Document:

Exhibit 10.26

 

LABORATORY SERVICES AGREEMENT

 

The terms stated herein are agreed to be those which will apply to studies performed by Dipexium Pharmaceuticals (“Sponsor”) by Covance Laboratories Inc. and Covance Bioanalytical Services LLC (collectively referred to as “Covance”):

 

1.0          Protocol

 

1.1                               Upon Covance’s written acceptance of a detailed protocol document (“Protocol” to be provided by Sponsor or prepared by Covance under Sponsor’s direction and approved by Sponsor, Covance will perform a study or studies (“Study”) for Sponsor in accordance with the Protocol. The Protocol will specify the Study design, information desired, estimated duration of the Study, and all other matters pertinent to completion of the Study, and will be deemed a part of this Agreement and is incorporated herein by reference.

 

1.2                               Covance will, at Sponsor’s request, consult with Sponsor to assist Sponsor in developing the Study design in a manner consistent with current regulatory guidelines. Covance does not warrant that the Study design and/or the Study results will satisfy the requirements of any regulatory agencies at the time of submission of Study results to such agencies.

 

1.3                               The terms of the Protocol shall prevail with respect to the detail, scope and regulatory guidelines used in the conduct of the Study. This shall include any conflicts that may arise between the Protocol and this Agreement with regard to archiving terms. This Agreement shall govern in all other instances.

 

1.4                               In the absence of a Protocol agreed to by both parties, Sponsor will notify Covance of the intended regulatory use (if any) of the Study and the applicable regulatory compliance standards (GLP, GMP, etc.) to be followed by Covance.

 

2.0                               Study Performance

 

Covance shall use commercially reasonable efforts in accordance with industry and industry standards to provide facilities, supplies and staff necessary to complete the Study as provided in the Protocol, as it may be modified as provided herein, and in accordance with the terms of this Agreement.

 

3.0          Study Materials

 

3.1                               Sponsor will provide Covance with sufficient amounts of all compounds, materials, or other substances (“Test Materials”) with which to perform the Study, as well as all such data as may be necessary to apprise Covance of the stability of the Test Materials and proper storage requirements.

 

3.2                               Sponsor will provide Covance with any relevant occupational safety information known by Sponsor, including a Material Safety Data Sheet (MSDS). The MSDS must conform

 

 

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to the requirements of the US Occupational Safety and Health Administration. Covance will supply a blank MSDS to Sponsor, if requested.

 

3.3                               Upon completion of the Study, any remaining samples of the Test Materials will be returned to Sponsor by retention in compliance with regulatory requirements.

 

4.0                               Study Director

 

Covance will appoint a Study director (“Study Director”) to be responsible for the completion of the Study by Covance. The Study Director will coordinate performance of the Study with a representative designated by Sponsor (“Sponsor Representative”), which representative shall have responsibility over all matters relating to performance of the Study on behalf of Sponsor. Unless otherwise agreed in the Protocol, all communication between Covance and Sponsor regarding the conduct of the Study pursuant to the Protocol shall be addressed to or routed through the Study Director and Sponsor Representative, directly. Covance may substitute Study Directors during the course of the Study.

 

5.0          Compliance with Government Regulations

 

5.1                               Covance will perform the Study in accordance with the current state of the laboratory research art and Protocol. Subject to 5.2 below, Covance will also comply with all applicable current government regulatory requirements concerning Good Laboratory Practices appropriate to the Study.

 

5.2                               Should such government regulatory requirements be changed, Covance will make every reasonable effort to satisfy the new requirements. In the event that compliance with such new regulatory requirements necessitates a change in the Protocol for the Study. Covance will submit to Sponsor a revised technical and cost proposal for Sponsor’s acceptance prior to making any changes in the Protocol or the Study.

 

5.3                               In the event of a conflict in government regulations. Sponsor will designate which regulations shall be followed by Covance in its performance of the Study.

 

6.0                               Laboratory Visits

 

Sponsor’s representatives may visit Covance’s laboratories at reasonable times and with reasonable frequency during normal business hours to observe the progress of the Study. Covance will assist Sponsor in scheduling such visits. All such visits shall be scheduled in advance by Sponsor. Sponsor acknowledges that Sponsor representatives granted access to Covance’s facilities during such visits may have access to confidential and proprietary information of Covance.  Sponsor agrees that all such confidential and proprietary information of Covance obtained or observed by Sponsor during such visits shall remain the sole property of Covance and Sponsor shall keep such information confidential and shall not use or disclose it to any third party without Covance’s prior written consent.

 

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7.0          Confidential Information/Legal Proceedings

 

7.1                               Neither party will disclose any information related to the Study to any third party, including but not limited to the Study materials, methodology, procedures, visual data obtained during a visit, research, received from the other party without the disclosing party’s written consent unless such information (i) is already known to the receiving party, (ii) is or becomes publicly available through no fault of the receiving party, (iii) is received from a third party which has the legal right to disclose it to the receiving party , (iv) is required for the pursuit of the registration of a product connected to a Study with a government agency, or (v) is required to be disclosed by any process of law. If legal disclosure is requested, the receiving party will notify, if allowed, the disclosing party promptly of such request.

 

7.2                               If Covance shall be obliged to provide testimony or records regarding any Sponsor Study in any legal or administrative proceeding, then Sponsor shall reimburse Covance its out-of-pocket costs plus a reasonable hourly fee for the involvement of its employees or representatives in such proceeding.

 

8.0                               Work Product

 

8.1                               All reports will be prepared in Covance’s standard format unless otherwise specified in the Protocol.

 

8.2                               At the end of *** after issuance of the audited draft report, if no requested revisions or instructions not to finalize have been communicated by Sponsor, then the audited draft report will be considered “final” and issued as the final report, signed by the Study Director, and submitted to Sponsor. Any modification or changes to the audited draft report requested after *** will be performed at additional cost to Sponsor.

 

8.3                               Sponsor will have title to all raw data, documentation, records, protocols, specimens and final reports generated as a result of this Study except for Covance procedural manuals, developing processes or data, personnel data and Covance developed know-how, technology and software for which title shall remain solely and exclusively with Covance.

 

8.4                               Sponsor is responsible to provide Covance with a copy of each draft report that is submitted to a regulatory agency within *** of the submission.

