1.52 “HSR Act” has the meaning set forth inSection 10.1.
1.53 “HSR Clearance Date” has the meaning set forth inSection 10.1.
1.54 “IND” means an investigational new drug application filed with the FDA with respect to a Compound, Product or other compound, product or therapy, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a Clinical Trial of pharmaceutical product.
1.55 “IND Approval” of a Product means that an IND for such Product has been submitted to the FDA or equivalent Regulatory Authority and not rejected (including placed on clinical hold) by the FDA or equivalent Regulatory Authority within thirty (30) days after such submission.
1.56 “Indemnified Party” has the meaning set forth inSection 14.3.1.
1.57 “Indemnifying Party” has the meaning set forth inSection 14.3.1.
1.58 “Indication” means a medical condition in humans that a Product is intended to treat, prevent or diagnose and/or for which a Product has received Marketing Authorization.
1.59“Internal Compliance Codes”means a Party’s internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party Specific Regulations, and such Party’s internal ethical, medical and similar standards.
1.60 “Invention” means any invention and/or anyKnow-How, composition of matter, article of manufacture, method of manufacture, method of use or other subject matter, whether patentable or not.
1.61 “Joint Inventions” has the meaning set forth inSection 7.4.1.
1.62 “JointKnow-How” has the meaning set forth inSection 7.4.1.
1.63 “Joint Patent Rights” has the meaning set forth inSection 7.4.1.
1.64 “JSC” has the meaning set forth inSection 3.7.1.
1.65 “Know-How” means all technical, scientific, and other information,know-how, data, inventions, discoveries, trade secrets, specifications, instructions, techniques, processes, designs, drawings, formulae, methods, practices, protocols, expertise and other information and technology applicable to formulations, compositions or products or to their manufacture, development, registration, use, marketing or sale or to methods of assaying or testing them, and all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data relevant to any of the foregoing. For clarity,Know-How includes any such information comprised or embodied in any applicable physical materials, and excludes Patent Rights.
Certain information in this Exhibit marked as [***] has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would be competitively harmful if publicly disclosed.
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