Legal and Regulatory Filings and Requests. (a) Pfizer shall (a) comply with all regulatory or government licenses and permits, and
(b) comply with all cGMP with respect to its manufacturing and packaging processes, the Facilities or otherwise, to permit the performance of its obligations hereunder. Notwithstanding the foregoing, Pfizer shall use Commercially Reasonable Efforts to obtain the Authorization provided that the Purchaser shall waive, to the extent applicable, all the requirements set out in Attachment H Part 2 of this Agreement in respect of the issue of the Authorization.
Legal and Regulatory Filings and Requests. (a) Manufacturer shall reasonably cooperate with Customer in responding to all requests for information from, and in making all legally required filings with, Governmental Authorities in the Territory having jurisdiction to make such requests or require such filings. Manufacturer shall: (a) obtain and comply with all licenses, consents and permits required under applicable Laws in the Territory (and Manufacturer shall provide Customer with a copy of all such licenses, consents and permits that are material upon Customer’s reasonable request); and (b) comply with all applicable Laws in the Territory with respect to its manufacturing and packaging processes, the Facility or otherwise, to permit the performance of its obligations hereunder. Upon Customer’s request, Manufacturer shall apply for and obtain Certificates of Pharmaceutical Production (“CPP”) from the Governmental Authorities of the country where the Facility is located, such CPPs to be issued to countries where CPPs according to Customer’s opinion are required. Manufacturer shall pay all reasonable costs necessary to obtain such CPPs and be entitled to be reimbursed against invoice by Customer at cost; provided that Manufacturer shall make good faith efforts to consolidate its invoices for such reimbursement for CPPs and submit to Customer on a Fiscal Year quarterly basis.
(b) In the event that Customer wishes to extend the Territory with respect to a certain Product, Customer shall notify Manufacturer of such request and Manufacturer shall consider Customer’s request in good faith. For the avoidance of doubt, in the event that the Parties agree to extend the Territory with respect to a certain Product, any resulting Manufacturing Change shall be treated as a discretionary Manufacturing Change and governed by Section 4.3(a).
Legal and Regulatory Filings and Requests. Eucodis and MDI shall cooperate and be diligent in responding to all requests for information from, and in making all required filings with, regulatory authorities having jurisdiction to make such requests or require such filings. Eucodis shall obtain and comply with all licenses, consents, permits and regulations which may from time to time be required by appropriate legal and regulatory authorities with respect to the performance of its obligations hereunder.
Legal and Regulatory Filings and Requests. Gilead shall cooperate and be diligent in making all required responses to all requests for information from, and in making all legally required responses to, Governmental Authorities having jurisdiction in the Territory to make such requests, pertaining to Manufacture of the Product, and shall provide Eyetech with copies of all such responses. If additional work is required to prepare such information, Gilead shall cooperate with Eyetech in preparing such information at Eyetech's expense, based on agreed to hourly fees established for out-of-scope services. For the avoidance of doubt, Eyetech acknowledges that for responding to requests involving but not limited to non-routine information, development protocols and studies, or additional regulatory documentation or filings, Gilead will be compensated based on the hourly rates set forth in Attachment 1, Section
Legal and Regulatory Filings and Requests. Wellness and Mannatech shall cooperate and be diligent in responding to all requests for information from, and on making all required filings with, regulatory authorities having jurisdiction to make such requests or require such filings. Wellness shall obtain and comply with all licenses, consents, permits and regulations which may from time to time be required by appropriate legal and regulatory authorities with respect to the performance of its obligations hereunder.
Legal and Regulatory Filings and Requests. Except as otherwise agreed to in the Quality Agreements, Manufacturer shall use commercially reasonable efforts to cooperate with Customer in responding to all requests for information from, and in making all legally required filings with, Governmental Authorities having jurisdiction to make such requests or require such filings. Manufacturer shall (a) obtain and comply with all licenses, consents and permits, and (b) comply with all Laws to the extent applicable to its manufacturing and packaging processes, the Facility or for the performance of its obligations hereunder.
Legal and Regulatory Filings and Requests. Sharp and Manufacturer shall cooperate and be diligent in responding to all requests for information from, and in making all required filings, at Manufacturer’s expense, with any Regulatory Authority having jurisdiction to make such requests or require such filings. Sharp shall, at its own expense, obtain and comply with all licenses, consents, permits and regulations which may from time to time be required by an appropriate Regulatory Authority in the Territories listed on Exhibit C (as in effect on the Effective Date) with respect to the performance of its obligations hereunder. The parties agree that in the event additional Territories are added to Exhibit C, the parties xxxx mutually agree the allocation of expenses incurred to obtain and comply with any licenses, consents, permits or regulations with respect thereto.
Legal and Regulatory Filings and Requests. The Contractor shall ensure that all Product is properly labelled and packaged in accordance with the provisions of Article I.6.8 and Good Manufacturing Practice and in accordance with the applicable EU legislation on information on packaging (Title V of Directive 2001/83/EC). Notwithstanding the above, [***]the Contractor shall comply with all conditions (in the relevant timescales) set out in the Authorisation (where applicable), subject to any exemption, exception or waiver of requirements for the Product granted or permitted by the Participating Member State (including but not limited to serialization).
Legal and Regulatory Filings and Requests. Paddock and Axcan Pharma shall cooperate and be diligent in responding to all requests for information from, and in making all required filings with, Governmental or Regulatory Authorities having jurisdiction to make such requests or require such filings. As marketing approval holder, Axcan Pharma shall retain primary responsibility for obtaining and maintaining approval for marketing from the Governmental or Regulatory Authorities in the Territory. Paddock shall, at its expense, obtain and comply with all licenses, consents, permits and regulations which may from time to time be required by appropriate Governmental or Regulatory Authorities with respect to the performance of its obligations hereunder.
Legal and Regulatory Filings and Requests. CEPH shall cooperate and be diligent in responding to all requests for information from, and in making all legally required filings with, the Regulatory Authorities.
