definiens: and replacing such definition with the following words : means each of ( i ) the Distributor 's first issuance of an invoice ( or invoices ) evidencing that the Complete System Sale has occurred and ( ii ) the final written approval by the FDA of the Products for Sales in the United States for any clinical indications for Stem Cell Therapy Applications . " ( iii ) Upon the consummation of the Cobe Share Purchase, Section 4.11(b ) of the Distribution Agreement shall be a mended by deleting the words and replacing such words with the words ) ; ( iv ) Upon the consummation of the Cobe Share Purchase, Section 5.03 of the Distribution Agreement shall be amended by deleting paragraphs 5.03(b ) and 5.03(c ) in their entirety and by redesignating paragraph 5.03(a ) as Section 5.03 ; ( v ) Upon the consummation of the Cobe Share Purchase, Section 7.05(e ) of the Distribution Agreement shall be amended by deleting the words and replacing such words with the words ; and ( vi ) Upon the consummation of the Cobe Share Purchase, Section 7.07(a ) of the Distribution Agreement shall be amended by deleting the words and replacing such words with the words