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Common use of Regulatory Responsibilities Clause in Contracts

Regulatory Responsibilities. (a) X4 shall have the sole right and responsibility for preparing, obtaining and maintaining Drug Approval Applications and any other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Products in the Field in the Territory. As between the Parties, all Drug Approval Applications and Regulatory Approvals relating to Licensed Products in the Field with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, X4 or its designated Affiliate or Sublicensee. (b) Genzyme hereby assigns to X4 all of Genzyme’s right, title and interest in and to the Drug Approval Applications and Regulatory Approvals with respect to the Licensed Compound Controlled by Genzyme on the Effective Date (the “Assigned Regulatory Documentation”), a list of which Assigned Regulatory Documentation is set forth on Schedule 3.2.1. Promptly following the completion of X4 First Financing, Genzyme shall take such steps as may be reasonably necessary to promptly complete the transfer to X4 of its ownership of the Assigned Regulatory Documentation. All such Assigned Regulatory Documentation will be owned by and held in the name of X4. (c) Schedule 3.2.1(c) sets forth all Regulatory Documentation, other than the Assigned Regulatory Documentation, that is Controlled by Genzyme as of the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and to all such Regulatory Documentation not assigned to X4 pursuant to Section 3.2.1(b), to use such Regulatory Documentation for the purposes of seeking Regulatory Approvals to Commercialize Licensed Products in the Field in the Territory in accordance with this Agreement. X4 may sublicense such rights in connection with any sublicense granted in accordance with Section 2.3. (d) Genzyme shall, upon the written request of X4, notify the applicable Regulatory Authorities in writing that it is transferring responsibility for Regulatory Documentation, including the Assigned Regulatory Documentation, to X4, and X4 shall notify the applicable Regulatory Authorities in writing that it is accepting all regulatory responsibilities associated with such Regulatory Documentation (including the responsibility for reporting Adverse Events).

Appears in 1 contract

Samples: License Agreement (X4 Pharmaceuticals, Inc)

