Document:

EXHIBIT 10.8

 

CONSULTING AGREEMENT

 

THIS AGREEMENT (this “Agreement”) is effective as of March 1, 2013 (the “Effective Date”), between:

 

Levine, Risen and Associates, Inc. (The Center for Marital and Sexual Health Inc.), 23425 Commerce Park Rd. Suite 104, Beachwood, Ohio 44122 216-831-2900 [sheridan@levinerisenandassociates.com]

 

(the “Consultant”)

 

AND:

 

S1 Biopharma, Inc., 1 Independence Way, #102, Jersey City, New Jersey 07305

 

(the “Company”)

 

RECITALS:

 

A.                                    The Company intends to conduct a 15-week Phase 1-b trial (the “Trial”) of the safety, tolerability and efficacy of Lorexys (S1P-104) in women with hypoactive sexual desire disorder.

 

B.                                    The Company desires to engage Consultant, and Consultant agrees to perform the Services in support of the Trial on the terms and conditions contained herein.

 

NOW THEREFORE, in consideration of the premises, the mutual covenants and agreements set forth in this Agreement and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by each of the parties, the parties hereby agree as follows:

 

ARTICLE 1
 DEFINITIONS AND INTERPRETATION

 

1.1                               Definitions

 

In this Agreement, the following words and expressions have the following meanings unless the context otherwise requires:

 

(a)                                 “Agreement” means this consulting agreement and schedules attached to this consulting agreement, as amended or supplemented from time to time.

 

(b)                                 “Board” means the board of directors of the Company.

 

(c)                                  “Business” means the commercialization of biopharmaceutical therapies for patients suffering from HSDD and SD.

 

 

(d)                                 “Competitive Business” means any one or more of the following: (i) any business engaged in the development of or business of researching and commercializing biopharmaceutical therapies for patients suffering from HSDD, FSD, or ED; or (ii) any other business in which the Company engages during the duration of this Consulting Agreement.

 

(e)                                  “Confidential Information” means trade secrets and other information, in whatever form or media, in the possession of the Company and owned by the Company or by any of its officers, directors, employees, agents and consultants (collectively, the “Associates”), which is not generally known to the public and has been specifically identified as confidential or proprietary by the Company or the Associate from whom the Company has obtained its rights, or its nature is such that it would generally be considered confidential in the industry in which the Company operates, or which the Company is obligated to treat as confidential or proprietary.

 

Confidential Information includes, without limitation, the following: (i) the Products and confidential or proprietary facts, data, techniques, materials and other information related to the Products or the Business of the Company; (ii) all Developments; (iii) information regarding the Company’s business operations, methods and practices, including market strategies, product pricing, margins and hourly rates for staff and information regarding the financial, legal and corporate affairs of the Company; (iv) the names of the Company’s Associates and the nature of the Company’s relationships with such Associates; and (v) technical and business information of or regarding the Company’s Associates.

 

(f)                                   “Developments” includes, without limitation, all:

 

(i)                                     products, software, documentation, research, data, designs, reports, flowcharts, trademarks, specifications and source code listings, and any related works, including any enhancements, modifications or additions to the Products owned, licensed, sold, marketed or used by the Company;

 

(ii)                                  copyrightable works of authorship including, without limitation, any technical descriptions for Products, user guides, illustrations and advertising materials; and

 

(iii)                               inventions, devices, integrated circuit topographies, discoveries, concepts, ideas, algorithms; formulae, know-how, processes, techniques, systems, methods, operating capabilities and improvements, whether patentable or not, developed, created, generated or reduced to practice by either of the Consultant, alone or jointly with others, as a result of this engagement, which result from this engagement or which result from the use of the premises or property (including equipment, supplies or Confidential Information) owned, leased or licensed by the Company or which reasonably relate to the Business of the Company.

 

(g)                                  “Person” means any individual, partnership, limited partnership, joint venture, syndicate, sole proprietorship, company or corporation with or without share capital, unincorporated association, trust, trustee, executor, administrator or other regal personal representative, regulatory body or agency, government or governmental agency or entity however designated or constituted.

 

(h)                                 “Products” means (i) therapies, approaches, screening methodologies, diagnostic assays and therapeutic molecules for treating sexual dysfunctions; (ii) any intellectual

 

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property or assets owned, licensed, sold, marketed or used by the Company in connection with the Business, including enhancements, modifications, additions or other improvements to such intellectual property; and (iii) any other products that the Company discovers or commercially develops during the consulting relationship.

 

(i)                                     “Services” means the services set forth in Schedule “A” to this Agreement, or on any replacement thereof initialed by the parties.

 

ARTICLE 2
 ENGAGEMENT

 

2.1                               Engagement

 

The Company hereby engages the Consultant to provide the Services to the Company, and the Consultant hereby covenants and agrees to provide such Services to the Company, subject to the terms end conditions of this Agreement. In providing the Services to the Company, both Consultant and the Consultant will:

 

(a)                                 act honestly and in good faith in what they reasonable believe to be in the best interests of the Company;

 

(b)                                 exercise the degree of care, diligence and skill that a reasonably prudent person would exercise in comparable circumstances; and

 

(c)                                  generally use their best efforts to promote the business and interests of the Company.

 

2.2                               Business of the Company

 

The Consultant will not, during the term of this Agreement, engage in any business, enterprise or activity that competes with, is contrary to or detracts from the due performance of the Business of the Company.  The Consultant will obtain the prior written consent of the Board if they wish to engage in any business, enterprise or activity that can be considered competitive with or contrary to the Business of the Company, which consent the Board may, within its sole discretion, withhold, grant or revoke at any time.

 

2.3                               Devotion of Time

 

The Consultant will devote as many hours as are required providing the Services in order to enroll at least 15 patients in clinical study S1P-104-1000 (the “Clinical Study”) within three (3) months from the Effective Date. The Consultant and the Company will reach an agreement in writing on the estimated number of hours required to achieve the patient enrollment goal set forth in the preceding sentence prior to the commencement of the Clinical Study, which estimate may be revised by mutual written agreement.  While providing the Services, the Consultant will give the Company the full benefit of his time, knowledge, expertise and ingenuity.

 

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2.4                               Consultant Fee

 

The following fee will be paid to the Consultant by the Company for each day, or part thereof, the Consultant is required to perform the Services:  one dollar ($1.00) per year, subject to modification to $300.00 per hour of contact with subjects being screened for, or accepted in, clinical study S1P-104-1000, at one-half hour to one hour per patient visit, which payment shall commence for all Services provided under this Agreement thirty (30) days after the Company consummates an equity or debt financing in which the Company receives gross proceeds of at least one million dollars ($1,000,000); provided, however, that such equity or debt financing is completed within thirty (30) days after the completion of the Clinical Trial.  Completion of the Clinical Trial is defined as the date on which the closeout visit occurs between the Consultant and the Company’s Clinical Research Associate (or the Company’s Study Monitor) after the final patient enrolled in the study completes their last clinical visit.

 

In the performance of this Agreement, the Consultant will at all times act in the Consultant’s own capacity and right as an independent contractor.  In such capacity, the Consultant will be responsible for all federal, state and local taxes, domestic or international, related to all compensation received and services performed, and no taxes will be withheld or any other deductions made by the Company.  The Company will issue you a IRS tax form 1099.  You will indemnify the Company and hold it harmless from any such taxes and from any payments, penalties and other costs of any kind related to your failure to pay such taxes.  A form W-9 and all necessary tax forms must be submitted along with your first invoice.

 

Unless authorized in writing by the Company, the Consultant and any of its employees will not act nor purport to net as the legal agent of the Company and will not enter or purport to enter into any agreement on behalf of the Company or otherwise bind or purport to bind the Company.

 

2.5                               Reimbursement

 

The Company shall reimburse the Consultant (or, in the Company’s sole discretion, shall pay directly), upon presentation of vouchers and other supporting documentation as the Company may reasonably require, for reasonable out-of-pocket expenses incurred by the Consultant relating to the business or affairs of the Company or the performance of the Consultant’s duties hereunder, such as for attending a pre-study or post-study investigator’s meeting, including, without limitation, reasonable expenses with respect to travel, dining and similar items, provided that the incurring of such expenses shall have been approved in accordance with the Company’s regular reimbursement procedures and practices in effect from time to time.

