Assignment of Regulatory Submissions Sample Clauses

Assignment of Regulatory Submissions. NVS will (a) [***] assign to HMI all of its rights, title, and interests in and to all Clinical Trial data, Regulatory Submissions, and Regulatory Approvals and Pricing Approvals (where applicable) solely related to any Terminated Targets, Terminated Candidates, and Terminated Products owned or Controlled by NVS or any of its Affiliates or its Sublicensees as of the effective date of termination, and (b) [***] transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals and Pricing Approvals (where applicable) to HMI, including submitting to each applicable Regulatory Authority a letter or other [***] documentation notifying such Regulatory Authority of the transfer of such ownership of such Regulatory Approval and Pricing Approval (where applicable).
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Assignment of Regulatory Submissions. NVS will (i) use Commercially Reasonable efforts to assign and transfer on an as-is, where-is basis to Pliant or its designee all of its rights, title, and interest in an to all Clinical Study data, Regulatory Materials (including drug master files), and Regulatory Approvals solely related to any Terminated Compounds and Terminated Products (A) owned or Controlled by NVS or any of its Affiliates or its Sublicensees as of the effective date of termination, (B) not already within Pliant's possession; and (C) to the extent permitted under Applicable Law; and (ii) take those steps reasonably necessary to transfer ownership of all such assigned Regulatory Materials and Regulatory Approvals to Pliant, including submitting to each applicable Regulatory Authority a letter or other necessary documentation notifying such Regulatory Authority of the transfer of such ownership of such Regulatory Approval. NVS shall reasonably cooperate, at no additional out-of-pocket cost to NVS, with reasonable requests by Pliant for reasonable assistance necessary to facilitate Pliant's assumption of regulatory responsibilities for such Terminated Compound or Terminated Product, if applicable, in the applicable countries in which direct transfer is not permitted.
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Assignment of Regulatory Submissions. Except with respect to any termination by Ionis under Section 14.2.2(a) (Ionis’ Right to Terminate), Ionis will, as promptly as practicable, transfer to Metagenomi possession and ownership of all Regulatory Approvals solely relating to the Exploitation of any Terminated Product in the Terminated Countries.
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Assignment of Regulatory Submissions. 5.2.1. Phase II Asset Clinical Trial Regulatory Submissions. a. Clinical Trial Regulatory Submissions. Takeda will remain the Regulatory Lead for the Phase II Ongoing Trials until the IND Transfer Date. Within [***] after the Phase II Ongoing Trials Data Read-Out for both of the Phase II Ongoing Trials, Takeda will transfer and assign to Neurocrine all rights, title, sponsorship, and interests in and to the Phase II Ongoing Trials Regulatory Submissions and assist Neurocrine with such transfer and assignment. The date of such transfer will be the “IND Transfer Date.” Neurocrine will take over as Regulatory Lead for the Phase II Asset on the IND Transfer Date. Prior to or on the IND Transfer Date, Takeda will submit written notification to the FDA informing it of the transfer of the Phase II Ongoing Trials Regulatory Submissions from Takeda to Neurocrine. Takeda will provide reasonable assistance from Takeda’s FTEs at no cost to Neurocrine as set forth in Section 2.8 (Knowledge and Technology Transfer), and Neurocrine will thereafter be responsible and reimburse Takeda for all documented FTE Costs at the FTE Rate and expenses associated with such assistance, to the extent consistent with a detailed budget agreed by the Parties in advance of Takeda’s commencing any particular assistance, and accordingly, Takeda may invoice Neurocrine for the FTE Costs and expenses, in each case, incurred in accordance with such budget in connection with providing such assistance, and Neurocrine will pay the undisputed invoiced amounts within [***] after the date of such invoice. Notwithstanding any provision to the contrary set forth in this Agreement, after the initial [***] FTE hours, Takeda will not be obligated to provide any additional assistance under this Section 5.2.1(a) (Clinical Trial Regulatory Submissions) or Section 2.8 (Knowledge and Technology Transfer) beyond that which can be provided in accordance with the amounts included in the budget agreed by the Parties (as such budget may be updated from time to time by agreement of the Parties).
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Assignment of Regulatory Submissions. Licensee will and hereby does, and will cause its Affiliates and its Sublicensees to, (a) effective as of the effective date of termination, assign to Licensor all of its rights, title, and interests in and to all Clinical Trial data, Regulatory Submissions, and Regulatory Approvals applicable to any Licensed Compounds or Licensed Products and then owned or otherwise Controlled by Licensee or any of its Affiliates or its Sublicensees, and (b) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Licensor to cross-reference and rely upon any Clinical Trial data, Regulatory Submissions, and Regulatory Approvals filed by Licensee or its Affiliates or Sublicensees with respect to any Licensed Product. Licensee will take all reasonable steps necessary to transfer, or will cause its Affiliates and Sublicensees to transfer, ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Licensor, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Licensor) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission or Regulatory Approval.
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Assignment of Regulatory Submissions. With respect to the then-existing Licensed Compounds and Licensed Products in each Terminated Country or the Territory (as applicable), to the extent permitted by Applicable Law, Company will and hereby does, and will cause its Affiliates and Sublicensees (excluding those Sublicensees that enter into a direct license with HUTCHMED pursuant to Section 9.6.2 (Continuation of Sublicenses)) to (a) assign to HUTCHMED all of its rights, title, and interests in and to all Clinical Trial data, Regulatory Submissions and Regulatory Approvals related to such Licensed Compounds and Licensed Products owned or Controlled by Company or any of its Affiliates or its Sublicensees as of the effective date of termination, and (b) take those steps reasonably necessary to transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals to HUTCHMED, including submitting to each applicable Regulatory Authority a letter or other necessary documentation notifying such Regulatory Authority of the transfer of such ownership of such Regulatory Submissions and Regulatory Approvals.
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Assignment of Regulatory Submissions. Ipsen will and hereby does, and will cause its Affiliates and Sublicensees to, (a) assign to Sutro all of its rights, title, and interests in and to all Clinical Trial data, submissions to any Regulatory Authority, Regulatory Approvals, and Pricing and Reimbursement Approvals (where applicable) related to the Licensed Compounds and Licensed Products owned or Controlled by Ipsen or any of its Affiliates or its or their Sublicensees as of the effective date of termination, and (b) take those steps reasonably necessary to transfer ownership of all such assigned regulatory submissions, Regulatory Approvals, and Pricing and Reimbursement Approvals (where applicable) to Sutro, including submitting to each applicable Regulatory Authority a letter or other necessary documentation notifying such Regulatory Authority of the transfer of such ownership of such regulatory submissions, Regulatory Approvals, and Pricing and Reimbursement Approvals (where applicable).
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Related to Assignment of Regulatory Submissions

