SERVICE AGREEMENT
Exhibit 10.35
THIS SERVICE AGREEMENT (this “Agreement”) is entered into as of May 15, 2017 by and between Covar Pharmaceuticals Incorporated, a Corporation having its principal place of business located at 0000 Xxxxxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxx, Xxxxxx (the “Consultant”), and Videns Incorporation Limited (and associated companies), a company having its correspondence address at Xxxx X, 00/X, Xxxxxxxxx Investment Tower, 000 Xxxxxxxxx Xxxx Xxxxxxx, Xxxx Xxxx (the “Corporation”).
W I T N E S S E T H :
WHEREAS the Corporation desires to engage the services of Consultant, and Consultant is willing to render services to the Corporation, each upon the terms and conditions herein set forth.
NOW, THEREFORE, in consideration of the mutual promises set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
| 1. | SERVICES |
Consultant shall be engaged as “Product and Clinical Development Advisor” of the Corporation.
Consultant shall be available to perform and shall perform for the Corporation the development of contrast agents (including, but not limited to, Curcumin Conjugated Magnetic Nanoparticles (CCMN)) for MRI imaging applicable to the human brain (the “Program”). Examples of the services shall include, but are not limited to, the following:
| (a) | Program Management Services |
| ● | Lead and support strategic planning to complete a Phase I (First Time in Humans [FTIH]) clinical study and, where possible, proof of concept clinical studies |
| ● | Project Plan Development |
| o | High level strategic plan and timeline |
| o | Detailed plan, timeline and budget |
| ● | Project Management |
| o | Set goals and define responsibilities of team members |
| o | Coordinate core project team meetings |
| o | Attend, coordinate and support functional project team meetings if required |
| o | Review and update of project plan and budget at regular intervals or as required |
| o | Follow up action items with team members |
| o | Risk assessment and mitigation strategies |
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| ● | Provide development services or support and identify outsourcing to service providers for services including, but not limited to: |
| o | Preclinical (non-clinical) toxicology studies |
| o | ADME |
| o | Functional ingredient sourcing/qualification/characterization/supplier site auditing |
| o | Excipient sourcing/qualification/characterization/supplier site auditing |
| o | Clinical trial batches (CTM batches) manufacturer |
| o | GLP/GMP testing laboratories |
| ● | Evaluate service providers including preparation of “Request for Proposal” details, reference checks, auditing, evaluation of proposals, recommendations and contract negotiation. |
| ● | Recruit experts to support the development program for strategic planning, protocol development, regulatory document preparation and filing, preclinical studies, material characterization and CMC development. |
| (b) | Technical Services by Consultant or Contractors |
| ● | Develop feasible, regulatory compliant manufacturing process for toxicology and clinical batches |
| ● | Develop regulatory acceptable method to characterize the contrast agents (including CCMN) |
| ● | Develop method of administration of contrast agents (including CCMN) to animals for pre-clinical studies and to humans for FTIH |
| ● | Develop sufficiently stable contrast agents (including CCMN) formulation if required. For example, stabilizer(s) for nanoparticles may be added or lyophilization excipients may be included in the formulation |
| ● | Source or fabricate (if needed by contractor) equipment for the manufacture of the pre-clinical/toxicology or clinical batches |
| ● | Develop and qualify suitable physical and/or chemical testing methods suitable for GLP or GMP product characterization or release |
| ● | Develop and qualify stability-indicating physical and chemical testing methods |
| ● | Technology transfer for CTM manufacturing site |
| ● | Support definition of animal and FTIH dosing ranges |
| ● | Support or perform audits to qualify contractors |
| ● | Coordinate the preparation of documentation for regulatory submission |
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Consultant shall perform such services at such times and such places as may be reasonably designated by:
Xx Xxx Xxxx
Xx Xxxx Ko
Xx Xxxxxxx Xxx
Xx Xxxxxx Xxx
Xxxxxxxxx Xxxxxx Xxx
Xx Xxxxxxx Xxx
The Corporation retains the right to amend the list of authorized individuals above at any time by written notification to the Consultant.
