1.119 “JRA Exception” has the meaning set forth in Section 9.1(b).
1.120 “Know-How” means all commercial, scientific, technical and other information or materials, including information comprising or relating to discoveries, inventions, trade secrets, knowledge, technology, data, designs, formulate, methods, models, assays, research plans, procedures, designs for experiments and test and results of experimentation and testing (including results of research or development of the Program), Materials, nucleic acid constructs or vectors, cells or cell lines, processes, laboratory records, biological, chemical, pharmacological, toxicological, pharmaceutical, physical, clinical, manufacturing, analytical and quality control data and know-how, safety and trial data, study designs, protocols, case report forms, data analyses, reports or summaries and information contained in submissions to and information from ethical committees and Regulatory Authorities. Know-How includes rights protecting Know-How, in all cases, whether or not confidential, proprietary, patentable, in written, electronic or any other form now known or hereafter developed, but excluding all Patents.
1.121 “Licensed Program” means any Research Program that has achieved the Pre-Clinical Candidate Attainment Date.
1.122 “Liens” means any lien, pledge, encumbrance, mortgage, security interest, purchase option, call or similar right, conditional and installment sale agreements, charges or claims of any kind (excluding any license rights granted as of the Effective Date under the Existing License Agreements).
1.123 “MAA” or “Marketing Authorization Application” means an application for Regulatory Approval for a Product in a country or region of the Territory.
1.124 “Major European Countries” means France, Germany, Italy, Spain and the United Kingdom.
1.125 “Major Market Countries” means Major European Countries, the United States, Japan and mainland China.
1.126 “Managed Care Organizations” or “MCOs” means pharmacies, managed health care organizations, group purchasing organizations, large employers, long-term care organizations, formularies, insurers, government agencies and programs (e.g., Medicare and the VHA and other federal, state and local agencies), or similar organizations.
1.127 “Materials” means all tangible compositions of matter, devices, articles of manufacture, assays, biological, chemical, or physical materials, and other similar materials.
1.128 “MHLW” means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.
1.129 “Necessary Third Party Patent” has the meaning set forth in Section 8.5(d)(ii).
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