 

2.6                               Administrative Fee

 

The Company shall pay directly, upon presentation of vouchers and other supporting documentation as the Company may reasonably require, for reasonable expenses incurred relating to the performance of Lorexys study S1P-104-1000, including reasonable expenses with respect to administrative fees according to Schedule B.

 

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2.7                               Publication

 

Subject to the terns of this section, Consultant reserves the right to publish research results from the Services to be performed hereunder.  However, the Consultant will not publish research results which disclose Confidential Information.  Prior to the disclosure and publication of any non-Confidential Information, the Consultant shall first deliver a copy of any proposed publication to the Chief Executive Officer of the Company at least 90-days in advance of such proposed publication, and provided the Chief Executive Officer does not, within that 90-day period, object in writing to such proposed publication on the grounds that it discloses Confidential Information or patentable subject matter, which belongs to the Company and needs protection.  If the Chief Executive Officer delivers a written objection to the Consultant within the 90-day period, the Consultant will remove the information or subject matter objected to, after which the Consultant may proceed with its proposed publication.

 

2.8                               No Partnership

 

This Agreement will not be construed as creating a partnership, joint venture or agency relationship between the parties or any other form of legal association that would impose liability upon one party for any act or failure to act by the other party.

 

2.9                               Consultant’s Representations and Warranties

 

The Consultant represents and warrants to the Company as follows and acknowledges that the Company has relied on such representations and warranties in entering into this Agreement:

 

(a)                                 the Consultant has the skill, capability, resources, knowledge and ability to provide the Services; and

 

(b)                                 the execution and delivery of this Agreement and the performance by the Consultant of all the covenants and agreements herein contained are not limited or restricted by or in conflict with, any contract, agreement or undertaking, oral or written, to which the Consultant is bound or any applicable lows.

 

ARTICLE 3
 CONFIDENTIAL INFORMATION

 

3.1                               General Obligation of Confidentiality

 

The Consultant acknowledges that the Confidential Information consists entirely of trade secrets, confidential and proprietary information that is the exclusive property of the Company or Associates from whom the Company has obtained the Associate’s rights. The Consultant will treat the Confidential Information in strict confidence and will not directly or indirectly, either during or subsequent to the consulting relationship, disclose, allow access to, transmit or transfer the Confidential Information to a third party (other than the Company’s directors, officers, legal advisors in the ordinary course of business) unless otherwise required by law or by a regulatory authority having jurisdiction over the Company, or except as previously approved in writing by the Company.  The Consultant will protect such Confidential Information from disclosure by exercising a standard of care as may reasonably be expected to preserve its secret and

 

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confidential nature. The Consultant acknowledges and agrees that nothing contained in this Agreement will be construed as an assignment to the Consultant of any right, title or interest in the Confidential Information.  All right, title and interest relating to the Confidential information is expressly reserved by the Company and the Associates from whom the Company has obtained such rights.  All documents containing Confidential Information are the property of the Company.

 

3.2                               Use of Confidential Information

 

Consultant agrees that at all times during and subsequent to the Consultant’s consulting relationship with the Company, the Consultant will not use any of the Confidential Information in any manner except as reasonably required for the Consultant to provide the Services. Without limiting the generality of the foregoing, the Consultant agrees that at all times during and subsequent to the consulting relationship, the Consultant will not use or take advantage of the Confidential Information for creating, maintaining or marketing, or aiding in the creation, maintenance or marketing, of any product that is competitive with any of the Products.

 

3.3                               Prohibition on Copying

 

The Consultant will not copy or reproduce the Confidential Information except in the course of the Consultant’s consulting relationship with and for the benefit of the Company or with the explicit prior written approval of the Company.  All such copies remain the property of the Company.

 

3.4                               Exceptions

 

Any obligations specified in this Article 3 will not apply to the following:

 

(a)                                 any information that is possessed by the Consultant prior to receipt from the Company, other than through prior disclosure by the Company, as evidenced by the respective business records of the Company and the Consultant;

 

(b)                                 any information that is published or available to the general public, other than through a breach of this Agreement or another agreement of confidentiality with the Company;

 

(c)                                  any information that is obtained by the Consultant from a third party with a valid right to disclose it, provided that the third party is not, directly or indirectly, under an obligation of confidentiality to the Company;

 

(d)                                 any information that is disclosed by the Consultant with the express prior written approval of the Company; or

 

(e)                                  any information that is required to he disclosed by operation of law or the requirement of a governmental agency, provided that the Consultant will provide the Company with reasonable advance notice of any such proposed disclosure to give the Company a reasonable period of time in which to object to such disclosure.

 

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3.5                               Injunctive Relief and Application to Courts

 

In the event of a breach or threatened breach by the Consultant of any of the provisions of this Agreement, the Company will be entitled to injunctive relief restraining the Consultant from breaching such provisions.  Nothing in this Agreement precludes the Company from obtaining, protecting or enforcing its intellectual property rights or enforcing the Consultant’s obligations pursuant to the provisions of this Agreement in accordance with Section 7.5 hereof, or from pursuing any other remedy available to it for such breach or threatened breach, including the recovery of damages from the Consultant.  The Consultant acknowledges that irreparable harm may result to the Company if the Consultant breaches its obligations under this Agreement.  The Consultant acknowledges that such a breach may not properly be compensated by an award of damages.  Accordingly, the remedy for any such breach may include, in addition to other available remedies and damages, injunctive relief or other equitable relief enjoining such breach at the earliest possible date.

 

3.6                               Assignment

 

The Consultant agrees to make full disclosure to the Company of each Development promptly after its creation.  The Consultant hereby assigns and transfers to the Company, and agrees that the Company will be the exclusive owner of, all of the Consultant’s right, title and interest in and to each Development throughout the world, including all trade secrets, patent rights, copyrights and all other intellectual property rights therein.  The Consultant further agrees to cooperate fully at all times during and subsequent to the consulting relationship with respect to signing further documents and doing such acts and other things seasonably requested by the Company, at the Company’s expense, to confirm such transfer of ownership of rights, including intellectual property rights, effective at or after the time the Development is created and to obtain patents or copyrights or other similar rights covering the Development.  The Consultant agrees that the obligations in this section will continue beyond the termination of the consulting relationship with respect to any and all Developments created during the consulting relationship.  For purposes of the copyright laws of the United States of America, to the extent, if any, that such laws are applicable to any Confidential Information, it will be considered a work made for hire and the Company will be considered the author thereof.

 

3.7                               Waiver

 

The Consultant agrees that the Company, its assignees and its licensees are not required to designate the Consultant as the author of any Developments.  The Consultant hereby waives in whole all moral rights that it may have in the Developments, including the right to the integrity of the Developments, the right to be associated with the Developments, the right to restrain or claim damages for any distortion, mutilation or other modification of the Developments, and the right to restrain use or reproduction of the Developments in any context and in connection with any product, service, cause or institution.

 

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ARTICLE 4

RESTRICTIONS

 

4.1                               Restrictions

 

The Consultant agrees to comply with all of the restrictions set forth below:

 

(a)                                 at all times during the consulting relationship and for a period of six months after the termination of the consulting relationship in accordance with this Agreement (regardless of which party terminates the consulting relationship and regardless of the reason for such termination, if any), the Consultant will not, either individually or in conjunction with any Person, as principal, agent, director, officer, employee, investor or in any other manner whatsoever, directly or indirectly, engage in or become financially interested in a Competitive Business anywhere without the prior written consent of the Company.  The foregoing will not prevent the Consultant from holding any class of publicly held shares of a company, partnership or other organization provided that the Consultant alone or in conjunction with any other Person, will not directly or indirectly hold more than 10% of the shares of any such class;

 

(b)                                 at all times during the consulting relationship and for a period of six months after the termination of the consulting relationship in accordance with this Agreement (regardless of which party terminates the consulting relationship and regardless of the reason for such termination, if any), the Consultant will not, either directly or indirectly, on his own behalf or on behalf of others, solicit, divert or appropriate or attempt to solicit, divert or appropriate to any Competitive Business;

 

(c)                                  at all times during the consulting relationship and for a period of one year after the termination of the consulting relationship in accordance with this Agreement (regardless of which party terminates the consulting relationship and regardless of the reason for such termination, if any), the Consultant will not, either directly or indirectly, on his own behalf or on behalf of others, solicit, divert or hire away, or attempt to solicit, divert, or hire away, any person employed by the Company or persuade or attempt to persuade any such individual to terminate his or her employment with the Company; and

 

(d)                                 at all times during the consulting relationship and thereafter, the Consultant will not directly or indirectly impair or seek to impair any relationships that the Company has with its employees, consultants, suppliers, agents or other parties with which the Company does business or has contractual relations.

