Transfer of Marketing Authorization Sample Clauses

Transfer of Marketing Authorization. As soon as practicable but no more than sixty (60) days after the Effective Date, Theravance will transfer to Clinigen the relevant Marketing Authorization(s) for the Licensed Product in the Territory. If the transfer of the relevant Marketing Authorization(s) for the Licensed Product is not possible within such sixty (60) day period, then Theravance and Clinigen will use Diligent Efforts to complete the transfer as promptly as possible thereafter. For the purpose of such transfer, Theravance shall transfer or assign the Marketing Authorization(s) for the Licensed Product to Clinigen and/or cause that Marketing Authorization(s) for the Licensed Product to issue in the name of Clinigen. Theravance shall execute and deliver all documents reasonably necessary to effect that transfer, assignment or issuance, and take all actions reasonably necessary to effect that transfer, assignment or issuance. Theravance hereby appoints Clinigen as Theravance’s attorney-in-fact, with full power of substitution, to execute, deliver and file in Theravance’s name any documents and take any actions reasonably necessary or desirable to transfer or assign any Marketing Authorization(s) for the Licensed Product to Clinigen or cause any Marketing Authorization(s) for the Licensed Product to issue in the name of Clinigen. It is expressly agreed that any communication with Governmental Authorities within the Territory (including but not limited to the EMA) after the Effective Date by Theravance or any other entity acting in the name or on behalf of Theravance requires the prior written approval of Clinigen. After the transfer, Clinigen will be the Marketing Authorization holder and will maintain such Marketing Authorization. Should there be a variation in the FDA approval that would necessitate a variation in Marketing Authorization(s), Theravance must inform Clinigen as soon as practicable, but not more than fifteen (15) days after such variation has become effective. Following the expiration of the Term, and except for such Countries (if any) for which Clinigen has exercised the Post-Term Option, Clinigen will transfer the relevant Marketing Authorization(s) to Theravance or Theravance’s designee in the Territory and Theravance or Theravance’s designee will become the Marketing Authorization holder for such Marketing Authorization(s).
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Transfer of Marketing Authorization. Chiesi shall procure the transfer of the Marketing Authorization currently held by [***] in the Territory to Cornerstone using Cornerstone Regulatory Counsel as of [***] (the “Transfer Date”). All expenses related to Marketing Authorization transfer procedures shall be borne by Cornerstone.
Sample 1
Transfer of Marketing Authorization. Upon issuance of the Marketing Authorization, Chiesi shall instruct its counsel to effect the transfer thereof to Cornerstone no later than thirty (30) days after such issuance (the “Transfer Date”). All expenses related to the transfer shall be borne by Cornerstone. Furthermore, Chiesi will make available to Cornerstone, copies of any and all Product regulatory data (including manufacturing, clinical and/or preclinical data) filed in the Territory.
Sample 1
Transfer of Marketing Authorization. Zogenix shall be the marketing authorization holder of the Product in the Territory for the [***] following Regulatory Approval of the Product in the Territory. Thereafter, Zogenix shall transfer the marketing authorization for the Product in the Territory to Distributor within [***] following [***], unless delayed or prohibited by a Regulatory Authority or Applicable Law or otherwise agreed by the Parties. Upon the transfer of the marketing authorization of the Product in the Territory to Distributor, then Distributor shall be deemed the MAH Party for purposes of this Agreement and Zogenix shall be deemed the Non-MAH Party.
Sample 1
Transfer of Marketing Authorization. Promptly following receipt of the initial Marketing Authorization in countries in the European Union, ****, in order to enable **** to negotiate price, package, distribute, market and sell the Products in the Territory. In addition, **** shall remain responsible for all payments due to all relevant Regulatory Authorities until transfer of all such Marketing Authorizations to ****. **** will **** for the governmental filing **** for the Products in the European Union, payable within **** days following receipt of **** invoice and reasonable supporting documentation.
Sample 1
Transfer of Marketing Authorization. [***], Biologix shall immediately transfer, without compensation, to Amarin or Amarin’s designees any Marketing Authorization documentation, licenses, permits and any other official approvals required for the importation, sale and distribution of Product in the Field in the Territory, including, the original documents relating thereto to ensure such transfer is effective on such expiration or termination date (or where such transfer is not Applicable Law, surrender the same and use its best efforts to ensure that Amarin obtains or Amarin’s designee obtains equivalent Product Registrations), if not already in Amarin’s name. Biologix shall promptly execute all documents reasonably required by Amarin in connection with such transfer or surrender and comply with Amarin’s instructions.
Sample 1
Transfer of Marketing Authorization 
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Related to Transfer of Marketing Authorization

  • 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.

