Common use of Preparation of Regulatory Filings Clause in Contracts

Preparation of Regulatory Filings. Each Party, at such Party’s sole cost and expense unless otherwise provided for herein, shall be responsible for preparing, filing, and maintaining, and shall own, the regulatory filings relating to the Product as set forth below: (a) At its expense, Nektar shall use Commercially Reasonable Efforts to prepare and maintain DMFs covering the Device, and Nektar shall own any such DMFs. Nektar shall also use Commercially Reasonable Efforts to prepare and maintain DMFs covering Formulated Amikacin and the Product; provided, however, that the Party conducting Manufacturing for Commercialization of the Formulated Amikacin and Product shall own and maintain any such DMFs, it being understood and agreed that during the term hereof, such Manufacture of Formulated Amikacin and Product may be conducted by Bayer. During the term of this Agreement, Nektar grants to Bayer and its Sublicensees a right of reference to the DMFs for the Device owned by Nektar to the extent necessary for, and for the purposes of, preparing, filing or maintaining INDs, NDAs, XXXx and other regulatory filings relating to the Product in the Shared Territory or the Royalty Territory, including without limitation CMC Data. Nektar shall share with Bayer relevant CMC Data (redacted, if deemed necessary in Nektar’s reasonable opinion) portions of such DMFs, with the right to inspect, upon Bayer’s request. The Party that owns a DMF shall be responsible for all interactions with Regulatory Authorities relating to such DMF. The foregoing notwithstanding, all Information required by Bayer for regulatory filings will be provided to Bayer by Nektar for all countries where such filings are required. (b) At its expense, Bayer, its Affiliates and its Sublicensees shall use Commercially Reasonable Efforts to prepare, obtain and maintain all regulatory dossiers and Regulatory Approvals covering the Product in the Territory, and shall provide Nektar, [***], with a copy of all documents included in such regulatory dossiers and Regulatory Approvals. Except as provided in Section 5.2(a), Bayer or its designee shall be the owner of all such filings and shall be responsible for all interactions with Regulatory Authorities relating thereto; provided, however, that at all times during the term hereof, Nektar shall have the opportunity to participate in all meetings and other communications with Regulatory Authorities relating to the Product, [***]. In addition to Bayer’s other obligations under this Section 5.2(b), Bayer shall keep Nektar informed, on a regular basis (but no less frequently than quarterly) of regulatory filings related to the Product. (c) During the term of this Agreement, Bayer grants to Nektar a right of reference (including, without limitation, the right to inspect) to the CMC Data pertaining to the Product or for Nektar’s use in applications within the Field that do not conflict with Nektar’s covenants set forth in Section 2.5.

Preparation of Regulatory Filings. Each Party, at such Party’s sole cost and expense unless otherwise provided for herein, shall be The Parties are responsible for preparing, filing, and maintaining, and shall own, the regulatory filings DMFs, Regulatory Applications and Regulatory Approvals relating to the Product Intermediates and Products as set forth below:. (a) At its expense, Nektar EIFFEL shall use Commercially Reasonable Efforts to prepare and maintain DMFs assist in the preparation of any DMF covering the Device, methods and Nektar shall own any such DMFs. Nektar shall also use Commercially Reasonable Efforts to prepare and maintain DMFs covering Formulated Amikacin and processes used in the Product; provided, however, that the Party conducting Manufacturing for Commercialization production of the Formulated Amikacin Product Intermediates using the EIFFEL Intellectual Property but at the cost of MAP with EIFFEL personnel being made available on the basis of charges at the rate of [ * ]. Any DMFs relating to manufacture of the Product Intermediate shall be processed by and at all times held in MAP’s name. For clarity, EIFFEL shall be responsible for creating any DMF relating to a Product Intermediate and MAP shall own and maintain be responsible for maintaining any such DMFs, it being understood and agreed that during the term hereof, such Manufacture of Formulated Amikacin and DMF relating to a Product may be conducted by Bayer. During Intermediate throughout the term of this Agreement, Nektar grants to Bayer . MAP shall own any DMFs covering the Formulations and its Sublicensees a right of reference to the Products should such DMFs for the Device owned by Nektar to the extent necessary for, and for the purposes of, preparing, filing or maintaining INDs, NDAs, XXXx and other regulatory filings be required. Any DMFs relating to the Product in the Shared Territory Formulations or the Royalty Territory, including without limitation CMC DataProducts shall be processed and maintained by MAP and shall be at all times held in MAP’s name. Nektar shall share with Bayer relevant CMC Data (redacted, if deemed necessary in Nektar’s reasonable opinion) portions of such DMFs, with the right to inspect, upon Bayer’s request. The Party that owns a DMF MAP shall be responsible for all interactions with Regulatory Authorities relating to creating and maintaining such DMF. The foregoing notwithstanding, all Information required by Bayer for regulatory filings will be provided to Bayer by Nektar for all countries where such filings are requiredDMFs throughout the term of this Agreement. (b) At its expense, Bayer, its Affiliates MAP shall be responsible for filing and its Sublicensees shall use Commercially Reasonable Efforts to prepare, obtain and maintain maintaining all regulatory dossiers Regulatory Applications and Regulatory Approvals covering with the FDA or any other Regulatory Health Authority whose approval is necessary to market the Product in such countries unless this right is transferred to a sublicensee. MAP, or its sublicensee, shall have sole control over all aspects of the Territory, filing and shall provide Nektar, [***], with a copy maintenance of all documents included in such regulatory dossiers Regulatory Applications and Regulatory Approvals. Except as provided in Section 5.2(a), Bayer or its designee MAP shall be the owner of own all such filings Regulatory Applications filed by MAP and shall be responsible for all interactions with Regulatory Authorities relating thereto; provided, however, that at all times during the term hereof, Nektar shall have the opportunity Approvals obtained pursuant to participate in all meetings and other communications with Regulatory Authorities relating to the Product, [***]. In addition to Bayer’s other obligations under this Section 5.2(b), Bayer shall keep Nektar informed, on a regular basis (but no less frequently than quarterly) of regulatory filings related to the Product. (c) During the term of this Agreement, Bayer grants to Nektar a right of reference (including, without limitation, the right to inspect) to the CMC Data pertaining to the Product or for Nektar’s use in applications within the Field that do not conflict with Nektar’s covenants set forth in Section 2.5.

