Overview of the Mode of Action Program
Overview of the Mode of Action Program Sample Clauses
Related to Overview of the Mode of Action Program
Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:
Overview Oxxx Xxxxxx played quarterback for the Cleveland Browns, and is considered one of the most dominant players of the NFL’s early years. He led the Browns to the championship game every season from 1946 to 1955, winning 7 times. He was also a 3-time league MVP. · He was selected All-League in 9 of his 10 seasons. Career highlights include throwing for 4 touchdowns in the 1950 title win, as well as 3 passing and 3 running touchdowns in the 1954 title game. · He would later coach Coast Guard for 9 seasons, over 2 separate stints. He was elected to the Pro Football Hall of Fame in 1965 Asset Description Overview and authentication: · PSA Card Facts states, “This important rookie card is one of the keys to the 1950 Bxxxxx set...This card is subject to the typical condition obstacles of the issue, including staining along the reverse that tends to penetrate the cardboard and downgrade the card...This popular issue is recognized as the first full-color, nationally distributed set of the post-World War II era.” · Graded a 9 by PSA, this card is one of 9 to receive that grade with NONE graded higher out of 720 total submissions to PSA. · PSA 9 copies sell very infrequently with the most recent sale being for $20,713 on 10/10/20. Notable Features: Graded Mint by PSA Notable Defects: There are none. Depreciation: The Company treats Memorabilia and Collectibles assets as collectible and therefore will not depreciate or amortize the SERIES #OttoGraham1950BowmanPSA9 going forward. Schedules to Thirteenth Amendment to Limited Liability Company Agreement – Collectable Sports Assets, LLC – Page 93 of 127 Schedule XXXIXto Thirteenth Amendment to Collectable Sports Assets, LLC Amended and Restated Limited Liability Company Agreement Series Designation of #ALKALINE1954TOPPSPSA9, a series of Collectable Sports Assets, LLC Capitalized terms used but not defined herein have the meanings assigned to such terms in the Limited Liability Company Agreement of Collectable Sports Assets, LLC, as in effect as of the effective date set forth below (the “Agreement”). References to Sections and Articles set forth herein are references to Sections and Articles of the Agreement. Name of Series #ALKALINE1954TOPPSPSA9, a series of Collectable Sports Assets, LLC, a Delaware limited liability company Date of establishment September 9, 2021 Managing Member CS Asset Manager, LLC, a Delaware limited liability company, is appointed as the Managing Member of #ALKALINE1954TOPPSPSA9 with effect from the effective date hereof and shall continue to act as the Managing Member of #ALKALINE1954TOPPSPSA9 until dissolution of #ALKALINE1954TOPPSPSA9 pursuant to Section 11.1(b) or its removal and replacement pursuant to Section 4.3 or ARTICLE X. Initial Member CS Asset Manager, LLC, a Delaware limited liability company Series Asset The Series Assets of #ALKALINE1954TOPPSPSA9 shall comprise the asset as further described in Schedule 1 attached hereto, which will be acquired by #ALKALINE1954TOPPSPSA9 through that certain Consignment Agreement dated as of August 30, 2021, as it may be amended from time to time, and any assets and liabilities associated with such asset and such other assets and liabilities acquired by #ALKALINE1954TOPPSPSA9 from time to time, as determined by the Managing Member in its sole discretion. Asset Manager CS Asset Manager, LLC, a Delaware limited liability company. Management Fee As stated in Section 7.1 of the Agreement. Issuance Subject to Section 6.3(a)(i), the maximum number of #ALKALINE1954TOPPSPSA9 Interests the Company can issue may not exceed the purchase price, in the aggregate, of $50,000. Number of #ALKALINE1954TOPPSPSA9 Interests held by the Managing Member and its Affiliates The Managing Member must purchase a minimum of 0.5% and may purchase additional #ALKALINE1954TOPPSPSA9 Interests (including in excess of 10%), in its sole discretion, through the Offering. Broker Dalmore Group, LLC, a New York limited liability company. Brokerage Fee Up to 1.00% of the gross proceeds of the Interests from #ALKALINE1954TOPPSPSA9 sold at the Initial Offering of the #ALKALINE1954TOPPSPSA9 Interests (excluding the #ALKALINE1954TOPPSPSA9 Interests acquired by any Person other than Investor Members). Schedules to Thirteenth Amendment to Limited Liability Company Agreement – Collectable Sports Assets, LLC – Page 94 of 127 Other rights Holders of #ALKALINE1954TOPPSPSA9 Interests shall have no conversion, exchange, sinking fund, redemption or appraisal rights, no preemptive rights to subscribe for any securities of the Company and no preferential rights to distributions of #ALKALINE1954TOPPSPSA9 Interests. Officers There shall initially be no specific officers associated with #ALKALINE1954TOPPSPSA9, although, the Managing Member may appoint Officers of #ALKALINE1954TOPPSPSA9 from time to time, in its sole discretion. Aggregate Ownership Limit As stated in Section 1.1. Minimum Interests One (1) Interest per Member. Schedule 1 Investment Overview · Upon completion of the SERIES #AlKaline1954ToppsPSA9 Offering, SERIES #AlKaline1954ToppsPSA9 will purchase a Ax Xxxxxx 1954 Topps PSA 9 (The “Underlying Asset” with respect to SERIES #AlKaline1954ToppsPSA9, as applicable), the specifications of which are set forth below.
Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.
Periodic Review of Compliance Policies and Procedures During the Term, Transfer Agent shall periodically assess its compliance policies and procedures (the “Policies”). Transfer Agent shall provide, (i) no less frequently than annually, electronic access to its Policies to the chief compliance officer of the Fund (the “Chief Compliance Officer”), and/or any individual designated by the Fund or such Chief Compliance Officer, including but not limited to members of the internal compliance and audit departments of Federated Investors, Inc., and any advisory board constituted by the Fund provided that the Transfer Agent may reasonably require any members of such advisory board that are not employees of the Fund or its Affiliates to execute a confidentiality agreement with respect to such information; (ii) at such reasonable times as he or she shall request, access by such Chief Compliance Officer to such individuals as may be necessary for the Chief Compliance Officer to conduct an annual review of the operation of such Policies for purposes of making his or her annual report to the Board of the Fund (the “Annual Report”), (iii) promptly upon enactment, notification of, and a copy of, any material change in such Policies, and (iv) promptly upon request, such other information as may be reasonably requested by such Chief Compliance Officer for purposes of making such Annual Report.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.
Timeline a. Year 1: 20[***] (spring) plant SG and evaluate herbicides. CERES-NOBLE Schedule BMP for switchgrass Confidential Treatment Requested and the Redacted Material has been separately filed with the Commission
Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.
Product Description The Products are described in the Product Unique Attachment(s). Products also include all FRUs, CSPs, Product code, and Product documentation.
Sub-Adviser Review of Materials Upon the Adviser’s request, the Sub-Adviser shall review and comment upon selected portions, relating to the Sub-Adviser and/or Strategy (including the Allocated Portion), of the Registration Statement, other offering documents and ancillary sales and marketing materials prepared by the Adviser for the Fund, and participate, at the reasonable request of the Adviser and as agreed to by the Sub-Adviser, in educational meetings with placement agents and other intermediaries about portfolio management and investment-related matters of the Fund. The Sub-Adviser will promptly inform the Fund and the Adviser if any information in the Registration Statement is (or will become) inaccurate or incomplete.
