Document:

Exhibit 10.30

 

MASTER AGREEMENT FOR SERVICES

 

THIS MASTER AGREEMENT (the “Master Agreement”) is made and entered into the 25th day of October, 2013 (the “Effective Date”), by and between Dipexium Pharmaceuticals, LLC (“Client”), together with its subsidiaries and affiliates, having its offices located at           , and ReSearch Pharmaceutical Services, Inc. (“RPS”), together with its subsidiaries and affiliates, having its primary office at           .

 

For purposes of this Agreement, an affiliate or subsidiary of a party shall mean any entity that directly or indirectly controls, is controlled by or is under common control with such party. Control, controls or controlled with respect to an entity shall mean an ownership or interest, direct or indirect, in at least 50% of such entity either through the ownership of such entity’s stock, voting power, membership interest or otherwise or the power to direct, or the power to cause the direction of the management and policies of such entity.

 

WHEREAS, Client is engaged in the research and development of pharmaceutical products; and

 

WHEREAS, RPS is a pharmaceutical resource organization engaged in the business of providing clinical research and/or consulting services; and

 

WHEREAS, Client may wish to retain the services of RPS from time to time to perform clinical research services and/or consulting services with respect to various projects Client is or may be conducting (individually, a “Project,” and collectively, the “Projects”), which shall be set forth in Exhibits to this Master Agreement; and

 

WHEREAS, RPS wishes to provide such clinical research services and/or consulting services to Client in accordance with the terms and conditions set forth in this Master Agreement and each Exhibit; and

 

WHEREAS, Client has engaged RRD International, LLC (“RRD”) to manage certain aspects of the development of Client’s drug development program, and RPS agrees to use all commercially reasonable efforts to work with RRD as Client’s representative;

 

NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Client and RPS hereby agree as follows:

 

1.                                      Scope of Master Agreement; Obligations

 

a.                                      The specific responsibilities and obligations to be performed by RPS with respect to a Project (the “Services”), are expressly set forth in Exhibit(s) which shall be attached to this Master Agreement and incorporated by reference herein. The Exhibits shall substantially be in the form of Attachment 1, attached hereto and incorporated herein by reference.

 

 

Any responsibilities and obligations which are not specifically assumed by RPS in this Master Agreement or the Exhibit(s) as constituting part of the Services shall be and remain the sole responsibility of Client. To the extent any terms set forth in an Exhibit shall conflict with the terms set forth in this Master Agreement, the terms of this Master Agreement shall control unless otherwise expressly agreed to by the parties as identified, in writing, in the applicable Exhibit.

 

b.                                      RPS agrees to provide the Services in accordance with (i) all applicable laws and regulations; and (ii) the standards and practices that are generally accepted in the industry and exercised by other persons engaged in performing similar services. In addition, all Services will be conducted in accordance with Dipexium Pharmaceuticals, LLC GCP or FDA regulations as appropriate and the additional standards, if any specified in the relevant Protocol. GCP is the standard defined in the TCH Harmonised Tripartite Guideline For Good Clinical Practice E6(Rl) Current Step 4 version dated April 1996 (including the Post Step 4 corrections).

 

c.                                       In the event that RPS is requested or required to perform services beyond those which are specifically set forth in an Exhibit, any such additional services and payment for such services shall be mutually agreed upon in writing by authorized representatives of the parties prior to the provision of such services.

 

2.                                      Payment

 

a.                                      In consideration of the Services, Client shall pay to RPS: (i) the Service Fees (as defined in Section 2 (b)); and (ii) the Pass Through Expenses (as defined in Section 2(c)). A payment schedule for the performance of the Services and related expenses shall be included in each Exhibit attached to this Master Agreement.

 

b.                                      As used in this Master Agreement, the term “Service Fees” means all amounts due for the Services, exclusive of the Pass Through Expenses. The estimated Service Fees and payment terms shall be set forth in the applicable Exhibit, and shall be increased to include: (i) the costs for any additional Services required as a result of Project changes by Client; and (ii) where a Project requires more time than allotted in the applicable Exhibit, and the parties agree to continue such Project beyond the expected conclusion date, any additional costs that may be incurred in order to complete such Project, at contractual rates to be mutually agreed upon by the parties.

 

c.                                       As used in this Master Agreement, the term “Pass Through Expenses” means all pass through expenses actually incurred by RPS under this Master Agreement or the Exhibit(s) in order to expedite successful completion of a Project, which costs are normal and routine to studies similar to such Project. Pass Through Expenses shall include, but not be limited to, travel expenses (airfare, meals, lodging, rental car, tolls, parking, gas, mileage reimbursement), cell phone and land line phone expenses.

 

d.                                      Unless otherwise agreed to in an Exhibit, RPS shall invoice Client for Service Fees and Pass Through Expenses on a monthly basis for Services performed and expenses incurred

 

 

in support of the applicable Project. Payment of Services Fees and Pass Through Expenses shall be payable upon receipt of invoice by Client via ACH at the address below:

 

	
Bank:
    	
Account   Number:
    
	
 
    	
Routing   (ABA) Number:
    
	
 
    	
Account   Type:
    

 

ReSearch Pharmaceutical Services, Inc.                          Federal Tax ID#: 23-273-5793

 

Unless otherwise agreed to in this Exhibit, Client shall pay for all applicable taxes in connection with this Agreement including, but not limited to, any sales, use, excise, value-added, goods and services, consumption and other similar taxes or duties. Each party shall be responsible for taxes based on its own net income, employment taxes of its own employees, and for taxes on any property it owns or leases.

 

e.                                       If applicable, the annual price increase will be addressed in each Exhibit.

 

f.                                        The currency to be used for invoicing and payment of Service Fees or Pass Through Expenses shall be the currency stated in the Exhibit(s) (the “Contracted Currency”). However, for the Services performed by RPS in any countries that use currencies other than the Contracted Currency (“Foreign Services”), the following currency exchange rate reconciliation shall be applied:

 

(i)                                     The currency exchange rate will be set based on the Oanda interbank rate (Oanda.com) current at the time the Service Fees are calculated and incorporated into the Exhibit; provided, however, should such exchange rate fluctuate by +\- 2.5% on a cumulative basis during the term of the Exhibit, the parties shall have the right to adjust the Service Fees based on the revised exchange rate upon thirty (30) days notice to the other party.

 

(ii)                                  Pass Through Expenses will be converted using the currency exchange rate in effect at the time RPS processes such Pass Through Expenses, as published by Oanda.com.

 

3.                                      Term and Termination

 

a.                                      This Master Agreement shall be effective upon the Effective Date and shall thereafter remain in full force and effect until either party terminates this Master Agreement in accordance with this Section 3.

 

b.                                      Termination for Cause. This Master Agreement may be terminated by either party upon written notice to the other party in the event of a material breach by the other party of this Master Agreement and/or the applicable Exhibit provided that the breaching party has been given written notice of the nature of the default and an opportunity to cure such default within a period of thirty (30) days after the giving of such notice of the nature of

 

 

the default. Notwithstanding the foregoing, if Client fails to pay any amounts owed to RPS, including but not limited to, payment for Service Fees and/or Pass Through Expenses, in accordance with this Master Agreement and/or Exhibit(s), and Client fails to cure such default within 10 days following written notice from RPS to Client of such default, then RPS shall have the right to terminate immediately this Master Agreement and any Exhibit(s) and stop all work and services in support of the applicable clinical trials without further notice or demand. In addition, RPS further reserves all rights to pursue any other additional remedies at law or in equity for such default by Client.

 

c.                                       Unless otherwise agreed to in the applicable Exhibit, either party may terminate this Master Agreement and/or any Exhibit at any time and for any reason upon a minimum of ninety (90) days prior written notice. Upon such termination, Client shall pay to RPS, within thirty (30) days of Client’s receipt of invoice, all Service Fees and Pass Through Expenses due and owing based upon Services completed and costs incurred through the effective date of termination, including costs for materials and/or Services previously incurred prior to the effective date of termination.

