Assignment of Regulatory Filings and Regulatory Approvals Sample Clauses

Assignment of Regulatory Filings and Regulatory Approvals. Acucela shall assign and transfer, or cause to be assigned and transferred, to Otsuka all Regulatory Filings and Regulatory Approvals for each Collaboration Product made or owned by Acucela and its Affiliates in the Shared Territory, and shall 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 and Regulatory Approvals to Otsuka (or, if not so assignable or not solely related to Collaboration Products, Acucela shall take all reasonable actions to make available to Otsuka the benefits of such Regulatory Filings and Regulatory Approvals). Acucela shall require each of its Sublicensees and any other Third Party that holds Regulatory Filing or Regulatory Approvals under authority from Acucela hereunder related to a Collaboration Product in the Shared Territory to transfer any such Regulatory Filings and Regulatory Approvals to Otsuka if this Agreement terminates pursuant to this Section 15.5.4 (or, if not so assignable or not solely related to Collaboration Products, Acucela shall take all reasonable actions to make available to Otsuka the benefits of such Regulatory Filings and Regulatory Approvals). In each case, unless otherwise prohibited by any applicable Laws, the foregoing assignment (or availability) shall be made within thirty (30) days after the effective date of termination of this Agreement pursuant to this Section 15.5.4, and for clarity, Acucela’s rights under Section 8.7 with respect to all Regulatory Filings and Regulatory Approvals for Collaboration Products in the Shared Territory shall continue with respect to Acucela’s Sole Territory;
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Assignment of Regulatory Filings and Regulatory Approvals. At IceCure’s option, which shall be exercised by written notice to Terumo, to the extent permitted under Applicable Laws and subject to the terms of this Agreement (including as otherwise set forth in this Article 12), Terumo shall assign or cause to be assigned to IceCure or its designee (or to the extent not so assignable, Terumo shall take all reasonable actions to make available to IceCure or its designee the benefits of), in consideration of the compensation which amount to be mutually agreed in good faith and in writing between the Parties, all Regulatory Filings for the Product in the Territory.
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Assignment of Regulatory Filings and Regulatory Approvals. Partner shall assign (or cause to be assigned) to Bioprojet or its designee (or to the extent not so assignable, Partner shall take all reasonable actions to make available to Bioprojet or its designee the benefits of) all Regulatory Filings for the Product in the Partner Territory, including any such Regulatory Filings made or owned by its Affiliates and/or Sublicensees. In each case, unless otherwise required by any applicable law or regulation or requested by Bioprojet, the foregoing assignment (or availability) shall be made within thirty (30) calendar days after the effective date of any termination of this Agreement. In addition, Partner shall promptly provide to Bioprojet a copy of all Data and Partner Know-How pertaining to the Product in the Partner Territory to the extent not previously provided to Bioprojet and Bioprojet shall have the right to use and disclose all Data and Partner Know-How pertaining to the Product following termination of this Agreement. In addition, all such Data and Partner Know-How, to the extent specifically pertaining to the Product, shall be deemed Confidential Information of Bioprojet and not Confidential Information of Partner (and will not be subject to the exclusions under Sections 10.1(a) or (e) above).
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Assignment of Regulatory Filings and Regulatory Approvals. Unless this Agreement is terminated by Zogenix under Section 12.2(c), at Zogenix’s option, which shall be exercised by written notice to Distributor, to the extent permitted under Applicable Laws, Distributor shall assign or cause to be assigned to Zogenix or its designee (or to the extent not so assignable, Distributor shall take all reasonable actions to make available to Zogenix or its designee the benefits of), at Zogenix’s cost, all Regulatory Filings and Regulatory Approvals for the Product in the Field in the Territory.
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Assignment of Regulatory Filings and Regulatory Approvals. Harmony shall assign (or cause to be assigned) to Bioprojet or its designee (or to the extent not so assignable, Harmony shall take all reasonable actions to make available to Bioprojet or its designee the benefits of) all Regulatory Filings for the Product(s) in the Harmony Territory, including any such Regulatory Filings made or owned by its Affiliates and/or Sublicensees. In each case, unless otherwise required by any Applicable Law or regulation or requested by Bioprojet, the foregoing assignment (or availability) shall be made within thirty (30) calendar days after the effective date of any termination of this Agreement. In addition, Harmony shall promptly provide to Bioprojet a copy of all Data and Harmony Know-How pertaining to the Product(s) in the Harmony Territory to the extent not previously provided to Bioprojet and Bioprojet shall have the right to use and disclose all Data and Harmony Know-How pertaining to the Product(s) following termination of this Agreement. In addition, all such Data and Harmony Know-How, to the extent specifically pertaining to the Product(s), shall be deemed Confidential Information of Bioprojet and not Confidential Information of Harmony (and will not be subject to the exclusions under Sections 10.1(a) or (e) above).
