EX-10.3 6 ex10-3.htm

Exhibit 10.3

Dated June 4, 2018

(1) ON TARGET THERAPEUTICS, LLC

- and -

(2) OKYO PHARMA LIMITED

COLLABORATION AGREEMENT

FOR THE PROPOSED “CHEMERIN” PROGRAM

COOLEY (UK) LLP, DASHWOOD, 69 OLD BROAD STREET, LONDON EC2M 1QS, UK T: +44 (0) 20 7583 4055 F: +44 (0) 20 7785 9355 WWW.COOLEY.COM

THIS AGREEMENT is made June 4, 2018

BETWEEN:

(1)	ON TARGET THERAPEUTICS LLC, a limited liability company organized under the laws of Delaware whose place of business is at 15 Wynnewood Road, Wellesley, MA 02481 (“On Target” ); and

(2)	OKYO PHARMA LIMITED, a limited company incorporated and registered in Guernsey whose registered office is at[·] (“OKYO”).

INTRODUCTION:

(A)	Dr. Alan Kopin and Dr. Benjamin Harwood are associated with On Target.

(B)	OKYO has taken an assignment of a licence and sub-licence, originally granted by On Target and Tufts Medical Center, Inc. (the “Licence and Sub-Licence”) of certain intellectual property rights detailed in the Licence and Sub-Licence agreement (the “Licence and Sub-Licence Agreement” ).

(C)	On Target and OKYO wish to enter into this Agreement which shall set out the terms (including financial terms) on which On Target shall provide assistance and research services to OKYO to develop the subject matter of the Licence and Sub-Licence and to carry out ancillary research.

(D)	This Agreement sets out the terms on which On Target shall execute and/or supervise the Research Plan (as defined below) .

(E)	On Target is party to this Agreement for the purposes of waiving any rights to Arising Project IP.

IT IS AGREED AS FOLLOWS:

1.	DEFINITIONS AND INTERPRETATION

In this Agreement, unless the context otherwise the following definitions shall apply:

“Affiliate”

of a person means a person, corporation, partnership or other entity, that Controls, is Controlled by, or is under common Control with such person (and for the purposes of this definition, “Control” and “Controlled” shall be construed solely by reference to sub-paragraph (a) of the definition of “Control”);

“Agreement”	means this document, including its Schedules;

“Arising IP”	means, collectively, Arising General IP and Arising Project IP;

“Arising General IP”	means all Intellectual Property Rights generated, discovered, conceived, originated, derived or developed in the course of the activities undertaken in the performance of the Research Plan that are not specific to particular chemerin analogs that are the subject of the Research Plan, excluding for the avoidance of doubt all On Target Background Rights;

“Arising Project IP”	means all Intellectual Property Rights generated, discovered, conceived, originated, derived or developed in the course of the activities undertaken in the performance of the Research Plan, including any Intellectual Property Rights created pursuant to this Agreement and the Research Plan but excluding for the avoidance of doubt (i) all On Target Background Rights and (ii) all Arising General IP;

“Confidential Information”	means confidential and proprietary information and materials, patentable or otherwise, whether disclosed in tangible or intangible form, marked or stated to be “Confidential” or “Proprietary” (or word of similar import), or which would, in the normal course of business, or by the nature of the subject matter and/or the manner of its disclosure, be considered as being confidential or proprietary, that is disclosed by one Party {the “Disclosing Party” ) to another Party (the “ Receiving Party”), including:

information relating to the business, affairs, customers, clients, suppliers, plans, intentions, or market opportunities of the Disclosing Party or of the Disclosing Party’s group or its suppliers;

the terms of this Agreement; and

any materials and/or Know-How generated in connection with the performance of this Agreement.

“Control”

means:

	(a)	with respect to any individual, legal entity, trust or joint venture the direct or indirect ownership or possession of: (i) the power to direct or cause the direction of the management and policies of a company or entity whether through the ownership of voting securities, by contract or otherwise; or (ii) more than fifty per cent (50%) (in the aggregate) of the voting power of all outstanding shares entitled to vote at a general meeting of a company or entity; or

	(b)	with respect to any Material, item of information, or Intellectual Property Right, the possession, whether by ownership or licence, of the right to grant a licence or sub licence with respect thereto or to disclose relevant information relating thereto, without breaching any prior written obligation to any Third Party,

	and “Controlled” shall be construed accordingly;

“Effective Date”	means the date written at the start of this Agreement;