 

d.                                      Bankruptcy. RPS shall have the right to immediately terminate this Master Agreement and any Exhibit(s) if an order, judgment or decree is entered adjudicating Client bankrupt or insolvent; or Client shall commence any case, proceeding or other action in bankruptcy or seeking reorganization liquidations, dissolution, winding-up, arrangement, composition or readjustment of debts, or for any other relief, under any bankruptcy, insolvency, reorganization, liquidation, dissolution, arrangement, composition or readjustment of debt or other similar act or law of any jurisdiction, domestic or foreign, now or hereafter existing; or if a receiver, custodian or trustee of Client for all or a substantial part of Client’s property shall be appointed; or if a warrant of attachment, execution or distraint, or similar process, shall be issued against any part of the property of Client.

 

4.                                      Independent Contractor

 

a.                                      The parties hereto are independent contractors and, except as specifically set forth herein or in the Exhibit(s), nothing shall be construed to place them in the relationship of partners, principal and agent, or employer-employee or joint venture. Both parties agree that neither party has any authority to bind or act on behalf of the other party without the prior written consent of the other party.

 

b.                                      RPS shall be responsible for paying and withholding all applicable FICA, FUTA, income taxes, unemployment and workers’ compensation insurance for its employees.

 

c.                                       RPS shall control the employment relationship with its employees. It is the responsibility of RPS to determine the hours, assignments, compensation and benefits for its employees. RPS regularly reviews and evaluates the work of its employees and may take appropriate measures, including, but not limited to, termination, if the employee is performing unsatisfactorily.

 

 

d.                                      If Client reasonably believes that an RPS employee assigned to perform Services pursuant to this Agreement is performing unsatisfactorily, Client shall inform RPS of such belief and concern and RPS shall replace such individual, if necessary.

 

5.                                      Confidentiality

 

a.                                      In connection with the performance of the Services, Client shall provide to RPS, and RPS will have access to, Client’s Confidential Information. As used in this Master Agreement, “Client Confidential Information” shall mean any and all information, data (technical and non-technical), tangible materials, samples, models, drawings or diagrams and case reports, data or information provided by, or developed for Client within the framework of this Master Agreement and the Exhibit(s).

 

b.                                      In connection with this Master Agreement, Client shall have access to, or become acquainted with RPS’s Confidential Information. As used in this Master Agreement, “RPS’s Confidential Information” includes, by way of description and not of limitation, any trade secrets, confidential information, ideas, inventions or research and development information; matters of a technical nature, including technology; notes, products, know-how, engineering or other data (including test data and data files); specifications, processes, techniques, formulae or work-in-process; manufacturing, planning or marketing procedures, strategies or information; accounting, financial or pricing procedures or information, budgets or projections, or personnel or salary and/or compensation information of any employee or personnel of RPS; lists or information regarding RPS’s suppliers, clients, customers, employees, contractors, investors or investigators; information which has been designated as confidential by RPS; programs, procedures (including operating procedures), processes, methods, guidelines, policies, proposals or contracts; computer software, data managements system, data bases or programming; and any other information which, if divulged to a third party, could have an adverse impact on RPS, or on any third party to which RPS owes a confidentiality obligation.

 

c.                                       Neither Client’s Confidential Information or RPS’s Confidential Information (collectively, “Confidential Information”) shall include any information that:

 

(i)                                     was known by the receiving party at the time of disclosure to it by the disclosing party, or that is independently developed or discovered by the receiving party, after disclosure by the disclosing party, without the aid, application or use of any item of the disclosing party’s Confidential Information, as evidenced by written records;

 

(ii)                                  is now or subsequently becomes, through no act or failure to act on the part of the receiving party, generally known or available;

 

(iii)                               is disclosed to the receiving party by a third party authorized to disclose it; or

 

 

(iv)                              is required by law or by court or administrative order to be disclosed; provided, that the receiving party shall have first given prompt notice to the other party of such required disclosure.

 

d.                                      Each party shall exercise due care to prevent the unauthorized use or disclosure of the other party’s Confidential Information, and shall not, without the other party’s prior written consent, (i) use the other party’s Confidential Information for any purpose other than performing its obligations under this Master Agreement and the Exhibit(s); or (ii) disclose or otherwise make available, directly or indirectly, any item of the other party’s Confidential Information to any person or entity other than those employees, independent contractors, agents or investigators of such party and/or its affiliated entities (collectively, “Representatives”) who reasonably need to know the same in the performance of such party’s obligations under this Master Agreement (including the Exhibit(s)), or in order to make decisions or render advice in connection therewith. For convenience of the parties, each party acknowledges that unless precluded in writing by the other party, Confidential Information may be transmitted to a party or its Representative via the Internet. Each party shall advise its Representatives who have access to the other party’s Confidential Information of the confidential nature thereof, and agrees that such Representative will be bound by the terms of confidentiality and restrictions on use with respect thereto that are at least as restrictive as the terms of this Section 5.

 

e.                                       The provisions of this Section 5 shall survive for a period of five (5) years from the date of any expiration or termination of this Master Agreement, however caused.

 

f.                                        Upon the written request of Client, at the termination of this Agreement or at such earlier time as Client may specify, RPS shall either destroy or return to Client (except as required by regulatory obligations), as Client may request in its sole discretion, all copies of the Confidential Information. RPS shall use all reasonable efforts to destroy all notes, summaries, analyses and reports made by RPS’ employees, agents and consultants containing such Confidential Information.

 

6.                                      Intellectual Property

 

a.                                      All inventions, data, processes and compounds involving the study drug(s) and/or product(s) covered by this Master Agreement and/or the Exhibit(s) that are conceived or reduced to practice as a direct result of the Project(s) (“Inventions”) shall be and remain the sole property of Client. RPS shall fully cooperate with Client in obtaining, at Client’s sole cost and expense, any patent protection as may be available for the Inventions, and shall execute all documents reasonably deemed necessary by Client for purposes of procuring such patent protection. RPS agrees that it shall endeavor to ensure contractually the prompt disclosure to Client by any investigator, employee or other individual retained by RPS for a Project of any Inventions, as well as the cooperation of such persons in securing patent protection as set forth herein.

 

b.                                      Notwithstanding the foregoing, Client acknowledges that RPS and its professional staff currently possess certain inventions, processes, know-how, trade secrets, methods,

 

 

approaches, analyses, improvements, other intellectual properties and other assets including, but not limited to, clinical trial management analyses, analytical methods, procedures and techniques, computer technical expertise and proprietary software, recruitment and professional personnel database, and technical and conceptual expertise, all of which have been developed independently by RPS without the benefit of any information provided by Client (collectively “RPS Property”). Client agrees that any RPS Property which is used, maintained, improved, modified or developed by RPS under or during the term of this Master Agreement shall be and remain the sole and exclusive property of RPS.

 

7.                                      Indemnification

 

a.                                      Client agrees to indemnify, defend and hold harmless RPS, its affiliated entities, officers, directors, employees, and agents from and against any claims, demands, investigations, suits or actions (each, a “Claim”) for any and all liabilities, losses, damages, penalties, costs or expenses (including without limitation court costs, legal fees, awards or settlements) arising out of or in connection with this Master Agreement and/or Exhibit(s); provided, however, that Client’s indemnity obligations under this Section 7 shall not apply to the extent arising directly from the negligence or willful malfeasance of RPS.

 

b.                                      RPS agrees to indemnify, defend and hold harmless Client, its affiliated entities, officers, directors, employees, and agents from and against any Claims for any and all liabilities, losses, damages, penalties, costs or expenses (including without limitation court costs, legal fees, awards or settlements) arising directly out of the negligence or willful malfeasance of RPS; provided, however, that RPS’ indemnity obligations under this Section 7 shall not apply to the extent arising directly from the negligence or willful malfeasance of Client.

