Common use of Development Data Clause in Contracts

Development Data. (a) To the extent permitted by law, Braeburn grants Camurus, its Affiliates and licensees the right to use and cross-reference any Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, Controlled by Braeburn, its Affiliates or Sublicensees as may be necessary or useful for Camurus, its Affiliates and licensees to make regulatory filings for (i) the Products, and (ii) any other products not being a Competing Product in the Territory, to the extent such Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, relate to Cam urns Platform IP. Braeburn shall give Camurus, its Affiliates and licensees reasonable access (including the right to copy where reasonably required) to a copy of (i) the complete NDA for the Products filed by Braeburn, its Affiliates or Sublicensees with FDA or any other applicable Regulatory Authorities in the Licensed Territory, and (ii) Regulatory Approvals for the Products granted by FDA or any other applicable Regulatory Authorities in the Licensed Territory. (b) To the extent permitted by law, Camurus grants Braeburn, its Affiliates and Sublicensees the right to use and cross-reference any Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, Controlled by Camurus, its Affiliates or licensees as may be necessary or useful for Braeburn, its Affiliates and Sublicensees to make regulatory filings for the Products in the Licensed Territory. Camurus shall give Braeburn, its Affiliates and Sublicensees reasonable access (including the right to copy where reasonably required) to a copy of (i) the complete NDA for the Products filed by Camurus, its Affiliates or licensees with the EMA or any other applicable Regulatory Authorities in the Camurus Territory, and (ii) Regulatory Approvals for the Products granted to Camurus, its Affiliates or its licensees by the EMA or any other applicable Regulatory Authorities in the Camurus Territory. Notwithstanding the foregoing, Camurus shall not be required to provide Braeburn, its Affiliates and Sublicensees the rights described in this Section 3.9, if Camurus is restricted from doing so pursuant to an agreement with a Third Party in effect prior to the Effective Date.

Development Data. (a) To the extent permitted by lawlaw and subject to the terms and conditions of this Agreement, Braeburn Ra Pharma grants Camurus, its Affiliates and licensees the right to use and cross-reference any portions of any Placebo Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, Controlled by BraeburnRa Pharma or its Affiliates that have been submitted to the FDA or any other applicable Regulatory Authorities by Ra Pharma, its Affiliates or Sublicensees licensees, solely as may be necessary or useful for Camurus’, its Affiliates Affiliates’ and licensees to make licensees’ regulatory filings in the Territory for (i) other products that utilize the ProductsFC Technology, provided that such other products do not consist of a Product. Camurus shall provide Ra Pharma with notice when it shares any Placebo Development Data with any licensee, and with at least [***] (ii[***]) days advanced written notice of the regulatory agency and division which is receiving any other products not being a Competing Product in cross-reference filing, before Camurus or any of its Affiliates or licensees exercises any right of cross-reference as contemplated under the Territory, to the extent such Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, relate to Cam urns Platform IPforegoing provisions of this Section. Braeburn Ra Pharma shall give Camurus, its Affiliates and licensees reasonable access to and right to use (including the right to copy where reasonably required) to a copy of (i) those portions of the complete NDA for the Products filed by BraeburnPlacebo Development Data, its Affiliates or Sublicensees with FDA or any other applicable Regulatory Authorities in the Licensed Territory, and (ii) Regulatory Approvals for the Products granted by FDA or any other applicable Regulatory Authorities in the Licensed Territory. (b) To each case only to the extent permitted by law, Camurus grants Braeburn, its Affiliates that such right of reasonable access and Sublicensees the right to use and cross-reference any Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, Controlled by Camurus, its Affiliates or licensees as may be is necessary or useful for Braeburn, its Affiliates and Sublicensees to make development or regulatory filings for products that utilize the Products in the Licensed TerritoryFC Technology and do not consist of a Product. Camurus shall give Braeburn, its Affiliates and Sublicensees reasonable access (including the right to copy where reasonably required) to a copy of (i) the complete NDA for the Products filed by Camurus, its Affiliates or licensees with the EMA or any other applicable Regulatory Authorities in the Camurus Territory, and (ii) Regulatory Approvals for the Products granted Ra Pharma hereby grants to Camurus, its Affiliates and licensees a right to reference and use Placebo Development Data Controlled by Ra Pharma or its Affiliates for the purpose of filing, maintaining, defending and enforcing patent applications and patents covering Camurus Collaboration Inventions. Camurus shall be responsible for reimbursement to Ra Pharma of any costs on an hourly fee basis incurred in connection with the provision of access to any data by Ra Pharma pursuant to this Section, including the costs of segregating data that relates solely to the FC Technology. Such costs shall be calculated on an hourly fee basis consistent with the FTE Rate. Within the scope of the license granted in Section 2.1, Camurus grants to Ra Pharma, its Affiliates, and sublicensees with a right of cross-reference, a right of reasonable access to and a right to use the Development Data, regulatory filings and approvals that Camurus or its Affiliates Control that are directly related to the FC Technology and that do not include information concerning any active pharmaceutical ingredient under development by Camurus or its Affiliates or licensees or sublicensees, in each Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. case only to the extent that such right to cross-reference, such right of reasonable access and such right of use is necessary or reasonably useful for regulatory filings for the Product(s) made or to be made by the EMA Ra Pharma or any other applicable Regulatory Authorities in the Camurus Territory. Notwithstanding the foregoing, Camurus shall not be required to provide Braeburn, of its Affiliates or sublicensees. Ra Pharma shall provide Camurus with at least [***] ([***]) days advanced written notice of the regulatory agency and Sublicensees division which is receiving the rights described cross- reference filing, before Ra Pharma or any of its Affiliates or sublicensees exercises any right of cross-reference as contemplated under the foregoing provisions of this Section. Ra Pharma shall be responsible for reimbursement to Camurus of any costs incurred in this Section 3.9, if connection with the provision of access to any data by Camurus is restricted from doing so pursuant to an agreement with a Third Party in effect prior this Section, including the costs of segregating data that relates solely to the Effective DateFC Technology. Such costs shall be calculated on an hourly fee basis, consistent with the FTE Rate.