Document:

Clinical Agreement, between EndoResearch Inc. and University of Kansas

 Exhibit 10.10 
 KUMCRI – Fernand Labrie, M.D., Ph.D. Clinical Supply Agreement for Acolbifene 
 CLINICAL SUPPLY AGREEMENT 
 between Endorecherche Inc. and the 
 University of Kansas Medical Center Research
Institute, Inc. 
 for Acolbifene 
 AGREEMENT 
 The following agreement serves as the basis for the distribution of Acolbifene by the University
of Kansas Medical Center Research Institute, Inc. (KUMCRI) for “Phase II Study of Acolbifene in Women at High Risk for Breast Cancer”, referred to hereunder as “the Study”, which will be conducted by Carol J, Fabian, M.D.
and will be funded by NCI via a contract to the University of Wisconsin Chemoprevention Consortium. 
 Article 1. Definitions 
 “Affiliates” means any corporation or other business entity controlled by, controlling, or under common control with Collaborator (see
“Collaborator”). For this purpose, a business entity shall be deemed to “control” another business entity if it (a) owns, directly or indirectly, fifty percent (50%) or more of the outstanding voting securities or other
ownership interest of such other business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity), or (b) otherwise possesses, directly or indirectly, the power to direct the
management or policies of such other business entity, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance. 
 “Agent” means Acolbifene, proprietary to Endorecherche, Inc. , 
 “Annual Report”
means a brief report of the progress of an IND-associated investigation which the IND sponsor is required to submit to the FDA within 60 days of the anniversary date that the IND went into effect (pursuant to 21 CFR 312.33). 
 “Clinical Data and Results” means all information, data, and results developed or obtained in connection with clinical trials conducted within the scope
of this Agreement. 
 “Collaborator” means Endorecherche, Inc., having a principal place of business at 2989 de la Promenade,Quebec City,
(Quebec) G1W 2J5, Canada 
 “CTEP” means the Cancer Therapy Evaluation Program, DCTD, NCI.  
 “DCTD” means the Division of Cancer Treatment and Diagnosis, NCI.  
 “DHHS” means the Department of Health and Human Services. 
  

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 KUMCRI – Fernand Labrie, M.D., Ph.D. Clinical Supply Agreement for Acolbifene 
 “FDA” means the Food and Drug Administration, DHHS.  
 “Government” means the U.S. Government and any of its agencies. 
 “Human Subjects” means individuals whose
physiologic or behavioral characteristics and responses are the objects of study in a research project. Under the Federal regulations for the protection of human subjects, human subjects are defined as living individuals about whom an investigator
conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information (45 CFR 46.102(f)). 
 “KUMCRI” means the University of Kansas Medical Center Research Institute, Inc., located in Kansas City, Kansas, U.S.A. 
 “Multi-Party Data” means clinical data which is collected from clinical studies sponsored by NCI for combinations of proprietary agents supplied by more than one Collaborator. 
 “NCI” means the National Cancer Institute, NIH, DHHS. 
 “NIH” means the National Institutes of Health, PHS, DHHS. 
 “PHS” means the Public Health Service, DHHS.

 “PMB” means Pharmaceutical Management Branch, CTEP, DCTD, NCI. 
 “Proprietary / Confidential Data” means confidential scientific, business or financial data, provided that such data: 
  

	 	i.	are not publicly known or available from other sources who are not under a confidentiality obligation to the source of the information; 

  

	 	ii.	have not been made available by its owners to others without a confidentiality obligation; 

  

	 	iii.	are not already known by or available to the receiving Party without a confidentiality obligation; and 

  

	 	iv.	do not relate to potential hazards or warnings associated with the production, handling or use of the subject matter of this Agreement. 

 If any one or more of the above provisions of this definition are not met, the relevant information shall no longer be considered proprietary. 

“Raw Data” means the primary quantitative and empirical data first collected by the investigators from clinical trials conducted under the scope of
this Agreement. 
  

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 KUMCRI – Fernand Labrie, M.D., Ph.D. Clinical Supply Agreement for Acolbifene 
 “Regulatory Affairs Branch” means the Regulatory Affairs Branch, CTEP, DCTD, NCI. 
 “Summary Data” means a summary of the Raw Data which will be made available to KUMCRI, which summary is used by KUMCRI to prepare an Annual Report to the FDA. 
 Article 2. Adverse Events (this section should be modified for commercial reporting) 
 KUMCRI shall report all serious or unexpected Grade 4 and Grade 5 adverse events that emerge during this study to FDA as described in the NCI Investigator’s Handbook and will, concurrently, forward all such
reports to Collaborator or the Alternate Collaborator contact. In the event that Collaborator informs the FDA of any serious or unexpected adverse events, Collaborator must notify the KUMCRI at the same time. KUMCRI shall conduct or have conducted
the Study in accordance with all applicable federal, state and local laws, regulations and guidelines, including but not limited to, the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder (“the Act”),
and FDA regulations governing the protection of human subjects and governing clinical investigators. 
 Article 3. Drug Information and Supply

 Collaborator agrees to provide to KUMCRI, without charge, the Investigational labeled Agent in sufficient quantity to complete the protocol sponsored
by KUMCRI. The contact person for KUMCRI will be Bruce F. Kimler, Ph.D., (Telephone Number 913-588-3660) and the Collaborator contact will be Fernand Labrie, M.D., Ph.D. (Telephone Number 418-654-2704 or 418-652-0197). KUMCRI shall use the Agent
solely for the treatment of patients registered to the Study, pursuant to the Protocol. KUMCRI will store the Agents properly in a secure location with limited access to prevent theft or misuse. KUMCRI will attach a label to each vial or package
prepared by Endorecherche stating that the Agent is for KUMCRI clinical trial use only and will maintain NCI Investigational Agent Accountability Records as described in the NCI Investigator Handbook. Previously dispensed packages, whether partial
or full packages, must be destroyed locally in accordance with KUMCRI’s institutional disposal policy. KUMCRI will destroy all expired or unused Agent remaining at the end of KUMCRI’s collaboration with Collaborator in accordance with
Federal or State Regulations and KUMCRI policy, unless requested by Collaborator to return the Agent to Collaborator. 
 Endorecherche warrants that
the Investigational Agent labeled Acolbifene is not adulterated or misbranded within the meaning of the Food Drug and Cosmetic Act, as amended. 
 Article 4. Data Rights and Access to Data 
 Subject to Article 5 hereof, the data generated under this Agreement are considered the property
of the party that generates the data KUMCRI shall own and retain all rights, title, and interest to the data generated through the performance of the Study Protocol. Under this Agreement, KUMCRI will provide to Collaborator the information relevant
to the Study in the Annual report, which consists of a summary of data and results from the Study and will also provide to 
  

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 KUMCRI – Fernand Labrie, M.D., Ph.D. Clinical Supply Agreement for Acolbifene 
 Collaborator the Clinical Data and Results, which Collaborator may, as an exclusive licensee of KUMCRI, use exclusively and-or sub-license for legitimate business and
regulatory purposes pertaining to the development of the Agent. No costs to Collaborator of any form will be associated with the KUMCRI summary data and Clinical Data and Results provided therein. Furthermore, KUMCRI will, upon request, provide to
Collaborator data produced by the clinical trial, including case report forms generated for data collection. In compliance with Article 5 hereof, Collaborator shall have the exclusive right to have access to use and/or grant a sublicense to use all
the data, Clinical Data and Results, including case report forms for legitimate business purposes and for any submissions to the FDA pertaining to its proprietary Agent in conformity with Article 5. 
 Discoveries or inventions made by the Principal Investigator or other KUMCRI agents in the performance of the Protocol and which do not incorporate the Study Drug shall
be the sole property of KUMCRI. Collaborator shall be given a sixty (60) day exclusive first right to negotiate a license to make, use, and sell such patentable inventions. Upon mutual agreement of the parties, the time period to negotiate such
a license may be extended. 
 Article 5. Proprietary/ Confidential Data 
 Any preclinical or formulation data considered proprietary by Collaborator will be treated as such by KUMCRI. KUMCRI shall treat in confidence any of Collaborator’s written information about the study for a
period of five (5) years from the date of disclosure, unless Collaborator informs KUMCRI that the Confidential Information is still secret and confidential, in which case the obligations hereof shall extend for a further period of two
(2) years. Any proprietary information which is orally disclosed must be reduced to writing within sixty (60) days of such disclosure. Such Proprietary Data shall not include information or data exempted from the definition of
“Proprietary Data” under Article 1. Primary proprietary data will, upon request by Collaborator, be returned to Collaborator by KUMCRI. However, summaries of all such studies will be retained in the KUMCRI files and KUMCRI shall have the
right to retain documents or data needed to fulfill any of KUMCRI’s reporting obligations under law. It is the intention of the NCI that except as may be required by the Freedom of Information Act or other applicable law or court order that all
data derived from clinical trials at a DCTD-sponsored institution will be made fully, and exclusively available for use by Collaborator in obtaining regulatory approval for legitimate business purposes. The data will be made available to DCTD in
summary form (Summary Data). 
 Article 6. Publications and Commercialization 
 KUMCRI investigators maintain the full right to present and publish the data at such time and place as they see fit. Manuscripts from all clinical trials involving Agent or those to which Collaborator has specifically
committed resources must have advisory review and comment by Collaborator prior to submission for publication. The amount of time required for the review shall not exceed thirty (30) days. The publication or other disclosure shall be delayed
for up to an additional thirty (30) days upon written request by either Party to this Agreement as necessary to preserve U.S. or foreign patent or other intellectual property rights. Abstracts presented by 
  

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 KUMCRI – Fernand Labrie, M.D., Ph.D. Clinical Supply Agreement for Acolbifene

 KUMCRI investigators will be sent to Collaborator before submission in order to assess the possibility of patentable information. The delay must not
exceed 30 days. 
 KUMCRI agrees to register the Study in a public trials registry as required by the International Committee of Medical Journal Editors
(ICMJE). 
 Article 7. Use of Name 
 Collaborator may use,
refer to, and disseminate reprints of scientific, medical, and other published articles which disclose the name of KUMCRI consistent with U.S. copyright laws, provided such use does not constitute an endorsement of any commercial product or service
by KUMCRI. Collaborator shall take every step possible to ensure that references to the articles are accurate, and shall explicitly state that any such reference does not claim, infer, or imply an endorsement or recommendation of the product by the
Investigator or KUMCRI. Collaborator shall not use the name of KUMCRI or any of the foregoing in any advertising, packaging, or promotional material in connection with Agent except with the written permission of KUMCRI, or as may be required by law.
Collaborator-issued press releases that reference or rely upon the work of KUMCRI under this Agreement shall be made available to KUMCRI at least seven days prior to publication for review and approval, except when the press release is issued in
response to a governmental order or directive that does not allow time for such prior review. In that case, the press release will be sent prior to issuance. 
 Article 8. Liability 
 Collaborator agrees that KUMCRI, the University of Kansas Medical Center, Kansas University Internal Medicine
Foundation, Kansas University Medical Center Division of Hematology, Kansas University Physicians, Inc., University of Kansas Hospital Authority, Principal Investigator and their officers, employees, agents and volunteers shall not be responsible
for claims, expenses, damages, or liability for personal injury or damage to property, real or personal, directly or indirectly arising from the negligent or wrongful act of Collaborator, its officers, employees, agents and volunteers. KUMCRI agrees
that Collaborator shall not be responsible for claims, expenses, damages, or liability for personal injury or damage to property, real or personal, directly or indirectly arising from the negligent or wrongful act of KUMCRI, the University of Kansas
Medical Center, Kansas University Internal Medicine Foundation, Kansas University Medical Center Division of Hematology, Kansas University Physicians, Inc., University of Kansas Hospital Authority, Principal Investigator and their officers,
employees, agents and volunteers. Claims against KUMCRI may be pursued in accordance with the provisions of the Kansas Tort Claims Act, K.S.A. 75-6101 et seq. 
 Article 9. Governing Law 
 This Agreement shall be governed by and construed in accordance with Federal and State law
as construed by the Courts of the State of Kansas, without regard to the conflict of laws principles thereof. 
  

