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:

Development Plan. No later than ​ during the Term, Licensee shall submit to Penn an updated Development Plan, which shall include amendments and revisions to any long term development activities and detailed activities to be conducted in the following ​, provided that such updated Development Plan for a given Product shall not be due after the First Commercial Sale of that Product in the United States.

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

Development Plan. Subject to Elan’s review and consultation rights under Sections 3.1, 10.1 and 10.2 of the Elan License Agreement with respect to Development plans for Licensed Product:

Development Plan”. Development Plan means the plan for the Development of Products in the Field in the Territory as it may be modified from time to time in accordance with this Agreement. The initial Development Plan will be agreed by the JDC and attached hereto as [Schedule 1.17] within ninety (90) days after the Effective Date.

Development Plan. Within ​ after payment of the Option Exercise Fee for a Program, Janssen shall submit to Arrowhead an initial annual Development Plan for Licensed Products and shall update such Development Plan at least once each year for such Program.

Development Plan. Everest shall conduct all Development of the Compound and Licensed Products in the Licensed Field in the Territory in accordance with a comprehensive development plan, the initial version of which is attached to this Agreement as [Exhibit E] (the “Initial Development Plan”, and as amended from time to time in accordance with this Agreement, the “Development Plan”). The Development Plan will include, among other things, the indications for which a Licensed Product is to be Developed and other exploratory indications for which a Licensed 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 be focused on efficiently obtaining Regulatory Approval for a Licensed Product in the Licensed Field in the Territory while taking into consideration Development, Regulatory Approval, or commercial impacts on the Licensed Product outside the Licensed Field and Territory. From time to time, but at least ​ per Calendar Year, the Parties will, with the assistance of the JDC, update the Development Plan and submit such updated plan to the JDC for review, discussion, and approval. The then-current Development Plan will at all times contain at least that level of detail and cover at least the same matters (to the extent applicable) as the Initial Development Plan. If any updated Development Plan is not approved by the JDC, any disagreement or dispute shall be resolved by the JDC in the manner set forth in Section 3.3 (JDC Decision-Making). If any updated or new terms of the Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern.

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 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).

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