Exclusive License Agreement, dated as of March 16, 2021, by and between the Edesa Biotech Research, Inc. andDr. Saul Yedgar

LICENSOR owns the rights to certain know-how, patents and data relating to formulations containing Di-Palmitoyl Phosphatidyl-Ethanolamine (DPPE)-conjugated Hyaluronic Acid (HA), or its derivatives (the “Products”) developed by LICENSOR.

EDESA is a pharmaceutical company having expertise in the discovery, development, manufacturing and commercialization of innovative human pharmaceutical products.

EDESA and LICENSOR desire to enter into an agreement under which EDESA will obtain exclusive rights to develop and commercialize the Products for therapeutic, prophylactic and diagnostic uses in all applications other than those covered in the Yissum License Agreement (as defined below) (the “Field”).

“Adverse Event” shall mean any undesirable medical occurrence in a patient or clinical investigation subject administered the Product that must be reported to the relevant Regulatory Authority and which does not necessarily have to have a causal relationship with the Product, or the equivalent of the foregoing under Applicable Law in the relevant jurisdiction.

“Affiliate” means with respect to a Party, any person or entity controlling, controlled by or under common control with such Party. For purposes of this Section 1.2 only, “control” shall mean: (a) in the case of a corporate entity, direct or indirect ownership of fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of such corporate entity; and (b) in the case of an entity that is not a corporate entity, the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.

“Applicable Law” means the laws, rules, statutes, orders, ordinances, regulations, written guidance and written guidelines having binding effect, and other written requirements of any Governmental Authority that having binding effect and may be in effect from time to time and that are applicable to a Party or a Party’s activities under this Agreement.

“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

“Calendar Year” means the respective periods of twelve (12) months commencing on January 1 and ending on December 31.

“Claimant” has the meaning set forth in Section ‎13.15.

“Clinical Material(s)” means the Product formulated in accordance with the Specifications and Applicable Law in the relevant jurisdiction: (a) for preclinical activities; and (b) for administration to subjects in Clinical Trials.

“Clinical Trial(s)” means clinical trials (as defined in the Applicable Law in the relevant jurisdiction) with respect to the Product in the Field.

“Commercialization” or “Commercialize” means activities undertaken after obtaining Regulatory Approval relating specifically to the launch, promotion, marketing, sales force recruitment, pricing determination, sale, use and distribution of a pharmaceutical product and post-launch medical activities, including: (a) manufacturing and distribution for commercial sale, (b) strategic marketing, sales force detailing, advertising, and market and product support; (c) medical education and liaison; (d) all customer support and product distribution, invoicing and sales activities; (e) all post-Regulatory Approval regulatory activities, including those necessary to maintain Regulatory Approvals; (f) target product profile, pricing, formulary and reimbursement related activities including pricing and reimbursement approvals; and (g) organizing formulary access and drug distribution.

“Confidential Information” has the meaning set forth in Section ‎8.1.

“Control,” “Controls” or “Controlled by” means (except as used in Section 1.2), with respect to any item of or right under the Licensed Technology, the ability of a Party (whether through ownership or license, other than pursuant to this Agreement) to grant access to, or a license or sublicense of, such item or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to grant the other Party such access or license or sublicense.

“demand for arbitration” has the meaning set forth in Section ‎13.15.

“Develop” or “Development” or “Developing” means research, discovery, process development, manufacturing for preclinical and clinical uses, preparation for drug reimbursement, preparation and initiation of medical education and liaison activities and preclinical and clinical drug or biological development activities, including test method development and stability testing, toxicology, formulation, quality assurance/quality control development, statistical analysis, preclinical and clinical studies and regulatory affairs, Regulatory Approval and registration, in each case, of a Product for use in the Field.

“DTAA” means the Convention between the Government of Canada and the Government of the State of Israel for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with respect to Taxes on Income.

“EDESA Data” means any scientific, technical, clinical or regulatory information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, filings, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological data, data and results arising from the conduct of Clinical Trials, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data that: (a) are conceived, discovered, invented, made or first reduced to practice by, or on behalf of, EDESA on or after the Effective Date; and (b) are related to the Product (or a composition containing the Product or the manufacturing or use of the Product).

“EMA” means the European Medicines Agency or any successor agency thereto.

“FDA” means the United States Food and Drug Administration or any successor agency thereto.

“Field” has the meaning ascribed to it in the recitals.

“First Commercial Sale” means, with respect to a Product in the Field, the first sale to a Third Party for end use or consumption of such Product in the Field in a country in the Territory after Regulatory Approval of such Product in the Field has been granted by the Regulatory Authority of such country, but excluding sales made under special access or similar program authorized by an applicable Regulatory Authority.