 

c.                                       Each person or entity seeking indemnification under this Section 7 shall, as a condition thereto, notify Client within twenty (20) days after the receipt of notice of the Claim; provided, however, that Client shall not be released from its obligations under this Section 7 if the failure to notify Client within twenty (20) days does not materially prejudice the defense of such claim. Client shall have the right to select defense counsel and to direct the defense or, with the consent of the indemnified party (which consent shall not be unreasonably withheld) settlement of, any Claim. In the event that representation of an indemnified party and Client by the same counsel would be a conflict of interest for such counsel, the indemnified party may select its own independent counsel without relieving Client of its obligations under this Section 7. Under no circumstances shall an indemnified party settle or otherwise compromise any Claim without Client’s prior written consent.

 

8.                                      Limitations

 

a.                                      Client acknowledges that the results of the Project(s) are inherently uncertain and that, accordingly, there can be no assurance, representation or warranty by RPS that the study

 

 

drug(s) and/or product(s) covered by this Master Agreement and/or the Exhibit(s) can, either during the term of this Master Agreement or thereafter, be developed successfully or, if so developed, will receive approval(s) from the FDA or other regulatory agency or authority.

 

b.                                      Both parties acknowledge that the Services constitute research and development. Accordingly, Client’s sole remedy for any breach or default hereof by RPS shall be termination of this Master Agreement or the applicable Exhibit as herein provided or a return of any Service Fees paid to RPS for Services improperly performed or not performed. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY LOSS IN THE NATURE OF INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES OR LOSS OF PROFITS, OPPORTUNITIES, OR GOODWILL RELATING TO THE SERVICES PERFORMED HEREUNDER.

 

9.                                      No Conflict

 

RPS and Client represent that they have full authority and right to enter into this Master Agreement, and that its terms will not conflict with any other agreement to which it is a party.

 

10.                               Restrictions on Announcements

 

Neither party shall employ or use the name of the other party in any publication or promotional material or in any form for public distribution, without the prior written consent of the other party, except as required by law or by court or administrative order.

 

11.                               Notices

 

Any notices, requests or other communications given under this Master Agreement shall be in writing and shall be given by personal delivery, or sent by (i) facsimile transmission (with message confirmed during normal business hours); (ii) first class mail, postage prepaid; or (iii) Federal Express (or equivalent nationally recognized overnight delivery service), delivery charges prepaid. All notices shall be given to a party at its respective address set forth below, or at such other address as such party from time to time may specify by notice in accordance with this Section 11. A notice shall be deemed to be given when actually received; provided, however, that if any facsimile notice is received after 5:00 P.M. local time at the place of receipt, it shall be deemed to have been given as of the next following business day.

 

	
If   to RPS:
    	
ReSearch   Pharmaceutical Services, Inc.
    
	
 
    	
Address:
    
	
 
    	
Attn:   Priscilla Lee
    
	
 
    	
Facsimile   No. 215-540-0770
    
	
 
    	
 
    
	
If   to Client:
    	
Dipexium   Pharmaceuticals, LLC
    

 

 

	
 
    	
Address:
    
	
 
    	
Attn:   Robert J. DiLuccia
    
	
 
    	
Facsimile   No.
    

 

12.                               Non-Debarment

 

a.                                      RPS certifies that RPS has never been and is not currently:

 

(i)                                     an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) (a “Debarred Individual”) from providing services in any capacity to a person that has an approved or pending drug product application, or an employer, employee or partner of a Debarred Individual; or

 

(ii)                                  a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) (a “Debarred Entity”) from submitting or assisting in the submission of an abbreviated new drug application, or an employee, partner, shareholder, member, subsidiary or affiliate of a Debarred Entity.

 

b.                                      RPS further certifies that it has no knowledge of any circumstances which may affect the accuracy of the representations set forth in Section 12(a) above, including, but not limited to, FDA investigations of, or debarment proceedings against, RPS or any person or entity performing, or rendering assistance related to, the Services. RPS shall notify Client promptly upon becoming aware of any such circumstances during the term of this Master Agreement.

 

13.                               Non-solicitation

 

a.                                      Unless permitted under the terms of an Exhibit, Client or any parent, affiliate or subsidiary shall not, or a period of one (1) year after RPS has provided to Client, information, whether in the form of a curriculum vitae or other written form, regarding any potential candidate for any project which Client may be conducting or plans to conduct, solicit, attempt to solicit or otherwise influence, either directly or indirectly, such candidate to apply for or accept any employment or consulting positions with Client or any of its affiliates, agents or contractors, without the prior written approval of RPS.

 

If the applicable candidate is in fact employed or otherwise contracted to perform work as a result of Client’s actions, Client shall pay to RPS a recruiting fee of twenty-five percent (25%) of the candidate’s first year’s salary.

 

b.                                      In addition to the foregoing, Client or any parent, affiliate or subsidiary, shall not, for a period of one (1) year from the date the applicable RPS Personnel (as defined below) commences the performance of Services under an Exhibit (the “Restricted Period”): i) solicit, attempt to solicit or otherwise influence, either directly or indirectly, any employee or independent contractor of RPS assigned to work on a Project for Client

 

 

pursuant to the applicable Exhibit (the “RPS Personnel”), to apply for or accept any employment or consulting positions with Client or any parent, affiliate, subsidiary or other organization to which the RPS Personnel was subsequently disclosed to by Client, without the prior written approval of RPS; or ii) hire or otherwise employ in any capacity whatsoever, the RPS Personnel without the prior written approval of RPS.

 

If Client wishes to offer a RPS Personnel full time employment during the Restricted Period, then Client shall pay to RPS the following conversion fee:

 

	
0- 6 months:
    	
25%   of the selected candidate’s first year’s salary exclusive of bonuses or any   other form of compensation
    
	
 
    	
 
    
	
7- 9 months:
    	
18%   of the selected candidate’s first year’s salary exclusive of bonuses or any   other form of compensation
    
	
 
    	
 
    
	
10- 12 months:
    	
8%   of the selected candidate’s first year’s salary exclusive of bonuses or any   other form of compensation
    
	
 
    	
 
    
	
After 12 months:
    	
No   Fee
    

 

Notwithstanding the foregoing, during the Restricted Period, if Client wishes to offer employment to RPS Personnel who is a medical physician, then Client shall pay to RPS the following conversion fee:

 

	
0-12 months:
    	
25%   of the selected candidate’s first year’s salary exclusive of bonuses or any   other form of compensation
    
	
 
    	
 
    
	
After 12 months:
    	
No   fee
    

 

14.                               Timely Review

 

a.                                      Client acknowledges that RPS will require, among other things: (a) timely review of RPS’s work product; and (b) timely supplies of documents, data, records, and investigational drug product(s) from Client in order to properly perform the Services hereunder and that RPS is not responsible for errors, delays or other consequences arising from the failure of Client to provide such review and/or materials. Client therefore agrees that it will: (a) promptly review RPS’s work product where such review is required and/or necessary; and (b) provide all documents, data, records, investigational drug product(s) and other materials necessary for completion of RPS’s tasks and Services in a timely manner and in accordance with the schedule or time line for the applicable Project.

 

b.                                      Client agrees to reasonably extend all deadlines hereunder due to delays by Client or contractors under its control in (a) reviewing RPS’s work product; and (b) providing documents, data, records and investigational drug product(s) and other materials needed for the completion of RPS’s tasks and Services.

 

 

15.                               Force Majeure

 

If either party is delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, labor troubles, restrictive government or judicial orders or decrees, insurrection, war, Acts of God, inclement weather or other similar reason or cause beyond such party’s control, then performance of such act shall be excused for the period of such delay. Notice of the beginning and end of such period shall be provided to the other party.

 

16.                               Miscellaneous

 

a.                                      This Master Agreement, together with all corresponding Exhibits, amendments or change orders, constitutes the entire agreement between the parties and supersedes all prior contracts, agreements, and understandings between the parties with respect to the subject matter hereof. The parties intend this Master Agreement to be a complete statement of the terms of their agreement, and no change or modification of any of the provisions of this Master Agreement (including the Exhibit(s)) shall be effective unless it is in writing and signed by duly authorized representatives of RPS and Client.

 

b.                                      The failure of either party to enforce any provision of this Master Agreement (including the Exhibit(s)) shall not be construed as a waiver or limitation of that party’s subsequent rights to enforce and compel strict compliance with every provision of this Master Agreement.

 

c.                                       If any clause, section, or paragraph of this Master Agreement, is determined by a court of competent jurisdiction to be illegal, invalid or unenforceable, it will be deemed severed from the remainder of this Master Agreement and will have no effect on the legality, validity or enforceability of the remaining provisions.

 

d.                                      This Master Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Pennsylvania without regard to provisions of conflicts of law.

 

e.                                       Neither party may assign this Master Agreement or any rights hereunder or delegate the performance of any duties hereunder without the prior written approval of the other party; provided, however, that without such approval, either party may assign this Master Agreement in connection with the transfer or sale of all or substantially all of its assets, stock or business, or its merger, consolidation or combination with or into another entity.

 

f.                                        Any terms of this Master Agreement which by their nature extend beyo d its performance, expiration or termination (including without limitation, Sections 2 through 8, 10, 13, 14, and this Section 16(f)) shall remain in effect indefinitely until fulfilled in accordance with their terms.

 

g.                                       This Master Agreement may be executed in counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when joined, shall

 

 

together constitute one and the same agreement. Any photocopy or facsimile of this Master Agreement, or of any counterpart, shall be deemed the equivalent of an original.

 

IN WITNESS WHEREOF, the parties have caused this Master Agreement to be executed by their respective duly authorized representatives effective as of this day and year above written.

 

 

	
Dipexium   Pharmaceuticals, LLC
    	
ReSearch   Pharmaceutical Services, Inc.
    
	
 
    	
 
    
	
By:
    	
/s/   Robert J. Delucia
    	
 
    	
By:
    	
/s/   Harris Koffer
    
	
Name:
    	
Robert   J. Delucia
    	
 
    	
Name:
    	
Harris   Koffer
    
	
Title:
    	
Managing   Partner
    	
 
    	
Title:
    	
President
    
	
Date:
    	
11/8/2013
    	
 
    	
Date:
    	
8-Nov-2013
    

 

 

ATTACHMENT 1

 

EXHIBIT      TO MASTER AGREEMENT FOR SERVICES BETWEEN

DIPEXTIJM PHARMACEUTICALS, LLC

AND RESEARCH PHARMACEUTICAL SERVICES, INC.,

DATED                

 

THIS EXHIBIT      is made the      day of                             , 2012, by and between Dipexium Pharmaceuticals, LLC (“Client”), together with its subsidiaries and affiliates, having its principal place of business at           , and ReSearch Pharmaceutical Services, Inc. (“RPS”), together with its subsidiaries and affiliates, having its primary office located at           .

 

WHEREAS, Client and RPS entered into a Master Agreement for Services, dated                       , 2012 (the “Master Agreement”), wherein Client and RPS agreed that RPS will perform certain clinical research services and/or consulting services; and

 

WHEREAS, pursuant to the Master Agreement, Client and RPS now desire to set forth the specific services to be provided by RPS.

 

NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Client and RPS hereby agree as follows:

 

I.                                        SERVICES

 

A.                                    Description of Services/Project Team

 

1.                                      RPS shall provide a Clinical Project Team (the “Project Team”) consisting of ADD PROJECT TEAM POSITIONS to provide services in support of the Project.

 

2.                                      The Project Team shall perform the services specified below (the “Services”):

 

Add description of services

 

B.                                    Term and Termination

 

1.                                      The Project Team shall provide the Services as set forth herein for approximately            (    ) months/years, commencing on or about              , 200     . The parties anticipate that the Services shall be completed on or about             , 200     , unless extended upon the mutual written agreement of the parties.

 

2.                                      Client agrees that if it elects to terminate an individual Project Team met her or the Project and/or otherwise terminate the services to be provided by the Project Team hereunder, Client shall provide no less than XXX (XX) days prior written notice of such termination. In the event of such an early termination, Client shall pay the termination fees as set forth in Section 3(b) of the Master Agreement.

 

 

3.                                      Client and RPS acknowledge that additional members may be added to the Project Team in order to provide services in support of the Project. Any agreement for such additional services and/or additional Project Team members shall be subject to the mutual written agreement of the parties and shall be set forth in a written amendment to this Exhibit

 

C.                                    Technology Infrastructure

 

1.                                      RPS shall be responsible for the following infonnation technology in support of Client’s Project:

 

·                                          Provide laptop computers, hardware, software (except as may be requested by Client, as set forth below) and other related equipment to the RPS Project Team members designated by RPS and Client.

 

·                                          Provide all necessary maintenance and technical support for all hardware and applications provided by RPS.

 

·                                          Provide a desktop multifunction printer/fax machine to the RPS Project team members designated by RPS and Client.

 

2.                                      Prior to the start of a Client study, Client must provide all technical requirements that will be needed to access Client’s systems or to complete the job specific workflow. If Client identifies any technical requirements after a study team has been deployed, such additional or revised technical requirement(s) shall be considered a technical change order (“Technical Change Order”). Any costs and/or expenses for a Technical Change Order(s) shall be the responsibility of Client, unless otherwise agreed to by the parties. Any Technical Change Order must be formally requested by Client and shall be subject to review and approval by RPS’ Director of Information Technology prior to implementation. Once the Technical Change Order has been evaluated to determine time and cost considerations, an implementation plan will be created and presented to Client to identify associated cost and implementation time lines.

 

3.                                      If requested by Client, RPS shall install other study specific software required for the performance of the Services. Any such software and installation thereof shall be at Client’s expense. Any necessary maintenance and technical support for such Client-specific software shall be provided by Client. Upon the mutual agreement of the parties, RPS may provide first-line response for technical support of the software; provided, however, that responsibility for technical support of such software will be the responsibility of Client.

 

4.                                      The parties shall cooperate in good faith to establish each party’s roles, responsibilities and processes for the efficient management of laptops and applications necessary for the performance of the Services.

 

 

II.                                   PAYMENT TERMS

 

A.                                    Payment Schedule

 

1.                                      The Service Fees to be paid by Client shall be a fixed monthly amount of                Dollars ($                .00). The contract price is based on the assumption that each Project Team member shall be working U hours per week at the following rates:             $/hour.

 

2.                                      The Service Fees and Pass Through Expenses shall be paid by Client in accordance with the following payment schedule:

 

	
Invoice Date
    	
 
    	
Service Fee
    	
 
    	
Estimated Pass Through
   Expenses
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Total Estimated Pass Through Expenses 
    	
 
    	
 
    	
 
    	
$
    	
 
    	
 
    
	
Total Service Fees
    	
 
    	
 
    	
 
    	
$
    	
 
    	
 
    

 

Unless otherwise agreed to in this Exhibit, Client shall pay for all applicable taxes in connection with this Agreement including, but not limited to, any sales, use, excise, value-added, goods and services, consumption and other similar taxes or duties. Each party shall be responsible for taxes based on its own net income, employment taxes of its own employees, and for taxes on any property it owns or leases.

 

3.                                      Client shall reimburse RPS for actual Pass Through Expenses incurred in support of the Project. Client acknowledges and agrees that the Estimated Pass Through Expenses set forth in Section 2 above are estimated monthly expenses and that Client shall be billed for and shall pay for actual expenses incurred. Payment of such Pass Through Expenses shall be paid by Client in accordance with Section 2 of the Master Agreement and the payment schedule set forth above. Client shall provide each Project Team member with specific travel guidelines and/or policies with respect to reimbursable expenses; provided, however, that Client agrees to reimburse RPS for travel expenses incurred by each Project Team member based on a portal-to-portal basis. Pass Through Expenses shall be paid by Client within thirty (30) days of receipt of invoice.

