definiens: competitor shall mean any organization which regularly engages in the contract development andlor contract manufacture of injectable controlled release drug delivery systems comprising a polymeric excipient based on lactic andlor glycolic acids andlor other closely related monomers . This Section 4(b ) specifically supercedes Section 7(B ) of the Development Agreement, which Section 7(B ) shall be of no further force or effect ( c ) The right of first refusal granted to [COMPANY] pursuant to Section 4(b ) above shall be contingent upon : ( i ) [COMPANY] and [COMPANY] reaching an agreement concerning the financing, scheduling and construction in Europe of a [COMPANY] manufacturing facility within twelve ( 12 ) months of the date first above written or the initiation of Phase m human clinical trials, whichever is later, and ( ii ) prior to the qualification of [COMPANY] ' s European manufacturing facility, [COMPANY] using reasonable efforts to supply from its United States manufacturing facilities all of [COMPANY] 's commercial requinnents for Product pursuant to the Product Supply Agreement anticipated by Section 7 ( A ) of the Development Agreement