physical embodiments of any of the foregoing; but excluding in any event any Patent Right and Trademarks.
1.68“Laws” means all applicable laws, statutes, rules, regulations, orders, judgments, injunctions, ordinances or other pronouncements having the binding effect of law of any Governmental Authority, including a legal obligation to a Regulatory Authority or other Governmental Authority to which either Party is or becomes subject (such as a corporate integrity agreement or settlement agreement with a Governmental Authority).
1.69“Licensed Product” means any product comprising or containing Bempedoic Acid, either alone or in combination with other active pharmaceutical ingredients including the Initial Product, any Combination Product and any Authorized Generic Product, for use in the Field, including all dosage strengths, presentations, forms and formulations.
1.70“Losses” has the meaning set forth in Section 11.1 (General Indemnification by Otsuka).
1.71“Manufacturing” or “Manufacture” means, as applicable, all activities associated with the production, manufacture, process of formulating, processing, purifying, filling, finishing, packaging, labeling, shipping, importing and storage of Licensed Products, and any part or component thereof, including process development, process validation, stability testing, manufacturing scale-up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing and release, but excluding for the avoidance of doubt Developing and Commercializing.
1.72“Material Communications” means formal written, telephonic or in-person communications from or with any Regulatory Authority concerning any of the following: key product quality attributes (e.g., purity) of Licensed Products, safety findings affecting a Licensed Product (e.g., Serious Adverse Events, emerging safety signals), clinical or non-clinical findings affecting patient safety, efficacy, receipt or denial of Regulatory Approval, the design of Clinical Studies or the need for additional non-clinical studies (e.g., additional toxicology or carcinogenicity studies).
1.73“MHLW” means the Japanese Ministry of Health, Labour and Welfare, or a successor agency thereto.
1.74Negotiation Period has the meaning set forth in Section 2.2 (Option to New Indications).
1.75“Net Sales” means, with respect to a Licensed Product, the aggregate gross invoiced sales prices from sales of all units of such Licensed Product sold by Otsuka or its Sublicensees to independent Third Parties in accordance with IFRS after deducting, if not previously deducted, from the amount invoiced or received: