Common use of Governmental Clearances Clause in Contracts

Governmental Clearances. (a) Access shall obtain and maintain all Governmental Clearances in the Territory concerning the Device and AMAG shall have the right to use and reference all such Governmental Clearances incident to and as an integral part of the License Grant set forth in Article 2 hereof. (b) Access shall make determinations of whether additional regulatory submissions are necessary to be made to FDA. Access shall provide AMAG with a copy of any additional regulatory submission, including 510(k) premarket notifications submitted for modifications to the Device or other correspondence with FDA exploring whether a 510(k) notice is required for a given Device modification, for AMAG’s review and comment prior to submission. AMAG shall provide such comments to Access within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. fifteen (15) days following its receipt of such materials from Access. Access shall provide AMAG with a copy of the final submission promptly after it is submitted to FDA. (c) Access and its Affiliates hereby grant to AMAG a [***], right of use and reference for any and all data and information contained in any FDA Approvals or filings with FDA, including non-clinical data, and any other data and information required by AMAG in connection with the Commercialization of the Device in the Territory; provided that AMAG shall not seek to utilize such right of reference unless and until [***] and AMAG shall not thereafter seek to alter the scope and terms of the Regulatory Clearance for the Device within the Territory without Access’s prior written consent, not to be unreasonably withheld or delayed. (d) Within five (5) Business Days after the Effective Date, Access and AMAG shall enter into an escrow agreement in substantially the form attached hereto as Schedule H (the “Escrow Agreement”). Subject to the terms and conditions set forth in the Escrow Agreement, Access will [***] and deposit with the escrow agent identified in the Escrow Agreement (the “Escrow Agent”) [***] attached hereto as Schedule F [***] to release from escrow [***] if a Release Event occurs pursuant to Section 4.9 of this Agreement. [***].