Additional Expenses Required for Additional Activities Required by Regulatory Authorities Sample Clauses

Additional Expenses Required for Additional Activities Required by Regulatory Authorities. In addition to the compensation under Section 8.1 and expenses contemplated in the Development Plan and Commercialization Plan, the Parties acknowledge that the Regulatory Authority may request the performance of additional activities not contemplated in the then-current Development Plan or Commercialization Plan. The JSC shall meet to discuss activities and the allocation of costs therefor. [***]. For sake of clarity and to the best of BTO’s knowledge, the Development Plan as of the Effective Date contains activities that BTO reasonably expects to be sufficient for Regulatory Approval of the BTO CDx. Hence the Parties recognize, that BTO does not warrant or represent that such activities will in fact satisfy all regulatory requirements for Regulatory Approval of the BTO CDx.
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  • IN WITNESS WHEREOF the parties hereto have executed this Agreement as of the date first above written.