 

4.                                      The parties agree that if the actual hours worked by any member of the Project Team during one quarter of the term of this Agreement is in excess of twenty percent (20%) of the billable hours for the prior quarter, the billable hours and service fees shall be renegotiated accordingly and shall be mutually agreed upon in writing by the parties.

 

5.                                      The Service Fees set forth in Section 2 above shall remain in effect through the calendar year of this Exhibit. Thereafter, the Service Fees shall be subject to a price increase of Five Percent (5%) each January for the remainder of the term of this Exhibit     .

 

 

6.                                      The currency to be used for invoicing and payment of Service Fees or Pass Through Expenses shall be as outlined in Section 2 above (the “Contracted Currency”) and all currency reconciliation for Service Fees and Pass Through Expenses shall be in accordance with Section 3 of the Master Agreement. The currency exchange rate used to calculate Service Fees and Estimated Pass Through Expenses in this Exhibit is based on the Oanda interbank rate (Oanda.com) XXX to as of (fill in date).

 

III.                              TERMS

 

The terms and conditions of this Exhibit      shall be subject to the terms and conditions of the Master Agreement, which are hereby incorporated herein by reference into this Exhibit     .

 

IN WITNESS WHEREOF, the parties have caused this Exhibit     to be executed by their respective duly authorized representatives effective as of this day and year first above written.

 

	
Dipexium   Pharmaceuticals, LLC
    	
ReSearch   Pharmaceutical Services, Inc.
    
	
By:
    	
 
    	
 
    	
By:
    	
 
    
	
Name:
    	
 
    	
 
    	
Name:
    	
 
    
	
Title:
    	
 
    	
 
    	
Title:
    	
 
    
	
Date:
    	
 
    	
 
    	
Date:Exhibit 10.31

 

LICENSE AGREEMENT REGARDING

MAGAININ PEPTIDE

 

This License Agreement is entered into as of 20 October, 1988, by and between SCRIPPS CLINIC AND RESEARCH FOUNDATION, a California nonprofit corporation (“SCRIPPS”), and MULTIPLE PEPTIDE SYSTEMS, a California corporation, whose principal offices are at 10955 John Jay Hopkins Drive, La Jolla, California, 92121, (“MPS”) with respect to the facts set forth below.

 

RECITALS

 

Whereas SCRIPPS is engaged in scientific biomedical and biochemical research, including research which relates to analogs of magainin; and

 

Whereas MPS is engaged in research, development, production and· sale of a wide range of health-care related products, including products used in connection with peptide synthesis; and

 

Whereas the research from which the inventions and know-how arose was funded in part by the United States Government through the National Institutes of Health.

 

Whereas SCRIPPS has the exclusive right to grant a license in and to an invention, subject only to any non-exclusive rights of the U.S. Government resulting from Government funding, for the U.S. Government to use the invention for its own purposes; and

 

Whereas SCRIPPS has disclosed to MPS certain Scripps Inventions and know-how arising from said research which relate to peptide synthesis; and 

 

Whereas MPS wishes to obtain license to make, use, and sell products utilizing said inventions and know-how; and

 

Whereas SCRIPPS desires to grant MPS an exclusive worldwide right and license to develop and market peptide synthesis;

 

NOW, THEREFORE, in consideration of the mutual covenants and conditions set forth herein, SCRIPPS and MPS hereby agree as follows:

 

ARTICLE I — DEFINITIONS

 

1.1                               Scripps Proprietary Property. The term “Scripps Proprietary Property” shall mean any and all technology, now existing or hereafter arising in which SCRIPPS shall have a proprietary interest, including without limitation any idea, data, know-how, technique, method, process, use, composition, skill, confidential information, trade secret or configuration of any kind, whether or not any such information would be enforceable as a trade secret, the copying of which would be enjoined or restrained by a court as constituting unfair competition, or is eligible for protection under the patent laws of the United States or elsewhere.

 

 

1.2                               Scripps Technology. The term “Scripps Technology” shall mean the Scripps Proprietary Property more particularly described in Scripps Disclosure No. 88-10, entitled “Improved Antibacterial Activity of Analogs of Magainin”, invented by Drs. Richard A. Houghten and Julio H. Cuervo, dated February 2, 1988, or otherwise relating to the subject matter described in such disclosures and existing as of the date set forth in the preamble hereof.

 

1.3                               Scripps Improvement. The term “Scripps Improvement” shall mean any improvement to Scripps Proprietary Property, including without limitation any improvement to Scripps Technology, consisting of such further or additional processes and technology as shall hereafter arise relating to the Scripps Technology which is developed, discovered, or invented during the term of this Agreement by SCRIPPS, its employees or its agents.

 

1.4                               Scripps Invention. The term “Scripps Invention” shall mean any invention using Scripps Technology and Scripps Improvement.

 

1.5                               Scripps Patent Rights. The term “Scripps Patent Rights” shall mean one or more United States and foreign patents and applications in part arising out of any Scripps Invention and all continuations, divisionals, continuations-in-part, reissues, re-examinations, and extensions thereof.

 

1.6                               Licensed Product. The term “Licensed Product” shall mean any product which cannot be developed, manufactured, used or sold without utilizing Scripps Patent Rights, or without using any Scripps Proprietary Property as related to Scripps Technology not otherwise includable within Scripps Patent Rights.

 

1.7                               Confidential Information. The term “Confidential Information” shall mean any and all information encompassed within Scripps Proprietary Property which may be delivered by SCRIPPS to MPS at any time and from time to time during the term hereof.

 

1.8                               Valid Claim. “Valid Claim” shall mean a claim of an issued patent which has not lapsed, become abandoned or dedicated to the public or been declared or rendered invalid or unenforceable by reason of reissue, reexamination, disclaimer or final judgment by a court of competent jurisdiction from which no appeal can be or is taken.

 

1.9                               Net Sales. The term “Net Sales” shall mean the gross amount invoiced by MPS on all sales of Licensed Products, less (a) discounts actually allowed, (b) credits for claims, allowances, retroactive price reductions or returned goods, (c) prepaid freights, (d) sales taxes or other governmental charges actually paid in connection with the sale (but excluding what is commonly known as income taxes), and (“e) brokerage, commissions and other fees paid to others for or in connection with sales of Licensed Products. For purposes of determining Net Sales, a sale shall be deemed to have occurred when payment is received for the sale.

 

 

ARTICLE II - LICENSE GRANT

 

2.1                               License. SCRIPPS hereby grants to MPS an exclusive, worldwide license to Scripps Patent Rights and to Scripps Invention, including the right to sublicense, to make, to have made, to use, and to sell Licensed Products.

 

ARTICLE III — ROYALTIES

 

3.1                               License Fee. MPS shall pay to SCRIPPS a license fee in the amount of ten thousand dollars ($10,000). The License Fee shall be credited against the royalties payable pursuant to Section 3.2 with the credit available to offset up to fifty percent (50%) of the royalties due in any calendar quarter, for so long as the credit remains unused. However, SCRIPPS shall have no obligation to return any of the License Fee if future royalties are less than the available credits for the License Fee.

 

3.2                               Royalty. MPS shall pay to SCRIPPS a royalty on all Net Sales respecting the Process, in an amount equal to five percent (5%) of the Net Sales (“Royalty”) of the Licensed Product, and where any sublicense is granted, fifty percent (50%) of royalties derived by MPS from all such sublicenses.

 

3.3                               Royalty.  On Valid Claim. On a country by country basis, MPS shall pay SCRIPPS a royalty of 5% on all Net Sales of Licensed Product covered by a Valid Claim of Scripps Patent Rights.

 

3.4                               Other Royalty. In the event that in any country, a Licensed Product is not covered by a Valid Claim of Scripps Patent Rights, in each such country, MPS shall pay a royalty of 5% on all Net Sales of Licensed Products, but only for as long as no third party in such country markets or sells a product substantially the same as or similar to such Licensed Product for which SCRIPPS has no cause of action for infringement.

