Common use of Unanticipated Changes Clause in Contracts

Unanticipated Changes. Sponsor acknowledges that some changes in costs associated with clinical research resulting from, for example, modifications to the study protocol, changes in amounts charged by third party suppliers or poor subject enrollment due to changes in clinical practices, cannot be reasonably anticipated in advance. Upon identification by either party of changes to the project assumptions or other unanticipated changes to the Project Specifications, the parties agree to negotiate in good faith an Amendment to accommodate increases or decreases to the Project Budget, Project Schedule or Payment Schedule that are reasonably associated with any such adjustments. Amendments shall be documented in accordance with the terms of this Section 2.2. Such unanticipated changes may include, but are not limited to, any of the following: i. delays in receiving from Sponsor technical information or Sponsor’s acceptance of documents submitted by PRA in the performance of its duties under this Agreement or any Task Order, or any other delay on the part of Sponsor; ii. delay in receipt of regulatory approval from a regulatory agency, Institutional Review Board or Ethics Committee; iii. delay in performance by a subcontractor not selected by PRA; iv. delay in shipment of study drug and/or clinical supplies; v. ▇▇▇▇▇ due to changes in standard of care imposed by law, regulation or changes in medical practice affecting participating sites; vi. by reason of force majeure as defined herein; vii. Sponsor requested changes to the Services or protocol; viii. delays due to questions received by either party from regulatory agencies or ethics committees regarding submission materials that relate to characteristics of the study drug or protocol design; ix. delays due to any changes in applicable law or regulatory environment; or x. for any other reason agreed upon in writing by Sponsor.

Unanticipated Changes. Sponsor acknowledges agrees that some changes in costs associated with clinical research resulting from, for example, changes to Project Specifications resulting from modifications to the study protocol, delays in receipt of study drugs from Sponsor, changes in amounts charged by third party suppliers or poor subject enrollment due to changes in clinical practices, cannot be reasonably anticipated in advance. Upon identification by either party of changes to the project assumptions or other unanticipated changes to the Project Specifications, the parties agree to Parties will negotiate in good faith an Amendment to accommodate increases or decreases to the Project Budget, Project Schedule or Payment Schedule that are reasonably associated with any such adjustments. Amendments shall will be documented in accordance with the terms of this Section 2.2. Such unanticipated changes may include, but are not limited to, any of the following: i. delays in receiving from Sponsor technical information or Sponsor’s 's acceptance of documents submitted by PRA in the performance of its duties under this Agreement or any Task Order, or any other delay on the part of Sponsor; ii. delay in receipt of regulatory approval from a regulatory agency, Institutional Review Board IRB or Ethics Committee; iii. delay in performance by a subcontractor Subcontractor not selected by PRA; iv. delay in shipment of study drug drug, clinical samples and/or clinical supplies; v. ▇. ▇▇▇▇▇ due to changes in standard of care imposed by law, regulation or changes in medical practice affecting participating sites; vi. delay by reason of force majeure as defined herein; vii. Sponsor requested changes to the Services or protocol; viii. delays due to questions received by either party from regulatory agencies or ethics committees regarding submission materials that relate to characteristics of the study drug or protocol design; ix. delays due to any changes in applicable law or regulatory environment; or x. changes for any other reason agreed upon in writing by Sponsor.