 

9.0          Inventions and Patents

 

Covance will disclose promptly to Sponsor any and all patentable inventions, discoveries and improvements conceived or made by Covance employees exclusively as a result of performing services for Sponsor’s Study pursuant to this Agreement and pertaining to the Test Materials and

 

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Covance agrees to assign all of its interests therein to Sponsor; provided Sponsor requests such assignment within one year of notification of such invention and agrees to grant to Covance and its affiliates a royalty fee, non-exclusive license to use any such patentable invention, discovery or improvement; provided, further, that Covance shall retain all rights to any data processes, software (including costs), technology, means, know-how and delta flags developed by Covance including, but not limited to, those which relate to laboratory testing or data-collection or data management. If Sponsor requests and at Sponsor’s expense, Covance will provide Sponsor with reasonable assistance to obtain patents covering such inventions.

 

10.0        Independent Contractor

 

Covance shall perform the Study as an independent contractor of Sponsor and shall have complete and exclusive control over its employees and agents.

 

11.0        Insurance

 

Each party shall secure and maintain in full force and effect throughout the performance of the Study the necessary insurance coverage in amounts appropriate to the conduct of its business. Certificates evidencing such insurance will be made available for examination upon written request by either Sponsor or Covance.

 

12.          Remedies/Indemnities

 

12.1                        In the event of a material error by Covance in the performance of the Study which renders the Study invalid, Covance’s sole obligations to Sponsor shall be for Covance, at its option, to either (a) repeat the Study at Covance’s own cost, or (b) refund to Sponsor to contract price paid. IN NO EVENT WILL SPONSOR BE ENTITLED TO, NOR SHALL COVANCE BE RESPONSIBLE FOR, ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL, LOSSES OR DAMAGE ARISING IN CONNECTION WITH COVANCE’S DEFAULT OR BREACH OF ITS OBLIGATIONS UNDER THIS AGREEMENT.

 

12.2                        Covance strictly limits it liability to Sponsor for loss, damage, delay, or non-delivery/non-collection of any samples dispatched by Covance to Sponsor or to any third party in connection with the Study. Covance shall pay to Sponsor such sums as are recoverable from the carriers under any applicable nation/international convention or rules.

 

12.3                        Covance shall indemnify Sponsor and its affiliates and their respective officers, directors and employees (the “Sponsor Group”) from any loss, cost, damage or expense (including reasonable attorneys’ fees) (a “Loss”) from any lawsuit, action, claim, demand or proceeding (a “Claim”) by Covance’s employees or others arising from or associated with, directly or indirectly, the negligence, gross negligence or intentional misconduct or

 

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inaction of Covance, except to the extent caused by Sponsor’s negligence, gross negligence or intentional misconduct or inaction.

 

12.4                        Sponsor shall indemnify Covance and its affiliates and their respective officers, directors and employees (the “Covance Group”) from any Loss from any Claim arising from or associated with, directly or indirectly, (i) Covance’s execution and/or performance of its obligations under this Agreement, (ii) the harmful or otherwise unsafe effect of the Test Materials, (iii) Sponsor’s use of the Study or its use or marketing of any substance tested by Covance, or (iv) the negligence, gross negligence, intentional misconduct or inaction of Sponsor except to the extent caused by Covance’s negligence, gross negligence or intentional misconduct or inaction.

 

13.0                        Force Majeure

 

Either party shall be excused from performing its obligations under this Agreement under  this Agreement if its performance is delayed or prevented by any event beyond such party’s reasonable control, including but not limited to, acts of God, fire, explosion, weather, disease, war, insurrection, civil strife, riots, government action, or power failure, provided that such performance in the Protocol falling due during or subsequent to the occurrence of any such events shall be automatically extended for a period of time equal to the period of such disability. Covance will promptly notify Sponsor if, by reason of any of the events referred to herein, Covance is unable to meet any such time for performance specified in the Protocol. If any part of the Study is invalid as a result of such disability, Covance will, upon written request from Sponsor but at Sponsor’s sole cost and expense, repeat that part of the Study affected by the disability.

 

14.0                        Allocation of Resources

 

If delays in the agreed commencement or performance of the Study occur because of Sponsor’s inability to supply Covance with Test Materials or any information required to begin or perform the Study two weeks prior to scheduled Study start, Covance may reallocate resources being held for performance of the Study without incurring liability to Sponsor.

 

15.0        Publicity

 

Neither party will use the name of the other or the existence of this Agreement for any promotional or advertising purpose without the prior written consent of the other. Neither party will state or imply that the other party endorses or approves of any service, material, product or compound of the other party without the prior written consent of the other.

 

16.0        Study Delay

 

16.1                        Upon receipt of authorization to proceed from Sponsor, Covance begins to incur costs (such as ordering of animals) and scheduled resources to complete a Study. However,

 

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Sponsor may at any time delay or cancel a Study prior to the scheduled start date. In event of a delay to an animal Toxicology Study, a room charge shall be applied.

 

16.2                        Non-rodent Toxicology Studies (eg. — primates and canines) where notification of the delay is received less than *** prior to scheduled Study start and rodent Toxicology Studies where notification is received less than *** prior to scheduled Study start will incur a charge of $***. If the delay results in a reschedule and Covance has the ability to determine the start date based on next best available dates, a charge may be incurred of $***.

 

16.3                        Covance reserves the right to implement the above charges to cover the loss of revenue incurred by Covance as a result of reserving rooms for the exclusive use of Sponsor and for the upkeep of the animals from arrival to Study start. These are in addition to any charges applied for other costs incurred, including, but not limited to, protocol preparation and discussion and cost of animals.

 

17.0                        Cancellation

 

17.1                        Either party may terminate this Agreement in the event of breach of a material obligation of the other if such breach remains uncured after *** prior written notice.

 

17.2                        In the event of any cancellation of a Study for reasons other than Covance’s breach, Sponsor shall be obligated to pay Cancellation Fees and a Cancellation Penalty to Covance, as set forth in Section 17.3.

 

17.3                        The Cancellation Fees will be the costs incurred preparing for the Study. After animals have been delivered for the Study, Sponsor is responsible for the purchase of the animals and all associated costs until their disposition is determined. Covance reserves the right to charge for the animals’ care up to two months after cancellation of the Study. In addition, Covance reserves the right to apply the following Cancellation Penalty to any Toxicology Study that is cancelled:

 

Non-rodent Toxicology Studied (eg. — primates and canines) where notification of the cancellation is received less than *** prior to scheduled Study start and rodent Toxicology Studies where notification is received less than *** prior to scheduled Study start will incur a charge of $***.