  • Regulatory Submissions With respect to the Governmental Approvals of the Agreement Products in the Territory: (a) Unless otherwise required by Applicable Law, any Governmental Approvals and any Regulatory Submissions relating to Agreement Products in the Territory shall be filed, owned and held in the name of EVOLUS or its Affiliates. (b) EVOLUS shall be solely responsible, at its expense, and shall use commercially reasonable efforts to timely prepare, file, prosecute, and maintain all Regulatory Submissions relating to Agreement Products in the Territory, including any reports or amendments necessary to maintain Governmental Approvals, and for seeking any revisions of the conditions of each Governmental Approval. (c) EVOLUS shall have sole authority and responsibility and shall use commercially reasonable efforts to develop, modify, seek and/or obtain any necessary Governmental Approvals of any Labeling, packaging, advertising or other promotional or informational materials used in connection with Agreement Products in the Territory, and Promotional Materials and for determining whether the same requires Regulatory Approval. (d) EVOLUS will be the primary contact with the Regulatory Authorities in the Territory and shall be solely responsible for all communications with such Regulatory Authorities that relate to any Regulatory Submission relating to Agreement Products in the Territory prior to and after any Governmental Approval. (e) Subject to the terms and conditions of this Agreement, EVOLUS may file any submissions that are intended to change or modify Labeling or prescribing information approved by Health Canada for the Agreement Products in the field for the Territory; provided that, except as required by Applicable Laws, EVOLUS will provide to the DISTRIBUTOR a draft of such submission at least ten (10) business days prior to a planned submission to the applicable Regulatory Authority and EVOLUS will give reasonable consideration to any comments the DISTRIBUTOR may have. For greater certainty it is acknowledged and agreed that the labeling with respect to Products for distribution in Canada will be different than labeling for Products for distribution in the United States, as a result of among other things, the requirement in Canada to have the label in both English and French languages.