Regulatory Responsibilities. Section 3.4(a) of the D&L Agreement is hereby deleted in its entirety and replaced with the following: (a) X4 It is understood that Alvogen has substantial experience and knowledge with filing NDAs pursuant to Section 505(b)(2) and Pfenex has substantial experience and knowledge with the Product. Therefore, the Parties agree as follows: (i) Within ten (10) days of the Amendment Effective Date, the Executive Steering Committee shall form a Working Committee to consult with the Parties and oversee the filing or submission of Regulatory Materials to the FDA with respect to the Product, including the NDA for Product. Such Working Committee will be comprised of three (3) employees of Alvogen (or its Affiliate) appointed by Alvogen and three (3) employees of Pfenex appointed by Pfenex. Each Party shall appoint one (1) employee to serve as the co-chair of the Working Committee. The Working Committee shall make all decisions by consensus pursuant to the terms set forth in Section 7.4(a). If the Working Committee is unable to reach a decision as to any matter within its authority after a period of ten (10) Business Days, then the matter may be escalated to either Party’s Chief Executive Officer as set forth in Section 7.4(b); (ii) Subject to Section 3.4(a)(i), (A) prior to the Transfer Notice, Pfenex shall have the sole right and responsibility for preparing, obtaining and maintaining Drug Approval Applications and any other to control filing or submission of Regulatory Approvals and other submissions, and for conducting communications with Materials to the Regulatory Authorities, for Licensed Products in the Field in the Territory. As between the Parties, all Drug Approval Applications and Regulatory Approvals relating to Licensed Products in the Field FDA with respect to the Territory shall be owned byProduct including the NDA for Product, subject to Section 3.1, and shall be responsible for managing all communications and interactions with the FDA with respect to Product in the Territory and (B) from and after the Transfer Notice, Alvogen shall have the sole property right to control filing or submission of Regulatory Materials with the FDA with respect to Product including the NDA Approval for Product, subject to Section 3.2, and held shall be responsible for managing all communications and interactions with the FDA with respect to Product in the name of, X4 or its designated Affiliate or Sublicensee.Territory; and (biii) Genzyme hereby assigns In either case of Section 3.4(a)(ii)(A) or Section 3.4(a)(ii)(B), and subject to X4 all of Genzyme’s rightSection 3.4(a)(i), title and interest in and the following provisions shall apply. Prior to the Drug Approval Applications filing of any Regulatory Materials (including the NDA) for Product with the FDA, the filing Party (the “Filing Party”) shall provide a copy thereof to the other Party (through the Executive Steering Committee, the “Reviewing Party”) for its review and comment. The Reviewing Party shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Approvals Materials with respect to the Licensed Compound Controlled Product to provide the Filing Party with comments regarding such Regulatory Materials, unless the FDA or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case the Reviewing Party shall [***]Certain confidential information contained in this document, marked by Genzyme on brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. have as much time as is reasonably practicable to provide the Effective Date (Filing Party with comments. The Filing Party shall consider such comments in good faith. The Filing Party shall, to the “Assigned Regulatory Documentation”)extent permitted by Applicable Law, a list of which Assigned Regulatory Documentation is set forth on Schedule 3.2.1. Promptly following provide the completion of X4 First Financing, Genzyme shall take such steps as may be reasonably necessary to promptly complete the transfer to X4 of its ownership co-chairs of the Assigned Working Committee described in Section 3.4(a)(i) with (A) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Documentation. All such Assigned Regulatory Documentation will be owned by and held in the name of X4. (c) Schedule 3.2.1(c) sets forth all Regulatory Documentation, other than the Assigned Regulatory Documentation, that is Controlled by Genzyme as of the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and to all such Regulatory Documentation not assigned to X4 pursuant to Section 3.2.1(b), to use such Regulatory Documentation for the purposes of seeking Regulatory Approvals to Commercialize Licensed Products in the Field Agency in the Territory that are either scheduled with or initiated by or on behalf of the Filing Party or its Affiliates, (B) an opportunity to have a reasonable number (but at least two (2)) representatives participate in accordance meetings with this Agreement. X4 may sublicense such rights in connection the FDA with any sublicense granted in accordance with Section 2.3. (d) Genzyme shall, upon the written request of X4, notify the applicable Regulatory Authorities in writing that it is transferring responsibility for Regulatory Documentation, including the Assigned Regulatory Documentation, respect to X4Product, and X4 in any case keep the Reviewing Party informed as to material interactions with the FDA with respect to Product, and (C) a copy of any material documents, information and correspondence submitted to or received from the FDA with respect to Product promptly, but in any event, no more than twenty-four (24) hours from receipt of such document, information or correspondence. Without limiting Section 3.4(a)(iii)(B), if Pfenex is the Filing Party, Pfenex shall notify meet with the applicable Regulatory Authorities FDA with respect to the Product only if either (A) Alvogen is present at such meeting, either in writing that it person or by telephone or (B) Alvogen is accepting all regulatory responsibilities associated with not present at such Regulatory Documentation (including the responsibility for reporting Adverse Events).meeting through no fault of Pfenex. ”

Appears in 1 contract

Samples: Development and License Agreement (Pfenex Inc.)

