Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. 5.1.1. For the avoidance of doubt, ViroPharma’s rights under the licenses granted in Section 2.1 include the exclusive right to: (a) obtain orphan drug designation for Licensed Products from the FDA in accordance with 21 CFR 316 and from the applicable foreign Regulatory Authority in accordance with the applicable requirements administered by such Regulatory Authority, (b) implement Clinical Trials and related Development activities that are conducted in support of Regulatory Authorizations for Licensed Products or Commercialization of Licensed Products, (c) obtain and maintain Regulatory Authorizations for the Licensed Products in the Field in the Territory, including all regulatory filings and applications for relevant Regulatory Authorizations, and (d) prepare and deliver other communications with Regulatory Authorities in regard to the Development and Commercialization of Licensed Products in the Field in the Territory, including (i) all correspondence submitted to Regulatory Authorities related to the design, conduct or results of non-clinical trials and Clinical Trials for Licensed Products, (ii) all correspondence submitted to Regulatory Authorities related to the Manufacture of Licensed Products, (iii) all pricing and reimbursement approval proceedings relating to the Exploitation of any Licensed Product, (iv) all drug naming approval proceedings, and (v) all proposed Labeling; provided, however, that the foregoing list of rights does not constitute, and shall not be deemed to constitute, independent obligations of ViroPharma, it being acknowledged and agreed that ViroPharma’s obligations with respect to the Development and Commercialization of Licensed Products are set forth, in their entirety, in Sections 3.1 and 4.1. 5.1.2. Subject to Article 12, all Regulatory Authorizations and related submissions relating to Licensed Products in the Field in the Territory shall be the property of ViroPharma and held in the name of ViroPharma.

Regulatory Responsibilities. 5.1.1. For Subject to the avoidance of doubtDevelopment Plan, ViroPharma’s rights under as between the licenses granted in Section 2.1 include the exclusive right toParties, Salix shall have sole responsibility and authority for: (a) obtain orphan drug designation for Licensed Products from the FDA in accordance with 21 CFR 316 and from the applicable foreign Regulatory Authority in accordance with the applicable requirements administered by such Regulatory Authority, (b) implement implementation of Clinical Trials and related Development activities that are conducted in support of Regulatory Authorizations for the Licensed Products Product or Commercialization of the Licensed ProductsProduct, in both cases in the Field in the Territory (and expressly excluding, for the avoidance of doubt, such Clinical Trials and related Development activities as may be conducted by Lupin outside the Territory or in the Territory outside the Field), (cb) obtain obtaining and maintain maintaining Regulatory Authorizations for the Licensed Products Product in the Field in the Territory, including all regulatory filings and applications for relevant Regulatory Authorizations, and (dc) prepare and deliver other communications with Regulatory Authorities in regard to the Development and Commercialization of the Licensed Products Product in the Field in the Territory, including (i) all correspondence submitted to Regulatory Authorities related to the design, conduct or results of non-clinical trials and trials, Clinical Trials and Post Approval Studies for the Licensed ProductsProduct, (ii) except as otherwise contemplated by this Agreement, the API Supply Agreement, or the Finished Product Supply Agreement, all correspondence submitted to Regulatory Authorities related to the Manufacture of the Licensed ProductsProduct, (iii) all pricing and reimbursement approval proceedings relating to the Exploitation of any the Licensed Product, (iv) all drug naming approval proceedings, and (v) all proposed Product Labeling; provided, however, that . Nothing in this Section 5.1.1 shall limit Lupin’s authority and responsibility as set forth in the foregoing list API Supply Agreement and the Finished Product Supply Agreement over the Manufacture of rights does not constitute, and shall not be deemed to constitute, independent obligations of ViroPharma, it being acknowledged and agreed that ViroPharma’s obligations with respect to the Development and Commercialization of Licensed Products are set forth, in their entirety, in Sections 3.1 and 4.1Product. 5.1.2. Subject to Article 1213, all Regulatory Authorizations and related submissions relating to the Licensed Products Product in the Field in the Territory shall be the property of ViroPharma Salix and held in the name of ViroPharmaSalix; provided that, except as may be otherwise required by Applicable Law or in respect of any Regulatory Authorization relating to the Licensed Product in the Field in the Territory, any Regulatory Documentation in support of Lupin’s Manufacture of the Licensed Product (including any Lupin U.S. DMF) shall be the property of Lupin and held in the name of Lupin.

Regulatory Responsibilities. 5.1.1. For (i) As between the avoidance of doubtParties, ViroPharma’s rights under the licenses granted in Section 2.1 include the exclusive right to: Licensee shall have sole responsibility for preparing and maintaining all Regulatory Documentation with respect to (a) obtain orphan drug designation Regulatory Approvals, including Drug Approval Applications, for the Licensed Products from Product in the FDA in accordance with 21 CFR 316 Territory and from the applicable foreign Regulatory Authority in accordance with the applicable requirements administered by such Regulatory Authority, (b) implement Clinical Trials and related Development activities for the Licensed Product that are conducted in support of Regulatory Authorizations Approvals for the Licensed Products Product or Commercialization of Licensed Products, (c) obtain and maintain Regulatory Authorizations for the Licensed Products in the Field Product in the Territory, including all regulatory filings and applications for relevant Regulatory Authorizations, and . Licensee will notify CanBas seven (d7) prepare and deliver Business Days in advance (as a general rule) of any meetings with the FDA or any other communications with Regulatory Authorities in regard to the Development and Commercialization of Licensed Products in the Field in the Territory, including (i) all correspondence submitted to Regulatory Authorities regulators related to the designforegoing and CanBas shall have the right to participate in its sole discretion but solely as an observer. Subject to ARTICLE XIV, conduct or results of non-clinical trials all Regulatory Approvals and Clinical Trials for Licensed Products, (ii) all correspondence submitted to related Regulatory Authorities related to Documentation within the Manufacture of Licensed Products, (iii) all pricing and reimbursement approval proceedings Territory relating to the Exploitation of any Licensed Product, (iv) all drug naming approval proceedings, and (v) all proposed Labeling; provided, however, that the foregoing list of rights does not constitute, and shall not be deemed to constitute, independent obligations of ViroPharma, it being acknowledged and agreed that ViroPharma’s obligations with respect to the Development and Commercialization of Licensed Products are set forth, in their entirety, in Sections 3.1 and 4.1. 5.1.2. Subject to Article 12, all Regulatory Authorizations and related submissions relating to Licensed Products in the Field in the Territory Product shall be the sole property of ViroPharma Licensee and held in the name of ViroPharmaLicensee (or in each such case Licensee’s Affiliate or Sublicensee). (ii) As between the Parties, CanBas shall have sole responsibility for preparing and maintaining all Regulatory Documentation with respect to (a) Regulatory Approvals, including Drug Approval Applications, for the Licensed Product outside the Territory and (b) Development activities for the Licensed Product that are conducted in support of Regulatory Approvals for the Licensed Product or Commercialization of the Licensed Product outside the Territory. CanBas will notify Licensee seven (7) Business Days in advance (as a general rule) of any meetings with the Regulatory Authorities related to the foregoing and Licensee shall have the right to participate in its sole discretion but solely as an observer. Subject to ARTICLE XIV, all Regulatory Approvals and related Regulatory Documentation outside the Territory relating to the Licensed Product shall be the sole property of CanBas and held in the name of CanBas (or in each such case CanBas’s Affiliate or Sublicensee).