“Governmental Authority” means any supranational, national, federal, state, provincial, country, city or local government or any agency, department, authority, court, or other instrumentality thereof, including any Regulatory Authority.

“IFRS” means International Financial Regulatory Standards as the same may be in effect from time to time.

“IND” means an Investigational New Drug application in the United States, a Clinical Trial Application in Canada, or a foreign equivalent application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

“Indication” means any separate and distinct disease (or stage of disease), disorder or medical condition in humans or non-human animals which a Product is intended to treat, prevent, diagnose, monitor or ameliorate and which, for a Product candidate, is intended to be reflected in the labeling for such Product as an approved indication, and which, for an approved Product, is reflected in the labeling for such Product.

“Information” means any and all scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information and data related to the Product, in any tangible or intangible form.

“Knowledge” shall mean actual knowledge of any of the current officers of the Party gained in the regular course of the relevant Party's business.

“Licensed Technology” means:

all Patents;

any proprietary scientific, technical, clinical or regulatory information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, filings, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological data, clinical trial data, analytical and quality control data, stability data, studies and procedures (including any data submitted as part of the IND), and manufacturing process and development information, results and data; and

any proprietary biological, chemical or physical materials (including any active pharmaceutical ingredient);

LICENSOR Indemnitee(s)” has the meaning ascribed to it in Section ‎10.1

“NDA” or “New Drug Application” means an application submitted to FDA pursuant to 21 U.S.C. § 505(b) or a Canadian or foreign equivalent application or submission to a Regulatory Authority under Applicable Law in the relevant jurisdiction which contains complete details of the manufacture and testing of a new drug, for purposes of obtaining Regulatory Approval for such new drug in the applicable jurisdiction, for a particular Indication, and also includes a Biologics License Application.

“Net Sales” means the gross amount invoiced, billed and collected by EDESA or its Affiliates to unrelated Third Parties (excluding any Sublicensee) for the Product in the Territory, less:

Trade, quantity and cash discounts actually allowed or paid;

Commissions, discounts, refunds, rebates (including wholesaler fees), chargebacks, retroactive price adjustments, and any other allowances actually allowed or paid which effectively reduce the net selling price;

Actual Product returns and allowances;

Any sales, use, excise, value added taxes or similar taxes measured by the billing amount, when included in billing;

Any freight, postage, shipping, and insurance charges related to delivery of the Product from an applicable warehouse, all to the extent included in the third party invoices; and

custom, import and export duties actually paid.

“Patent(s)” means:

all patents and patent applications in any country or supranational jurisdiction; and

any provisionals, substitutions, divisions, continuations, continuations in part, reissues, renewals, registrations, confirmations, reexaminations, extensions, supplementary protection certificates and the like, of any such patents or patent applications;

“Products” has the meaning ascribed to it in the recitals.

“Regulatory Approval(s)” means all approvals or authorizations by Regulatory Authorities necessary to market and sell the Product in the Field in the Territory.

“Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the conduct of Clinical Trials or for an NDA in the Territory, including in the United States, the FDA, and in Canada, Health Canada.

“Respondent” has the meaning set forth in Section ‎13.15(b).

“Royalties” has the meaning set forth in Section ‎6.2.

“Specifications” means the specifications for the Product as provided by LICENSOR as part of the Licensed Technology.

“Sublicensee” means a Third Party that is granted a sublicense under the licenses granted to a Party under this Agreement.

“Sublicensing Fees” has the meaning set forth in Section ‎6.2.

“Sublicensing Revenue” means the net amount of all revenues, royalties, receipts, and monies, including upfront payments, milestone payments, and license fees, earned or received by EDESA and its Affiliate(s) from Sublicensee(s) with respect to the Product.

“Term” has the meaning set forth in Section ‎12.1.

“Territory” means the entire world.

“Third Party” means an entity other than: (a) EDESA and its Affiliates; and (b) LICENSOR and its Affiliates.

“United States” means the United States of America and its territories and possessions, including the Commonwealth of Puerto Rico and the U.S. Virgin Islands.

“Yissum License Agreement” means the Exclusive License Agreement entered into by EDESA and Yissum Research Development Company of the Hebrew University of Jerusalem dated June 29, 2016, as amended by the First Amendment to the Exclusive License Agreement dated April 3, 2017 and the Second Amendment to the Exclusive License Agreement dated May 7, 2017.