 

17.4                        The termination of this Agreement for any reason shall not relieve either party of its obligation to the other for obligations in respect of (i) confidentiality of information, (ii) publicity, (iii) indemnification, (iv) limitation of liability, (v) compensation for services performed, and any other section which would reasonably survive the termination of this Agreement.

 

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

 

18.0                        Assignment

 

18.1                        This Agreement shall not be assigned in whole or in part by either party without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed. Any attempt to assign this Agreement without such consent shall be void and of no effect.

 

18.2                        Subsection 18.1 notwithstanding certain tasks specified in the Protocol may be subcontracted by Covance as may be agreed during Protocol development.

 

19.0                        Notice

 

Except as otherwise provided, all communication and notices required under this Agreement shall be mailed by overnight delivery or first class mail, postage prepaid, to the addresses set forth below, or via electronic mail or facsimile with hard copy confirmation, or to such other addresses as the parties from time to time specify in writing. Any notice or other communication required or permitted under this Agreement shall be in writing and will deemed given as of the date it is received by the receiving party.

 

Notice shall be given to the parties at the addresses listed below:

 

As to Covance:

 

Facsimile:

 

With a copy to:

Legal Department, Covance Inc.

Facsimile:

 

As to Sponsor:

 

Dipexium Pharmaceuticals

Attn: Robert J. DeLuccia

 

20.0        Choice of Law

 

All matters affecting the interpretation, validity and performance of this Agreement shall be governed by the laws of the State of Wisconsin applicable to agreements made and to be performed wholly within the State of Wisconsin, without regard or giving effect to its principles of conflicts of law, and with the express exclusion of the United Nations Convention on Contracts for the International Sale of Goods.

 

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21.0        Waiver

 

No right or the benefit of any provision may be waived, except by a writing duly executed by the party to be charged therewith. No waiver of any term, right or condition under this Agreement or any one occasion shall be construed or deemed to be a waiver or continuing waiver of any such term, right or condition on any subsequent occasion or a waiver of any other term, right or condition hereunder.

 

22.0        Price and Payment Schedule

 

Covance will provide a price and payment schedule for this Study to be performed. Invoices shall be issued in accordance with Exhibit A. Sponsor shall pay Covance’s Invoices within *** of Sponsor’s receipt of such invoices.

 

23.0        Entire Agreement; Modification

 

This document sets forth the entire Agreement between the parties hereto with respect to the performance of the Study or Studies by Covance for Sponsor and as such, supersedes all prior and contemporaneous negotiations, agreements, representations, understandings, and commitments with respect thereto and shall take precedence over all terms, conditions, and provisions on any purchase order form or form of other acknowledgment or order release purporting to address the same subject matter. The terms of this Agreement shall not be waived, released, discharged, changed, or modified in any manner except by an instrument signed by the duty authorized officers of each of the parties hereto, which instruments shall make specific reference to this Agreement and shall express the plain or intention to modify same.

 

 

	
DIPEXIUM PHARMACEUTICALS
    	
COVANCE   LABORATORIES INC, and
   COVANCE BIOANALYTICAL
    
	
 
    	
SERVICES   LLC
    
	
 
    	
3301   Kinsman Boulevard
    
	
 
    	
Madison,   Wisconsin 53704
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   R. J. Deluccia
    	
 
    	
By:
    	
/s/   Cathryn D. Jordan
    
	
Name:
    	
Robert   J. Deluccia
    	
 
    	
Name:
    	
Cathryn   D. Jordan
    
	
Title:
    	
Managing   Director
    	
 
    	
Title:
    	
Contracts   Manager
    
	
Date:
    	
5/23/2012
    	
 
    	
Date:   
    	
22   May 2012
    

 

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Price and payment schedule(s) are as follows;

 

	
Study No.:
    	
8266294
    
	
 
    	
 
    
	
Proposal No.:
    	
108589D
    
	
 
    	
 
    
	
Title:
    	
Collection   of Samples for Determination of the Pharmacokinetics of Pexiganan After   Single Dermal Dose to Rabbits
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Price:
    	
Main   Study Price 
    	
$***
    	
 
    	
 
    
	
 
    	
Method   Development-Estimate *** hours @ $***/hour 
    	
*** 
    	
 
    	
*
    
	
 
    	
LCMS   Sample Analysis 
    	
***
    	
 
    	
 
    
	
 
    	
PK   Calculations and Evaluation 
    	
***
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
Total   
    	
$***
    	
 
    	
**
    

 

*Not to be exceeded without prior Sponsor authorization. Final Price will reflect the actual number of hours used.

 

**Price is based on draft protocol and may change based on the final protocol. Changes in the protocol may result in a change in price and a modification to this Price and Payment Schedule.

 

This above price is subject to verification or adjustment if accepted after 60 days of Covance’s signing of this Agreement. Price quoted is also predicted on Covance’s receiving all necessary test material and other data required to conduct the Study outlined in this proposal within 90 days of Covance’s signing of this Agreement.

 

	
Payment   Schedule:
    	
Billed   Monthly Based on Actual Number of Hours Used
    	
$***
    	
 
    
	
 
    	
Upon   Initiation of Study
    	
***
    	
 
    
	
 
    	
Upon   Completion of Study
    	
***
    	
 
    
	
 
    	
Upon   Issuance of Draft Report
    	
***
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
Total
    	
$***
    	
 
    

 

Invoices are due within ***; unpaid invoices will be charged interest from the date due at a rate of ***.

 

This Agreement becomes effective and binding on both parties upon Covance’s receipt of written acceptance of its proposal as offered by this Agreement from Sponsor. Should terms and conditions herein be at variance with the terms and conditions specified in Sponsor’s written acceptance, then the terms and conditions contained herein take precedence.

