Psyence Biomedical Ltd 6-K, filed Dec 19, 2024
Psyence Biomedical Ltd. (PBM)
About this 6-K
Psyence Biomedical Ltd filed this 6-K on December 19, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THESECURITIES EXCHANGE ACT OF 1934
For the month of December 2024
Commission File Number: 001-41937
Psyence Biomedical Ltd.
(Translation of registrant’s name into English)
121 Richmond Street West
Penthouse Suite 1300
Toronto, Ontario M5H 2K1
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
x Form 20-F ¨ Form 40-F
Explanatory Note
On December 5, 2024, Psyence Biomedical Ltd. (the “Company” or “Psyence”) entered into three definitive agreements with Optimi Health Corp. (together with their affiliates, “Optimi”): an IP and Mutual Exclusivity Agreement (the “MEA”), a Quality Agreement (the “Quality Agreement”), and a Supply Agreement (the “Supply Agreement,” and collectively with the MEA and Quality Agreement, the “Optimi Agreements”). These agreements govern the supply, quality control, intellectual property licensing exclusivity, and regulatory compliance of pharmaceutical-grade psilocybin products.
Pursuant to the MEA, Psyence was granted limited, exclusive, worldwide, royalty-bearing rights to specified psilocybin products for use in clinical trials and therapeutic applications in designated fields of use. The MEA also outlines obligations related to intellectual property ownership, protection, and enforcement. The Quality Agreement establishes quality standards, including current Good Manufacturing Practices (cGMP) compliance, product testing, and certification processes. It specifies the parties’ responsibilities concerning product release, regulatory submissions, and inspections by regulatory authorities. Under the Supply Agreement, Optimi committed to a long-term supply of pharmaceutical-grade psilocybin products, ensuring an uninterrupted supply for Psyence’s clinical trial programs. The agreement includes minimum purchase requirements, supply forecasts, pricing terms, and volume-based discounts.
The Company agreed to pay Optimi exclusivity fees in three tranches, development and commercial milestone payments upon achieving specific milestones, and a percentage of the Net Invoice Price (as defined in the MEA) on all commercial sales in certain specified jurisdictions.
The exclusivity of Psyence’s rights may terminate if Psyence fails to maintain its Common Shares listed from Nasdaq prior to the commencement of its phase III clinical trial.
The agreements contain customary representations, warranties, covenants, and indemnification provisions, including assurances regarding regulatory compliance, intellectual property ownership, and liability limitations.
The above summary of the MEA, Quality Agreement, and Supply Agreement is qualified in its entirety by reference to the full text of such agreements, filed as Exhibits 10.1, 10.2, and 10.3, respectively, to this Report on Form 6-K and incorporated herein by reference.
On December 10, 2024, the Company issued a press release announcing the execution of the Optimi Agreements. A copy of the press release is furnished hereto as Exhibit 99.1.
EXHIBIT INDEX
EXHIBIT INDEX
| * | Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: December 19, 2024
| Psyence Biomedical Ltd. | ||
| By: | /s/ Neil Maresky | |
| Name: | Dr. Neil Maresky | |
| Title: | Chief Executive Officer and Director | |
Exhibit 10.1
IP LICENSING
AND MUTUAL EXCLUSIVITY AGREEMENT
("IP and Mutual Exclusivity Agreement")
between
OPTIMI HEATH CORP.
and
PSYENCE BIOMEDICAL LTD.
made on 5 December 2024
| Page 1 of 15 |
| A. | Parties: |
| 1) | "Optimi" is Optimi Health Corp, a company incorporated in British Columbia under number BC 1251418, (which expression shall include its successors and assigns) of 600 - 21 Water Street, Vancouver, B.C., V6B 1A1. |
| 2) | "Psyence" is Psyence Biomedical Limited (which expression shall include its successors and assigns) the of 121 Richmond Street West, Penthouse Suite 1300, Toronto, ON M5H2K1, Canada. |
| B. | Recitals: |
| 1) | Optimi: |
| a) | is a psychedelics pharmaceutical manufacturer in Canada with both a Controlled Drugs and Substances Dealer's Licence and a Drug Establishment Licence (DEL). |
| b) | specializes in controlled substances such as botanical psilocybin–containing mushrooms and 3,4-Methylenedioxymethamphetamine ("MDMA"). |
| c) | is dedicated to supplying safe, GMP-grade products and API to researchers, drug developers, and authorized patients in markets across the world. |
| 2) | Psyence: |
| a) | is a biotech company focused on the use of natural psilocybin to treat psychological trauma, addiction and the diagnosable disorders that can result therefrom. |
| b) | wishes to use the controlled substances produced by Optimi relating to botanical psilocybin containing mushrooms in connection with pre-clinical and clinical studies involving human subjects, for the purpose of discovering or verifying the safety, pharmacokinetics or effects of such products. The trials will be conducted in multiple countries in due course in the treatment of anxiety and depression, including associated ailments, such as PTSD, stress, grief, and adjustment disorder, all within the exclusive context of Palliative Care. |
| c) | if such trials are successful, Psyence wishes to hold a right to commercialise such products. |
A letter of intent was concluded between the Parties on August 1, 2024 and the parties have now agreed to conclude this bundle of agreements ("Bundle of Agreements") comprising:
| 1. | the Supply Agreement; |
| 2. | the IP and Mutual Exclusivity Agreement; and |
| 3. | the Quality Agreement |
recording the terms agreed between the parties. If any conflict should exist between the provisions or interpretation of the above-mentioned agreements such conflicts shall be resolved by applying preference to the interpretation of the agreements in the sequence referenced above, with the Supply Agreement being given the highest priority and the Quality Agreement given the lowest priority in the Bundle of Agreements.
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Operative provisions
| 1. | Definitions |
| 1.1. | In this Agreement except where the context otherwise requires the following terms shall have the following meanings: |
| 1.1.1. | "ASSOCIATED COMPANY" a subsidiary or holding company of Optimi or Psyence (as appropriate), or any subsidiary of any such holding company from time to time; |
| 1.1.2. | "CLINICAL TRIALS" the clinical trials to be conducted by Psyence using the Product; |
| 1.1.3. | "COMMENCEMENT DATE” 5 December 2024 ; |
| 1.1.4. | "EXCLUSIVE" in respect of a right granted under this Agreement the grantor will not itself exercise that right and will not authorise others to exercise that right; |
| 1.1.5. | "FIELD OF USE" the treatment of anxiety and depression, including associated ailments, such as Post-Traumatic Stress Disorder, stress, grief, and adjustment disorder, all within the context of Palliative Care; |
| 1.1.6. | "IMPROVEMENT" any improvement, enhancement, substantial alteration or modification to or of the Product or Optimi’s process of making it; |
| 1.1.7. | "KNOW-HOW" information, knowledge, experience, trade secrets, formulae and data in the possession of Optimi from time to time during the term of this Agreement relating to the Product or the process of making it; |
| 1.1.8. | "PRODUCT" OPTI-PSIE Psilocybin, 5mg, encapsulated drug candidate and placebos of such product, which placebos may take the form of a 1mg active dose based on health regulatory requirements; |
| 1.1.9. | "NET INVOICE PRICE" [*] |
| 1.1.9.1. | [*] |
| 1.1.9.2. | [*] |
| 1.1.9.3. | [*] |
| 1.1.9.4. | [*] |
[*]
| 1.1.10. | "PALLIATIVE CARE" [*] |
| 1.1.11. | "PATENTS" any and all granted patents and patent applications held by Optimi at any time during the term of this Agreement relating to the Product and/or the process for making the Product. Psyence acknowledging that as at the Commencement Date of this Agreement Optimi does not hold any patents or patent applications in relation to the Product; |
| 1.1.12. | "PERSON(S)" any person, firm or company or group of persons or unincorporated body; |
| 1.1.13. | "PRINCIPAL MARKET" shall mean any of the national exchanges (i.e. NYSE, AMEX, Nasdaq) or other principal exchange or recognized quotation system which is at the time the principal trading platform or market for Psyence's common stock; |
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| 1.1.14. | "SIGNATURE DATE" means the date upon which this Agreement is signed by both Parties; |
| 1.1.15. | "TERRITORY" any and all countries, territories and regions of the world. |
| 1.2. | The singular includes the plural and vice versa. |
| 1.3. | Unless the context otherwise indicates, references to clauses, sub-clauses, recitals and to Schedules are to clauses and sub-clauses of, and recitals and Schedules to this Agreement. |
| 1.4. | Headings to clauses in this Agreement are included for the purpose of ease of reference only and shall not have any effect on the construction or the interpretation of this Agreement. |
| 1.5. | References in this Agreement to any statute or statutory provision shall include any statute or statutory provision which amends, extends, consolidates or replaces the same and shall include any orders, regulations, instruments or other subordinate legislation made under the relevant statute. |
| 2. | LIMITED LICENSE |
| 2.1. | Optimi hereby grants to Psyence a limited, exclusive, royalty-bearing right in the Territory under the Patents and the Know-How within the Field of Use (including any Improvement) to: |
| 2.1.1. | use the Product in conducting research, pre-clinical and Clinical Trials within the Field of Use; |
| 2.1.2. | sell the Product for use in the Field of Use; and |
| 2.1.3. | manufacture and have manufactured the Product, in the following limited circumstances: |
| 2.1.3.1. | in the event that Optimi is unable to meet Psyence’s demand for the Product as provided in the Forecasts (as defined below); or |
| 2.1.3.2. | where Optimi becomes insolvent, files for bankruptcy, or enters into any agreement with its creditors; or |
| 2.1.3.3. | where Optimi (whether due to its facilities, contract manufacturers or otherwise) cannot meet the manufacturing requirements of the end-purchaser or end-user (which for illustrative purposes could include a requirement for EU-GMP produced product); or |
| 2.1.3.4. | where Optimi (whether due to its facilities, contract manufacturers or otherwise) cannot not meet the regulatory requirements or quality specifications of a regulator assessing the use of the Product; or |
| 2.1.3.5. | where Optimi experiences regulatory delays or prohibitions (for example, an inability to secure a required export or import permit). |
| 2.2. | Psyence has the right to sublicense its rights under this agreement, provided that: |
| 2.2.1. | any such sub-licence shall be non-exclusive and shall be limited and subject to the rights and obligations granted under this Agreement; |
| 2.2.2. | every such sub-licence shall be in writing and a copy of the executed version shall be made available to the Licensor promptly after completion; |
| 2.2.3. | no sub-licence shall include the right for the sub-licensee to grant further sub-licences or to disclose confidential know-how of Optimi other than to its own directors and employees; |
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| 2.2.4. | all sub-licences shall expire on or prior to the expiry of this Agreement; and |
| 2.2.5. | Psyence shall be responsible to Optimi for any failure of each sub-licensee to observe and perform the terms and conditions of its sub-licence on its behalf to be observed and performed, with Psyence hereby guaranteeing as principal any and all royalty payments due to Optimi arising out of such sub-licensing agreement. |
| 2.3. | No further right or licence is granted to Psyence under the Licensed Patents, save as set out expressly in this clause 2. |
| 2.4. | Optimi shall not offer a license or grant the rights granted to Psyence in this clause 2 to a third party during the term of this Agreement. |
| 3. | Duration of agreement |
| 3.1. | This Agreement shall come into force on the Commencement Date and remain in force indefinitely unless determined in accordance with clause 12 (Termination and Liquidation). |
| 3.2. | Psyence shall use commercially reasonable efforts to maintain and continue the listing or quotation and trading of its common stock on the Principal Market prior to the commencement its Phase III Clinical Trial. In the event that Psyence's common stock is finally delisted from the Principal Market (without the right of appeal or review) prior to the commencement its Phase III Clinical Trial, then the rights granted to Psyence under this Agreement will become non-exclusive, and shall continue on the same terms of the Agreement mutandis mutatis save that: |
| 3.2.1. | no Milestone Payments or Royalty will be payable by Psyence and the terms of clauses 6, and 8.3 to 8.7 shall no longer be applicable; and |
| 3.2.2. | Optimi shall be free to offer a non-exclusive license or grant the rights provided for in this clause 2 to a third party on terms no more favourable than the terms set forth in this Agreement. |
| 4. | Supply of Product |
The Parties are entering into the Supply Agreement, which together with the Quality Agreement govern the terms of the supply of the Product.
