Changes to the Development Plan Clause Samples

Changes to the Development Plan. The Development Team shall review the DEVELOPMENT PLAN on an ongoing basis, and may propose revisions thereto to the Alliance Management Committee; provided, however, the DEVELOPMENT PLAN in effect for a year shall not be materially modified (which shall include any change to the budget for activities to be conducted under the DEVELOPMENT PLAN) except as approved by the Alliance Management Committee.

Changes to the Development Plan. During the Term, any changes to the Development Plan, including any country-specific appendices required by Applicable Law and changes made in response to any communications with any Regulatory Authorities that require a submission to a Regulatory Authority, an IRB or other ethics committee, will be prepared by OPKO with respect to the clinical activities in the Development Plan and Pfizer with respect to the CMC and regulatory activities in the Development Plan, or an Approved CRO or Approved Vendor, and, except as otherwise set forth in this Article 3, will require the JDC’s approval, to the *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. extent responsibility is not already allocated to the Parties under the Development Plan.

Changes to the Development Plan. If, over the term of a Development Plan, either Party recognizes a need for a specific Improvement, it may notify the other Party of such a need and the Parties will then promptly discuss in good faith modifying the Development Plan to incorporate the development of the Improvement.

Changes to the Development Plan. The City and the Authority acknowledge and agree that Developer may modify the Development Plan from time to‌‌ time as Developer deems reasonably necessary to accommodate the actual development of the Project, taking into account changing entitlement and financing timelines for a particular Element or Public Open Space, changing market conditions, the reasonable construction requirements of Secondary Developers, and such other factors affecting the actual development of the Project, provided such change does not require regulatory approval under applicable Legal Requirements. Neither the City’s nor the Authority’s approval will be required for any such changes to the Development Plan so long as each of the following items are true with respect to the Development Plan as revised: (A) the Development Plan and phasing of the Public Infrastructure continue to conform to the Legal Requirements; (B) the Development Plan and phasing of the Public Infrastructure continue to conform to the requirements of this Agreement and the Site Improvement Performance Agreement, including the Affordable Housing Requirements and the Affordable Housing Schedule (including approved Affordable Housing Modifications in accordance with the applicable provision of Section 9.1); (C) no component of the Public Infrastructure is materially changed or affected; and (D) no change will affect the ability of an Element or Public Open Space to obtain a building permit and a temporary certificate of occupancy, as applicable. Developer shall not have any right to change the Development Plan with respect to any Lot that has been transferred to a Secondary Developer and after a Lot is transferred to a Secondary Developer, only the Secondary Developer may make changes in the Development Plan with respect to that Lot.

Changes to the Development Plan. Any variation of the Development Plan must be agreed in writing by NTT and Company.

Changes to the Development Plan. If a Party wishes to make a change to the Development Plan (including to add additional Clinical Trials for the Initial Indications, or Development activities for any Additional Indications), then such Party will submit its proposed change to the JDMRC for the JDMRC to review, discuss and determine whether to approve. Each such update to the Development Plan will become effective and will supersede the previous Development Plan upon approval thereof by the JDMRC (which approval will be memorialized in the minutes of such JDMRC meeting). [***] Without limiting the JDMRC’s right to review, discuss and determine whether to approve any updates to the Development Plan, Licensor will have the right, without seeking JDMRC review and approval, to make day-to-day operational decisions with respect to the performance of the Development activities set forth in the Development Plan provided such decisions are consistent with the then-current Development Plan.

Changes to the Development Plan. During the Term, any changes or other amendments to the Development Plan (excluding any country-specific appendices required by Applicable Laws or any changes made in response to any communications with any Regulatory Authorities that require a submission to a Regulatory Authority, an IRB or other ethics committee, each of which shall be added to and implemented in the Development Plan in accordance with Applicable Law or instructions from Regulatory Authorities, as applicable) shall require the JDC’s approval, subject to the tie-breaking provisions and limitations on tie-breaking authority set forth in Section 3.2.5. If the JDC agrees to change or otherwise amend the Development Plan so that a Party shall perform new Development or Manufacturing activities, then the Parties shall meet and discuss, in good faith, an appropriate allocation of costs with respect to such activities and shall amend the Development Budget to reflect the agreed to allocation of costs.