Common use of General Responsibilities; Ownership of Regulatory Approvals Clause in Contracts

General Responsibilities; Ownership of Regulatory Approvals. Subject to Section 5.2.5, Actelion 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 Patient Information Leaflets, labeling and packaging for the Finished Product in the Field in the Territory) and Actelion shall submit such Regulatory Materials, Regulatory Approval and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. Auxilium shall provide reasonably necessary and timely assistance to Actelion in connection with all activities undertaken by Actelion relating to the obtaining and maintaining of the Regulatory Approvals. To the extent not prohibited by Laws, Actelion 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 Finished Product in the Field in the Territory. All Regulatory Approvals for the Finished Product in the Territory (other than those related solely to the Manufacture of the Product in the Territory, if any) shall be in the name of Actelion, and Actelion shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials. In furtherance of the foregoing, Auxilium shall assign (and shall cause its Affiliates to assign), and hereby does assign, to Actelion any and all of its right, title and interest in and to the Regulatory Materials for the Finished Product in Canada. 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. The Parties will use their Commercially Reasonable Efforts to transfer any Marketing Authorization Applications or Regulatory Approvals for the Product in the Territory to Sobi within 180 days following the Effective Date. Subject to Section 5.2.5, Actelion Sobi 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 Patient Information Leaflets, labeling and packaging for the Finished Product in the Field and in the Territory) and Actelion Sobi shall submit such Regulatory Materials, Regulatory Approval and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. Auxilium shall provide reasonably necessary and timely assistance to Actelion Sobi in connection with all activities undertaken by Actelion Sobi relating to the obtaining and maintaining of the Regulatory Approvals. To the extent not prohibited by Laws, Actelion Sobi and Auxilium shall each be entitled to to, and upon the reasonable request of the other Party required to, attend key meetings with the relevant Regulatory Authorities with respect to obtaining or maintaining the Product Approvals for the Finished Product in the Field in the Territory. All Regulatory Approvals for the Finished Product in the Territory (other than those related solely to the Manufacture of the Product in the Territory, if any) shall be in the name of ActelionSobi, and Actelion Sobi shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials. In furtherance of the foregoing, Auxilium shall assign (and shall cause its Affiliates to assign), and hereby does assign, to Actelion Sobi any and all of its right, title title, and interest in and to the Regulatory Materials for the Finished Product in Canadathe Territory. 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 5.2.55.2.4, Actelion as between the Parties, (a) Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining such the Regulatory Approvals for the Product in the Field in the Territory (including in connection with Patient Information Leaflets, labeling and packaging for the Finished Product in the Field in the Territory) and Actelion Licensee shall submit such Regulatory Materials, Regulatory Approval and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory and (b) VBL 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 outside of the Territory. Auxilium shall provide reasonably necessary and timely assistance to Actelion , including in the U.S. (including in connection with all activities undertaken by Actelion relating Patient Information Leaflets, labeling and packaging for the Product in the Field outside of the Territory), and VBL shall, or shall cause its affiliates or licensees to, submit such Regulatory Materials, as applicable, to the obtaining and maintaining applicable Governmental Authorities outside of the Territory and maintain such Regulatory ApprovalsApprovals outside of the Territory, including in the U.S., for the Term of this Agreement. To For clarity, to the extent not prohibited allowed by Applicable Laws, Actelion all Regulatory Approvals for the Product in the Field in the Territory (other than those related solely to the Manufacture of the Finished Product, if any, which it is agreed shall be held and Auxilium owned by VBL) shall each be entitled 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 Approvals for the Product in the Territory, such Regulatory Approval shall be held by VBL in its name with the intent to provide under this Agreement to Licensee the privileges of ownership of (and related usage rights for) 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 VBL), or (ii) at the reasonable request of Licensee, then VBL or its designee shall attend key meetings with the relevant Regulatory Authorities with respect to obtaining or maintaining the Product Regulatory Approvals for the Finished Product in the Field in the Territory. All Regulatory Approvals for the Finished Product in the Territory (other than those related solely , at Licensee’s cost and expense; provided, that, to the Manufacture extent the subject matter of such meeting makes it appropriate given the Product in allocation of responsibilities herein (e.g., VBL’s responsibility for Manufacturing the Territory, if any) shall be in the name of Actelion, and Actelion shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials. In furtherance of the foregoing, Auxilium shall assign (and shall cause its Affiliates to assignProduct), then VBL or its designee may attend such meeting at VBL’s cost and hereby does assign, to Actelion any and all of its right, title and interest in and to the Regulatory Materials for the Finished Product in Canadaexpense. The provisions of this Section 5.2.1 shall be subject to the provisions of Section 5.2.2CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934,AS AMENDED.