Regulatory Responsibilities. (a) X4 shall have the sole right and responsibility for preparing, obtaining and maintaining Drug Approval Applications and any other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Products in the Field in the Territory. As between the Parties, all Drug Approval A. Marketing Authorization Applications and Regulatory Approvals relating – RADIUS, itself or through its Affiliates or (sub)licensees, will be responsible for preparing and submitting all Regulatory Filings, including but not limited to Licensed Products providing any clinical data to be submitted in the Field with respect 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 byby RADIUS, its Affiliates or (sub)licensees, and shall remain with RADIUS, its Affiliates or (sub)licensees. Nothing in this Agreement should be the sole property construed as transferring ownership of XXXx, Regulatory Filings or Regulatory Approvals to 3M. All 3M DMFs and held MAFs referenced in the name ofXXXx, X4 or its designated Affiliate or Sublicensee. (b) Genzyme hereby assigns to X4 all of Genzyme’s right, title and interest in and to the Drug Approval Applications 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 the Licensed Compound Controlled by Genzyme on the Effective Date (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 “Assigned Right of reference or use” for any product. 3M will provide to RADIUS, its Affiliates or its (sub)licensees and to any specified Regulatory Documentation”)Authority a letter of authorization, a list of which Assigned Regulatory Documentation is set forth on Schedule 3.2.1. Promptly following the completion of X4 First Financing, Genzyme shall take or other such steps executed instrument as may be necessary under, or as RADIUS, its Affiliates or its (sub)licensees may reasonably necessary request, to promptly complete effectuate the transfer to X4 rights of its ownership of the Assigned Regulatory Documentation. All such Assigned Regulatory Documentation will be owned by and held in the name of X4. (c) Schedule 3.2.1(c) sets forth all Regulatory Documentation, other than the Assigned Regulatory Documentation, that is Controlled by Genzyme as of the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and reference or use to all such DMFs and MAFs, contemplated in this Section 4.4A in order to obtain, maintain support of all XXXx, Regulatory Documentation Filings and Regulatory Approvals for Product in the Territory. 3M shall provide or cause to be provided CMC information required for RADIUS’, its Affiliates’ or its (sub)licensees’ Regulatory Filing as required by the relevant Regulatory Authority in markets or territories where DMF/MAF is not assigned available for registration. For clarity, notwithstanding anything in this Agreement to X4 pursuant the contrary, during the Term, 3M may redact from documents provided or made available to Section 3.2.1(b)RADIUS, its Affiliates or its (sub)licensees, and otherwise decline to use disclose or provide RADIUS, its Affiliates or its (sub)licensees access to, all confidential CMC-related data and information for Product proprietary manufacturing processes relating to such confidential CMC-related data. B. Maintaining Regulatory Approval for Product– Once Regulatory Approval for the Product and Applicator is obtained from a Regulatory Authority, RADIUS, itself or through its Affiliates or (sub)licensees, shall have responsibility to maintain such Regulatory Documentation Approval for the purposes of seeking Product and Applicator with all applicable Regulatory Approvals to Commercialize Licensed Products in the Field Authority(ies) in the Territory in accordance which the Product and Applicator are sold. RADIUS shall be responsible for all preclinical, clinical, CMC (referencing information included in 3M’s DMFs and MAFs) and quality sections of the Regulatory Approvals for the Product and Applicator, as well as all labeling issues with this AgreementRegulatory Authorities (such as the FDA) and for all dealings with Regulatory Authorities on advertising and marketing matters and all clinical studies. X4 RADIUS shall file any and all reports required for Product and Applicator by Regulatory Authorities in the Territory. C. Maintaining DMFs and MAFs – 3M shall have responsibility to maintain the DMFs and MAFs referenced in any Regulatory Filings for Product and Applicator with all applicable Regulatory Authority(ies) in the Territory. 3M shall promptly (and in any event within thirty (30) days) notify RADIUS in advance of any material change in any such DMF or MAF. D. Adverse Drug Experience Reports - RADIUS shall be responsible for filing with applicable Regulatory Authorities any adverse event reports (“AEs”) which it receives directly from Third Parties or from 3M relating to Product or Applicator. If 3M or a CMO receives an adverse event report for the Product or Applicator, 3M shall provide such report to RADIUS as soon as practicable, but no later than [*] after such report is received by 3M’s or a CMO’s (as applicable) Quality or Regulatory Department. Upon request by RADIUS, 3M and RADIUS will negotiate in good faith and enter into a pharmacovigilance agreement for the Product and Applicator, including any safety data relating to the Patch and Applicator. E. Product Recall and/or Field Alert – In the event that either Party determines an event, incident or circumstance has occurred which may sublicense result in the need for a “recall”, “market withdrawal” or “field alert” of Product or Applicator or any Lot(s) thereof, as such rights terms are defined in connection the United States Code of Federal Regulations 21 CFR § 7.3 (“Recall”) and 21 CFR§ 314 (“Field Alert”), or other Applicable Law or regulation of a country, such Party shall advise and consult with any sublicense granted in accordance with Section 2.3the other Party regarding such event as set forth below. (di) Genzyme shallRecall Procedure - RADIUS shall be the Party primarily responsible for administrating any recall of Product or Applicator. If RADIUS believes 3M or a CMO is responsible for the recall of Product or Applicator, upon the written request of X4, RADIUS shall promptly notify the applicable Regulatory Authorities 3M in writing to that it is transferring responsibility effect and consult with 3M regarding the strategy for Regulatory Documentationany recall. Following notification, including the Assigned Regulatory Documentation3M shall respond to RADIUS and make available its representatives from business, regulatory, quality assurance and legal functions (and any others deemed necessary by a Party) as soon as possible to X4, and X4 shall notify the applicable Regulatory Authorities in writing that it is accepting all regulatory responsibilities associated discuss with such Regulatory Documentation (including representatives from RADIUS whether or not to conduct a recall of Product, and, if so, the breadth, extent and level of customer to which the recall shall reach, what strategies and notifications should be used and the responsibility for reporting Adverse Eventsthe Recall Expenses (defined below). RADIUS shall have the final authority to decide whether a recall of such Product or Applicator shall be made and to what extent and level it shall be conducted. For all recalls other than those falling within Section [*] shall be responsible for all Recall Expenses. Any disagreement on the amount of and responsibility for Recall Expenses that cannot be resolved by the Parties shall be resolved pursuant to Section 17.7. In the event [*] conducts a recall [*] without [*] will not be responsible for any costs or expenses incurred by [*], except if it is determined under Section 17.7 that (a) [*] was justified in instituting such recall and reasonably believed following the above procedures would delay instituting such recall and thereby possibly cause patient harm; and (b) [*] was not [*] not [*]. (ii) [*] Recall - To the extent and only to the extent that a recall of Product or Applicator is mandated by the relevant Regulatory Authorities and is shown to be due to [*], and where [*] described in Section 4.4E(i), [*] shall bear all reasonable out-of-pocket costs and expenses of such recall, including and limited to, expenses and other costs or obligations to Third Parties (for example, costs imposed by distributors, but not including payments for [*]), the cost and expense of notifying customers, the cost and expense associated with shipment of such recalled Product or Applicator, the cost and expense of the Compound (if recall is related to Product, or if recall is related to Applicator where the Applicator and Product are packaged together ), and the cost and expense of replacing and destroying such Product or Applicator which is removed from the market, if necessary (the “Recall Expenses”). If [*] claims that [*] is responsible for the recall, [*] will provide all relevant information, data and agency correspondence to [*]. F. RADIUS shall have the responsibility to comply with the Drug Quality and Security Act (“DQSA”) requirements as required for Product and Applicator distribution. 3M and the CMOs shall meet their respective obligations with respect to DQSA requirements as required for Product and Applicator Manufacture, to be set forth in a Quality Agreement.