 

ARTICLE 5
 TERMINATION

 

5.1                               Termination by Consultant

 

The Consultant may, at any time, give 90 days’ advance written notice to the Company of his intention to terminate this Agreement and on the expiration of such period the Consultant’s obligations to perform the Services under this Agreement will be terminated.  Such notice may expire on any day of the month and any fees payable hereunder will be proportioned to the date of such termination.

 

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5.2                               Termination by Company

 

The. Company may, at any time, give 90 days’ advance written notice to the Consultant of its intention to terminate this Agreement and on the expiration of such period the Consultant’s obligations to perform the Services under this Agreement will be terminated.  Such notice may expire on any day of the month and any fees payable hereunder will be proportioned to the date of such termination.  Notwithstanding any other provision of this Agreement to the contrary, the Company may immediately terminate this Agreement if Robert Taylor Segraves, MD, PhD, ceases to be actively engaged as the Principal Investigator for this Trial.

 

5.3                               Termination Upon Occurrence of Event

 

The Company may terminate this Agreement immediately without advance written notice to the Consultant upon the occurrence o f any of the following events:

 

(a)                                 the Consultant’s commission of a crime during the consulting relationship (indictable level or penalized by incarceration or a lesser crime related to the provision of the Services), or any act involving money or other property of the Company that would constitute a crime in the jurisdiction involved; or

 

(b)                                 any material breach by the Consultant of any term of this Agreement that remains uncured after the expiration of five calendar days following the delivery of written notice of such breach to the Consultant by the Company.

 

5.4                               Return of Property

 

Upon termination of this Agreement, the Consultant will promptly return to the Company all Company property including all written information, tapes, discs or memory devices and copies thereof, and any other material on any medium in the Consultant’s possession or control pertaining to the consulting relationship, without retaining any copies or records of any Confidential Information whatsoever.

 

ARTICLE 6
 INDEMNIFICATION

 

6.1                               Indemnification by the Company

 

The Company agrees to and hereby does indemnify and hold harmless the Consultant, its affiliates involved in the Clinical Study, and their agents, officers, subcontractors, and employees, including without limitation, the Principal Investigator, sub-investigators and other qualified personnel working under the Principal Investigator’s supervision (“Consultant Indemnitees”), from and against any loss, expense, cost (including reasonable attorney fees), liability, damage, or claim by any study subjects or third-parties for personal injury, including death, that arises out of the conduct of the Clinical Study by the Consultant or that arises out of the gross negligence or willful misconduct of the Company (“Consultant Claim”), provided that the Company shall not indemnify any Consultant Indemnitee for any Consultant Claim to the extent the Consultant Claim arose out of:  (i) failure by the Consultant or Consultant Indemnitees to conduct the Clinical Study in strict accordance with the protocol for the Clinical Study, the 

 

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Company’s written instructions, or applicable federal, state or local laws or regulations; (ii) the gross negligence or willful misconduct of Consultant or Consultant Indemnitees; or (iii) the errors, wrongful acts or omissions of the Consultant or Consultant Indemnitees.

 

The Company’s obligations under this Section 6.1 with respect to a Consultant Claim are conditioned on:

 

i.                                          prompt written notification to the Company of the Consultant Claim so that the Company’s ability to defend or settle the Consultant Claim is not adversely affected;

 

ii.                                       Consultant Indemnitees’ agreement that the Company has sole control over the defense or settlement of the Consultant Claim and to fully cooperate with the Company in the defense or settlement of the Consultant Claim; provided, that, no Consultant Indemnitee shall be required to admit fault or responsibility in connection with any settlement.

 

iii.                                    Written notification of the Consultant Claim shall be sent via overnight courier to the Company in accordance with Section 7.7 hereof.

 

6.2                               Indemnification by the Consultant

 

The Consultant agrees to and hereby does indemnify and hold harmless the Company, its affiliates involved in the Clinical Study, and their agents, officers, subcontractors, and employees (“Company Indemnitees”), from and against any loss, expense, cost (including reasonable attorney fees), liability, damage, or claim by any study subjects or third-parties for personal injury, including death, that arises out the Consultant’s or the Consultant Indemnitees failure to conduct the Clinical Study in strict accordance with the protocol for the Clinical Study, the Company’s written instructions, or applicable federal, state or local laws or regulations or that arises out of the gross negligence or willful misconduct of the Consultant (“Company Claim”), provided that the Consultant shall not indemnify any Company Indemnitee for any Company Claim to the extent the Company Claim arose out of:  (i) the gross negligence or willful misconduct of the Company or Company Indemnitees; or (iii) the errors, wrongful acts or omissions of the Company or Company Indemnitees.

 

The Consultant’s obligations under this Section 6.2 with respect to a Company Claim are conditioned on:

 

i.                                          prompt written notification to the Consultant of the Company Claim so that the Consultant’s ability to defend or settle the Company Claim is not adversely affected;

 

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ii.                                       Company Indemnitees’ agreement that the Consultant has sole control over the defense or settlement of the Company Claim and to fully cooperate with the Consultant in the defense or settlement of the Company Claim; provided, that, no Company Indemnitee shall be required to admit fault or responsibility in connection with any settlement.

 

iii.                                    Written notification of the Company Claim shall be sent via overnight courier to the Consultant in accordance with Section 7.7 hereof.

 

ARTICLE 7

GENERAL

 

7.1                               Entire Agreement

 

This Agreement constitutes the entire agreement between the parties with respect to the subject matter herein and cancels and supersedes all previous invitations, proposals, letters, correspondence, negotiations, promises, agreements, covenants, conditions, representations and warranties with respect to the subject matter of this Agreement.  There is no representation, warranty, collateral term or condition affecting this Agreement for which any party can be held responsible in any way, other than as expressed in writing in this Agreement.

 

7.2                               Amendments

 

No change or modification of this Agreement will be valid unless it is in writing and signed by each party to this Agreement.

 

7.3                               Invalidity of Particular Provision

 

It is intended that all of the provisions of this Agreement will be fully binding and effective between the parties. In the event that any particular provision or provisions or a part of one or more Is found to be void, voidable or unenforceable for any reason whatsoever, then the particular provision or provisions or part of the provision will be deemed severed from the remainder of this Agreement. The other provisions of this Agreement will not be affected by the severance and will remain in full force and effect.

 

7.4                               Governing Law

 

This Agreement will be governed by and construed in accordance with the laws of the State of                             , without regard to conflicts of law, principles that would result in application of laws of any other jurisdiction.  The prevailing party in any legal action brought by one party against the other shall be entitled, in addition to any rights and remedies it may have, to reimbursement of its expenses incurred thereby, including court costs and reasonable attorney’s fees and disbursements.

 

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7.5                               CONSENT TO THE EXCLUSIVE JURISDICTION OF THE COURTS OF THE STATE OF FLORIDA

 

(a)                                 EACH OF THE PARTIES HERETO HDREBY CONSENTS TO THE EXCLUSIVE JURISDICTION OF ALL STATE AND FEDERAL COURTS LOCATED IN                                       ,                                  AS WELL AS TO THE JURISDICTION OF ALL COURTS TO WHICH AN APPEAL MAY BE TAKEN FROM SOUCH COURTS, FOR THE PURPOSE OF ANY SUIT, ACTION OR OTHER PROCEEDING ARISING OUT OF, OR IN CONNECTION WITH, THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY PROCEEDING RELATING OT PROVISIONAL REMEDIES AND INTERIM RELIEF, OR ANY PROCEEDING TO ENFORCE ANY DECISION OR AWARD.

