Indemnified Party shall have the meaning set forth in Section 9.4.
Indemnifying Party shall have the meaning set forth in Section 9.4.
Indication shall mean a separate and distinct disease or medical condition in humans or animals that a product is intended to treat, prevent, diagnose, monitor or ameliorate, as set forth in the IND or label for such product, as applicable, as approved by the applicable Regulatory Authority. The Parties agree and acknowledge that [***].
Initial Public Offering shall mean the closing of Purchasers first firm commitment underwritten initial public offering of the Purchasers common stock pursuant to a registration statement filed under the Securities Act of 1933, as amended.
Interim Report shall have the meaning set forth in Section 3.4
IP Contracts shall have the meaning set forth in Section 4.8(c).
Know-How means any proprietary information and materials, including records, discoveries, improvements, modifications, processes, techniques, methods, assays, chemical or biological materials, designs, protocols, formulas, data (including physical data, chemical data, toxicology data, animal data, raw data, clinical data, and analytical and quality control data), dosage regimens, control assays, product specifications, marketing, pricing and distribution costs, inventions, algorithms, technology, forecasts, profiles, strategies, plans, results in any form whatsoever, know-how and trade secrets (in each case, whether or not patentable or copyrightable).
Knowledge of Seller shall mean [***].
Law shall mean, as applicable, any federal, state or local or any foreign statute, law, rule, regulation, ordinance, code or any other requirement or rule of law including Regulatory Laws of any Governmental Entity.
Liabilities shall mean any and all debts, Taxes, liabilities, costs, guarantees, commitments, assessments, expenses, claims, penalties, Losses, damages, deficiencies and obligations, whether accrued or fixed, known or unknown, liquidated or unliquidated, asserted or unasserted, absolute or contingent, matured or unmatured, determined or determinable, accrued or not accrued, due or to become due, direct or indirect, whenever or however arising (including whether arising out of any Contract, common law or tort based on negligence or strict liability) and whether or not the same would be required by GAAP to be reflected in financial statements or disclosed in the notes thereto.
License Agreement shall mean the license agreement, executed by each of the Parties, attached hereto as Exhibit C.
Live Biotherapeutic Product means a biological product that: (i) contains live organisms, such as bacteria; (ii) is applicable to the prevention, treatment, or cure of a disease or condition of human beings; and (iii) is not a vaccine. Live Biotherapeutic Products are not filterable viruses, oncolytic bacteria, or products intended as gene therapy agents and, as a general matter, are not administered by injection.