  • 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;

  • 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.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Regulatory Approvals; No Defaults (a) No consents or approvals of, or waivers by, or filings or registrations with, any Governmental Authority are required to be made or obtained by HCBF or any of its Subsidiaries in connection with the execution, delivery or performance by HCBF of this Agreement or to consummate the transactions contemplated by this Agreement, except as may be required for (i) filings of applications and notices with, and receipt of consents, authorizations, approvals, exemptions or nonobjections from, the SEC, NASDAQ, state securities authorities, the Financial Industry Regulatory Authority, Inc., applicable securities, commodities and futures exchanges, and other industry self-regulatory organizations (each, an “SRO”), (ii) filings of applications or notices with, and consents, approvals or waivers by the FRB, the FDIC and applicable state banking agencies, the Office of the Comptroller of the Currency (the “OCC”), the Florida Office of Financial Regulation (the “FOFR”) and other banking, regulatory, self-regulatory or enforcement authorities or any courts, administrative agencies or commissions or other Governmental Authorities and approval of or non-objection to such applications, filings and notices (taken together with the items listed in clause (i), the “Regulatory Approvals”), (iii) the filing with the SEC of the Proxy Statement-Prospectus and the Registration Statement and declaration of effectiveness of the Registration Statement, (iv) the filing of the Articles of Merger and the filing of documents with the OCC, applicable Governmental Authorities, and the Secretary of State of the State of Florida to cause the Bank Merger to become effective and (v) such filings and approvals as are required to be made or obtained under the securities or “Blue Sky” laws of various states in connection with the issuance of the shares of CenterState Common Stock pursuant to this Agreement and approval of listing of such CenterState Common Stock on the NASDAQ. Subject to the receipt of the approvals referred to in the preceding sentence and the Requisite HCBF Shareholder Approval, the execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby by HCBF do not and will not (1) constitute a breach or violation of, or a default under, the articles of incorporation, bylaws or similar governing documents of HCBF or any of its respective Subsidiaries, (2) violate any statute, code, ordinance, rule, regulation, judgment, order, writ, decree or injunction applicable to HCBF or any of its Subsidiaries, or any of their respective properties or assets, (3) conflict with, result in a breach or violation of any provision of, or the loss of any benefit under, or a default (or an event which, with or without notice or lapse of time, or both, would constitute a default) under, result in the creation of any Lien under, result in a right of termination or the acceleration of any right or obligation under any permit, license, credit agreement, indenture, loan, note, bond, mortgage, reciprocal easement agreement, lease, instrument, concession, contract, franchise, agreement or other instrument or obligation of HCBF or any of its Subsidiaries or to which HCBF or any of its Subsidiaries, or their respective properties or assets is subject or bound, or (4) require the consent or approval of any third party or Governmental Authority under any such Law, rule or regulation or any judgment, decree, order, permit, license, credit agreement, indenture, loan, note, bond, mortgage, reciprocal easement agreement, lease, instrument, concession, contract, franchise, agreement or other instrument or obligation.

  • Waiver of Notice; Approval of Meeting; Approval of Minutes The transactions of any meeting of Limited Partners, however called and noticed, and whenever held, shall be as valid as if it had occurred at a meeting duly held after regular call and notice, if a quorum is present either in person or by proxy. Attendance of a Limited Partner at a meeting shall constitute a waiver of notice of the meeting, except when the Limited Partner attends the meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened; and except that attendance at a meeting is not a waiver of any right to disapprove the consideration of matters required to be included in the notice of the meeting, but not so included, if the disapproval is expressly made at the meeting.

  • Government Authorization No consent, approval, order or authorization of, or registration, declaration or filing with, or notice to, any Governmental Entity, is required by or with respect to Pubco in connection with the execution and delivery of this Agreement by Pubco, or the consummation by Pubco of the transactions contemplated hereby, except, with respect to this Agreement, any filings under the Nevada Statutes, the Securities Act or the Exchange Act.

  • 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.

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