“Intellectual Property Rights”	means any and all inventions, Patents, utility models, registered designs, unregistered design rights, copyright, database rights, trademarks, trade names, rights in respect of Confidential Information, rights under data exclusivity Law, rights under orphan drug Law, Know-How, extensions of the terms of any such rights (including supplementary protection certificates), registrations and/or applications for and the right to apply for any of the foregoing, and similar or analogous rights, anywhere in the world;


“Know-How”	means unpatented technical and other information in written tangible form which is not in the public domain including information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development) processes (including manufacturing process, specifications and techniques), laboratory records, specifications, drawings, manuals, information, methods and processes for synthesis thereof, chemical compounds including derivatives, analogues and precursors, instrumentation, procedures for experiments and tests and results of experimentation and testing, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, report or summaries and information contained in submissions to and information from ethical committees and regulatory authorities and the fact that an item is known to the public shall not be taken to exclude the fact that a compilation including the item, and/or a development relating to the item, is (and remains) not known to the public;

“Law”	means any law, statute, constitution, principle of common law, ordinance, code, permit, rule, regulation, policy, guideline, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any governmental entity or securities exchange or securities quotation system, and any orders, writs, injunctions, binding awards of a court or arbitrator, judgments and decrees;

“Materials”	means, reagents, compounds, biopharmaceutical, biological and/or any other chemical materials and “Material” shall be construed accordingly;

“OKYO Science Adviser”	means Dr. Kunwar Shailubhai or another individual, reasonably acceptable to On Target, then serving as a science adviser to OKYO;

“On Target Background Rights”	means (i) the Patents and Know-How which are the subject of the Licence and Sub-Licence which has been assigned to OKYO, and (ii) all other Intellectual Property Rights owned or Controlled by On Target that (x) were generated, discovered, conceived, originated, derived or developed, or licensed or otherwise acquired, by On Target prior to the Effective Date, and/or (y) are generated, discovered, conceived, originated, derived or developed, or licensed or otherwise acquired, by On Target on or after the Effective Date other than in the course of activities comprising the Research Plan;

“Parties”	means On Target and OKYO and” Party” means any of them;

“Patents”	means patents and patent applications and all substitutions, divisions, continuations, continuations-in-part, any patent issued with respect to any such patent applications (including certificates of invention), any reissue, re-examination, utility models or designs, renewal or extension of any such patent, any term extension, a supplementary protection certificate and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts and patents and patent applications based on, corresponding to or claiming the priority date thereof in any country;

“Phase 1”	phase 1 of the Development Plan as set out in Schedule 1;

“Phase 2”	phase 2 of the Development Plan as set out in Schedule 1;

“Phase 1 Report”	a report on the research and findings in respect of activities carried out in Phase 1;

“Phase 2 Report”	a report on the research and findings in respect of activities carried out in Phase 2;

“Research Plan”	means the work plan as set out in Schedule 1 or as otherwise agreed and identified by the Parties in writing;

“Term”	has the meaning given to it in Clause 8.1; and

“Third Party”	means any entity other than a Party or its Affiliates.

2.	APPOINTMENT

2.1.	On Target undertakes to perform the activities set out in the Research Plan and shall perform such work in accordance with the terms of this Agreement.

2.2.	On Target may engage a subcontractor to carry out any activities assigned to it provided that:

	2.2.1	any subcontractor is made aware of the obligations of the subcontracting Party to the other Party under this Agreement; and

	2.2.2	On Target shall ensure that the activities carried out are performed under the supervision of Dr. Alan Kopin and Dr. Benjamin Harwood.

2.3.	On Target shall at all times while undertaking the activities set out in the Research Plan:

	2.3.1	perform such activities in a timely, diligent and professional manner using its reasonable efforts;

	2.3.2	to conduct all research in accordance with industry standard laboratory practices at all times (it being understood and agreed, for the avoidance of doubt, that the research is not required to be GLP-compliant);

	2.3.3	comply with all applicable Laws, regulations and guidelines in the performance of its obligations under this Agreement;

	2.3.4	keep a detailed record of all things done in relation to its performance of its obligations under the Research Plan and provide OKYO with a Phase 1 Report after Phase 1 is completed and a Phase 2 Report after Phase 2 is completed; and

	2.3.5	be reasonably available, on a quarterly basis, to report to the board of directors of OKYO or any scientific advisory board established by OKYO in respect of the Phase 1 Report and the Phase 2 Report to take questions and engage in discussions relating to the same.

3.	REVIEW

3.1.	Within thirty (30) days from the date of receipt by OKYO of the Phase 1 Report OKYO shall determine, by written notice to On Target (the “Phase 2 Election Notice”), whether to enter into Phase 2.

