FDA代理人协议英文

AGREEMENT FOR SERVICES ASUNITED STATES AGENTPursuant to 21 CFR 807.40THIS AGREEMENT is entered into by and between International RegulatoryConsultants,LLC,(hereinafter AGENT),and(请在此写制造商英文名字)，(hereinafter COMPANY)Country:P.R.ChinaWHEREAS AGENT offers regulatory services to medical device companies pursuant tothe United States Food and Drug Administration regulations found at 21 CFR 807.40,(hereinafter the Regulation),requiring appointment of a resident U.S.agent effectiveand,WHEREAS Company wishes to engage the professional services of Agent incompliance with the above said regulation;NOW THEREFORE,for the mutual promises,covenants,and other good and valuableconsideration further described hereinafter,the parties agree as follows:1.TERM:A.This Agreement is effective on the Nov.1,2006,(the Effective Date),and is for aperiod of five years as indicated by the selection made in Section 1(D)below.Termination of the Agreement shall occur on the first,second,or third anniversarycommensurate with said selection.B.This Agreement shall automatically renew each year,unless Company notifies Agentin writing at least sixty (60)days prior to the anniversary of the then current contract.Any renewal hereof shall be at the then current Engagement FeeC.In the event Agent does not intend to renew this Agreement Agent must so notifyCompany of this intent within thirty (30)days of the termination of the then currentcontract.D.The term of this Agreement is for 5 years US Agent Service authorized by Company.on 10/23/2006 11:51 AM1/5Confidential