 

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Confidential Treatment Requested by Dipexium Pharmaceuticals, LLC

IRS Employer Identification No. 27-1707962

Confidential treatment requested with respect to certain portions hereof denoted with “***”

 

	
DIPEXIUM PHARMACEUTICALS
    	
COVANCE   LABORATORIES INC, and
    
	
 
    	
COVANCE   BIOANALYTICAL
    
	
 
    	
SERVICES   LLC
    
	
 
    	
3301   Kinsman Boulevard
    
	
 
    	
Madison,   Wisconsin 53704
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   R. J. Deluccia
    	
 
    	
By:
    	
/s/   Cathryn D. Jordan
    
	
Name:
    	
Robert   J. Deluccia
    	
 
    	
Name:
    	
Cathryn   D. Jordan
    
	
Title:
    	
Managing   Director
    	
 
    	
Title:
    	
Contracts   Manager
    
	
Date:
    	
5/23/2012
    	
 
    	
Date:
    	
22   May 2012
    

 

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Confidential Treatment Requested by Dipexium Pharmaceuticals, LLC

IRS Employer Identification No. 27-1707962

Confidential treatment requested with respect to certain portions hereof denoted with “***”

 

Exhibit A              Standard Invoicing Terms

 

Non-Animal Studies:

 

Sample Studies will be invoiced based on the number of samples analyzed each month. This shall include both original samples and any billable re-assays that occur during the month. The Sponsor shall be invoiced for all billable samples unless specific limitations or a maximum number of samples have been specified on the Price and Payment schedule.

 

Hourly Work shall be billed following the completion of the month for the number of billable hours worked during the month. The total number of hours invoiced shall not exceed the limitations set forth on the Price and Payment schedule.

 

Non-Animal Fixed Price Work without a draft or final report shall be billed based on the following milestones:

 

·              ***% upon initiation of work

·              ***% upon completion of work

 

Non-Animal Fixed Price Work which includes a report shall be billed based on the following milestones:

 

·              ***% upon initiation of work

·              ***% upon completion of analysis

·              ***% upon issuance of the Draft Report

 

Animal Studies:

 

Small Animal studies with an In-Life period of *** or less or Large Animal studies with an In-Life period of *** or less shall be invoiced based on the following milestones:

 

·              ***% upon the initiation of In-Life

·              ***% upon the completion of In-Life (including any recovery period)

·              ***% upon the issuance of the Draft Report

 

Small Animal studies with an In-Life period between *** and *** shall be invoiced based on the following milestones:

 

·              ***% upon initiation of In-Life

·              ***% upon mid-point of In-Life

·              ***% upon completion of In-Life

·              ***% upon issuance of Draft Report

 

Large Animal studies with an In-Life period between *** and *** shall be invoiced based on the following milestones:

 

·              ***% upon initiation of In-Life

·              ***% divided into *** equal payments of ***% each spread out over the duration In-Life and any subsequent recovery period. The *** invoice shall be issued upon completion of the In-Life period and any subsequent recovery period.

 

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·              ***% upon issuance of Draft Report

 

All studies with an In-Life period in excess of *** shall be based on the following milestones:

 

·              ***% upon initiation of In-Life

·              ***% divided into *** equal payments spread out over the duration of In-Life and any subsequent recovery period. The *** invoice shall be issued upon completion of the In-Life period and any subsequent recovery period.

·              ***% upon issuance of Draft Report.

 

12Exhibit 10.27

 

MASTER SERVICES AGREEMENT

 

This Master Services Agreement (hereinafter the “Agreement”) is made and entered into this 3rd day of September, 2013 (the “Effective Date”) by and between Dipexium Pharmaceuticals, an emerging biotechnology organization, having its principal place of business at           , and its affiliates (hereinafter collectively “Dipexium”), and PolyPeptide Laboratories San Diego, having its principal place of business at            (together with its affiliates hereinafter referred to as “PPL-SD”). When signed by both Parties, this Agreement will set forth the terms and conditions under which PPL-SD agrees to provide certain services to DIPEXIUM as set forth herein. DIPEXIUM and PPL-SD are hereinafter individually referred to as a “Party” and collectively referred to as the “Parties”.

 

Recitals:

 

1.0.                            DIPEXIUM is in the business of research, developing, manufacturing and/or commercializing pharmaceutical products. PPL-SD is in the business of providing custom peptide development and contract peptide manufacturing services and other services for the pharmaceutical industries.

 

2.0.                            DIPEXIUM and PPL-SD desire to enter into this Agreement to provide the terms and conditions upon which DIPEXIUM may engage PPL-SD from time-to-time to provide services for individual studies or projects by executing individual Work Orders (as defined below) specifying the details of the services and the related terms and conditions.

 

Agreement:

 

1.0                               Scope of the Agreement; Work Orders; Nature of Services

 

1.1                               Scope of Agreement  As a “master” form of contract, this Agreement allows the Parties to contract for multiple projects regarding manufacture and its related activities of DIPEXIUM’s peptides (the “PEPTIDES”) through the issuance of multiple Work Orders (as discussed in Section 1.2 below), without having to re-negotiate the basic terms and conditions contained herein. This Agreement covers the provision of services by PPL-SD, and accordingly, this Agreement represents a vehicle by which DIPEXIUM can efficiently contract with PPL-SD and its corporate affiliates for a broad range of services.

 

1.2                               Work Orders  The specific details of each project under this Agreement (each “Project”) shall be separately negotiated and specified in writing on terms and in a form acceptable to the Parties (each such writing, a “Work Order”). Each Work Order will include, as appropriate and among others, budget and payment schedule. Each Work Order shall be subject to all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Work Order. To the extent any terms or provisions of a Work Order conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control,

 

 

except to the extent that the applicable Work Order expressly and specifically states an intent to supersede the Agreement on a specific matter.

 

1.3                               Nature of Services  The services covered by this Agreement may include synthetic process development, chemical synthesis, analytical method development and analysis of the PEPTIDES, and other services relating to chemistry services requested by DIPEXIUM and agreed to by PPL-SD as set forth in the relevant Work Order (collectively, the “Services”).

 

1.4                               Test Materials  If the Parties agree, DIPEXIUM will provide PPL-SD with sufficient amounts of all materials including the PEPTIDES or other substances (collectively the “Test Materials”) with which to perform the Project, as well as all such data as may be necessary to apprise PPL-SD of the stability of the Test Materials and proper storage requirements.

 

DIPEXIUM shall provide PPL-SD with any relevant occupational safety information known by DIPEXIUM, including a Material Safety Data Sheet (MSDS), relating to the Test Materials when available. The MSDS must conform to the requirements of the US Occupational Safety and Health Administration. PPL-SD shall supply a blank MSDS to DIPEXIUM, if requested.