Within sixty (60) days of the Effective Date, the Parties will meet (in person or through other means) and work in good faith to create a mutually agreeable plan for the Development of the Product by EDESA (the “Development Plan”), including development targets (the “Development Targets”). EDESA shall be responsible for executing the Development Plan and will allocate the time and resources required to do so. EDESA shall periodically prepare an update to the Development Plan and deliver same to LICENSOR within sixty (60) days following each twelve (12) month anniversary of the execution of this Agreement and shall keep LICENSOR reasonably informed concerning the Development Plan, its progress and its results on an oral basis.

The Parties will meet (in person or through other means) and work in good faith to amend and adjust the Development Plan as needed, in good faith judgment, in order to improve EDESA’s ability to meet the Development Targets. Notwithstanding the foregoing or anything to the contrary in this Agreement, EDESA shall not be entitled to change the Development Targets or the time frames for achieving the Development Targets without LICENSOR’s prior written consent which shall not be unreasonably withheld. Such consent shall not be required in connection with a Development Target delayed or revised due to an action, decision, recommendation or position taken by a Regulatory Authority to the extent that EDESA continues to actively and continuously invest the required financial resources to meet the respective Development Target, as confirmed to LICENSOR in writing by EDESA’s senior management.

An EDESA representative and LICENSOR shall meet or conduct a teleconference (at their election) no less than once every Calendar Year during the term of this Agreement commencing with the Effective Date, at locations and times to be mutually agreed upon by the Parties, (i) to review the progress being made under the Development Plan and the progress being made in any other research and development activities conducted by EDESA, its Affiliates and Sublicensees relating to Products, (ii) to review and agree upon any necessary or desired revisions to the then current Development Plan, (iii) to review the progress being made towards fulfilling the Development Targets and (iv) to discuss intended efforts for fulfilling such targets.

EDESA will keep and maintain (and to the extent applicable, will cause its Affiliates, and their respective Sublicensees, assignees and transferees to keep and maintain) proper and complete records and books of account in such form and detail as is necessary for the determination of the amounts payable by EDESA (on behalf of itself and its Affiliates and their respective Sublicensees, assignees and transferees) to LICENSOR under this Agreement and for the purposes of this Agreement.

Upon the written request of LICENSOR and not more than once in each Calendar Year, EDESA shall permit an independent certified public accounting firm of nationally recognized standing in the United States (that has been retained on an hourly or flat fee basis and receives no contingency fee or other bounty or bonus fee) selected by LICENSOR, at LICENSOR’s expense, to have access during normal business hours to such of the records of EDESA as may be reasonably necessary solely to verify the accuracy of the royalty reports hereunder for any Calendar Year ending not more than thirty six (36) months prior to the date of such request. This right to audit shall remain in effect throughout the life of this Agreement and for a period of three (3) years after the termination of this Agreement.

LICENSOR shall share the accounting firm’s final written report with EDESA within thirty (30) days of its receipt by LICENSOR. If such accounting firm identifies a discrepancy by EDESA made during such period, EDESA shall pay LICENSOR the amount of the discrepancy within thirty (30) days of the date LICENSOR delivers to EDESA such accounting firm’s written report so concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by LICENSOR unless the underpayment exceeded ten percent (10%) of the amount owed by EDESA to LICENSOR for such Calendar Year, in which case, EDESA shall pay to LICENSOR the reasonable fees charged by such accounting firm which fees shall not exceed $25,000. EDESA shall pay interest on the amounts owed to LICENSOR, and said interest shall be calculated as being 2% greater than the U.S. commercial prime rate as published by the Wall Street Journal on the date of the first discrepancy identified in the audit, and shall accrue from the date payments should have been made.

EDESA shall include in each sublicense granted by it pursuant to this Agreement a provision requiring the Sublicensee to make reports to EDESA, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by LICENSOR’s independent accountant to the same extent required of EDESA under this Agreement.

LICENSOR shall treat all financial information subject to review in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with EDESA, its Affiliates or Sublicensees, as applicable obligating it to retain all such information in confidence pursuant to such confidentiality agreement.

Except as provided in this Section ‎8.1, all confidential or proprietary information disclosed by one Party or any of its Affiliates to the other Party or any of its Affiliates hereunder in connection with this Agreement, whether disclosed or provided prior to or after the Effective Date and whether provided orally, visually, electronically or in writing, shall be maintained in confidence by the receiving Party and shall not be disclosed to any Third Party or used for any purpose except as set forth herein without the prior written consent of the disclosing Party, until [_____] ([__]) years following the Term of this Agreement, except to the extent that such Information: [Length of non-disclosure obligations omitted as competitively sensitive information.]

is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party under a confidentiality agreement, as documented by the receiving Party’s business records;

is or becomes part of the public domain through no fault of the receiving Party;

is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or

is developed by the receiving Party independently of Information received from the disclosing Party, as documented by the receiving Party’s business records.