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 KUMCRI – Fernand Labrie, M.D., Ph.D. Clinical Supply Agreement for Acolbifene 
 Article 10. Severability 
 The terms of this Agreement are severable.
If any item or provision of this Agreement shall to any extent be invalid or unenforceable, the remainder of this Agreement shall not be affected, and each remaining item and provision of this Agreement shall be valid and shall be enforceable to the
fullest extent permitted by law. 
 Article 11. Survivability 
 The provisions of this Agreement as they relate to confidentiality and drug supply shall survive the expiration or earlier termination of this Agreement. 
 Article 12. Compliance with DHHS Regulations 
 KUMCRI and Collaborator agree to comply with all Department of Health and Human Services
regulations relating to Human Subject use, and all Public Health Service policies relating to the use and care of laboratory animals. 
 Article 13.
Termination 
  

	 	A.	This Agreement expires on the earlier to occur of the completion of the research or three (3) years from the date of execution of this Agreement. Said expiration date may be
changed by mutual agreement and written amendment of this Agreement. 

  

	 	B.	This Agreement may be terminated at any time by the mutual written consent of the Parties. 

  

	 	C.	Either Party may unilaterally terminate the Agreement at any time by giving written notice to the other Party at least sixty (60) days prior to the desired termination date.

  

	 	D.	On expiration or earlier termination of this Agreement, Collaborator will supply enough Agent to complete the clinical study ongoing or approved, pursuant to the provisions of
Article 3. 

 Article 14. Clinical Supply Agreement Amendments 
 Upon mutual agreement of both parties, this Agreement may be amended as necessary to ensure the Agreement accurately reflects the terms and scope of the collaborative research project. The Amendment shall be in
writing signed by both the authorized representatives of Collaborator and KUMCRI. 
  

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 KUMCRI – Fernand Labrie, M.D., Ph.D. Clinical Supply Agreement for Acolbifene 
 SIGNATURES 
 This Agreement, and any Amendments
hereto, provides the basis for mutually satisfactory co-development of Agent as an anti-cancer agent. 
 By executing this Agreement, each of the undersigned
represents and confirms that he or she is fully authorized to bind the identified entity to its terms. Each of the undersigned expressly certifies or affirms that the contents of any statement made or reflected in this document are truthful and
accurate. 
 AGREED TO AND ACCEPTED BY: 
 For the University of Kansas Medical Center Research Institute, Inc.: 
  

					
	 /s/ Ted R. Knous, Ph.D.
	  	 1-7-06
	  	
	Ted R. Knous, Ph.D.	  	Date	  	
	Executive Director, University of Kansas Medical Center Research Institute, Inc

 READ AND UNDERSTOOD: 
 I have read and understand this Agreement and accept the terms as they relate to my activities as Investigator. 
  

					
	 /s/ Carol J. Fabian, M.D.
	  	 1-5-06
	  	
	Carol J. Fabian, M.D.	  	Date	  	
	Professor, Department of Internal Medicine	  		  	
	
	Address correspondence related to this Agreement to:

 University of Kansas Medical Center Research Institute, Inc. 
 Attn: Ted R. Knous, Ph.D. 
 3901 Rainbow Boulevard, Mail Stop 1039 

Kansas City, KS 66160 
 For
Endorecherche Inc.: 
  

					
	 /s/ Fernand Labrie, M.D., Ph.D.
	  	 2-03-06
	  	
	Fernand Labrie, M.D., Ph.D.	  	Date	  	
	President, Endorecherche, Inc.	  		  	
	2989 de la Promenade	  		  	
	Quebec City,( Quebec ) G1W 2J5	  		  	
	Canada	  		  	

  

 Page 7 of 7Research Collaboration Agreement, among EndoResearch Inc. and each of Monash