 

(b)                                 EACH PARTY HEREBY EXPRESSLY WAIVES ANY AND ALL RIGHTS TO BRING ANY SUIT, ACTION OR OTHER PROCEEDING IN OR BEFORE ANY COURT OR TRIBUNAL OTHER THAN THE COURTS DESCRIBED ABOVE AND COVENANTS THAT IT SHALL NOT SEEK IN ANY MANNER TO RESOLVE ANY DISPUTE OTHER THAN AS SET FORTH IN THIS ARTICLE 7 OR TO CHALLENGE OR SET ASIDE ANY DECISION, AWARD OR JUDGMENT OBTAINED IN ACCORDANCE WITH THE PROVISIONS HEREOF.

 

(c)                                  EACH OF THE PARTIES HERETO HEREBY EXPRESSLY WAIVES ANY AND ALL OBJECTIONS IT MAY HAVE TO VENUE, INCLUDING, WITHOUT LIMITATION, THE INCONVENIENCE OF SUCH FORUM, IN ANY OF SUCH COURTS.  IN ADDITION, EACH OF THE PARTIES CONSENTS TO THE SERVICE OR PROCESS BY PERSONAL SERVICE OR ANY MANNER IN WHICH NOTICES MAY BE DELIVERED HEREUNDER IN ACCORDANCE WITH ARTICLE 7, SECTION 7.1

 

7.6                               WAIVER OF JURY TRIAL

 

EACH OF THE PARTIES HERETO HEREBY VOLUNTARILY AND IRREVOCABLY WAIVES TRIAL BY JURY IN ANY ACTION OR OTHER PROCEEDING BROUGHT IN CONNECTION WITH THIS AGREEMENT OR ANY OF THE TRANSACTION CONTEMPLATED HEREBY.

 

7.7                               Notices

 

Any notice, direction, request or other communication required or contemplated by any provision of this Agreement will be given in writing and will be given by delivering or faxing same to the Company or the Consultant, as the case may be, as follows:

 

(a)                                 To the Consultant at:

 

 

 

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(b)                                 To the Company at:

 

 

 

Attention:                  

 

Any such notice, direction, request or other communication will be deemed to have been given or made on the date on which it was delivered or, in the case of fax, on the next business day after receipt of transmission.  Either party may change its fax number or address for service from time to time by notice in accordance with the foregoing.

 

7.8                               Waiver

 

No failure or delay on the part of any party in exercising any power or right under this Agreement will operate as a waiver of such power or right, nor will any single or partial exercise of any such right or power preclude any further or other exercise of such right or power under this Agreement. No modification or waiver of any provision of this Agreement and no consent to any departure by any party from any provision of this Agreement will be effective unless it is in writing. Any such waiver or consent will be effective only in the specific instance and for the specific purpose for which it was given.  No notice to or demand on any party in any circumstances will entitle such party to any other or further notice or demand in similar or other circumstances.

 

7.9                               Enurement

 

This Agreement will enure to the benefit of and be binding on the parties and their respective helm, executors, administrators, successors and assigns.

 

7.10                        Survival

 

The provisions of Articles 1, 2.5, 3, 4 and 5.4, 6 and 7 of this Agreement will survive the termination of this Agreement and the consulting relationship.

 

{signature page follows}

 

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IN WITNESS WHEREOF the parties have executed this Agreement as of the date first above written.

 

 

	
S1 Biopharma, Inc.
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/ John F. Kaufmann
    	
 
    
	
 
    	
John F. Kaufmann
    	
 
    
	
 
    	
Chief Financial Officer
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
Consultant
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
/s/ Robert Seagraves
    	
 
    

 

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Schedule “A” Consultant Services (to be updated with current amendment changes)

 

Responsibilities of Consultant:

 

1.              Obtain permission from a central Institutional Review Board (IRB, e.g., Schulman Associates IRB in Cincinnati) to serve as a principal investigator for this study.

 

2.              Find and contact suitable patients to serve as study subjects.

 

3.              Wait to screen any subjects until cleared by the FDA to do so (30 days after first signed protocol reaches FDA, if FDA then requires no further delay).

 

4.              For each subject to be screened, first administer informed consent as set by/with the IRB.

 

5.              At screening visit, perform psychiatric history, relation history, receptivity question, sexual function interview to diagnose sexual disorders, standing and supine blood pressure and pulse, physical examination if any new symptoms in the prior 3 months warrant it.  Ask 6-item suicidality screener (C-SSRS SCREEN).  Have subject complete, then collect and review, five self-rated forms: 9-item depression screener (PHQ-9), 19-item sexual function form (Female Sexual Function Index, FSFI), 13-item sexual distress scale (FSDS-R), 15-item Marital Adjustment Test, 15-item adverse event questionnaire (AEQ). Draw blood tests.

 

6.              At each of the three baseline/pre-treatment visits: Have subject complete, then collect and review, two self-rated forms: FSFI, FSDS-R.  Just before and 3 1⁄2-4 hours after giving first dose of new study medication, perform standing and supine blood pressure and pulse, and ask AEQ.  Dispense bottles of study medication to be taken at home for the next 4 weeks.

 

7.              Once each week during treatment: have subject complete, then collect three self-rated forms: FSFI-6 item version, FSDS-R #13, and Patient’s Global Impression of Change.  Sponsor and PI will decide whether this will be done physically, by mail, or by e-mail.

 

8.              At each of the three end-of-treatment visits: collect and count remaining study medication.  Administer, collect and review the FSFI, FSDS-R, and Patient’s Global Impression question.  Perform standing and supine blood pressure and pulse, and AEQ.

 

9.              At final visit (3rd end-of-treatment visit), also draw blood tests and perform physical exam as needed to evaluate any new symptoms.

 

10.       Keep accurate, complete, and timely records on case report forms (CRF) and a separate medical chart of source documents for each subject.  Submit CRFs to sponsor in a timely way.  Sponsor will decide whether CRFs should be submitted by courier, e-mail, or fax.

 

11.       Keep a master study file binder readily accessible to include all study-related documents (FDA form 1572, c.v. for each staff member with any responsibility over study subjects, protocol, contract, informed consent form (ICF), IRB submissions, sponsor’s monitoring 

 

 

reports, study medication records, any amendments to protocol or ICF, and all other study-related correspondence)

 

12.       Report any adverse findings, e.g., serious AE, to sponsor and IRB as required by federal regulations.

 

13.       Modify ICF to reflect any changes of substance that could affect subjects’ willingness to participate, e.g., new adverse findings.

 

14.       Accommodate onsite the sponsor’s medical monitor and clinical research associate attending an initiation meeting, periodic monitoring visits every 1-2 months, and a close-out visit to account for and dispose of remaining study medication, supplies, and study documentation.

 

15.       Accommodate onsite any requested auditing visit by the sponsor, the IRB, or the FDA (not expected as this is a small, early-phase study)

 

16.       Notify IRB promptly of study initiation and, at close-out, of study’s main findings.  If study last more than one year, update the IRB yearly.

 

17.       Utilize Robert Taylor Segraves, MD, PhD as the Principal Investigator for the Trial.

 

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Schedule “B”  Administrative Services

 

Responsibilities of Consultant’s Corporate entity:

 

The Administrative Services to be provided by the Consultant’s Corporate Entity Levine, Risen and Associates, Inc.,(The Center for Marital and Sexual Health Inc.) 23425 Commerce Park Rd.

 

Suite 104, Beachwood, Ohio 44122 216-831-2900 sheridan@levinerisenandassociates.com] will be compensated as per the following compensation schedule:

 

COMPENSATION SCHEDULE FOR ADMINISTRATIVE SERVICES (US dollars)

 

	
Visit
    	
 
    	
1
    	
 
    	
2
    	
 
    	
3
    	
 
    	
4
    	
 
    	
5
    	
 
    	
6
    	
 
    	
7
    	
 
    	
Final Eval.
    	
