Transfer of Regulatory Filings and Regulatory Approvals Sample Clauses

Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination), after Lyra’s written request, Lian will, to the extent permitted under applicable Laws and not commercially infeasible, and at Lyra’s sole cost and expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) was for Lian’s material breach pursuant to Section 12.3(a) (Termination for Material Breach), in which case such transfer will be at Lian’s sole cost and expense), assign and transfer to Lyra all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian or its Affiliates or Sublicensees as of the effective date of termination and will take such actions and execute such other instruments, assignments, and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to Lyra. If applicable Laws or relevant Regulatory Authorities prevent or delay the transfer of ownership of any such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations to Lyra, or if it is commercially infeasible for Lian to do so, then Lian will grant, and hereby does grant, to Lyra and its Affiliates, Sublicensees, and licensees an exclusive and irrevocable right of access and right of reference to such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products in the Field in the Territory, as the case may be, and will reasonably cooperate with Lyra, at Lyra’s expense (unless the applicable termination giving rise to Lyra’s rights under this Section 12.5(h) (Transfer of Regulatory Filings and Regulatory Approvals) was for Lian’s material breach pursuant to Section 12.3(a) (Termination for Material Breach) in which case such transfer will be at Lian’s sole cost and expense), to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Lyra or its designee(s).
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Transfer of Regulatory Filings and Regulatory Approvals. If ownership of a Regulatory Filing or Regulatory Approval in any country cannot be transferred from the owning Party to the other Party pursuant to the terms of this Agreement, the owning Party shall grant to the other Party an exclusive right of access and reference to such Regulatory Filing or Regulatory Approval in such country in order to enable the other Party to become a sponsor and party of record of an IND or equivalent foreign filing. If such right of access and reference is not sufficient to permit the other Party to file a Drug Approval Application and receive Regulatory Approval or to Develop, manufacture or Commercialize a Collaboration Product, the owning Party shall provide the other Party with any and all information necessary for the other Party to carry out such activities and to receive Regulatory Approval in its own name.
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Transfer of Regulatory Filings and Regulatory Approvals. 2.5.1 Within thirty (30) days after the Effective Date, Akcea shall, with respect to each country in the PTC Territory, assign and transfer to PTC the ownership and sponsorship of such Regulatory Approval and any pricing and reimbursement approvals held in its or any of its Affiliate’s or sublicensee’s name in such country, to the extent any exist and to the extent consistent with applicable Law, and provide PTC with copies of all Regulatory Filings relating to the Products in the PTC Territory, including all reports, correspondence and conversation logs and all pre-clinical and clinical data and results related thereto. Thereafter, PTC shall prepare, file and maintain all Regulatory Filings and Regulatory Approvals for the applicable Product in such country. Akcea shall further appoint, and ensure that Ionis Pharmaceuticals and its other Affiliates and sublicensees appoint, PTC as their agent for all matters relating to such Products and Compounds involving Regulatory Authorities in the PTC Territory until all Regulatory Approvals, Regulatory Filings, and any pricing and reimbursement approvals held in its or its Affiliate’s or sublicensee’s name have been transferred to PTC. In addition, Akcea shall ensure that PTC shall have access to all data contained or referenced in Regulatory Approvals and Regulatory Filings in the Akcea Territory that are reasonably necessary for the Exploitation of the Compounds and the Products in the PTC Territory.
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Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination), after Landos’ written request, Lian will, to the extent permitted under applicable Laws, and at Landos’ sole cost and expense (unless the applicable termination giving rise to Landos’ rights under this Section 12.4(h) (Transfer of Regulatory Filings and Regulatory Approvals) was initiated by Landos pursuant to Section 12.3 (Early Termination), in which case such transfer will be at Lian’s sole cost and expense), assign and transfer to Landos all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian or its Affiliates or Sublicensees as of the effective date of termination, with respect to the terminated Region, as the case may be.