 

3.5                               Maximum Royalty. Upon payment of royalties to SCRIPPS by MPS hereunder in an aggregate amount equal to twenty-five million dollars, thereafter the licenses and rights granted hereunder shall be royalty free.

 

3.6                               Quarterly Payments. Royalties shall be payable on a quarterly basis, within ninety (90) days after the end of each calendar quarter, based upon the Net Sales during each calendar quarter, commencing with the calendar quarter in which the first commercial sale of the Licensed Product is made.

 

3.7                               Duration of Royalty Obligations. Royalty obligations of MPS shall terminate on a country-by-country basis in each country in which Licensed Products are sold pursuant to a Valid Claim, with the expiration of the last to expire of Scripps Patent Rights utilized by or in the Licensed Product in such country, or after a period of ten (10) years from the date of first sale of the Licensed Product in any such country where there are no Valid Claims of Scripps Patent Rights which cover Licensed Product.

 

 

3.8                               Reports. MPS shall furnish to SCRIPPS, at the same time as each royalty payment is made, a detailed written report of the Net Sales of the Licensed Product and the royalty due and payable, on a country-by-country basis, for the calendar quarter upon which the royalty payment is based.

 

3.9                               Records. MPS shall keep full, complete and proper records and accounts of its sales of Licensed Products in sufficient detail to enable the royalties payable on Net Sales to be determined. SCRIPPS shall have the right at its own expense to appoint an independent certified public accounting firm approved by MPS, which approval shall not be unreasonably withheld, to audit MPS’s records which are necessary to verify the royalties payable pursuant to this Agreement. Such audit shall be at SCRIPPS’ expense; provided, however, that if the audit disclosed that SCRIPPS was underpaid royalties by at least ten percent (10%) for any calendar quarter, then MPS shall reimburse to SCRIPPS any such reasonable audit costs, together with an amount equal to the additional royalties to which SCRIPPS is entitled as disclosed by the audit. SCRIPPS may exercise its right no more frequently than once in any calendar year. The accounting firm shall disclose to SCRIPPS only information relating solely to the accuracy of the royalty payments. - MPS shall preserve and maintain all such records required for audit for a period of three (3) years after the calendar quarter for which the record applies.

 

3.10                        Foreign Sales. The remittance of royalties payable on sales outside the United States shall be payable to SCRIPPS in united States Dollar Equivalents at the official rate of exchange of the currency of the country from which the royalties are payable, as quoted by the (Bank of Company) for the last business day of the calendar quarter in which the royalties are payable. If the transfer of or the conversion into United States Dollar Equivalent of any such remittance in any such instance is not lawful or possible, the payment of such part of the royalties as is necessary shall be made by the deposit thereof, in the currency of the country where the sale was made on which the royalty was based to the credit and account of SCRIPPS or its nominee in any commercial bank or trust company of SCRIPPS’ choice located in that country, prompt notice of which shall be given by MPS to SCRIPPS.

 

3.11                        Foreign Taxes. Any tax required to be withheld by MPS under the laws of any foreign country for the account of SCRIPPS, shall be promptly paid by MPS for and on behalf of SCRIPPS to the appropriate governmental authority, and shall use its best efforts to furnish SCRIPPS with proof of payment of such tax together with official or other appropriate evidence issued by the appropriate government authority. Any such tax actually paid on SCRIPPS’ behalf shall be deducted from royalty payments due SCRIPPS.

 

ARTICLE IV - OBLIGATIONS RELATED TO COMMERCIALIZATION

 

4.1                               Commercial Development Obligation. In order to maintain the license granted hereunder in force, MPS shall use reasonable efforts and due diligence to develop the Scripps Patent Rights which are licensed into a commercially feasible Licensed Product, as promptly as is reasonably and commercially feasible. MPS shall keep SCRIPPS generally informed as to the MPS’s progress in the development, including its efforts, if any, to sublicense the Scripps Patent Rights, by delivery to SCRIPPS of an annual written report and such other reports as

 

 

SCRIPPS may reasonably request. If SCRIPPS has a reasonable basis to believe that MPS is not using reasonable efforts and due diligence to commercially develop the Licensed Product, upon notice by SCRIPPS to MPS which specifies the basis for SCRIPPS’ belief, MPS and SCRIPPS shall negotiate in good faith to attempt to mutually resolve the issue. In the event SCRIPPS and MPS cannot agree upon any matter related to MPS’s commercial development obligations, the parties agree to utilize arbitration pursuant to Section 12.2 in order to resolve the matter.

 

4.2                               Foreign Registration. MPS agrees to register this Agreement with a foreign governmental agency whenever required to do so by the foreign country’s law, and agrees to pay all costs and legal fees in connection therewith, and to otherwise ensure that the local foreign laws affecting this Agreement are fully satisfied.

 

4.3                               Governmental Approvals and Marketing of Licensed Product. MPS shall be responsible for obtaining all necessary governmental approvals for the development, production, distribution and use of any Licensed Product, at MPS’s expense, including without limitation, any safety studies. MPS shall have sole responsibility for any warning labels, packaging, instructions as to use, and quality control as to any Licensed Product.

 

4.4                               Product Liability Indemnity. MPS hereby agrees to indemnify and defend SCRIPPS and its trustees, officers, employees and scientists from and against any liability or expense arising from any product liability claim asserted by any party as to any Licensed Product or as to the use of any Scripps Patent Rights pursuant to rights or obligations of MPS under this Agreement. Said indemnity and defense obligation shall apply to any claims made by employees, subcontractors, sublicensees, or other agents of MPS as well as any member of the general public. MPS shall use its best efforts to have SCRIPPS and its trustees, officers, employees, and scientists named as additional insured parties on any products liability insurance policy maintained by MPS applicable to each Licensed Product.

 

4.5                               U.S. Manufacture. To the extent required by applicable United States law, if at all, MPS agrees that each Licensed Product will be manufactured in the United States, or its territories, subject to such waivers as may be required, if at all, from the U.S. Department of Health and Human Services, or its designee. In the event any such applicable law interferes with MPS’s efforts to develop the Licensed Product for commercial use, MPS shall be excused from any obligations under Section 4.1 and such interference shall be taken into account in the royalties therefor.

 

4.6                               Patent Marking. To the extent required by applicable law, MPS shall mark Licensed Products or their container in accordance with the patent marking laws of the country in which the Licensed Products are manufactured, used, or sold.

 

4.7                               No Use of Name. The use of the name “SCRIPPS CLINIC AND RESEARCH FOUNDATION”, or any variation thereof, in connection with the advertising or sale of the Licensed Product is expressly prohibited.

 

 

ARTICLE V - SUBLICENSE

 

5.1                               Sublicense. MPS shall have the right to grant sublicenses to any party with respect to any rights conferred upon MPS under this Agreement, provided however, that (i) any such sublicense shall be subject in all respects to the restrictions, exceptions, royalty obligations, reports, termination provisions, and other provisions contained in this Agreement, and (ii) each such sublicensee, and the form and substance of each such sublicense, shall have received the prior written approval of SCRIPPS, which approval shall not be unreasonably withheld. MPS shall pay or cause the sublicensee to pay SCRIPPS the same royalties on all Net Sales of the sublicensee the same as if said Net Sales had been made by MPS. Additionally, in the event of any compensation payable by a sublicensee to MPS in excess of the royalties otherwise payable by MPS to SCRIPPS, then MPS shall divide such excess compensation equally between MPS and SCRIPPS, and shall pay SCRIPPS promptly upon receipt of such compensation from the sublicensee. Each sublicensee shall report its Net Sales to SCRIPPS through MPS which Net Sales shall be aggregated with any Net Sales upon which royalties are to be paid to SCRIPPS.