Each Party may disclose Confidential Information of the other Party, without such other Party's prior written consent, to its and its Affiliates' directors, officers, employees, agents, consultants, Sublicensees, suppliers, and other persons or entities who:

need to know such Confidential Information to assist the Party in fulfilling its obligations hereunder; and

are bound by written confidentiality and non-use obligations consistent with those the Party uses to protect its own Confidential Information.

Each Party shall promptly disclose to the other Party the nature and scope of any breach of this provision by it, or its Affiliates, directors, officers, employees, agents, consultants, Sublicensees, suppliers, or other persons or entities permitted hereunder and the steps taken to contain and address the breach, and shall be liable to the other Party for any breach of this Article 8 caused by any of the aforesaid, as applicable.

Each Party may also disclose the Confidential Information of the other Party, without such other Party's prior written consent, to any person, entity, stock exchange or government or Regulatory Authority to the extent that the law requires such disclosure, including filings pursuant to applicable securities or tax laws and regulations. The Party disclosing such Confidential Information shall take such actions as are reasonable to preserve the confidentiality of such Confidential Information, such as requesting confidential treatment. In addition, EDESA may also disclose LICENSOR's Confidential Information, without the LICENSOR's prior written consent, to any person, entity, or government or Regulatory Authority to the extent that such disclosure is necessary for obtaining, maintaining, or amending any Regulatory Approvals, seeking approval for reimbursement or pricing of a Product in the Territory or satisfying any other regulatory obligation regarding the Product, or seeking or obtaining consent from a participant in a Clinical Trial. Each Party may also disclose the Confidential Information of the other Party, without such other Party's prior written consent, pursuant to an order of a Regulatory Authority or court of competent jurisdiction, provided that it: (i) promptly notifies the other Party of the required disclosure in order to provide such Party an opportunity to take legal action to prevent or limit such disclosure and, if asked, reasonably assists the other Party in pursuing such action; and (ii) shall only disclose the Confidential Information to the minimum extent required by law.

At its sole discretion, EDESA may publicly disclose the execution and material terms of this Agreement and, from time to time, milestones achieved and activities conducted hereunder. No disclosure of the existence of, or the terms of, this Agreement or activities conducted hereunder, may be made by LICENSOR without the prior express written permission by EDESA. However, that no approval of EDESA shall be required if a subsequent public disclosure solely discloses the information that: (1) a milestone under this Agreement has been achieved and/or any payments associated therewith have been received; (2) the filing and/or Regulatory Approval of the NDA with the FDA or the EMA generally has occurred (provided, however, that specific dates of filing shall not be disclosed); (3) commercial launch of the Product in any country, or (4) any information that has previously been approved and disclosed as permitted by this Section ‎8.2. Except as otherwise provided in this Section ‎8.2(a), neither Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity or news release relating to this Agreement or its subject matter, without the prior express written permission of the other Party.

Notwithstanding the terms of this ‎Article 8, either Party shall be permitted to disclose the existence and terms of this Agreement, to the extent required, in the reasonable opinion of such Party’s legal counsel, to comply with applicable laws, rules or regulations, including the rules and regulations promulgated by securities law regulatory agencies or any other governmental agency or applicable stock exchange on which a Party’s stock may be listed.

Either Party may also disclose the existence and terms of this Agreement to its legal counsel, investment bankers, accountants and advisors, and to potential Sublicensees, Third Party contractors, investors, lenders or acquirers, and their legal counsel, investment bankers, accountants and advisors, in each case under an agreement or in the case of legal counsel, a professional obligation, to keep the terms of this Agreement confidential under terms of confidentiality and non-use substantially similar to the terms contained in this Agreement and to use such Confidential Information solely for the purpose permitted pursuant to this Section ‎8.2(c).

LICENSOR has the full right, power and authority to enter into this Agreement, to perform its obligations under this Agreement, and to grant the license granted under Section ‎7.1, and the fulfillment of its obligations and performance of its activities hereunder do not materially conflict with, violate, or breach or constitute a default under any material contractual obligation or court or administrative order by which LICENSOR is bound;

there are no legal claims, judgments or settlements against or owed by LICENSOR or to the Knowledge of LICENSOR, pending legal claims or litigation, in each case relating to the Product, the LICENSOR or Licensed Technology;

all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by LICENSOR as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained;

LICENSOR is the exclusive legal and beneficial owner of the Patents listed in Appendix A.