 Exhibit 10.11 
 RESEARCH COLLABORATION AGREEMENT 
 This Research Collaboration Agreement (the
“Agreement”) is effective as of 19th December, 2005 (the “Effective Date”) by
and between Endorecherche Inc., a Canadian company, having its head office and principal place of business at 2989, de la Promenade Street, Sainte-Foy, Quebec, G1W 2J5, Canada (“Company”) and Bayside Health (ABN 27 318 956
319,(through The Alfred Hospital, Commercial Road, Melbourne, Vic, 3004, Australia (“Hospital”) and Monash University (ABN 12 377 614 012), through its Department of Medicine, Alfred Hospital, Medical School Building, Prahan, Vic,
3181, Australia (“University”). Hospital and University are hereinafter collectively referred to as “Institution”. 
 WHEREAS, Company owns or otherwise controls the Materials and the Patent Rights (as defined in Section 1 below); 
 WHEREAS,
Institution wishes to conduct the research project more fully described in Schedule 1 annexed hereto and to form an integral part hereof (the “Project”) and under which University personnel engaged on the Project who have a
Hospital appointment will be undertaking the Project in their Hospital capacity; and 
 WHEREAS, Institution desires to obtain samples of the
Materials in order to use such samples for the sole purpose of conducting the Project; 
 NOW, THEREFORE, in consideration of the mutual covenants
contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows: 
 1. DEFINITIONS 
 1.1 Definitions. Unless otherwise specifically
provided in this Agreement, the following terms shall have the following meanings: 
  

	 	(a)	“Affiliates” means, with respect to a Person, any Person that controls, is controlled by or is under common control with such first Person. For purposes of this
definition only, “control” means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate
governance, or (b) to own, directly or indirectly, fifty percent (50%) or more of the outstanding voting securities or other ownership interest of such Person; 

  

	 	(b)	“Confidential Information” means any and all information, whether patentable or not, disclosed orally, in writing or in any other form by or on behalf of Company to
University relating to the Materials and the Patent Rights, including, without limitation, proprietary, scientific, technical, trade secret, know-how, data, clinical data, financial or business information and any information relating to regulatory
documentation, clinical studies and tests performed on the Materials by or on behalf of Company which has already been provided or disclosed to institution or which will be provided or disclosed to Institution (whether or not purposely) under this
Agreement; 

  

	 	(c)	“DHEA” means the prehormone known as dehydroepiandrosterone; 

	 	(d)	“Effective Date” shall have the meaning set forth in the first paragraph of this Agreement; 

  

	 	(e)	“Earned Royalty” means the following percentages of Net Sales of the Products for use in the Field, calculated in accordance with Section 5.4 hereof;

  

	 	(f)	“Field” means exclusively the therapeutic and/or prophylactic use of Products containing DHEA for the treatment of sexual dysfunctions in humans;

  

	 	(g)	“Loss” means any and all liabilities, claims, demands, causes of action, damages, loss and expenses, including interest, penalties, and reasonable lawyers’
fees and disbursements; 

  

	 	(h)	“Materials” means those materials listed in Schedule 2 hereto, in the aggregate quantities specified in Schedule 2; 

  

	 	(i)	“Net Sales” means the gross amounts received from sales of the Products by Company, its Affiliates, licensees or sublicensees to third party customers after
deduction of [***] 

  

	 	(j)	“Parties” means Institution and Company and “Party” means either Institution or Company; 

  

	 	(k)	“Patent Rights” means any and all patent rights owned by Company and/or licensed to Company, including all patent applications and/or patent pending, which claim
the use of DHEA, either alone or in combination, for all protected applications or uses; 

  

	 	(l)	“Person” means an individual, corporation, company, cooperative, sole proprietorship, partnership, limited partnership, limited liability partnership, limited
liability company, business trust, joint stock company, trust, incorporated association, joint venture or any similar entity or organization, including a government or political subdivision, department or agency of a government;

  

	 	(m)	“Products” means DHEA or any pharmaceutical composition which contains DHEA as an active ingredient for the treatment of sexual dysfunctions in humans;

  

	 	(n)	“Project” shall have the meaning set forth in the preamble; 

  

	 	(o)	“Regulatory Approval” shall mean any and all approvals (including NDA approvals), licenses, registrations, or authorizations of any federal, national,
multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity necessary for the manufacture, use, storage, import, export, transport, promotion, marketing or sale of a pharmaceutical product for use in
humans in any country (including without limitation, any pricing or pricing reimbursement approvals); 

  

	 	(p)	“Research” means those tests, studies and other activities that will be carried out by Institution for the sole purpose of the Project; 

  

	 	(q)	“Researchers” means Professor Susan R. Davis who will act as principal investigator and all other members of her team who are engaged in carrying out the Research;
and 

  

	[***] 	Represents information redacted and filed separately with the Commission pursuant to a request for confidential treatment under Rule 406 of the Securities Act of 1933, as
amended. 

  

 2 

	 	(r)	“Results” means any and all data, reports, tests results, laboratory notes, tangible materials (excluding Materials), techniques, know-how, copyrights, discoveries,
trade secrets, inventions (whether patentable or not), trademarks, technologies and other information, recorded in any form, that are generated, obtained, developed, created, conceived or reduced to practice as a result of or in connection with the
Research or the use of the Materials by or on behalf of Institution (whether solely or jointly with others), provided, however, that “Results” shall exclude any of the foregoing that is exclusively referable to research methods and
technologies owned or controlled by Institution prior to the Effective Date; 

  

	 	(s)	“Valid claim” means any claim contained in any pending patent application or issued patent included within the Patent Rights or the Results which has not been
abandoned or declared invalid in a non-appealable order and which would be infringed by the manufacture or sale of Products of use in the Field in the absence of ownership of such patent rights or of a valid license for the use of same.