 

ARTICLE VI — WARRANTIES

 

6.1                               Warranty of Title. No Other Warranties. SCRIPPS hereby warrants and represents that it has the full right and power to grant the exclusive license, with the right of sublicense, as set forth in this Agreement. SCRIPPS shall make no other warranties concerning the Scripps Patent Rights covered by this Agreement. SCRIPPS makes no expressed or implied warranty of merchantability or fitness for a particular purpose as to any Licensed Product. SCRIPPS makes no warranty or representation as to the validity or scope of the Scripps Patent Rights or that any Licensed Product will be free from an infringement of patents of third parties, or that no third parties are in any way infringing Scripps Patent Rights.

 

VII - INTERESTS IN SCRIPPS RIGHTS ARTICLE

 

7.1                               Preservation of Title. SCRIPPS shall retain full ownership and title to Scripps Patent Rights and shall use its best efforts to preserve and maintain said full ownership and title.

 

7.2                               Governmental Interest. MPS and SCRIPPS acknowledge that SCRIPPS has received and expects to continue to receive funding from the United States Government in support of SCRIPPS’ research activities. MPS and SCRIPPS acknowledge and agree that their respective rights and obligations pursuant to this Agreement with respect to Scripps Patent Rights, as applicable, shall be subject to SCRIPPS’ obligations and the rights of the United States Government, if any, which arise or result from SCRIPPS’ receipt of research support from the United States Government.

 

7.3                               Reservation of Rights. SCRIPPS reserves the right to use any of Scripps Patent Rights solely for SCRIPPS’ own education and research purposes, without SCRIPPS being obligated to pay MPS any royalties or other compensation related thereto.

 

 

ARTICLE VIII - PATENT MATTERS

 

8.1                               Patent Prosecution and Maintenance. For each Scripps Invention, Scripps Improvement, and Licensed Product for which MPS requests SCRIPPS to file a patent application or for which SCRIPPS elects to file a patent application, SCRIPPS shall direct, control, and diligently conduct the patent application process (including interferences and foreign oppositions) and such process as appropriate for extension, renewal or other maintenance of each resulting patent, subject to such requirements, limitations and conditions as are expressly set forth in this Agreement. SCRIPPS shall select the patent attorney, subject to MPS’s written approval of such patent attorney, which approval shall not be unreasonably withheld. MPS shall have full rights of consultation with the patent attorney with respect to a patent application or patents for a Scripps Invention or Licensed Product for which MPS has rights hereunder. SCRIPPS shall use its best effort to implement all reasonable requests made by MPS with regard to the patent application and maintenance processes for a Scripps Invention, Scripps Improvement or Licensed Product.

 

8.2                               Provision of Information to MPS. SCRIPPS shall keep MPS informed with regard to the patent application and maintenance processes. SCRIPPS shall promptly deliver to MPS copies of all patent applications, amendments, related correspondence, and other related matters.

 

8.3                               Patent Costs. MPS shall pay for all reasonable expenses incurred in preparing, filing and prosecuting patent applications and maintaining patents which are obtained for each Scripps Invention, Scripps Improvement or Licensed Product for which MPS requests SCRIPPS to file a patent application or SCRIPPS elects to file pursuant to this Article. MPS agrees to pay said expenses within ninety (90) days after receipt of an itemized invoice therefor. MPS may elect to cease paying for further patent expenses for a Scripps Invention, Scripps Improvement or Licensed Product, and thereupon MPS license hereunder to the Scripps Invention, Scripps Improvement or Licensed Product in the country of concern shall terminate. MPS shall give SCRIPPS at least sixty (60) days prior written notice of such election. With respect to each Scripps Invention, Scripps Improvement for which MPS obtains a license hereunder, MPS may deduct from its royalty payments due to SCRIPPS pursuant to this Agreement an amount equal to the expenses paid by MPS pursuant to this section, provided that, for any calendar quarter MPS may not deduct more than fifty percent (50%) of the royalties payable for the calendar quarter for reimbursement for said expenses.

 

8.4                               Ownership. Each patent application filed and patent obtained for each Scripps Invention, Scripps Improvement or Licensed Product shall be owned solely by SCRIPPS and assigned to SCRIPPS and shall be deemed a part of Scripps Patent Rights.

 

8.5                               SCRIPPS’ Right to Pursue Patent. If, at any time during the Agreement Term, MPS’s rights with respect to a Scripps Invention, Scripps Improvement or Licensed Product are terminated, pursuant to Section 8.4, SCRIPPS shall have the right to take whatever action SCRIPPS deems appropriate to obtain or maintain the corresponding patent protection at its own expense. If SCRIPPS pursues patents under this section, MPS agrees to cooperate fully, including by providing at no charge to SCRIPPS, all appropriate technical data and executing all necessary legal documents. -

 

 

8.6                               Infringement Actions. MPS shall have the sole right to prosecute at its discretion, any and all infringements of any Scripps Patent Rights to which MPS obtains rights hereunder and to defend all charges of infringement arising as a result of said Scripps Patent Rights, and to enter all settlements, judgments, or other arrangements respecting the same all at its own expense; provided, however, that SCRIPPS shall permit any action to be brought in its name if required by law, and MPS shall hold SCRIPPS harmless from any costs, expense or liability respecting all such infringements or charges of infringement. Any damages or other recovery from such infringement actions in excess of the expenses and costs incurred by MPS in connection with such action shall be allocated as follows: (i) eighty percent (80%) to MPS and (ii) twenty percent (20%) to SCRIPPS. SCRIPPS agrees to provide reasonable assistance of a technical nature that may be required in any litigation arising in accordance with the provisions of this section. In the event MPS elects not to prosecute any such infringement, MPS shall notify SCRIPPS promptly and thereafter SCRIPPS shall have the right to prosecute such infringement on its own behalf.

 

ARTICLE IX CONFIDENTIALITY AND PUBLICATION

 

9.1                               Confidential Information. MPS recognizes the proprietary interests and rights of SCRIPPS in the Scripps Patent Rights, including any technical information which may be disclosed to MPS from time to time pursuant to this Agreement. MPS agrees to keep confidential all such information, excepting only (a) information which at the time of the disclosure is in the Public domain, or (b) information which thereafter becomes part of the public domain without violation by MPS or its agents of this section, or (c) information which was received by MPS from a third party having the legal right to transmit the same to MPS, or (d) information which MPS independently develops without the reliance on any information received from SCRIPPS, or (e) information which -MPS· is required by law to provide. If at any time SCRIPPS shall likewise maintain the confidentiality of such information, subject to the same exceptions as set forth above. This covenant of confidentiality shall remain in full force and effect notwithstanding the expiration or other termination of this Agreement.

 

9.2                               Publications. The parties agree that each party shall have a right to publish in accordance with its general policy. However, prior to their publication, a party proposing to publish shall submit to the other party copies of proposed publications which contain subject matter relating to a Scripps Improvement, Scripps Patent Rights, or a Licensed Product, and afford the other party a reasonable opportunity to review the publications. Upon timely written request by the other party, the party proposing to publish shall delay any such publication until the preparation and filing of a patent application pursuant to Section 8.2.

 

9.3                               Publicity. Except as otherwise provided herein or required by law, no party shall originate any publicity, news release or other public announcement, written or oral, whether in the public press, or stockholders’ reports, or otherwise, relating to this Agreement or to any License Agreement, or to the performance under any such agreements, without the prior written approval of the other parties, which approval shall not be unreasonably withheld.

 

 

ARTICLE X TERM AND TERMINATION

 

10.1                        Term. Unless terminated sooner in accordance with the terms herein, the term of the license granted pursuant to this Agreement shall expire and this Agreement shall terminate upon the termination of MPS’s royalty obligations hereunder.