Consultant shall perform such services in a manner consistent with industry standards for similar professional consulting work. Upon mutual agreement and under the request of the Corporation, Consultant may need to travel from time to time to perform the services described herein.
| 2. | COMPENSATION |
In consideration of Consultant’s performance of the consulting services described above, the Corporation shall compensate Consultant based on:
| (a) | A fixed fee approach with a defined scope to be agreed between the Consultant and the Corporation for each critical study, project or milestone; |
| (b) | In all other circumstances, the hourly rate of its employees who perform the services. Both Xx. Xxxxxx Xxxxxxxx, Xx. Xxxx Xxxx and technical and supporting staff at the Consultant company will provide the technical services. The Consultant may bring qualified external consultants with the Corporation’s agreement to support the Program. Xxxxxx Xxxxxxxx shall provide his services at an hourly rate of USD $150 per hour; Xx. Xxxx Xxxx shall provide technical and consulting services, including pharmaceutical and analytical development services, at an hourly rate of USD $200 per hour. The technical and supporting staff will provide services at an hourly rate of USD $65 to $100 per hour depending on their backgrounds and experience. The fee for external consulting will be determined on a case by case basis with prior Corporation approval. |
Both parties agree that:
| (a) | Xx. Xxxxxx Xxxxxxxx, Executive Director, Cover Pharmaceuticals Incorporated, will provide the lead program management services for the Project; |
| (c) | Xx. Xxxx Xxxx, President, Cover Pharmaceuticals Incorporated, will also provide program management support when needed. |
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| 3. | EXPENSES |
The Corporation shall reimburse Consultant for all direct out-of-pocket expenses of Consultant actually and reasonably incurred in connection with the performance of Consultant’s obligations under this Agreement insofar as such expenses relate to travel expenses, third party payments and other reasonable expenses, provided that such expenses are specifically approved in advance in writing by the Corporation.
| 4. | RECORDS AND REPORTS |
| 4.1. | Books and Records |
Consultant shall maintain books and records adequate for the determination of all services rendered, expenses and other data, which shall be available for inspection by the Corporation through its agents or representatives during normal working hours as the Corporation shall reasonably request.
| 4.2. | Payment of Invoices |
Consultant shall submit invoices to the Corporation within ten (10) days after the end of each calendar month during the term of this Agreement, specifying in reasonable detail the nature and extent of the services performed by Consultant for the preceding month, and the amount of expenses incurred by Consultant which are subject to reimbursement by the Corporation in accordance with Article 3. The Corporation shall remit payment for all such compensation and expenses in the amounts called for by this Agreement within 30 days after receipt of such invoices.
A retainer fee of USD $10,000 will be provided by the Corporation upon execution of this Agreement and the retainer fee will be deducted from the last payment upon termination of the Agreement or completion of the Program. Any remaining funds, if any, will be refunded.
The Consultant will provide the Corporation a quotation with estimated time and cost for individual service items exceeding USD $10,000 for approval before execution.
| 4.3. | Monthly Status Reports |
Upon request by the Corporation, Consultant shall prepare and submit to the Corporation on a monthly basis a status report setting forth a summary of Consultant’s activities and progress during the preceding month with respect to the matters set forth in Article 1.
| 5. | TERM AND TERMINATION |
| 5.1. | Term |
Subject to the termination provisions set forth in Article 5.2, this Agreement shall have an initial term of 12 months, commencing on the date this agreement is executed, which term may be automatically renewable for another 12 months, and thereafter extended from time to time by the mutual written agreement of Consultant and the Corporation.