 2. TRANSFER OF MATERIALS 
 2.1
Transfer of Materials. Company agrees, under the terms set forth herein, to provide Hospital with the Materials solely to allow Institution to carry out the Research in compliance with Section 3.7 hereof. 
 2.2 Shipment. Company will be responsible for the delivery of the Materials to Hospital at the cost of Company (including freight and insurance). 
 2.3 DISCLAIMER AND WARRANTY. THE COMPANY WARRANTS THAT ALL MATERIALS PROVIDED BY COMPANY WILL BE FREE OF DEFECTS AND OF MERCHANTABLE QUALITY TO THE MAXIMUM EXTENT
PERMITTED BY APPLICABLE LAW, COMPANY HEREBY DISCLAIMS AND EXCLUDES ANY AND ALL OTHER REPRESENTATIONS, WARRANTIES, CONDITIONS OR OTHER TERMS, WHETHER WRITTEN OR ORAL, EXPRESSED OR IMPLIED, WITH RESPECT TO THE MATERIALS, INCLUDING ANY REPRESENTATION
OR WARRANTY OF PERFORMANCE OR FITNESS FOR A PARTICULAR USE OR PURPOSE. 
 2.4 NO LIABILITY. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, COMPANY
SHALL NOT BE LIABLE TO INSTITUTION, OR ANY OF ITS EMPLOYEES OR AGENTS, WHETHER FOR BREACH OF CONTRACT, NEGLIGENCE OR OTHERWISE, WITH REGARD TO THE PROVISION OF MATERIALS TO INSTITUTION, EXCEPT TO THE EXTENT OF ANY LOSS ARISING FROM A BREACH OF THE
WARRANTY IN SECTION 2.3 
 3. CONDITIONS OF TRANSFER 
 3.1
Permitted Use of Materials. The Materials supplied to Hospital pursuant to this Agreement (a) shall be used by Institution only for the Research and shall at all times remain solely under the control of Institution; (b) shall not be
used by or delivered by Institution to or for the benefit of any third Party without the prior written consent of Company; (c) shall not be used by Institution for the sole purpose of the Research unless all required ethical approvals have been
obtained; and (d) shall not be used by Institution in any product for commercial use or distribution or for any other purpose. 
  

 3 

 3.2 Not Used. 
 3.3
No Sale or Transfer. Institution hereby agrees that this Agreement does not grant to Institution any property, license, title, interest or other rights in the Confidential Information or the Patent Rights and that the use of the Materials
and/or of the Confidential Information and/or the Patent Rights authorized pursuant to this Agreement in no way obliges Company to grant any such rights to Institution. 
 3.4 Experimental Nature. Institution acknowledges (and shall inform the Researchers) that not all of the characteristics of the Materials may be known. Institution shall use, and shall cause its Researchers to
use, the Materials with prudence and appropriate caution in any experimental work. 
 3.5 Compliance with Law. Institution shall use, and shall cause
its Researchers to use, the Materials in compliance with all applicable laws, rules, regulations, guidelines and requirements. In accordance with the requirements of any applicable national or foreign law governing the shipment of drugs, Institution
hereby certifies that (a) it is regularly engaged in conducting tests on human beings, and (b) the Materials received pursuant to this Agreement shall actually be used only for tests in connection with the Research. 
 3.6 Study Protocols. Institution shall be responsible (at its own expense) for the design of all preclinical and clinical studies involving Materials to be
undertaken in connection with the Project. Institution shall provide Company with advance copies of all protocols for proposed studies involving Materials in order to provide Company a reasonable opportunity to review and comment on the protocol and
study design which must be found acceptable by Company. Company shall provide any comments to the protocol within thirty (30) days of receipt and Institution shall consider in good faith any comments made by Company with respect to the
protocols and/or study design which must be found acceptable by Company. In addition, Company shall have the right to operate clinical monitoring of the study through its own personnel and at its own expenses, while the Research program is being
conducted. Moreover, Institution shall submit to Company, for approval, all case record forms and formularies before starting the study. 
 3.7 Good
Clinical Practice (GCP) Rules. The Research shall be conducted in accordance with all Good Clinical Practice Rules including clinical monitoring, in order to allow Company to seek any and all Regulatory Approvals using the Results. 

4. DISCLOSURES AND REPORTS 
 4.1 Disclosure and Reports.
Institution shall promptly keep Company informed of all uses that Institution makes of the Materials. Within 90 days of the completion of the Research or any termination of this Agreement, Institution shall submit a final written report to Company
which report shall include a description of the study design followed as agreed previously with Company and the Results obtained accompanied with an executive summary of the Results. In addition, Institution shall also destroy all unused Materials
and supply Company with a duly sworn declaration certifying that all such unused Materials have been property destroyed. 
 5. OWNERSHIPS OF MATERIALS,
PATENT RIGHTS, CONFIDENTIAL INFORMATION AND RESULTS AND PAYMENTS 
 5.1 Ownership of Patent Rights and Confidential Information. Company shall own
and retain all right, title and interest in and to the Patent Rights and the Confidential Information. Accordingly, Institution hereby agrees not to claim any right, title or ownership in the Patent Rights or the Confidential Information, and that
rights, titles and ownership in the Patent Rights and the Confidential Information is and shall remain the property of Company. 
  

