Exclusive Supply and Distribution Agreement between CytoDyn Inc. and Macleods Pharmaceuticals Ltd., dated May 11, 2021
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
KNOW ALL PERSONS BY THESE PRESENTS:
This Exclusive Supply and Distribution Agreement (“Agreement”), made and entered into this 11th day of May, 2021 (“Effective Date”), by and between:
Macleods Phamaceuticals Ltd with registered office at 304, Atlanta Arcade, Marol Church Road, Opp. Hotel Leela, Andheri (East) Mumbai 400 059, an India corporation
CytoDyn Inc. a Delaware corporation, with business address at 1111 Main Street, Suite 660, Vancouver, WA 98660 (“CYTODYN”).
Collectively known as the “Parties”
WHEREAS, CYTODYN is the owner of product Leronlimab.
WHEREAS, CYTODYN has represented that it is in the process to commercialise the product Leronlimab and is keen to partner with entities to distribute the same.
WHEREAS, MACLEODS has obtained and is continuing to obtain Compassionate Special Permit (“CSP”) or Emergency Use Authorization (“EUA”) from the India Central Drugs Standard Control Organization (“CDSCO”) to treat confirmed coronavirus disease 2019 (“COVID-19”) patients in India.
NOW THEREFORE, the Parties hereto have agreed as follows:
|2.3.1.||If the quantity of Product contained in any Purchase Order is less than [*] vials, then MACLEODS shall reimburse CYTODYN for [*] percent [*] of CYTODYN’s out-of-pocket shipping and insurance expenses related to such deliveries.|
|2.3.2.||Delivery on each Firm Order will take place on or before twenty (20) days after CYTODYN’s receipt of the Purchase Order.|
|2.3.3.||CYTODYN shall have satisfied its obligations with respect to a Firm Order if (a) the actual delivery date is within plus or minus five (+/-5) days of the specified delivery date specified in the corresponding Purchase Order, and (b) if the actual quantity of Product delivered is within plus or minus five percent (+/-5%) of the accepted Purchase Order quantity specified in the accepted Purchase Order.|
|2.4.1.||CYTODYN shall be responsible for Product test procedures for quality assurance, including Product storage and shipping requirements, before Product is released to MACLEODS. With each delivery, CYTODYN shall provide a certificate of analysis and other documents (collectively, the “COA”) as specified in the Quality Agreement.|
|2.4.2.||CYTODYN shall notify in advance to MACLEODS of any variation or change that affects the formulation, design, packaging, specifications, or any notable change in the Products, change in the plant or production lines, to the extent the same may affect the process of importing and marketing of the Products.|
|2.4.3.||MACLEODS shall inspect each shipment of Product promptly upon receipt. MACLEODS may reject any Product which does not conform to the Specifications, or the shipping and storage requirements for the Product, at the time of receipt at MACLEODS’s location. MACLEODS shall make any such rejection in writing, within seven (7) days of the later of the receipt of the COA and the Product at the facility designated by MACLEODS in the applicable Firm Order (the “Stipulated Rejection Period”), to CYTODYN, and shall specify the reasons for such rejection (the “Rejection Notice”).|
|2.4.4.||If MACLEODS has not delivered a Rejection Notice within the Stipulated Rejection Period, MACLEODS shall be deemed to have accepted that shipment of Product. Once MACLEODS has accepted or has been deemed to have accepted a shipment of Product, and MACLEODS may not exercise any rights to subsequently reject such shipment.|
|2.5.1.||After CYTODYN receives the Rejection Notice, it will evaluate process issues and|
|the reasons given by MACLEODS for the rejection. CYTODYN shall use commercially reasonable efforts to promptly notify MACLEODS whether it agrees with the basis for MACLEODS’ rejection. If CYTODYN agrees with the basis for MACLEODS’ rejection, CYTODYN shall use commercially reasonable efforts to promptly replace, at no cost to MACLEODS, such rejected Product.|
|2.5.2.||If CYTODYN disagrees with the basis for MACLEODS’ rejection specified in the Rejection Notice: (i) CYTODYN shall use commercially reasonable efforts to promptly replace such rejected Product; and (ii) the Parties shall submit samples of the rejected Product to a mutually acceptable third party laboratory, which shall determine whether such Product meets the Specifications. The determination of the third-party laboratory shall be final and determinative. If the third-party laboratory determines that the rejected shipment meets the Specifications, the rejection by MACLEODS is unjustified, and MACLEODS shall promptly pay CYTODYN for any replacement Product and, if the Product can no longer be distributed, Purchase Price on the unjustifiably rejected Product. If the third-party laboratory determines that the rejected shipment does not meet the Specifications, CYTODYN shall not invoice MACLEODS for the replacement Product. The Party against whom the third-party laboratory rules shall also bear the fees in connection with resolution of the disagreement.|
|2.5.3.||Notwithstanding any of the other provisions in this Agreement and without limiting any other provision herein, MACLEODS agrees that the remedies set forth in this Section 2.5 are MACLEODS’s sole and exclusive remedies with respect to the rejection of Product.|
With respect to the Product Manufactured by CYTODYN, each Party shall promptly notify the other Party of any Regulatory Authorities’ notices of violation or deficiency letters received and
promptly deliver to the other Party all related reports, data information and correspondence received from such Regulatory Authorities with respect to API(s)/API in the Product, any GMP issues relating thereto and any written response, information, data or correspondence delivered by such Party to the Regulatory Authority with respect to the API(s)/ Product and shall cooperate to the extent reasonably requested by the other Party in its response to the Regulatory Authorities.