LICENSOR Controls the right, title and interest in and to the Licensed Technology that it purports to Control, and has the right to grant to EDESA the licenses that it purports to grant hereunder and has not granted any Third Party rights that would interfere or be inconsistent with EDESA’s rights hereunder;

there is no action, suit, inquiry, investigation or other proceeding ongoing, or to the Knowledge of LICENSOR, threatened or pending, brought by any Third Party that alleges the use of the Licensed Technology or the Development and/or Commercialization of the Product would infringe or misappropriate the intellectual property or intellectual property rights of any Third Party (and it has not received any notice alleging such an infringement or misappropriation). In the event that LICENSOR becomes aware of any such action or proceeding, it shall promptly notify EDESA in writing;

to the Knowledge of LICENSOR, the use of the Licensed Technology or the Development and/or Commercialization of the Product will not infringe or misappropriate the intellectual property or intellectual property rights of any Third Party;

LICENSOR does not have any current knowledge that would cause any of its representations or warranties to EDESA to be incorrect or untrue.

it has the full right, power and authority to enter into this Agreement, to perform its obligations under this Agreement and the fulfillment of its obligations and performance of its activities hereunder do not materially conflict with, violate, or breach or constitute a default under any material contractual obligation or court or administrative order by which EDESA is bound;

all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by EDESA as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained;

EDESA does not have any current knowledge that would cause any of its representations or warranties to LICENSOR to be incorrect or untrue;

to the Knowledge of EDESA, neither EDESA nor any of its Affiliates, nor any of its employees or agents (i) is debarred, excluded, suspended, proposed for debarment or otherwise ineligible for participation in any federal, state or provincial health care program; (ii) has been convicted of or had a civil judgment rendered against it for commission of fraud or a criminal offense; and (iii) is presently indicted for or otherwise criminally or civilly charged by a governmental entity or agency with commission of any of the offenses set out in this paragraph;

EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

LICENSOR MAKES NO EXPRESS OR IMPLIED WARRANTIES THAT ANY FREEDOM TO OPERATE (FTO) SEARCH WAS MADE OR CONDUCTED BY OR ON BEHALF OF LICENSOR IN RELATION TO ANY AND ALL PATENTS. IN ADDITION, NOTHING IN THIS AGREEMENT MAY BE DEEMED A REPRESENTATION OR WARRANTY BY LICENSOR AS TO THE ACCURACY, SAFETY, EFFICACY, OR USEFULNESS, FOR ANY PURPOSE, OF THE LICENSED TECHNOLOGY, WHICH IS BEING LICENSED TO EDESA STRICTLY ON AN "AS IS" BASIS. LICENSOR HAS NO OBLIGATION, EXPRESS OR IMPLIED, TO SUPERVISE, MONITOR, REVIEW OR OTHERWISE ASSUME RESPONSIBILITY FOR THE PRODUCTION, MANUFACTURE, TESTING, MARKETING OR SALE OF ANY PRODUCT. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, TO THE EXTENT PERMITTED BY APPLICABLE LAW, NEITHER LICENSOR, NOR THE REPRESENTATIVES OF LICENSOR SHALL HAVE ANY LIABILITY WHATSOEVER TO EDESA, AN AFFILIATE OR A SUBLICENSEE, OR TO ANY THIRD PARTY FOR OR ON ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE WHETHER DIRECT OR INDIRECT, SUSTAINED BY EDESA, AN AFFILIATE OR A SUBLICENSEE, OR BY ANY THIRD PARTY, FOR ANY DAMAGE ASSESSED OR ASSERTED AGAINST EDESA, OR FOR ANY OTHER LIABILITY INCURRED BY OR IMPOSED UPON EDESA OR ANY OTHER PERSON OR ENTITY, DIRECTLY OR INDIRECTLY ARISING OUT OF OR IN CONNECTION WITH OR RESULTING FROM THIS AGREEMENT AND/OR THE EXERCISE OF THE LICENSE, INCLUDING, (i) THE PRODUCTION, MANUFACTURE, USE, PRACTICE, LEASE, OR SALE OF ANY PRODUCT; (ii) THE USE OF THE LICENSED TECHNOLOGY; OR (iii) ANY ADVERTISING OR OTHER PROMOTIONAL ACTIVITIES WITH RESPECT TO ANY OF THE FOREGOING.

Notice. Each Party shall promptly provide, but in no event later than forty-five (45) days, the other with written notice reasonably detailing any known or alleged infringement or misappropriation of any Licensed Technology.