General Responsibilities; Ownership of Regulatory Approvals. Subject to Section 5.2.5, Actelion Asahi 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 Patient Information Leaflets, labeling and packaging for the Finished Product in the Field in the Territory) and Actelion Asahi shall submit such Regulatory Materials, Regulatory Approval and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. Auxilium shall provide reasonably necessary and timely reasonable assistance to Actelion Asahi in connection with all activities undertaken by Actelion Asahi relating to the obtaining and maintaining of the Regulatory Approvals. To the extent not prohibited by Laws, Actelion and Auxilium shall each be entitled to attend attend, at its cost and expense, key meetings as an observer with the relevant Regulatory Authorities with respect to obtaining or maintaining the Product Approvals for the Finished Product in the Field in the Territory; provided that, for clarity, to the extent that a Regulatory Authority, or Laws, so requires, or the subject matter of such meeting makes it appropriate given the allocation of responsibilities herein (e.g., Auxilium’s responsibility for Manufacturing the Product), then Auxilium’s role shall not be limited to that of an observer and Auxilium shall be allowed to actively participate in such meeting. All Regulatory Approvals for the Finished Product in the Territory (other than those related solely to the Manufacture of the Product in the TerritoryProduct, if any) shall be in the name of ActelionAsahi, and Actelion Asahi shall own all right, title and interest in and to all such Regulatory Approvals and all related Regulatory Materials. In furtherance of the foregoing, Auxilium shall assign (and shall cause its Affiliates to assign), and hereby does assign, to Actelion any and all of its right, title and interest in and to the Regulatory Materials for the Finished Product in Canada. The provisions of this Section 5.2.1 shall be subject to the provisions of Section 5.2.2. The Parties acknowledge and agree that as of the Effective Date Asahi intends to pursue an “orphan drug” designation for the Product for the indications of Dupuytren’s Contracture and Peyronie’s Disease in the Territory.

General Responsibilities; Ownership of Regulatory Approvals. Subject to Section 5.2.55.2.4, Actelion Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining such the Regulatory Approvals for the Product in the Field in the Territory (including in connection with Patient Information Leaflets, labeling and packaging for the Finished Product in the Field in the Territory) and Actelion Licensee shall submit such Regulatory Materials, Regulatory Approval and MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. Auxilium shall provide reasonably necessary and timely assistance to Actelion in connection with all activities undertaken by Actelion relating For clarity, to the obtaining and maintaining 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 ApprovalsApproval for the Product in the Territory, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. To 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 not prohibited required by LawsApplicable Laws or a Regulatory Authority (which requirement shall be notified in writing by Licensee to Amarin), Actelion at Amarin’s cost and Auxilium expense, or (ii) at the reasonable request of Licensee, at Licensee’s cost and expense, then Amarin or its designee shall each be entitled to attend key meetings with the relevant Regulatory Authorities with respect to obtaining or maintaining the Product Approvals for the Finished 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. All 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 Finished Product in the Territory (other than those related solely to the Manufacture of the Product Field in the TerritoryTerritory to be held by, if any) shall be and in the name of Actelionof, and Actelion Licensee, then Amarin shall own all right, title and interest in and to all transfer any such Regulatory Approvals and all related Regulatory Materials. In furtherance of the foregoing, Auxilium shall assign (and shall cause its Affiliates to assign), and hereby does assign, to Actelion any and all of its right, title and interest in and to the Regulatory Materials for the Finished Product in Canada. The provisions of this Section 5.2.1 shall be subject to the provisions of Section 5.2.2Licensee.