4.	TRANSFER OF MATERIALS

4.1.	From time to time during the Term, the Parties may supply each other with Materials as set out in Schedule 2 or as otherwise agreed by the Parties in writing. In such circumstances:

	4.1.1	such transfer shall be recorded using the material transfer record form set out in Schedule 2, which the transferor shall complete and submit to the transferee(s) for counter-signature prior to the transfer of the Materials;

	4.1.2	the Party providing that Material under that material transfer record form shall warrant that, to its reasonable knowledge without having undertaken any searches of any intellectual property registers, that Party has the full right and authority to transfer the Materials to the transferee for use as described in Schedule 2;

	4.1.3	Materials and related information provided by a Party shall remain the property of such Party or remain under the Control of such Party, and shall be kept securely by the other Party and shall not be provided by the other Party to any Third Party, except with the express written consent of the Party providing such Materials and related information;

	4.1.4	A Party receiving Materials from the other Party shall only use such Materials for the purpose of performing its obligations pursuant to this Agreement and shall use such Materials in accordance with all applicable Laws;

	4.1.5	other than as expressly permitted under this Agreement, (i) On Target shall not publish or attempt to publish any information or findings constituting Arising Project IP without the prior written consent of OKYO, (ii) OKYO shall not publish or attempt to publish any information or findings constituting Arising General IP without the prior written consent of On Target, and (iii) a Party receiving Materials from the other Party shall not otherwise characterise or reproduce such Materials without the prior written consent of the Party providing such Materials; and

	4.1.6	A Party receiving Materials from the other Party shall, at the election of such other Party, following completion of the purpose for which such Materials were transferred, destroy or return such Materials.

5.	INTELLECTUAL PROPERTY RIGHTS

5.1.	On Target shall own all rights, title and interest in and to (i) the On Target Background Rights and (ii) the Arising General IP, and OKYO shall own all rights title and interest in the Arising Project IP. No licence to use any On Target Background Rights or Arising IP or other Intellectual Property Rights is granted or implied by this Agreement except for the rights expressly granted in this Agreement and the Licence and Sub-Licence Agreement.

5.2.	On Target hereby unconditionally assigns (by way of present assignment of future rights) to OKYO, irrevocably and absolutely, all right, title and interest in and to all Arising Project IP (it being understood and agreed, for the avoidance of doubt, that On Target shall retain, and does not hereby or otherwise assign to OKYO, all right, title and interest in and to all Arising General IP). On Target hereby waives any moral rights (other than any moral rights relating to or constituting Arising General IP) in any works generated in the course of achieving the Research Plan to which On Target may become entitled at any future time under any provisions of Law in any jurisdiction including without limitation the right to be identified, the right of integrity and the right against false attribution, and agrees to institute, support, maintain or permit any action or claim to the effect that any treatment, exploitation or use of such works infringes On Target’ moral rights (in each case, at OKYO’s written request and sole expense).

5.3.	To the extent that the assignment set out in Clause 5.2 is not effective to assign any Arising Project IP to OKYO, On Target shall hold such Arising Project IP in trust for OKYO. On Target shall, as and when requested to do so by OKYO in writing, execute all documents and do all things reasonably requested by OKYO to give effect to Clause 5.2 (in each case, at OKYO’s sole expense).

6.	COSTS

Except as provided otherwise in Clauses 5.2 and 5.3 and in the Research Plan, each Party agrees that it shall bear its own costs in connection with carrying out the Research Plan save for the committed funding costs that OKYO has agreed to pay to On Target for its work.

7.	REPRESENTATIONS, WARRANTIES AND LIMITATION OF LIABILITY

7.1.	OKYO and On Target each warrants to the other that it has full power and authority under its constitution, and has taken all necessary actions and obtained all authorisations, licences, consents and approvals, to allow it to enter into this Agreement and to perform its obligations hereunder.

7.2.	No Party makes any representation or gives any warranty to the other that any advice or information given by it or any of its employees, contractors or other personnel who carry out the research set out in the Research Plan, or the content or use of any Arising IP, Materials or information provided in connection with the Research Plan, shall not constitute or result in the infringement of the rights of any Third Party (including, but not limited to, Intellectual Property Rights).

7.3.	No Party accepts any liability or responsibility for any use which may be made by the other Party of any Arising IP, nor for any reliance which may be placed by that other Party on any Arising IP, nor for advice or information given in connection with any results.