 

2.0                               Payment of Fees and Expenses

 

2.1                               DIPEXIUM shall pay PPL-SD for fees, expenses and pass-through costs in accordance with each Work Order. The following shall apply: (a) DIPEXIUM shall reimburse PPL-SD for all reasonable and necessary expenses and pass-through costs incurred in the performance of the Services as far as those expenses and costs are clearly specified in each Work Order; (b) PPL-SD shall invoice DIPEXIUM the mutually agreed amount of milestone of the Project upon achieving such agreed milestone; (c) DIPEXIUM shall pay each invoice within thirty (30) days of receipt or within the time specifically specified in each Work Order; and (d) in no event shall DIPEXIUM be required to pay any amount exceeding that specified in each Work Order unless otherwise agreed by both Parties by Change Order(s) (as specified in Section 4.0 below).

 

2.2                               If any portion of an invoice is disputed, then DIPEXIUM shall pay the undisputed amounts as set forth in the preceding paragraph and the Parties shall use good faith efforts to reconcile the disputed amount as soon as practicable.

 

2.3                               All payment by DIPEXIUM to PPL-SD under this Agreement shall be made by check or by bank wire transfer with bank name and account number designated by PPL-SD and specified in each invoice.

 

3.0                               Term

 

This Agreement shall commence on the Effective Date and shall continue for five (5) years (the “Term”) unless otherwise terminated in accordance with Section 15 or extended by the Parties in writing.

 

 

4.0                               Change Orders

 

Any material change in the details of a Work Order or the assumptions upon which the Work Order is based (including, but not limited to, changes in an agreed starting date for the Project or suspension of the Project) may require changes in the budget and/or time lines, and shall require written amendment to the Work Order (a “Change Order”). Each Change Order shall detail the requested changes to the applicable task, budget, or other matter. The Change Order shall become effective upon the execution of the Change Order by both Parties, and PPL-SD shall be given a reasonable period of time within which to implement the changes. Both Parties agree to act in good faith and promptly when considering a Change Order requested by the other Party, and further agree that either Party shall not unreasonably withhold approval of a Change Order requested by the other.

 

5.0                               Confidentiality

 

5.1                               It is understood that during the course of this Agreement, PPL-SD, its affiliates, its or their respective employees may be exposed to Test Materials, data and information which is confidential and proprietary to DIPEXIUM. All such Test Materials, data and information (hereinafter “DIPEXIUM Confidential Information”), written or verbal, tangible or intangible, made available, disclosed, or otherwise made known to PPL-SD, its affiliates, its or their respective employees as a result of the Services under this Agreement shall be considered confidential and the sole property of DIPEXIUM. All information regarding PPL-SD’s pricing and PPL-SD’s Property (as defined in Section 6.0 below), disclosed by PPL-SD to DIPEXIUM in connection with this Agreement is proprietary, confidential information belonging to PPL-SD (the “ PPL-SD Confidential Information”, and together with the DIPEXIUM Confidential Information, the “Confidential Information”). The Confidential Information shall be (a) marked as confidential, provided, however, the failure to do so shall not destroy the confidential nature of the information, whereas identifying such information as confidential shall be conclusive evidence that Parties consider the information to be Confidential Information, (b) otherwise represented by the disclosing Party as being confidential either before or within a reasonable time after its disclosure, or (c) otherwise represented the type of information normally afforded confidential treatment. The Parties further understand that this Agreement itself, the fact of concluding the Agreement and any terms and conditions thereof and any Work Order shall also be considered as the Confidential Information of the Parties.

 

5.2                               The Confidential Information shall be used by the receiving Party, its affiliates, its or their respective employees only for purposes of performing the receiving Party’s obligations hereunder. Each Party shall keep the Confidential Information in confidence and shall exercise in relation to the Confidential Information of the other Party adequate security measures and degree of care and in any event no Jess than those which it applies to its own confidential information of a similar nature. Each Party agrees that it will not reveal, publish or otherwise disclose the Confidential Information of the other Party to any third party without the prior written consent of the disclosing Party. These obligations of confidentiality and non-disclosure shall survive the termination or expiration of the applicable Work Order.

 

 

5.3                               The foregoing obligations shall not apply to Confidential Information to the extent that it: (a) is in the public domain by public use, publication, general knowledge or the like, or after disclosure hereunder becomes general or public knowledge, through no fault of the receiving Party; (b) is in the possession of the receiving Party prior to receipt of said Confidential Information from the disclosing Party, as evidenced by written records; (c) is properly obtained by the receiving Party from a third party for use or disclosure without restriction and without breach of this provisions; or (d) is independently developed by the receiving Party without the benefit of the Confidential Information, as evidenced by written records.

 

5.4                               The receiving Party shall be entitled to disclose the Confidential Information if it is required by law or by a court of competent jurisdiction or by another appropriate regulatory authority to be disclosed, provided that said Confidential Information disclosed pursuant to law or governmental requirements remain confidential unless it becomes publicly available. In such event, the receiving Party shall notify the disclosing Party of the required disclosure promptly, and if practicable in advance of such disclosure, to enable the disclosing Party to have an opportunity to object to such governmental entity or court of law regarding the required disclosure. The receiving Party shall use all reasonable efforts to obtain confidential treatment of such Confidential Information required to be disclosed.

 

6.0                               Ownership and Inventions

 

6.1                               All data and information generated or derived by PPL-SD as the result of the Services performed by PPL-SD under this Agreement shall be and remain the exclusive property of DIPEXIUM and shall be deemed DIPEXIUM Confidential Information for the purpose of Section 5.0 hereabove. Any inventions that may evolve from the data and information described above or specifically as the result of the Services performed by PPL-SD under this Agreement shall belong to DIPEXIUM and PPL-SD agrees to assign its rights in all such inventions and/or related patents to DIPEXIUM. Notwithstanding the foregoing, DIPEXIUM acknowledges that PPL-SD possesses certain inventions, processes, know-how, trade secrets, improvements, other intellectual properties and other assets, including but not limited to synthetic procedures, analytical methods, procedures and techniques, procedure manuals, personnel data, financial information, computer technical expertise and software, which have been independently developed by PPL-SD and which relate to its business or operations (collectively “ PPL-SD’s Property”). DIPEXIUM and PPL-SD agree that any of PPL-SD’s Property or improvements thereto which are used, improved, modified or developed by PPL-SD under or during the Term of this Agreement are the sole and exclusive property of PPL-SD, except to the extent that such improvements or modifications include, incorporate or are based on DIPEXIUM Confidential Information.

