Give me more for this agreement: 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 media comment, or otherwise significantly, adversely affect the reputation or business of Sekisui or Qualigen. 1.18. Products shall mean all of Qualigen's current and future products, including without limitation those listed on Exhibit D, for sale under the trade names listed with such products, including any improvements thereto. 1.19. Qualigen Retained Customers shall mean certain of Qualigen's existing direct sales customers, all as listed on Exhibit E. 1.20. Regulatory Approval shall mean the approval of the applicable Regulatory Authority required for the promotion, marketing, distribution and/or sale of the Products in any territory in which they are being sold, including any Product registration or license, and any supplement, amendment or variation thereto, required before the commencement of commercial sales of the Products in such territory, and export and import approvals for the Products. 2
Source: RITTER PHARMACEUTICALS INC, S-4/A, 3/13/2020
1.21. Regulatory Authorities shall mean the FDA, each Competent Authority, Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency. 1.22. Revenue Affiliate shall mean any entity of which Sekisui 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 that entity. 1.23. Sale Transaction shall mean (i) any transaction in which Qualigen, Qualigen's business or control of Qualigen is acquired, (ii) any license, sale, lease, transfer, or other disposition, in a single transaction or series of related transactions, of all or substantially all of Qualigen's assets other than in the ordinary course of business, (iii) any sale of a majority of the outstanding shares of capital stock of Qualigen, (iv) any sale or license of any rights to any Qualigen products, now or hereafter existing, other than in the ordinary course of business, (v) any liquidation or dissolution of Qualigen, (vi) any similar transaction resulting in a change of control of Qualigen, or (vii) any of the foregoing with respect to any now or hereafter existing subsidiary of Qualigen which holds, on a consolidated basis, all or substantially all of Qualigen's assets (i.e., of the assets of Qualigen and all its Affiliates considered together). 1.24. Serious Incident shall mean an incident involving the Products, which is reportable to a Competent Authority and as defined in Section 5 of Annex III of the IVD Directive, and the European Commission Medical Devices Vigilance Guidelines 2.12-1 or such other Guidelines as may be issued from time to time. 1.25. Territory shall mean worldwide excluding Qualigen Retained Customers. 1.26. Third Party shall mean a party other than Sekisui or Qualigen or any Affiliate of Sekisui or Qualigen. 2. Appointment and Term 2.1. Appointment. Qualigen hereby appoints Sekisui, and Sekisui accepts the appointment to act on an exclusive basis pursuant to the terms and conditions of this Agreement, as a distributor for the sale of the Products in the Territory. Sekisui shall be permitted to appoint sub-distributors in the Territory (including any current Qualigen distributors) with the approval of Qualigen, not to be unreasonably withheld or delayed. Sekisui shall purchase the Products exclusively from Qualigen, and Qualigen shall supply the Products exclusively to Sekisui, in each case for the Territory. Qualigen shall assign to Sekisui Qualigen's agreements with Qualigen's current distributors (such that such current Qualigen distributors shall become Sekisui subdistributors), each of which is set forth on Schedule 2.1 hereto; if any of such agreements do not allow such assignment and the current distributor declines to consent to such an assignment to Sekisui, Qualigen shall (if Sekisui so requests) act pursuant to such agreement to terminate such agreement. 2.2. Term. The initial term of this Agreement shall commence on the Effective Date and shall continue for a period of five (5) years unless earlier terminated pursuant to Section 14 hereof (the "Term"). The initial term of this Agreement and any renewal term thereof shall be automatically extended at the end of the initial term and any renewal term thereof for an additional one (1) year period unless either Party notifies the other Party not less than six (6) months before the end of the then in effect term of its intent to terminate this Agreement. References in this Agreement to "Term" shall be deemed to include the initial five (5) year term as well as a reduction or extension of that time period that may occur as a result of the provision of this Section 0 or the provisions of Section 14. 3
Source: RITTER PHARMACEUTICALS INC, S-4/A, 3/13/2020