Common use of Modifications to Project Plan Clause in Contracts

Modifications to Project Plan. If either Party becomes aware of any changes of the Key Assumptions or of any other circumstances outside of the control of the Parties, such as changes in the regulatory environment, which could reasonably be expected to result in a material impact on the Project Plan or RMS’ ability to obtain Regulatory Approval for or commercialize the RMS Product in the Major Markets (the “Changes”), then such Changes shall be promptly reported to the other Party, and the Parties shall negotiate in good faith an amended Project Plan and Payment Plan taking into account such Changes. For clarity, the Parties are assuming that for the countries in the Major Markets, aside from the United States and Japan, all such countries shall accept CE-IVD filing for obtaining Regulatory Approval on the RMS Product, without the need for further testing, data or registrational studies, but any changes in the regulatory environment which alters this assumption with respect to such a country prior to obtaining Regulatory Approval for such a country (a “Regulatory Change”) shall not be deemed to be a Change subject to the provisions of this Section 3.2, provided that, unless Pharmaceutical Partners agree to reimburse RMS for all incremental out-of-pocket costs that RMS is required to incur in order to obtain the requisite Regulatory Approval for the RMS Product (but not any separate submission for the RMS Technology that is not specific to the RMS Product) in the applicable country as a result of such Regulatory Change, the country affected by such Regulatory Change shall be excluded from the Major Markets unless and until such country is reinstated as a Major Market pursuant to Section 3.5. Any dispute with respect to any amendments to the Project Plan or Payment Plan in connection with any Change shall be resolved according to Sections 4.2 and, if necessary, 4.3. Notwithstanding anything in this Agreement to the contrary, unless otherwise agreed by the Parties, there shall be no change to the Payment Plan, and RMS shall not have the right to terminate the Agreement, in connection with any Change to the extent that such Change results from or arises out of RMS’ negligence or failure to exercise due care in the performance of its obligations under this Agreement. For any amendments to the Project Plan relating to Changes or for any agreed upon modifications to the Project Plan independent of any Changes which does not lead to an increase or decrease of the amended or modified Payment Plan, the Project Team shall have the authority to agree, approve and sign off such modified Project Plan. If the Project Team is unable to agree on an amended or modified Project Plan, the escalation process according to Section 4.2(d) shall apply. If and to the extent the above amendment or modification of the Project Plan leads to an increase or decrease of the amended or modified Payment Plan, the Project Team shall submit to the JSC the amended or modified Project Plan and only the JSC shall have the authority to recommend approval of such amended or modified Project Plan (including associated amendment or modification to the Payment Plan) provided that such amended or modified Project Plan and Payment Plan shall not become effective unless agreed upon in writing and signed by authorized representatives of Epizyme, Eisai and RMS, such agreement not to be unreasonably withheld, delayed or conditioned. If the JSC is unable to recommend approval of an amended or modified Project Plan, including an amended or modified Payment Plan reflecting the appropriate increase or decrease in resulting incremental costs, the escalation process according to Section 4.3 and Article 16, respectively shall apply.