7.4.	Each Party (the “Indemnifying Party”) shall indemnify, defend and hold harmless the other Party, its Affiliates, directors, officers, employees, agents, subcontractors or sub-licensees (together, the” Indemnified Parties”) from and against each and every claim made by a Third Party against any of the Indemnified Parties, such Third Party claims arising as a result of the gross negligence or wilful misconduct of the Indemnifying Party (or any of its Affiliates, directors, officers, employees, agents, subcontractors or sub-licensees) in performing its obligations or exercising its rights under this Agreement, provided that the Indemnified Parties must, except with respect to any claim made in a criminal proceeding brought against an Indemnified Party:

	7.4.1	promptly (and in any event, within ten (10) business days of receipt of such claim) notify the Indemnifying Party of details of such claim;

	7.4.2	not make any statement, admission, settlement or compromise in relation to the claim;

	7.4.3	allow the Indemnifying Party to take such action as it shall deem necessary, in its absolute discretion, to avoid, dispute, resist, appeal, compromise or contest any such claim in the name of the applicable Indemnified Parties and to have the sole conduct of any related proceedings, negotiations or appeals (provided, however, that the Indemnifying Party may not, without each relevant Indemnified Party’s prior written consent which shall not be unreasonably withheld, (i) admit fault or guilt on behalf of such Indemnified Party or (ii) agree to compel such Indemnified Party to do, or refrain from doing, any act); and

	7.4.4	give the Indemnifying Party all reasonable assistance and information (including procuring access to relevant personnel in order to investigate the claim) (at the Indemnifying Party’s expense) as the Indemnifying Party reasonably requires in connection with resisting, appealing, compromising or contesting any such claim.

	The indemnity in this Clause 7.4 shall not apply to the extent that the Third Party claim arises as a result of any Indemnified Party’s negligence, reckless act or omission or intentional misconduct, breach of confidentiality, material breach of this Agreement or its infringement of any Third Party’s Intellectual Property Rights. For the avoidance of doubt: (i) this Clause 7.4 is without prejudice to any other rights which the Indemnifying Party may have at Law against the other Party or Third Party; (ii) the Indemnifying Party shall not be obliged to indemnify any of the Indemnified Parties to the extent any admission or statement made by any of the Indemnified Parties or any failure by any of the Indemnified Parties to notify the Indemnifying Party of the claim, materially prejudices the defense of the Third Party claim; and (iii) the Indemnifying Party shall not be obliged to indemnify the Indemnified Parties to the extent any Third Party claim is indemnified by the same Indemnifying Party pursuant to an indemnity under the Licence and Sub-Licence Agreement.

7.5.	Nothing in this Agreement limits or excludes any Party’s liability for:

	7.5.1	death or personal injury resulting from negligence;

	7.5.2	fraud; or

	7.5.3	any liability that, by Law, cannot be limited or excluded.

7.6.	Subject to Clause 7.5, the Parties shall not be liable to each other or any of their directors, officers, employees or agents for any of the following types of loss, damage, cost or expense arising (whether in contract, tort, negligence, breach of statutory duty or otherwise) under or in relation to this Agreement or the subject-matter of this Agreement for:

	7.6.1	any loss of profits, business, contracts, anticipated savings, goodwill, or revenue; or

	7.6.2	any indirect or consequential loss or damage whatsoever ; or

	7.6.3	any exemplary or punitive damages,

	even if the Party was advised in advance of the possibility of such loss or damage.

7.7.	Subject to Clause 7.5, the aggregate liability of each Party for all claims under this Agreement shall be limited to the aggregate amount actually received by On Target from OKYO pursuant to this Agreement.

7.8.	The express undertakings and warranties given by the Parties in this Agreement are in lieu of all other warranties, conditions, terms, undertakings and obligations, whether express or implied by statute, common law, custom, trade usage, course of dealing or in any other way. All of these are excluded to the fullest extent permitted by Law.

8.	TERM & TERMINATION

8.1.	This Agreement shall come into effect on the Effective Date and shall continue until (i) if OKYO elects to enter into Phase 2 of the Research Plan by giving to On Target the Phase 2 Election Notice to that effect, then upon expiration of 30 days after the date on which the Phase 2 Report is delivered to OKYO (or, if the OKYO Scientific Advisor notifies On Target in writing, within such 30-day period, of specific deficiencies with respect to the Phase 2 Report that are susceptible of reasonable remediation, then the date on which such deficiencies have been reasonably remedied by On Target), or (ii) otherwise, the date on which OKYO notifies On Target of OKYO’s election not to enter into Phase 2 of the Research Plan as contemplated by Clause 3.1 or, if OKYO fails to so notify On Target of such election within such 30-day period, expiration of 30 days after the date on which the Phase 1 Report is delivered to OKYO (or, if the OKYO Science Adviser notifies On Target in writing, within such 30-day period, of specific deficiencies with respect to the Phase 1 Report that are susceptible of reasonable remediation , then the date on which such deficiencies have been reasonably remedied by On Target), in each case unless terminated earlier in accordance with this Clause 8 (the” Term” ).