 4 

 5.2 Ownership and License of Results. University shall own and retain all right, title and interest in and to the
Result. University agrees to promptly disclose to Company the Results. University hereby grants to Company an irrevocable, royalty-free, worldwide exclusive license to use, reproduce, publish and exploit the Results. Company must not publish or
exploit the Result using the name of University or Hospital or any of their personnel, without the prior written consent of University or Hospital (which consent will not be unreasonably withheld). Company acknowledges that any right to receive,
disclose or use Results does not include confidential patient information or any other information that cannot be disclosed under relevant privacy laws. 
 5.3 Company bears own risk in using Results. Company assumes sole responsibility and risk in interpreting, using and exploiting the Results (including any findings, outcomes and recommendations therein) and shall indemnify
Institution and its officers and employees against any actions, proceedings, suits, claims and demands made against them arising from such interpretation, use or exploitation by Company or any third party deriving the Results directly or indirectly
from Company. 
 5.4 “Royalties”. In consideration for the grants of rights to Company contained in this Agreement, and subject to the other
terms of this Agreement, Company agrees to pay to University Earned Royalty established as follows: 
  

	 	5.4.1. 	[***] percent ([***] %) of the Net Sales by Company and/or its Affiliates of a Product for use in the Field in any country for which there exists a Valid claim and in
which country the Results are used to support Regulatory Approval to sell the drug for the sexual dysfunction indication and no additional data (being data related to other research – not data that is known by the Company or in the public
domain) is required by the relevant regulatory authority to support such Regulatory Approval; and [***] percent ([***]%) if the relevant regulatory authority does require such additional data to support such Regulatory Approval; and

  

	 	5.4.2. 	[***] percent ([***]%) of the Net Sales by Company and/or its Affiliates for a period of [***] years from the data of the first commercial sale by Company
and/or its Affiliates in any country of a Product for use in the Field for which there is no Valid claim or a Valid claim no longer exists and in which country the Results are used to support Regulatory Approval to sell the drug for the sexual
dysfunction indication and no additional data (being data related to other research – not data that is known by the Company or in the public domain) is required by the relevant regulatory authority to support such Regulatory Approval; and
[***] percent ([***]%) if the relevant regulatory authority does require such additional data to support such Regulatory Approval; and 

  

	 	5.4.3. 	An amount equal to those stated in Subsections 5.4.1 and 5.4.2 hereof derived form all royalty payments received by Company from its licensee(s) in connection with the Net Sales by
such licensee(s) of a Product in any country for use in the Field subject to the same conditions as apply in Subsections 5.4.1 and 5.4.2. 

 All Earned Royalty owing by Company to University shall be payable [***] of each calendar year. 
  

	[***] 	Represents information redacted and filed separately with the Commission pursuant to a request for confidential treatment under Rule 406 of the Securities Act of 1933, as
amended. 

  

 5 

 Company must not, and must ensure that its licensees do not, do anything to artificially reduce the
amount of royalty payments that are payable to University under this Agreement. This includes, but is not limited to, providing Products at below reasonable prices to Persons associated with Company, Affiliates or licensees. If any such artificial
reduction does occur, the relevant transactions shall be taken to have been made at full market price for the calculation of royalties under this Agreement. 
 Company shall provide to University a true statement of each payment payable to University under this Section 5.4 at the time that it makes its payment remittance. Where no payments are payable for any six
monthly period, Company must provide a statement to University to that effect. Company must make available to University for inspection at reasonably times and upon reasonable notice, such books, records and other documents as are relevant in
ascertaining royalty payments under this Agreement and allow University to take copies. 
 5.5 Commercialization of the Results. Company shall use
reasonable commercial efforts in a manner consistent with the objectives of the Project to commercialize the Results for the sale of Products in the Field in such countries in the world where, in Company’s opinion and entire discretion, it is
commercially viable to do so. Company shall not represent that Institution or any Institution staff in any way endorse, support or approve of, any products, services, intellectual property or business of Company unless institution has given its
express written consent to such representation. 
 5.6 Regulatory Approvals. Institution hereby also agrees to cooperate fully with Company, at the
Company’s request and expenses, for the obtaining by Company and/or its licensee(s) and/or its assignee(s) of all Regulatory Approvals, including, but not limited to, the preparation, filing and presentation of all studies necessary to support
an NDA in the United States of America (i.e. completion of appropriately powered Phase II clinical trials meeting the established endpoints for safety and efficacy of the Materials, as set forth in the protocol for such study) and its equivalent in
Australia and in other jurisdictions. For greater certainty, University agrees to allow the U.S. FDA and its Australian and foreign counterparts to conduct audits of the Research and to support same with all required information. 
 5.7 Project Funds. Company will pay University by way of grant, within 30 days of the signing of this Agreement, the amount of one hundred and twenty-five
thousand Canadian Dollars (CAD $125,000) to assist in funding the infrastructure of the Project. University undertakes that it will only use such funds for those purposes of the Project. 
 6. CONFIDENTIALITY AND NON-DISCLOSURE 
 6.1 Confidentiality Obligations. Institution shall, subject to the
provisions set forth in Section 3.1 hereof, (a) only use the Confidential Information for the purpose of carrying out the Research and (b) keep confidential and or publish, make available or otherwise disclose Confidential
Information, except to its directors, officers, employees, advisors or representatives of Institution with a need to know such Confidential Information to meet the said purpose and who are bound by confidentiality and non-use obligations in all
material respects equal to those undertaken by Institution hereunder. Institution will maintain the Confidential Information consistent with the policies and procedures that Institution uses to 
  

