system: You are a contract-analysis assistant performing a span-extraction task. You are given an excerpt from a commercial contract and the name of a clause type to locate within it.

Return the exact text of the requested clause, copied verbatim from the excerpt — identical wording and punctuation, with no paraphrasing, summarising, explanation, or added commentary.

The excerpt is one window of a much longer contract and often will not contain the requested clause. If the requested clause does not appear in this excerpt, respond with exactly: Not found.

Output only the extracted clause text, or the exact string `Not found.` — nothing else.

user: Contract excerpt:
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Exhibit 10.54 DISTRIBUTION AND DEVELOPMENT AGREEMENT This Distribution and Development Agreement (this "Agreement") is made and entered into as of May 1, 2016 by and between Sekisui Diagnostics, LLC and its Affiliates, a Delaware limited liability company with principal offices at 4 Hartwell Place, Lexington, Massachusetts 02421 ("Sekisui"), and Qualigen, Inc. and its Affiliates, a Delaware corporation with principal offices at 2042 Corte Del Nogal, Carlsbad, California 92011 ("Qualigen" and together with Sekisui, each a "Party" and together the "Parties"). WHEREAS, Qualigen is engaged in the manufacture, supply and development of certain clinical rapid diagnostic test devices and controls; and WHEREAS, Qualigen wishes to appoint Sekisui as its exclusive distributor for such products in the Territory (as defined below); and WHEREAS, Sekisui wishes to be appointed as the exclusive distributor of such products and to fund the development of certain future products. NOW, THEREFORE, in consideration of the mutual covenants hereinafter contained, the parties hereto agree as follows: 1. Definitions 1.1. Adverse Event shall mean an incident in which the Product was alleged to have caused or contributed to the death or serious injury of a patient or operator and would require submitting a Medical Devices Report to the FDA (as hereinafter defined) as per 21 CFR 803, or a similar report to a Competent Authority (as hereinafter defined) as per Vigilance Guidance MEDDEV 2.12-1. 1.2. Affiliate shall mean, (i) with respect to Qualigen, any corporation or other form of business organization, which directly or indirectly owns, controls, is controlled by, or is under common control with Qualigen, and (ii), with respect to Sekisui, shall mean Sekisui Diagnostics (UK) Ltd., Sekisui Diagnostics PEI, Inc., SEKISUI MEDICAL CO., LTD., and Sekisui Diagnostics GmbH. An entity shall be regarded as being in control of another entity if the former entity has the direct or indirect power to vote more than fifty percent (50%) of the outstanding voting securities (or other ownership interest for a business organization other than a corporation) of that entity, or the direct or indirect ability to direct or cause the direction of the general management and policies of the other entity. 1.3. Applicable Markets shall mean the United States, Canada, the European Union, Japan and other additional geographies that are added from time to time at the request of Sekisui, but only to the extent that it is commercially reasonable for Qualigen to expand to such additional geographies. 1.4. Available Margin is defined on Exhibit A. 1.5. Business Plan shall mean the business plan attached as Exhibit B hereto, which business plan may be amended from time to time by mutual agreement of Qualigen and Sekisui. 1.6. COGS is defined on Exhibit A. Source: RITTER PHARMACEUTICALS INC, S-4/A, 3/13/2020 1.7. Competent Authority shall mean the governmental authority in a member state of the European Union which has competence in relation to the Products. 1.8. Development Plan shall mean the development plan attached as Exhibit C hereto, which development plan may be amended from time to time by mutual agreement of Qualigen and Sekisui. 1.9. Effective Date shall mean May 1, 2016. 1.10. European Union shall mean the countries in Europe that are under the CE mark regulatory regime. 1.11. Exclusivity Period shall mean the period from the Effective Date until December 31, 2018. 1.12. FDA shall mean the U.S. Food and Drug Administration or any successor agency. 1.13. Health Canada shall mean the department of the government of Canada with responsibility for national public health. 1.14. Intellectual Property Rights means all intellectual property rights in any jurisdiction worldwide, including, without limitation: (a) Patent Rights; (b) rights associated with works of authorship including copyrights, copyright applications, and copyright registrations; (c) rights relating to the protection of trade secrets, know-how or confidential information; and (d) rights in any trade names, trademarks, service marks, domain names, logos, trade dress and brand features. 1.15. Net Revenue is defined on Exhibit A. 1.16. Patent Rights means all patents, patent applications and inventions on which patent applications are filed and all patents issuing therefrom worldwide, together with any extensions, registrations, confirmations, reissues, continuations, divisionals, continuations- in-part, re-examination certificates, substitutions or renewals, supplemental protection certificates, term extensions (under applicable patent law or other law), provisional rights and certificates of inventions. 1.17. Potentially Serious Complaint shall mean any information coming to the notice of Qualigen or Sekisui which might relate to a Serious Incident (as hereinafter defined), or to a significant lapse in the quality of the Products, or might lead to significant adverse public or
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Extract the exact clause related to "Volume Restriction" from the excerpt above.