8.2.	A Party may by notice in writing to the other Party terminate this Agreement if the other Party:

	8.2.1	is in breach of any of the terms of this Agreement which, in the case of a breach capable of remedy, shall not have been remedied by the other Party within thirty (30) days of receipt by the Party in breach of a notice from the Party specifying the breach and requiring its remedy; or

	8.2.2	becomes insolvent, is dissolved or liquidated, makes a general assignment for the benefit of its creditors, files or has filed against it, a petition in bankruptcy, or has a receiver appointed for a substantial part of its assets or make any arrangement or composition with its creditors.

8.3.	OKYO may terminate this Agreement:

	8.3.1	immediately on providing written notice to On Target in the event that the OKYO Science Advisor determines that the Research Plan should be terminated for any reason; or

	8.3.2	on three months’ notice in writing to On Target in the event that OKYO reasonably concludes that the Research Plan is not being executed in accordance with its reasonable expectations and after having raised such concerns with On Target and given On Target not less than 30 days to rectify performance issues so identified.

8.4.	Upon termination or expiry of this Agreement for any reason, each Party shall as soon as reasonably practicable:

	8.4.1	return to the transferee (or, at the transferee’s direction, destroy) (to the extent technically possible) any of the transferee’s Materials which are at the date of termination or expiry in its possession or Control; and

	8.4.2	return to the transferee all copies of documents whether in paper, electronic or other form which contain Confidential Information of the transferee and are in its possession or Control save that the Party in Control of the same shall be entitled to keep a copy of such documents for archiving purposes.

8.5.	The provisions of Clauses 1, 4.1.3 to 4.1.6 (inclusive), 5, 7.3 to 7.8 (inclusive), 8.4 to 8.5 (inclusive), 9.1, 9.2, 9.4 to 9.7 (inclusive), 9.8 to 9.13 (inclusive) and 9.15 to 9.20 (inclusive) shall survive termination or expiry of this Agreement. Any rights or remedies of either Party arising prior to termination or expiry of the Agreement shall continue to be enforceable.

9.	MISCELLANEOUS

9.1.	Confidentiality. Each Party recognises that the other Party is engaged in a continuous program of research and development respecting its present and future business activities. Each Party agrees as follows:

	9.1.1	at all times during the term of this Agreement and thereafter, such Party will hold in strictest confidence and will not disclose, use, lecture upon or publish any of the other Party’s Proprietary Information (as the same is defined below), except to the extent such disclosure, use or publication may be required in direct connection with such Party’s performance of its obligations or exercise of its rights under this Agreement, or as expressly authorised in writing by the other Party;

	9.1.2	the term “Proprietary Information” shall mean any and all trade secrets, confidential knowledge, know-how, data or other proprietary information or materials of the specified Party. By way of illustration but not limitation, Proprietary Information includes: (i) inventions, ideas, samples, devices, media and/or cell lines and procedures for producing any such samples, devices, media and/or cell lines, processes, formulas, formulations, data, software, hardware, mask works, know-how, improvements, discoveries, developments, designs and techniques; (ii) information regarding plans for research, development, new products, marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers; and (iii) information regarding the skills and compensation of employees or other consultants of the specified Party; and

	9.1.3	in addition, each Party understands that the other Party has received and in the future may receive from third parties confidential or proprietary information (“Third Party Information”) subject to a duty on such Party’s part to maintain the confidentiality of such information and to use it only for certain limited purposes. During the term of this Agreement and thereafter , each Party will hold Third Party Information received from the other Party in the strictest confidence and will not disclose or use such Third Party Information, except in connection with such Party’s performance of its obligations or exercise of its rights under this Agreement, or as expressly authorised in writing by the other Party.

9.2.	Assignment. Neither this Agreement nor any rights or obligations under this Agreement may be assigned by any Party, without the prior written consent of the other Parties, except that a Party may assign its rights or obligations under this Agreement to an Affiliate.

