definiens: GMP " means, as relevant to the Products, the principles and guidelines of good manufacturing practice as contained in either directive 91/356 / EEC ( medicinal products for human use ) or directive 911412 / EEC ( medicinal products for veterinary use ), as such principles and guidelines are interpreted and expanded in " The Rules Governing Medicinal Products in the European Community, Volume IV . Good Manufacturing Practice for medicinal Products " or, with respect to Products explicitly ordered for disttibution or sale in jurisdictions not subject to the foregoing, good manufacturing practices reasonably sufficient to satisfy the cOlTesponding requirements of Competent Authorities in such jurisdictions . " { 00091142.DOC.2)6 CONFIDENTIAL TREATMENT REQUESTED BY BIODELIVERY SCIENCES INTERNATIONAL, INC . ; IRS EMPLOYER IDENTIFICATION NUMBER 35 - 2089858 b. Section 2 shall be amended by replacing the first sentence thereof in its entirety with the following sentence : " This Agreement shall be effective for a period begilming on the Effective Date and continue until the earlier of ( i ) any termination of the License Agreement other than a termination by BDSI under Section 13.03A thereof, ( ii ) an Arius Two Termination Event ( as defined in that celiain Sublicensing Consent between Arius Two, Inc. ( ), Arius, and Meda dated August 2, 2006 ), ( iii ) a CDC Tennination Event ( as defined in that certain Sublicensing Consent and Amendment between Parent, Arius, and CDC dated August 2,2006 ) ( termination of this Agreement resulting from the occurrence of the events described in clause ( ii ) above or this clause ( iii ), a ), ( iv ) upon written notice of termination by Meda if, following expiration of the last to expire of the Licensed Patent Rights in the European Countries, the Minimum Unit Price exceeds thirty - three per cent ( 33 % ) of Meda 's weighted average Net Sales per UniOn a particular calendar quarter for the European Countries, and if the parties are unable to reach, after discussing in good faith a mutually­agreeable revision to the economic terms of this Agreement and the License Agreement with respect to the European Countries, such an agreement within thirty ( 30 ) days of initiating such discussions, or ( v ) upon written notice of termination by Meda if, following expiration of the last to expire of the Licensed Patent Rights in the European Countries, the Minimum Unit Price exceeds thirty - three per cent ( 33 % ) of Meda 's weighted average Net Sales per Unit in a particular calendar quarter for that portion of the Territorv other than the European Countries, and if the parties are unable to reach, after discussing in good faith a mutuallv - agreeable revision to the economic terms of this Agreement and the License Agreement with respect to that portion of the Territory other than the European Countries, such an agreement within thirty ( 30 ) days of initiating such discussions, provided that, notwithstanding anything to the contrarv, ( a ) any termination pursuant to clause ( iv ) above shall only be effective with respect to the European Countries and ( b ) any termination pursuant to clause ( v ) above shall only be effective with respect to that portion of the Territory other than the European Countries . " 3 . Fee . Meda shall pay to BDSI, upon execution of this LA, a non - refundable, non - creditable payment ofUS$3,000,000 in United States dollars by wire - transfer of immediately available funds to an account designated by BDSI