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protect its own confidential information of a similar nature and will notify Company immediately, and cooperate fully, at Company’s reasonable request,
upon Institution’s discovery of any loss or compromise of the Confidential Information. 
 6.2 Exceptions. Institution’s obligations in
Section 6.1 and elsewhere in this Agreement in relation to Confidential Information will not extend to any Confidential Information: (a) that is or hereafter becomes part of the public domain without breach of this Agreement; (b) that
is received from a third party, other than an Affiliate of Company, not bound by confidentiality towards Company or its Affiliates; (c) that was known to Institution prior to receiving it from Company as evidenced by written record; or
(d) that is developed by Institution without use or reference to the Confidential Information as evidenced by written record. 
 6.3 Authorized
Disclosure. Institution shall be entitled to disclose the Confidential Information to the extent required by applicable law or court order. In such case, Institution shall, to the extent possible, furnish Company with written notice that the
Confidential Information is proposed to be disclosed sufficiently in advance of the proposed disclosure so as to provide Company with reasonably opportunity to seek to prevent the disclosure of, or to obtain a protective order for the Confidential
Information. Institution shall also make any required disclosure in consultation with Company. If such protective order or other remedy is not obtained, or if Company waives compliance with the provisions of this Agreement, Institution will furnish
only that portion of the Confidential Information which is legally required. 
 6.4 Press Releases and Use of Name. Each Party shall keep the
existence of, the terms of and the transactions covered by this Agreement confidential and shall not disclose such information to any other Person through a press release or otherwise, or mention or otherwise use the name, insignia, symbol,
trademark, trade name or logotype of the other Party or its Affiliates in any manner without the prior written consent of the other Party in each instance (which shall not be unreasonably withheld). 
 6.5 Principal Investigator’s Right to Publish. Company acknowledges that, as University will own the Results, it and its personnel will retain the right to
publish the Results provided however that Company be supplied at least thirty (30) days in advance (or such less period as agreed by Company) with copies of all proposed publications and communications regarding the Results for the purposes of
review. Notwithstanding the above, University agrees to defer publishing any such proposed publication for such reasonable period of time not exceeding 12 months, as determined by Company, if Company notifies University in writing within the said
thirty (30) day period (or agreed lesser period) that it is of the opinion that such proposed publication could be detrimental to the legal protections by patent rights of any of the Results. If Company does not respond in writing to University
within the said thirty (30) day period (or agreed lesser period) it shall be taken to have approved for publishing the relevant proposed publication. 
 7. TERMINATION 
 7.1 Term and Termination. This Agreement shall commence upon the Effective Date and shall continue until the Research
is completed (the “Term”). The Parties may termination this Agreement by mutual agreement. A Party may also terminate this Agreement by notice in writing to the other Party if the other Party has commented a material breach of this
Agreement and has not taken reasonable steps to remedy that breach or the effect of that breach within twenty (20) business days of receiving written notice to do so by the first mentioned Party. 
 7.2 Effect of Termination. Upon expiration or termination of this Agreement Institution shall promptly cease performing the Research. The expiration or
termination of this Agreement shall be without prejudice to any rights or obligations of the Parties that may have accrued prior to the expiration 

  

 7 

 
or termination and, except as otherwise expressly provided herein, shall not limit any rights or remedies which may be available by law or otherwise. Upon
termination or expiration of this Agreement, Institution shall promptly (a) destroy all Materials, provided that Institution shall certify in writing to Company that such Materials have been destroyed; (b) at Company’s option, either
destroy or return to Company all other Confidential Information received from the Company; and (c) provide Company with a final written report in accordance with Section 4.1 hereof. 
 7.3 Audit. Company shall be permitted to audit Institution’s relevant records during the Term and for three (3) years thereafter, for the purpose of
confirming that Institution has fulfilled its obligations under this Agreement. 
 7.4 Survival. Sections 2.3, 2.4, 3.1(b), (c) and (d), 3.2, 4,
5, 6, 7.2, 7.3, 7.4, 8 and 10.4 shall survive the expiration or termination of this Agreement for any reason. 
 8. INDEMNIFICATION 
 8.1 Indemnification. In addition to any other remedy available to the Parties, each Party (the “Indemnifying Party”) shall defend, indemnify and
hold harmless the other Party, its Affiliates and its and their respective officers, directors, partners, shareholders, employees and agents (the “Indemnified Party”) from and against any and all Loss incurred by the Indemnified
Party to the extent resulting from, arising out of, or in connection with, (a) a material breach of any covenant in this Agreement by the Indemnifying Party, (b) the inaccuracy or material breach of any representation warranty made by the
Indemnifying Party in this Agreement or (c) the enforcement of the Indemnified Party’s rights under this Section 8. The Indemnifying Party shall not admit liability on behalf of any Indemnified Party without that Indemnified
Party’s prior written Consent. 
 9. REPRESENTATIONS, WARRANTIES AND COVENANTS 
 9.1 Representation, Warranties and Covenants of University. Institution represents, warrants and covenants to Company that (a) it has full power and authority, and has taken all necessary actions and has
obtained all necessary authorizations, licenses, consents and approvals required, to execute and perform this Agreement and (b) that neither it nor any Researcher has been debarred or is subject to debarment or has otherwise been disqualified
or suspended from performing scientific or clinical investigations or otherwise subjected to any restrictions or sanctions by the FDA or any other governmental or regulatory authority or professional body with respect to the performance of
scientific or clinical investigations (a “Debarred Person”), and University shall not use in any capacity, in connection with the Research, any Debarred Person. 
 9.2 Representation, Warranties and Covenants of Company. Company represents, warrants and covenants to Institution that it has full power and authority, and has taken all necessary actions and has obtained all
necessary authorizations, licenses, consents and approvals required, to execute and perform this Agreement. 
 10. MISCELLANEOUS 
 10.1 Assignment. None of the rights or obligation of this Agreement may be assigned by Institution without the prior written consent of Company. Company may,
without the consent of University, assign its rights pursuant to this Agreement to an affiliate or in connection with the transfer or sale of all or substantially all of its assets related to the division or the subject business relating hereto.
This Agreement shall be binding upon and enure to the benefit of each Party and its permitted successors and assigns. Company shall always have the right to perform any or all of its obligations and exercise any or all of its rights under this
Agreement through any of its Affiliates. 
  