Appears in 1 contract

Samples: Scale Up and Commercial Supply Agreement (Radius Health, Inc.)

Regulatory Responsibilities. (a) X4 shall have the sole right and responsibility for preparing, obtaining and maintaining Drug Approval Applications and any other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Products in the Field in the Territory. As between the Parties, all Drug Approval Applications and Regulatory Approvals relating to Licensed Products in the Field with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, X4 or its designated Affiliate or Sublicensee. (b) Genzyme hereby assigns to X4 all of Genzyme’s right, title and interest in and to the Drug Approval Applications and Regulatory Approvals with respect to the Licensed Compound Controlled by Genzyme on the Effective Date (the “Assigned Regulatory Documentation”), a list of which Assigned Regulatory Documentation is set forth on Schedule 3.2.1. Promptly following the completion of X4 First Financing, Genzyme shall take such steps as may be reasonably necessary to promptly complete the transfer to X4 of its ownership of the Assigned Regulatory Documentation. All such Assigned Regulatory Documentation will be owned by and held in the name of X4. Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (c) Schedule 3.2.1(c) sets forth all Regulatory Documentation, other than the Assigned Regulatory Documentation, that is Controlled by Genzyme as of the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and to all such Regulatory Documentation not assigned to X4 pursuant to Section 3.2.1(b), to use such Regulatory Documentation for the purposes of seeking Regulatory Approvals to Commercialize Licensed Products in the Field in the Territory in accordance with this Agreement. X4 may sublicense such rights in connection with any sublicense granted in accordance with Section 2.3. (d) Genzyme shall, upon the written request of X4, notify the applicable Regulatory Authorities in writing that it is transferring responsibility for Regulatory Documentation, including the Assigned Regulatory Documentation, to X4, and X4 shall notify the applicable Regulatory Authorities in writing that it is accepting all regulatory responsibilities associated with such Regulatory Documentation (including the responsibility for reporting Adverse Events).

Appears in 1 contract

Samples: License Agreement (Arsanis, Inc.)