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Transfer of Regulatory Filings and Regulatory Approvals. If ownership of a Regulatory Filing or Regulatory Approval in any country cannot be transferred from the owning Party to the other Party pursuant to any one of Sections 4.3, 4.4(b), 5.8(b), 16.9(a)(iii) or 16.9(c)(ii), the owning Party shall grant to the other Party an exclusive right of access and [***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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Transfer of Regulatory Filings and Regulatory Approvals. Company will, and hereby does, assign to Licensee any and all Regulatory Filings, Regulatory Approvals or any other rights or permissions granted by any Regulatory Authority to Licensee related to the Licensed Product that exist on the Effective Date and to the extent [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. they can be transferred. If any Regulatory Filings or Regulatory Approvals cannot be transferred Company will and does hereby grant the right to Licensee to reference any such Regulatory Filings and Regulatory Approvals. Further, Company will take all actions and provide all assistance reasonably requested by Licensee to effect the assignments in this Section 2.2.3. To the extent such Regulatory Filings, Regulatory Approvals or any other rights or permissions granted by any Regulatory Authority cannot be transferred in a reasonable time, Company will maintain them for the benefit of the Licensee.
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Transfer of Regulatory Filings and Regulatory Approvals. At the Closing, EMD Serono shall assign, convey and transfer to Thera, and Thera shall accept and assume all of EMD Serono’s right, title and interest in and obligations under the Regulatory Filings and Regulatory Approvals. EMD Serono and Thera shall (a) submit to the FDA, on the Closing Date, all information required in order to document the change of the ownership of the New Drug Application and the Investigational New Drug Application from EMD Serono to Thera, including without limitation, the information required pursuant to 21 C.F.R. §314.72 and 21 C.F.R. §312; and (b) promptly after the Closing Date, take all actions required by the FDA to effect or evidence the change of ownership of any other Regulatory Filings and Regulatory Approvals from EMD Serono to Thera. On the Closing Date, EMD Serono shall provide to Thera copies of all Regulatory Filings and Regulatory Approvals.
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Transfer of Regulatory Filings and Regulatory Approvals. If ownership of a Regulatory Filing or Regulatory Approval in any country cannot be transferred from the owning Party to the other Party pursuant to any one of Sections 4.3, 4.4(b), 5.8(b), 16.9(a)(iii) or 16.9(c)(ii), the owning Party shall grant to the other Party an exclusive right of access and reference to such Regulatory Filing or Regulatory Approval in such country in order to enable the other Party to become a sponsor and party of record of an IND. If such right of access and reference is not sufficient to permit the other Party to file a Drug Approval Application and receive Regulatory Approval or to Develop, manufacture or Commercialize a Collaboration Product, the owning Party shall provide the other Party with any and all information necessary for the other Party to carry out such activities and to receive Regulatory Approval in its own name.
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Transfer of Regulatory Filings and Regulatory Approvals. Following the effectiveness of any termination of this Agreement pursuant to Section 12.3 (Early Termination), after Licensor’s written request, Lian will, to the extent permitted under applicable Laws, and at Licensor’s sole cost and expense (unless the applicable termination giving rise to Licensor’s rights under this Section 12.4(h) (Transfer of Regulatory Filings and Regulatory Approvals) was initiated by Licensor pursuant to Section 12.3 (Early Termination), in which case such transfer will be at Lian’s sole cost and expense), assign and transfer to Licensor all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Licensed Products that are held by or owned by Lian or its Affiliates or Sublicensees as of the effective date of termination, with respect to the terminated Region, as the case may be.
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Related to Transfer of Regulatory Filings and Regulatory Approvals

