Common use of Right of Reference Clause in Contracts

Right of Reference. Ironwood hereby grants to Astellas a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation in the Field in the Territory to the data included in the Ironwood Technology to the extent necessary or useful to Develop the Licensed Compound or Product solely for IBS-C or CC, and Astellas hereby grants to Ironwood (and Ironwood’s partners and/or licensees, as long as such Ironwood partners and/or licensees grant a [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. corresponding right of reference, in connection with Astellas’s rights hereunder, to their corresponding data to Astellas) such a Right of Reference to the data included in the Astellas Technology to the extent necessary or useful to (i) manufacture the Licensed Compound or Product in an Oral Formulation throughout the world for purposes of commercialization in the Field outside the Territory, (ii) develop the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, or (iii) to commercialize the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, in all cases solely for IBS-C or CC, and in each case subject to the terms and conditions of this Agreement. Each Party will provide a signed statement to this effect, if requested by the other, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation, in the case of a request by either Party, for the limited purpose of such Party exercising its rights or performing its obligations under this Agreement. For the avoidance of doubt, neither Party may publish or otherwise publicly disclose any data to which a Right or Reference is granted under this Section 2.4, and each Party will treat such data as the Confidential Information of the other Party in accordance with the terms hereof.

Right of Reference. Ironwood 4.3.1. POZEN hereby grants to Astellas Licensee and its Affiliates and Sublicensees a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor law) to, and any foreign counterpart a right to such regulation in the Field in the Territory to the copy, access and otherwise use all information and data included in in, any regulatory filing, Marketing Approval, marketing authorization, drug master file or other regulatory documentation Controlled by POZEN or any of its Affiliates that relates to any Licensed Product inside or outside the Ironwood Technology Territory, to the extent necessary or useful for Licensee to Develop the obtain, maintain, supplement or amend any IND, NDA or Marketing Approval for a Licensed Compound or Product solely for IBS-C or CC, and Astellas hereby grants to Ironwood (and Ironwood’s partners and/or licensees, as long as such Ironwood partners and/or licensees grant a [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. corresponding right of reference, in connection with Astellas’s rights hereunder, to their corresponding data to Astellas) such a Right of Reference to the data included in the Astellas Technology to the extent necessary or useful to (i) manufacture the Licensed Compound or Product in an Oral Formulation throughout the world for purposes of commercialization in the Field outside inside the Territory, (ii) develop the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, or (iii) to commercialize the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, in all cases solely for IBS-C or CC, and in each case subject to the terms and conditions of this Agreement. Each Party will POZEN shall provide a signed statement to this effect, if requested required by the otherLicensee, in accordance with 21 C.F.R. § 314.50(g)(3) (or any foreign counterpart successor law). 4.3.2. Licensee hereby grants POZEN and its Affiliates and its licensees of any Licensed Product outside the Territory a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor law), to, and a right to such regulationcopy, access and otherwise use all information and data included in the case following: (i) the NDA [* * *] and (ii) any regulatory filing, NDA Approval, drug master file or other regulatory documentation owned or Controlled by Licensee or its Affiliates that relates to the manufacture of any Licensed Product within the Territory, to the extent necessary or useful for POZEN or any POZEN licensee of any Licensed Product outside the Territory to obtain regulatory approval for a request by either Party, for Licensed Product outside the limited purpose of such Party exercising its rights or performing its obligations under this Agreement. For the avoidance of doubt, neither Party may publish or otherwise publicly disclose any data to which a Right or Reference is granted under this Section 2.4Territory, and each Party will treat such data as the Confidential Information of the other Party Licensee shall provide a signed statement to this effect, if required by POZEN, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor law). Notwithstanding the terms hereof.foregoing, solely with respect to the “Right of Reference” under clause (ii) above, such “Right of Reference” does not [* * *]. If POZEN requests a “Right of Reference” for [* * *], the Parties agree to [* * *] amend this