Regulatory Responsibilities. (a) X4 Each Party shall have provide to the sole right and responsibility for preparingother copies of all label-enabling Regulatory Submissions, obtaining and maintaining Drug Approval Applications and any other Regulatory Approvals and other submissions, and for conducting communications with including the Regulatory Authoritiesinitial BLA, for Licensed Products in the Field in the Territory. As between the Parties, all Drug Approval Applications and submission to a Regulatory Approvals relating to Licensed Products in the Field Authority [ * ] with respect to the Territory shall be owned byRC48 Licensed Product and Opt-In Products reasonably in advance of such submission for the other Party’s review and comment (including English translations thereof), and shall be consider in good faith any reasonable comments received from the sole property and held other Party with respect thereto. Each Party shall keep the other Party reasonably informed of all Regulatory Approvals and, [ * ], other material, regulatory developments related to the Royalty Products (in the name ofcase of Seagen) and the RC48 Licensed Product and Opt-In Products (in the case of RemeGen) in its respective Territory [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, X4 MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. and shall promptly notify such other Party in writing of any decision by any Regulatory Authority in the notifying Party’s Territory regarding any Royalty Product in the Field. All regulatory activities conducted, and Regulatory Submissions prepared, by or its designated Affiliate or Sublicenseeon behalf of each Party with respect to the Royalty Products (in the case of Seagen) and the RC48 Licensed Product and Opt-In Products (in the case of RemeGen) shall be conducted and prepared in strict compliance with Applicable Laws. (b) Genzyme hereby assigns to X4 all of Genzyme’s right, title and interest Except as set forth in and to the Drug Approval Applications and Regulatory Approvals Global Development Plan or with respect to the Licensed Compound Controlled by Genzyme on the Effective Date (the “Assigned Regulatory Documentation”), Seagen’s conduct of any Global Trial for a list of which Assigned Regulatory Documentation is set forth on Schedule 3.2.1. Promptly following the completion of X4 First Financing, Genzyme shall take such steps as may be reasonably necessary to promptly complete the transfer to X4 of its ownership of the Assigned Regulatory Documentation. All such Assigned Regulatory Documentation will be owned by and held Royalty Product in the name of X4. (c) Schedule 3.2.1(c) sets forth all Regulatory DocumentationRemeGen Territory as permitted hereunder, other than the Assigned Regulatory Documentation, that is Controlled unless required by Genzyme as of the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and to all such Regulatory Documentation not assigned to X4 pursuant to Section 3.2.1(b)Authority, to use in which case such Party shall notify the other Party of such order within [ * ] of such communication, neither Party shall file any Regulatory Documentation Submissions nor communicate with any Regulatory Authority for the purposes of seeking Regulatory Approvals to Commercialize Licensed Products any Royalty Product in the Field other Party’s Territory. With respect to (i) [ * ], or (ii) [ * ], in each case ((i) and (ii)) to the Territory in accordance with this Agreement. X4 may sublicense such rights in connection with any sublicense granted in accordance with Section 2.3. (d) Genzyme shall, upon the written request of X4, notify extent permitted by Applicable Law and by the applicable Regulatory Authorities Authorities, Seagen and RemeGen, respectively, shall have the right (but not the obligation) to attend (including attending in writing person as applicable) as an observer in all such meetings, provided that it is transferring responsibility for Regulatory Documentation, including such attendance shall be (a) limited to up to [ * ] of the Assigned Regulatory Documentation, to X4attending Party, and X4 (b) at [ * ] cost unless such attendance is at the other Party’s request, in which case [ * ]. Each Party shall notify provide the applicable other Party with written notice [ * ]. The notifying Party shall lead any such meeting or discussion with Regulatory Authorities. Each Party shall provide the other Party with a written summary of each such meeting or discussion, and meeting minutes from such meetings with Regulatory Authorities promptly (but in writing that it is accepting all regulatory responsibilities associated with any event within [ * ], and an English translation (if applicable) within [ * ] (or within [ * ] if pertaining to a Collaborative Global Trial) following such Regulatory Documentation (including the responsibility for reporting Adverse Events)meeting or discussion.

Appears in 1 contract

Samples: License Agreement (Seagen Inc.)

