Common use of Right of Reference Clause in Contracts

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]

Right of Reference. (a) Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right right of Reference,reference” (as that term is defined in 21 C.F.R. § §314.3(b) (or any successor rule or analogous Law recognized outside of the United States)), toor similar “right of reference” as defined in applicable regulations in the relevant jurisdiction, with respect to any regulatory filings and a right approvals Controlled by such Party or its Affiliates in the Territory that solely relates to copyits Product (including, accessfor clarity, and otherwise use, all CMC information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications for its Product) and designations) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, data contained therein solely to the extent necessary or useful for the other Party to (i) obtain Regulatory Approval for, and conduct, the Combination Therapy Trials and (ii) perform its obligations and exercise its rights with respect to the Combination Therapy as expressly permitted under this Agreement, and for no other purpose. (b) Affimed hereby grants to Artiva a “right of reference” (as defined in 21 C.F.R. §314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant jurisdiction, with respect to any Regulatory Materials for the Combination Therapy in the Territory and the Combination Therapy Clinical Data contained therein solely (i) to the extent necessary for Artiva to apply for, obtain and maintain Regulatory Approvals for the Artiva Product either as a monotherapy or in combination with, or as part of a Regional Licensed combination therapy with, agents or products other than the Affimed Product (but in no case in combination with an Innate Cell Engager Technology other than the Affimed Product), and (ii) for inclusion in the Novartis Territory safety database for the Artiva Product. (c) Each Party shall provide to the other Party a cross-reference letter or similar communication to the Surface Territoryapplicable Regulatory Authority to effectuate such right of reference set forth in Section 6.3(a) or Section 6.3(b). If, in any regulatory jurisdiction, it is not possible for a Party to provide such right of reference to the other Party pursuant to Section 6.3(a) or Section 6.3(b), such Party shall take commercially reasonable steps, subject to the terms and conditions of any applicable confidentiality obligations, to provide in lieu of such right of reference the right to use such regulatory filings, approvals and data contained therein (including, for clarity, Regulatory Materials and Combination Therapy Clinical Data contained therein) to the other Party solely for the purposes set forth in Section 6.3(a) or Section 6.3(b), as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “. [***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Other than as set forth in this Section 6.3 and Section 4.2, AS AMENDED. effectno other right of reference (or right of use, if requested as applicable) is granted by a Party to the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***].

Right of Reference. Each Party hereby grants to the other Party the right of reference to all Regulatory Submissions pertaining to Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates or, with respect to Jazz, sublicensees, solely to the extent reasonably necessary for the purposes set forth in this Section 6.3 and requested by such other Party. Without limiting the foregoing, and at Zymeworks may file a drug master file (“DMF”) with the request FDA or other Regulatory Authorities in the Territory, setting forth the Zymeworks Know-How related to the manufacture of the other Party will grant Licensed Antibody and such DMF shall be a Regulatory Submission subject to the other Partyright of reference granted to Jazz in the foregoing sentence, and, upon Jazz’s Related Partieswritten request, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and Zymeworks will provide Jazz with a right to copyreference and full access to such DMF[***]. Upon Jazz’s reasonable written request [***], access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional Zymeworks shall [***] Activities, a right of reference to (i) Regulatory Submissions pertaining to Licensed Products in the Field submitted by or early access/named patient programs on behalf of the Ex-Territory Partner in the Ex-Territory (including Regulatory Submissions for the Regional combination studies of Licensed Products) included in and (ii) Regulatory Submissions pertaining to Companion Diagnostics submitted by or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of such any Third Party (engaged by Zymeworks or its Related Parties) that relates Affiliates to develop such Companion Diagnostics. Jazz may use such right of reference to Zymeworks’ Regulatory Submissions or, if applicable, the Ex-Territory Partner’s Regulatory Submissions or other Third Party solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any Regional pricing or reimbursement approvals, as applicable, of Licensed ProductProducts in the Field in the Territory. Zymeworks, or its Ex-Territory Partner, may use the right of reference to Jazz’s Regulatory Submissions and Regulatory Approvals solely for the purpose of seeking, obtaining and maintaining Regulatory Approval and any pricing or reimbursement approvals, as applicable, of Licensed Products outside the Territory or, to the extent necessary or useful permitted pursuant to obtain Regulatory Approval of a Regional Licensed Product this Agreement, in the Novartis Territory or the Surface Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “. [***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if ] Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.3 and to give the other Party, in accordance with 21 C.F.R. § 314.50(g)(3its Affiliates, licensees (including the Ex-Territory Partner) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, sublicensees the benefit of any regulatory vouchers [***]the rights of reference to the granting Party’s Regulatory Submissions in the other Party’s territory as provided herein.

