FDA Registration. Buyer shall: (a) file an application and/or registration with each appropriate Governmental Authority, including without limitation, the U.S. Food & Drug Administration within seven (7) Business Days after the Closing Date to obtain all approvals reasonably necessary for Buyer to serve as a public cord blood bank and actively engage in the public cord blood business (including the ability to sell any of the Public Cord Blood Inventory) in at least the same manner as conducted by Seller (collectively, the “Cord Blood Approvals”); and (b) use its commercially reasonable efforts to obtain and maintain all of the Cord Blood Approvals.
FDA Registration. The Facility is registered with the FDA pursuant to Section 510 of FFDCA. Dow will keep and maintain records as required by Dow's customary operating guidelines and all applicable Authority including the FFDCA, TSCA, CERCLA and RCRA. Dow retains exclusive ownership and responsibility of all Facility materials, reports and records.
FDA Registration. During the Term, subject to the provisions of Section 4.5, PSS shall apply for, shall use commercially reasonable best efforts to obtain and shall maintain any FDA registrations or approvals and other regulatory registrations and approvals that are required for the performance of its obligations under this Agreement, including but not limited to an FDA Medical Device Registration Certificate if the FDA requires medical device distributors to maintain such certificates. Upon Xxxxxx’x request, PSS shall provide Abbott with copies of all such registrations and approvals. The parties acknowledge their mutual belief that PSS is not required to be registered as a medical device distributor with the FDA as of the Effective Date. If PSS should be required to be registered as a medical device distributor because of its distribution of Products, then PSS and Abbott shall share equally in the cost of such registration. If either Abbott or PSS determines that such registration costs are unacceptable, such party shall give written notice of its intent to terminate this Agreement within thirty (30) days of the effective date of such registration requirement, such termination to take effect sixty (60) days after the effective date of such requirement.
FDA Registration. Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) all domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States are required to be registered with the Food & Drug Administration (FDA) no later than December 12, 2003. This registration includes owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States. All domestic facilities, whether or not food enters interstate commerce, are required to register. Facilities may complete their registration with the FDA online at: xxxx://xxx.xxxxx.xxx.xxx/~furls/ovffreg.html When applicable, by signature affixed on Page 1, the bidder, or their supplier, certifies that they comply with this requirement. NOTICE ON THE USE OF SOCIAL SECURITY NUMBERS AS FEDERAL TAX IDENTIFICATION NUMBERS The Department of Administrative Services (Department) requires vendors and contractors wishing to do business with the State to provide their Federal Taxpayer Identification Number to the Department. The Department does this so that it can perform statutorily required “responsibility” analyses on those vendors and contractors doing business with the State and, under limited circumstances, for tax reporting purposes. If you are a vendor or contractor using your Social Security Number as your Federal Taxpayer Identification Number, please be aware that the information you submit is a public record, and the Department may be compelled by Ohio law to release Federal Taxpayer Identification Numbers as a public record. If you do not want to have your Social Security Number potentially disclosed as a Federal Taxpayer Identification Number, the Department encourages you to use a separate Employer Identification Number (EIN) obtained from the United States Internal Revenue Service’s to serve as your Federal Taxpayer Identification Number. *Indicates update to Contract Analyst. SPECIAL CONTRACT TERMS AND CONDITIONS cont’d DISCLOSURE OF SUBCONTRACTORS / JOINT VENTURES (See Standard Contract Terms and Conditions, Section (roman numeral) V. General Provisions: Paragraph Q.,): List names of subcontractors who will be performing work under the Contract. BD & K Foods (Co-Packer) 000 Xxxxxxx Xx Columbus, GA 31906 By the signature affixed to Page 1 of this Bid, Bidder hereby certifies that the above information i...