 
    	
Post tx
    	
 
    	
Total/subject
    	
 
    
	
Total by visit
    	
 
    	
420
    	
 
    	
260
    	
 
    	
230
    	
 
    	
290
    	
 
    	
230
    	
 
    	
290
    	
 
    	
230
    	
 
    	
230
    	
 
    	
30
    	
 
    	
2646.00
    	
 
    
	
Overhead @ 20% of 2205.00
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
441
    	
 
    
	
Total per subject
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
2646.00
    	
 
    
	
Total for 15 subjects
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
39,690.00
    	
 
    

 

A payment of $5000 will be made prior to the first visit of the first patient enrolled in this study. The Center will then bill on a monthly basis for procedures completed  The remainder of the expenses will be paid within thirty (30) days after the completion of the Clinical Trial.  Completion of the Clinical Trial is defined as the date on which the closeout visit occurs between the Consultant and the Company’s Clinical Research Associate (or the Company’s Study Monitor) after the final patient enrolled in the study completes their last clinical visit. Screen fails will be reimbursed at a ratio of 2:1 to randomizations for a maximum of 30 screen fails.  The screen fail rate will be the V1 420 + 20% for a total of 504 per screen fail.

 

An additional $1,500.00 of non-refundable start-up costs for regulatory and administrative costs and $5000.00 Advertising expense will be paid prior to the commencement of the Clinical Trials.  Also, there will be a charge of $25 per phone screen conducted by the Consultant, which will be invoiced to the Company on a monthly basis.  These fees are in addition to the ‘Compensation Schedule for Administrative Services’ expenses listed in the table above.

 

Physical examinations will be billed as pass-through cost if required at a rate of $165 per exam (not included in total).

 

Additional lab cost will be billed on pass-through basis.

 

Subject compensation will be provided by the sponsor.

 

	
 
    	
Company:
    	
 
    
	
 
    	
 
    
	
 
    	
Consultant:
    	
 
    
	
 
    	
 
    
	
 
    	
Date:
    	
 
    

 

17EXHIBIT 10.9

 

INDEMNIFICATION AGREEMENT

 

This Indemnification Agreement (the “Agreement”) is entered into as of                           , 2014, by and among S1 Biopharma, Inc., a Delaware corporation (the “Company”) and the undersigned party (the “Indemnitee”).

 

RECITALS

 

A.                                    The Company and the Indemnitee recognize the substantial increase in corporate litigation in general, subjecting directors, officers, employees, controlling persons, agents and fiduciaries to expensive litigation risks at the same time as the availability and coverage of liability insurance has been severely limited.

 

B.                                    The Indemnitee does not regard the current protection available as adequate under the present circumstances, and the Indemnitee and other directors, officers, employees, controlling persons, agents and fiduciaries of the Company may not be willing to serve in such capacities without additional protection.

 

C.                                    The Company:  (i) desires to attract and retain the involvement of highly qualified individuals and entities, such as the Indemnitee, to [continue to] serve the Company and, in part, to induce the Indemnitee to [continue to] be involved with the Company and (ii) wishes to provide for the indemnification and advancing of expenses to the Indemnitee to the maximum extent permitted by law.

 

D.                                    Although the bylaws of the Company require indemnification of the officers and directors of the Company, and the Indemnitee may also be entitled to indemnification pursuant to the General Corporation Law of the State of Delaware (the “DGCL”), the bylaws and the DGCL expressly provide that the indemnification provisions set forth therein are not exclusive, and thereby contemplate that contracts may be entered into between the Company and members of the board of directors, officers and other persons with respect to indemnification.

 

E.                                     This Agreement is a supplement to and in furtherance of the bylaws of the Company and any resolutions adopted pursuant thereto, and shall not be deemed a substitute therefor, nor to diminish or abrogate any rights of the Indemnitee thereunder.

 

F.                                      In view of the considerations set forth above, the Company desires that the Indemnitee be indemnified by the Company as set forth herein.

 

NOW, THEREFORE, the Company and the Indemnitee hereby agree as follows:

 

1.                                      Indemnification.

 

a.                                      Indemnification of Expenses.  The Company shall indemnify and hold harmless the Indemnitee (including his or her respective directors, officers, partners, employees, agents and spouses, if any) and each person who controls any of them or who may be liable within the meaning of Section 15 of the Securities Act of 1933, as amended (the 

 

 

“Securities Act”), or Section 20 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) to the fullest extent permitted by law if the Indemnitee was or is or becomes a party to or witness or other participant in, or are threatened to be made a party to or witness or other participant in, any threatened, pending or completed action, suit, proceeding or alternative dispute resolution mechanism, or any hearing, inquiry or investigation that the Indemnitee believes might lead to the institution of any such action, suit, proceeding or alternative dispute resolution mechanism, whether civil, criminal, administrative, investigative or other (hereinafter a “Claim”) (i) by reason of (or arising in part or in whole out of) any event or occurrence related to the fact that the Indemnitee is, was or may be deemed a director, officer, stockholder, employee, controlling person, agent or fiduciary of the Company, or any subsidiary of the Company, or is, was or may be deemed to be serving at the request or consent of the Company as a director, officer, stockholder, employee, controlling person, agent or fiduciary of another corporation, partnership, limited liability company, joint venture, trust or other enterprise, or (ii) by reason of any action or inaction on the part of such Indemnitee while serving in such capacity including, without limitation, any and all losses, claims, damages, expenses and liabilities, joint or several (including any investigation, legal and other expenses incurred in connection with, and any amount paid in settlement of, any action, suit, proceeding or any claim asserted) under the Securities Act, the Exchange Act or other federal or state statutory law or regulation, at common law or otherwise, that relate directly or indirectly to the registration, purchase, sale or ownership of any securities of the Company or to any fiduciary obligation owed or alleged to be owed to the Company or its stockholders or any other constituency of the Company with respect thereto (hereinafter an “Indemnifiable Event”), against any and all expenses (including attorneys’ fees and all other costs, expenses and obligations incurred in connection with investigating, defending a witness in or participating in (including on appeal), or preparing to defend, be a witness in or participate in, any such action, suit, proceeding, alternative dispute resolution mechanism, hearing, inquiry or investigation), judgments, fines, penalties and amounts paid in settlement (if such settlement is approved in advance by the Company, which approval shall not be unreasonably withheld) of such Claim and any federal, state, local or foreign taxes imposed on the Indemnitee as a result of the actual or deemed receipt of any payments under this Agreement (collectively, hereinafter “Expenses”), including all interest, assessments and other charges paid or payable in connection with or in respect of such Expenses.  Such payment of Expenses shall be made by the Company as soon as practicable but in any event no later than twenty (20) days after written demand by the Indemnitee therefor is presented to the Company.

