(d) If neither the Licensed Product nor the other active ingredient(s) or product(s) in the Combination Product are sold separately in such country, the Parties shall [***].
1.11 “Commercially Reasonable Efforts” means the level of efforts and resources (including the promptness with which such efforts and resources would be applied) consistent with the efforts and resources normally used by a similarly situated (i.e., in terms of size, stage and resources) biopharmaceutical, biotech or pharmaceutical (as applicable) company in the exercise of commercially reasonable business discretion relating to the research, development, manufacture, or commercialization of a biopharmaceutical product with similar product characteristics that is of similar market potential at a similar stage of development or commercialization, taking into account issues such as efficacy, safety, product profile, anticipated or approved labeling, present and future risk-adjusted market potential, competitive market conditions, the proprietary position of the drug substance or product, the regulatory factors and structure involved, and other key technical, legal, scientific, medical or commercial factors, and the risk-adjusted potential profitability of the product.
1.12 “Competing Contract Manufacturer” shall mean any Third Party listed in Schedule G, which may be amended from time-to-time to remove any Third Party listed that both Lonza and TDTx agree is no longer a Competing Contract Manufacturer, as such criteria is defined below in both (i) and (ii), or any other Third Party provider of fee-for-service contract manufacturing services that Lonza proposes to add to Schedule G after the Effective Date which Lonza can demonstrate by credible evidence in writing, that, at the time that Lonza proposes to add the Third Party to the list in Schedule G, which shall be at least [***] prior to the time of the proposed assignment of this Agreement by TDTx under Article 17: (i) [***], and (ii) [***], such that in all cases both (i) and (ii) are met.
1.13 “Compulsory License” means a compulsory license under the Licensed Intellectual Property obtained by a Third Party through the order, decree, or grant of a competent governmental body or court, authorizing such Third Party to develop, make, have made, use, sell, offer to sell, import or otherwise exploit a Licensed Product or a product equivalent to a Licensed Product in the Field of Use in any country in the Territory.
1.14 ”Confidential Information” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, specifications, data, results and other material, pre-clinical and Clinical Study results, manufacturing procedures, test procedures and purification and isolation techniques, and any tangible embodiments of any of the foregoing, and any scientific, manufacturing, marketing and business plans, any financial and personnel matters relating to a Party or its present or future products, sales, suppliers, customers, employees, investors or business, furnished by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) on or after the Effective Date. Without limiting the foregoing, the terms of this Agreement will be deemed “Confidential Information” of both Parties and will be subject to the terms and conditions set forth in Article 7, and all records and reports delivered by TDTx to Licensors hereunder shall be the Confidential Information of TDTx.
1.15 “Contract Year” shall mean each calendar year period during the Term; provided, however, that the first such Contract Year shall commence on the Effective Date and end one year thereafter with the last such Contract Year ending on the final day of the Term. “Contract Year One” shall mean the first such year; “Contract Year Two” shall mean the second such year, and so on, year-by-year.
1.16 “Control” or “Controlled” means, with respect to rights in any Intellectual Property, that a Party owns or has a license or sublicense to such rights and has the right and ability to grant an exclusive license. or sublicense thereto as provided for in this Agreement, without violating the terms of any agreement or other arrangement with any Third Party, and without payment of any additional consideration to such Third Party.
1.17 “Cover”, “Covering” or “Covered” means, with respect to a Licensed Product, that the manufacture, use or sale of the Licensed Product would, but for a license granted in this Agreement, infringe a Valid Claim of the Ancestral Technology Patent Rights in the country in which the manufacture, use or sale occurs.
4.
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.