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Governmental and Regulatory Approvals Other than the filing of the Articles of Merger provided for under Section 1.3, all consents, approvals and actions of, filings with and notices to any Governmental Entity required by the Company, Parent or any of their subsidiaries under applicable law or regulation to consummate the Merger and the transactions contemplated by this Agreement, the failure of which to be obtained or made would result in a material adverse effect on Parent’s ability to conduct the business of the Company in substantially the same manner as presently conducted, shall have been obtained or made (all such approvals and the expiration of all such waiting periods, the “Requisite Regulatory Approvals”).

  • FDA and Regulatory Matters Except as set forth in the Prospectus and the Prospectus Supplement, there is no legal or governmental proceeding to which the Company or any of its subsidiaries is a party or of which any property or assets of the Company or any of its subsidiaries or any officer or director of the Company, in their roles as such, or any employee benefit plan sponsored by the Company, is the subject, including any proceeding before the United States Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or comparable federal, state, local or foreign governmental authorities (it being understood that the interaction between the Company and the FDA and such comparable governmental bodies relating to the clinical development and product approval process shall not be deemed proceedings for purposes of this representation), which is required to be described in the Registration Statement, the Prospectus or the Prospectus Supplement or a document incorporated by reference therein and is not described therein, or which, singularly or in the aggregate, if determined adversely to the Company or any of its subsidiaries, could reasonably be expected to have a Material Adverse Effect; and to the Company’s knowledge after reasonable investigation (“Knowledge”), no such proceedings are threatened by governmental authorities. The Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing its business as prescribed by the FDA, or any other federal, state or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect. All preclinical and clinical studies conducted by or on behalf of the Company to support approval for commercialization of the Company’s products have been conducted by the Company, or to the Company’s Knowledge by third parties, in compliance with all applicable federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in compliance as could not reasonably be expected to have, singularly or in the aggregate, a Material Adverse Effect. The Company and each of its subsidiaries possess all licenses, certificates, authorizations and permits issued by, and have made all declarations and filings with, the appropriate local, state, federal or foreign governmental or regulatory agencies or bodies (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) that are necessary for the ownership or lease of their respective properties or the conduct of their respective businesses as described in the Registration Statement, the Prospectus and the Prospectus Supplement (collectively, the “Governmental Permits”), except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries are in compliance with all such Governmental Permits and all such Governmental Permits are valid and in full force and effect, except where the noncompliance, validity or failure to be in full force and effect would not, singularly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any subsidiary has received notification of any revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and to the Knowledge of the Company, no event has occurred that allows or results in, or after notice or lapse of time or both would allow or result in, revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed, except where such revocation, modification, suspension, termination, invalidation or nonrenewal would not, singularly or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries, and to the Company’s Knowledge, its directors, officers, employees or agents, each in their respective roles with the Company, are and have been in compliance in all material respects with applicable federal, state, local and foreign health care regulatory laws, including without limitation, laws related to fraud and abuse, payment transparency, and privacy and security of protected health information (collectively, “Health Care Laws”). The Company and its subsidiaries have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator or governmental or regulatory authority or third party alleging that the Company, its subsidiaries or its personnel have violated any applicable Health Care Law, nor, to the Company’s Knowledge, has any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action been threatened, which, individually or in the aggregate, might result in any Material Adverse Effect. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Prospectus and the Prospectus Supplement (the “Company Studies and Trials”) were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained or incorporated by reference in the Registration Statement, the Prospectus and the Prospectus Supplement are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Prospectus and the Prospectus Supplement, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement, the Prospectus and the Prospectus Supplement; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Prospectus and the Prospectus Supplement, the Company has not granted rights to develop, manufacture, produce, assemble, distribute, license, market or sell its products or product candidates to any other person and is not bound by any agreement that affects the exclusive right of the Company to develop, manufacture, produce, assemble, distribute, license, market or sell its products or product candidates.

  • Required Regulatory Approvals Certain transactions required, permitted or otherwise contemplated by this Agreement may under certain circumstances require prior filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner. Such transactions include: (a) issuance or purchase of any additional capital stock of the Company or other securities convertible into or exchangeable or exercisable for capital stock of the Company pursuant to Sections 1.2 or 3.4; (b) transfer of Shares to a wholly owned subsidiary of a Shareholder, to another Shareholder or to a wholly owned subsidiary of another Shareholder pursuant to Sections 3.1(a) or 3.4; (c) exercise of preemptive rights by a Shareholder pursuant to Section 3.2; and (d) exercise of call rights by the Company or a Shareholder pursuant to Section 3.3 (including pursuant to the two provisos in Section 3.1(b)). Notwithstanding anything to the contrary contained in this Agreement, any such transactions requiring filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner shall not, to the extent within the control of a party hereto, be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained, and to the extent not within the control of an applicable party hereto, such party shall use best efforts to cause such transactions not to be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Approvals of Regulatory Authorities Niagara Bancorp shall have received all required approvals of Regulatory Authorities of the Merger (without the imposition of any conditions that are in Niagara Bancorp's reasonable judgment unduly burdensome); and all notice and waiting periods required thereunder shall have expired or been terminated;

  • Regulatory Filings Except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

  • No Regulatory Approval By the Company or Parent, if its Board of Directors so determines by a vote of a majority of the members of its entire Board, in the event any Requisite Regulatory Approval shall have been denied by final, nonappealable action by such Governmental Authority or a Governmental Authority shall have requested the permanent withdrawal of an application therefor.

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