definiens: shall have the meaning as defined in Section 24.1 ; 1.25 shall mean any Infonnation generated or conceived, during the Term, exclusively by employees of or consultants to Bradley or its Affiliates or Sublicensees ; 2 1.26 shall have the meaning as defined in Section 1 0.1.2 ; 1.27 has the meaning as defined in Section 10.5 ; 1.28 shall mean, collective1y . all licenses and sublicenses granted to Bradley under Sections 2.1, 22, 2.3,2.4 and 2.5 ofthi5 Agreement ; 1.29 shall mean all Information obtained from or arising out of market research activities and market surveillance studies, relating to any Product, that are conducted by Bradley ; 1.30 shall have the meaning as defined in Section 4.1 ; 1.31 shall have the meaning as defined in Section 4.1 ; 1.32 shall mean, collectively, the Bradley IPR, the Bradley Information and any Patents covering the Bradley IPR ; 1.33 shall mean, with respect to any Jointly - Funded Product, the budget for the Development and Registration Costs relating to such Jointly - Funded Product, as contained in the Development Plan, if any, relating thereto, and as the same may be amended from time to time by the JSC ; 1.35 shall have the meaning as defined in Section 11.9 ; 1.36 '' CIN '' shall mean cervical intraepithelial neoplasia ; 1.37 shall mean and U : tclude any claim, cause of action or lawsuit ; 1.38 shall mean a pharmaceutical product containing both API and one or more other products ( other than Products ) now or hereafter sold by Bradley ; 1.39 means, collectively, any and all infonnation that is not in the public domain ( regardless whether the same shall be oral, written or electronically or magnetically encoded ) relating to the business affairs of either Bradley or [COMPANY], as the case may be, including without limitation proprietary data, Imow - how, databases, copyrights, regulatory submissions, practices, methods, techniques, specifications, product development plans, marketing plans, unpatented technical infonnation, trade secrets, fonnulations, compounds, compositions, fonnulae and the like ( including all infonnation obtained in pre­clinical and clinical trials and market surveillance studi~, and in the pursuit of other activities by the Parties under this Agreement ) ; 1.40 shall mean each twelve ( 12 ) month period, beginning on the day and month of the Effective Date and ending on the day immediately preceding the anniversary of the Effective Date, during the Tenn hereof ( for example, if the Effective Date is May I, 2005, each hereunder shalliJegin on May 1st and end on the following April 30th ) ; 1.41 means, with respect to an item of Infonnation or an Intellectual Property right, possession of the ability, whether by ownership or license, to grant a license or sublicense under such item or right, as provided for herein, without violating the tenns of any contract with any Third Party ; 1.42 shall hav~ the meaning as defined in Section 5_11 ; 1.43 shall have the meaning as defined in Section 5.11 ; 3 1.44 shall have the meaning as defined in Section t 05 ; 1.45 shall have the meaning as defined in Section 10.7.2 ; 1.46 shall mean, with respect to any given Jointly - Funded Product, any Party who shall, in accordance with the terms of this Agreement, be charged with performing any Development and Registration Activities relating thereto ; 1.47 shall mean, ( a ) with respect to any Jointly - Funded Product, ( i ) any and all activities specifically prescribed in the Development Plan relating to such Product and ( ii ) any and all activities necessary or reasonably appropriate in connection with the implementation of such Development Plan and ( b ) with respect to any other product, any activities associated with the development of such product and the obtaining of any Market Approvals with respect thereto ; 1.48 shall mean any reasonable costs and expenses incurred by a Development Party in connection with Development and Registration Activities undertaken by it with respect to a Jointly - Funded Product in accordance with this Agreement and the Development Plan relating thereto, consisting of ( to the extent they meet the above description ): 1.48.1 All fees paid to any external consultants, external service providers or other subcontractors ; 1.48.2 Development and Registration FTE Costs ; 1.48.3 Pre - clinical and clinical out-<>f·pocket supply costs ; 1.48.4 all out - of - pocket costs and expenses incurred in connection with ( a ) manufacturing process, fonnulation and delivery system development and validation, ( b ) manufacturing scale - up and improvements, ( c ) stability testing, ( d ) quality assurance / quality control, ( e ) qualification and validation of Third Party contract manufacturers, if any, and ( f ) establishing -a primary or secondary source supplier, including, without limitation, the transfer of process and manufacturing technology and analytical methods, scale - up, equipment and method and process validation, and initial manufacturing licenses, approvals and inspections ; 1.48.5 all out - of - pocket costs associated ' with the submission to the relevant Governmental Authority of an application seeking any Market Approval or pricing or reimbursement approval and with the subsequent maintenance of such approvals, and shall include, without limitation, any testing application, marketing authorization application, supplementary application or variation thereof, IND or NDA ; 1.48.6 any other out - of - pocket costs or expenses specifically identified and included in the relevant Development Plan ; 1.48.7 any out - of - pocket costs or expenses -incurred in connection with any post - Market Approval activities ( including but not limited to any Market Approval Clinical Trials ) on which the granting of a Market Approval is conditioned ; and 1.48.8 The Parties acknowledge that there are two types of Development and Registration Costs : Development and Registration FTE Costs ( described in Section 1.49 ) and Development and Registration Out­of - Pocket Costs ( all other costs ) ; 1.49 shall mean those DeVelopment and Registration Costs representing the fully - burdened ( i.e., intended to reflect the costs of salary, benefits, pension, vacation, etc . ) internal costs, to a Development Party, of the contributions of its own employees ( i.e., salaried employees, not independent contractors ) to Development and Registration Activities undertaken in accordance Vvith this Agreement and the applicable Development Plan . The Development and Registration PTE Cost for any given employee during - any given calendar quarter shall be obtained by multiplying ( a ) the number of hours 4 worked by such employee during such calendar quarter on Development and Registration Activities undertaken in accordance with this Agreement ( which number is intended to be reflected on such individual 's Time Sheets ) by ( b ) such individual ' 5 Development and Registration FTE Rate ; 1.50 shall mean the following rates for employees of either Bradley or [COMPANY] : ( al Medical Doctor : ( b ) Research Associate : ( c ) Research Scientist, Project Manager, Regulatory Affairs Manager, Quality Manager and Other Professionals : If Salary Paid in Dollars tlH!2 : L'l per hour W1IL"'l per hour If Salary Paid In Euras ~11j1!l per hour mCl per hour ~L!l per hour Such rates shall be adjusted as of January 1, 2007 and annually thereafter by the percentage increase or decrease, if any, in the Price Index since the Effective Date or the preceding January 1st, whicbever is later