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.
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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.
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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
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FDA Contacts. 55 5.18 Payables................................................................ 56 5.19
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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.
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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.
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Related to FDA Contacts

  • Customer Contacts CLEC, or CLEC's authorized agent, are the single point of contact for its End User Customers' service needs, including without limitation, sales, service design, order taking, Provisioning, change orders, training, maintenance, trouble reports, repair, post-sale servicing, Billing, collection and inquiry. CLEC will inform its End User Customers that they are End User Customers of CLEC. CLEC's End User Customers contacting Qwest will be instructed to contact CLEC, and Qwest's End User Customers contacting CLEC will be instructed to contact Qwest. In responding to calls, neither Party will make disparaging remarks about the other Party. To the extent the correct provider can be determined, misdirected calls received by either Party will be referred to the proper provider of Local Exchange Service; however, nothing in this Agreement shall be deemed to prohibit Qwest or CLEC from discussing its products and services with CLEC's or Qwest's End User Customers who call the other Party. 10.1 In the event Qwest terminates Service to CLEC for any reason, CLEC will provide any and all necessary notice to its End User Customers of the termination. In no case will Qwest be responsible for providing such notice to CLEC's End User Customers.

  • Contacts 1. Florida Housing’s contract administrator for this Agreement is: Contract Administrator Florida Housing Finance Corporation 000 Xxxxx Xxxxxxxx Xx., Xxxxx 0000 Xxxxxxxxxxx, Xxxxxxx 00000-0000 Phone: 000.000.0000 E-mail: Xxxxxxxx.Xxxxx@xxxxxxxxxxxxxx.xxx 2. The Florida Housing program contact for this Agreement is: Xxxxx X. Xxx, Director of Asset Management & Guarantee Program Florida Housing Finance Corporation 000 Xxxxx Xxxxxxxx Xx., Xxxxx 0000 Xxxxxxxxxxx, Xxxxxxx 00000-0000 Phone: 000.000.0000 E-mail: Xxxxx.Xxx@xxxxxxxxxxxxxx.xxx or the designated successor. 3. The Grantee’s contract administrator for this Agreement is: Xxxxx Xxxxx, Manager 0000 Xxxxxxxx Xxxxxx Xxxxxxx, Xxx. X Xxxxxxxx, XX 00000 Phone: (000) 000-0000 E-mail: Xxxxx.xxxxx@xxxxxxxxxx.xxx or the designated successor. 4. All written approvals referenced in this Agreement shall be obtained from the parties’ contract administrator or their respective designees. 5. All notices shall be given to the parties’ contract administrator.

  • Customer Contact During the delivery phase of a Project Supplier may have direct communication with a Customer, limited solely to those communications necessary to affect provision of Services and/or Deliverables.

  • Contact If You have any concerns or questions to this Agreement, please contact Us at xxxxxxx@xxxxxxxxxxxx.xxx.

  • Operational Contacts Each Interconnection Party shall designate, and provide to each other Interconnection Party contact information concerning, a representative to be responsible for addressing and resolving operational issues as they arise during the term of the Interconnection Service Agreement.

  • Authorized Contacts LightEdge Solutions provides reliable and secure managed services by requiring technical support and information requests come only from documented, authorized client-organization contacts. Additionally, in compliance with federally regulated CPNI (Customer Proprietary Network Information) rules, a customer contacting LightEdge Solutions to request an add, move, or change and/or to request information on their account, must provide LightEdge representative with customer’s Code Word. Code Word is not required or verified to open trouble tickets related to service issues, however, any subsequent information/updates or authorization of intrusive testing related to the trouble ticket will require the Code Word. Customer shall provide a “contact list” which will contain one (“1”) Administrative contact and may contain up to three (“3”) Technical contacts per service. Administrative and Technical contacts are authorized to request service changes or information, including the contact name, contact e-mail address and contact phone number for each contact but must provide customer Code Word for any CPNI related requests. Requests to change a contact on the list or to change the Code Word must be submitted by the Administrative contact. Requests to replace the Administrative contact shall be submitted via fax to LightEdge on customer company letterhead. All requests are verified per procedure below.  Requests for CPNI, configuration information or changes are accepted only from documented, authorized client-organization contacts via e-mail, fax or phone and will require Customer’s Code Word. E-mail and fax requests must be submitted without the Code Word. Customer contact will be called to verify Code Word. E- mail requests that include the Code Word will be denied and the client Administrative Contact will be notified and required to change the Code Word.  E-mail and fax requests are verified with a phone call to the documented client contact. Phone call requests must be validated with an e-mail request from a documented client contact.

  • Primary Contacts The Parties will keep and maintain current at all times a primary point of contact for this contract. The primary contacts for this this Contract are as follows:

  • Abuse Contact Registry Operator shall provide to ICANN and publish on its website its accurate contact details including a valid email and mailing address as well as a primary contact for handling inquiries related to malicious conduct in the TLD, and will provide ICANN with prompt notice of any changes to such contact details.

  • Communications and Contacts The Institution: [NAME AND TITLE OF INSTITUTION CONTACT PERSON] [INSTITUTION NAME] [ADDRESS] [TELEPHONE NUMBER] [FACSIMILE NUMBER] The Contractor: [NAME AND TITLE OF CONTRACTOR CONTACT PERSON] [CONTRACTOR NAME] [ADDRESS] [TELEPHONE NUMBER] [FACSIMILE NUMBER] All instructions, notices, consents, demands, or other communications shall be sent in a manner that verifies proof of delivery. Any communication by facsimile transmission shall also be sent by United States mail on the same date as the facsimile transmission. All communications which relate to any changes to the Contract shall not be considered effective until agreed to, in writing, by both parties.

  • Emergency Contact Information Resident must complete and provide to University an emergency contact information form provided by University Housing before Resident will be allowed to move into the Residence Facility.

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