Regulatory Lead. 20 5.3 RESPONSIBILITIES AND RIGHTS OF REGULATORY LEAS ................ 20 5.4 RIGHT TO CROSS-REFERENCE IND AND EQUIVALENT FOREIGN FILINGS ... 21 5.5
Regulatory Lead. ViaCell shall be responsible for all regulatory matters for Cell Therapy Products and Amgen shall be responsible for all regulatory matters for Collaboration Products and each shall be referred to as the "Regulatory Lead" therefor. Regulatory matters shall include, without limitation, the filing and support of any Drug Approval Applications and matters concerning Post-Approval Clinical Studies.
Regulatory Lead. BeiGene shall be the regulatory lead for all Products in the Collaboration Territory and ensure alignment with Amgen’s global strategy with respect to the applicable Product and Amgen shall be the regulatory lead for all Products in the ROW (each of BeiGene and Amgen in such capacity, the “Regulatory Lead” and the other Party, the “Non-Regulatory Lead”). Amgen shall be the Marketing Authorization Holder for all Products in the Collaboration Territory. BeiGene shall be the local legal representative of Amgen for all Products in the Collaboration Territory and BeiGene shall be the main point of contact for the regulatory relationship and communications with Regulatory Authorities within the Collaboration Territory. The nature and objectives of each communication with Regulatory Authorities shall be consistent with the Global Development Plan and Amgen’s manufacturing specifications. Each Party will use Commercially Reasonable Efforts to conduct the activities assigned to it pursuant to the foregoing. BeiGene shall organize and attend meetings with Regulatory Authorities solely with respect to the Products and Development thereof in the Collaboration Territory to identify and review issues as set forth in Section 3.2.5 (Regulatory Meetings). In order to meet Amgen’s requirements for data security, standardization, integrity and compatibility, all activities of BeiGene to generate, review and compile regulatory submissions for the Products will be conducted using Amgen systems, processes and policies, including quality and compliance systems, standard operating procedures, processes and policies, unless otherwise mutually agreed.
Regulatory Lead. Licensor (or its designee) shall be the holder of all Regulatory Filings and Regulatory Approvals for Licensed Products in the Field in the Territory, and Licensee shall be the local legal representative of Licensor (or Licensor’s designee) for all regulatory matters with respect to the Licensed Products in the Field in the Territory; provided that, if Applicable Laws in the Territory allow Licensee to hold such Regulatory Approvals and Regulatory Filings for the Licensed Product in the Territory and such transfer would be mutually beneficial, the Parties shall discuss in good faith (but shall have no obligation to enter into) an amendment to this Agreement providing for the transfer of such Regulatory Approvals and Regulatory Filings to Licensee. Licensee shall be the main point of contact for the regulatory relationship and communication with Regulatory Authorities within the Territory, and shall be responsible, at Licensee’s sole expense (including payment of all filing fees and all other associated costs), for making Regulatory Filings, and obtaining and maintaining Regulatory Approvals for Licensed Products in the Field in Territory, in accordance with this Agreement and the applicable Development Plan.
Regulatory Lead. Licensee shall be the Regulatory Lead with respect to any Drug Approval Applications and other Regulatory Approvals for the Licensed Product (which, for clarity, does not include filings of or with respect to INDs and other filings with respect to the Development of the Licensed Product, which shall be the responsibility of the applicable Development Lead) in the Licensee Territory. GPC Biotech shall be the Regulatory Lead with respect to any Drug Approval Applications or Regulatory Approvals for the Licensed Product (which, for clarity, does not include filings of or with respect to INDs and other filings with respect to the Development of the Licensed Product, which shall be the responsibility of the applicable Development Lead) in the GPC Biotech Territory.
Regulatory Lead. Effective from and after the Option Exercise Date for a given Optioned Product (and any Optioned Biologic therein) on an Indication-by-Indication and jurisdiction-by-jurisdiction basis: (a) Denali shall be the Regulatory Lead until the commencement of regulatory activities related to the Late Stage Development Activities with respect to such Optioned Product (or, if earlier, Denali’s exercise of the Denali Worldwide Royalty Option with respect to the applicable Collaboration Program); (b) Takeda shall be the Regulatory Lead beginning on commencement of regulatory activities related to the Late Stage Development Activities for such Optioned Product [***]; and (c) on a jurisdiction-by-jurisdiction basis, the Commercial Lead shall be the Regulatory Lead [***].
Regulatory Lead. The Parties will develop and agree, through the Core Team, to a detailed regulatory plan for each Co-Co Product in or for the Co-Co Territory (the “Regulatory Plan”), which Regulatory Plan will be deemed to form part of the Development Plan. Subject to Sections 2.2(a) and 2.2(h) and unless otherwise agreed by the Core Team, Allergan will be responsible, on a country-by-country basis, for submitting Regulatory Filings to the respective Regulatory Authority with regard to each Co-Co Product for the purpose of filing, maintaining and operating Regulatory Approval, including pharmacovigilance and safety reporting for each Co-Co Product and the natural history study of LCA10 patients. Allergan shall provide Editas a meaningful opportunity to review and comment on, and Allergan shall in good faith consider incorporating such comments into, any such Regulatory Filings in the Co-Co Territory. Allergan shall use reasonable efforts to provide Editas with copies of minutes from any meetings with Regulatory Authorities with respect to each Co-Co Product, and filings submitted to, and correspondence with, the applicable Regulatory Authorities with respect to each Co-Co Product; provided, however, that Allergan shall only be required to provide Editas with copies of such minutes, filings and correspondence in the Licensee Territory to the extent they are material.
Regulatory Lead. The Development Lead (Hyseq) shall be responsible for all regulatory matters for Development, i.e., concerning each indication for a Collaboration Product prior to the Transition Date for such Collaboration Product in such indication. On an indication-by-indication basis, the Commercial Lead (as determined pursuant to Sections 5.1 and 5.8) shall be responsible for all regulatory matters for Commercialization, i.e., concerning each indication for a Collaboration Product upon the Transition Date for such Collaboration Product in each such indication including, without limitation, the filing and support of any Drug Approval Applications and matters concerning Post-Approval Clinical Studies. Each Party having responsibility for regulatory matters during the time periods (pre- and post-Transition Date) as set forth in this Section 4.1 shall be designated as the "Regulatory Lead" for such regulatory matters during such time periods.
Regulatory Lead. Except as set forth in the applicable Development Plan, Alnylam shall be the “Regulatory Lead” with respect to ALN-HBV and ALN-HBV02 until [***], and Vir shall be the Regulatory Lead thereafter. Except as set forth in the applicable Development Plan, Alnylam shall be the Regulatory Lead with respect to each RNAi Product in an ID Program until [***], at which point Vir shall be the Regulatory Lead for such ID Program.
Regulatory Lead. On a jurisdiction-by-jurisdiction basis for a Licensed Product: (a) Denali shall be the Regulatory Lead with respect to regulatory matters and interactions related to the Denali Development Activities with respect to such Licensed Product; and (b) Biogen shall be the Regulatory Lead with respect to regulatory matters and interactions related to the Biogen Development Activities [***] and all Commercialization activities for such Licensed Product, including filing, in its own name or the name of its designee, all XXXx for the Licensed Products throughout the Territory (subject to Section 3.1.4(d) (Performance of Independent Study)). [***]