 

b.                                      Reviewing Party.  Notwithstanding the foregoing, (i) the obligations of the Company under Section 1(a) shall be subject to the condition that the Reviewing Party (as described in Section 10(e) hereof) shall not have determined (in a written opinion, in any case in which the Independent Legal Counsel referred to in Section 10(d) hereof is involved) that the Indemnitee would not be permitted to be indemnified under applicable law, and (ii) the Indemnitee acknowledges and agrees that the obligation of the Company to make an advance payment of Expenses to the Indemnitee pursuant to Section 2(a) (an “Expense Advance”) shall be subject to the condition that, if, when and to the extent that the Reviewing Party determines that the Indemnitee would not be permitted to be so indemnified under applicable law, the Company shall be entitled to be reimbursed by the Indemnitee (who hereby agrees to reimburse the Company) for all such amounts theretofore paid; provided, however, that if the Indemnitee has commenced or thereafter commences legal proceedings in a court of competent jurisdiction to secure a determination that the Indemnitee should be indemnified under 

 

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applicable law, any determination made by the Reviewing Party that the Indemnitee would not be permitted to be indemnified under applicable law shall not be binding and the Indemnitee shall not be required to reimburse the Company for any Expense Advance until a final judicial determination is made with respect thereto (as to which all rights of appeal therefrom have been exhausted or lapsed).  The Indemnitee’s obligation to reimburse the Company for any Expense Advance shall be unsecured and no interest shall be charged thereon.  If there has not been a Change in Control (as defined in Section 10(c) hereof), the Reviewing Party shall be selected by the Board of Directors, and if there has been such a Change in Control (other than a Change in Control that has been approved by a majority of the Company’s Board of Directors who were directors immediately prior to such Change in Control), the Reviewing Party shall be the Independent Legal Counsel referred to in Section 10(d) hereof.  If there has been no determination by the Reviewing Party or if the Reviewing Party determines that the Indemnitee substantively would not be permitted to be indemnified in whole or in part under applicable law, the Indemnitee shall have the right to commence litigation seeking an initial determination by the court or challenging any such determination by the Reviewing Party or any aspect thereof, including the legal or factual bases therefor, and the Company hereby consents to service of process and to appear in any such proceeding.  Any determination by the Reviewing Party otherwise shall be conclusive and binding on the Company and the Indemnitee.

 

c.                                       Contribution.  If the indemnification provided for in Section 1(a) above for any reason is held by a court of competent jurisdiction to be unavailable to an Indemnitee in respect of any losses, claims, damages, expenses or liabilities referred to therein, then the Company, in lieu of indemnifying the Indemnitee thereunder, shall contribute to the amount paid or payable by the Indemnitee as a result of such losses, claims, damages, expenses or liabilities (i) in such proportion as is appropriate to reflect the relative benefits received by the Company and the Indemnitee, or (ii) if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company and the Indemnitee in connection with the action or inaction that resulted in such losses, claims, damages, expenses or liabilities, as well as any other relevant equitable considerations.  In connection with the registration of the Company’s securities, the relative benefits received by the Company and the Indemnitee shall be deemed to be in the same respective proportions that the net proceeds from the offering (before deducting expenses) received by the Company and the Indemnitee, in each case as set forth in the table on the cover page of the applicable prospectus, bear to the aggregate public offering price of the securities so offered.  The relative fault of the Company and the Indemnitee shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company or the Indemnitee and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission.

 

The Company and the Indemnitee agree that it would not be just and equitable if contribution pursuant to this Section 1(c) were determined by pro rata or per capita allocation or by any other method of allocation that does not take account of the equitable considerations referred to in the immediately preceding paragraph.  In connection with the registration of the Company’s securities, in no event shall an Indemnitee be required to contribute any amount under this Section 1(c) in excess of the lesser of:  (i) that proportion of the total of such losses, 

 

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claims, damages or liabilities that are indemnified against, equal to the proportion of the total securities sold under such registration statement that is being sold by the Indemnitee or (ii) the proceeds received by the Indemnitee from its sale of securities under such registration statement.  No person found guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not found guilty of such fraudulent misrepresentation.

 

d.                                      Survival Regardless of Investigation.  The indemnification and contribution provided for in this Section 1 will remain in full force and effect regardless of any investigation made by or on behalf of any Indemnitee or any officer, director, employee, agent or controlling person of an Indemnitee.

 

e.                                       Change in Control.  The Company agrees that if there is a Change in Control of the Company (other than a Change in Control that has been approved by a majority of the Company’s Board of Directors who were directors immediately prior to such Change in Control) then, with respect to all matters thereafter arising concerning the rights of an Indemnitee to payments of Expenses under this Agreement or any other agreement or under the Company’s certificate of incorporation or bylaws as now or hereafter in effect, Independent Legal Counsel (as defined in Section 10(d) hereof) shall be selected by the Indemnitee and approved by the Company (which approval shall not be unreasonably withheld).  Such counsel, among other things, shall render its written opinion to the Company and the Indemnitee as to whether and to what extent the Indemnitee would be permitted to be indemnified under applicable law.  The Company agrees to abide by such opinion and to pay the reasonable fees of the Independent Legal Counsel referred to above and to fully indemnify such counsel against any and all expenses (including attorneys’ fees), claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.

 

f.                                        Mandatory Payment of Expenses.  Notwithstanding any other provision of this Agreement, to the extent that an Indemnitee has been successful on the merits or otherwise, including, without limitation, the dismissal of an action without prejudice, in the defense of any action, suit, proceeding, inquiry or investigation referred to in Section 1(a) hereof or in the defense of any claim, issue or matter therein, the Indemnitee shall be indemnified against all Expenses incurred by the Indemnitee in connection herewith.

 

2.                                      Expenses; Indemnification Procedure.

 

a.                                      Advancement of Expenses.  The Company shall advance all Expenses incurred by an Indemnitee.  The advances to be made hereunder shall be paid by the Company to the Indemnitee as soon as practicable but in any event no later than twenty (20) days after written demand by the Indemnitee therefor to the Company.

 

b.                                      Notice/Cooperation by the Indemnitee.  The Indemnitee shall give the Company notice in writing as soon as practicable of any Claim made against the Indemnitee for which indemnification will or could be sought under this Agreement.  Notice to the Company shall be directed to the Chief Executive Officer of the Company at the Company’s address (or such other address as the Company shall designate in writing to the Indemnitee).

 

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c.                                       No Presumptions; Burden of Proof.  For purposes of this Agreement, the termination of any Claim by judgment, order, settlement (whether with or without court approval) or conviction, or upon a plea of nolo contendere, or its equivalent, shall not create a presumption that the Indemnitee did not meet any particular standard of conduct or have any particular belief or that a court has determined that indemnification is not permitted by applicable law.  In addition, neither the failure of the Reviewing Party to have made a determination as to whether the Indemnitee has met any particular standard of conduct or had any particular belief, nor an actual determination by the Reviewing Party that the Indemnitee has not met such standard of conduct or did not have such belief, prior to the commencement of legal proceedings by the Indemnitee to secure a judicial determination that the Indemnitee should be indemnified under applicable law, shall be a defense to the Indemnitee’s claim or create a presumption that the Indemnitee has not met any particular standard of conduct or did not have any particular belief.  In connection with any determination by the Reviewing Party or otherwise as to whether an Indemnitee is entitled to be indemnified hereunder, the burden of proof shall be on the Company to establish that the Indemnitee is not so entitled.

 

d.                                      Notice to Insurers.  If, at the time of the receipt by the Company of a notice of a Claim pursuant to Section 2(b) hereof, the Company has liability insurance in effect that may cover such Claim, the Company shall give prompt notice of the commencement of such Claim to the insurers in accordance with the procedures set forth in each of the policies.  The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of the Indemnitee, all amounts payable as a result of such Claim in accordance with the terms of such policies.

 

e.                                       Selection of Counsel.  If the Company shall be obligated hereunder to pay the Expenses of any Claim, the Company shall be entitled to assume the defense of such Claim, with counsel approved by the Indemnitee (which approval shall not be unreasonably withheld), upon the delivery to the Indemnitee of written notice of its election to do so.  After delivery of such notice, approval of such counsel by the Indemnitee and the retention of such counsel by the Company, the Company will not be liable to the Indemnitee under this Agreement for any fees of counsel subsequently incurred by the Indemnitee with respect to the same Claim; provided that, (i) the Indemnitee shall have the right to employ the Indemnitee’s counsel in any such Claim at the Indemnitee’s expense and (ii) if (A) the employment of counsel by the Indemnitee has been previously authorized by the Company, (B) the Indemnitee shall have reasonably concluded that there is a conflict of interest between the Company and the Indemnitee in the conduct of any such defense, or (C) the Company shall not continue to retain such counsel to defend such Claim, then the fees and expenses of the Indemnitee’s counsel shall be at the expense of the Company.