 

6.2                               At the completion of the Services by PPL-SD, all materials and all other data owned by DIPEXIUM, regardless of the method of storage or retrieval, shall either be (a) delivered to DIPEXIUM in such form as is currently in the possession of PPL-SD, subject to the payment obligations set forth in Section 2.0 herein, or (b) retained by PPL-SD for DIPEXIUM for a period required by applicable laws, regulations and/or requirements. Alternatively, PPL-SD shall dispose of, at DIPEXIUM’s written request, such materials and all other data pursuant to

 

 

DIPEXIUM’s written directions unless such materials are otherwise required to be stored or maintained by PPL-SD as a matter of law or regulation.

 

6.3                               Upon expiration of such retention period, PPL-SD shall advise the same to DIPEXIUM, and shall comply with DIPEXIUM’s written instruction either (a) to continue retention for DIPEXIUM, (b) to deliver to DIPEXIUM, or (c) to dispose of, those information and data. The costs associated with any of the above options shall be paid by DIPEXIUM. In the event that those materials and all other data are decided to be disposed of, as specified in Sections 6.2 and 6.3, PPL-SD shall provide DIPEXIUM with a certificate of disposal in writing and signed by PPL-SD’s duly authorized representative.

 

7.0                               Independent Contractor Relationship

 

For the purposes of this Agreement, the Parties are independent contractors and nothing contained in this Agreement shall be construed to place them in the relationship of partners, principal and agent, employer/employee or joint ventures. Neither Party shall have the power or right to bind or obligate the other Party, nor shall it hold itself out as having such authority.

 

8.0                               Regulatory Compliance: Inspections

 

8.1                               PPL-SD represents and certifies that any Services shall be conducted in compliance with all applicable laws, rules and regulations, including but not limited to the U.S. Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and with the standard of care customary in the contract research organization industry. PPL-SD certifies that it has not been debarred under the Generic Drug Enforcement Act and that it will not knowingly employ any person or entity that has been so debarred to perform any Services under this Agreement. DIPEXIUM represents and certifies that, to the best of its knowledge, no assignments or tasks requested by DIPEXIUM shall violate any applicable law or regulation. PPL-SD shall promptly notify DIPEXIUM if PPL-SD finds any of DIPEXIUM’s assignments or tasks that may become a possible or a threatened violation of any law or regulation and both Parties shall discuss any steps to be taken for achieving such DIPEXIUM’s requested assignments or tasks without violating any law or regulation.

 

8.2                               If FDA or other governmental or regulatory authority conducts, or gives notice to DIPEXIUM or PPL-SD of its intent to conduct, an inspection at PPL-SD or to take any other regulatory action with respect to any Project or Services provided under this Agreement, DIPEXIUM or PPL-SD will promptly notify DIPEXIUM or PPL-SD (as the case may be), where reasonably practicable, prior to complying with such a demand or request. DIPEXIUM, however, acknowledges that it may not direct the manner which prevents PPL-SD from fulfilling its obligations to permit inspection by governmental entities. PPL-SD agrees that during an inspection by any governmental or regulatory authority concerning any study or Project of DIPEXIUM in which PPL-SD is providing the Services, it shall not disclose information or materials that are not required to be disclosed to such agency without the prior written consent of DIPEXIUM, which consent shall not be unreasonably withheld.

 

 

8.3                               During the Term, PPL-SD shall permit DIPEXIUM’s representatives, which are not competitors of PPL-SD, to examine or audit the work performed hereunder and the facilities at which the work is conducted upon reasonable advance written notice, during regular business hours, to determine that the Project assignment is being conducted in accordance with the agreed task and that the facilities are adequate. Unless the costs of governmental or DIPEXIUM audits and investigations are specifically included in the budget for a particular Work Order, DIPEXIUM shall reimburse PPL-SD for PPL-SD’s reasonable expenses associated with such audits and investigations.

 

9.0                               Conflict of Agreements

 

PPL-SD represents to DIPEXIUM that it is not a party to any agreement which would prevent it from fulfilling its obligations under this Agreement and that during the Term, PPL-SD agrees that it will not enter into any agreement to provide services which would in any way prevent it from providing the Services contemplated under this Agreement and any Work Order.

 

10.0                        Publication

 

It is acknowledged and agreed by PPL-SD that publication of Project results in whole or in part shall be within the sole and absolute discretion of DIPEXIUM, and that PPL-SD or its affiliates shall not publish or refer to any Project results, in whole or in part, without the prior express written consent of DIPEXIUM. Neither Party will use the other Party’s name in connection with any publication or promotion without the other Party’s prior written consent which shall not be unreasonably withheld or delayed.

 

11.0                        Warranty of PPL-SD

 

11.1                        PPL-SD shall render the Services under this Agreement and any Work Order in accordance with applicable professional standards and shall make all reasonable efforts to produce a consistently high level of accuracy and expertise. Furthermore, the personnel of PPL-SD and/or its affiliates assigned to perform the Services under this Agreement and any Work Order shall have the skills necessary to reasonably and efficiently perform such Services. In carrying out its responsibilities under this Agreement and any Work Order, PPL-SD agrees that the Services will be conducted in compliance with any applicable protocol and written specifications and in accordance with all applicable laws, rules and regulations.

 

11.2                        Furthermore, PPL-SD understands the importance to DIPEXIUM that any Project proceeds in accordance with the time schedule agreed to by both Parties and specified in any Work Order, and PPL-SD warrants that it shall make all reasonable efforts not to delay the progress of any Project. In this regard, if PPL-SD finds, during the Term or the course of its activities under the Work Order, that any Project is, or may be, delayed, then PPL-SD shall promptly notify DIPEXIUM of any such delay or threatened delay, and PPL-SD and DIPEXIUM shall discuss what steps should be taken as they reasonably deem appropriate to remedy such delay or threatened delay.

 

 

12.0                        Limitation of Liability

 

12.1                        NEITHER PPL-SD, NOR ITS AFFILIATES, NOR ANY OF ITS OR THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES OR AGENTS SHALL HAVE ANY LIABILITY OF ANY TYPE (INCLUDING, BUT NOT LIMITED TO, CONTRACT, NEGLIGENCE, AND TORT LIABILITY), FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, THE LOSS OF OPPORTUNITY, LOSS OF USE, OR LOSS OF REVENUE OR PROFIT, IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT, ANY WORK ORDER, OR THE SERVICES PERFORMED BY PPL-SD HEREUNDER, EVEN IF SUCH DAMAGES MAY HAVE BEEN FORESEEABLE TO PPL-SD.