  • COPIES OF REGULATORY REPORTS AND FILINGS Upon reasonable request, Competitive Supplier shall provide to the Town a copy of each public periodic or incident-related report or record relating to this ESA which it files with any Massachusetts or federal agency regulating rates, service, compliance with environmental laws, or compliance with affirmative action and equal opportunity requirements, unless the Competitive Supplier is required by law or regulation to keep such reports confidential. The Town shall treat any reports and/or filings received from Competitive Supplier as confidential information subject to the terms of Article 16. Competitive Supplier shall be reimbursed its reasonable costs of providing such copies.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Regulatory Filing In the event that this Interconnection Service Agreement contains any terms that deviate materially from the form included in Attachment O of the Tariff, Transmission Provider shall file the Interconnection Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff within thirty days after execution. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix 2. An Interconnection Customer shall have the right, with respect to any Interconnection Service Agreement tendered to it, to request (a) dispute resolution under Section 12 of the Tariff or, if concerning the Regional Transmission Expansion Plan, consistent with Schedule 5 of the Operating Agreement, or (b) that Transmission Provider file the agreement unexecuted with the Commission. With the filing of any unexecuted Interconnection Service Agreement, Transmission Provider may, in its discretion, propose to FERC a resolution of any or all of the issues in dispute between or among the Interconnection Parties.

  • Indemnification for Marketing Materials In addition to the foregoing indemnification, the Fund and the Investment Adviser also, jointly and severally, agree to indemnify and hold harmless each Underwriter, affiliates, directors, officers, employees and agents of each Underwriter, and each person, if any, who controls any Underwriter within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act, against any and all loss, liability, claim, damage and expense described in the indemnity contained in Section 6(a), as limited by the proviso set forth therein, with respect to any sales material.

  • Application Submission Submissions of a rental application does not guarantee approval or acceptance. It does not bind us to accept the application or to sign a Lease contact.

  • NOTIFICATIONS AND SUBMISSION OF REPORTS Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this IA shall be submitted to the following entities: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxx Building, Room 5527 000 Xxxxxxxxxxxx Xxxxxx, XX Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000 LFAC: Xxxxxxx X. Xxxxx, DPM 0000 Xxxxxxxxxxx Xx. X-000 Xxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Email: xx.xxxxx@xxxxx.xxx Unless otherwise specified, all notifications and reports required by this IA may be made by electronic mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. Upon request by OIG, LFAC may be required to provide OIG with an additional copy of each notification or report required by this IA in OIG’s requested format (electronic or paper).

  • Notice of Regulatory Action To the extent permitted by applicable Law, each Seller shall promptly notify the applicable Purchaser of any action, claim, inquiry, audit, investigation or examination taken or made by a Government Authority that may affect the conduct of a Serviced Appointment and shall consult with such Purchaser as to any changes in duties or other arrangements hereunder to be taken in connection therewith.

  • Certification Regarding Lobbying Applicable to Grants Subgrants, Cooperative Agreements, and Contracts Exceeding $100,000 in Federal Funds Submission of this certification is a prerequisite for making or entering into this transaction and is imposed by section 1352, Title 31, U.S. Code. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. The undersigned certifies, to the best of his or her knowledge and belief, that: (1) No Federal appropriated funds have been paid or will be paid by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of congress, or an employee of a Member of Congress in connection with the awarding of a Federal contract, the making of a Federal grant, the making of a Federal loan, the entering into a cooperative agreement, and the extension, continuation, renewal, amendment, or modification of a Federal contract, grant, loan, or cooperative agreement.

  • Tax and Regulatory Matters No Buyer Entity or, to the Knowledge of Buyer, any Affiliate thereof has taken or agreed to take any action, and Buyer does not have any Knowledge of any agreement, plan or other circumstance, that is reasonably likely to (i) prevent the Merger from qualifying as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code, or (ii) materially impede or delay receipt of any of the Requisite Regulatory Approvals.

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