Right of Reference. Each All (a) pre-clinical and clinical work conducted by Prometheus, its Affiliates or Sublicensees which is necessary for Regulatory Approval of the First Indication of the Product inside the Prometheus Territory, (b) pre-clinical and clinical work conducted by Alizyme and/or its Affiliates inside or outside the Prometheus Territory which is relevant to the Product, and (c) pre-clinical and clinical work conducted by Alizyme's licensees inside or outside the Prometheus Territory which is necessary for Regulatory Approval of the First Indication of the Product inside the Prometheus Territory, in each case (a), (b) or (c), shall be made available for cross-referencing for Regulatory Filings, scientific presentations, publications and promotional materials (provided such scientific presentations, publications and promotional materials shall be subject to at least sixty (60) days prior review by the other Party hereby grants to determine if such presentations, publications and/or materials contain confidential information of such other Party or its Affiliates, Sublicensees or licensees or contain patentable subject matter, and provided further that the party who has funded the preclinical or clinical work shall have the right to present or publish the results of such work at a scientific conference and/or in a peer reviewed scientific journal before the non-funding Party), at no cost to either Party. Alizyme shall cause its Affiliates and licensees to make their pre-clinical and clinical work on the Product available for cross-referencing for Regulatory Filings by Prometheus, its Affiliates and Sublicensees for the Prometheus Territory; and Prometheus shall cause its Affiliates and Sublicensees to make their pre-clinical and clinical work on the Product available for cross-referencing for Regulatory Filings by Alizyme, its Affiliates and licensees; in each case to the extent set forth in sub-Sections (a), (b) and (c) above. Except with respect to the foregoing use rights, as between the Parties, all pre-clinical and clinical work remains the property of the Party that funded such work, provided that if the pre-clinical or clinical work is jointly funded (as unanimously agreed by the Committee), then the data shall be owned by both Parties equally, and each Party shall have the right to freely use all such jointly funded data, without the obligation to account to the other Party, in each case in their respective territory. Without limiting any of the foregoing, if: (i) Alizyme, its Affiliates and/or its licensees desire to access any pre-clinical and/or clinical work conducted by Prometheus, its Affiliates or Sublicensees which is not necessary for Regulatory Approval of the First Indication of the Product inside the Prometheus Territory, the Parties shall negotiate in good faith the terms and at conditions (including fair and reasonable license and transfer fees) for the request license and/or transfer of such pre-clinical or clinical work, provided that if the Parties are unable to negotiate such terms and execute an addendum or agreement with respect thereto, no transfer or license shall be implied nor granted by Section 3.3.2. (ii) Prometheus, its Affiliates and/or its Sublicensees desire to access any pre-clinical and/or clinical work conducted by Alizyme's licensees outside the Prometheus Territory which is not necessary for Regulatory Approval of the First Indication of the Product inside the Territory, the Parties shall negotiate in good faith the terms and conditions (including fair and reasonable license and transfer fees) for the license and/or transfer of such pre-clinical or clinical work, provided that if the Parties are unable to negotiate such terms and execute an addendum or agreement with respect thereto, no transfer or license shall be implied nor granted by Section 3.3.2. For the avoidance of doubt, and notwithstanding the foregoing, each Party, their Affiliates, Sublicensees and licensees shall make all safety data relating to the Product freely available to the other Party will grant to the other Party’s Related Partiesand its Affiliates, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside Sublicensees and licensees for all indications and/or applications of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***].

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] ActivitiesStudies, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including pediatric and orphan drug applications and designations) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Xencor Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Xencor Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concernssafety concerns, neither Party will voluntarily withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.37.1.3. For clarity, the benefit of any regulatory vouchers with respect to Regional Licensed Products will be allocated to the Parties on a [...***]...] basis.

Right of Reference. Each Party During the Licensed Period, each Party, on behalf of itself and its Related Parties, hereby grants to the other Party, Party and at the request of the other Party will grant to the other Party’s its Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) Regulatory Materials maintained on behalf of such Party (or its Related Parties) that relates to any Regional the Licensed ProductProducts, to the extent necessary or useful to obtain Regulatory Approval of a Regional the Licensed Product Products in the Novartis Territory Field in the Shionogi Territory, or in the Surface ▇▇▇▇▇ Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon the reasonable request of either Party (on behalf of itself or a Sublicenseeany of its Related Parties), the other Party will, and will cause its Related Parties to, obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory Field in the Shionogi Territory, or in the Surface ▇▇▇▇▇ Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s requestrequest and cost, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party nor any of its Related Parties will withdraw or inactivate any regulatory filing Regulatory Filing that the other Party or the other Party’s Related Parties references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]5.5.