 

3.                                      Additional Indemnification Rights; Nonexclusivity.

 

a.                                      Scope.  The Company hereby agrees to indemnify the Indemnitee to the fullest extent permitted by law, even if such indemnification is not specifically authorized by the other provisions of this Agreement, the Company’s certificate of incorporation, the Company’s bylaws or by statute.  In the event of any change after the date of this Agreement in any applicable law, statute or rule that expands the right of a Delaware corporation to indemnify a member of its Board of Directors or an officer, stockholder, employee, controlling person, 

 

5

 

agent or fiduciary, it is the intent of the parties hereto that the Indemnitee shall enjoy by this Agreement the greater benefits afforded by such change.  In the event of any change in any applicable law, statute or rule that narrows the right of a Delaware corporation to indemnify a member of its Board of Directors or an officer, employee, agent or fiduciary, such change, to the extent not otherwise required by such law, statute or rule to be applied to this Agreement, shall have no effect on this Agreement or the parties’ rights and obligations hereunder except as set forth in Section 8(a) hereof.

 

b.                                      Nonexclusivity.  The indemnification provided by this Agreement shall be in addition to any rights to which the Indemnitee may be entitled under the Company’s certificate of incorporation, its bylaws, any agreement, any vote of stockholders or disinterested directors, the DGCL, or otherwise.  The indemnification provided under this Agreement shall commence upon the date an Indemnitee first serves in an indemnified capacity and shall continue as to the Indemnitee for any action the Indemnitee took or did not take while serving in an indemnified capacity even though the Indemnitee may have ceased to serve in such capacity. The Company hereby acknowledges that the Indemnitee may have other sources of indemnification or insurance, whether currently in force or established in the future (collectively, the “Outside Indemnitors”).  The Company hereby agrees: (i) that it is the indemnitor of first resort (i.e., its obligations to the Indemnitee are primary and any obligation of the Outside Indemnitors to advance expenses or to provide indemnification for the same expenses or liabilities incurred by the Indemnitee are secondary); (ii) that it shall be required to advance the full amount of expenses incurred by the Indemnitee and shall be liable in full for all indemnifiable amounts to the extent legally permitted and as required by the certificate of incorporation and bylaws (or any agreement between the Company and the Indemnitee), without regard to any rights the Indemnitee may have against the Outside Indemnitors and (iii) that it irrevocably waives, relinquishes and releases the Outside Indemnitors from any and all claims against the Outside Indemnitors for contribution, subrogation or any other recovery of any kind in respect thereof.  The Company further agrees that no advancement or payment by the Outside Indemnitors on behalf of the Indemnitee with respect to any claim for which the Indemnitee have sought indemnification from the Company shall affect the foregoing and the Outside Indemnitors shall have a right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of the Indemnitee against the Company.  The Company and the Indemnitee agree that the Outside Indemnitors are express third party beneficiaries of the terms hereof.

 

4.                                      No Duplication of Payments.  Except as otherwise set forth in Section 3(b) above, the Company shall not be liable under this Agreement to make any payment in connection with any Claim made against an Indemnitee to the extent the Indemnitee has otherwise actually received payment (under any insurance policy, certificate of incorporation, bylaw or otherwise) of the amounts otherwise indemnifiable hereunder.

 

5.                                      Partial Indemnification.  If an Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for any portion of Expenses incurred in connection with any Claim, but not, however, for all of the total amount thereof, the Company shall nevertheless indemnify the Indemnitee for the portion of such Expenses to which the Indemnitee is entitled.

 

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6.                                      Mutual Acknowledgement.  The Company and the Indemnitee acknowledge that in certain instances, Federal law or applicable public policy may prohibit the Company from indemnifying its directors, officers, employees, controlling persons, agents or fiduciaries under this Agreement or otherwise.  The Indemnitee understands and acknowledges that the Company has undertaken or may be required in the future to undertake with the Securities and Exchange Commission to submit the question of indemnification to a court in certain circumstances for a determination of the Company’s rights under public policy to indemnify an Indemnitee.

 

7.                                      Liability Insurance.  To the extent the Company maintains liability insurance applicable to directors, officers, employees, control persons, agents or fiduciaries, the Indemnitee shall be covered by such policies in such a manner as to provide the Indemnitee the same rights and benefits as are accorded to the most favorably insured (i) of the Company’s directors, if the Indemnitee is a director, or (ii) of the Company’s officers, if the Indemnitee is not a director of the Company but is an officer; or (iii) of the Company’s key employees, controlling persons, agents or fiduciaries, if the Indemnitee is not an officer or director but is a key employee, agent, control person or fiduciary.

 

8.                                      Exceptions.  Any other provision herein to the contrary notwithstanding, the Company shall not be obligated pursuant to the terms of this Agreement:

 

a.                                      Claims Initiated by an Indemnitee.  To indemnify or advance expenses to an Indemnitee with respect to Claims initiated or brought voluntarily by the Indemnitee and not by way of defense, except:  (i) with respect to actions or proceedings to establish or enforce a right to indemnify under this Agreement or any other agreement or insurance policy or under the Company’s certificate of incorporation or bylaws now or hereafter in effect relating to Claims for Indemnifiable Events; (ii) in specific cases if the Board of Directors has approved the initiation or bringing of such Claim; or (iii) as otherwise required under Section 145 of the DGCL, regardless of whether the Indemnitee ultimately is determined to be entitled to such indemnification, advance expense payment or insurance recovery, as the case may be; or

 

b.                                      Claims Under Section 16(b).  To indemnify an Indemnitee for expenses and the payment of profits arising from the purchase and sale by the Indemnitee of securities in violation of Section 16(b) of the Exchange Act or any similar successor statute; or

 

c.                                       Claims Excluded Under Section 145 of the DGCL.  To indemnify the Indemnitee if:  (i) the Indemnitee did not act in good faith and in a manner reasonably believed to be in or not opposed to the best interests of the Company or (ii) with respect to any criminal action or proceeding, the Indemnitee had reasonable cause to believe the conduct was unlawful or (iii) the Indemnitee shall have been adjudged to be liable to the Company unless and only to the extent the court in which such action was brought shall permit indemnification as provided in Section 145(b) of the DGCL.

 

9.                                      Period of Limitations.  No legal action shall be brought and no cause of action shall be asserted by or in the right of the Company against an Indemnitee or an Indemnitee’s estate, spouse, heirs, executors or personal or legal representatives after the 

 

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expiration of five (5) years from the date of accrual of such cause of action, and any claim or cause of action of the Company shall be extinguished and deemed released unless asserted by the timely filing of a legal action within such five (5)-year period; provided, however, that if any shorter period of limitations is otherwise applicable to any such cause of action, such shorter period shall govern.

 

10.                               Construction of Certain Phrases.

 

a.                                      For purposes of this Agreement, references to the “Company” shall include, in addition to the resulting corporation, any constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger that, if its separate existence had continued, would have had power and authority to indemnify its directors, officers, stockholders, employees, agents or fiduciaries, so that if an Indemnitee is, was or may be deemed a director, officer, stockholder, employee, agent, control person, or fiduciary of such constituent corporation, or is or was serving at the request of such constituent corporation as a director, officer, employee, control person, agent or fiduciary of another corporation, partnership, limited liability company, joint venture, employee benefit plan, trust or other enterprise, the Indemnitee shall stand in the same position under the provisions of this Agreement with respect to the resulting or surviving corporation as the Indemnitee would have with respect to such constituent corporation if its separate existence had continued.

 

b.                                      For purposes of this Agreement, references to “other enterprises” shall include employee benefit plans; references to “fines” shall include any excise taxes assessed on an Indemnitee with respect to an employee benefit plan; and references to “serving at the request of the Company” shall include any service as a director, officer, employee, agent or fiduciary of the Company that imposes duties on, or involves services by, such director, officer, employee, agent or fiduciary with respect to an employee benefit plan, its participants or its beneficiaries; and if an Indemnitee acted in good faith and in a manner the Indemnitee reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan, the Indemnitee shall be deemed to have acted in a manner “not opposed to the best interests of the Company” as referred to in this Agreement.