 

10.2                        Termination Upon Default. In the event of default by a party (“Defaulting Party”), the other party (“Non-Defaulting Party”) may give the Defaulting Party written notice of the default and the election to terminate this Agreement within sixty (60) days after receipt of the notice if, within said time period, the Defaulting Party fails to resolve the default by (i) curing the default to the satisfaction of the Non-Defaulting Party, (ii) providing a written explanation satisfactory to the Non-Defaulting Party that a default has not occurred, or (iii) entering into a written agreement with the Non-Defaulting Party for the cure or other resolution of the default. Upon failure of the Defaulting Party to resolve the default as required, the Non-Defaulting Party may terminate this Agreement by giving written notice to the Defaulting Party, said termination to be effective upon the date specified in the notice.

 

Such termination rights shall be in substitution for any other remedies that may be available to the party serving such notice against the party in default. Termination pursuant to this section shall not relieve the party in default from liability and damages to the other party for breach of this Agreement. Waiver by either party of a single default or a succession of defaults shall not deprive such party of any right to terminate this Agreement arising by reason of any subsequent default.

 

10.3                        Termination Upon Insolvency. This Agreement may be terminated by either party giving written notice of termination to the other party upon the bankruptcy or insolvency of said other party or the appointment of a receiver of any of the party’s assets, or the making by the party of any assignment for the benefit of creditors, or the institution of any proceedings against the party under any bankruptcy or insolvency law. Termination shall be effective upon the date specified in the notice.

 

10.4                        Rights Upon Expiration. Upon the termination of this Agreement at its regularly scheduled expiration date, neither party shall have any further rights or obligations with respect to the Agreement, other than MPS shall make any all final reports and payments for the final quarter period. After any such regularly scheduled termination, without any further obligations whatsoever to SCRIPPS, MPS shall be entitled to continue (i) utilizing the Scripps Patent Rights which were previously so licensed, and (ii) manufacturing, using, and/or selling any Licensed Product which was the subject of the terminated Agreement.

 

10.5                        Rights Upon Termination. Upon any termination of this Agreement by either SCRIPPS or MPS prior to the regularly scheduled expiration date of this Agreement, the license granted thereunder shall terminate. Except as otherwise provided in this Agreement with respect to work-in-progress, upon such termination, MPS shall have no further right to develop, manufacture or market the Licensed Product, or to otherwise use any of the Scripps Patent Rights which are covered by this Agreement. Upon any such termination, MPS shall promptly return all materials, samples, documents, information, and any other matter which embody or disclose the Scripps

 

 

Patent Rights, including Scripps Improvements, which were previously covered by this Agreement~ provided, however, MPS shall not be obligated to provide SCRIPPS with proprietary information which MPS can show that it independently developed. Any such termination shall not relieve either party from any obligations accrued to the date of such termination.

 

10.6                        Work-in-Progress. Upon any termination of this Agreement MPS shall be entitled to finish any work-in-progress and to sell any completed inventory of a Licensed Product covered by this Agreement which remain on hand as of the date of the termination, so long as MPS pays to SCRIPPS the royalties applicable to said subsequent sales in accordance with the same terms and conditions as set forth in this Agreement.

 

ARTICLE XI ASSIGNMENT; SUCCESSORS

 

11.1                        Assignment. This Agreement shall not be assignable by either of the parties without the prior written consent of the other party except to a successor in interest to all or substantially all of the business assets of a party hereto. For purposes of this Article, the business assets of MPS shall mean the business assets of one or more of the MPS entities, which assets are specifically related to research, development, production and sale of a type of products in which Scripps Patent Rights may be utilized.

 

11.2                        Binding Upon Successors and Assigns. Subject to the limitations on assignment herein, this Agreement shall be binding upon and inure to the benefit of said successors in interest and assigns of SCRIPPS and MPS. · Any such successor or assign in a party’s interest shall expressly assume in writing the performance of all the terms and conditions of this Agreement to be performed by said party.

 

ARTICLE XII GENERAL PROVISIONS

 

12.1                        Independent Contractors. The relationship between SCRIPPS and MPS is that of independent contractors. SCRIPPS and MPS are not joint venturers, partners, principal and agent, master and servant, employer or employee, and have no other relationship other than independent contracting parties. SCRIPPS shall have no power to bind or obligate in any manner, other than as is expressly set forth in this Agreement. Likewise, MPS shall have no power to bind or obligate SCRIPPS in any manner, and as is expressly set forth in this Agreement.

 

12.2                        Arbitration. Any matter or disagreement which this Agreement specifies is to be resolved by arbitration shall be submitted to a mutually selected arbitrator to so decide any such matter or disagreement. The arbitrator shall conduct the arbitration in accordance with the Rules of the American Arbitration Association, unless the parties agree otherwise. If the parties are unable to mutually select an arbitrator, the arbitrator shall be selected in accordance with the procedures of the American Arbitration Association. The decision and award rendered by the arbitrator shall be final and binding. Judgment upon the award may be entered in any court having jurisdiction thereof. Any arbitration pursuant to this section shall be held in San Diego, California, or such other place as may be mutually agreed upon in writing by the parties.

 

 

12.3                        Entire Agreement. This Agreement sets forth the entire agreements and understandings between the parties as to the subject matters set forth in said Agreement. There shall be no amendments or modifications to this Agreement, except by a written document which is signed by both parties.

 

12.4                        California Law. This Agreement shall be construed and enforced in accordance with the laws of the State of California.

 

12.5                        Headings. This Agreement reference only meaning of the section. The headings for each article and section in have been inserted for the convenience of and are not intended to limit or expand on the language contained in the particular article or section.

 

12.6                        Severability. If any provision of this Agreement is ultimately held to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

 

12.7                        No Waiver. Any delay in enforcing a party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of a party’s right to the future enforcement of its rights under this Agreement, excepting only as to an expressed written and signed waiver as to a particular matter for a particular period of time.

 

12.8                        Name. Whenever there has been an assignment or a sublicense as permitted by this Agreement, the term MPS as used in this Agreement shall also include and refer to such assignee and sublicensee.

 

12.9                        Attorneys’ Fees. In the event of a dispute between the parties hereto or in the event of any default hereunder, the party prevailing in the resolution of any such dispute or default shall be entitled to recover its attorneys’ fees and other costs incurred in connection with resolving said dispute or default.

 

12.10                 Notices. Any notices given pursuant to this Agreement shall be in writing and shall be deemed delivered upon the earlier of (i) when received at the address set forth below, or (ii) three (3) business days after mailed by certified mail in the United States mails, postage prepaid and properly addressed, with return receipt requested. Notices shall be delivered to the respective parties as indicated:

 

	
For SCRIPPS:
    	
Scripps Clinic & Research   Foundation
    
	
 
    	
Research Institute of Scripps Clinic
    
	
 
    	
10666 North Torrey Pines Road
    
	
 
    	
La Jolla, CA 92037
    
	
 
    	
 
    
	
 
    	
Attention: Industrial Liaison Officer
    
	
 
    	
 
    
	
For MPS:
    	
Multiple Peptide Systems
    
	
 
    	
10955 John Jay Hopkins Drive
    
	
 
    	
San Diego, CA 92121
    

 

 

	
 
    	
Attention:
    	
Suzanne M. Pratt
    

 

12.11                 Compliance with U.S. Laws. Nothing contained in this Agreement shall require or permit SCRIPPS or MPS to do any act inconsistent with the requirements of any United States law, regulation or executive order as the same may be in effect from time to time.

 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date set forth above.

 

	
SCRIPPS:
    	
Company:
    
	
 
    	
 
    
	
Scripps   Clinic & Research Foundation
    	
Multiple   Peptide Systems, Inc.
    
	
 
    	
 
    
	
By:   
    	
/s/   Richard A. Lerner
    	
 
    	
By:
    	
/s/   Suzanne M. Pratt
    
	
 
    	
Richard   A. Lerner, M.D.
    	
Title:
    	
Chief   Operating Officer
    
	
 
    	
Director,   Research Institute of
    	
 
    	
/s/   Chirsty Hendirchor
    
	
 
    	
Scripps   Clinic, Scripps Clinic &
    	
 
    	
President
    
	
 
    	
Research   Foundation

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