9.3.	Force Majeure. Each Party shall be excused from the performance of its obligations under this Agreement (except a payment obligation) to the extent that such performance is prevented by Force Majeure and the non-performing Party promptly provides notice of the prevention to the other Parties. Such excuse shall be continued so long as the condition constituting Force Majeure continues and the non-performing Party makes commercially reasonable efforts to remove the condition. Any Party affected by such Force Majeure shall take all reasonable steps to minimise the effects of such Force Majeure upon performance of this Agreement. If any event of Force Majeure persists for a period of ninety (90) days, any Party affected by the Force Majeure may by written notice terminate this Agreement.

9.4.	Notices. Any notice or notification required or permitted to be provided pursuant to the terms and conditions of this Agreement shall be in writing and shall be deemed given:

	9.4.1	upon receipt if delivered personally (receipt verified);

	9.4.2	on the third Business Day if sent by overnight delivery using an internationally recognised express courier service and specifying next available Business Day delivery (receipt verified}; or

	9.4.3	by confirmation of receipt if delivered by electronic mail,

	to the relevant Party at the addresses set out above (or at such other address for a Party as shall be specified by notice in writing, provided, however, that notices of a change of address shall be effective only upon receipt thereof).

9.5.	Amendments . No amendment, modification or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorised representative of each Party.

9.6.	Disputes. Any dispute or disagreement that arises between any of the Parties in respect of this Agreement, shall follow the following procedures in an attempt to resolve the dispute or disagreement:

	9.6.1	the Party claiming that such a dispute exists shall give notice in writing (“Notice of Dispute”) to the Party with whom the dispute exists (each, a “ relevant Party” in relation to that dispute) of the nature of the dispute;

	9.6.2	the dispute will be referred to the senior officers of the relevant Parties who shall meet to discuss and seek to resolve the issue;

	9.6.3	if, within a further period of thirty (30) days, or if in any event within sixty (60) days of initial receipt of the Notice of Dispute, whichever is shorter, the dispute has not been resolved, or if, for any reason, the meeting of the senior officers of the relevant Parties has not been held within sixty (60) days of initial receipt of the Notice of Dispute, then the Parties agree that any relevant Party may initiate arbitration proceedings to resolve the dispute; and

	9.6.4	notwithstanding any provision of this Agreement to the contrary, any relevant Party may immediately initiate litigation in any court of competent jurisdiction seeking any remedy at Law or in equity, including application for the issuance of a preliminary, temporary or permanent injunction, to preserve or enforce its rights under Clause 9.1.

9.7.	Arbitration. If the informal resolution mechanism of Clause 9.6 proves unsuccessful within the allotted period, then the relevant Parties shall submit their dispute to binding arbitration before one (1) arbitrator in New York, New York, USA pursuant to the Rules of Arbitration of the International Chamber of Commerce (“ICC”). The arbitrators shall be qualified in New York Law and shall be selected in accordance with the rules of the ICC. Any arbitrator so selected shall have substantial experience regarding the issues in dispute and the pharmaceutical industry. The arbitrators may permit limited discovery as they deem appropriate in the circumstances of the dispute. The arbitration shall be conducted, and all documents submitted to the arbitrators shall be, in English. The arbitrators shall have no power to award punitive, special, incidental or consequential damages. The arbitrator’s decision and award shall be final and binding upon all Parties. The costs for each relevant Parties’ counsel and other expenses, and the costs of the arbitration shall be borne by the relevant Parties as determined by the arbitrator’s judgment and the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction.

9.8.	Entire Agreement. This Agreement, including its Schedules, constitutes and contains the complete, final and exclusive understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter hereof and thereof.

9.9.	Independent Contractors. The Parties are independent contractors under this Agreement. Nothing contained in this Agreement shall be deemed to create an agency relationship between the Parties or any of their agents or any legal arrangement that would impose liability upon one Party for the act of failure of the other Party, except as expressly set out in this Agreement. None of the Parties shall have any express or implied power to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of the other Party, or to bind the other Party in any respect whatsoever.

9.10.	Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be an original and all of which shall constitute together the same document. Counterparts may be signed and delivered by courier or by electronic mail with attached PDF file, each of which shall be binding when received by the applicable Party.

9.11.	No Third Party Rights or Obligations. Except as otherwise expressly provided herein, no provision of this Agreement shall be deemed or construed in any way to result in the creation of any rights or obligations in any person not a Party to this Agreement.

9.12.	Further Actions . Each Party shall promptly execute and deliver such documents and perform such acts as may reasonably be required for the purpose of giving full effect to this Agreement.