CYTODYN shall retain all of its rights, title and interest in and to all industrial and intellectual property rights embodied in or which covers the Product, in each case which is owned, held, or licensed by it as of the Effective Date or thereafter or developed, created or discovered by it or on its behalf. Except as otherwise expressly provided in this Agreement, MACLEODS has and shall have no right, title or interest in any intellectual property right relating to the Product.
|10.4.1.||MACLEODS shall (i) promptly return to CYTODYN, or, at CYTODYN’s request, destroy (and certify such destruction in writing) all of CYTODYN’s Confidential Information, and (ii) cease using Confidential Information in any way for any purpose.|
|10.4.2.||MACLEODS may, where permitted by applicable laws, sell Product then in its inventory until the expiry of the Product (“Selloff Period”), all in accordance with the terms of this Agreement. Promptly after the expiration of the Selloff Period, MACLEODS shall, at its cost, destroy any unsold Product remaining in its inventory and will provide appropriate evidence of such destruction to CYTODYN. Furthermore, CYTODYN may cancel any Firm Order accepted by CYTODYN before termination and requires delivery of Product after the date of termination.|
This Agreement does not constitute either Party as agent or legal representative of the other Party for any purpose whatsoever. A Party is not granted any right or authority to assume or to create any obligation or responsibility, express or implied, on behalf of or in the name of the other Party, with regard to any manner or thing whatsoever, unless otherwise specifically agreed upon in writing.
MACLEODS shall not assign, delegate or transfer its rights and obligations under this Agreement in whole or in part without prior written authorization from CYTODYN; any purported assignment, delegation or transfer in violation of the foregoing is void. CYTODYN may assign, delegate or transfer its rights and obligations under this Agreement in whole or in part.
Each of the Parties hereto shall be excused from the performance of its obligations hereunder, other than the payment of money, in the event that such performance is prevented by force majeure, provided that each of the Parties shall use its best efforts to complete such performance by other means. For the purpose of this Agreement force majeure is defined as causes beyond the control of MACLEODS or CYTODYN, including but not limited to, acts of God, acts, regulations or laws of any government, war, civil commotion, destruction of production facilities or materials by fire, earthquake or storm, labor disturbances, epidemic and failure of public utilities or common carriers.
Should any part or provision of this Agreement be held unenforceable or in conflict with the applicable laws or regulations of any applicable jurisdiction, the invalid or unenforceable part or provision shall, provided that it does not affect the essence of this Agreement, be replaced with a revision which accomplishes, to the extent possible, the original commercial purpose of such part or provision in a valid and enforceable manner, and the balance of this Agreement shall remain in full force and effect and binding upon the Parties hereto.
This Agreement constitutes the entire agreement between the Parties with respect to its subject matter and supersedes all prior agreements, arrangements, dealings or writings between the Parties. This Agreement may not be varied except in writing signed by the Parties' authorized representatives.
No waiver of any right, breach or default hereunder shall be considered valid unless in writing and signed by the Party giving such waiver, and no such waiver shall be deemed a waiver of any subsequent right, breach or default of the same or similar nature.
This Agreement shall be governed, interpreted and construed in accordance with the laws of the State of New Jersey, without to the principles of conflicts of law. Any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating to this Agreement (other than good-faith third party actions or proceedings filed or instituted in an action or proceeding by a third party against a Party) shall be finally resolved by binding arbitration conducted in the English language, in Singapore, under the Arbitration Rules of Singapore International Arbitration Centre ("SIAC Rules") , by a panel of one arbitrator appointed in accordance with the SIAC Rules. Notwithstanding the foregoing, either Party may, without waiving any right or remedy available to such Party, seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrator hereunder or pending the arbitrator’s determination of any dispute, controversy or claim hereunder. The Parties undertake to use all reasonable best efforts in order to solve in an
amicable manner any controversy arising in connection with this Agreement. The award of the arbitrator shall be final and binding.
Unless otherwise stated in this Agreement, all requests and notices required or permitted to be given to the Parties hereto shall be given in writing, shall expressly reference the section(s) of this Agreement to which they pertain, and shall be delivered to the other Party, effective on receipt, at the appropriate address as set forth below or to such other addresses as may be designated in writing by the Parties from time to time during the term of this Agreement.
If to MACLEODS:
Macleods Phrmaceuticals Ltd
304, Atlanta Arcade, Maroi Church Road, Opp. Hotel Leela, Andheri (East) Mumbai 400 059
Attention: Vijay Agarwal
If to CYTODYN:
CYTODYN Inc., 1111 Main Street, Suite 660, Vancouver, WA 98660, USA
Attention: Chief Executive Officer
Email: ***@*** and ***@***
Product complaints and quality issues: ***@***
This Agreement may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be one and the same agreement.
IN WITNESS WHEREOF, the Parties hereto have each caused this Agreement to be executed by their duly-authorized representatives as of the Effective Date.
/s/ Nader Pourhassan
Chief Executive Officer
MACLEODS PHARMACEUTICAL LTD.
/s/ Vijay Agarwal
Business Development Director
SIDE LETTER TO EXCLUSIVE SUPPLY AND DISTRIBUTION AGREEMENT
[Dated and Effective as of May 11, 2021]
This side letter agreement (“Side Letter”) is entered into by and among Macleods Pharmaceuticals Ltd, an India corporation (the “Macleods”) and CytoDyn Inc., a Delaware corporation (“CytoDyn”) with reference to the Exclusive Supply and Distribution Agreement, dated and effective as of May 11, 2021 by and between Macleods and CytoDyn (the “Agreement”). Macleods and CytoDyn are referred to herein collectively as the “Parties”
IN WITNESS WHEREOF, the parties have executed this Side Letter as of the date first written above.
_/s/ Nader Pourhassan___________________/s/ Vijay Agarwal_________________
Nader PourhassanVijay Agarwal
Chief Executive OfficerBusiness Development Director