Right of Reference. Each Party will grant, and hereby grants does grant, to the other Party, Party a right of reference to all Regulatory Approvals and at the request of the other Party will grant Regulatory Materials pertaining to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated Licensed Products in the conduct of any Clinical Studies Field Controlled and submitted by or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of such Party (or its Related PartiesAffiliates, subject to payment of any amounts agreed in writing by the Parties or specified to be due under Section 4.2 (Ongoing JS001 Clinical Trials) that relates to any Regional through and including Section 4.6 (Development of Optioned Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface TerritoryProducts), as applicable, to obtain such right or reference. Coherus may use such right of reference to such Regulatory Approvals and Regulatory Materials Controlled by Junshi or its Affiliates, if any, solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Pricing and Reimbursement Approvals of the Licensed Products in the Coherus Territory. Junshi may use such right of reference to such Regulatory Approvals and Regulatory Materials Controlled by Coherus or any of its Affiliates solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Pricing and Reimbursement Approvals of (a) the Licensed Products in the Junshi Territory and (b) any product Controlled by Junshi that is included in any Combination Regimen in the Coherus Territory. The Party using such right of reference will bear (i) its own costs and expenses and (ii) the reasonable and verifiable costs and expenses incurred by the other Party associated with providing assistance to enable such use of the right of reference pursuant to this Section 5.5 (Right of Reference), including (A) internal costs (calculated at the FTE Rate) reasonably incurred by or on behalf of the other Party or its Affiliates in connection with such activities, and (B) all verifiable external or out- of-pocket costs reasonably incurred by or on behalf of the other Party or its Affiliates in connection with such activities under this Section 5.5, in each case ((A) and (B)), within 45 days after receiving the invoice therefor. Each Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if take such actions as may be reasonably requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3Party to give effect to the intent of this Section 5.5 (Right of Reference) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), and to give the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of the granting Party’s Regulatory Approvals and Regulatory Materials in the other Party’s territory as provided herein, including by executing any regulatory vouchers [***]letters of authorization or similar correspondence for submitting to an applicable Regulatory Authority to further evidence or give effect to the rights contemplated hereby. ​

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected collected, or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] ActivitiesStudies, or early access/named patient programs for the Regional Licensed Collaboration Compounds, Collaboration Products) , or Companion Diagnostics directed to a Collaboration Target included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of Controlled by such Party (or its Related Parties) Parties that relates to any Regional Licensed Collaboration Compound, Collaboration Product, or Companion Diagnostic directed to a Collaboration Target solely for the extent necessary purpose or useful to obtain obtaining or maintaining any Regulatory Approval of a Regional Licensed Collaboration Product in or Companion Diagnostic directed to a Collaboration Target. In addition, upon the Novartis Territory reasonable request of the other Party (on behalf of itself or the Surface Territorya Sublicensee), as applicable, and such each Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States)) that the other Party may rely on, and the Regulatory Authority may access, in support of the other Party’s application for Regulatory Approval in its Territory, any underlying raw data or information submitted by such Party to the Regulatory Authority with respect to any regulatory filing, Regulatory Approval, drug master file, or other regulatory documentation (including orphan drug applications and designations) Controlled by such Party or its Related Parties that relates to any Collaboration Compound, Collaboration Product, or Companion Diagnostics directed to a Collaboration Target. In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products Collaboration Compounds, Collaboration Products, or Companion Diagnostics directed to a Collaboration Target in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s requestin each case, and provided further that such attestations are as is reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything in this Agreement to the contrary in this Agreement other than for Safety Concerns, unless otherwise agreed by the Parties, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.36.7 (Right of Reference). For clarity, the benefit of any regulatory vouchers [***].

Right of Reference. Each Party Party, on behalf of itself and its Related Parties, hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, any Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) Regulatory Materials maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Licensee Territory or the Surface C▇▇▇▇▇ Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon the reasonable request of either Party (on behalf of itself or a Sublicenseeany of its Related Parties), the other Party will, and will cause its Related Parties to, obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Licensee Territory or the Surface C▇▇▇▇▇ Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s requestrequest and cost, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. For clarity, Licensee’s rights under this Section 5.4 may be exercised solely as is necessary to support filing for, obtaining and maintaining Regulatory Approval for any Licensed Product in the Initial Indications in the Licensee Territory. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party nor any of its Related Parties will withdraw or inactivate any regulatory filing Regulatory Filing that the other Party or the other Party’s Related Parties references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]5.4.

