Common use of Reference Rights Clause in Contracts

Reference Rights. (a) Subject to Section 4.03(f), each Party hereby grants to the other Party (and their respective sublicensees or designees) a right of reference to Regulatory Filings owned or controlled by such Party as reasonably necessary to support the other Party’s Regulatory Filings made for the following purposes: (1) for MYLAN to Develop, manufacture and Commercialize Licensed Products in the Field in the Territory in accordance with this Agreement, including conducting any bridge programs to support a change in manufacturer and (2) for THERAVANCE to (w) Develop Licensed Products in the Field in the Territory in accordance with this Agreement, (x) file the initial NDA to Commercialize the first Licensed Products in the Field in the U.S. in accordance with this Agreement, (y) Commercialize Licensed Product in the Field in the U.S. under the Co-Promotion Agreement, and (z) Develop, manufacture and Commercialize Licensed ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Products (i) in the Field in China and the Reverted Countries and (ii) outside of the Field worldwide. Such rights of reference may include: i. the right for MYLAN to reference any and all drug master files (DMFs) referenced in the NDA for the Licensed Product in the Field in the Territory that is filed by THERAVANCE. THERAVANCE will enable right of reference to any and all such DMFs held by its contract manufacturer(s) which are relevant to Licensed Product to the extent that MYLAN elects to continue using such manufacturer for the Development or Commercialization of the Licensed Products in the Field in the Territory or as necessary to bridge to a new manufacturer. Such rights shall apply to DMFs relevant to API Compound and formulated Licensed Product, together with all updates to each of the foregoing; and ii. the right to reference any and all trial master files (TMFs) that are relevant to Licensed Products held by each Party or any of its contract research organization(s), together with all updates to each of the foregoing. (b) For clarity, the rights of reference set forth in Section 7.03(a)(2)(z) shall be subject to THERVANCE’s reimbursement obligations under Section 4.03(f)(ii), and all rights of reference set forth in Section 7.03(a)(2) shall be subject to the limitations set forth in Section 4.03(f)(iii). (c) Each Party granting a right of reference pursuant to this Section 7.03 shall file any notices or authorizations with Regulatory Authorities that are necessary to effect the foregoing rights of reference, at the request and expense of the other Party.

Reference Rights. (a) Subject to Section 4.03(f), each Party hereby grants to the other Party (and their respective sublicensees or designees) a right of reference to Regulatory Filings owned or controlled by such Party as reasonably necessary to support the other Party’s 's Regulatory Filings made for the following purposes: (1) for MYLAN to Develop, manufacture and Commercialize Licensed Products in the Field in the Territory in accordance with this Agreement, including conducting any bridge programs to support a change in manufacturer and (2) for THERAVANCE to (w) Develop Licensed Products in the Field in the Territory in accordance with this Agreement, (x) file the initial NDA to Commercialize the first Licensed Products in the Field in the U.S. in accordance with this Agreement, (y) Commercialize Licensed Product in the Field in the U.S. under the Co-Promotion Agreement, and (z) Develop, manufacture and Commercialize Licensed ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ​ Products (i) in the Field in China and the Reverted Countries and (ii) outside of the Field worldwide. Such rights of reference may include: i. the right for MYLAN to reference any and all drug master files (DMFs) referenced in the NDA for the Licensed Product in the Field in the Territory that is filed by THERAVANCE. THERAVANCE will enable right of reference to any and all such DMFs held by its contract manufacturer(s) which are relevant to Licensed Product to the extent that MYLAN elects to continue using such manufacturer for the Development or Commercialization of the Licensed Products in the Field in the Territory or as necessary to bridge to a new manufacturer. Such rights shall apply to DMFs relevant to API Compound and formulated Licensed Product, together with all updates to each of the foregoing; and ii. the right to reference any and all trial master files (TMFs) that are relevant to Licensed Products held by each Party or any of its contract research organization(s), together with all updates to each of the foregoing. (b) For clarity, the rights of reference set forth in Section 7.03(a)(2)(z) shall be subject to THERVANCE’s 's reimbursement obligations under Section 4.03(f)(ii), and all rights of reference set forth in Section 7.03(a)(2) shall be subject to the limitations set forth in Section 4.03(f)(iii). (c) Each Party granting a right of reference pursuant to this Section 7.03 shall file any notices or authorizations with Regulatory Authorities that are necessary to effect the foregoing rights of reference, at the request and expense of the other Party.