definiens: shall mean in relation to any undertaking and any circumstance, the exercise of that degree of skill, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances ; 1.1.20 shall mean all governmental and regulatory bodies, agencies, departments or entities that regulate, direct or control commercial and other related activities in the Territory, including any relevant government health authority ( or successor agency thereof ) in any country or countries in the Territory whose approval is necessary to market the Finished Product in such country or countries in the Territory ; 1.1 .21 shall mean all indications in men, including hypogonadism ; 1.1 .22 shall mean, in relation to either Party, any one of the following : ( a ) a notice shall have been issued to convene a meeting for the purpose of passing a resolution to wind up that Party or such resolution shall have been passed other than a resolution for the solvent reconstruction or reorganisation of that Party or for the purpose of inclusion of any part of the share capital of that Party in the Official List of the London r Stock Exchange or in the list of the American Stock Exchange or quotation of the same on the National Association of Securities Dealers 6 Signature Copy Automated Quotation System or any other international stock exchange or an application by that Party for registration as a public company in accordance with the requirements of the Companies Act 1985 ; or ( b ) a resolution shall have been passed by that Party 's directors to seek a winding up or an administration order or a petition for a winding up or administration order shall have been presented against that Party which, in the case of a petition presented against a Party, shall not have been appealed within 7 days ofhaving been lodged or such an order shall have been made and shall have been dismissed within thirty ( 30 ) days thereafter ; or ( c ) a receiver, administrative receiver, receiver and manager, interim receiver, custodian, sequestrator or similar officer is appointed in respect of that Party or over a substantial part of its assets or any third party takes steps to appoint such an officer in respect of that Party or an encumbrancer takes steps to enforce and enforces its security which shall not have been dismissed by a court of competent jurisdiction within thirty ( 30 ) days thereafter ; or ( d ) a proposal for a voluntary arrangement shall have been made in relation to that Party under Part I Insolvency Act 1986 ; or ( e ) a step or event shall have been taken or arisen outside the United Kingdom which is similar or analogous to any of the steps or events listed at ( a ) to ( d ) above in the case of Columbia under the laws of Bermuda and in the case of Columbia Laboratories Inc under the laws ofUSA but for avoidance of doubt including in the case ofColumbia Laboratories, Inc. filing of a petition under the US Bankruptcy Code including a filing under Chapter 11 proceedings, which, in the case of a filing made against a Party, shall not have been appealed within 7 days of having been lodged or such an order shall have been made and dismissed within thirty ( 30 ) days thereafter ; or 7 Signature Copy ( f ) that Party takes any step ( including starting negotiations ) with a view to readjustment, reschedulin g or deferral of any part of that Party 's indebtedness, or proposes or makes any general assigmnent, composition or arrangements with or for the benefit of all or some of that Party 's creditors or makes or suspends or threatens to suspend making payments to all or some of that Party 's creditors or the Party submits to any type of voluntary arrangement ; or ( g ) where that Party is resident in the United Kingdom it is deemed to be unable to pay its debts within the meaning of Section 123 Insolvency Act 1986 ; 1.1.23, or shall mean all labels and other written, printed or graphic matter upon ( i ) the Product or any container or wrapper utilized with the Product, or ( ii ) any written material accompanying the Product, including, without limitation, package inserts and patient information leaflet ; 1.1.24 shall mean t C9 1.1.25 or means any Regulatory Approval for Finished Product granted by the Governmental Authority of any country of the Territory as the same may be varied from time to time during the Term ofthis Agreement ; 1.1.26 means the minimum purchase requirements set out in Exhibit D as the same may be amended from time to time during the tenn of this Agreement under the provisions of Clause 7.5 ; 1.1.27 means the Regulatory Application for Product which is a new drug application submitted by Columbia Laboratories, Inc. with the FDA on August 19 2002 ; 1.1.28 with respect to Finished Product shall mean the gross amount received by a Party, its Affiliates or sub - licensees for sale of Finished Product to unrelated third parties less : ( a ) quantity, trade andior cash discounts actually granted ; ( b ) amounts repaid or credited and allowances including cash, credit or free goods allowances, given by reason of chargebacks, retroactive price reductions or billing errors and rebates ( including government - mandated rebates ), actually allowed or paid ; ( c ) amounts refunded or credited for Finished Product which was rejected, spoiled, damaged, outdated or returned ; ( d ) freight, shipment and insurance costs incurred transporting Finished Product to a third party purchaser ; ( e ) taxes, tariffs, customs duties and surcharges and other governmental charges incurred in connection with the sale, exportation or importation of Finished Product Subject to the foregoing provisions if there are any other issues surrounding the calculation of Net Sales these shall to the extent possible be detennined in accordance with UK GAAP or its successor