Common use of Access to and Use of Data Clause in Contracts

Access to and Use of Data. (a) Regulatory Data. Both Parties shall have access to pre-clinical and clinical data for Licensed Products, and the right to use for incorporation in any Regulatory Filing to exercise their rights and responsibilities under this Agreement. Both Parties shall provide to each other access to that part of all such Regulatory Filings together with the underlying pre-clinical and clinical data, at reasonable times and on reasonable notice, and at the FTE costs and Out-of-Pocket Expenses of the requesting Party. In case that data in a Regulatory Filing of a Licensed Product is required or reasonably useful for a Regulatory Filing for the BN Technology, then Crucell shall provide BN with the appropriate written authorizations to permit BN to send directly such data to the appropriate Regulatory Authority, and Crucell shall diligently cooperate with BN to supply data to that Regulatory Authority in the required formats at the FTE costs and Out-of-Pocket Expenses of BN. In case that data in a Regulatory Filing for the BN Technology is required or reasonably useful for a Regulatory Filing for a Licensed Product, then Crucell shall provide BN with the appropriate written authorizations to permit BN to directly send such data to the appropriate Regulatory Authority.