| 5. | bioequivalence study |
| 5.1. | The Parties agree that Psyence shall conduct a bio-equivalence study on the Product (with Optimi doing all things necessary at its own cost to support such study) which may include: |
| 5.1.1. | a bioequivalence study; |
| 5.1.2. | further testing, processing or modification of the Product in accordance with the determinations of the relevant health authority or as require by applicable laws and regulations; and |
| 5.1.3. | pharmacovigilance and risk model to support commercialization in accordance with the determinations of the relevant health authority or as require by applicable laws and regulations, |
[*]
| Page 5 of 15 |
| 5.2. | In the event that the bioequivalence study is unsuccessful the nature of this agreement will convert to being a non-exclusive agreement, where: |
| 5.2.1. | no Milestone Payments or Royalty will be payable by Psyence and the terms of clauses 6, and 8.3 to 8.7 shall no longer be applicable; and |
| 5.2.2. | Optimi shall be free to offer a non-exclusive license or grant the rights provided for in this clause 2 to a third party on terms no more favourable than the terms set forth in this Agreement. |
| 6. | EXCLUSIVITY |
| 6.1. | During the term of this Agreement and for so long as the nature of the relationship remains exclusive Psyence agrees that it shall not purchase or acquire from any other person, or manufacture or cause to be manufactured the Product or any similar or bioequivalent product in conducting research, pre-clinical and Clinical Trials within the Field of Use, save in accordance with the terms of this Agreement.In the event that the relationship is converted to a non-exclusive relationship under clauses 3.2 or 4.3 this Agreement or under any other agreement in the Bundle of Agreements: |
| 6.1.1. | no Milestone Payments or Royalty will be payable by Psyence under the IP and Mutual Exclusivity Agreement; |
| 6.1.2. | the provisions of clauses 6.1, and 8.3 to 8.7 shall no longer be applicable; and |
| 6.1.3. | Optimi shall not offer or sell the Goods to a third Party on terms more favourable than the terms set forth in this Agreement. |
| 7. | Warranties on intellectual property |
| 7.1. | All Know-How is (or where appropriate in the case of pending applications will be): |
| 7.1.1. | legally and beneficially vested in Optimi; |
| 7.1.2. | not subject to any limitation or restriction over its use or right to be licensed; |
| 7.1.3. | not being used unlawfully, or the subject of any claim for ownership or compensation by any person; and |
| 7.1.4. | not subject to any licence, waiver, option, right of first refusal, contingent assignment or agreement for or obligation as to these, or any other encumbrance, of any sort in favour of a third party. |
| 7.2. | The Product itself and none of the processes and methods used by the Licensor in making the Product, use, embody or infringe (and at the time of their being employed, provided, conducted, manufactured used or dealt in did not use, embody or infringe) any Intellectual Property other than that belonging to the Company. |
| 7.3. | No claims or applications have been made against, no notifications (including 'non-threatening letters’) have been received by, and no circumstances are known to, the Company in respect of the Company which (notwithstanding any view taken by the Company as to the merits of such claim application, notification or circumstances) if pursued, granted or acted on would affect the accuracy of the warranties in clauses 7.1 and 7.2. |
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| 8. | Provision of Know-How |
| 8.1. | Optimi shall: |
| 8.1.1. | provide all relevant Chemistry Manufacturing Control ("CMC") information to support submissions (during the clinical and IND phase); |
| 8.1.2. | subject to the acceptance of a Project Appendix by Optimi, make available to Psyence such know-how relating to the manufacture of the Products as is in writing and as is reasonably necessary for the manufacture of the Product; and |
| 8.1.3. | attend the premises of Psyence and to respond to subsequent requests for information or assistance from Psyence in the event that Optimi is unable to meet Psyence’s demand for the Product and Psyence exercises its right to manufacture and have manufactured the Product in terms of clause 2.1.3. |
| 8.2. | Such Know-How furnished by Optimi under clause 8.1 shall be used by Psyence in accordance with the terms of this Agreement and shall be subject to the provisions of clause 11 (Confidentiality). |
| 9. | Fees and Royalty |
| 9.1. | In consideration for the rights granted under this Agreement Psyence shall pay to Optimi: |
| 9.1.1. | the Exclusivity Fees; |
| 9.1.2. | Milestone Payments; and |
| 9.1.3. | a Royalty, |
as set out below.
| 9.2. | Psyence shall pay to Optimi the following fees (each, an "Exclusivity Fee") upon the dates listed below: |
| 9.2.1. | [*] |
| 9.2.2. | [*] |
| 9.2.3. | [*] |
| 9.3. | Psyence shall pay to Optimi (each, a "Milestone Payment") upon the achievement of the following development milestone events: |
| 9.3.1. | Milestone 1: [*] upon submission and approval of Phase III CTA (or jurisdiction specific equivalent), or an equivalent, and provision of the Product on an ex-works basis from a suitable release site, as designated by Optimi, save that – |
| 9.3.1.1. | [*] |
| 9.3.1.2. | [*] |
| 9.3.2. | Milestone 2: [*] upon first marketing approval permitting commercial sales and [*] for each subsequent marketing approval permitting commercial sales in [*] |
| 9.4. | Psyence shall pay to Optimi a royalty (a "Royalty") of [*]) of Net Invoice Price on all commercial sales of the Product in the Field of Use to any customer in any country or territory where Optimi holds granted and in force patent rights in such country or territory with claims covering the Product in the Field of Use, with Royalty payments commencing upon first commercial sale of Product. |
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| 9.5. | Royalties payable under this Agreement are inclusive of any value added, general sales, withholding (or like) tax which may be payable on them. |
| 9.6. | Royalties payable under this Agreement shall be paid in United States dollars within 30 days of the end of each successive quarterly period of three months commencing on 1 October, 1 January, 1 April, 1 July in each year. Interest shall be payable (calculated on a daily basis) on any overdue payments from the date payment is due until the actual date of payment at a rate of five per cent per annum. |
| 9.7. | At the same time as payment of any such royalties falls due Psyence shall submit or cause to be submitted to Optimi a statement in writing recording the calculation of royalty payable under this Agreement in particular: |
| 9.7.1. | the Net Invoice Price of each Product supplied during the previous quarter; and |
| 9.7.2. | the amount of royalties due and payable and the amount of any tax deductible or due to be deducted from such amount. |
| 9.8. | Psyence shall keep proper records and books of account showing the quality, description and price of Products supplied. Such records and books shall be kept separate from any records and books not relating solely to the Products and be open at all times to inspection and audit by Optimi or its duly authorised agent or representative who shall be entitled to take copies of or extracts from the same. |
| 9.9. | Except as provided in clause 11 (Confidentiality) the provisions of this clause shall remain in force notwithstanding expiry or earlier termination of this Agreement for any reason until the settlement of all subsisting claims of Optimi under this Agreement. |
| 9.10. | On seventy-two (72) hours’ notice, Optimi may audit Psyence's files relating to its sales, marketing and inventory of the Product regarding transactions that took place in the immediately preceding twelve (12) months. Optimi may conduct such an audit at any time during regular business hours and no more frequently than semi-annually. |
| 10. | Intellectual Property and Improvements |
| 10.1. | The Parties agree (inter se) that: |
| 10.1.1. | as at the date of signature of this Agreement Optimi owns all intellectual property rights in the Product and the Know-How relating to the manufacture of the Product; |
| 10.1.2. | If Psyence shall at any time during the term of this agreement devise, discover or acquire rights in any Improvement in the Field of Use arising out of its performance of its obligations under this Agreement, the parties agree that: |
| 10.1.2.1. | Optimi shall own all rights in and to such Improvement, and Psyence hereby assigns to Optimi, and shall cause its employees, agents and contractors to assign to Optimi any and all rights in such Improvement; and |
| 10.1.2.2. | Any such Improvement shall form part of the rights and license granted by Optimi to Psyence under this Agreement. |
| 10.2. | It is the intention of the Parties that Psyence shall own all intellectual property rights and data relating to the Clinical Trial and the use of the Product in the Field of Use. Optimi hereby assigns to Psyence, and shall cause its employees, agents and contractors to assign to Psyence and to do all things necessary to give effect to this intention. |
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| 11. | CONFIDENTIALITY |
| 11.1. | As used herein, the "Confidential Information" of a Party will mean, subject to clause 11.2 2, any and all technical and non-technical information disclosed by such Party (the "Disclosing Party") to the other Party (the "Receiving Party"), which may include without limitation: (a) patent and patent applications; (b) trade secrets; (c) proprietary and confidential information, either Party’s, ideas, samples, media, chemical compounds, assays, biological materials, techniques, sketches, drawings, works of authorship, models, inventions, know-how, processes, apparatuses, equipment, algorithms, software programs, software source documents, and formulae related to the current, future, and proposed products and services of each of the Parties, such as information concerning research, experimental work, development, design details and specifications, engineering, financial information, procurement requirements, purchasing, manufacturing, customer lists, investors, employees, business and contractual relationships, business forecasts, sales and merchandising, pricing information, licensing terms and marketing plans; and (d) all other information that the Receiving Party knew, or reasonably should have known, was the Confidential Information of the Disclosing Party. |
| 11.2. | Subject to clause 11.3, the Receiving Party agrees that at all times and notwithstanding any termination or expiration of this Agreement it will hold in strict confidence and not disclose to any third party any Confidential Information of the Disclosing Party, except as approved in writing by the Disclosing Party, and will use the Confidential Information of the Disclosing Party for no purpose other than as required to exercise its rights and obligations under the Bundle of Agreements. The Receiving Party will also protect such Confidential Information with at least the same degree of care that the Receiving Party uses to protect its own Confidential Information, but in no case, less than reasonable care. The Receiving Party will limit access to the Confidential Information of the Disclosing Party to only those of the Receiving Party’s employees or authorized representatives having a need to know and who have signed confidentiality agreements containing, or are otherwise bound by, confidentiality obligations at least as restrictive as those contained herein. Optimi expressly agrees and approves that the Company shall be entitled to share Optimi's technical information regarding product development with the Company’s customers, subject to such right to disclose Optimi's technical information is strictly for the purposes of fulfilling compliance obligations with customers and subject to having the prior written approval from Optimi for such disclosure. |
| 11.3. | The Receiving Party will not have any obligations under this Agreement with respect to a specific portion of the Confidential Information of the Disclosing Party if such Receiving Party can demonstrate with competent evidence that such portion of Confidential Information: |
| 11.3.1. | was in the public domain at the time it was disclosed to the Receiving Party; |
| 11.3.2. | entered the public domain subsequent to the time it was disclosed to the Receiving Party, through no fault of the Receiving Party; |
| 11.3.3. | was in the Receiving Party’s possession free of any obligation of confidence at the time it was disclosed to the Receiving Party; |
| 11.3.4. | was rightfully communicated to the Receiving Party free of any obligation of confidence subsequent to the time it was disclosed to the Receiving Party; or |
| 11.3.5. | was communicated by the Disclosing Party to an unaffiliated third party free of any obligation of confidence. |
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| 11.4. | Notwithstanding the above, the Receiving Party may disclose certain Confidential Information of the Disclosing Party, without violating the obligations of this Agreement, to the extent such disclosure is required by a valid order of a court or other governmental body having jurisdiction, provided that the Receiving Party (where it is legally permitted to do so) provides the Disclosing Party with reasonable prior written notice of such disclosure and makes a reasonable effort to obtain, or to assist the Disclosing Party in obtaining, a protective order preventing or limiting the disclosure and/or requiring that the Confidential Information so disclosed be used only for the purposes for which the law or regulation required, or for which the order was issued. |
| 11.5. | The Receiving Party will immediately notify the Disclosing Party upon discovery of any loss or unauthorized disclosure of the Confidential Information of the Disclosing Party. |
| 11.6. | Upon termination or expiration of this Agreement, or upon written request of either Party, each Party will promptly return to the Disclosing Party or destroy all documents and other tangible materials representing the Disclosing Party’s Confidential Information and all copies thereof. |
| 11.7. | Confidential Information is and shall remain the sole property of the Disclosing Party. The Receiving Party recognizes and agrees that nothing contained in this Agreement will be construed as granting any property rights, by license or otherwise, to any Confidential Information of the Disclosing Party, or to any invention or any patent, copyright, trademark, or other intellectual property right that has issued or that may issue, based on such Confidential Information. Neither Receiving Party will make, have made, use or sell for any purpose any product or other item using, incorporating or derived from any Confidential Information of the Disclosing Party. Neither this Agreement nor the disclosure of any Confidential Information hereunder shall result in any obligation on the part of either Party to enter into any further agreement with the other, license any products or services to the other, or to require either Party to disclose any particular Confidential Information. Nothing in this Agreement creates or shall be deemed to create any employment, joint venture, or agency between the Parties. |