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| 5.2. | Termination and Actions Thereafter |
| (a) | This Agreement may be terminated by the Corporation by written notice to Consultant at any time upon (i) Consultant’s permanent disability or incapacity to perform services hereunder; or (ii) a breach by Consultant of any of the provisions of this Agreement. |
| (b) | Either party may, at any time and with or without cause, terminate this Agreement upon written notice to the other party given not less than fifteen (15) days prior to such termination. Such notice shall specify the effective date of termination for all purposes hereunder. |
| (c) | Upon termination or expiration of this Agreement, Consultant (or his representatives) shall promptly submit to the Corporation an invoice covering all unbilled compensation and expenses to date, together with an estimate of the compensation and expenses that would be chargeable to the Corporation if any particular services for work then in progress were to be completed by Consultant. Except in the case of termination under Article5.2(a)(i), upon request by the Corporation (but not otherwise) Consultant shall complete such work in progress as the Corporation shall designate, and this Agreement shall in such case be deemed extended until such work is completed and paid for. The Corporation shall pay Consultant for any services performed to and including the date of termination in accordance with the provisions for compensation set forth in Articles 2 and 3. |
| (d) | The provisions of Articles 7 and 8 shall survive expiration or termination of this Agreement for any reason whatsoever. |
| 6. | RELATIONSHIP OF THE PARTIES |
| 6.1. | Independent Status |
The relationship of Consultant to the Corporation hereunder shall be that of an independent contractor, Nothing in this Agreement is intended or shall be construed to constitute Consultant an employee, agent or partner of the Corporation nor shall Consultant have authority to bind the Corporation in any respect. The Corporation shall not be liable for any act or omission of Consultant or his employees or agents, and Consultant agrees to indemnify and hold harmless the Corporation from any and all losses, damages, costs and expenses (including attorneys’ fees) in any manner resulting from or arising out of any such act or omission or any breach of Consultant’s obligations under this Agreement.
| 6.2. | Services for Third Parties |
Nothing in this Agreement shall be construed to prevent Consultant from concurrently providing services to persons other than the Corporation, subject to the limitations set forth in Articles 7 and 8.
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| 6.3. | Certain Tax Matters |
Consultant shall not be treated as an employee for tax purposes with respect to the services performed pursuant to this Agreement. Consultant shall be responsible for the filing of all necessary income tax returns and the payment of all taxes required by law. Consultant acknowledges that he understands his tax obligations.
| 6.4. | Disclosure of Consultant Relationship by Corporation |
Subject to article 6.1 above, the Corporation may include and disclose, for example, in its corporate presentations, marketing materials, due diligence related documentation to third parties, the credentials and advisory role of the Consultant and its employees (for example, Xx Xxxx Xxxx and Xx. Xxxxxx Xxxxxxxx). On this basis, the Corporation will seek the Consultant’s approval prior to such inclusion.
| 7. | RESTRICTIVE COVENANTS |
| 7.1. | Confidential Information |
Unless authorized or instructed in writing by the Corporation, Consultant shall not, during or at any time after the term of this Agreement except as required in the conduct of the Corporation’s business, disclose to others, or use, or permit to be disclosed to others or used, any of the Corporation’s inventions, discoveries, works, ideas, information, knowledge or data (whether in oral, written, or machine-readable form) which Consultant may develop or obtain during the course of or in connection with Consultant’s engagement, including such inventions, discoveries, works, ideas, information, knowledge, or data relating to machines, equipment, products, systems, software, research and/or development, designs, compositions, formulae, processes, manufacturing procedures, business methods, present and prospective customers of the Corporation, business dealings with such customers, prospective marketing, promotion, sales and advertising programs and strategies, and agreements with representatives or prospective representatives of the Corporation, present or prospective sources of supply or any other business arrangements of the Corporation, including but not limited to customers, customer lists, costs, prices and earnings, whether or not developed by Consultant, by others in the Corporation or obtained by the Corporation from third parties, and irrespective of whether or not such inventions, discoveries, works, ideas, information, knowledge or data have been identified by the Corporation as secret or confidential, unless and until, and then to the extent and only to the extent that, such inventions, discoveries, works, ideas, information, knowledge or data become available to the public otherwise than by Consultant’s act or omission. All inventions, discoveries, works, ideas, information, knowledge, and data described or referred to in this Article 7.1 are referred to herein collectively as “Confidential Information”.
| 7.2. | Essence of Agreement |
Consultant acknowledges (i) that the use, misappropriation or disclosure of the Confidential Information (as defined in Article 7.1) would constitute a breach of trust and cause irreparable injury to the Corporation, (ii) that all such Confidential Information is the property of the Corporation and (iii) that it is essential to the protection of the Corporation’s goodwill and to the maintenance of the Corporation’s competitive position that the Confidential Information be kept secret and that the Confidential Information not be disclosed by Consultant to others or used by Consultant to Consultant’s own advantage or the advantage of others. Consultant further acknowledges that Consultant’s agreement to the provisions of this Article 7 and the enforceability of such provisions against Consultant are an essential element of this Agreement and that, absent such provisions and the enforceability thereof, the Corporation would not (a) engage Consultant nor (b) permit Consultant access to and use of Confidential Information.