 

c.                                       For purposes of this Agreement a “Change in Control” shall be deemed to have occurred if:  (i) any “person” (as such term is used in Sections 13(d)(3) and 14(d)(2) of the Exchange Act), other than a trustee or other fiduciary holding securities under an employee benefit plan of the Company or a corporation owned directly or indirectly by the stockholders of the Company in substantially the same proportions as their ownership of stock of the Company, (A) who is or becomes the beneficial owner, directly or indirectly, of securities of the Company representing twenty percent (20%) or more of the combined voting power of the Company’s then outstanding Voting Securities, increases his beneficial ownership of such securities by five percent (5%) or more over the percentage so owned by such person, or (B) becomes the “beneficial owner” (as defined in Rule 13d-3 under said Exchange Act), directly or indirectly, of securities of the Company representing more than thirty percent (30%) of the total voting power represented by the Company’s then outstanding Voting Securities, (ii) during any period of two (2) consecutive years, individuals who at the beginning of such period constitute the Board of Directors of the Company and any new director whose election by the Board of Directors or nomination for election by the Company’s stockholders was approved by a 

 

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vote of at least two-thirds (2/3) of the directors then still in office who either were directors at the beginning of the period or whose election or nomination for election was previously so approved, cease for any reason to constitute a majority thereof, or (iii) the stockholders of the Company approve a merger or consolidation of the Company with any other corporation other than a merger or consolidation that would result in the Voting Securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into Voting Securities of the surviving entity) at least eighty percent (80%) of the total voting power represented by the Voting Securities of the Company or such surviving entity outstanding immediately after such merger or consolidation, or the stockholders of the Company approve a plan of complete liquidation of the Company or an agreement for the sale or disposition by the Company of (in one transaction or a series of transactions) all or substantially all of the Company’s assets.

 

d.                                      For purposes of this Agreement, “Independent Legal Counsel” shall mean an attorney or firm of attorneys, selected in accordance with the provisions of Section 2(e) hereof, who shall not have otherwise performed services for the Company or the Indemnitee within the last three (3) years (other than with respect to matters concerning the right of the Indemnitee under this Agreement, or of other indemnitees under similar indemnity agreements).

 

e.                                       For purposes of this Agreement, a “Reviewing Party” shall mean any appropriate person or body consisting of a member or members of the Company’s Board of Directors or any other person or body appointed by the Board of Directors who is not a party to the particular Claim for which the Indemnitee is seeking indemnification, or Independent Legal Counsel.

 

f.                                        For purposes of this Agreement, “Voting Securities” shall mean any securities of the Company that vote generally in the election of directors.

 

11.                               Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall constitute an original.

 

12.                               Binding Effect; Successors and Assigns.  This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors, assigns, including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of the business and/or assets of the Company, spouses, heirs and personal and legal representatives.  The Company shall require and cause any successor (whether direct or indirect by purchase, merger, consolidation or otherwise) to all, substantially all, or a substantial part, of the business and/or assets of the Company, by written agreement in form and substance satisfactory to the Indemnitee, expressly to assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place.  This Agreement shall continue in effect with respect to Claims relating to Indemnifiable Events regardless of whether the Indemnitee continues to serve as a director, officer, employee, agent, controlling person or fiduciary of the Company or of any other enterprise, including subsidiaries of the Company, at the Company’s request.

 

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13.                               Attorneys’ Fees.  In the event that any action is instituted by an Indemnitee under this Agreement or under any liability insurance policies maintained by the Company to enforce or interpret any of the terms hereof or thereof, the Indemnitee shall be entitled to be paid all Expenses incurred by the Indemnitee with respect to such action if the Indemnitee is ultimately successful in such action, and shall be entitled to the advancement of Expenses with respect to such action, except, in the case of both payment and advancement of Expenses, as and solely to the extent of Expenses incurred with respect to a material assertion made by the Indemnitee as a part of such action which a court of competent jurisdiction over such action determines was not made in good faith or was frivolous.  In the event of an action instituted by or in the name of the Company under this Agreement to enforce or interpret any of the terms of this Agreement, an Indemnitee shall be entitled to be paid Expenses incurred by such Indemnitee in defense of such action (including costs and expenses incurred with respect to his or its counterclaims and cross-claims made in such action), and shall be entitled to the advancement of Expenses with respect to such action, except, in the case of both payment and advancement of Expenses, as and solely to the extent of Expenses incurred with respect to a material assertion made by the Indemnitee as a part of such action which a court of competent jurisdiction over such action determines was not made in good faith or was frivolous.

 

14.                               Notice.  All notices and other communications required or permitted hereunder shall be in writing, shall be effective when given, and shall in any event be deemed to be given:  (a) five (5) days after deposit with the U.S. Postal Service or other applicable postal service, if delivered by first class mail, postage prepaid; (b) upon delivery, if delivered by hand; (c) one (1) business day after the business day of deposit with Federal Express or similar overnight courier, freight prepaid; or (d) one (1) day after the business day of delivery by facsimile transmission, if deliverable by facsimile transmission, with copy by first class mail, postage prepaid, and shall be addressed if to an Indemnitee, at the Indemnitee’s address as set forth beneath the Indemnitee’s signature to this Agreement and if to the Company at the address of its principal corporate offices (attention: Secretary) or at such other address as such party may designate by ten (10) days’ advance written notice to the other party hereto.

 

15.                               Consent to Jurisdiction.  The Company and the Indemnitee each hereby irrevocably consent to the jurisdiction of the courts of the State of Delaware for all purposes in connection with any action or proceeding that arises out of or relates to this Agreement and agree that any action instituted under this Agreement shall be commenced, prosecuted and continued only in the Court of Chancery of the State of Delaware in and for New Castle County, which shall be the exclusive and only proper forum for adjudicating such a claim.

 

16.                               Severability.  The provisions of this Agreement shall be severable in the event that any of the provisions hereof (including any provision within a single section, paragraph or sentence) are held by a court of competent jurisdiction to be invalid, void or otherwise unenforceable, and the remaining provisions shall remain enforceable to the fullest extent permitted by law.  Furthermore, to the fullest extent possible, the provisions of this Agreement (including, without limitations, each portion of this Agreement containing any provision held to be invalid, void or otherwise unenforceable, that is not itself invalid, void or unenforceable) shall be construed so as to give effect to the intent manifested by the provision held invalid, illegal or unenforceable.

 

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17.                               Choice of Law.  This Agreement shall be governed by and its provisions construed and enforced in accordance with the laws of the State of Delaware, as applied to contracts between Delaware residents, entered into and to be performed entirely within the State of Delaware, without regard to the conflict of laws principles thereof.

 

18.                               Subrogation.  In the event of payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of the Indemnitee who shall execute all documents required and shall do all acts that may be necessary to secure such rights and to enable the Company effectively to bring suit to enforce such rights.

 

19.                               Amendment and Termination.  No amendment, modification, termination or cancellation of this Agreement shall be effective unless it is in writing signed by all parties hereto.  No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing waiver.

 

20.                               Integration and Entire Agreement.  This Agreement sets forth the entire understanding between the parties hereto and supersedes and merges all previous written and oral negotiations, commitments, understandings and agreements relating to the subject matter hereof between the parties hereto.

 

21.                               No Construction as Employment Agreement.  Nothing contained in this Agreement shall be construed as giving the Indemnitee any right to be retained in the employ of the Company or any of its subsidiaries.

 

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IN WITNESS WHEREOF, the parties hereto have executed this Indemnification Agreement on and as of the day and year first above written.

 

	
 
    	
COMPANY:
    
	
 
    	
 
    
	
 
    	
S1   BIOPHARMA, INC.,
    
	
 
    	
a   Delaware corporation
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
 
    
	
 
    	
 
    	
Nicolas   G. Sitchon
    
	
 
    	
 
    	
Chief   Executive Officer and President
    
	
 
    	
 
    
	
 
    	
Address   for Notice:
    
	
 
    	
 
    
	
 
    	
1   Independence Way
    
	
 
    	
Suite 102
    
	
 
    	
Jersey   City, NJ 07305-5442
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
INDEMNITEE:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Address:
    
	
 
    	
 
    
	
 
    	
 
    

Signature Page to Indemnification Agreement

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