| 11.8. | The Receiving Party will not reproduce the Confidential Information of the Disclosing Party in any form except as required to accomplish the intent of this Agreement. Any reproduction by a Receiving Party of any Confidential Information of the Disclosing Party will remain the property of the Disclosing Party and will contain any and all confidential or proprietary notices or legends that appear on the original, unless otherwise authorized in writing by the Disclosing Party. |
| 11.9. | The provisions of this clauses shall remain in force notwithstanding expiry or earlier termination of this Agreement for any reason. |
| 11.10. | Notwithstanding any other provision of this Agreement, all intellectual property arising in trial data and results acquired or developed by Psyence through the exercising of its rights under this Agreement shall be owned by Psyence and Optimi shall keep such data and results strictly confidential and shall not disclose such data or results to any third party, and to use such data or results for any purpose other than: |
| 11.10.1. | to carry out its obligations under the grant; |
| 11.10.2. | as required by applicable law; or |
| 11.10.3. | as expressly agreed between the Parties in writing as permitted uses or disclosures. |
| 12. | Termination and Liquidation |
| 12.1. | Optimi shall have the right to terminate this Agreement immediately by notice in writing to Psyence if: |
| 12.1.1. | Psyence shall fail to make any payment when it becomes due or shall fail to perform or observe any material obligation on its part to be performed or observed under this Agreement PROVIDED THAT in a case where the breach is remediable such notice from Optimi shall also require Psyence to remedy the breach and if Psyence so remedies within 30 days of the notice being served such notice to terminate this Agreement shall be deemed to be void and of no effect; or |
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| 12.1.2. | if an interim order is applied for or made, or a voluntary arrangement approved, or if a petition for a bankruptcy order is presented or a bankruptcy order is made against Psyence or if a receiver or a voluntary arrangement is proposed or approved or an administration order is made, or a receiver or administrative receiver is appointed over any of Psyence’s assets or undertaking or a winding-up resolution or petition is passed or presented (otherwise than for the purposes of reconstruction or amalgamation) or if any circumstances arise which would entitle the court or a creditor to appoint a receiver, administrative receiver or administrator or to present a winding-up petition or make a winding-up order or other similar or equivalent action is taken against or by Psyence by reason of its insolvency or in consequence of debt; |
| 12.1.3. | in any of the other events expressly identified in this Agreement as giving a right to terminate. |
| 12.2. | Psyence shall have the right to terminate this Agreement immediately by notice in writing to Optimi if Optimi shall fail to perform or observe any material obligation on its part to be performed or observed under this Agreement PROVIDED THAT in a case where the breach is remediable such notice from Psyence shall also require Optimi to remedy the breach and if Optimi so remedies within 30 days of the notice being served such notice to terminate this Agreement shall be deemed to be void and of no effect. |
| 12.3. | If an interim order is applied for or made, or a voluntary arrangement approved, or if a petition for a bankruptcy order is presented or a bankruptcy order is made against Optimi or if a receiver or a voluntary arrangement is proposed or approved or an administration order is made, or a receiver or administrative receiver is appointed over any of Optimi’s assets or undertaking or a winding-up resolution or petition is passed or presented (otherwise than for the purposes of reconstruction or amalgamation) or if any circumstances arise which would entitle the court or a creditor to appoint a receiver, administrative receiver or administrator or to present a winding-up petition or make a winding-up order or other similar or equivalent action is taken against or by Optimi by reason of its insolvency or in consequence of debt. |
| 13. | Consequences of termination |
| 13.1. | On termination of this IP and Mutual Exclusivity Agreement, or the Supply Agreement or the Quality Agreement however arising: |
| 13.1.1. | each of the agreements comprising, and all of, the Bundle of Agreements terminate simultaneously; |
| 13.1.2. | all outstanding sums repayable by Psyence to Optimi shall immediately become due and payable; |
| 13.1.3. | all rights and licences shall cease; |
| 13.1.4. | Psyence shall cease all and any exploitation of the Patents; and |
| 13.1.5. | Psyence shall co-operate in cancelling any registration of this Agreement. |
| 13.2. | The termination of this Agreement, however arising, shall be without prejudice to the provisions of this clause 13 and to any rights of either party which may have accrued by at or up to the date of termination and termination shall not relieve either party from any liability or obligation arising out of events occurring prior to such termination. |
| Page 11 of 15 |
| 13.3. | Notwithstanding the termination or expiration of any of agreements in the Bundle of Agreements for any reason, the following provisions shall survive and remain in full force and effect, as applicable: |
| 13.3.1. | clause 11 (Confidentiality) of the IP and Mutual Exclusivity Agreement; |
| 13.3.2. | clause 16 (Indemnification) of the IP and Mutual Exclusivity Agreement; |
| 13.3.3. | clause 7 (Indemnification and Liability) of the Supply Agreement; |
| 13.3.4. | article 8 (PRODUCT RECALL) of the Quality Agreement; |
| 13.3.5. | article 9 (PRODUCT QUALITY COMPLAINTS AND ADVERSE EVENTS) of the Quality Agreement; |
| 13.3.6. | Article 10.3 (STABILITY STUDIES) of the Quality Agreement |
| 13.3.7. | article 14 (TERM AND TERMINATION) of the Quality Agreement; and |
| 13.3.8. | any other provisions expressly stated to survive termination under any of agreements in the Bundle of Agreements. |
| 14. | Audit Rights & REVIEWS. |
| 14.1. | Psyence has the right (by itself or through its representatives) to review all audit reports issued with respect to the Product and/or the facilities in which such Product is being produced and Optimi agrees to make such audit reports available to Psyence within 20 business days of receipt and finalization thereof. Psyence will comply with Optimi's reasonable security, health and safety, and confidentiality procedures that are provided to Psyence in advance in writing. During normal working hours and upon reasonable notice, Psyence or its designee shall be entitled to inspect areas within Optimi's (or its contract manufacturer's) facility where the Product is manufactured or stored, and to inspect the manufacturing, packaging, and quality control records relating to the Product if i) a critical observation was identified on any audit report, or (ii) where required to do so by a health regulatory authority having jurisdiction of the Clinical Trials. |
| 14.2. | In the event that Psyence exercises its right to manufacture and have manufactured the Product in terms of clause 2.1.3, Optimi has the right (by itself or through its representatives) to review all audit reports issued with respect to the Product and/or the facilities in which such Product is being produced and Psyence agrees to make such audit reports available to Optimi within 20 business days of receipt and finalization thereof. Optimi will comply with Psyence's reasonable security, health and safety, and confidentiality procedures that are provided to Optimi in advance in writing. During normal working hours and upon reasonable notice, Optimi or its designee shall be entitled to inspect areas within Psyence's facility where the Product is manufactured or stored, and to inspect the manufacturing, packaging, and quality control records relating to the Product if i) a critical observation was identified on any audit report, or (ii) where required to do so by a health regulatory authority having jurisdiction of the Clinical Trials. |
| 15. | INSURANCE |
During the term of this Agreement, both Parties shall carry, at its sole expense, with financially sound and reputable insurers, insurance coverage (including workers compensation, errors and omissions, professional liability and comprehensive liability) with respect to the conduct of its business in such amounts as are customary for well-insured companies engaged in similar businesses. Upon the request of either Party to the other Party, such other Party shall provide to the requesting Party a copy of a certificate of insurance as evidence of its coverage.
| Page 12 of 15 |
| 16. | INDEMNIFICATION |
| 16.1. | Psyence shall indemnify, defend, and hold harmless Optimi and its employees, officers, directors and agents (the "Optimi Indemnitees") from and against, any and all claims, suits, losses, expenses (including reasonable attorneys' fees and legal expenses), costs and damages of every kind and nature (including but not limiting the generality of the foregoing, in respect of death, injury, loss or damage to any person or property) (together, "Claims") of any Optimi Indemnitee arising from the: |
| 16.1.1. | the negligence or wilful misconduct of Psyence or its directors, officers, employees and agents; |
| 16.1.2. | Psyence’s breach of any covenant or obligation under this Agreement; and |
| 16.1.3. | any loss relating to Psyence’s use sale or manufacture of the Product, |
except to the extent any such Claim is caused by any of the Optimi Indemnitees.
| 16.2. | Optimi shall indemnify, defend, and hold harmless Psyence and its directors, officers, employees, and agents (the "Psyence Indemnitees") from and against any and all third party Claims resulting from or arising out of: |
| 16.2.1. | the negligence or wilful misconduct of Psyence or its directors, officers, employees and agents; and |
| 16.2.2. | Psyence’s breach of any covenant or obligation under this Agreement; |
| 16.2.3. | any loss relating to Optimi’s sale or manufacture of Product; except to the extent any such Claim is caused by any of the Psyence’s Indemnitees. |
| 17. | General |
| 17.1. | Except as expressly permitted in this Agreement Psyence shall not assign, transfer, charge, encumber or otherwise deal with the whole or any part of this Agreement or any of its rights or obligations under this Agreement, save that Psyence may assign its rights to an affiliated company as part of a corporate restructuring. |
| 17.2. | If any clause or any part of any clause in this Agreement is declared invalid or unenforceable by the judgment or decree, by consent or otherwise of a court of competent jurisdiction from whose decision no appeal is or can be taken all other clauses or parts of clauses in this Agreement shall remain in full force and effect and shall not be affected thereby for the term of this Agreement. |
| 17.3. | No relaxation forbearance delay or indulgence by either party in enforcing any of the terms and conditions of this Agreement or the granting of time by either party to the other shall prejudice, affect or restrict the rights and powers of that party nor shall any waiver by either parry of any breach of this Agreement operate as a waiver of or in relation to any subsequent or any continuing breach of this Agreement. |
| 17.4. | This Agreement may not be amended unless in writing signed by the duly authorised officer of each party. |
| 17.5. | The parties shall execute all further documents as may be necessary or desirable to give full effect to the terms of this Agreement and to protect the rights of the parties under it. |
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| 17.6. | This Agreement constitutes the entire agreement between the parties relating to its subject-matter and each party confirms to the other that it has not entered into this Agreement on the basis of or in reliance on any representations or warranties made or given by the other party its servants or agents. |
| 17.7. | Any notice or other document to be given under this Agreement shall be given by sending the same in a pre-paid courier to the address of the relevant party set out in this Agreement or to any other address which that party may have notified to the other for such purpose. Any notice sent by post shall be deemed (in the absence of evidence of earlier receipt) to have been delivered 14 days after despatch and in proving the fact of despatch it shall be sufficient to show that the envelope containing such notice was properly addressed stamped and posted. |
| 18. | Governing Law |
This Agreement contemplated herein, if entered into, will be construed in all respects under and be subject to the laws of British Columbia which are applicable to agreements entered into and performed within British Columbia. The Parties hereby irrevocably and unconditionally consent to and submit to the exclusive jurisdiction of the courts of the Province of British Columbia for any actions, suits or proceedings arising out of the interpretation or enforcement of the matters contemplated herein (and agree not to commence any action, suit or proceeding relating thereto except in such courts) and further agree that service of any process, summons, notice or document by personal delivery to the addresses set forth below shall be effective service of process for any action, suit or proceeding brought in any such court. The Parties hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding arising out of this LOI or the matters contemplated hereby in the courts of the Province of British Columbia and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding so brought has been brought in an inconvenient forum.
| 19. | Counterparts |
This Agreement may be signed in counterparts which together shall be deemed to constitute one (1) agreement, and delivery of the counterparts may be effected by means of electronic transmission from us to you and from you to us.
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IN WITNESS of which the parties have caused this Agreement to be duly executed the day and year first above written.
SIGNED for and on behalf of Optimi by:
In the presence of:
SIGNED for and on behalf of Psyence by:
In the presence of:
| Page 15 of 15 |
Exhibit 10.2
PSYENCE BIOMEDICAL LIMITED
PSYENCE AUSTRALIA PTY LTD
and
OPTIMI LABS INC.