Right of Reference. Ironwood 4.3.1. POZEN hereby grants to Astellas Licensee and its Affiliates and Sublicensees a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor law) to, and any foreign counterpart a right to such regulation in the Field in the Territory to the copy, access and otherwise use all information and data included in in, any regulatory filing, Marketing Approval, marketing authorization, drug master file or other regulatory documentation Controlled by POZEN or any of its Affiliates that relates to any Licensed Product inside or outside the Ironwood Technology Territory, to the extent necessary or useful for Licensee to Develop the obtain, maintain, supplement or amend any IND, NDA or Marketing Approval for a Licensed Compound or Product solely for IBS-C or CC, and Astellas hereby grants to Ironwood (and Ironwood’s partners and/or licensees, as long as such Ironwood partners and/or licensees grant a [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. corresponding right of reference, in connection with Astellas’s rights hereunder, to their corresponding data to Astellas) such a Right of Reference to the data included in the Astellas Technology to the extent necessary or useful to (i) manufacture the Licensed Compound or Product in an Oral Formulation throughout the world for purposes of commercialization in the Field outside inside the Territory, (ii) develop the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, or (iii) to commercialize the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, in all cases solely for IBS-C or CC, and in each case subject to the terms and conditions of this Agreement. Each Party will POZEN shall provide a signed statement to this effect, if requested required by the otherLicensee, in accordance with 21 C.F.R. § 314.50(g)(3) (or any foreign counterpart successor law). 4.3.2. Licensee hereby grants POZEN and its Affiliates and its licensees of any Licensed Product outside the Territory a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor law), to, and a right to such regulationcopy, access and otherwise use all information and data included in the case following: (i) the NDA [* * *] and (ii) any regulatory filing, NDA Approval, drug master file or other regulatory documentation owned or Controlled by Licensee or its Affiliates that relates to the manufacture of any Licensed Product within the Territory, to the extent necessary or useful for POZEN or any POZEN licensee of any Licensed Product outside the Territory to obtain regulatory approval for a request by either Party, for Licensed Product outside the limited purpose of such Party exercising its rights or performing its obligations under this Agreement. For the avoidance of doubt, neither Party may publish or otherwise publicly disclose any data to which a Right or Reference is granted under this Section 2.4Territory, and each Party will treat such data as the Confidential Information of the other Party Licensee shall provide a signed statement to this effect, if required by POZEN, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor law). Notwithstanding the terms hereofforegoing, solely with respect to the “Right of Reference” under clause (ii) above, such “Right of Reference” does not [* * *]. If POZEN requests a “Right of Reference” for [* * *], the Parties agree to [* * *] amend this Section 4.3.2 to provide POZEN with such “Right of Reference.” In addition, upon request of POZEN or its licensees, Licensee shall obtain and provide to the requesting party certificates or other formal or official attestations concerning the regulatory status of the Licensed Products in the Territory (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments); provided that (a) POZEN shall provide to Licensee any such certificates or other formal or official attestations complete with all necessary information and (b) POZEN shall be responsible for [* * *], which [* * *] shall be [* * *] within [* * *] Business Days of POZEN receiving an [* * *] from Licensee. In no event shall Licensee have any responsibility for obtaining or maintaining Marketing Approvals outside of the Territory.

Right of Reference. Ironwood hereby grants to Astellas a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation in the Field in the Territory to the data included in the Ironwood Technology to the extent necessary or useful to Develop the Licensed Compound or Product solely for IBS-C or CC, and Astellas hereby grants to Ironwood (and Ironwood’s partners and/or licensees, as long as such Ironwood partners and/or licensees grant a [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. corresponding right of reference, in connection with Astellas’s rights hereunder, to their corresponding data to Astellas) such a Right of Reference to the data included in the Astellas Technology to the extent necessary or useful to (i) manufacture the Licensed Compound or Product in an Oral Formulation throughout the world for purposes of commercialization in the Field outside the Territory, (ii) develop the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, or (iii) to commercialize the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, in all cases solely for IBS-C or CC, and in each case subject to the terms and conditions of this Agreement. Each Party will provide a signed statement to this effect, if requested by the other, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation, in the case of a request by either Party, for the limited purpose of such Party exercising its rights or performing its obligations under this Agreement. For the avoidance of doubt, neither Party may publish or otherwise publicly disclose any data to which a Right or Reference is granted under this Section 2.4, and each Party will treat such data as the Confidential Information of the other Party in accordance with the terms hereof.

Right of Reference. Ironwood hereby grants to Astellas a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation in the Field in the Territory to the data included in the Ironwood Technology to the extent necessary or useful to Develop the Licensed Compound or Product solely for IBS-C IBS­C or CC, and Astellas hereby grants to Ironwood (and Ironwood’s partners and/or licensees, as long as such Ironwood partners and/or licensees grant a [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. corresponding right of reference, in connection with Astellas’s rights hereunder, to their corresponding data to Astellas) such a Right of Reference to the data included in the Astellas Technology to the extent necessary or useful to (i) manufacture the Licensed Compound or Product in an Oral Formulation throughout the world for purposes of commercialization in the Field outside the Territory, (ii) develop the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, or (iii) to commercialize the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, in all cases solely for IBS-C IBS­C or CC, and in each case subject to the terms and conditions of this Agreement. Each Party will provide a signed statement to this effect, if requested by the other, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation, in the case of a request by either Party, for the limited purpose of such Party exercising its rights or performing its obligations under this Agreement. For the avoidance of doubt, neither Party may publish or otherwise publicly disclose any data to which a Right or Reference is granted under this Section 2.4, and each Party will treat such data as the Confidential Information of the other Party in accordance with the terms hereof.

Right of Reference. Ironwood hereby grants to Astellas a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation in the Field in the Territory to the data included in the Ironwood Technology to the extent necessary or useful to Develop the Licensed Compound or Product solely for IBS-C or CC, and Astellas hereby grants to Ironwood (and Ironwood’s partners and/or licensees, as long as such Ironwood partners and/or licensees grant a [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. corresponding right of reference, in connection with Astellas’s rights hereunder, to their corresponding data to Astellas) such a Right of Reference to the data included in the Astellas Technology to the extent necessary or useful to (i) manufacture the Licensed Compound or Product in an Oral Formulation throughout the world for purposes of commercialization in the Field outside the Territory, (ii) develop the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, or (iii) to commercialize the Licensed Compound or Product in an Oral Formulation in the Field outside the Territory, in all cases solely for IBS-C or CC, and in each case subject to the terms and conditions of this Agreement. Each Party will provide a signed statement to this effect, if requested by the other, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation, in the case of a request by either Party, for the limited purpose of such Party exercising its rights or performing its obligations under this Agreement. For the avoidance of doubt, neither Party may publish or otherwise publicly disclose any data to which a Right or Reference is granted under this Section 2.4, and [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. each Party will treat such data as the Confidential Information of the other Party in accordance with the terms hereof.