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| 7.3. | Non-solicitation/Noncompetition |
Consultant further recognizes and acknowledges that it is essential for the proper protection of the business of the Corporation that Consultant be restrained (a) from soliciting or inducing any employee of the Corporation to leave the employ of the Corporation, (b) from hiring or attempting to hire any employee of the Corporation, (c) from soliciting the business of the customers (actual or potential) and suppliers of the Corporation for any business purpose, and (d) from competing against the Corporation, including, but not limited to, provides services relating to generic drug development to any third party in China.
| 7.4. | Ability to Earn Livelihood |
Consultant represents that his experience and capabilities are such that the provisions of this Article 7 will not prevent him from earning his livelihood, and acknowledges that it would cause the Corporation serious and irreparable injury and cost if Consultant were to use his ability and knowledge in competition with the Corporation or to otherwise breach the obligations contained in Article 7.
| 8. | PROPRIETARY RIGHTS |
| 8.1. | Assignment of Rights |
For the term of this Agreement, the Corporation hereby grants to the Consultant, a non-exclusive, paid-up, royalty-free, non-transferable license of Client’s Intellectual Property which the Consultant must use in order to perform the Services.
All Intellectual Property generated or derived by the Consultant in the course of performing the Services, to the extent it is specific to the development. manufacture, use and sale of the Client’s Product that is the subject of the Services, will be the exclusive property of the Corporation.
All Intellectual Property generated or derived by the Consultant while performing the Services which is not specific to, or dependent upon, the Corporation’s Product and which has application to manufacturing processes or formulation development of pharmaceutical products or pharmaceutical delivery systems will be the exclusive property of the Consultant. The Consultant hereby grants to the Corporation, a non-exclusive, paid-up, royalty-free, transferable license of the Intellectual Property which the Corporation may use for the manufacture of Client’s Product.
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| 8.2. | Return of Materials |
Upon expiration or termination of this Agreement, Consultant agrees to return to the Corporation all computer software, computer programs, source codes, object codes, magnetic tapes, printouts, designs, proposals, samples, notes, records, reports, documents, customer and prospective customer lists, memoranda, plans, blue prints, correspondence, proposals, drawings, letters, flow-charts, manuals, strategies, techniques, photographs, catalogs and writings and all copies thereof, directly or indirectly, related to, or developed, prepared or created during, Consultant’s engagement by the Corporation and, without limiting the foregoing, Consultant shall promptly deliver to the Corporation any and all documents or materials constituting or, directly or indirectly, relating to any Confidential Information. The Corporation may withhold Consultant’s outstanding compensation against return of these materials and any other materials of the Corporation or its customers.
| 9. | REPRESENTATIONS AND WARRANTIES BY CONSULTANT |
Consultant represents and warrants to the Corporation that neither the execution and delivery of this Agreement nor the carrying out of any of the transactions contemplated hereby will in any respect result in any violation of or be in conflict with any term or provision of any agreement, document or instrument to which Consultant is a party or by which he is bound. Consultant further represents and warrants to the Corporation that he has furnished the Corporation with copies of all such agreements, documents or instruments to which Consultant is a party or by which he is bound. Consultant agrees not to divulge to the Corporation any information which would violate any such agreement, document or instrument, nor to divulge to the Corporation any trade secrets of prior employers or contracting parties.
| 10. | MISCELLANEOUS |
| 10.1. | Additional Actions and Documents |
Each of the parties hereto hereby agrees to take or cause to be taken such further actions, to execute, deliver and file or cause to be executed, delivered and filed such further documents, and will obtain such consents, as may be necessary or as may be reasonably requested in order to fully effectuate the purposes, terms and conditions of this Agreement.