GMP AGREEMENT
Between
I. Psyence Biomedical Limited
121 Richmond Street West
Penthouse Suite 1300
Toronto
ON M5H2K1
Canada
("Psyence Biomed")
Psyence Australia PTY LTD
Level 7, 330 Collins Street
Melbourne VIC 3000
("Psyence Australia")
Herein referred to collectively as PURCHASER
II. OPTIMI LABS INC.
269 David Brown Way
Princeton, BC V0X 1W0
CANADA
Herein referred to as SUPPLIER
GMP AGREEMENT
between Psyence Biomedical Ltd and Psyence Australia Pty Ltd as PURCHASER and Optimi Labs Inc. as SUPPLIER
| On behalf of PURCHASER | On behalf of SUPPLIER | |||
| Signature: | Signature: | |||
| Neil Maresky | Karina Lahnakoski | |||
| CEO | Director of Quality | |||
| PSYENCE BIOMEDICAL LIMITED | OPTIMI LABS INC. | |||
| Signature: | Date: | |||
| Tim Waugh | ||||
| Director | ||||
| Psyence Australia PTY LTD | ||||
| Date: | ||||
2
II. CONTENTS
| Article 1 | Definitions and Abbreviations | 4 |
| Article 2 | Introduction and Scope | 5 |
| Article 3 | Starting Materials and Packaging Materials | 6 |
| Article 4 | Processing, Analysis, Packing and Release | 7 |
| Article 5 | Quality Assurance and Quality Control | 8 |
| Article 6 | Specifications of PRODUCTS | 8 |
| Article 7 | Release Procedure and Transportation | 9 |
| Article 8 | Product Recall | 9 |
| Article 9 | Product Quality Complaints | 9 |
| Article 10 | Stability Studies | 10 |
| Article 11 | Product Quality Review | 10 |
| Article 12 | Quality Management | 10 |
| Article 13 | Miscellaneous | 10 |
| Article 14 | Term and Termination | 11 |
| Article 15 | Premature Termination | 11 |
| Article 16 | Applicable Law and Jurisdiction | 11 |
| Appendix 1 | Contacts List | 12 |
| Appendix 2 | Delineation of Responsibilities | 13 |
| Appendix 3 | List of Bulk Products, intermediate and / or Finished product (hereinafter 'PRODUCTS") covered by this agreement | 17 |
| Appendix 4 | PRODUCT Specifications PRODUCT Requirements | 18 |
| Appendix 5 | Certificate of Conformance (template) | 19 |
| Appendix 6 | Content of the Product Quality Review | 20 |
| Appendix 7 | Guidelines for Changes Affecting Product Requirements | 21 |
| Appendix 8 | List of Significant Quality Events | 22 |
| Appendix 9 | Transportation Information | 23 |
This Agreement is made between (street address):
(1) PSYENCE BIOMEDICAL LIMITED and Psyence Australia PTY LTD collectively as the PURCHASER
121 Richmond Street West
Penthouse Suite 1300
Toronto
ON M5H2K1
Canada
Level 7, 330 Collins Street
Melbourne VIC 3000
(2) OPTIMI LABS INC. as the SUPPLIER
269 David Brown Way
Princeton, BC V0X 1W0
CANADA
Wherein:
A letter of intent was concluded between the Parties on August 1, 2024 and the parties have now agreed to conclude this bundle of agreements comprising:
| 1. | the Supply Agreement; |
| 2. | the IP and Mutual Exclusivity Agreement; and |
| 3. | this Quality Agreement, |
recording the terms agreed between the parties. If any conflict should exist between the provisions or interpretation of the above-mentioned agreements such conflicts shall be resolved by applying preference to the interpretation of the agreements in the sequence referenced above, with the Supply Agreement being given the highest priority and the Quality Agreement given the lowest priority in the Bundle of Agreements.
PURCHASER and SUPPLIER are entering into this Quality Agreement in terms of which the SUPPLIER has agreed to manufacture, analyse, pack and supply PRODUCTS for PURCHASER in consideration of the covenants and agreements contained in 'Supply Agreement'.
1. ARTICLE 1 - DEFINITIONS AND ABBREVIATIONS
1.1 GMP
Good Manufacturing Practice as stated in GUI-0001 Good manufacturing practices guide for drug products, Health Canada, July 2020.
1.2 PRODUCTS
Any or all variants of a product that is supplied to the PURCHASER under the Supply Agreement, as stated in Appendix 3. For purpose of the Agreement, PRODUCTS include bulk, intermediate and finished packaged product.
1.3 STARTING MATERIALS
The active ingredient or excipients used in the manufacture of a PRODUCT.
1.4 REFERENCE SAMPLE
A sample of a batch of starting material, packaging material, bulk product or finished product.
1.5 RETENTION SAMPLE
A sample of a fully packaged unit from a batch of finished form.
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1.6 PACKAGING MATERIAL
Any primary and / or printed packaging material used in the packaging of a PRODUCT
1.7 ARTWORK
Artwork applies to all printed materials, which include but are not limited to labels, finished product display cartons, Consumer Medicine Information (CMI), Product Information (PI) and symbols displayed or affixed to the container or primary and secondary packaging. It also includes marketing materials such as brochures.
1.8 PQR - Product Quality Review
Product Quality Review is a mechanism to ensure that data captured by the Pharmaceutical Quality System is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and implementing recommendations for required improvements.
1.9 COA - Certificate of Analysis
1.10 COC - Certificate of Compliance
1.11 NA - Not Applicable
1.12 PIC - Pharmaceutical Inspection Conventions
1.13 NA - Not Applicable
1.14 QMS – Quality Management System (also Pharmaceutical Quality System, PQS)
The principles of the pharmaceutical quality system (PQS), also called Quality Management System (QMS), is to ensure medicinal products are fit for their intended use and comply with regulatory requirements.
1.16 OOS - Out of Specification
Results of in-process of finished product testing that falls out of the specified limits as defined in the applicable pharmacopeia or defined requirements.
2. ARTICLE 2 - INTRODUCTION AND SCOPE
2.1 The purpose of this Agreement is to define and establish the obligations and responsibilities of the PURCHASER and the SUPPLIER relating to Quality Assurance requirements of the manufacture, packing, analysis, release and / or distribution by SUPPLIER of PRODUCTS and the supply to PURCHASER of PRODUCTS in accordance with GMPs.
2.2 The Quality Assurance Department of each of the parties are located at the addresses above and as specified in Appendix 1. Any Changes in such quality assurance contacts set forth in Appendix 1 shall be informed in writing and updated.
2.3 This Agreement is entered into pursuant to and is supplemental to the Supply Agreement.
2.4 This Agreement shall come into effect on the date of the last of the parties to sign on the front page of this agreement and it shall remain in force and effect coterminously with the Supply Agreement.
2.5 It is agreed between the parties that the following should apply:
2.5.1 SUPPLIER shall possess and maintain valid and appropriate licences under the relevant local public authority or authorities for the premises where PRODUCTS are produced. PURCHASER will possess and maintain valid and appropriate licences where PRODUCTS are received and distributed.
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2.5.2 SUPPLIER shall implement and maintain a quality system based Good Manufacturing Practices (GMP) as enforced by Health Canada, ensuring all practices and procedures are performed according to written and approved procedures.
2.5.3 SUPPLIER shall ensure that technologies, facilities, processes and equipment used to produce the PRODUCTS are in compliance with GMP.
2.5.4 PURCHASER and SUPPLIER are responsible as defined in Appendix 2 for the steps involved in processing, analysis, packing, release and / or distribution of PRODUCTS.
2.5.5 PURCHASER and SUPPLIER must approve any changes that potentially impact on the product specification prior to implementation.
2.5.6 SUPPLIER shall immediately inform the PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications.
2.5.7 This Agreement and appendices shall be accessible to Regulatory Agencies as required by law.
2.5.8 SUPPLIER is responsible for ensuring this document is updated. This document shall be revision controlled. SUPPLIER shall notify PURCHASER of any potential changes that may impact this agreement prior to implementation.
2.6 PURCHASER is to provide the SUPPLIER with all information and knowledge necessary to carry out the contracted operations correctly in accordance with Laws and Regulations for the product concerned.
2.7 SUPPLIER shall ensure that all activities at the Facilities and locations, including activities of SUPPLIER'S approved Contract Manufacturers, associated with the Manufacture and supply of PRODUCT are carried out in compliance with Applicable Laws and Regulations and the PRODUCT Requirements.
3. ARTICLE 3 - STARTING MATERIALS AND PACKAGING MATERIALS
3.1 Starting materials and packaging materials shall be procured by the SUPPLIER from approved suppliers. Where no supplier is defined in the PRODUCT specific annex SUPPLIER shall procure such materials from suppliers according to internal written procedures.
3.2 SUPPLIER shall ensure packaging maintains quality and purity of PRODUCT packed.
3.3 Artwork shall be provided by the PURCHASER to the SUPPLIER for organisation and procurement of printed materials.
3.4 SUPPLIER is responsible for validating, qualifying and auditing the Suppliers of any input material used including applicable Active Pharmaceutical Ingredients used in production of the PRODUCTS.
3.5 SUPPLIER is responsible for the Quality Management of the suppliers of starting and / or packaging materials appropriate to the stage of manufacture that the SUPPLIER is undertaking.
3.6 SUPPLIER shall maintain records of each batch of starting materials and packaging materials.
3.7 Upon receipt of starting materials and / or packaging materials the containers will be examined by SUPPLIER for:
· External conditions including defects and cleanliness;
· Intactness and authenticity of seal (if applicable). If the seal should be present and is missing or damage SUPPLIER to record defect and investigate;
· Compliance of the type and number of containers and labelling of contents with the delivery documents.
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4. ARTICLE 4 - PROCESSING, ANALYSIS, PACKING AND RELEASE
4.1 SUPPLIER shall ensure that the processing, packing, and analysis of PRODUCTS are in compliance with the requirements of GMP and in compliance with Appendix 4, PRODUCT Requirements applicable to the markets that will be supplied with the product.
4.2 SUPPLIER facilities together with any other peripheral services shall be subject to audit and / or inspection by PURCHASER. PURCHASER is to provide SUPPLIER reasonable notice of not less than 20 business days. PURCHASER must provide agenda at time of notice to SUPPLIER. Audit and / or Inspection frequency of SUPPLIER shall be no more than once per twelve (12) months. SUPPLIER shall permit a competent regulatory authority access to the facilities for audit and/or inspection upon request by PURCHASER. Nothing in this clause 4.2 will detract from any rights which the PURCHASER (or an affiliate thereof) may have under any other agreement concluded between the PURCHASER (or an affiliate thereof) and the SUPPLIER.
4.3 The proposed use of a Sub-contractor that directly impacts product quality by SUPPLIER shall be notified to the PURCHASER and approved in writing prior to implementation. SUPPLIER shall perform periodic audits of their sub-contractors of manufacturing, laboratories, warehouses, and any other peripheral services that are used in connection with supply of PRODUCTS to PURCHASER.
4.4 SUPPLIER is responsible for reviewing and ensuring analytical methods used by SUPPLIERS sub-contracted laboratories are correct and validated and conform to relevant Regulations (ie: ICH Q2).
4.5 SUPPLIER shall inform PURCHASER Quality Assurance Contacts by the next working day of becoming aware of quality issues, including non-conformities and significant deviations, which might compromise PRODUCTS already shipped to PURCHASER. PURCHASER shall not distribute such PRODUCTS until SUPPLIER and PURCHASER have determined in writing, that such issues are consistent with GMP and / or Detailed Requirements. PURCHASER is responsible for final disposition of PRODUCTS.
4.6 SUPPLIER shall maintain local change control systems that assure that only changes that comply with GMPs and Detailed Requirements, are authorised and implemented. Where SUPPLIER is considering changes that impact the Detailed Requirements, SUPPLIER shall notify PURCHASER. PURCHASER will obtain internal PURCHASER approval and Regulatory Authority approval, where necessary, prior to implementation by SUPPLIER. SUPPLIER is not required to inform PURCHASER of changes that do not impact production batches being purchased by PURCHASER.
4.7 SUPPLIER is responsible for performing and documenting the establishment of qualification of equipment and facilities, and validation processes, equipment cleaning and computer applications in accordance with GMPs.
4.8 PURCHASER is responsible for designing PRODUCT labels according the PURCHASERS jurisdiction and providing the approved pack text for labels, leaflets, cartons, and pack inserts to SUPPLIER where SUPPLIER is conducting packing on behalf of the PURCHASER.
4.9 Where PRODUCTS supplied is a Finished Pack SUPPLIER is responsible for transferring the approved pack text to the pack components.
4.10 SUPPLIER is responsible for assigning a unique identification number to each batch of PRODUCT packaged. The unique identification number shall appear on all documents related to the batch and issued by the SUPPLIER.
4.11 SUPPLIER is responsible for printing variable information such as the unique identification number as batch no, expiry date or re-test date on the product labels.
4.12 SUPPLIER shall affix approved labels required by the PURCHASERS jurisdiction to packed goods prior to shipment.
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4.13 SUPPLIER shall ensure production equipment are properly maintained and used to avoid contamination.
5. ARTICLE 5 - SPECIFICATIONS OF PRODUCTS
5.1 The specification of each PRODUCT to be manufactured, packed, tested, shipped and released by SUPPLIER under this agreement is set out in the PRODUCT specific annexes to this agreement. Such annexes may include but are not limited to:
| · | Name of PRODUCT |
| · | Composition |
| · | Specification of starting materials |
| · | Quality Control procedures for PRODUCT |
| · | Release specifications of PRODUCT |
| · | Follow-up stability program, if applicable |
| · | Storage conditions of PRODUCT |
6. ARTICLE 6 - QUALITY ASSURANCE AND QUALITY CONTROL
6.1 Where Regulatory Inspections or PURCHASER audits identify quality and compliance issues SUPPLIER shall agree to implement corrective and preventative action.
6.2 SUPPLIER shall notify PURCHASER of any regulatory inspections that are announced that may directly or indirectly impact on the PRODUCTS supplied to the PURCHASER. SUPPLIER shall inform PURCHASER of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to PURCHASER.
6.3 SUPPLIER is responsible for the quality control of the PRODUCTS, including testing, documentation review, retention of samples and producing required documentation as defined in GMPs.
6.4 SUPPLIER shall, where required, develop internal control limits for production processes. Where batches fail the internal control limits, the product shall not be shipped to PURCHASER. Development of limits for expiration will be developed by SUPPLIER and notified to the PURCHASER.
6.5 SUPPLIER shall supply an agreed Certificate of Analysis (COA) as defined in Appendix 6, and an agreed Certificate of Compliance (COC) as defined in Appendix 7 for PRODUCTS indicating that the batch complies with agreed specifications and GMPs.
