Regulatory Responsibilities. A. Marketing Authorization Applications and Regulatory Approvals – RADIUS, itself or through its Affiliates or (sub)licensees, will be responsible for preparing and submitting all Regulatory Filings, including but not limited to providing any clinical data to be submitted in the XXXx. 3M will perform all activities to support the CMC section of the Regulatory Filings, and will submit all CMC data required for the Regulatory Filings in DMFs or MAFs. All XXXx, Regulatory Filings and Regulatory Approvals in the Territory shall be owned by RADIUS, its Affiliates or (sub)licensees, and remain with RADIUS, its Affiliates or (sub)licensees. Nothing in this Agreement should be construed as transferring ownership of XXXx, Regulatory Filings or Regulatory Approvals to 3M. All 3M DMFs and MAFs referenced in the XXXx, Regulatory Filings and Regulatory Approvals shall be owned by 3M, and nothing is this Agreement should be construed as transferring ownership of such DMFs and MAFs at any time to RADIUS, its Affiliates or (sub)licensees. 3M shall grant and hereby does grant to RADIUS an exclusive (solely as to the Product and in the case of Applicator, solely for use with Product), “Right of reference or use,” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous law recognized outside of the U.S.), with the right to grant further Rights of reference or use to its (sub)licensees and Affiliates through multiple tiers to all such DMFs and MAFs owned or controlled by 3M. The right granted in the previous sentence shall be for use with the Product, does not include any rights except as relates to the Product, and is subject to the provisions of Section 6.8 of this Agreement; for avoidance of doubt, the right granted in the previous sentence specifically excludes any right in such DMFs or MAFs with respect to or for use with anything other than Product. Other than as provided above, 3M specifically reserves all other rights in all DMFs and MAFs for all other purposes, including without limitation the “Right of reference or use” for any product. 3M will provide to RADIUS, its Affiliates or its (sub)licensees and to any specified Regulatory Authority a letter of authorization, or other such executed instrument as may be necessary under, or as RADIUS, its Affiliates or its (sub)licensees may reasonably request, to effectuate the rights of reference or use to all such DMFs and MAFs, contemplated in this Section 4.4A in order to obtain, maintain suppo...
Regulatory Responsibilities. Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Products including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material *Confidential Treatment Requested. correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.
Regulatory Responsibilities. Unless otherwise agreed between the Parties:
Regulatory Responsibilities. Each Development Plan shall set forth the regulatory strategy for seeking Regulatory Approval of the applicable Product in the Territory. ARES TRADING shall be solely responsible for the preparation and submission of any and all Regulatory Materials for the Products in the Field in the Territory and shall own all such Regulatory Materials.
Regulatory Responsibilities. 6.6.1 From and after the Closing, subject to the terms of the Transition Services Agreement and except as required by a Party to comply with applicable Law or to exercise its rights and obligations hereunder or under any other Ancillary Agreement, Purchaser shall have the sole right and responsibility for preparing, obtaining and maintaining all Regulatory Approvals necessary for the Product Business, and for conducting communications with Governmental Authorities of competent jurisdiction, for Seller Products. Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchaser’s own Product labeling and shall comply with such FDA approvals upon receipt thereof.
Regulatory Responsibilities. The Parties’ respective rights and obligations with respect to Regulatory Approvals in the Purchaser Territory, communications with Regulatory Authorities in the Purchaser Territory, and other regulatory matters relating to the Product in the Purchaser Territory are set forth in the License Agreement.
Regulatory Responsibilities. As between the Parties, AxxxXxxx shall have the exclusive right and sole responsibility and decision-making authority, to prepare, file, seek and maintain all regulatory materials necessary for the Development and Commercialization of any Compound or Product in the Field in the Territory, and to interact with Regulatory Authorities in connection therewith. Without limiting the foregoing, ArriVent will, as between the Parties, be solely responsible for all regulatory matters relating to any Compound or Product, including (a) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to any Compound or Product; and (b) interfacing, corresponding and meeting with each Regulatory Authority with respect to any Compound or Product. Aarvik shall, at ArriVent’s cost, provide reasonable assistance to ArriVent in connection with the regulatory matters related to any Compound or Product upon ArriVent’s request. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Regulatory Responsibilities. 6.1.1 Hana shall use its Commercially Reasonable Efforts to ensure that none of its Representatives who participate in any Development activities:
Regulatory Responsibilities. (a) From and after the date hereof, Distributor shall assume (subject to Section 6(f) and Section 7(b)) at Distributor’s expense all responsibilities for the PMA application and program, and for other similar Territory regulatory approvals, for the pre-filled saline Breast Implant. Additionally, Distributor shall assume general management responsibilities for the explant investigation program.
Regulatory Responsibilities. Subject to the terms and conditions of this Agreement, Licensee shall conduct all regulatory activities related to Development and Commercialization activities in its own or the Designated Parties’ name for Licensor, including the preparation of Regulatory Materials and communications and interactions with Regulatory Authorities in the Territory with respect to the same. Licensee shall be responsible for all of its costs and expenses in connection with obtaining and maintaining Regulatory Approvals for Products in the Territory.
