EXCLUSIVE SUPPLY AND DISTRIBUTION AGREEMENT
Exhibit 10.8
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 15th day of April, 2021 (“Effective Date”), by and between:
CHIRAL PHARMA CORPORATION with business address at P. Antonio St., cor X. Xxxxxxx St., Ugong, Pasig, Metro Manila, a Philippines corporation
(“CPC”);
&
CytoDyn Inc. a Delaware corporation, with business address at 0000 Xxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, XX 00000 (“CytoDyn”).
Collectively known as the “Parties”
WITNESSETH;
WHEREAS, CytoDyn is the owner of product Leronlimab (“Product”).
WHEREAS, CPC has obtained and is continuing to obtain Compassionate Special Permit (“CSP”) applications or Emergency Use Authorization (“EUA”) from the Food and Drug Administration of the Philippines (“Philippines FDA”) to use Leronlimab to treat confirmed coronavirus disease 2019 (“COVID-19”) patients in the Philippines.
NOW THEREFORE, the Parties hereto have agreed as follows:
| 1.1 | Appointment. Subject to and conditioned on CPC complying with all of its obligations under this Agreement, CytoDyn hereby appoints CPC as the exclusive distributor of the Product in the Territory during the period beginning on the Effective Date and ending on the first (1st) anniversary thereafter (“Exclusivity Period”). CPC hereby accepts such appointment and shall purchase all of its required quantities of Product from CytoDyn at the Purchase Price and distribute Product solely in the Territory and in accordance with the applicable CSP. |
| 1.2 | “Product” means Vyrologix TM (350 mg), a subcutaneous injectable biopharmaceutical drug product that contains CytoDyn’s Leronlimab (a humanized monoclonal antibody (also known as PRO 140) |
| targeting against the CCR5 receptor) as the only active pharmaceutical ingredient, as further described in the applicable product specification provided by CytoDyn (“Specifications”). “Territory” means the Republic of Philippines. “Purchase Price” means [*] U.S. Dollars ([*]) per vial of Product, CIF (Incoterms® 2020) Manila Xxxxx Xxxxxx International Airport in Manila, Philippines. |
| 1.5 | Restrictions. CPC shall use the Products (and shall ensure the Products be used) solely in accordance with the treatment protocols approved under the applicable CSPs or EUA. CPC shall not distribute, resell, reverse engineer, administer, or otherwise use or make available the Products to anyone in any way or for any purpose. CPC shall store and handle the Products in accordance with the handling and storage instructions as specified in labeling or as provided by CytoDyn from time to time. |
| 2.2 | Purchase Order Acceptance. CytoDyn shall, within two (2) days of receipt of a Purchase Order, confirm in writing whether a given Purchase Order has been accepted. CytoDyn shall use commercially |
| 2.4 | Acceptance; Rejection. |
| 2.5 | Rejection Procedures. |
| 2.5.3. | Notwithstanding any of the other provisions in this Agreement and without limiting any other provision herein, CPC agrees that the remedies set forth in this Section 2.5 are CPC’s sole and exclusive remedies with respect to the rejection of Product. |
| 2.6 | No serialization. The Parties acknowledge and agree that all Products delivered to CPC under this Agreement are not required to be and will not be serialized. |
| 3.2 | Payment. All payments due to Cytodyn shall be payable in US Dollars. CPC shall open an irrevocable import letter of credit to be issued by a local bank acceptable to CytoDyn and confirmed by a reputable international bank. The terms of payment shall be within [*] days credit from the date of delivery. Letter of credit should be received before the product shipment to CPC. |
| 3.3 | In the event that the Product obtains commercial approval in another market, it is understood by the Parties that the purchase price to CPC shall remain at par or less than other purchase contracts made by CytoDyn during the Term of this Agreement. |
| 3.4 | Any price increase after the Exclusivity Period should be fair and reasonable, following the prevailing market conditions and in accordance with all regulatory approvals. |
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, CPC has and shall have no right, title or interest in any intellectual property right relating to the Product.
