FDA Contacts Sample Clauses

FDA Contacts. From and after the transfer by the Seller to the Acquiror of each Evamist Product Registration held by the Seller or any of its Subsidiaries pursuant to the terms hereof, except as required by applicable Law, the Acquiror shall be solely responsible and liable for (i) taking all actions, paying all fees and conducting all communication with the appropriate Governmental or Regulatory Authority required by Law in respect of such Evamist Product Registration, including preparing and filing all reports (including adverse drug experience reports) and responding to and answering all questions and complaints requested by the appropriate Governmental or Regulatory Authority, (ii) taking all actions and conducting all communication with third parties in respect of Evamist manufactured, tested, used or distributed pursuant to such Evamist Product Registration (whether manufactured, tested, used or distributed before or after transfer of such Evamist Product Registration), including responding to all complaints in respect thereof, including complaints related to tampering or contamination, and (iii) investigating all complaints and adverse drug experiences in respect of Evamist manufactured, tested, used or distributed pursuant to such Evamist Product Registration (whether manufactured, tested, used or distributed before or after transfer of such Evamist Product Registration, as set forth in Section 8.5(e) below). It is understood and agreed that Seller shall be responsible for all foregoing obligations listed in this Section 8.5(d) prior to the transfer of the Evamist Product Registrations and shall use commercially reasonable efforts to timely and appropriately fulfill such obligations.
Sample 1Sample 2Sample 3See All (4)
AutoNDA by SimpleDocs
FDA Contacts. On and after the Closing Date, Horizon shall be responsible for all contacts with the FDA and other regulatory authorities with respect to the Product, and all other responsibilities under the Registrations; provided that either party shall notify the other party immediately, and in no event later than (A) forty-eight (48) hours after receipt of any contact or communication from the FDA or any other Governmental or Regulatory Authority in the Territory and (B) five (5) Business Days after receipt of any contact or communication with any other third party, that in either case, in any way requests or suggests the need for a recall or withdrawal of a lot of Product manufactured by or on behalf of Warnxx-Xxxxxxx xx otherwise calls into question the quality or safety of such a Product lot. Horizon shall be responsible for investigating any such request or suggestion and for any communications with any Governmental or Regulatory Authority relating thereto; provided that Horizon shall comply with all reasonable requests by Warnxx-Xxxxxxx.
Sample 1Sample 2
FDA Contacts. Commencing on the Closing Date, Salix shall be the contact for review and discussion of all promotional materials for the Products with the FDA. In connection with the transfer hereunder of the NDAs, Salix shall file on a timely basis after the Closing Date, all promotional materials for the Products as may be required with the FDA.
Sample 1
FDA Contacts. 55 5.18 Payables................................................................ 56 5.19
Sample 1
FDA Contacts. Prior to the Effective Time, neither Parent nor Merger Sub shall, directly or indirectly, engage in any independent contact with the FDA regarding the Company's pending BLA. Parent shall, however, be entitled to designate, by notice given to the Company, one person to represent the Parent in connection with communications, meetings and correspondence between the Company and the FDA. Such designated representative shall be entitled to participate in all of the Company's scheduled internal planning meetings and post-FDA meeting reviews that cover substantive issues relating to the BLA and shall be entitled to participate as a passive listener on all regularly scheduled telephone conferences between the Company and the FDA that cover substantive issues relating to the BLA. The Company shall provide such designated representative with a copy of all correspondence between the Company and the FDA relating to the BLA and all substantive internal reports and memoranda generated by the Company to the extent the same relate to the BLA. Following mailing by the Company of the Proxy Statement, the aforesaid designated representative of the Parent shall be entitled to attend all meetings between Company representatives and the FDA in person and to actively participate in all regularly scheduled telephone conferences between Company representatives and the FDA. -55- 61 5.18 Payables. From the date hereof through the Closing Date, the Company shall provide to Parent, within ten (10) days of the end of a calendar month, a summary of the outstanding Preclosing Company Payables as of the end of such calendar month, including a summary of any potential or actual disputes regarding such payables. Parent shall have the right to pay any Preclosing Company Payable, in its sole discretion; provided any such payment by Parent shall be deducted from the aggregate value of Stock Consideration included in the Distributable Closing Consideration.
Sample 1
FDA Contacts. On and after the Closing Date, Horizon shall be responsible for all contacts with the FDA and other regulatory authorities in the Territory with
Sample 1
AutoNDA by SimpleDocs