Enforcement of Intellectual Property Rights. EDESA shall have the right, but not the obligation, to institute and direct legal proceedings against any Third Party believed to be infringing or misappropriating or otherwise violating the Licensed Technology. LICENSOR agrees to co-operate to the extent reasonably necessary, including signing of all necessary documents to vest in EDESA the right to start such legal proceedings, provided that all the direct and indirect costs and expenses of bringing and conducting the legal proceedings are paid by EDESA (except for the expenses of LICENSOR’s counsel, if any). All amounts recovered by EDESA as the result of such legal proceedings will accrue to the benefit of EDESA, provided that, after deduction of EDESA’s costs and expenses of legal proceedings, such amounts awarded as compensation for lost sales revenue will be included in EDESA’s Sublicensing Revenue if the action occurs in any country in the territory EDESA does not directly commercialize the Product and treated as Net Sales in any country in the Territory that EDESA commercializes the Product upon which Royalties will be paid to LICENSOR.

Each Party shall notify the other in writing of any allegations it receives from a Third Party that the Development or Commercialization of the Product or use of the Licensed Technology infringes the intellectual property rights of such Third Party. Such notice shall be provided promptly, but in no event after more than forty five (45) days, following receipt of such allegations.

In the event that a Party receives notice that it or any of its Affiliates have been individually named as a defendant in a legal proceeding by a Third Party alleging infringement of a Third Party’s patents or other intellectual property right as a result of the Development or Commercialization of the Product or use of the Licensed Technology, such Party shall immediately notify the other Party in writing and in no event notify such other Party later than forty five (45) days after the receipt of such notice. Such written notice shall include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Each Party shall assert and not waive the joint defense privilege with respect to all communications between the Parties reasonably the subject thereof. In such event, the Parties shall agree how best to mitigate or control the defense of any such legal proceeding; provided however, that EDESA shall assume the primary responsibility for the conduct of the defense of any such claim that is specific to the Field, at EDESA’s expense, and LICENSOR shall assume the primary responsibility for the conduct of the defense of any other such claim, at LICENSOR’s expense. Notwithstanding the foregoing, LICENSOR may forego assuming the primary responsibility for the conduct of the defense of any such claim outside the Field, in which case EDESA shall have the right, but not the obligation, to assume such primary responsibility at its own expense. The Party that does not assume primary responsibility for the conduct of the defense shall have the right, but not the obligation, to participate and be separately represented in any such suit at its sole option and at its own expense. Each Party shall reasonably cooperate with the Party conducting the defense of the claim. If a Party or any of its Affiliates have been individually named as a defendant in a legal proceeding relating to the alleged infringement of a Third Party’s patents or other intellectual property right as a result of the Development or Commercialization of the Product, the other Party shall be allowed to join in such action, at its own expense.

Status; Settlement. The Parties shall keep each other informed of the status of and of their respective activities regarding any litigation or settlement thereof initiated by a Third Party concerning the Development or Commercialization of the Product or the Licensed Technology; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this subsection ‎11.5(c) may be undertaken by a Party without the consent of the other Party which consent shall not be unreasonably withheld or delayed.

Breach. This Agreement may be terminated upon written notice by either Party if the other Party has materially breached its obligations under this Agreement and has not cured such breach within forty-five (45) days of receipt of written notice of such breach by the other Party.

Bankruptcy. This Agreement may be terminated upon written notice by either Party if the other Party (i) makes a general assignment for the benefit of creditors; (ii) files any petition, or commences any proceeding voluntarily, for any relief under any bankruptcy or insolvency laws or any law relating to the relief of debtors; (iii) consents to the entry of an order in an involuntary bankruptcy or insolvency case; (iv) is the subject of an order or decree for relief against it by a court of competent jurisdiction in an involuntary case under any bankruptcy or insolvency laws or any law relating to the relief of debtors, which order or decree is unstayed and in effect for a period of 60 consecutive days; (v) is subject to appointment, with or without its consent, of any receiver, liquidator, custodian, assignee, trustee, sequestrator or other similar official of such other Party or any substantial part of its property; or (vi) admits in writing of its inability to pay its debts generally as they become due.

Failure to Develop or Commercialize. If LICENSOR alleges that EDESA has failed to use commercially reasonable efforts to Develop or Commercialize the Product, LICENSOR shall notify EDESA of its intention to terminate this Agreement. EDESA shall have three hundred and sixty days (360) from receipt of notification from LICENSOR to demonstrate and satisfy LICENSOR that commercially reasonable efforts are being used by EDESA to Develop and Commercialize the Product, and if EDESA fails to demonstrate and satisfy LICENSOR that commercially reasonable efforts are being used by EDESA to Develop and Commercialize the Product, then LICENSOR may terminate this Agreement.