Preparation of Regulatory Filings. Each (a) The Parties will develop and agree to a detailed regulatory plan for the Product in or for the Territory (the “Regulatory Plan”), which Regulatory Plan, once mutually agreed by the Parties, will be deemed to form part of the Development Plan. Unless otherwise provided in the Development Plan, each Party, at such Party’s sole cost and expense unless otherwise provided for hereinin this Agreement, shall will be responsible for preparing, filing, and maintaining, and shall will own, the regulatory filings relating to the Product as set forth below: in Section 5.2(b). (ab) At Until the date of Initial BLA Approval, Fibrocell or its expense, Nektar shall use Commercially Reasonable Efforts to prepare and maintain DMFs covering the Device, and Nektar shall own any such DMFs. Nektar shall also use Commercially Reasonable Efforts to prepare and maintain DMFs covering Formulated Amikacin and the Product; provided, however, that the Party conducting Manufacturing for Commercialization of the Formulated Amikacin and Product shall own and maintain any such DMFs, it being understood and agreed that during the term hereof, such Manufacture of Formulated Amikacin and Product may be conducted by Bayer. During the term of this Agreement, Nektar grants to Bayer and its Sublicensees a right of reference to the DMFs for the Device owned by Nektar to the extent necessary for, and for the purposes of, preparing, filing or maintaining INDs, NDAs, XXXx and other regulatory filings relating to the Product in the Shared Territory or the Royalty Territory, including without limitation CMC Data. Nektar shall share with Bayer relevant CMC Data (redacted, if deemed necessary in Nektar’s reasonable opinion) portions of such DMFs, with the right to inspect, upon Bayer’s request. The Party that owns a DMF shall designee will be responsible for all interactions with Regulatory Authorities relating to such DMF. The foregoing notwithstanding, all Information required by Bayer for and will submit regulatory filings will be provided to Bayer by Nektar the respective Regulatory Authority with regard to the Product for all countries where such filings are required. (b) At its expensethe purpose of filing, Bayerobtaining and maintaining Regulatory Approval thereof, its Affiliates and its Sublicensees shall use Commercially Reasonable Efforts to prepare, obtain and maintain all regulatory dossiers and Regulatory Approvals covering the Product in the Territory, . CCP or its designee will be responsible for such interactions and shall filings thereafter. Fibrocell will provide Nektar, [***], CCP with a copy of all regulatory filings, correspondence with and minutes of meetings with Regulatory Authorities, documents included in such regulatory dossiers and Regulatory Approvals. Except as provided in Section 5.2(a), Bayer or its designee shall be the owner of all such filings and shall be responsible for all interactions with Regulatory Authorities relating thereto; provided, however, that at At all times during the term hereofof this Agreement, Nektar shall (i) Fibrocell will keep CCP informed of all regulatory filings for the Product and will provide CCP a meaningful opportunity to review and comment on those filings prior to submission thereof, and Fibrocell will in good faith consider incorporating such comments into, any such regulatory filings in the Territory; and (ii) CCP will have the opportunity opportunity, unless such Regulatory Authorities object, to participate in all meetings and other communications with Regulatory Authorities relating to the Product, [***]. In addition to Bayer’s other obligations under this Section 5.2(b), Bayer shall keep Nektar informed, on a regular basis (but no less frequently than quarterly) of regulatory filings related to the Product. (c) During the term of this Agreement, Bayer grants to Nektar a right of reference (including, without limitation, the right to inspect) to the CMC Data pertaining to the Product or for Nektar’s use in applications within the Field that do not conflict with Nektar’s covenants set forth in Section 2.5.20 US-DOCS\106669270.9