Agreement Term has the meaning set forth in Section 11.1.
Alliance Manager will have the meaning set forth in Section 3.1.
Applicable Law means any federal, state, local or foreign law (including, common law), statute or ordinance, or any rule, regulation, judgment, order, writ or decree of or from any court, or other Regulatory Authority having jurisdiction over or related to the subject item that may be in effect from time to time, including, as applicable, GCP, GLP, and GMP.
Auditor has the meaning set forth in Section 8.7(b).
Biomarker/Companion Diagnostic means any molecule, product or combination of molecules or products that characterize a patient tissue sample to inform patient treatment with respect to a Compound and/or Product, including for example, to determine whether such patient is eligible for treatment with a Compound and/or Product, to determine the dosing regimen for such patient with a Compound and/or Product, and/or to determine biological target engagement when such patient is treated with a Compound or Product.
Breakthrough Designation means a Compound has received breakthrough therapy designation by the FDA as contemplated by Title IX of the United States Food and Drug Administration Safety and Innovation Act of 2012.
Calendar Quarter means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31.
Calendar Year means a period of twelve consecutive calendar months ending on December 31.
Claims means all Third Party demands, claims, actions, proceedings and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, reasonable legal costs, and other reasonable expenses of any nature whatsoever in connection therewith.
Commercialize means to market, promote, distribute, import, export, offer to sell and/or sell Products or Biomarkers/Companion Diagnostics (including manufacture of the Compounds and/or Products or Biomarkers/Companion Diagnostics for commercial use), as well as conducting all associated post-launch regulatory activities, including medical affairs oversight, and Commercialization means commercialization activities relating to Products or Biomarkers/Companion Diagnostics.
Commercially Reasonable Efforts means, with respect to a Party, the efforts and resources typically used by reasonable, similarly situated biotechnology or pharmaceutical companies to perform the obligation at issue, which efforts will not be less than those efforts made by such Party with respect to [***].
Compound means (i) all compositions of matter that are claimed in the Exclusively Licensed Novartis Patents, including LXS196, and (ii) any radioisomer, stereoisomer, racemates, solvates, salt forms, crystal forms, bases, anhydrides, hydrates, polymorphs, ester forms, analogs, homologs, derivatives or pro drugs of the compounds referenced in
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the omitted portions.