Upon the termination of this Agreement, then:

The license granted to EDESA under Section ‎7.1 and any sublicenses that have been granted to a Sublicensee with respect to Licensed Technology shall terminate.

Unless the Parties agree otherwise, all activities underway at the time of termination shall be terminated as soon as possible except for winding down activities (including such activities in connection with any Clinical Trials) (the cost of which shall continue to be borne by EDESA as provided in this Agreement until completion of such activities in the normal course). For the sake of clarity, the costs of winding down activities shall include any incurred costs or otherwise unavoidable wind down costs that would otherwise have been payable by EDESA.

Unless this Agreement is terminated by EDESA pursuant to Section 12.2(a) or 12.2(b), EDESA shall transfer and assign to LICENSOR, upon LICENSOR’s request, all of the EDESA Data and any patent applications and issued patents relating to the Product owned by EDESA (the “EDESA Assigned IP”), provided that LICENSOR pays all reasonable, out-of-pocket expenses actually incurred by EDESA in connection with such transfer and assignment. EDESA shall fully cooperate with the LICENSOR to effect such transfer and assignment and shall execute any document and perform any acts required to do so. The EDESA DATA SHALL BE PROVIDED ON AN "AS IS, WHERE IS" BASIS WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES AS TO THE FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY OR CONDITION OR AS TO THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON OR AS TO ANY OTHER MATTER.

For the avoidance of doubt, the Parties acknowledge and agree that neither the termination of this Agreement for any reason nor the assignment contemplated by Section 12.4(a)(iii) will derogate from the force and effect of, or otherwise limit EDESA rights under, the Exclusive License Agreement entered into by EDESA and Yissum Research Development Company of the Hebrew University of Jerusalem dated June 29, 2016, as amended by the First Amendment to the Exclusive License Agreement dated April 3, 2017 and the Second Amendment to the Exclusive License Agreement dated May 7, 2017.

Without derogating from the force and effect of the foregoing assignment undertaking in Section 12.4(a)(iii), the Parties acknowledge and agree that if under applicable law the aforesaid assignment undertaking will not be fully enforceable, then the part (if any) of such undertaking which is enforceable shall remain in full force and effect, and the part (or whole) which is not enforceable shall be automatically replaced with an irrevocable grant by EDESA to LICENSOR, binding upon all of EDESA’S acquirers, successors and assignees, of an unrestricted, perpetual, irrevocable, world-wide, royalty-free, exclusive license to use, exploit, transfer and sub-license (on a multi-tier basis) the EDESA Assigned IP for any and all purposes and uses. To the extent permitted by applicable law, such license will be exclusive. Notwithstanding anything to the contrary in Section 8 or elsewhere in this Agreement, LICENSOR (on its own or via third parties) shall be entitled to freely exploit the EDESA Assigned IP without any obligation of confidentiality to EDESA.

Notwithstanding anything to the contrary in this Section ‎12.4, if this Agreement is terminated by EDESA pursuant to Section ‎12.2 or ‎12.3, EDESA shall have the right to sell its remaining inventory of Product(s) so long as EDESA has fully paid, and continues to pay fully when due, any and all Royalties and Sublicensee Fees owed to LICENSOR hereunder based on such sales.

