1.1.69 In Vivo Validation means confirmation, through In Vivo Validation Activities, of the Target to Lesion Synthetic Lethal relationship, as determined by the JSC.
1.1.70 In Vivo Validation Activities means, with respect to a given Target and a given Campaign, confirmation of the Synthetic Lethal relationship between such Target and the Campaign Lesion(s) that are the subject of such Campaign in vivo using [***].
1.1.71 IND means any Investigational New Drug application, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any supplements or amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the United States (such as a Clinical Trial Application (CTA) in the countries that are officially recognized as member states of the EU).
1.1.72 Independently Validated means with respect to a given Target and given Lesion(s), that a Synthetic Lethal relationship has been shown to exist between such Target and such Lesion(s) in [***], as demonstrated [***], and has been demonstrated to be due to [***]; provided that Independent Validation shall not be deemed to have been achieved to the extent that it is [***]. Independent Validation will have its correlative meaning. For clarity, with respect to a given Target and given Lesion(s), a Synthetic Lethal relationship that has been shown to exist between such Target and such Lesion(s) that is Independently Validated will not be deemed to be Validated.
1.1.73 Indication means, with respect to a particular compound or product, the use of such compound or product for treating a separate and distinct patient population based on the results of a clinical trial, and not a sub-category of patients previously covered by the label for such product. For clarity, a labelling change based on the results of a clinical trial that removes a requirement for certain specified prior treatment shall be deemed a new Indication.
1.1.74 Initial Screening means the first round of Synthetic Lethal screens to be conducted in [***].
1.1.75 Joint Collaboration IP means any Collaboration Intellectual Property, other than the Repare Collaboration Intellectual Property and Resulting Compound/Product Collaboration IP, that is jointly made, invented, created, designed, conceived, produced, reduced to practice or otherwise developed by or on behalf of Repare or any of its Affiliates, on the one hand, and BMS or any of its Affiliates or Sublicensees, on the other hand.
1.1.76 Know-How means any tangible or intangible trade secrets, know-how, expertise, discoveries, inventions, information, data or materials, including ideas, concepts, formulas, methods, procedures, designs, technologies, compositions, plans, applications, technical data, assays, manufacturing information or data, samples, chemical and biological materials and all derivatives, modifications and improvements thereof, but excluding any Patents.
1.1.77 Law means any law, statute, rule, regulation, ordinance or other pronouncement having the effect of law, of any federal, national, multinational, state, provincial, county, city or other political subdivision, as from time to time enacted, repealed or amended, including Good Clinical Practices and adverse event reporting requirements, guidance from the International Conference on Harmonization or other generally accepted conventions, the FDCA and similar laws and regulations in countries outside the United States, and all other rules, regulations and requirements of the FDA and other applicable Regulatory Authorities.
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