Common use of Development Data Clause in Contracts

Development Data. To the extent permitted by law and subject to the terms and conditions set forth in this Section 3.7, Rhythm grants Camurus, its Affiliates and licensees the right to cross-reference those portions of any Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, Controlled by Rhythm or its Affiliates that are directly related to safety and CMC aspects of the FC Technology and do not include information concerning the Drug and that have CONFIDENTIAL * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED been submitted to the FDA or any other applicable Regulatory Authorities, in each case only to the extent that such right to cross-reference, is necessary or useful for Camurus’, its Affiliates’ and licensees’ regulatory filings for other products that utilize the FC Technology, provided that such other products do not consist of a Product or a Competing Product. Camurus shall provide Rhythm with at least thirty (30) days advanced written notice of the regulatory agency and division which is receiving the cross-reference filing, before Camurus or any of its Affiliates or licensees exercises any right of cross-reference as contemplated under the foregoing provisions of this paragraph. Rhythm shall give Camurus, its Affiliates and licensees reasonable access and right to use (including the right to copy where reasonably required) to a copy of those portions of the Development Data, IND, NDA or Regulatory Approvals Controlled by Rhythm, its Affiliates or its Sublicensees that are directly related to safety and CMC aspects of the FC Technology and do not include information concerning the Drug , in each case only to the extent that such right of reasonable access and use is necessary or useful for development or regulatory filings for products that utilize the FC Technology and do not consist of a Product or a Competing Product. Camurus shall be responsible for reimbursement to Rhythm of any costs on an hourly fee basis incurred in connection with the provision of access to any data by Rhythm pursuant to this Section 3.7, including the costs of segregating data that relates solely to the FC Technology. Such costs shall be calculated on an hourly fee basis. Camurus shall provide Rhythm, its Affiliates, Sublicensees with a right of cross-reference, a right of reasonable access and a right to use the development data and regulatory filings and regulatory 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 case only to the extent that such right to cross-reference, such right of reasonable access and such right of use is necessary or useful for regulatory filings for the Product made or to be made by Rhythm, its Affiliates or Sublicensees. Rhythm shall provide Camurus with at least thirty (30) days advanced written notice of the regulatory agency and division which is receiving the cross-reference filing, before Rhythm or any of its Affiliates or Sublicensees exercises any right of cross-reference as contemplated under the foregoing provisions of this paragraph. Rhythm shall be responsible for reimbursement to Camurus of any costs incurred in connection with the provision of access to any data by Camurus pursuant to this Section 3.7, including the costs of segregating data that relates solely to the FC Technology. Such costs shall be calculated on an hourly fee basis. It is noted that Camurus is currently negotiating sublicensing rights under its license agreement with [ ]* to [ ]* generated know-how pertaining to the FC Technology and that do not include information concerning any active pharmaceutical ingredient under development by [ ]* or its Affiliates. The Parties agree that until Camurus succeeds in securing such sublicensing rights from [ ]* under such license agreement that would permit Camurus to grant to Rhythm rights to such know-how as provided in Section 3.7, Camurus shall not sublicense or otherwise grant or provide the rights granted by Rhythm to Camurus in this Section 3.7 or Section 2.4 to [ ]* or its Affiliates. CONFIDENTIAL * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED

Appears in 3 contracts

Samples: License Agreement (Rhythm Pharmaceuticals, Inc.), License Agreement (Rhythm Pharmaceuticals, Inc.), License Agreement (Rhythm Pharmaceuticals, Inc.)

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Development Data. To the extent permitted by law and subject to the terms and conditions set forth in of this Section 3.7Agreement, Rhythm Ra Pharma grants Camurus, its Affiliates and licensees the right to cross-reference those any portions of any Placebo Development Data and regulatory filings, including INDs, NDAs and Regulatory Approvals, Controlled by Rhythm Ra Pharma or its Affiliates that are directly related to safety and CMC aspects of the FC Technology and do not include information concerning the Drug and that have CONFIDENTIAL * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED been submitted to the FDA or any other applicable Regulatory AuthoritiesAuthorities by Ra Pharma, in each case only to the extent that such right to cross-referenceits Affiliates or licensees, is solely as may be necessary or useful for Camurus’, its Affiliates’ and licensees’ regulatory filings in the Territory for other products that utilize the FC Technology, provided that such other products do not consist of a Product or a Competing Product. Camurus shall provide Rhythm Ra Pharma with notice when it shares any Placebo Development Data with any licensee, and with at least thirty [***] (30[***]) days advanced written notice of the regulatory agency and division which is receiving the any cross-reference filing, before Camurus or any of its Affiliates or licensees exercises any right of cross-reference as contemplated under the foregoing provisions of this paragraphSection. Rhythm 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 those portions of the Placebo Development Data, IND, NDA or Regulatory Approvals Controlled by Rhythm, its Affiliates or its Sublicensees that are directly related to safety and CMC aspects of the FC Technology and do not include information concerning the Drug , in each case only to the extent that such right of reasonable access and use is necessary or useful for development or regulatory filings for products that utilize the FC Technology and do not consist of a Product Product. Ra Pharma hereby grants to Camurus, its Affiliates and licensees a right to reference and use Placebo Development Data Controlled by Ra Pharma or a Competing Productits 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 Rhythm Ra Pharma of any costs on an hourly fee basis incurred in connection with the provision of access to any data by Rhythm Ra Pharma pursuant to this Section 3.7Section, including the costs of segregating data that relates solely to the FC Technology. Such costs shall be calculated on an hourly fee basisbasis consistent with the FTE Rate. Within the scope of the license granted in Section 2.1, Camurus shall provide Rhythmgrants to Ra Pharma, its Affiliates, Sublicensees and sublicensees with a right of cross-reference, a right of reasonable access to and a right to use the development data and Development Data, regulatory filings and regulatory 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 Product(s) made or to be made by Rhythm, Ra Pharma or any of its Affiliates or Sublicenseessublicensees. Rhythm Ra Pharma shall provide Camurus with at least thirty [***] (30[***]) days advanced written notice of the regulatory agency and division which is receiving the cross-cross- reference filing, before Rhythm Ra Pharma or any of its Affiliates or Sublicensees sublicensees exercises any right of cross-reference as contemplated under the foregoing provisions of this paragraphSection. Rhythm Ra Pharma shall be responsible for reimbursement to Camurus of any costs incurred in connection with the provision of access to any data by Camurus pursuant to this Section 3.7Section, including the costs of segregating data that relates solely to the FC Technology. Such costs shall be calculated on an hourly fee basis. It is noted that Camurus is currently negotiating sublicensing rights under its license agreement , consistent with [ ]* to [ ]* generated know-how pertaining to the FC Technology and that do not include information concerning any active pharmaceutical ingredient under development by [ ]* or its Affiliates. The Parties agree that until Camurus succeeds in securing such sublicensing rights from [ ]* under such license agreement that would permit Camurus to grant to Rhythm rights to such know-how as provided in Section 3.7, Camurus shall not sublicense or otherwise grant or provide the rights granted by Rhythm to Camurus in this Section 3.7 or Section 2.4 to [ ]* or its Affiliates. CONFIDENTIAL * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDFTE Rate.

Appears in 1 contract

Samples: License Agreement (Ra Pharmaceuticals, Inc.)

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