| a minimum shelf-life of [*] months upon receipt of Products, such shelf life being determined based solely on CytoDyn’s internal stability test data. |
| 5.4 | No Additional Warranties. CPC shall not make any representation or give any warranty in respect of the Products other than those authorized in writing by CytoDyn from time to time. |
| 5.5 | Insurance. In addition, each Party agrees to obtain commercially reasonable and customary insurance sufficient to cover its respective potential liabilities hereunder and provide each other a copy thereof. |
| 7.1 | CPC and CytoDyn shall notify each other within twenty-four (24) hours by confirmed facsimile or email of any information concerning any serious or unexpected side effect, injury, toxicity, or sensitivity reaction, any unexpected incidents, or any adverse drug experience reports and the severity thereof associated with the Products, the use and sale thereof (collectively “Adverse Events”). To enable CytoDyn to comply with its regulatory reporting responsibilities, CPC shall use commercially reasonable efforts to deliver to CytoDyn all Adverse Event information received by CPC and all other information as required by CytoDyn by notice in writing to CPC. |
| 7.2 | CytoDyn and CPC shall each comply with Philippines FDA pharmacovigilance policy (i.e., Adverse drug experience reports). |
| 7.3 | Complaints with regard to the Products received by CPC will be promptly sent by facsimile or email to CytoDyn at: xxxxxxx@xxxxxxx.xxx and XXXX_Xxxx@xxxxxxx.xxx. |
| 7.4 | If, for any reason, it shall become necessary to trace back or recall any particular batch of the Products, or to identify the customer or customers to whom Products from such batch will have been delivered, CPC shall cooperate fully with CytoDyn in doing so in accordance with the procedure established for the said purpose. If the recall is due to manufacturing defects of the Products, all costs and expenses related to said recall shall be borne by Cytodyn. |
| 7.5 | The obligation relating to Section 7.2 and to the Pharmacovigilance Policy and its subsequent amendments shall survive for one (1) year after the expiry date of the last batch of Products marketed by CPC in the Territory. |
| 7.6 | The obligation relating to Products complaints under Section 7.3 shall survive until the expiry date of the last batch of Products marketed by CPC in the Territory. |
| 7.7 | The obligation relating to Products recall under Section 7.4 shall survive until the expiry date of the last batch of Products marketed by CPC in the Territory. |
| 8.2 | CPC shall take all necessary steps to ensure that its employees who gain access to Confidential Information are bound in writing by terms similar to the terms of this Agreement, not to divulge Confidential Information, except that they may divulge it to the extent that CPC may do so in accordance with the provisions hereof. |
| 8.3 | CPC agrees that all Confidential Information that it receives from CytoDyn and/or its affiliates in connection with the Products are the sole property of CytoDyn and shall be used by it only in accordance with the terms and provisions of this Agreement. |
| 8.5 | CPC’s obligations under Section 8 shall survive for five (5) years after termination of this Agreement and indefinitely as to any trade secret. |
| 9.1 | Term. This Agreement shall commence on the Effective Date and shall be valid for one (1) year thereafter, unless terminated earlier pursuant to Section 9. |
| 9.2 | Termination for Breach. A Party may terminate this Agreement upon prior written notice to the other Party for material breach of this Agreement by the other Party (which includes any failure by CPC to pay amounts when due to CytoDyn in accordance with the terms of this Agreement). Any notice of material breach shall specify the breach in reasonable detail. Unless otherwise provided in this Agreement, the termination shall be effective thirty (30) days after receipt of the written notice, unless the breaching Party cures the breach within that thirty (30) day notice period. |
| 9.3 | Termination for Convenience. Each Party may terminate this Agreement for convenience upon sixty (60) days’ notice to the other Party. |
| 9.4 | Effects of Termination. Upon termination: |
| 9.4.1. | CPC 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. |
| 9.4.2. | CytoDyn shall within thirty (30) days from effective date of termination of this Agreement, repurchase all inventory of Products of marketable quality and having a remaining shelf life of at least fifty percent (50%) based on CytoDyn’s Invoice date held by CPC. In the event that CytoDyn transfers the right to distribute to another distributor, then said distributor shall purchase all stocks of the products held by CPC, in good and marketable condition. In both cases, CytoDyn shall pay CPC for a price equivalent to the Products’ landed cost plus 15%. |
| 9.4.3. | In the event Cytodyn decides not to repurchase, CPC may, where permitted by applicable laws, sell Product then in its inventory for a period of six (6) months thereafter (“Selloff Period”), all in accordance with the terms of this Agreement. Promptly after the expiration of the Selloff Period, CPC shall, at its cost, destroy any unsold Product remaining in its inventory and will provide appropriate evidence of such destruction to CytoDyn. |
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.
CPC 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 CPC 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 Republic of Singapore, without reference 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 the Republic of Singapore, under the Arbitration Rules of the 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.
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 CPC:
Chiral Pharma Corporation, P. Antonio St., cor X. Xxxxxxx St., Ugong, Pasig,
Metro Manila
Attention: Xxxxxxx Xxxx X. Xxxxx
Email: xxxxxxx@xxxx.xxx.xx
If to CytoDyn:
CytoDyn Inc., 0000 Xxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx, XX 00000, XXX
Attention: Chief Executive Officer
Email: xxxxxxxxxxx@xxxxxxx.xxx and XXXX_Xxxx@xxxxxxx.xxx
Product complaints and quality issues: xxxxxxx@xxxxxxx.xxx
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/ Xxxxx Xxxxxxxxxx Xxxxx Pourhassan Chief Executive Officer | Chiral Pharma Corporation /s/ Xxxxxxx Xxxx X. Xxxxx, XX Xxxxxxx Xxxx X. Xxxxx, IV President |