| 10.2. | Assignment |
Consultant shall not assign his rights and obligations under this agreement, in whole or in part, whether by operation of law or otherwise, without the prior written consent of the Corporation, and any such assignment contrary to the terms hereof shall be null and void and of no force and effect.
| 10.3. | Entire Agreement; Amendment |
This Agreement constitutes the entire agreement between the parties hereto with respect to the transactions contemplated herein, and it supersedes all prior oral or written agreements, commitments or understandings with respect to the matters provided for herein. No amendment, modification or discharge of this Agreement shall be valid or binding unless set forth in writing and duly executed and delivered by the party against whom enforcement of the amendment, modification, or discharge is sought.
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| 10.4. | Waiver |
No delay or failure on the part of any party hereto in exercising any right, power or privilege under this Agreement or under any other documents furnished in connection with or pursuant to this Agreement shall impair any such right, power or privilege or be construed as a waiver of any default or any acquiescence therein. No single or partial exercise of any such right, power or privilege shall preclude the further exercise of such right, power or privilege, or the exercise of any other right, power or privilege. No waiver shall be valid against any party hereto unless made in writing and signed by the party against whom enforcement of such waiver is sought and then only to the extent expressly specified therein.
| 10.5. | Governing Law |
This Agreement, the rights and obligations of the parties hereto, and any claims or disputes relating thereto, shall be governed by and construed in accordance with the laws of Ontario, excluding the choice of law rules thereof).
| 10.6. | Notices |
All notices, demands, requests, or other communications that may be or are required to be given, served, or sent by any party to any other party pursuant to this Agreement shall be in writing and shall be hand delivered, sent by overnight courier or mailed by first-class, registered or certified mail, return receipt requested, postage prepaid, or transmitted by telegram, telecopy or telex, to the addresses indicated at the beginning of this agreement for each party.
Each party may designate by notice in writing a new address to which any notice, demand, request or communication may thereafter be so given, served or sent. Each notice, demand, request, or communication that shall be hand delivered, sent, mailed, telecopied or telexed in the manner described above, or that shall be delivered to a telegraph Corporation, shall be deemed sufficiently given, served, sent, received or delivered for all purposes at such time as it is delivered to the addressee (with the return receipt, the delivery receipt, or (with respect to a telecopy or telex) the answerback being deemed conclusive, but not exclusive, evidence of such delivery) or at such time as delivery is refused by the addressee upon presentation.
| 10.7. | Execution in Counterparts |
To facilitate execution, this Agreement may be executed in as many counterparts as may be required. It shall not be necessary that the signatures of, or on behalf of, each party, or that the signatures of all persons required to bind any party, appear on each counterpart; but it shall be sufficient that the signature of, or on behalf of, each party, or that the signatures of the persons required to bind any party, appear on one or more of the counterparts. Ail counterparts shall collectively constitute a single agreement. It shall not be necessary in making proof of this Agreement to produce or account for more than a number of counterparts containing the respective signatures of, or on behalf of, all of the parties hereto.
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| 10.8. | Limitation on Benefits |
The covenants, undertakings and agreements set forth in this Agreement shall be solely for the benefit of, and shall be enforceable only by, the parties hereto and their respective successors, heirs, executors, administrators, legal representatives and permitted assigns.
| 10.9. | Binding Effect |
Subject to any provisions hereof restricting assignment, this Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors, heirs, executors, administrators, legal representatives and assigns.
IN WITNESS WHEREOF, the Corporation has caused this Agreement to be executed by its duly authorized officer and Consultant has hereunto set his hand as of the date first above written.
Videns Incorporation Limited
| By: | /s/ Xxx Xxxx | Date: | May 31, 2017 | |
| Name: Xxx Xxxx | ||||
| Title: Chief Executive Officer | ||||
Covar Pharmaceuticals Incorporated
| By: | /s/ Xxxx Xxxx | Date: | May 25, 2017 | |
| Name: Xxxx Xxxx, Ph.D. | ||||
| Title: President | ||||
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