9.13.	No Additional Rights. Except for the rights expressly granted herein, nothing in this Agreement shall be construed as conferring upon either Party by implication, estoppel or otherwise any additional rights, including, but not limited to, any additional rights in or to the Confidential Information and/or Intellectual Property Rights of the other Party.

9.14.	[Intentionally Omitted].

9.15.	Compliance. The Parties shall comply with the anti-bribery and corruption, research and scientific engagement policies of OKYO as in force from time to time. No Party shall knowingly undertake any action pursuant to this Agreement which is reasonably likely to have material adverse effect on another Party’s reputation, including any action involving: (i) the breach of international government sanctions regarding the export of goods or undertaking of activities with certain countries identified by Her Majesty’s Government in the UK or the US Government, (ii) the tobacco industry, (iii) child labour, or (iv) bringing opportunistic patent infringement proceedings under Patents which do not relate to the substantive business operations of the patent owner or licensee (known as “patent trolling”).

9.16.	Non-reliance. Each Party acknowledges and agrees that it has not entered into this Agreement in reliance upon any representation, warranty or undertaking of any other Party which is not expressly set out or referred to in this Agreement.

9.17.	Non-repudiation. No act or omission of any Party which shall be carried out:

	(a)	in compliance or purported compliance with any provision of this Agreement; or

	(b)	pursuant to a decision taken or purportedly taken in accordance with this Agreement,

	or which shall otherwise constitute or involve a breach of any provision of this Agreement shall be regarded as a repudiation of this Agreement or affect the continued application of this Agreement to the Parties but (for the avoidance of doubt) nothing in this Clause 9.17 shall limit the right of either Party to pursue a claim for damages or any other relief (whether interim or otherwise) in respect of any breach or threatened breach of this Agreement.

9.18.	Illegality. If any provision of this Agreement is held to be illegal, void, invalid or unenforceable under the Laws of any jurisdiction, the legality, validity and enforceability of the remainder of this Agreement in that jurisdiction shall not be affected, and the legality, validity and enforceability of the whole of this Agreement in any other jurisdiction shall not be affected.

9.19.	Waiver.

	9.19.1	No failure on the part of any Party to exercise, and no delay on its part in exercising, any right or remedy under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy preclude any other or further exercise thereof or the exercise of any other right or remedy. The rights and remedies provided in this Agreement (including its Schedules) are cumulative and not exclusive of any rights or remedies provided by Law; and

	9.19.2	No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its officers, agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorised officer of the waiving Party. The waiver by any of the Parties of any breach of any provision hereof by the other Parties shall not be construed to be a waiver of any succeeding breach of such provision or a waiver of the provision itself.

9.20.	Governing Law. This Agreement and any contractual or non-contractual obligations arising from or connected with this Agreement, and the rights of the Parties, shall be governed by the laws of the State of New York without regard to principles of conflict of laws that would have the effect of applying the laws of a different jurisdiction.

[Signature page to follow]





EXECUTED FOR AND ON BEHALF OF)
ON TARGET THERAPEUTICS LLC )


Name:	Alan S. Kopin MD
Position:	OTTX Chief Scientific Officer
Date:	June 4, 2018

EXECUTED FOR AND ON BEHALF OF)
ON OKYO PHARMA LIMITED )


Name:
Position:

Schedule 1

RESEARCH PLAN FOR DRY EYE TECHNOLOGY

The proposed research plan that follows will be completed within a six-month period for a budget of $400K.

Phase 1

1. Selection of optimized ligand.

Pharmacological assessment of 6 novel lipidated stable chemerin analogs. The efficacy and potency of the ligands will be compared with the prototype compound. In vitro assays will be done in HEK293 cells transiently expressing recombinant CMKLR1. Pharmacologic characterization of the 6 novel lipidated stable chemerin analogs will be done by assessing receptor mediated Gai signaling. HEK293 cells will be transiently transfected with cDNAs encoding CMKLR1, an SRE luciferase reporter gene and Gq5i. Efficacy and potency of stable chemerin analogs will be determined using methods that are well established at On Target Therapeutics. Compounds will be rank ordered based on pharmacologic properties.

Output: Phase 1 Report with final recommendation.

2. Stability testing of the most promising compound: overnight incubation at room temp and at 37 degrees followed by in vitro assessment.