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Assignment of Regulatory Filings and Regulatory Approvals. Shire shall assign and transfer, or cause to be assigned and transferred, to Amicus all Regulatory Filings and Regulatory Approvals solely for the Reverted Products made or owned by Shire and its Affiliates, and shall 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 and Regulatory Approvals to Amicus (or, if not so assignable or not solely related to Related Products, Shire shall take all reasonable actions to make available to Amicus the benefits of such Regulatory Filings and Regulatory Approvals). Shire shall require each of its Sublicensees and any other Third Party that holds Regulatory Filing or Regulatory Approvals under authority from Shire hereunder solely related to Reverted Products to transfer any such Regulatory Filings and Regulatory Approvals to Amicus if this Agreement terminates (or, if not so assignable or not solely related to Related Products, Shire shall take all reasonable actions to make available to Amicus the benefits of such Regulatory Filings and Regulatory Approvals). In each case, unless otherwise prohibited by any applicable Laws, the foregoing assignment (or availability) shall be made within [***] after termination of this Agreement.
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Assignment of Regulatory Filings and Regulatory Approvals. At Array’s request, and to the extent permitted under applicable law, Novartis shall assign or cause to be assigned to Array or its designee (or to the extent not so assignable, Novartis shall take all reasonable actions to make available to Array or its designee the benefits of) all Regulatory Filings for all Product in the Territory, including any such Regulatory Filings made or owned by Novartis’ Affiliates and/or Sublicensees. In each case, unless otherwise required by any applicable law, the foregoing assignment (or availability) shall be made as soon as reasonably practicable after the effective date of any termination of this Agreement and in any event no later than thirty (30) days after the effective date of such termination, or if such assignment cannot legally be made within such thirty-day period, as soon thereafter as such assignment can legally be made. Array shall use Commercially Reasonable Efforts to assist Novartis in any manner reasonably requested by Novartis to effectuate such assignments.
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Assignment of Regulatory Filings and Regulatory Approvals. Licensee shall, at the request of Licensor, assign (or cause to be assigned) to Licensor or its designee (or to the extent not so assignable, Licensee shall take all reasonable actions to make available to Licensor or its designee the benefits of) all Regulatory Filings for Products in the Territory, including any such Regulatory Filings made or owned by its Affiliates and/or Sublicensees. In each case, unless otherwise required by any Applicable Laws or requested by Licensor, the foregoing assignment (or availability) shall be made within [***] after the effective date of any termination of this Agreement. In addition, Licensee shall promptly provide to Licensor a copy of all Licensee Know-How pertaining to the Product and in the Territory to the extent not previously provided to Licensor and Licensor shall have the right to use and disclose Licensee Know-How pertaining to Products following termination of this Agreement. In addition, all such Licensee Know-How, to the extent specifically pertaining to the Product, shall be deemed Confidential Information of Licensor and not Confidential Information of Licensee.
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Related to Assignment of Regulatory Filings and Regulatory Approvals

  • 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.

  • 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.

  • 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”).

  • 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.

  • 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.

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • Tax and Regulatory Matters Neither BB&T nor any BB&T Subsidiary has taken or agreed to take any action which would or could reasonably be expected to (i) cause the Merger not to be accounted for as a pooling-of-interests or not to constitute a reorganization under Section 368 of the Code, or (ii) materially impede or delay receipt of any consents of regulatory authorities referred to in Section 5.4(b) or result in failure of the condition in Section 6.3(b).

  • 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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