definiens: shall mean the date of the closing of the transaction transferring SMITH & NEPHEW INC.’sclinical therapies business, including the Product business, to Distributor the principal owners of which are SMITH & NEPHEW, INC . and/or its Affiliates and Essex Woodland Health Ventures and/or its Affiliates . For purposes of theforegoing, of SMITH & NEPHEW, INC . shall mean Affiliates as such term is defined in this Section 22,excluding, however, its clause ( i ) with regard to shall mean the gross amount invoiced by Distributor or its Affiliates for the sale of the Product to thirdparties in the Territory, less ( i ) returns of Products ; ( ii ) sales, use, value - added, excise, or other similar taxes, whichtaxes are included in the gross amount invoiced by Distributor or its Affiliates for the sale of the Product to thirdparties in the Territory ; ( iii ) trade discounts ; and ( iv ) freight and insurance costs . A shall not include [ * * * ], or anytransfer or disposition of the Product for pre - clinical, regulatory or governmental purposes prior to receiving marketingapproval . For purposes of calculating Product shall be considered upon the invoicing of suchProduct by Distributor or Distributor ’s Affiliate to a third party