The candidate peptide will be resuspended in sterile PBS at the concentration used for DED studies (currently anticipated to be 210µM). Peptides will be incubated in low retention Eppendorf tubes at both room temperature and at 37 Celsius for 24 hours. The peptide will then be serially diluted along with freshly prepared peptide. Potency and efficacy will then be assessed using the in vitro assay described in section 1. Any issues with solubility or peptide aggregation that alter pharmacological activity can be identified using this method.

Output: results summarized in Phase 1 Report

3. Mini-scale up synthesis of compounds for mouse study: The scale up synthesis of lead compounds will be conducted to prepare adequate quantities for mouse dry eye studies.

Phase II

4. Scale up of the most promising compound.

Synthesis of the candidate compound nominated following DED studies with be scaled to 1- gram. Solid phase FMOC synthesis will be used to produce 1-gram of peptide as an acetate salt. Peptides will be purified to a minimum of 95% purity which will be confirmed by RP-HPLC. Peptide identity will be further confirmed by LC/MS. In addition, impurities will also be measured by RP HPLC.

Output: results summarized in Phase 2 Report

5. Assessment of the two most promising lipidated stable chemerin analogs (without the PEG linker) in the scopolamine dry eye mouse model (DED).

The two analogs (without PEG) will be compared with the prototype compound (containing a PEG linker) and with vehicle. Efficacy in a murine scopolamine DED model will be measured using the following measurements: i) tear break up time using fluorescein sodium, ii) tear production using phenol red, iii) corneal epitheliopathy using fluorescein sodium under slit lamp.

Output: Results summarized in Phase 2 Report

6. Rabbit ocular tolerability/ irritant study.

New Zealand white (NZW) rabbits will be used. Advantages of these animals include large eyes, well described anatomy and physiology, easy to handle, and readily available. The test substance (0.1 ml), the most efficacious of the lipidated chemerin constructs, will be applied onto the cornea and conjunctiva! sac of one eye of a conscious rabbit for 72 h. The other eye will serve as an untreated control. Six rabbits will be used per test, comparison will be made with vehicle alone. Rabbits will be examined daily for at least 7 days for signs of ocular inflammation (redness, swelling, cloudiness, edema, hemorrhage, discharge and blindness). Assessment will be done using penlighU slit lamp. Subjective scoring from non-irritating to severely irritating will be done.

Output: results summarized in Phase 2 Report 7. Coordination and oversight of research plan.

After screening selected CROs, Dr. Alan Kopin will select vendors based on relevant experience and recommendations. Pharmacological assessments will be done in the OTTX laboratory by Dr. Benjamin Harwood. Compounds will be assessed for efficacy and potency after synthesis (including after scaleup). Aliquots of test compounds will be distributed to the relevant CROs by OTTX. Parallel vials will be retained and retested to confirm pharmacological activity. All methods and results will be provided to Kunwar Shailubhai, along with the corresponding conclusions based on the investigations. Protocols may be modified based on the recommendations of the CRO/lab director carrying out the study.

Payment Schedule

The budget of US$400,000 is an all in package to cover research time; consumables; laboratory hire; animal models and any third party costs. An initial payment of $200,000 will be made by OKYO to On Target upon presentation of On Target’s invoice therefor, which invoice may be presented by On Target at any time after the Effective Date and shall be payable on receipt. The remaining balance of $200,000 will be paid by OKYO to On Target upon presentation of On Target’s invoice therefor, which invoice may be presented by On Target at any time after On Target’s receipt of OKYO’s Phase 2 Election Notice setting forth OKYO’s election to enter into Phase 2, and shall be payable on receipt.

Schedule 2

MATERIAL TRANSFER RECORD FORM

Capitalised terms used in this material transfer record form (“MTRF”) that are not defined herein shall have the meanings set forth in the Collaboration Agreement dated [●] made between On Target and OKYO (the “Agreement”).

Pursuant to the terms of the Agreement, [●] will transfer [●]the Materials identified below.

This MTRF shall be used as the record of all such Materials transferred, regardless of the transferor or transferee.

Transfer date:

Description of Materials:

EXECUTED BY ON TARGET:

Date:

EXECUTED BY OKYO PHARMA LIMITED:

[name]

[position]

Date:

Note: This MTRF is to be completed and signed by On Target and OKYO for each transfer. A copy of each completed MTRF is to be provided to the respective Chief Executive Officer of OKYO and Chief Scientific officer of On Target. This MTRF should not be used to transfer any Materials in which Third Parties may have rights, or which may infringe, or violate any Intellectual Property Rights held by any Third Party. If there are any questions about the appropriateness of a transfer, please contact the representatives identified herein before making such transfer.