6.6 PURCHASER shall review and access Certificate of Analysis (COA) and Certificate of Conformance (COC).
6.7 PURCHASER shall perform visual (label) inspection of the PRODUCTS within 30 days of receipt of PRODUCTS from SUPPLIER.
6.8 SUPPLIER shall investigate all non-conformities, deviations and out of specification (OOS) results in accordance with GMPs and SUPPLIER will inform PURCHASER of any major or critical deviations/non-conformities and OOS results in accordance with GMPs. If product does not conform to specifications, it will not be supplied to PURCHASER.
6.9 SUPPLIER shall inform PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications.
6.10 SUPPLIER shall retain batch documentation for 5 years.
8
6.11 SUPPLIER shall retain retention samples from each batch of the PRODUCTS and starting materials in accordance with GMPs. For the subsequent stages that are conducted at the PURCHASER's facility, PURCHASER shall retain retention samples from each batch of the resultant product in accordance with GMPs.
6.12 SUPPLIER shall be responsible for the specification of packaging components. SUPPLIER shall be responsible for the quality control and labelling of packaging components in accordance with the approved packaging text. PURCHASER shall provide the artwork and packaging specifications.
6.13 SUPPLIER shall retain records necessary to ensure traceability from initial raw materials through to each finished product.
7. ARTICLE 7 - RELEASE PROCEDURE AND TRANSPORTATION
7.1 SUPPLIER shall provide an Authorised Person to release PRODUCTS to the PURCHASER using existing site Procedures and in accordance with GMPs and Detailed Requirements. SUPPLIER shall perform quality assurance review of all batch documentation and associated data in accordance with GMPs, prior to the release of PRODUCTS to the PURCHASER.
7.2 PURCHASER shall use an Internal Complaints and Deviation Reporting System for reporting any quality problems to the SUPPLIER.
7.3 SUPPLIER shall ensure that PRODUCTS are stored, under the conditions such that the quality, purity and integrity of PRODUCTS are not compromised. SUPPLIER must notify PURCHASER of the appropriate transport and storage conditions for the PRODUCTS. Where required, specific monitoring devices shall be consigned with the PRODUCTS to verify the required conditions have not been exceeded. PURCHASER shall conduct transit checks, e.g., seal integrity, temperate data loggers as appropriate.
7.4 PURCHASER shall maintain copies of shipping information for lots or batches shipped in accordance with approved operating procedures.
7.5 SUPPLIER shall provide applicable transport information for the PRODUCT prior to shipment to the PURCHASER as detailed in Appendix 9 Transport Information.
7.6 SUPPLIER and PURCHASER shall agree the process for the auditing of the distribution arrangements from SUPPLIER to the location specified by PURCHASER.
8. ARTICLE 8 - PRODUCT RECALL
8.1 SUPPLIER shall inform PURCHASER immediately (within 24 hours) of a potential recall of any batch of the PRODUCT shipped to the PURCHASER. SUPPLIER and PURCHASER shall agree on the coordination of the recall prior to initiation of the recall. The PURCHASER shall have responsibility for any communication with regulatory authorities governing the PURCHASER or its activities.
8.2 PURCHASER shall inform SUPPLIER immediately (within 24 hours) of a potential recall of any batch of PRODUCTS that implicate the processing, analysis, packing, release and / or distribution conducted by SUPPLIER.
8.3 SUPPLIER shall conduct an immediate investigation to determine root cause of the potential recall and provide PURCHASER with the interim and final reports on an agreed frequency.
9. ARTICLE 9 - PRODUCT QUALITY COMPLAINTS AND ADVERSE EVENTS
9.1 SUPPLIER shall be responsible for the investigation of complaints relating to the PRODUCTS, where such complaints may be attributable to the manufacturing stages carried out by SUPPLIER.
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9.2 PURCHASER shall inform SUPPLIER of any complaints concerning the quality of PRODUCTS using Internal Complaints system. PURCHASER shall give SUPPLIER all possible support to resolve any problems in connection with such complaints.
9.3 PURCHASER shall communicate all customer complaints relating to PRODUCTS, that implicate the quality of PRODUCTS, supplied by SUPPLIER. SUPPLIER shall respond to PURCHASER within four (4) working days of receipt of complaint. The investigation shall be completed within ten (10) working days unless otherwise agreed, based on the severity of the problem. The report shall be issued to the PURCHASER.
9.4 SUPPLIER shall collect and investigate all complaints according to relating to PRODUCTS and shall communicate the data to PURCHASER on an annual basis in the Annual Product Quality Review.
9.5 PURCHASER shall make the final decision, after consultation with the SUPPLIER, of whether to conduct a recall.
9.6 Each party will notify the other within one business day of receipt of a report of an adverse event. Each party will retain procedures to investigate (if applicable) trend and report adverse events as required in their jurisdiction.
10. ARTICLE 10 - STABILITY STUDIES
10.1 SUPPLIER shall be responsible for carrying out and reporting stability testing [*]
10.2 SUPPLIER shall notify any stability failure or adverse trend in results likely to lead to a stability failure during the period of a study to PURCHASER within five (5) days of becoming aware of such stability failure or adverse trend. SUPPLIER shall investigate all OOS stability results or adverse trends in accordance with this Agreement.
10.3 In the event that this agreement or the Bundle of Agreements is terminated the SUPPLIER will do all things necessary to enable the PURCHASER to continue to generate stability data (either itself or through a third party supplier) to support the acceptability of PRODUCT until all PRODUCTS distributed by the PURCHASER have reached the end of their shelf life, with the Parties undertaking to act in the utmost good Fatih in enabling the execution of this obligation.
11. ARTICLE 11 - PRODUCT QUALITY REVIEW
11.1 SUPPLIER shall conduct a periodic quality review of PRODUCT on an annual basis in accordance with defined procedures and regulatory requirements.
12. ARTICLE 12 - QUALITY MANAGEMENT
12.1 SUPPLIER and PURCHASER shall agree to the frequency, which they shall discuss technical and quality matters.
12.2 PURCHASER shall inform SUPPLIER of any changes in Appendix 1 and sale or transfer of ownership if and when they occur.
13. ARTICLE 13 - MISCELLANEOUS
13.1 Should any provision of this agreement be or become void, in whole or in part, this shall not affect the validity of the remaining provisions. This void provision shall be replaced by an effective and enforceable provision that legally and economically comes as close as possible to what the parties intend or would have intended in accordance with the meaning and purpose of the agreement if they had considered the point upon conclusion of the agreement.
13.2 Amendments of the agreement must be made in writing to be binding. This agreement shall be binding by all parties. Any other assignment shall be subject to the other party's approval.
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13.3 The commercial terms of the purchase and sale of the PRODUCTS shall be subject to the supply agreement and the ancillary purchase orders. Where there is a disconnect between the supply agreement and Quality Agreement relating to PRODUCT quality the Quality Agreement takes precedence.
14. ARTICLE 14 - TERM AND TERMINATION
14.1 Upon signature by both parties this agreement shall remain in effect indefinitely from the date of the last signature, and will only terminate on termination of the Supply Agreement. Notwithstanding the foregoing this agreement shall continue to remain in effect as long as the manufacturing and supply obligations and / or parties' quality assurance obligations under the 'Contract for the International Sale of Goods' continue to apply.
14.2 This agreement shall be valid for all contract manufacture orders issued by PURCHASER to SUPPLIER for PRODUCT provided that such orders were confirmed by SUPPLIER. Irrespective of a termination of this agreement it shall remain valid for orders having been placed and confirmed prior to termination.
14.3 Upon termination SUPPLIER shall submit to PURCHASER all relevant documents such as GMP related information and data required to demonstrate the past and current compliance of the product supply agreement. Any further obligations that SUPPLIER may have agreed to under the 'Contract for the International Sale of Goods' agreement or any other agreement shall remain unaffected.
14.4 Without detracting from the provisions of Article 14 above, the following clauses of the IP and Mutual Exclusivity Agreement shall apply to this Agreement, as if incorporated in this Agreement directly:
14.4.1 Clause 3 (Duration of Agreement);
14.4.2 Clause 12 (Termination and Liquidation); and
3. Clause 13 (Consequences of Termination).
1. 14.5 Psyence hereby undertakes that in the event that Psyence Australia ceases to be a wholly-owned subsidiary of Psyence Biomed:
2. 14.5.1 it will immediately provide written notice hereof to Optimi; and
3. 14.5.2 Psyence Australia will immediately cease to be a party to the Bundle of Agreements in accordance with the terms of Clause 13 (Consequences of Termination) of the IP and Mutual Exclusivity Agreement.
15. ARTICLE 15 - PREMATURE TERMINATION
15.1 Both parties shall have the right to dissolve this agreement or in writing at any time without previous notice if the other party hereto shall have a receiver appointed over all or any part of its assets or shall compound with its creditors or shall go into liquidation, voluntary or otherwise.
16. ARTICLE 16 - APPLICABLE LAW AND JURISDICTION
16.1 In relation to any claim or any proceedings or other matter under or in connection with the agreement instituted against PURCHASER by SUPPLIER the following shall apply:
| · | this agreement shall be governed by and construed in accordance with the laws of the province of British Columbia and the applicable laws of Canada; and |
| · | any proceedings instituted against PURCHASER must only be brought in the Courts of the province of British Columbia, which shall have exclusive jurisdiction in all such proceedings. |
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APPENDIX 1
CONTACT LIST
| [*] |
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APPENDIX 2
DELINEATION OF RESPONSIBILITIES
| RESPONSIBILITIES |
SUPPLIER CONTRACT RECEIVER |
PURCHASER CONTRACT GIVER | |
| SCOPE | |||
| 2.5.1 | Possess and maintain appropriate valid licence or licences under local public authority or authorities | ¨ | ¨ |
| 2.5.2 | Produce and handle PRODUCTS under a quality system based on GMP | ¨ | ¨ |
| 2.5.3 | Ensure all stages of manufacture comply with the relevant authority. | ¨ | |
| 2.5.5 | Approve changes that impact product specification prior to implementation. | ¨ | ¨ |
| 2.5.6 | Inform PURCHASER of incidents that affect conformance to the PRODUCT Specifications | ¨ | |
| 2.6 | Provide all information and knowledge required to carry out contracted operations correctly according to the applicable regulations | ¨ | ¨ |
| 2.7 | All activities, including sub-contacted activities comply with applicable laws and regulations. | ¨ | |
| STARTING MATERIALS AND PACKAGING MATERIALS | |||
| 3.1 | Starting materials and packaging materials to be procured according to specifications from approved suppliers | ¨ | |
| 3.2 | Ensure packaging maintains the quality and purity of the packed PRODUCT | ¨ | |
| 3.3 | Provide artwork for organisation and procurement | ¨ | |
| 3.4 | Qualification, validation and supplier auditing of API, qualifying of starting materials and packaging | ¨ | |
| 3.5 | Maintain records of each batch of starting and packaging materials | ¨ | |
| 3.7 | Inspection of starting materials and packaging materials | ¨ | |
| PROCESSING, ANAYSIS, PACKING, RELEASE AND / OR DISTRUBUTION | |||
| 4.1 | Ensure processing, packing and analysis of products comply with agreed specifications. | ¨ | |
| 4.2 | Visiting or inspection of SUPPLIER grating not less than 30 days notice | ¨ | |
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| RESPONSIBILITIES |
SUPPLIER CONTRACT RECEIVER |
PURCHASER CONTRACT GIVER |
| 4.3 | Proposal for use of Sub-contractor. Approval of use of Sub-contractors that directly impact product quality. | ¨ | |
| 4.3 | Audit and / or inspect Sub-contractors connected with the supply of PRODUCT | ¨ | |
| 4.4 | Review and approve contacted laboratories analytical methods | ¨ | |
| 4.5 | Report quality issues | ¨ | ¨ |
| 4.6 | Maintenance of local Change Control systems | ¨ | |
| 4.7 | Qualification and Validation of equipment, facilities, processes and cleaning. Verification of analytical methods used by contract laboratories. | ¨ | |
| 4.8 | Provision of approved printed text | ¨ | |
| 4.9 | Transferring approved printed text to components (where applicable) | ¨ | |
| 4.10 | Assign unique identifying numbers | ¨ | |
| 4.11 | Printing variable information such as the unique identification number as batch no, expiry date or re-test date on the product labels | ¨ | |
| 4.12 | Ensure production equipment are properly maintained | ¨ | |
| SPECIFICATIONS OF PRODUCTS | |||
| 5.1 | Supply of PRODUCT specifications | ¨ | |
| - | Approval of PRODUCT specifications | ¨ | |
| - | Provide information and data for PRODUCT specifications | ¨ | ¨ |
| QUALITY ASSURANCE AND QUALITY CONTROL | |||
| 6.1 | Implement corrective actions in response to audits | ¨ | |
| 6.2 | Notifying and providing information about inspections, if there is an impact on quality agreement | ¨ | |
| 6.3 | Perform quality control requirements | ¨ | |
| 6.4 | Internal control limits where required | ¨ | |
| 6.5 | Supply COA or Analytical reports and COC | ¨ | |
| 6.6 | Review and assessment of COA and COC | ¨ | |
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| RESPONSIBILITIES |
SUPPLIER CONTRACT RECEIVER |
PURCHASER CONTRACT GIVER |
| 6.5 | Checking the suitability of product upon receipt | ¨ | |
| 6.7 | Identification testing on receipt | ¨ | |
| 6.8 | Investigation and report non-conformities, deviations and Out of Specification results for PRODUCTS | ¨ | |
| 6.9 | Notification of any major incidents that may affect PRODUCT conformance | ¨ | |
| 6.10 | Retention of batch manufacturing and / or packaging records including control records for PRODUCTS | ¨ | |
| 6.11 | Retention samples of PRODUCTS | ¨ | |
| 6.12 | Specifications of packaging components | ¨ | |
| 6.12 | Specifications for artwork | ¨ | |
| 6.13 | Ensure traceability from initial raw materials through to each finished product. | ¨ | |
| RELEASE PROCEDURE AND TRANSPORTATION | |||
| 7.1 | Review and release of PRODUCTS by an Authorised Person. | ¨ | |
| 7.2 | Reporting of Quality problems to SUPPLIER | ¨ | |
| 7.3 | Definition of storage and transportation requirements | ¨ | |
| 7.3 | Ultimate responsibility to ensure storage and transportation conditions are fulfilled up to receipt by PURCHASER | ¨ | ¨ |
| 7.4 | Maintain copies of shipping information | ¨ | ¨ |
| 7.5 | Provide shipping documents prior to dispatch | ¨ | |
| 7.6 | Agreement on auditing distribution arrangements | ¨ | ¨ |
| PRODUCT RECALL | |||
| 8.1 | Inform potential recall of PRODUCTS | ¨ | ¨ |
| 8.2 | Management of recall, including contacts with regulatory bodies | ¨ | ¨ |
| 8.3 | Investigation into potential recall | ¨ | ¨ |
| PRODUCT QUALITY COMPLAINTS | |||
| 9.1 | Collection and investigation of complaints relating to PRODUCTS | ¨ | |
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| RESPONSIBILITIES |
SUPPLIER CONTRACT RECEIVER |
PURCHASER CONTRACT GIVER |
| 9.5 | Responsibility for final conclusions and close out | ¨ | ¨ |
| POST MARKETING STABILITY STUDIES | |||
| 10.1 | Definition of Stability Protocol | ¨ | |
| 10.1 | Conduct stability studies for PRODUCTS and provide results to SUPPLIER | ¨ | |
| 10.2 | Notification of stability failure | ¨ | |
| ANNUAL PRODUCT REVIEW | |||
| 11.1 | Conduct Annual Product Review | ¨ | |
| QUALITY MANAGEMENT | |||
| 12.1 | Agree frequency for technical and quality meetings | ¨ | ¨ |
| 12.2 | Inform PURCHASER if there are any changes to personnel in Appendix 1 and sale or transfer of ownership if and when they occur | ¨ | ¨ |
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APPENDIX 3
LIST OF PRODUCTS COVERED BY THIS AGREEMENT
| · | OPTI-PSIE Psilocybin, 5mg, encapsulated drug candidate and placebos of such product, which placebos may take the form of a 1mg active dose based on health regulatory requirements. |
| · | In [*] |
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APPENDIX 4
DETAILED REQUIREMENTS
PRODUCT SPECIFICATIONS
All product specifications will be developed by SUPPLIER and approved as per SUPPLIER procedure SOP TES-003 prior to implementation.
