General Responsibilities; Ownership of Regulatory Approvals. Subject to Section 5.2.4, Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Field in the Territory (including in connection with Patient Information Leaflets, labeling and packaging for the Product in the Field in the Territory) and Licensee shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. For clarity, to the extent allowed by Applicable Laws, all Regulatory Approvals for the Product in the Field in the Territory (other than those related solely to the Manufacture of the Bulk Product and Finished Product, if any, which it is agreed shall be held and owned by Amarin) shall be held and owned by Licensee in its name. In the event that the Applicable Law does not allow Licensee to be the holder of certain Regulatory Approval for the Product in the Territory, 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 UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. such Regulatory Approval shall be held by Amarin in its name with the intent to provide under this Agreement to Licensee the privileges of ownership of such Regulatory Approvals and related Regulatory Materials. In furtherance of the foregoing, (i) to the extent required by Applicable Laws or a Regulatory Authority (which requirement shall be notified in writing by Licensee to Amarin), at Amarin’s cost and expense, or (ii) at the reasonable request of Licensee, at Licensee’s cost and expense, then Amarin or its designee shall attend key meetings with the relevant Regulatory Authorities with respect to obtaining or maintaining the Product Approvals for the Product in the Field in the Territory; provided, that, to the extent the subject matter of such meeting makes it appropriate given the allocation of responsibilities herein (e.g., Amarin’s responsibility for Manufacturing the Bulk Product or the Finished Product), then Amarin or its designee may attend such meeting. Notwithstanding the foregoing, if changes during the Term in the activities performed by Licensee with respect to the Product, or in Applicable Laws, would permit any of the Regulatory Approvals for the Product in the Field in the ...
General Responsibilities; Ownership of Regulatory Approvals. Except with respect to the On-Going Studies, and subject to Section 3.4 and Section 4.4.3, Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Licensed Field (including in connection with Patient Information Leaflets, labeling and packaging for Products) and Licensee shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities. For clarity, to the extent allowed by Applicable Law, all Regulatory Approvals for the Product in the Licensed Field shall be held and owned by Licensee in its name. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
General Responsibilities; Ownership of Regulatory Approvals. Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Field in the Territory (including in connection with Patient Information Leaflets, labeling and packaging for the Product in the Field in the Territory) and Licensee shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. For clarity, to the extent allowed by Applicable Laws, all Regulatory Approvals for the Product in the Field in the Territory shall be held and owned by Licensee in its name.
General Responsibilities; Ownership of Regulatory Approvals. Pfizer shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining such Regulatory Approvals in the Territory (including in connection with PIL’s, labeling and packaging for the Product in the Field in the Territory). Auxilium shall review the materials and provide advice to Pfizer on the proposed strategy and documentation for submission in the Territory and Pfizer shall act in good faith to take such comments into account in preparing the materials. Pfizer shall submit such Regulatory Materials, Regulatory Approval and MAA applications, as applicable, to the applicable Governmental Authorities in the Territory. Auxilium shall cooperate with and provide reasonable assistance to Pfizer in connection with all activities undertaken by Pfizer relating to the obtaining and maintaining of the Regulatory Approvals. To the extent not prohibited by applicable Law, Pfizer and Auxilium shall each be entitled to attend key meetings with the relevant Regulatory Authorities with respect to obtaining or maintaining the Product Approvals for the Product in the Field in the Territory, including oral explanations before the Committee for Human Medicinal Products (“CHMP”) and to participate fully in such meetings. All Regulatory Approvals for the Product in the Territory (other than those related solely to the Manufacture of the Product in the Territory) shall be in the name of Pfizer, and Pfizer shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials. The provisions of this Section 5.2.1 shall be subject to the provisions of Section 5.2.2.
General Responsibilities; Ownership of Regulatory Approvals. Subject to Section 2.5, Licensee or its nominee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Compound (to the extent necessary) and Product (including in connection with Patient Information Leaflets, labeling and packaging for the Product) and Licensee shall, directly or through any of its nominees, submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities.
General Responsibilities; Ownership of Regulatory Approvals. Ono shall use Commercially Reasonable Efforts to obtain Regulatory Approval for Product in the Field in the Territory on the timelines described in the Development Plan. Subject to Section 5.2.5, Ono shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining Regulatory Approvals in the Territory (including in [ ** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. connection with Patient Information Leaflets, and labeling and packaging for Product in the Field in the Territory) and Ono shall submit such Regulatory Materials, Regulatory Approvals and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Approvals for Product in the Territory (other than those related solely to the Manufacture of Product in the Territory, if any) shall be in the name of Ono, and Ono shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials.
General Responsibilities; Ownership of Regulatory Approvals. UroGen shall be responsible for the preparation, submission, and expense for all Regulatory Materials necessary or desirable for obtaining and maintaining Regulatory Approvals for the Combined Product(s) (including Product and UroGen Formulation contained therein to the extent separate Regulatory Approvals are required for them) in the Field in the Territory. All Regulatory Approvals for the Combined Product(s) in the Territory shall be in the name of UroGen or its sublicensees, and UroGen or its sublicensees shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials. At UroGen’s reasonable request, medac shall use Commercially Reasonable Efforts to provide reasonable and timely assistance for information and documents regarding the Product, subject to potential extra costs and expense which are to be borne solely by UroGen. Following UroGen’s reasonable request, Medac shall without undue delay notify UroGen in advance of the estimated extra costs and shall not incur such costs unless approved, in advance and in writing, by UroGen.
General Responsibilities; Ownership of Regulatory Approvals. Licensee shall use Commercially Reasonable Efforts to obtain Regulatory Approval in its name for Licensed Product in the Field in the Territory on the timelines described in the Development Plan. Subject to Section 5.2.2, Licensee shall be responsible for the preparation of all Regulatory Materials necessary or useful for obtaining and maintaining Regulatory Approvals in the Territory (including labeling and packaging for Licensed Product in the Field in the Territory) and Licensee shall submit such Regulatory Materials, Regulatory Approvals and XXXx, as applicable, to the applicable Governmental Authorities in the Territory.
General Responsibilities; Ownership of Regulatory Approvals. Aimmune shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product and Aimmune shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities. For clarity, to the extent allowed by Applicable Law, all Regulatory Approvals for the Product shall be held and owned by Aimmune in its name.
General Responsibilities; Ownership of Regulatory Approvals. Subject to Sections 5.3.2 and 5.3.5, AKP shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Field in the Territory (including in connection with Packaging and Labeling for the Product (including the DCS Product) in the Field in the Territory) and AKP shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. For clarity, to the extent allowed by Applicable Laws, all Regulatory Approvals for the Product in the Field in the Territory shall be held and owned by AKP in its name, provided that the underlying Regulatory Materials and Regulatory Data Controlled by VectivBio (other than pursuant to any licenses granted by AKP to VectivBio under this Agreement), and the global safety database maintained by VectivBio for the Product, are and shall remain the sole property of VectivBio. In furtherance of the foregoing, to the extent permitted by Applicable Laws, if attendance of VectivBio at a meeting with the Regulatory Authority with respect to obtaining or maintaining the Regulatory Approvals for the Product in the Field in the Territory is required by a Regulatory Authority (which requirement shall be notified in writing by AKP to VectivBio) and if AKP requests VectivBio to attend such meeting, VectivBio or its designee shall attend such meeting with the relevant Regulatory Authorities; provided that AKP agrees to reimburse VectivBio for the VectivBio FTE Costs incurred in connection with such attendance, as well as the reasonable Out-of-Pocket Costs incurred by VectivBio in connection with such attendance at such meeting with the relevant Regulatory Authorities.