Regulatory Responsibilities. (a) X4 shall have the sole right and The Parties will share responsibility for preparingleading regulatory matters relating to the SYNGAP1 Co-Co Products, as described in this Section 6.9 (each Party, when designated as provided herein to provide such leadership with respect to designated activities is the “Lead Regulatory Party” with respect to such activities). With respect to each SYNGAP1 Co-Co Product, Acadia shall (x) lead the overall strategy for obtaining Regulatory Approval of such SYNGAP1 Co-Co Product (including labeling for such SYNGAP1 Co-Co Product), including by selecting the jurisdictions within which XXXx will be pursued and maintaining Drug Approval Applications the timing and any other order in which such approvals will be sought (“Regulatory Approvals and other submissionsStrategy”), and for conducting communications will be the Lead Regulatory Party with respect to such strategic activities with respect to such SYNGAP1 Co-Co Product, (y) be the Lead Regulatory Authorities, for Licensed Products in the Field in the Territory. As between the Parties, all Drug Approval Applications and Regulatory Approvals relating to Licensed Products in the Field Party with respect to the Territory shall be owned bysubmission of any MAA for such SYNGAP1 Co-Co Product, and shall (z) following the first Regulatory Approval of such SYNGAP1 Co-Co Product, be the sole property Lead Regulatory Party in connection with such SYNGAP1 Co-Co Product and held in the name of, X4 or its designated Affiliate or Sublicensee. (b) Genzyme hereby assigns to X4 all of Genzyme’s right, title and interest in and to the Drug Approval Applications and Regulatory Approvals with respect to Commercialization and regulatory activities (including post-marketing studies). Subject to the Licensed Compound Controlled by Genzyme on foregoing, the Effective Date (the “Assigned JSC shall designate a Party to lead all other pre-Regulatory Documentation”), a list of which Assigned Regulatory Documentation is set forth on Schedule 3.2.1. Promptly following the completion of X4 First Financing, Genzyme shall take such steps as may be reasonably necessary Approval regulatory matters relating to promptly complete the transfer to X4 of its ownership of the Assigned Regulatory Documentation. All such Assigned Regulatory Documentation will be owned by and held in the name of X4. (c) Schedule 3.2.1(c) sets forth all Regulatory Documentation, other than the Assigned Regulatory Documentation, that is Controlled by Genzyme as of the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and to all such Regulatory Documentation not assigned to X4 pursuant to Section 3.2.1(b), to use such Regulatory Documentation for the purposes of seeking Regulatory Approvals to Commercialize Licensed Products in the Field in the Territory each SYNGAP1 Co-Co Product in accordance with this Agreement. X4 may sublicense such rights in connection with any sublicense granted in accordance with Section 2.3. (d) Genzyme shall, upon the written request of X4, notify the applicable SYNGAP1 Co-Development Plan (each Party in such capacity will be deemed the Lead Regulatory Authorities Party with respect to such activities). The Lead Regulatory Party shall be responsible for (i) filing for in writing that it is transferring responsibility for Regulatory Documentation, including the Assigned Regulatory Documentation, to X4its name, and X4 shall notify owning, all Regulatory Materials relating to regulatory activities with respect to such SYNGAP1 Co-Co Product in the applicable Regulatory Authorities in writing that it is accepting relevant country, (ii) overseeing, monitoring, and coordinating all regulatory responsibilities associated actions, communications and filings with, and submissions to, each Regulatory Authority with respect to such activities; and (iii) interfacing, corresponding, and meeting with each Regulatory Documentation (including Authority with respect to such activities, in each case consistent with the responsibility for reporting Adverse Events)Regulatory Strategy and applicable SYNGAP1 Co-Development Plan or SYNGAP1 Co-Commercialization Plan.

Appears in 1 contract

Samples: License and Collaboration Agreement (Stoke Therapeutics, Inc.)