Following any termination of this Agreement by LICENSOR, LICENSOR shall pay to EDESA [__] percent ([__]%) of the amounts received by LICENSOR or its Affiliates as royalties or sublicensing fees arising from the license of the EDESA Assigned IP to a Third Party, up to a maximum amount equal to twice the documented amount EDESA has expended on the Development or Commercialization of the Product in order to generate the EDESA Assigned IP as certified by external independent auditors agreed upon by the Parties, less any amounts received or receivable by EDESA from Third Parties in connection with the Licensed Technology or the EDESA Assigned IP prior to the transfer of the EDESA Assigned IP to EDESA. In furtherance of EDESA’s right under this Section ‎12.4(vi), LICENSOR shall provide prompt notice to EDESA upon the Commercialization of any products incorporating the EDESA Assigned IP by LICENSOR or its Affiliate and upon execution of any such license and shall thereafter provide to EDESA written reports for each Calendar quarter and each Calendar Year; each such report showing in relation to the reporting period, as applicable: the net sales of any products incorporating the EDESA Assigned IP and any the royalties and sublicensing fees received by LICENSOR under such license. Reports in respect of a Calendar Quarter shall be due on the thirtieth (30th) day following the close of such Calendar Quarter and annual reports shall be due on the sixtieth (60th) day following the close of such Calendar Year. Royalties and sublicensing fees shown to have been received in each report shall be due and payable by LICENSOR on the date such report is due. LICENSOR shall keep complete and accurate records in sufficient detail to enable the revenue sharing payments payable by LICENSOR and its Affiliates and the royalties and sublicensing fees received by LICENSOR under such license to be determined and EDESA shall have the right to audit such records on terms consistent with those set forth in Section ‎6.4 of this Agreement. For purposes of this Section ‎12.4‎(vii): (x) the term “net sales” shall have the same meaning as set forth on this Agreement, but replacing references to “EDESA” with “LICENSOR” and “Product” with “products incorporating the EDESA Assigned IP”; (y) the term “sublicensing fees” in relation to amounts received from Third Parties shall have the same meanings as are set forth in this Agreement, but replacing references to “EDESA” with “LICENSOR” and “Product” with “products incorporating the EDESA Assigned IP”. [Percentage omitted as competitively sensitive information.]

Any controversy, claim or dispute arising out of or relating to this Agreement shall first be submitted to the CEO of each Party for attempted resolution. If the CEOs of the Parties do not resolve such matter within thirty (30) days of the matter being submitted to them, then such matter shall be resolved through binding arbitration as follows. For the sake of clarity, this Section ‎13.15 is not intended to alter the rights of the Parties as established by Section ‎13.6, herein. The dispute shall be resolved by final and binding arbitration. The place of arbitration shall be London, England. The arbitration shall be in accordance with the rules of LCIA except as modified herein. The number of arbitrators shall be three. The language of the arbitration shall be English.

The Party wishing to commence an arbitration (“Claimant”) shall notify the other party (“Respondent”) in writing of its decision to commence arbitration hereunder (sometimes referred to in this Agreement as its “demand for arbitration”), setting out briefly its claims in its notice, and with its notice, name the arbitrator it is appointing.

The Respondent shall, within thirty (30) days of receipt of a demand for arbitration, notify the Claimant in writing of the name of the arbitrator it is appointing.

The third arbitrator shall be chosen by the first two arbitrators within twenty (20) days after the second of such arbitrators was appointed.

All arbitrators shall be chosen taking into account the type of issues to be addressed in the arbitration, whether legal, business, scientific, or a combination thereof, and having regard to their availability to conduct the arbitration within the times provided below.

Within thirty (30) days of completion of the hearing, the arbitrators shall render a reasoned arbitration award describing, in writing, the essential finding and conclusions on which the decision is based, including the calculation of any damages awarded. Any monetary award shall be made within thirty (30) days of the rendering of such award.

All information and documents in relation to the arbitration shall be deemed Confidential Information to the full extent permitted by law. No individual shall be appointed as an arbitrator unless the individual first agrees in writing to be bound by this subsection and to conduct the arbitration in a manner that in his/her judgment is most likely to maintain the confidentiality of Confidential Information. Neither Party may retain any expert in connection with the arbitration unless the expert first agrees in writing to be bound by this subsection, as applicable. The fact of and subject matter of the arbitration, including the fact that any dispute has been submitted to arbitration, and all evidence given and submissions made in connection with any arbitration, shall be Confidential Information, and shall be treated as such by the Parties and all persons employed by or contracted to them. Any meetings, conferences or hearings in connection with or during the arbitration may be attended only by those individual persons whose presence, in the opinion of the arbitral tribunal, is reasonably necessary for the determination or other resolution of the dispute and such person first agrees in writing to be bound by the provisions of these sections, as applicable. The obligations under this subsection continue notwithstanding any determination or other resolution of the arbitration.

The arbitrators shall be paid reasonable fees plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:

If the arbitrators rule in favour of one Party on all disputed issues in the arbitration, the losing Party shall pay 100% of such fees and expenses.

If the arbitrators rule in favour of one Party on some issues and the other Party on other issues, the arbitrators shall issue with the ruling a written determination as to how such fees and expenses shall be allocated between the Parties. The arbitrators shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the arbitration, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.

Any final award of the arbitrators shall be final, conclusive and binding on the Parties, and judgment may be entered in any court of competent jurisdiction. To the extent lawful, the Parties exclude any right of review or appeal to Canadian, United States, English, Israeli or other courts, including in connection with any question of law arising in the arbitration or in connection with any award or decision made by the arbitrators, except as is necessary to recognize or enforce such award or decision.