Example ContractsClausesAmendments to Development Plan
Amendments to Development Plan
Amendments to Development Plan contract clause examples

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. From time to time during the Term, either Party may submit to the JDC any proposed amendment of the Development Plan to Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets ​ and an asterisk*, have been separately filed with the Securities and Exchange Commission.

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 the Development Plan. From time to time during the Term, Licensee may propose amendments to the Development Plan and submit such proposed amended Development Plan to the JSC for review and discussion in accordance with Section 3.1, which shall become effective upon submission to the JSC, provided that at all times the activities covered by the Development Plan are # limited to development activities that are necessary to support MAA filing and Regulatory Approval of such Product in the Field in the Territory (which may include activities outside of the Territory within the scope of the License), and # consistent with the obligations of Licensee under this Agreement; provided, further, that if any such amendment results in a material change to Licensee’s overall development strategy (including any new Clinical Trials or any material delays in timelines) or materially decreases its obligations, in each case as compared to the last-reviewed Development Plan, for the development of Product in the Field in the Territory, such amendment shall require the approval of the JSC (with such approval not to be unreasonably withheld, conditioned, or delayed, taking into account any regulatory requirements Confidential

Amendments to the Development Plan. From time to time during the Term, but at least every ​ months, Verrica shall propose amendments to the Development Plan and submit such proposed amended Development Plan to the JSC for review, discussion, and approval in accordance with [Section 0]. Each amended Development Plan becomes effective on the date of approval by the JSC. References to the “Development Plan” in this Agreement refer to the Development Plan as then in effect (including all amendments thereto).

Development Plan. All Development of the Products in the Territory will be governed by a written development plan, as such development plan may be revised by Akebia in its sole discretion from time to time (the “Development Plan”). The initial Development Plan is attached hereto as [Schedule 3.3]. For the avoidance of doubt, Akebia is under no obligation to provide Cyclerion notice of, or copies of, any changes to the Development Plan.

Development Plan. Licensee shall develop Products in the Field in the Territory pursuant to the Development Plan. The Development Plan includes # an outline of all major development activities for Products for each Indication within the Field in the Territory to be conducted by or on behalf of Licensee, its Affiliates, or its or their Sublicensees, including clinical/non-clinical development activities necessary for obtaining and maintaining the MAAs for the Products in the Field in the Territory; # estimated timelines for the conduct of such major development activities and for MAA applications for the Products in each Indication the Field in the Territory; and # estimated timelines of any other major development activities in the Territory, including any participation in any investigator-initiated clinical studies of a Product.

Development Plan. Within […​…] days of the delivery of the [Exhibit D] Documents pursuant to the first sentence of Section 2.1, [[Organization A:Organization]] shall deliver a copy of its proposed written plan describing in reasonable detail the proposed program of its initial Development for the first therapeutic indication of the Licensed Product(s). The initial Development Plan will focus on anticipated […​…] and […​…] (“Early Stage Development”) with an overview of [[Organization A:Organization]]’s […​…] and […​…] for Licensed Products (“Development Plan”) for [[Agenus:Organization]]’ review. During Early Stage Development [[Organization A:Organization]] plans to screen [[Agenus:Organization]] Antibody for incorporation into or admixture with [[Organization A:Organization]]’s proprietary sustained release gel formulation(s) known as RTGel™ or other proprietary or licensed technologies. Once a determination has been made by [[Organization A:Organization]] regarding whether [[Agenus:Organization]] Antibody is the lead candidate for use in development of the Licensed Product the next Development Plan update shall include the strategy for the initial Clinical Trials and the regulatory plan to support such Clinical Trials for such Licensed Product, as well as a rolling forecast of the quantity of [[Agenus:Organization]] Antibody that [[Organization A:Organization]] expects to need for preclinical studies and Clinical Trials (the “Forecast”) of the Licensed Product. The Forecast shall cover the remainder of the calendar year in which the Development Plan was approved and the […​…] years thereafter. The Forecast shall be divided into […​…] and shall include a delivery 36165924.6

Development Plan. Without limiting the generality of the other provisions in this Article 4, an initial, mutually agreed Development Plan is attached hereto as Exhibit D (the “Initial Development Plan”). Within ​ after the Effective Date, [[3D Medicines:Organization]] (in conjunction with assistance from [[Aravive:Organization]]) will prepare and submit to the JSC a detailed plan containing the strategy, activities, study designs, timeline, study material needs (Drug Substance and drug product) and budget for research and Development of the Licensed Compound and Licensed Products in the Field in the [[3D Medicines:Organization]] Territory (the “First Supplemental Development Plan,” and together with the Initial Development Plan and any subsequent updates pursuant to this Section 4.2, the “Development Plan”). The First Supplemental Development Plan shall include among other things, all material non-clinical and clinical studies, CMC Information collection activities and regulatory activities with respect to the Licensed Compound and Licensed Products to be conducted by or on behalf of [[3D Medicines:Organization]] or its Affiliates or their respective Sublicensees in the [[3D Medicines:Organization]] Territory. From time to time during the Term (but at least ​ per Fiscal Year), [[3D Medicines:Organization]] shall prepare amendments and updates, as appropriate, to the then-current Development Plan, and shall submit such amendments and updates to the JSC in accordance with Section 4.3. For clarity, if there are no amendments or updates to the then-current Development Plan that are applicable in a Fiscal Year, [[3D Medicines:Organization]]’ sole responsibility under this Section 4.2 during such Fiscal Year shall be to inform [[Aravive:Organization]] that the then-current Development Plan is up to date. [[3D Medicines:Organization]] shall be solely responsible for all decisions regarding the day-to-day conduct of Development within the [[3D Medicines:Organization]] Territory.

Development Plan. All Development of the Product conducted by or on behalf of Ji Xing under this Agreement shall be conducted pursuant to a comprehensive written Development plan that sets forth the timeline and details of all clinical and regulatory activities to be conducted by or on behalf of Ji Xing to obtain and maintain Regulatory Approval of the Product in the Field in each Market in the Territory (the “Development Plan”). The Development Plan shall, except as expressly agreed by [[Cytokinetics:Organization]] in writing (e.g., to the extent required by the applicable Regulatory Authority or to address specific operational requirements in the Territory), be ​ and shall be focused ​. As of the Effective Date, the Parties have agreed to the initial Development Plan, which is attached hereto as [Exhibit B]. The JDC shall review and update the Development Plan within ​ after the Effective Date. From time to time, but at least once every ​, Ji Xing shall propose updates or amendments to the Development Plan in consultation with [[Cytokinetics:Organization]] and submit such proposed updated or amended plan to the JDC for review, discussion, and approval, including the protocols of all Clinical Trials of the Product to be conducted by Ji Xing in the Territory and all investigator-sponsored and investigator-initiated trials of the Product in the Territory, in each case prior to any patient enrollment. Once approved by the JDC, the updated or amended Development Plan shall become effective. From time to time at its discretion, ​ may propose updates or amendments to the Development Plan if it reasonably believes that the then effective Development Plan is insufficient or may have an adverse effect on ​.

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