Regulatory Responsibilities. (a) X4 shall have the sole right and The Party with primary responsibility for preparing, obtaining filing and maintaining Drug Approval Applications and any other holding Regulatory Approvals and other submissions, and Materials for conducting communications with the Regulatory Authorities, for Licensed Products Product in a particular country or territory in the Field in the Territory. As between the Parties, all Drug Approval Applications and Regulatory Approvals relating to Licensed Products in the Field Territory with respect to the Territory Product shall be owned byreferred to as the “Regulatory Lead”. Subject to Section 14.2(b)(ii), AMAG shall be the Regulatory Lead for the Product with respect to the EMA, Swissmedic and Health Canada, unless and until Takeda elects to assume such responsibility pursuant to Section 5.2(b). Takeda, or its sublicensee(s), pursuant to Section 2.1(c)(ii) and (iii), shall be the Regulatory Lead for the Product in all other countries in the Licensed Territory, unless the Parties mutually agree that AMAG shall be the Regulatory Lead in any such country. Except as provided in Section 5.2(f), the Regulatory Lead with respect to a particular territory shall be the sole property owner of and held shall hold in its name all Regulatory Materials for the name ofProduct in such territory; provided, X4 however, that Takeda shall solely own all promotional materials for the Product throughout the Licensed Territory. The Regulatory Lead shall cooperate with the other Party, through the JDC or other committee or subcommittee formed by the Parties, in conducting its designated Affiliate or Sublicenseeactivities under this Article 5. (b) Genzyme hereby assigns to X4 all of Genzyme’s Takeda shall have the right, title and interest upon reasonable advance written notice to AMAG, but in and no event less than [***] written notice, to become the Drug Approval Applications and Regulatory Approvals Lead for the Product with respect to the Licensed Compound Controlled by Genzyme on EMA, Swissmedic and/or Health Canada; provided that Takeda shall become the Effective Date (Regulatory Lead for the “Assigned Product with respect to the EMA, Swissmedic and Health Canada as soon as reasonably practicable but not later than First Commercial Sale of the Product in Europe. Upon Takeda’s becoming Regulatory Documentation”)Lead, the Parties shall establish a list of which Assigned timeframe for AMAG to transfer and assign to Takeda all Regulatory Documentation is set forth on Schedule 3.2.1Materials for the Product with respect to the EMA, Swissmedic and/or Health Canada, including the IND for the Product with respect to [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. Promptly following ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the completion of X4 First FinancingEMA, Genzyme Swissmedic and/or Health Canada. In accordance with such timeframe, the Parties shall execute such documents and take such steps actions as may be are reasonably necessary to promptly complete effectuate the foregoing transfer to X4 and assignment of its ownership of the Assigned such Regulatory DocumentationMaterials. All Takeda shall be responsible for all reasonable Out-of-Pocket Costs incurred for such Assigned Regulatory Documentation will be owned by transfer and held in the name of X4assignment. (c) Schedule 3.2.1(c) sets forth all Regulatory DocumentationTakeda and AMAG shall, other than through the Assigned Regulatory DocumentationJDC, that is Controlled by Genzyme as of establish the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and to all such Regulatory Documentation not assigned to X4 pursuant to Section 3.2.1(b), to use such Regulatory Documentation regulatory strategy for the purposes of seeking Regulatory Approvals to Commercialize Licensed Products Product in the Field in Licensed Territory, including a plan and schedule of regulatory activities to be performed by the Territory in accordance with this Agreement. X4 may sublicense such rights Parties in connection with any sublicense granted obtaining approval for the initial MAA for the Product in accordance the Licensed Territory and for amendments or supplements thereto. In establishing such strategy, the JDC shall discuss each Party’s interpretation of applicable regulatory guidance, regulatory precedents, scientific advice and study data. Each Party shall assist and cooperate with Section 2.3the other Party as such other Party may reasonably request in connection with the preparation and filing of such Regulatory Materials in a timely manner. (d) Genzyme shallThe Regulatory Lead shall provide the other Party with copies of any proposed Regulatory Materials to be submitted (other than routine correspondence) at least ten (10) business days in advance of submission and shall reasonably consider any comments thereto provided by the other Party, upon to the written request extent practicable. (e) The Regulatory Lead shall inform each applicable Regulatory Authority in the Licensed Territory that two (2) representatives of X4the other Party will attend and, notify to the extent permitted by applicable Laws, participate in all major meetings between the Regulatory Lead and such Regulatory Authority, subject to the confidentiality provisions set forth under Article 12. The Regulatory Lead shall timely inform the other Party of any such scheduled meetings, as soon as practicably possible. (f) AMAG, in consultation with Takeda, shall be primarily responsible for the preparation of any components of Regulatory Materials to be filed by Takeda that relate to the Manufacture of Product and for communicating with Regulatory Authorities in writing that it is transferring responsibility the Licensed Territory regarding Manufacture of Product. Takeda shall provide AMAG with at least [***] notice of any intended filing date of Regulatory Materials containing components to be prepared by AMAG. Takeda shall cooperate with AMAG and take such actions as AMAG may reasonably request in connection with the foregoing activities and communications as related to the Manufacture of Product for Regulatory Documentation, including the Assigned Regulatory Documentation, to X4, and X4 shall notify the applicable Regulatory Authorities in writing that it is accepting all regulatory responsibilities associated with such Regulatory Documentation (including the responsibility for reporting Adverse Events)Licensed Territory.

