Common use of Request for Modifications Clause in Contracts

Request for Modifications. Either party may propose either Material or Non-material Modifications to any part of the WNV Development Program from time to time during the term of this West Nile Virus Addendum, including without limitation a request for a change to the FTE Labor Rate, as defined in Section 5.2.1. The process applicable to any such proposed modifications shall be as described in this Section 3. Changes, modifications or improvements to the WNV Assay Product, after the Completion Date, are governed by the provisions of Section 4 below. The Project Manager, and under his or her supervision, the Project Leaders and their respective teams, will review any proposed modification to the WNV Development Program; if the two Project Leaders mutually agree in writing that a particular modification is a Material Modification or is a Non-material Modification, then such determination shall be conclusive. Unless the two Project Leaders determine to the contrary, any one or more of the following modifications shall be deemed to be a Material Modification: a modification that (i) reflects an increase in the actual WNV Development Costs incurred that, when aggregated with all previously authorized modifications, is greater than [***] over the Development Costs reflected in the original Budget approved as of the Addendum Effective Date, or (ii) contains a proposal to alter any Interim Event as compared to the most recently approved Timeline, or (iii) contains a proposal to submit a BLA in the United States for approval from the FDA, or (iv) increases the sales forecast of the WNV Assay Product to greater than [***] of the WNV Assay Product per month for [***]. If the Project Leaders are unable to agree whether a particular requested modification is a Material or Non-material Modification, then the Supervisory Board shall review the requested change and make a determination with respect to whether such requested modification is a Material or Non-material Modification. If the Supervisory Board has met and consulted without resolution, then either party may, in its discretion, determine that the parties have reached an impasse with respect thereto and implement the escalation procedure described in Article 13 of the Agreement to resolve such impasse.

Request for Modifications. Either party may propose either Material or Non-material Modifications to any part of the WNV Development Program from time to time during the term of this West Nile Virus Addendum, including without limitation a request for a change to the FTE Labor Rate, as defined in Section 5.2.1. The process applicable to any such proposed modifications shall be as described in this Section 3. Changes, modifications or improvements to the WNV Assay Product, after the Completion Date, are governed by the provisions of Section 4 below. The Project Manager, and under his or her supervision, the Project Leaders and their respective teams, will review any proposed modification to the WNV Development Program; if the two Project Leaders mutually agree in writing that a particular modification is a Material Modification or is a Non-material Modification, then such determination shall be conclusive. Unless the two Project Leaders determine to the contrary, any one or more of the following modifications shall be deemed to be a Material Modification: a modification that (i) reflects an increase in the actual WNV Development Costs incurred that, when aggregated with all previously authorized modifications, is greater than [...***...] over the Development Costs reflected in the original Budget approved as of the Addendum Effective Date, or (ii) contains a proposal to alter any Interim Event as compared to the most recently approved Timeline, or (iii) contains a proposal to submit a BLA in the United States for approval from the FDA, or (iv) increases the sales forecast of the WNV Assay Product to greater than [...***...] units of the WNV Assay Product per month for [...***]. If the Project Leaders are unable to agree whether a particular requested modification is a Material or Non-material Modification, then the Supervisory Board shall review the requested change and make a determination with respect to whether such requested modification is a Material or Non-material Modification. If the Supervisory Board has met and consulted without resolution, then either party may, in its discretion, determine that the parties have reached an impasse with respect thereto and implement the escalation procedure described in Article 13 of the Agreement to resolve such impasse....