definiens: means the period of twelve ( 12 ) mon ths from the Effective Date and each consecutive period of twelve ( 12 ) months thereafter except that the last Contract Year of this Agreement shall expire on the expiry o r termination of this Agreement ; means the date of this Agreement as specified on pa ge 4 ; means the small molecule tyrosine kin ase inhibitor known as Tucatinib, in tablet form ; means the European Medicines Evaluation Agency ; means the U.S. Food and Drug Administration ; shall have the meaning set out in Section 3.2 ; means in relation to either Party, any unforeseen circumstances beyond the reasonable control of that Party which directly pre vents or has a material adverse effect on that Party ’s performance of this Agreemen t ( includi ng without limitation any acts or restraints of governments or public aut horities, war, revolution, riot, civil commotion, breakdown of facility or equipment, shortage of raw materials or utilities, extreme weather conditions including excessive rain fall or atmospheric changes ) ; shall have the meaning set out in Section 3.1 ; means any Intellectual Property first created, made, conceived, discovered or reduced to practice as a direct or indirect result of the performance by the Parties of their respective obligations under this Agreemen t ( excluding any know how of general application ) ; means any Foreground which may be useable by the Su pplier in its general business and is capable of exploitation without usi ng or infringing any of the Background of the Purchaser ; means the ICH Harmonised Tripartite Guidel ine, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7A, as amended from time to time ; means such laboratory as shall be mutually agreed b etween the Parties as shall be used for the purpose of Section 22.3 ; means patents, trademarks, service marks, design ri ghts ( whether capable of registration or otherwise ), including applications for any of the foregoing, copyright, know- how, trade or business names and other similar righ ts or forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist anywhere in the world, wheth er capable of registration or not ; means all licences necessary for or required in con nection with the manufacture of the Product at the Manufacturing Site ; means the manufacturing facility of the Supplier at [ * ] or such other manufacturing facility of the Supplier as shall have been approve d in writing by the Purchaser for the manufacture of the Product under this Agreement ; means the raw materials ( including Star ting Materials ) and components used in the manufacture of the Product ; shall have the meaning set out in Section 3 .1 ; means the Producer Price Index for [ * ] or such other index as the Parties may agree in writing ; means the price of the Product as stated in Schedule 1 ( including costs of Materials and conversion costs ) and calculated pursuant to Se ction 6 ; means the product under Purchaser ’s product code [ * ] and Supplier ’s product code [ * ] in such form as is necessary per the current effective Specification to commence the next step in, or stage of, the supply chain therefor ; means, for each batch of the Product, the Certifica te of Compliance, the Certificate of Analysis, and the Batch Records ( inc luding analytical testing data, if any ) ; means each and every product lice nce, marketing authorisation or any other authorisation(s ) ( as the case may be ) relating to t he marketing, sales and/or distribution of any End -Product ; " Purchaser Indemnitees means the Purchaser, a relevant Affiliate, licensee, sublicensee or collaboration partner and its respective officers, directors, emp loyees and agents ; means a quality agreement to be agreed between the Parties as soon as practicable but in no event later than [ * ] days following the execution of this Agreement, describing the quality assurance responsibilities a nd obligations of the Parties for the manufacture of the Product ; means any relevant Authority which regu lates any aspect of the manufacture of the Product and/or the sale or marketing of any End -Product ; means for the purpose of Section 11 the appropriate member of the Supplier ’s Quality Unit appointed to carry out the activity in question in accordance with Applicable Law ; means the specification for the Product as identifi ed in Schedule 2, as may be amended from time to time in accordance with Sectio n 2.6 ; means [ * ] complying with the current effective specification for the Starting Material ; means the Supplier, its Affiliates, and its and the ir respective officers, directors, employees and ag ents ; means the term of this Agreement specified u nder Section 27.1 ; and [ * ] means [ * ]