Common use of Changes to the Development Plan Clause in Contracts

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. 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.