Exclusive Supply and Distribution Agreement
Exhibit 10.7
CERTAIN IDENTIFIED INFORMATION MARKED BY [*] HAS BEEN EXCLUDED FROM THIS
EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE
COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED
Exclusive Supply and Distribution Agreement
Entered into by and between
Biomm S.A.
And
_________________________
April 6, 2021
________________________
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Exclusive Supply and Distribution Agreement
This Exclusive Supply and Distribution Agreement (the “Agreement”) is made as of 6th of April, 2021 (“Effective Date”), by and between
CYTODYN INC. (“CytoDyn”), a corporation incorporated and legally existing under the laws of USA, with its principal office and place of business at 0000 Xxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxxxx 00000, hereby duly represented in accordance with its By-Laws, and
BIOMM S.A. (“Biomm”), a corporation incorporated and legally existing under the laws of Brazil, with headquarters at Xxxxxx Xxxxxx, 000, Xxxxxxxxxx – Lagoa dos Ingleses, city of Nova Lima, State of Minas Gerais, enrolled with the CNPJ/MF under # 04.752.991/0001-10, hereby duly represented in accordance with its By-Laws,
CytoDyn and Biomm, individually, hereinafter referred to as “Party”, and jointly, “Parties”.
RECITALS
Whereas, CytoDyn is an American company that develops pharmaceutical products and intends to establish a distribution system in Brazil by qualified and specially trained partner that meets the established requirements;
Whereas, Biomm is a Brazilian pharmaceutical company engaged in the business of manufacturing and/or distributing pharmaceutical products in the Territory (as such term is defined below);
Whereas, CytoDyn has developed a drug substance and drug product, manufacturing process and the Intellectual Property Rights (as defined hereinafter) for the Product which, among other indications, is intended for COVID-19´s treatment (as defined hereinafter);
Whereas, CytoDyn has recently requested the Authorization For Emergency Use of Vyrologix before US FDA and other regulatory agencies;
Whereas, Brazilian National Health Surveillance Agency has recently allowed the Authorization For Emergency Use of products intended for COVID-19´s treatment, in order to immediately make
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available certain pharmaceutical drugs that are able to control the current public health emergency arising from the pandemic;
Whereas, Biomm intends to supply the Product to private and/or public healthcare providers that use the Product solely to treat patients, including but not limited to the MOH (“Entities”) as of now on an emergency basis, upon submission and approval of the Authorization For Emergency Use for the Product before ANVISA and, subsequently, on an ordinary basis;
Whereas, Biomm holds all necessary licenses and authorizations, at all government levels, to take the position of the Marketing Authorization Holder of the Product in the Territory;
Whereas, Biomm and CytoDyn have decided to join efforts to act immediately before ANVISA with the primary purpose of supplying the Product on an emergency basis to save as many lives as possible;
Whereas, Biomm and CytoDyn now desire to enter into this Agreement to provide the terms and conditions upon which CytoDyn supplies the Product on an exclusive basis for distribution and sale of Vyrologix in the Territory to private and/or public institutions.
Agreement
Now Therefore, in consideration for the covenants set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as set forth below.
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7.a Mutual Indemnification. Each Party (the “Indemnifying Party”) shall indemnify and hold harmless the other Party and its Affiliates, and their respective directors, employees, consultants and agents (the “Indemnified Parties”) from and against any and all liabilities, losses, damages, costs, and other expenses (including attorneys’ and expert witnesses’ costs and fees) (“Losses”) incurred by the Indemnified Parties (or any of them) as a result of any claim, demand, action or proceeding by any third party (a “Claim”) to the extent arising from or relating to any material breach of any representation, warranty, covenant, or obligation of the Indemnifying Party under this Agreement or any intentional misconduct or negligence by the Indemnifying Party or any of its employees, agents, or subcontractors (including, with respect to Biomm, any subdistributor), except to the extent such Losses result from the intentional misconduct or negligence of, any of the Indemnified Parties. Under any circumstances, CytoDyn shall be responsible for losses, damages, adverse effects, accidents or product liability of any kind whatsoever, whenever the same can be proved to have occurred because the undertaking by CytoDyn, as defective quality of the Product supplied by CytoDyn, and/or its components, package, leaflet, drug leaflet (printed directions for the use of the Product), etc, information to final consumers or other motive attributed by CytoDyn. Under any circumstances, Biomm shall be responsible for losses, damages, adverse effects, accidents or product liability of any kind whatsoever, whenever the same can be proved to have occurred because the undertaking by Biomm regarding the marketing, sale or distribution of the Product or other reasons attributed to Biomm.
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[Signature page follows]
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In Witness Whereof, the Parties hereto have this day caused this Agreement to be executed by their duly authorized officers.
By: /s/ Xxxxx Pourhassan____________ Name: Xxxxx Xxxxxxxxxx, Ph.D. Title: President & CEO | Biomm S.A. By: _/s/ Xxxxxxx Xxxxxxxx Marchezini ____ Name: Xxxxxxx Xxxxxxxx Marchezini Title: CEO By: _/s/ Xxxxxxx Xxxxxx _________________ Name: Xxxxxxx Xxxxxx Title: CTO |
Witnesses:
1. /s/ Xxxxx Xxxxxxxx | 2. /s/ Xxxxx Xxxxxxxx Xxxxx Figueiroa |
Name Xxxxx Xxxxxxxx | Name: Xxxxx Xxxxxxxx Xxxxx Xxxxxxxxx |
ID: General Counsel and Corporate Secretary | ID: OAB/MG 71710 |
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SCHEDULE B
PHARMACOVIGILANCE AGREEMENT
[TO BE INSERTED UPON EXECUTION]
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SCHEDULE C
QUALITY AGREEMENT
[TO BE INSERTED UPON EXECUTION]
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