SUPPLIER will provide PURCHASER with copy of COA to confirm specifications.
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APPENDIX 5
Optimi Labs Inc.
269 David Brown Way
Princeton, BC V0X 1W0
CERTIFICATE OF COMPLIANCE
| SUPPLIER | Optimi Labs Inc. |
| SITE OF MANUFACTURE | |
| LICENSING AUTHORITY | |
| PRODUCT NAME | |
| BATCH NUMBER | |
| DATE OF MANUFACTURE |
THIS IS TO CERTIFY THAT BATCH DOCUMENTATION HAS BEEN REVIEWED BY OPTIMI HEALTH QUALITY ASSURANCE PERSONNEL AND FOUND TO BE ACCEPTABLE TO PERMIT RELEASE FROM SUPPLIER.
A review of the Documentation and Process has assured that:
1. No change has occurred to the product specifications This includes the quality, grade and test methods of the starting materials used in this batch.
2. The documentation for each step drug product processing including final product testing to pre-determined specified limits has been followed. All batch documentation has been completed satisfactorily.
3. Deviations from the batch documentation have been reported in accordance with Article 4.5 of the Quality Assurance Agreement and have been thoroughly investigated and where appropriate corrective actions put in place.
4. The batch documentation has been reviewed for the above batch of material and it is confirmed that the batch was manufactured / packed in accordance with the batch documentation.
5. Operations have been carried out in accordance with the requirements of Health Canada’s GUI-0001.
Reference samples and complete records of testing are maintained and are available.
Signed:
Name:
Position: Director of QA
Date:
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APPENDIX 6
CONTENT OF PRODUCT QUALITY REVIEW
The Annual Quality Review / Product Quality Review should contain at least the following items:
SUPPLIER
| · | Number of batches produced |
| · | Batch failures |
| · | Significant deviations and non-conformances |
| · | Starting materials for new sources |
| · | Qualification status of relevant equipment and utilities |
| · | Quality agreements (status of Quality agreements with Sub-contractors) |
| · | Changes to analytical methods |
| · | Product complaints / Conclusions / Recommendations |
PURCHASER
| · | Significant deviations and non-conformances |
| · | Quality related returns, complaints and recalls |
| · | Stability program and results supporting shelf-life |
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APPENDIX 7
GUIDELINES FOR CHANGES AFFECTING PRODUCT REQUIREMENTS
General guidance on changes requiring PURCHASER'S approval:
| · | Site of Facility of manufacture |
| · | Site of Analysis |
| · | Type, supplier or specification of API |
| · | Qualitative composition and shape of immediate packaging material |
| · | Release specifications |
| · | Shelf-life and storage conditions |
| · | Sub-contracting or change of Sub-contactor that impacts product quality |
General guidance on process changes not requiring PURCHASER'S approval:
Process changes may be considered to fall into two general categories. Certain changes are expected to have a minor, if any, impact on product quality and can be effectively controlled and validated by the SUPPLIER without notification to the PURCHASER. Major changes are deemed significant to the PURCHASER'S processes and registration, and required advanced notification and PURCHASER'S approval prior to implementation. Where there is any doubt clarification must be sought from PURCHASER. Changes that do not require PURCHASER'S approval may include:
| · | Minor process changes |
| · | Changes with no relevance to the Detailed Requirements (Specifications) |
| · | Batch documentation changes to wording, format not impacting process |
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APPENDIX 8
LIST OF SIGNIFICANT QUALITY EVENTS
Any Product Quality event determined by SUPPLIER to result in deviation or require failure investigation and impact product quality is a Significant Event, including each of the following events, (if such event is significant enough to required deviation or failure investigation).
| · | Rejection of batch or lot supplied |
| · | Confirmed Out of Specification (OOS) - quarantine or rejection of batch or any part of batch or lot due to failure to meet established release specification or in-process specifications. |
| · | Stability failure or significant change in adverse trend compared to expected results. |
| · | Product, packaging or labelling mix-up involving batch or lot. |
| · | Probable or known cross contamination of a Product with another product, extraneous foreign material or microorganisms. |
| · | In-process or finished Product testing trends that indicate that a batch performs outside the established processing capability limits or alert limits or action limits. |
| · | Batches subject to re-work or reprocessing |
| · | Batches associated with an equipment malfunction where detailed process parameters are impacted. |
| · | Batches subject to a major malfunction of a facility utility system |
| · | Batches subject to natural disasters such as flooding, fire, earthquake, lightning strike. |
| · | Batches requiring formal investigation for the following: reconciliation discrepancy, line clearance failure, environmental monitoring failure or alert. |
| · | Bulk or packaged lots that exceed the established Product Hold Times in bulk containers. |
| · | In-process or finished Product stored outside the established environmental conditions. |
| · | Deviations from established time limits for the completion of production steps. |
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APPENDIX 9
TRANSPORTATION INFORMATION
TBD
TRANSPORTATION ARRANGEMENTS
Must align with supply agreement
TRANSPORTATION DOCUMENTATION
SUPPLIER to provide the documents listed below prior to shipment of each batch of PRODUCTS.
Manifest / packaging list with the following:
| · | Quantity of bags / containers |
| · | Net quantity of PRODUCT in each container |
| · | Seal number (if applicable) |
| · | Lot number(s) |
| · | Shipping number and corresponding purchase order number, order number and invoice number |
| · | Commercial Invoice |
| · | Bill of Landing (BOL) |
| · | Export Permit(s) |
| · | Phytosanitary Certificate |
SHIPPER REQUIREMENTS
Each shipper (container of the PRODUCT) is to be labelled with the following information:
| · | Net weight |
| · | Lot number |
| · | Identification of material |
| · | Licence Holder: Optimi Labs Inc. |
| · | Email: |
| · | Phone no: |
| · | Packed on date: |
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Exhibit 10.3
5 December 2024
Re: Supply of Goods Agreement ("Supply Agreement")
This supply of goods agreement ("Supply Agreement") is entered into by and between:
"Optimi" Optimi Health Corp, a company incorporated in British Columbia under number BC 1251418, (which expression shall include its successors and assigns) of 600 - 21 Water Street, Vancouver, B.C., V6B 1A1.
"Psyence" means collectively Psyence Biomedical Limited (which expression shall include its successors and assigns) of 121 Richmond Street West, Penthouse Suite 1300, Toronto, ON M5H2K1, Canada ("Psyence Biomed") and Psyence Australia PTY LTD (which expression shall include its successors and assigns) of Level 7, 330 Collins Street, Melbourne VIC 3000 ("Psyence Australia").
(the "Parties", and each, a "Party").
WHEREAS Optimi:
| a) | is a psychedelics pharmaceutical manufacturer in Canada with both a Controlled Drugs and Substances Dealer's Licence and a Drug Establishment Licence (DEL); |
| b) | specializes in controlled substances such as botanical psilocybin–containing mushrooms and 3,4-Methylenedioxymethamphetamine ("MDMA"); |
| c) | is dedicated to supplying safe, GMP-grade products and API to researchers, drug developers, and authorized patients in markets across the world; and |
| d) | has existing and exclusive rights to supply psilocybin for the treatment of PTSD and treatment resistant depression in Australia through binding, current commercial agreements with Mind Medicine Australia. |
AND WHEREAS Psyence:
| a) | is a biotech company focused on the use of natural psilocybin to treat psychological trauma, addiction and the diagnosable disorders that can result therefrom; |
| b) | wishes to use the controlled substances produced by Optimi relating to botanical psilocybin containing mushrooms in connection with pre-clinical and clinical studies involving human subjects, for the purpose of discovering or verifying the safety, pharmacokinetics or effects of such products. The trials will be conducted in multiple countries in due course in the treatment of anxiety and depression, including associated ailments, such as PTSD, stress, grief, and adjustment disorder, all within the exclusive context of Palliative Care; |
| c) | if such trials are successful, Psyence holds a right to commercialise such products. |
AND WHEREAS a letter of intent was concluded between the Parties on August 1, 2024 and the parties have now agreed to conclude this bundle of agreements (collectively the "Bundle of Agreements") comprising:
| 1. | this Supply Agreement; |
| 2. | the IP and Mutual Exclusivity Agreement; and |
| 3. | the Quality Agreement, |
recording the terms agreed between the parties. If any conflict should exist between the provisions or interpretation of the above-mentioned agreements such conflicts shall be resolved by applying preference to the interpretation of the agreements in the sequence referenced above, with the Supply Agreement being given the highest priority and the Quality Agreement given the lowest priority in the Bundle of Agreements.
