Budget contained therein) shall become effective and supersede the previous Global Development Plan and Development Budget as of the date of such approval or at such other time as decided by the JSC.
Amendments to Development Plan. In the event that Dermavant desires to amend the Development Plan in any material respect, it shall notify NovaQuest in reasonable detail of the proposed amendment (the “Proposed Amendment Notice”). During the [***] period following NovaQuest’s receipt of a Proposed Amendment Notice, NovaQuest shall notify Dermavant that the amendment described in such Proposed Amendment Notice either (i) does not constitute a material amendment to the Development Plan, in which case Dermavant shall be free to amend the Development Plan as described in the Proposed Amendment Notice or (ii) constitutes a material amendment to the Development Plan, in which case Dermavant shall not amend the Development Plan without NovaQuest’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that NovaQuest’s consent for an amendment shall not be required if such amendment is being made pursuant to the recommendation or direction of the FDA that is either conveyed in writing or conveyed orally and subsequently confirmed in writing (e.g., documented in FDA meeting minutes); and provided, further, that if Dermavant amends the Development Plan in a manner that is inconsistent with this Section 3.1(a)(ii) (Amendments to Development Plan), such amendment shall be deemed to constitute a termination due to a reason other than for a Technical Failure of the applicable Indication (for clarity, such termination is solely with respect to the Indication that is affected by the Proposed Amendment Notice). For the purposes of this Section 3.1(a)(ii) (Amendments to Development Plan), a “material” amendment to the Development Plan shall be an amendment that, either alone or together with one or more other amendments, would reasonably be expected to (I) delay the receipt of Marketing Approval of either Indication in the U.S. by more than [***] from the projected approval date set forth in the Development Plan (as amended), or (II) result in a Material Adverse Effect.
Amendments to Development Plan. Each Party may propose an amendment to the Development Plan by submitting such proposed amendment in writing to the Joint R&D Working Group, for review and approval, subject to the final decision-making process set forth in Section 5.6.3; provided, however, that any material amendments to the Development Plan shall be mutually agreed to by the Parties either in writing, such agreement not to be unreasonably withheld, conditioned or delayed, or through the JGC as reflected in JGC meeting minutes signed by the Alliance Managers in accordance with Section 5.5.1. Material amendments to the Development Plan include: [**]. Upon the Alliance Managers’ signing the minutes of the JGC pursuant to Section 5.5.1 memorializing the agreement of the JGC to, or mutual written agreement by the Parties of, as applicable, an amendment to the Development Plan, the Development Plan shall be deemed to be amended by such amendment.
Amendments to Development Plan. Any amendment to the Development Plan for the Compound and Products under this Agreement, including the Ovid Ongoing Trials, Licensee Territory Development Activities for registrational purposes, all Joint Development Activities, and all Independent Development Activities shall be conducted pursuant to a comprehensive written updated (from time to time) Development Plan (the “Amended Development Plan”), which shall be incorporated by reference into this Agreement. The Amended Development Plan will include Clinical Trials for the Initial Indications that the Parties have agreed to conduct jointly (unless modification is required by a Regulatory Authority or any local or regional IRB/ethics committee, or is reasonably necessary to protect patient safety), the Clinical Trials for the Second Indication that Ovid may conduct under its sole responsibility and cost if Licensee exercises the Second Indication Opt-Out and not the Second Indication Opt-In, as well as Clinical Trials for the Additional Indications that the Parties (through the CGB) mutually agree to conduct and include in accordance with Section 4.3. The Amended Development Plan will also include:
Amendments to Development Plan. Either Party, directly or through its representatives on the JDC may propose amendments to the Development Plan from time to time as appropriate, including in light of changed circumstances. Such amendments shall be reviewed and approved in accordance with Section 3.2.
Amendments to Development Plan. Due to the fact that the PROPERTY comprises a significant land area and its development will occur in phases over a number of years, modifications to the DEVELOPMENT PLAN may become desirable due to changes in market conditions or other factors. Variations of a preliminary plat or final plat from the DEVELOPMENT PLAN that do not increase the overall density of development of the PROPERTY will not require an amendment to the DEVELOPMENT PLAN. Minor changes to the DEVELOPMENT PLAN, including minor modifications of street alignments; minor changes in lot lines; the designation of land for public or governmental uses; changes in lot sizes that do not result in an increase in the overall density of development of the PROPERTY (including any increase in lot sizes resulting in a decrease in the total number of lots); or any change to a public use, including, but not limited to school use, will not require an amendment to the DEVELOPMENT PLAN or City approval. Major changes to the DEVELOPMENT PLAN must be consistent with the terms of this Agreement and will be subject to review and approval by the City, which will not be unreasonably withheld.
Amendments to Development Plan. On an annual basis, or more often as the Parties may deem appropriate, the JDC shall prepare proposed amendments to the then-current Development Plan, and, subject to this Agreement, the corresponding Development Budget, for approval of the JSC no later than December 1 of each Calendar Year. Such amended Development Plan shall cover the applicable period as set forth therein and shall contain corresponding updates to the Development Budget included therein, which shall appropriately itemize the costs and expenses separately for each Development activity, to the extent practicable. Such updated and amended Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or revisions to the then-current Development Plan. In addition, the JDC may prepare amendments to the Development Plan and corresponding allocation of the Development Budget for the JSC’s approval from time to time during the Calendar Year in order to reflect changes in such plan and budget, in each case, in accordance with the foregoing. Once approved by the JSC, the amended Development Plan (and Development Budget) shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify). Any JSC-approved amended Development Plan (and Development Budget) shall supersede the previous Development Plan (and Development Budget) for the applicable period. Notwithstanding the foregoing, in the event that the JSC does not approve a given amended Development Plan (or Development Budget, as applicable), then the then-current Development Plan (or Development Budget, as applicable) shall continue in effect without modification (i.e., no changes shall be made to the Development Plan (and Development Budget) unless and until agreed to by the JSC) such that only the Development activities set forth in the then-current Development Plan shall continue (in accordance with the then-current Development Budget, as applicable, without any additional budget changes being made). 5.2.4 Additional Development of Next Generation Compounds, Combination Therapies, Combination Products and Companion Diagnostics. (a) In the event that Merck provides a Licensed Compound Notice pursuant to Section 2.9.2 for SGN-LIV-1-B, SGN-LIV-1-C or any other Next Generation Compound (or, with respect to SGN-LIV-1-C, Merck is deemed to have provided a Licensed Compound Notice pursuant to Section 2.9.2 for SGN-LIV-1-C) such th...
Amendments to Development Plan. During the Term prior to the Option Effective Date, the Parties shall, through the JGC, and in accordance with Section 2.1.1 (Development Plan and Activities), review the then-current Development Plan, and as appropriate, propose any amendment, including a Material Amendment, to the then-current Development Plan through the JGC, so long as such amendment, if approved, would amend the Development Plan in a manner consistent with the requirements of this Agreement, including those set forth in Section 2.1.1 (
Amendments to Development Plan. Either Party may submit suggestions for amendments to the Development Plan to the Joint Steering Committee for review. Any amendment to the Development Plan shall require the approval of the Joint Steering Committee.
Amendments to Development Plan. The JDC will actively participate in amending and revising the Development Plan with respect to a Drug Product Candidate as may be necessary or desirable from time to time. The JDC shall not have the power to amend or modify this Agreement, which may only be amended or modified as provided in Sections 15.2 and 15.15 hereof.