Related to FDA Contacts

  • Contacts The Prime shall be the sole contact with potential customers concerning the Procurement. However, the Subcontractor may contact a potential customer concerning the Procurement, with the prior written approval of the Prime, which shall not be unreasonably withheld.

  • Contact Consultant's principal Company contact: Name: Xxxxxx Xxxxxx Title: President and Chief Executive Officer

  • Project Leaders Within [**] Business Days after the Effective Date, each Party will appoint (and provide written notice to the other Party of the identity of) a senior representative having a general understanding of biopharmaceutical discovery and development issues to act as its project leader under this Agreement (each, a “Project Leader”). The Project Leaders will serve as the contact point between the Parties with respect to the Research Program, and will be primarily responsible for: (a) facilitating the flow of information and otherwise promoting communication, coordination of the day-to-day work and collaboration between the Parties; (b) providing single point communication for seeking consensus internally within the respective Party’s organization; and (c) raising cross-Party or cross-functional disputes in a timely manner. The Project Leaders shall conduct regular telephone conferences as deemed necessary or appropriate, to exchange informal information regarding the progress of the Research Program. Each Party may change its designated Project Leader from time to time upon prior written notice to the other Party. Each Project Leader may designate a substitute to temporarily perform the functions of that Project Leader by prior written notice to the other Party.

  • Review Systems; Personnel It will maintain business process management and/or other systems necessary to ensure that it can perform each Test and, on execution of this Agreement, will load each Test into these systems. The Asset Representations Reviewer will ensure that these systems allow for each Review Receivable and the related Review Materials to be individually tracked and stored as contemplated by this Agreement. The Asset Representations Reviewer will maintain adequate staff that is properly trained to conduct Reviews as required by this Agreement.

  • Customer Relationships The Executive understands and acknowledges that the Company has expended significant resources over many years to identify, develop, and maintain its clients. The Executive additionally acknowledges that the Company’s clients have had continuous and long-standing relationships with the Company and that, as a result of these close, long-term relationships, the Company possesses significant knowledge of and confidential information about its clients and their needs. Finally, the Executive acknowledges the Executive’s association and contact with these clients is derived solely from Executive’s employment with the Company. The Executive further acknowledges that the Company does business throughout the United States and that the Executive personally has significant contact with the Company’s clients and customers solely as a result of Executive’s relationship with the Company.

  • Coordinators 9.1 Any notice required or permitted to be made by either party to this Agreement must be in writing. Notices are effective when received by the appropriate coordinator as demonstrated by reliable written confirmation (for example, certified mail receipt or facsimile receipt confirmation sheet).

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • Management Team Subject to any approval or consulting rights of the --------------- Joint Operations Committee, Manager shall engage or designate one or more individuals experienced in dental group management and direction, including, but not limited to, an administrator, who will be responsible for the overall administration of the Practice including day-to-day operations and strategic development activities.

  • Customer Relations A. Actively promote DCP Holding Company in all Marketing, Sales, Public Relations, and Community activity.

  • Training State Street agrees to provide training, at a designated State Street training facility or at the Designated Locations, to the Fund’s personnel in connection with the use of the System on the Designated Configuration. The Fund agrees that it will set aside, during regular business hours or at other times agreed upon by both parties, sufficient time to enable all operators of the System and the Data Access Services, designated by the Fund, to receive the training offered by State Street pursuant to this Addendum.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!