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NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
| 1. | Definitions |
| 1.1. | In this Agreement except where the context otherwise requires terms shall have the meanings ascribed to them in Clause 1 of the IP and Mutual Exclusivity Agreement. |
| 1.2. | The singular includes the plural and vice versa. |
| 1.3. | Unless the context otherwise indicates, references to clauses, sub-clauses, recitals and to Schedules are to clauses and sub-clauses of, and recitals and Schedules to this Agreement. |
| 1.4. | Headings to clauses in this Agreement are included for the purpose of ease of reference only and shall not have any effect on the construction or the interpretation of this Agreement. |
| 1.5. | References in this Agreement to any statute or statutory provision shall include any statute or statutory provision which amends, extends, consolidates or replaces the same and shall include any orders, regulations, instruments or other subordinate legislation made under the relevant statute. |
| 2. | Supply of the Goods |
| 2.1. | During the period of this Agreement (the "Term", see Article 8 of this Agreement) Optimi shall sell, and Psyence shall purchase the Goods ordered by Psyence, subject to the following provisions. |
| 2.2. | The specifications of the Goods shall be as set out in Schedule 1, but the Optimi reserves the right to make changes to the specification of the Goods that is necessary for them to conform with any applicable laws, provided that Optimi first notifies Psyence in writing of any such change that it proposes to make and the Parties agree (in writing) that such change is required. |
| 2.3. | Change Request |
Psyence shall promptly notify Optimi in writing of any change to the Goods necessary to conform with existing law or proposed changes in the applicable laws in the territories of Psyence. Psyence may request changes to the product specifications for any product to be delivered under this Agreement by submitting a written change request ("Change Request") to Optimi. A Change Request must clearly specify the proposed changes to the product specifications, including, but not limited to, modifications in design, materials, quantity, or delivery requirements.
| 2.4. | Optimi’s Review and Proposal |
Upon receipt of a Change Request, Optimi shall promptly review the request and assess its impact on the terms of the Agreement, including but not limited to, pricing, delivery schedules, lead times, production processes, and any other relevant factors. Within 10 business days, Optimi shall provide Psyence with a written proposal ("Change Order Proposal") that details the adjustments necessary to accommodate the requested changes, including any revisions to the price, delivery timelines, or other contractual terms.
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| 2.5. | Agreement on Terms |
The Parties shall negotiate in good faith to agree upon the adjustments set forth in the Change Order Proposal. No changes to the product specifications or other terms shall be implemented by Optimi unless and until both parties have mutually agreed to the terms of the Change Order Proposal in writing ("Change Order"). The Change Order shall become an amendment to this Agreement and shall supersede any conflicting provisions in this Agreement.
| 2.6. | Effect of Change Order |
Once a Change Order has been agreed upon in writing by both Parties, Optimi shall proceed with the implementation of the changes as specified therein. Psyence acknowledges that any delay in agreeing to the Change Order or in providing necessary approvals may impact Optimi’s ability to meet the original delivery schedule.
| 2.7. | Failure to reach agreement |
Should the Parties fail to reach agreement on the terms of the Change Order Proposal, either Party shall have the right to terminate the mutual exclusivity provided in the IP and Mutual Exclusivity Agreement and the following rights granted to Psyence under this Agreement will become non-exclusive, and this Agreement shall continue on the same terms mutandis mutatis, save that:
| 2.7.1. | no Milestone Payments or Royalty will be payable by Psyence under the IP and Mutual Exclusivity Agreement; |
| 2.7.2. | the terms of clauses 6, and 8.3 to 8.7 of the IP and Mutual Exclusivity Agreement shall no longer be applicable; and |
| 2.7.3. | Optimi shall not offer or sell the Goods to a third Party on terms no more favourable than the terms set forth in this Agreement. |
| 2.8. | Optimi shall provide Psyence with any instructions concerning the use of the Goods which are reasonably required by lawful regulation, in which case Psyence undertakes to comply with those instructions. |
| 2.9. | Subject to the provisions of this Agreement, the supply of the Goods shall be made on the basis of the Terms of Supply set out in Schedule 2. |
| 3. | Procedure for Ordering and Delivering the Goods |
| 3.1. | Psyence shall give the Optimi its written order for the Goods to be delivered to Psyence when it is required. |
| 3.2. | Each order for the Goods must be given in writing and shall be subject to confirmation and acceptance in writing by the Optimi. The Optimi shall confirm and accept the order in writing to Psyence within ten (10) days after it is given. Upon confirmation and acceptance by the Optimi each order shall be final and binding on the Parties, except for mutually agreed upon amendments. Email addresses are found in the article entitled "Notices and Writing." |
| 3.3. | Psyence shall be responsible to the Optimi for: |
| 3.3.1. | Ensuring the accuracy of each order for the Goods given by Psyence; |
| 3.3.2. | Promptly giving the Optimi all necessary information relating to the Goods which is reasonably requested by the Optimi to enable the Optimi to fulfil each order in accordance with its terms. |
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| 3.4. | Upon confirmation of each order the Optimi shall as soon as is practicable and in any event within ten days inform Psyence of the Optimi’s estimated delivery date for the Goods. |
| 3.5. | Subject to force majeure (as set out in Article 10), Optimi shall use best commercial endeavors to deliver the Goods on the estimated delivery date for each order. Time is of the essence. |
| 3.6. | Optimi shall have no liability for any delay in delivery of the Goods that is due to any failure by Psyence to provide any required information in the required timeframe. |
| 4. | Price of the Goods & Delivery |
| 4.1. | The initial pricing of the Goods shall be [*] per [*] of the Goods, which may be amended from time to time during the term of this Agreement by agreement between the Parties. The Parties acknowledge that as at the date of concluding this Agreement: |
| 4.1.1. | they have had to estimate the pricing of [*] of the Goods [*] and agreed on an initial range of pricing for a [*] dose between [*], based on incomplete information; and |
| 4.1.2. | that Psyence’s preferred format of the Goods is a 25mg dose, in line with its clinical trial program, and Optimi undertakes to use its best efforts to deliver the Goods fully formulated at a 25mg dose to Psyence for use in Psyence’s Phase III trials, subject to the terms set out in Appendix 3 of the Quality Agreement. |
| 4.1.3. | The initial pricing is the median of the above range on a [*]. As such, the Parties agree that this pricing will require review from time to time and undertake to conduct such negotiations in good faith. |
| 4.2. | [*] |
| 4.3. | The prices of the Goods are exclusive of any applicable goods and services taxes (GST), value added tax or similar federal or provincial sales tax, for which Psyence shall be liable in addition to the price. Psyence will also pay for all taxes, duties, levies and costs associated with the importation of the Goods into, and distribution of the Goods into any jurisdiction outside Canada. |
| 4.4. | Subject to the provisions of clause 4.2, Optimi may, from time to time, vary the price of the Goods provided under this Agreement on the following terms: |
| 4.4.1. | Optimi shall notify Psyence in writing of any such price variation at least 30 days in advance of the proposed new price taking effect ("Notice Period"); |
| 4.4.2. | Psyence shall have the right to accept or reject the proposed new price within the Notice Period. If Psyence rejects the new price by providing written notice to Optimi within the Notice Period, the new price shall not apply; |
| 4.4.3. | In the event that Psyence rejects the new price, the following shall apply: |
| 4.4.3.1. | The original price for the Goods shall remain unchanged and continue to apply under the terms of this Agreement; |
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| 4.4.3.2. | This Agreement shall not terminate due to the rejection of the price variation; |
| 4.4.3.3. | This Agreement and the Bundle of Agreements shall convert from an exclusive supply agreement to a non-exclusive supply agreement; Psyence shall be free to source the Goods from other suppliers, without penalty or further obligation. |
| 4.5. | The provisions of clause 4.4 shall apply mutates mutandis as between the Parties to any proposal to vary the price, as proposed by Psyence to Optimi. |
| 4.6. | Optimi agrees to deliver the Goods to Psyence at Optimi’s premises on an ex-works basis. Title, and risk of loss or damage, to any purchased Goods will pass from the Optimi to Psyence on delivery and Psyence will thereafter be responsible for all risks of loss of or damage to such Product. |
| 4.7. | Optimi will obtain and maintain at its own cost, all necessary credentials, certifications, authorizations, licences and permits required for the exportation of the Product (as defined under the Quality Agreement) from Canada into any jurisdiction where the Goods are to be shipped to. |
| 4.8. | In the event that delays caused by Psyence in turn causes the Goods to be out of specification, Psyence agrees to be financially responsible for additional production and testing requirements related to the delivery of replacement Goods. |
| 4.9. | [*] |
| 4.10. | Optimi shall notify any stability failure or adverse trend in results likely to lead to a stability failure during the period of a study to Psyence within five (5) days of becoming aware of such stability failure or adverse trend. Optimi shall investigate all OOS stability results or adverse trends in accordance with this Agreement. |
| 4.11. | In the event that this agreement or the Bundle of Agreements is terminated Optimi will do all things necessary to enable Psyence to continue to generate stability data (either itself or through a third party supplier) to support the acceptability of the Goods until all Goods distributed by Psyence have reached the end of their shelf life, with the Parties undertaking to act in the utmost good faith in enabling the execution of this obligation. |
| 4.12. | In the event that a health regulator having the applicable jurisdiction over Psyence’s use of the Product (as defined under the Quality Agreement) requires additional stability testing and/or requires an extended shelf-life of the PRODUCT over and above those already considered in Article 10 of the Quality Agreement , then the cost of such additional stability testing and/or the formulation of the Product (as defined under the Quality Agreement) with the extended shelf-life will be for Psyence’s account. |
| 5. | Payment |
| 5.1. | The price of the Goods shall be paid by Customer: |
| 5.1.1. | A deposit payment of [*]of the total purchase price for the applicable order shall be paid by Psyence and received by the Optimi within five (5) days of confirmation by Optimi to Psyence that the order will be fulfilled; and |
| 5.1.2. | The balance within [*] days of delivery of the Goods. |
| 5.2. | All invoices must be addressed to Customer and submitted to the email address for Psyence provided in Article 12. All payments shall be made by wire–transfer to a bank account, specified by the Optimi in writing, without any set–off, deduction, or withholding. |
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| 5.3. | If Psyence fails to pay an undisputed invoice otherwise sent in accordance with this Agreement the Optimi may (without limiting any other right or remedy): |
| 5.3.1. | suspend any further delivery to Psyence until such undisputed invoice is paid; and |
| 5.3.2. | Charge Psyence interest on the outstanding amount at [*]p.a. of the outstanding amount from the due date until the outstanding amount is paid in full. |
| 6. | Warranties Relating to the Goods |
| 6.1. | Subject to the following provisions, the Optimi warrants to Psyence that: |
| 6.1.1. | Optimi will have good title to the Goods supplied under this Agreement; |
| 6.1.2. | The use or resale of the Goods supplied under this Agreement will not infringe the patent, design, copyright, trademark or other intellectual property rights of any third party; and |
| 6.1.3. | Subject to Article 6.2, the Goods supplied under this Agreement will comply with the specifications set put in the Quality Agreement, will be compliant moreover with manufacturing practices of Canadian domestic law and with GMP, and will not perish for a period of a minimum of thirty (30) days from date of delivery to Psyence. |
| 6.2. | Optimi shall be under no liability in respect of any defect in the Goods arising from fair wear and tear, or any wilful damage, negligence, misuse or alteration or tampering of the Goods after delivery without Optimi’s approval, on the part of Psyence, its employees or agents or any third party. |
| 6.3. | At the time any order is confirmed and accepted, Psyence will be deemed to warrant to Optimi that Psyence holds the required licenses and permits from all applicable authorities necessary to engage in its business, to purchase the Goods and to carry out its obligations under this Agreement and any order. The Customer will handle the Goods in compliance with applicable Canadian laws and regulations and in compliance with the laws and regulations of any other jurisdiction to where the Goods are be shipped and will assume all responsibility with regard to the nature, content and use of all promotional, marketing and informational materials used by Psyence in respect of the Goods. |
| 6.4. | All other warranties or other terms, express or implied by statute or otherwise, are excluded to the fullest extent permitted by law. |
| 7. | Indemnification and Liability |
| 7.1. | The Optimi shall defend, indemnify, and hold harmless Psyence and its affiliates, and each of their officers, directors, partners, shareholders, personnel, and agents from and against any and all losses arising out of or in connection with: |
| 7.1.1. | any gross negligence or wilful misconduct of Optimi in the performance of its obligations under this Agreement; |
| 7.1.2. | any alleged or actual infringement of intellectual property or proprietary rights of any third party arising out of the Optimi’s performance of its obligations under this Agreement; or |
| 7.1.3. | any breach by the Optimi of this Agreement, including without limitation any of its representations or warranties. |
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| 7.2. | Psyence shall defend, indemnify, and hold harmless the Optimi and its affiliates, and each of their officers, directors, partners, shareholders, personnel, and agents from and against any and all losses arising out of or in connection with: |
| 7.2.1. | any gross negligence or wilful misconduct of Psyence in the performance of its obligations under this Agreement; |
| 7.2.2. | any breach by Psyence of this Agreement, including without limitation any of its representations or warranties. |
| 8. | Duration, Termination and Consequences of Termination |
| 8.1. | The following clauses of the IP and Mutual Exclusivity Agreement shall apply to this Agreement, as if incorporated in this Agreement directly: |
| 8.1.1. | Clause 3 (Duration of Agreement) |
| 8.1.2. | Clause 12 (Termination and Liquidation) |
| 8.1.3. | Clause 13 (Consequences of Termination) |
| 8.2. | Psyence hereby undertakes that in the event that Psyence Australia ceases to be a wholly-owned subsidiary of Psyence Biomed: |
| 8.2.1. | it will immediately provide written notice hereof to Optimi; and |
| 8.2.2. | Psyence Australia will immediately cease to be a party to the Bundle of Agreements in accordance with the terms of Clause 13 (Consequences of Termination) of the IP and Mutual Exclusivity Agreement. |
| 9. | Positioning of Optimi by Customer |
Each Party retains the right to make public (via press release, social media post or any other promotional venue accessible by the public) the existence of this Agreement and the identity of Optimi and Psyence (but without including specific Agreement attributes such as pricing, quantity and term). If a Party is obliged by applicable laws, regulations and rules (including stock exchange rules and regulations), in such case the legally obligated party must present the intended publication to the other party for review and comment prior to submission to the applicable regulatory authority.