Appears in 1 contract

Samples: License, Development and Commercialization Agreement (Amag Pharmaceuticals Inc.)

Regulatory Responsibilities. (a) X4 shall have the sole right and responsibility for preparing, obtaining and maintaining Drug Approval Applications and any other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Products in the Field in the Territory. As between the Parties, all Drug Approval A. Marketing Authorization Applications and Regulatory Approvals relating – RADIUS, itself or through its Affiliates or (sub)licensees, will be responsible for preparing and submitting all Regulatory Filings, including but not limited to Licensed Products providing any clinical data to be submitted in the Field with respect 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 byby RADIUS, its Affiliates or (sub)licensees, and shall remain with RADIUS, its Affiliates or (sub)licensees. Nothing in this Agreement should be the sole property construed as transferring ownership of XXXx, Regulatory Filings or Regulatory Approvals to 3M. All 3M DMFs and held MAFs referenced in the name ofXXXx, X4 or its designated Affiliate or Sublicensee. (b) Genzyme hereby assigns to X4 all of Genzyme’s right, title and interest in and to the Drug Approval Applications 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 the Licensed Compound Controlled by Genzyme on the Effective Date (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 “Assigned Right of reference or use” for any product. 3M will provide to RADIUS, its Affiliates or its (sub)licensees and to any specified Regulatory Documentation”)Authority a letter of authorization, a list of which Assigned Regulatory Documentation is set forth on Schedule 3.2.1. Promptly following the completion of X4 First Financing, Genzyme shall take or other such steps executed instrument as may be necessary under, or as RADIUS, its Affiliates or its (sub)licensees may reasonably necessary request, to promptly complete effectuate the transfer to X4 rights of its ownership of the Assigned Regulatory Documentation. All such Assigned Regulatory Documentation will be owned by and held in the name of X4. (c) Schedule 3.2.1(c) sets forth all Regulatory Documentation, other than the Assigned Regulatory Documentation, that is Controlled by Genzyme as of the Execution Date. Genzyme hereby grants to X4 the exclusive right, and right of reference, under Genzyme’s right, title, and interest in and reference or use to all such DMFs and MAFs, contemplated in this Section 4.4A in order to obtain, maintain support of all XXXx, Regulatory Documentation not assigned to X4 pursuant to Section 3.2.1(b), to use such Regulatory Documentation for the purposes of seeking Filings and Regulatory Approvals to Commercialize Licensed Products for Product in the Field Territory. 3M shall provide or cause to be provided CMC information required for RADIUS’, its Affiliates’ or its (sub)licensees’ Regulatory Filing as required by the relevant Regulatory Authority in markets or territories where DMF/MAF is not available for registration. For clarity, notwithstanding anything in this Agreement to the Territory in accordance with this Agreement. X4 contrary, during the Term, 3M may sublicense such rights in connection with any sublicense granted in accordance with Section 2.3. redact from documents provided or made available to RADIUS, its Affiliates or its (d) Genzyme shall, upon the written request of X4, notify the applicable Regulatory Authorities in writing that it is transferring responsibility for Regulatory Documentation, including the Assigned Regulatory Documentation, to X4sub)licensees, and X4 shall notify the applicable Regulatory Authorities in writing that it is accepting otherwise decline to disclose or provide RADIUS, its Affiliates or its (sub)licensees access to, all regulatory responsibilities associated with confidential CMC-related data and information for Product proprietary manufacturing processes relating to such Regulatory Documentation (including the responsibility for reporting Adverse Events)confidential CMC-related data.

Appears in 1 contract

Samples: Scale Up and Commercial Supply Agreement