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of such Party (or its Related Parties) that relates to any Regional Licensed Product, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Territory, as applicable, and such Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Secondary Indication Studies or Regional [***] Activities, or early access/named patient programs for the Regional Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of owned or controlled by such Party (or its Related Parties) Parties that relates to (a) any Regional Licensed ProductProduct or (b) with respect to such information and data provided to Genzyme, the siRNA Controlled by Alnylam and known as ALN-TTR01, to the extent necessary or useful to obtain Regulatory Approval of a Regional Licensed Product in the Novartis Territory or the Surface Genzyme Territory, as applicable, and such Party will shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon request of either Party (on behalf of itself or a Sublicensee), the other Party shall obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Genzyme Territory or the Alnylam Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments). Notwithstanding anything to the contrary in these Regional License Terms, neither Party shall withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 3.4. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO UNDER RULE 406 PROMULGATED UNDER 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED1934. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Licensed Products in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concerns, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]REGIONAL LICENSE TERMS

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related PartiesAffiliates and Sublicensees, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Applicable Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected collected, or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Studies or Regional [***] ActivitiesTrials, or early access/named patient programs for the Regional any Licensed Products) Candidates or Licensed Products included in or used in support of any regulatory filing, Regulatory Approval, drug master file file) or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of Controlled by such Party (or its Related Parties) Affiliates or Sublicensees that relates to any Regional Licensed ProductCandidates or Licensed Products solely for the purpose of (a) in the case of Licensee, to the extent necessary obtaining or useful to obtain maintaining any IND or Regulatory Approval of a Regional any Licensed Product Candidates or Licensed Products (including any Licensee Combination) or (b) in the Novartis Territory case of Relay, obtaining or maintaining any IND or Regulatory Approval for any Relay Pipeline Combination or Relay Pipeline Product. Licensee will provide Relay with copies of Regulatory Materials related to any Relay Pipeline Combination Eligible Licensed Products that are reasonably requested by Relay for use by or on behalf of Relay, its Affiliates or Relay Sublicensees in connection with Developing, Manufacturing or Commercializing any Relay Pipeline Combination as permitted hereunder. In addition, upon the Surface Territoryreasonable request of the other Party (on behalf of itself or a Sublicensee), as applicable, and such each Party will provide a signed statement to this CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Applicable Law outside of the United States)) that the other Party may rely on, and the Regulatory Authority may access, in support of the other Party’s application for Regulatory Approval in its Territory, any underlying raw data or information submitted by such Party to the Regulatory Authority with respect to any regulatory submission, Regulatory Approval, drug master file, or other regulatory documentation (including orphan drug applications and designations) Controlled by such Party or its Affiliates or Sublicensees that relates to any Licensed Candidates or Licensed Products or Licensee Combinations or Relay Pipeline Combinations, as applicable. In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional any Licensed Candidates or Licensed Products or Licensee Combinations or Relay Pipeline Combinations, as applicable, in the Novartis Territory or the Surface Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s requestin each case, and provided further that such attestations are as is reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding Other than for safety concerns, notwithstanding anything to the contrary in this Agreement other than for Safety Concernsto the contrary, neither Party will withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, 6.5 unless otherwise mutually agreed by the benefit of any regulatory vouchers [***]Parties.

Right of Reference. Each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or upon exercise of the Additional Development Opt-In Right, Supplemental Secondary Indication Studies or Regional [***] Activities, or early access/named patient programs for the Regional Co-Co Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) maintained on behalf of owned or controlled by such Party (or its Related Parties) Parties that relates to (a) any Regional Co-Co Licensed ProductProduct or (b) with respect to such information and data provided to Genzyme, the siRNA Controlled by Alnylam and known as ALN-TTR01, to the extent necessary or useful to obtain Regulatory Approval of a Regional Co-Co Licensed Product in the Novartis Territory or the Surface Genzyme Territory, as applicable, and such Party will shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon request of either Party (on behalf of itself or a Sublicensee), the other Party shall obtain and CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO UNDER RULE 406 PROMULGATED UNDER 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1933, AS AMENDED1934. effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor or analogous Law outside of the United States). In addition, upon reasonable request of either Party (on behalf of itself or a Sublicensee), the other Party will obtain and CO-CO LICENSE TERMS provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Regional Co-Co Licensed Products in the Novartis Genzyme Territory or the Surface Co-Co Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments), at the requesting Party’s request, and provided further that such attestations are reasonably necessary for the requesting Party to exercise its rights under this Agreement. Notwithstanding anything to the contrary in this Agreement other than for Safety Concernsthese Co-Co License Terms, neither Party will shall withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 7.2.3. For clarity, the benefit of any regulatory vouchers [***]3.5.