| 10. | Force Majeure |
| 10.1. | "Force majeure" means war, emergency, accident, fire, earthquake, pandemic, flood, storm, industrial strike or other event or impediment which is beyond the reasonable control of the affected Party. Force majeure also includes any event or circumstance beyond the reasonable control of the Party which causes any failure of the Goods to be produced in accordance with specifications or in sufficient quantities to fill any accepted order or any failure to meet stability expectations. |
| 10.2. | A Party affected by force majeure shall not be deemed to be in breach of this Agreement, or otherwise be liable to the other, by reason of any delay in performance, or the non– performance, of any of its obligations under this Agreement to the extent that the delay or non–performance is due to any force majeure of which it has notified the other Party in accordance with Article 10.3. The time for performance of that obligation shall be extended accordingly, subject to Article 10.4. |
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| 10.3. | If any Force Majeure occurs in relation to either Party which affects or is likely to affect the performance of any of its obligations under this Agreement, it shall notify the other Party within a reasonable time as to the nature and extent of the circumstances in question and their effect on its ability to perform. |
| 10.4. | If the performance by either Party of any of its obligations under this contract is prevented or delayed by Force Majeure for a continuous period in excess of three (3) months, the other Party shall be entitled to terminate this Agreement by giving written notice to the Party affected by the Force Majeure. |
| 11. | General Warranties |
Each Party warrants to the other that:
| 11.1. | It has the authority to enter into this Agreement; |
| 11.2. | The signatory to this Agreement for and on behalf of that Party is authorized and fully empowered to execute this Agreement on that Party’s behalf; |
| 11.3. | The entry into and performance of this Agreement by that Party will not breach any contractual or other obligation owed by that Party to any other person, any rights of any other person or any other legal provision; |
| 11.4. | The entry into and performance of this Agreement by that Party require no governmental or other approvals or, if any such approval is required, it has been obtained; and |
| 11.5. | It will at all times during the Term of this Agreement comply with the terms of and maintain in force any necessary governmental or other approvals, consents, notifications, registrations or other legal requirements for the performance by that Party of its obligations under this Agreement. |
| 12. | Notices by email |
| 12.1. | Any notice under this contract shall be in writing, which may include email, and may be served by sending it as specified in Article 12.2 below, in a manner that ensures receipt of the notice can be proved. Use of email and physical writing as notification must be done in every notification circumstance arising out of this Agreement, unless specified that alone will suffice in the respective notice clauses. |
| 12.2. | For the purposes of Article 12.1, notification details are the following, unless other details have been duly notified in accordance with this Article: |
| 12.2.1. | [*] |
| 12.2.2. | [*] |
| 13. | General |
| 13.1. | Except as expressly permitted in this Agreement Psyence shall not assign, transfer, charge, encumber or otherwise deal with the whole or any part of this Agreement or any of its rights or obligations under this Agreement, save that Psyence may assign its rights to an affiliated company as part of a corporate restructuring. |
| 13.2. | If any clause or any part of any clause in this Agreement is declared invalid or unenforceable by the judgment or decree, by consent or otherwise of a court of competent jurisdiction from whose decision no appeal is or can be taken all other clauses or parts of clauses in this Agreement shall remain in full force and effect and shall not be affected thereby for the term of this Agreement. |
| 13.3. | No relaxation forbearance delay or indulgence by either party in enforcing any of the terms and conditions of this Agreement or the granting of time by either party to the other shall prejudice, affect or restrict the rights and powers of that party nor shall any waiver by either parry of any breach of this Agreement operate as a waiver of or in relation to any subsequent or any continuing breach of this Agreement. |
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| 13.4. | This Agreement may not be amended unless in writing signed by the duly authorised officer of each party. |
| 13.5. | The parties shall execute all further documents as may be necessary or desirable to give full effect to the terms of this Agreement and to protect the rights of the parties under it. |
| 13.6. | This Agreement constitutes the entire agreement between the parties relating to its subject-matter and each party confirms to the other that it has not entered into this Agreement on the basis of or in reliance on any representations or warranties made or given by the other party its servants or agents. |
| 13.7. | Any notice or other document to be given under this Agreement shall be given by sending the same in a pre-paid courier to the address of the relevant party set out in this Agreement or to any other address which that party may have notified to the other for such purpose. Any notice sent by post shall be deemed (in the absence of evidence of earlier receipt) to have been delivered 14 days after despatch and in proving the fact of despatch it shall be sufficient to show that the envelope containing such notice was properly addressed stamped and posted. |
| 14. | Governing Law |
| 14.1. | This Agreement contemplated herein, if entered into, will be construed in all respects under and be subject to the laws of British Columbia which are applicable to agreements entered into and performed within British Columbia. The Parties hereby irrevocably and unconditionally consent to and submit to the exclusive jurisdiction of the courts of the Province of British Columbia for any actions, suits or proceedings arising out of the interpretation or enforcement of the matters contemplated herein (and agree not to commence any action, suit or proceeding relating thereto except in such courts) and further agree that service of any process, summons, notice or document by personal delivery to the addresses set forth below shall be effective service of process for any action, suit or proceeding brought in any such court. The Parties hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the matters contemplated hereby in the courts of the Province of British Columbia and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding so brought has been brought in an inconvenient forum. |
| 15. | Counterparts |
This Agreement may be signed in counterparts which together shall be deemed to constitute one (1) agreement, and delivery of the counterparts may be effected by means of electronic transmission from us to you and from you to us.
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have caused this Agreement to be executed on the date first written above.
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| OPTIMI HEALTH CORP. | PSYENCE BIOMEDICAL LIMITED | |
| Name: Dane Stevens | Name: Neil Maresky | |
| Title: CEO | Title: CEO |
PSYENCE AUSTRALIA PTY LIMITED
| Name: Tim Waugh | |
| Title: Director |
[*]
SCHEDULE 2: TERMS OF SUPPLY
| 1. | Quantity |
| 1.1. | The quantity of the Goods, defined in Schedule 1, to be supplied by the Optimi shall be as set out in each order submitted by Psyence (if confirmed by the Optimi). |
| 1.2. | Each order shall be subject to the details specified in Schedules 2 and 3. |
| 2. | Packaging of the Goods |
The Goods shall be shipped in a vacuum—packed, non—transparent, tamper proof container.
| 3. | Inspection and Acceptance of the Goods |
| 3.1. | Inspection Optimi's Premises: Psyence shall have the right to inspect the Goods at Optimi's premises prior to collection, at a mutually agreed time, to verify that the Goods conform to the agreed specifications and are free from visible defects. Any defects identified during this inspection shall be promptly communicated to Optimi. Psyence shall be responsible for the costs associated with such inspection. |
| 3.2. | Acceptance Upon Collection: Goods shall be deemed to be accepted by Psyence at the time of collection from Optimi's premises, subject to any visible defects identified during the inspection at Optimi’s premises. |
| 3.3. | Latent Defects: Notwithstanding Psyence's inspection at Optimi's premises, Psyence shall have a further period of 5 business days from the arrival of the Goods at Psyence’s premises to identify any latent defects or defects that were not reasonably identifiable during the initial inspection. A "latent defect" is defined as a defect that could not have been reasonably detected by Psyence through a reasonable inspection at Optimi’s premises or at the time of collection. |
| 3.4. | Notification of Defects: If latent defects or any defects not reasonably identifiable at the time of collection are discovered within the specified period after arrival at Psyence’s premises, Psyence shall notify Optimi in writing within 5 business days of discovering the defect(s). The notice shall include a detailed description of the defect(s) and the circumstances under which they were discovered. |
| 3.5. | Remedy for Defects: If any defects, whether visible or latent, are confirmed and notified by Psyence within the applicable time frame, Optimi shall replace the defective Goods, or if such replacement is not possible for reasons beyond the reasonable control of Optimi, provide a refund for the defective Goods, in accordance with the terms of this Agreement. |
| 4. | Documents |
The Optimi shall make a Packing List available to Psyence.
| 5. | Transfer of Risk |
Risk of damage to or loss of the Goods shall pass to Psyence in accordance with the relevant Incoterms or otherwise at the time of delivery of the Goods.
| 6. | Retention of Title |
| 6.1. | Notwithstanding the delivery of and the passing of risk in the Goods, or any other provision of this contract, the property in the Goods shall not pass to Psyence until the Optimi has received payment in full of the price of the Goods. |
| 6.2. | Psyence shall hold the Goods on behalf of the Optimi, and shall keep the Goods separate from those of Psyence and third parties and properly stored, protected and insured and identified as the Optimi’s property; |
| 6.2.1. | Provided none of the events referred to in the "Force Majeure" Article of this Agreement has taken place in relation to Psyence, Psyence may resell or use up the Goods in the ordinary course of its business (in which case property in the Goods will be deemed to pass to Psyence); |
| 6.2.2. | Provided the Goods have not been sold or used up, the Optimi may at any time require Psyence to deliver up to the Optimi the Goods for which the Optimi has not received payment in full of the price; and |
| 6.2.3. | The Customer shall not pledge or in any way charge by way of security for any indebtedness any of the Goods which remain the property of the Optimi, but if Psyence does so, all money owing by Psyence to the Optimi shall become due and payable. |
Exhibit 99.1
Psyence Biomed Executes Binding Agreements with Optimi Health Corp.
Psyence Biomed obtains exclusive worldwide supply rights to Optimi’s GMP-certified, nature-derived psilocybin for its drug development and commercialization initiatives in Palliative Care
NEW YORK, December 10, 2024 -- Psyence Biomedical Ltd. (Nasdaq: PBM) ("Psyence Biomed" or the "Company") today announced that it has progressed beyond the previously-announced non-binding Letter of Intent (LOI) and executed binding agreements with Optimi Health Corp. Under the terms of the agreements, Optimi becomes the exclusive supplier of GMP-certified, nature-derived (non-synthetic) psilocybin extract for Psyence’s global drug development and commercialization initiatives for FDA-approved uses in the Palliative Care context.
Optimi will provide comprehensive Chemistry, Manufacturing, and Control (“CMC”) support for regulatory submissions related to Psyence’s clinical trials in Palliative Care and any future Investigational New Drug (“IND”) applications. Psyence will obtain exclusive rights to Optimi’s drug candidate for treatment use in the Palliative Care context.
Dane Stevens, Chief Executive Officer of Optimi Health, stated, “We are very excited to have the opportunity to support Psyence Biomed as it works toward the potential initiation of pivotal registrational Phase III studies in Adjustment Disorder. As psychedelic research and development activities gain traction globally, we strive to be the partner-of-choice for companies like Psyence Biomed who are on the leading edge of psilocybin-based drug development. We look forward to a mutually successful partnership.”
“As we continue to efficiently advance our Phase IIb clinical trial for Adjustment Disorder in Palliative Care, these binding agreements with Optimi ensure that we have a consistent supply of very high quality, nature derived psilocybin for pivotal registrational Phase III studies, commercial production if approved, and potential expansion into new indications,” said Dr. Neil Maresky, M.B.,B.Ch., Chief Executive Officer of Psyence Biomed. “We are pleased to have found a partner in Optimi that shares our commitment to the development of psilocybin-based therapeutics as potential treatments for a broad range of underserved mental health conditions.”
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicines to be listed on Nasdaq. Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, regulatory-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
Forward Looking Statements
This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the advancement of Psyence Biomed's Phase IIb clinical trial and planned Phase III studies, and the quality and consistency of its supply chain for nature derived psilocybin. These forward-looking statements are based on a number of assumptions, including the assumptions that the parties will obtain all such regulatory approvals as may be required to execute on the Phase IIb clinical trial and planned Phase III studies, there will not be any unforeseen delays in the implementation schedule of such clinical trial and studies, and that Optimi will be able to meet Psyence Biomed's supply needs.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) delays in the implementation schedule of Psyence Biomed's Phase IIb clinical trials; (ii) the inability of Optimi to meet Psyence Biomed's supply needs to execute on its product development strategy (iii) the ability of Psyence Biomed to execute its obligations in respect of its product development objectives; (iv) changes in applicable laws which may impact drug development, clinical trials and/or the conducting thereof; (v) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the final prospectus (File No. 333-282468) filed with the Securities and Exchange Commission on October 10, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.