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 10.2 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of
Victoria, Australia and the laws of Australia applicable therein. 
 10.3 Dispute Resolution. The Parties shall mutually consult in good faith in an
attempt to settle amicably in the spirit of cooperation any and all disputes arising out of or in connection with this Agreement or questions regarding the interpretation of the provision thereof. Prior to the commencement of any legal proceedings,
the Parties shall appoint their designated representatives, who shall have appropriate authority to meet and confer to use their best efforts to resolve the matter in issue within two months from the date of notification of either Party to the other
of such dispute or question. Once this process has been exhausted, either Party may resort to whatever other action is available to it. Nothing in this Section is intended to prevent a Party from seeking urgent interlocutory relief before the
Courts. 
 10.4 Notices. Any notices required or permitted under this Agreement shall be in writing shall specifically refer to this Agreement, and
shall be sent by hand, recognized national courier, confirmed facsimile transmission, confirmed electronic mail, or registered or certified mail, postage prepaid, return receipt requested, to the following addresses or facsimile numbers of the
Parties: 
 If to Company: 
 ENDORECHERCHE INC. 
 2989, de la Promenade street, 
 Sainte-Foy, Quebec, G1W 2J5 
 CANADA 
 Attention: Dr Fernand Labrie 
 Fax:
(418) 651-1856 
 E-mail: flabrie@___________ 
 If to Institution: 
 MONASH UNIVERSITY 
 Department of Medicine 
 Alfred Hospital,
Medical School Building 
 Prahan, Vic, 31_____ 
 AUSTRALIA 
 Attention: Professional Susan R. Davis 
 Fax: (61 3) 9903 0828 
 E-mail:
Susan.Davis@med.monash.edu.au 
 All notices under this Agreement shall be deemed effective upon receipt. A Party may change its contact information
immediately upon written notice to the other Party in the manner provided in this Section 10.4. 
  

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 10.5 Relationship of the Parties. The status of a Party under this Agreement shall be that of an independent
contractor. Nothing contained in this Agreement shall be construed as creating a partnership, joint venture or agency relationship between the Parties or, except as otherwise expressly provided in this Agreement, as granting either Party the
authority to bind or contract any obligation in the name of or on the account of the other Party or to make any statements, representations, warranties or commitments on behalf of the other Party. 
 10.6 Equitable Relief. A breach by either Party may cause irreparable damage and the non-breaching Party will not be adequately compensated by monetary damages.
In the event of a breach, or threatened breach the non-breaching Party shall be entitled to obtain equitable relief, whether preliminary or permanent, without the need to show irreparable harm or the inadequacy of monetary damages as a remedy.
Nothing in this Section is intended, or shall be construed, to limit the Parties’ rights to equitable relief or any other remedy for a breach of any provision of this Agreement. 
 10.7 Waiver. No waiver of or consent to depart from the requirements of any provision of this Agreement shall be binding against a Party unless it is in writing and is signed by the Party giving it. Such waiver
or consent shall be effective only in the specific instance and for the specific purpose for which it has been given. All rights and remedies are cumulative and do not exclude any other right or remedy provided by law or otherwise available.

 10.8 Severability. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then, to the fullest extent
permitted by applicable law and if the rights and obligations of any Party will not be materially and adversely affected; (a) such provision will be given no effect by the Parties and shall not form part of this Agreement, (b) all other
provisions of this Agreement shall remain in full force and effect, and (c) the Parties shall use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with
applicable law and achieves, as nearly as possible, the original intention of the Parties. To the fullest extent permitted by applicable law, the parties waive any provision of law that would render any provision in this Agreement invalid, illegal
or unenforceable in any respect. 
 10.9 Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the
subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter of the Agreement. Each Party confirms that is not relying on any representations, warranties or covenants of
the other Party except as specifically set out in this Agreement. Nothing in this Agreement is intended to limit or exclude any liability for fraud. All Schedules referred to in this Agreement are intended to be and are hereby specifically
incorporated into and made a party of this Agreement. No modification will be effective unless in writing and signed by authorized representatives of both Parties. 
 10.10 Convention for the International Sales of Goods. The Parties hereby specifically exclude the application of the Convention for the International Sales of Goods. 
 10.11 Language. The Parties hereto have requested that this Agreement and all notices given pursuant to be drafted in the English language. Les Parties aux présentes conferment et déclarent
qu’elles ont demandé que cette Convention et les avis qui s’y rattachent socient rédigés en anglais. 
  

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 IN WITNESS WHEREOF, the undersigned have duly executed and delivered this Agreement as of the
Effective Date. 
  

									
	ENDORECHERCHE INC.	 		 	MONASH UNIVERSITY
					
	Per:	 	/s/ Dr. Fernand Labrie	 		 	Per:	 	/s/ illegible
	Title:	 	President	 		 	Title:	 	illegible
	Date:	 	23/12/05	 		 	Date:	 	20 December 2005
				
		 		 		 	BAYSIDE HEALTH
					
		 		 		 	Per:	 	/s/ Graeme B. Ryan
		 		 		 	Title:	 	Director Research Strategy
		 		 		 	Date:	 	22/12/05
			
		 		 	Read and acknowledged by the Principal Investigator
		 		 	Professor SUSAN R. DAVIS
				
		 		 		 	/s/ Professor Susan R. Davis
		 		 		 	 Professor Susan R. Davis

				
		 		 		 	Date: 21 December 2005

  

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