 

12.2                        IN ADDITION, IN NO EVENT SHALL THE COLLECTIVE, AGGREGATE LIABILITY (INCLUDING, BUT NOT LIMITED TO, CONTRACT, NEGLIGENCE AND TORT LIABILITY, BUT EXCLUDING INDEMNIFICATION UNDER SECTION 13.0) OF PPL-SD AND ITS AFFILIATES AND ITS AND THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES AND AGENTS UNDER THIS AGREEMENT OR ANY WORK ORDER HEREUNDER EXCEED THE AMOUNT OF FEES ACTUALLY RECEIVED BY PPL-SD FROM DIPEXIUM FOR THE ASSIGNMENT OR TASK FROM WHICH SUCH LIABILITY AROSE. IN THE EVENT OF A MATERIAL ERROR BY PPL-SD IN THE PERFORMANCE OF THE SERVICES WHICH RENDERS THE PROJECT INVALID, PPL-SD’s SOLE OBLIGATION TO DIPEXIUM SHALL BE FOR PPL-SD TO EITHER (A) REPEAT THE SERVICES AT PPL-SD’S OWN COST, OR (B) REFUND TO DIPEXIUM THE FEES RECEIVED BY PPL-SD FOR THE PROJECT RENDERED INVALID.

 

12.3                        The limitations of liability provided for under Sections 12.1 and 12.2 above shall not apply in relation to any liability or right for indemnification under Section 13.0 herebelow.

 

13.0                        Indemnification

 

13.1                        DIPEXIUM shall indemnify, defend and hold harmless PPL-SD and its affiliates, and its and their directors, officers, employees and agents (each, a “PPL-SD Indemnified Party”), from and against any and all losses, damages, liabilities, reasonable attorney fees, court costs, and expenses (collectively “PPL-SD Losses”) resulting or arising from any third-party claims, actions, proceedings, investigations or litigation relating to or arising from or in connection with this Agreement, any Work Order, or Services contemplated herein (including, without limitation, any PPL-SD Losses arising from or in connection with (i) any study, test, device, product or potential product to which this Agreement or any Work Order relates and any personal injury claims arising therefrom, (ii) PPL-SD’s performance of Services in compliance with all terms and conditions of this Agreement and Work Order, (iii) the harmful or otherwise unsafe effect of the Test Materials, (iv) DIPEXIUM’s use of the study or its use or marketing of any substance tested by PPL-SD, or (v) the negligence or intentional misconduct of DIPEXIUM), except to the extent such PPL-SD Losses are determined to have resulted from the negligence or misconduct of a PPL-SD Indemnified Party.

 

13.2                        PPL-SD shall indemnify, defend and hold harmless DIPEXIUM and its affiliates, and its and their directors, officers, employees and agents (each, an “DIPEXIUM Indemnified

 

 

Party”), from and against any and all losses, damages, liabilities, reasonable attorney fees, court costs, and expenses (collectively “DIPEXIUM Losses”) resulting or arising from any third-party claims, actions, proceedings, investigations, or litigation relating to or arising from or in connection with (i) PPL-SD’s breach of its obligations under this Agreement or (ii) the Services contemplated herein to the extent such DIPEXIUM Losses are determined to have resulted from the negligence or misconduct of a PPLSD Indemnified Party, except to the extent such DIPEXIUM Losses are determined to have resulted from the negligence or misconduct of an DIPEXIUM Indemnified Party.

 

14.0        Indemnification Procedure

 

A Party seeking indemnification under this Section 14.0 (“Indemnitee”) shall give prompt notice to the other Party (“Indemnitor”) of any such claim or lawsuit (including a copy thereof) served upon it, and shall fully cooperate with Indemnitor and its legal representatives in the investigation of any matter the subject of indemnification. It shall be conditional for indemnification that Indemnitor shall have the right to assume the defense thereof with its counsel. Indemnitor may not settle any claim, liability, or action or otherwise consent to an adverse judgment in such action that diminishes the rights or interests of Indemnitee without the express written consent of Indemnitee, which consent shall not unreasonably be withheld.

 

15.0        Termination: Cancellation

 

15.1        This Agreement may be terminated by DIPEXIUM without cause at any time during the Term on sixty (60) days prior written notice to PPL-SD.

 

15.2        DIPEXIUM may terminate this Agreement and any Work Order, immediately upon giving written notice to PPL-SD, for serious adverse events caused by the PEPTIDES administered to clinical subjects.

 

15.3        Either Party may terminate this Agreement or any Work Order for material breach of the other Party upon thirty (30) days’ written notice specifying the nature of the breach, if such breach remains uncured at the end of such thirty (30) day period.

 

15.4        In case of termination of this Agreement or any Work Order after the completion of certain Work Order and before the commencement of any activities by PPL-SD for a subsequent Work Order, then DIPEXIUM shall not be required to make any payment to PPL-SD for such subsequent Work Order.

 

In the event this Agreement or a particular Work Order is terminated by DIPEXIUM in accordance with Section 15.1 above before a certain milestone under such terminated Work Order is achieved, DIPEXIUM shall pay PPL-SD any fees and expenses incurred by PPL-SD for actual work performed toward achieving that milestone up to the date of termination and those fees and expenses for achieved milestone.

 

However, it is agreed by PPL-SD that, if such non-achievement of any milestone is caused by negligence, misconduct, or breach by PPL-SD or its affiliates, DIPEXIUM shall be

 

 

required to pay PPL-SD’s fees and expenses for achieved milestone only and not be required to pay any fees and expenses for such non-achieved milestone.

 

15.5        Upon receipt of a termination notice from DIPEXIUM, PPL-SD shall cease performing any work not necessary for the orderly close out of the affected Project or for the fulfillment of regulatory requirements. DIPEXIUM shall pay for all actual costs incurred for PPL-SD to complete activities associated with the termination and close out of affected Project, including the fulfillment of any regulatory requirements.

 

15.6        Upon the termination of this Agreement or any Work Order, PPL-SD shall deliver to DIPEXIUM all data and materials, including but not limited to, DIPEXIUM Confidential Information provided by DIPEXIUM to PPL-SD for the conduct of the Services under the impacted Project or any reference standards used by PPL-SD to manufacture product supply on behalf of Dipexium. All statistical data, all statistical reports, all data entries and any other documentation produced as the result of the Services performed by PPL-SD under the impacted Project shall be delivered to DIPEXIUM upon payment to PPL-SD for all Services having been completed in accordance with the applicable Work Order. PPL-SD reserves the right to retain one copy of all materials provided to DIPEXIUM as the result of the Services performed by PPL-SD under the impacted Project for a period as determined by applicable law, which will remain subject to the confidentiality provisions herein, to be used only if a dispute arises regarding the Services performed by PPL-SD hereunder.

