Definitions

Definitions. Capitalized terms used in this Amendment and not otherwise defined shall have the meanings ascribed to such terms in the Loan Agreement.

Definitions. As used in this Third Supplemental Indenture, terms defined in the Indenture or in the preamble or recital hereto are used herein as therein defined.

Definitions. 1.1 "Affiliate" of a party hereto shall mean any entity that controls or is controlled by such party, or is under common control with such party. For purposes of this definition, an entity shall be deemed to control another entity if it owns or controls, directly or indirectly, at least 50% of the voting equity of another entity (or other comparable interest for an entity other than a corporation). 1.2 "Althea SOPs" shall mean Althea's Standard Operating Procedures, which will be customized on... a product specific basis, as necessary, for manufacture of Client Product. Client will review and approve each product specific SOP prior to production of Client Product and any subsequent revisions to these product-specific SOPs. 1.3 "Batch" shall mean a specific quantity of Client Product mutually agreed upon between Client and Althea, and that (a) is intended to have uniform character and quality within specified limits, and (b) is Produced according to a single manufacturing order during the same cycle of manufacture. 1.4 "Bulk Compound" shall mean the bulk drug or active pharmaceutical ingredient of Client Product, in bulk form, supplied by Client. 1.5 "cGMP" shall mean current Good Manufacturing Practices as defined in the FDA rules and regulations, 21 CFR Parts 210-211. 1.6 "Cancellation Fees" shall mean the cancellation fees payable by Client under section 3.4. 1.7 "Certificate of Analysis" shall mean a certificate of analysis that certifies that a Batch meets the release Specifications. 1.8 "Client Product" shall mean the pharmaceutical product(s) to be Produced by Althea in finished dosage form under this Agreement as identified on Appendix B hereto, which Appendix may be updated by mutual agreement of the parties from time to time during the Term.. 1.9 "Components" shall mean all components used by Althea in Production of Client Product under this Agreement. 1.10 "Confidential Information" shall have the meaning set forth in Section 9.1. 1.11 "Facility" shall mean Althea's facility located at 11040 Roselle Street, San Diego, CA 92121. 1.12 "FDA" shall mean the United States Food and Drug Administration or any successor entity thereto. 1.13 "Invention" shall mean any creative work, invention, innovation, improvement, development, discovery, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained, and whether or not patentable or copyrightable. 1.14 "Intellectual Property" shall mean all rights, privileges and priorities provided under applicable international, national, federal, state or local law, rule, regulation, statute, ordinance, order, judgment, decree, permit, franchise, license, or other government restriction or requirement of any kind relating to intellectual property, whether registered or unregistered, in any country, including without limitation: (a) all (i) patents and patent applications (including any patent that in the future may issue in connection therewith and all divisions, continuations, continuations-in-part, extensions, additions, registrations, confirmations, reexaminations, supplementary protection certificates, renewals or reissues thereto or thereof), (ii) copyrights and copyrightable works, including reports, software, databases and related items, and (iii) trademarks, service marks, trade names, brand names, product names, corporate names, logos and trade dress, the goodwill of any business symbolized thereby, and all common-law rights relating thereto; and (b) all registrations, applications, recordings, rights of enforcement, rights of recovery based on past infringement and any and all claims of action related thereto and licenses or other similar agreements related to the foregoing. 1.15 "Labeling" shall mean all labels and other written, printed, or graphic matter upon: (i) Client Product or any container, carton, or wrapper utilized with Client Product or (ii) any written material accompanying Client Product. 1.16 "Master Batch Record" or "MBR" shall mean the formal set of written instructions for Production of Client Product, approved in writing by both parties. The MBR shall be developed and maintained in Althea's standard format by Althea, using Client's master formula and technical support. 1.17 "Production" or "Produce" shall mean all steps and activities necessary to produce Client Product to be performed by Althea as set forth in the SOW, including, without limitation and as applicable, the filling, packaging, inspection, Labeling, testing, quality control and release. 1.18 "Purchase Price" shall mean the amount(s) to be paid by Client as specified in the SOW, subject to adjustment from time to time in accordance with section 2.11. 1.19 "Quality Agreement" shall mean a written, mutually executed agreement between Althea and Client that defines the quality roles and responsibilities of each party in connection with Production of Client Product. 1.20 "Regulatory Authority" shall mean any agency or authority responsible for regulation of Client Product in the United States or any foreign regulatory jurisdiction provided that Althea shall have no obligation to Produce Client Product in compliance with the requirements of any non-U.S. Regulatory Authority, except as expressly specified in the SOW 1.21 "Released Executed Batch Record" shall mean the completed batch record and associated deviation reports, investigation reports, and Certificates of Analysis created for each Batch of Client Product, in the standard form used by Althea. 1.22 "Specifications" shall mean the applicable specifications for Client Product or Components, as applicable, set forth in the SOW and the MBR. 1.23 "Statement of Work" or "SOW" shall mean a written proposal or similar document, when manually signed by both parties and made a part of this Agreement as Appendix A, which sets forth the particulars of Production and all other services to be provided under this Agreement, including without limitation, all Specifications, Components, the Purchase Price, any timelines, milestones, payment schedules, technology transfer plans, and validation protocols. 1.24 "Term" shall have the meaning provided in Section 3.1. 1.25 "Territory" means the United States of America and any other county that the parties agree in writing to add to this definition of Territory in an amendment to this Agreement. 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Definitions. All capitalized terms not otherwise defined herein are used as defined in the Agreement (including terms incorporated therein by reference).

Definitions. The definitions in Appendix A are hereby incorporated in this Agreement.

Definitions. Any reference in this Agreement to a 'termination of employment,' severance from employment, separation from employment, resignation or discharge otherwise entitling the Executive to payment hereunder shall be deemed to mean a Termination of Employment; provided, however, that with respect to any benefit or payment described in this Agreement which is subject to Code Section 409A, no Termination of Employment shall occur unless a separation from service under Code Section 409A has occurred.

Definitions. Except as otherwise provided herein, capitalized terms used in this Amendment shall have the definitions set forth in the Agreement amended hereby.

Definitions. In this Agreement, unless the context otherwise requires, the following words and expressions shall have the following meanings: -

Definitions. Unless otherwise defined within this Amendment, a capitalized term within this Amendment shall have the same meaning ascribed to the same capitalized term within the Agreement.

Definitions. Exhibit A to this Letter Agreement sets forth the applicable definitions of capitalized terms in this Letter Agreement.