definiens: shall mean Mesalamine, USP ; 1.1.2 means, with respect to any Person, any other Person controlling, controlled by orunder direct or indirect common control with such Person . A Person shall be deemed to controlanother Person if such Person possesses, directly or indirectly, the power to direct or cause thedirection of the management and policies of such other Person, whether through the ownership ofvoting securities, by contract or otherwise ; 1.1.3 means [ * * ] or such other supplier of Active Ingredient designated inwriting by Axcan Pharma from time to time ; 1.1.4 means the certificate prepared by Paddock in respect of each Productlot for in - process testing, which shall ( i ) list any and all in - process test methods performed byPaddock in respect of said Product lot and ( ii ) any and all test results obtained ; 1.1.5 means the certificate prepared by Paddock in respect of eachProduct lot which shall certify that such Product lot was manufactured in accordance with theSpecifications and cGMP ; 1.1.6 means the regulatory standards for current good manufacturing practices established byeach Governmental or Regulatory Authority relating to the supply of the Products including, butnot limited to, standards for equipment, facilities, production and quality control ; 1.1.7 means Paddock ’s manufacturing facility located at 3940 Quebec Avenue North, Minneapolis, Minnesota 55427, and, subject to Axcan Pharma ’s prior written approval ( whichapproval shall be conditioned upon Paddock providing a detailed transfer plan acceptable toAxcan, acting reasonably ), such other facilities to be used by Paddock in the supply of Productsor materials utilized in the supply of Products hereunder ; 1.1.8 means any court, tribunal, arbitrator, agency, commission, official or other instrumentality of any U.S. federal, state, county, city or otherpolitical subdivision including, without limitation, the United States Food and Drug Administration, as well as any court, tribunal, arbitrator, agency, commission or other instrumentality of anyCanadian federal, provincial or municipal government including, without limitation, the HealthProducts and Food Branch Inspectorate of Health Canada, as well as similar entities located inthe Territory ; 1.1.9 means trademarks, trademark applications, trade names, service marks, brand names, patents, slogans, logos, copyrights, trade dress, know - how, trade secrets, industrialsecrets and any right to the foregoing ; 1.1.10 means any law, statute, rule, regulation, ordinance, code, guideline, order, directive, decree or other pronouncement having the effect of law ( including, without limitation, common lawand cGMP ) of any applicable Governmental or Regulatory Authority ; 1.1.11 means all raw materials, ingredients, packaging materials and any other materialsused in the manufacture and packaging of Products by Paddock, other than the Active Ingredient ; 1.1.12 means any individual, corporation, company, partnership, trust, incorporated orunincorporated association, joint venture or other entity of any kind, including, without limitation, aGovernmental or Regulatory Authority ; 1.1.13 means a one ( 1 ) gram Mesalamine Suppository, in finished and packaged form, asmore specifically identified on Exhibit A ; -2- 1.1.14 means the quality agreement referred to in paragraph 4.14 and entered intobetween Axcan Pharma and Paddock concurrently with the execution of this Agreement, a copyof which is attached as Exhibit E ; 1.1.15 means those efforts that would be made by a reasonablyprudent businessperson acting in good faith and in the exercise of reasonable commercialjudgment under the applicable circumstances ; 1.1.16, with respect to any Product, means a, or, asthose terms are defined in 21 CFR 7.3 and in the equivalent provisions of the Canadian legislation, as the same may be amended from time to time, and shall include any post - sale warning ormailing of information regarding such product ; 1.1.17 means the Specifications for the Product attached hereto as Exhibit B and thepackaging and labelling specifications provided in accordance with paragraph 2.9.4 ; 1.1.18 shall mean the United States, its territories and possessions and Canada, and suchother countries as the parties may from time to time agree in writing to add to this Agreement