 

16.0        Relationship with Affiliates

 

DIPEXIUM agrees that PPL-SD may use services of its corporate affiliates to fulfill PPL-SD’s obligations under this Agreement and any Work Order subject to DIPEXIUM’s prior written content. Such affiliates of PPL-SD shall abide by all of the terms and conditions applicable to PPL-SD under this Agreement or any Work Order, and entitled to all rights and protections afforded PPL-SD under this Agreement and any Work Order. The term “affiliate” shall mean all entities controlling, controlled by or under common control with DIPEXIUM or PPL-SD, as the case may be. The term “control” shall mean the ability to vote fifty percent (50%) or more of the voting securities of any entity or otherwise having the ability to influence and direct the policies and direction of any entity. Both Parties agree that PPL-SD and DIPEXIUM shall assume responsibility for any services or performance done by the Parties’ respective affiliates.

 

17.0        Cooperation

 

All data and information in DIPEXIUM’s possession or control necessary for PPL-SD to conduct the Services will be forwarded by DIPEXIUM to PPL-SD. PPL-SD shall not be liable to DIPEXIUM nor be deemed to have breached this Agreement or any Work Order for errors, delays or other consequences arising from DIPEXIUM’s failure to timely provide documents, materials or information or to otherwise cooperate with PPL-SD in order for PPL-SD to timely and properly perform its obligations. If DIPEXIUM, for reasons other than a breach by PPL-SD or for reasons other than those out of DIPEXIUM’s control, materially delays an agreed starting date for the Services or suspends performance for a material length of time, then PPL-SD

 

 

reserves the right to reallocate resources or personnel originally allocated to the performance of the Services. Both Parties agree to cooperate with one another in connection with all matters related directly or indirectly to the services to be performed pursuant to this Agreement and during the term of this Agreement.

 

18.0        Force Majeure

 

In the event either Party is delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor troubles, inability to procure materials or services, failure of power or restrictive government or judicial orders, or decrees, riots, insurrection, war, Acts of God, acts of terrorism, inclement weather or other similar reason or cause beyond that Party’s control, then performance of such act (except for the payment of money owed to the other prior to the occurrence of such delay or hindrance due to the above events) shall be excused for the period of such delay.

 

19.0        Notices

 

Any notice required or permitted to be given hereunder by either Party shall be in writing and shall be deemed given on the date received if delivered personally or by a reputable overnight delivery service, or seven (7) days after the date postmarked if sent by registered or certified mail, return receipt requested, postage prepaid, or the next day if sent by facsimile transmission (confirmed by registered or certified mail above) to the following addresses:

 

	
If   to PPL-SD:.
    	
 
    	
PolyPeptide   Laboratories San Diego
    
	
 
    	
 
    	
Address:
    
	
 
    	
 
    	
Attn:   Robert Hagopian
    
	
 
    	
 
    	
 
    
	
If   to DIPEXIUM:.
    	
 
    	
Dipexium   Pharmaceuticals
    
	
 
    	
 
    	
Address
    
	
 
    	
 
    	
Attention:   David Luci
    

 

20.          Insurance

 

Each Party shall maintain, for the Term, insurance in an amount that it reasonably believes will be adequate to cover its obligations hereunder.

 

21.0        Assignment

 

DIPEXIUM may assign any of its rights or obligations under this Agreement to any third party without consent of PPL-SD. PPL-SD may not assign any of its rights or obligations under this Agreement to any third party without the express, written consent of DIPEXIUM; provided, however, that PPL-SD may, without such consent, assign this Agreement and its rights and obligations hereunder in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger, acquisition or consolidation or change in control or similar

 

 

transaction. Any permitted assignee shall assume all rights and obligations of its assignor under this Agreement and any Work Order.

 

22.0        Choice of Law and Enforceability

 

This Agreement shall be construed, governed, interpreted, and applied in accordance with the laws of the state of Delaware, exclusive of its conflicts of laws provisions. The failure to enforce any right or provision herein shall not constitute a waiver of that right or provision. If any provisions herein are found to be unenforceable on the grounds that they are overly broad or in conflict with applicable laws, it is the intent of the Parties that such provisions be replaced, reformed or narrowed so that their original business purpose can be accomplished to the extent permitted by Jaw, and that the remaining provisions shall not in any way be affected or impaired thereby.

 

23.0        Survival

 

The rights and obligations of DIPEXIUM and PPL-SD (including, but not limited to, rights with respect to inventions, confidentiality, indemnification and limit of liability) created or arising by virtue of the Agreement or by virtue of Work Orders entered into before the date of termination or expiration shall survive the expiration or termination of this Agreement or any Work Order.

 

24.0        Entire Agreement and Modification

 

This Agreement and each Work Order contain the entire understandings of the Parties with respect to the subject matter herein, and supersede all previous agreements (oral and written), negotiations and discussions. Any modifications to the provisions herein must be in writing and signed by the Parties.

 

25.0        Arbitration

 

In the event any dispute arises out of, in connection with or relating to this Agreement, both Parties shall endeavor, in good faith, to settle such dispute amicably between themselves. In the event the Parties fail to agree, the Parties will agree to explore resolution of such dispute by arbitration. Any arbitration hereunder shall be conducted under the arbitration rules of Conciliation and Arbitration of International Chamber of Commerce, then in force. Such arbitration shall take place in the place where a defendant Party resides. It is further agreed by both Parties that the arbitration award shall be binding on both Parties and that judgment on the award may be entered by any competent court having jurisdiction thereover.

 

IN WITNESS WHEREOF, this Agreement has been executed by the Parties through their duly authorized officers on the Effective Date.

 

 

	
PolyPeptide   Laboratories San Diego
    	
 
    	
Dipexium   Pharmaceuticals
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/   Robert Hagopian
    	
 
    	
By:
    	
/s/   David Luci
    
	
Name:   Robert Hagopian
    	
 
    	
Name:   David Luci
    
	
Title:   Director, Business Development
    	
 
    	
Title:   Managing Partner

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