RECITALS:

 

A.

MEDPACE hereby agrees to perform Services for SPONSOR from time to time.  The precise Services to be performed by MEDPACE shall be mutually agreed upon by the Parties and set forth in one or more task orders (each a “Task Order”), a form of which is attached hereto as Exhibit A.  Each Task Order shall be signed by an authorized representative of each Party and shall include detailed information concerning a given project, including a description of the specific services to be provided (“Scope of Work”), project milestones and target completion dates (“Project Schedule”), the applicable protocol, a detailed budget (“Project Budget”), and a schedule of payments related to the Project Schedule and the Project Budget (“Payment Schedule”).  Each Task Order shall contain a Transfer of Obligations list (“Transfer of Obligations”) in conjunction with the relevant Task Order and consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D (Responsibilities of Sponsors and Investigators).  Any responsibilities not specifically transferred in the Transfer of Obligations shall remain the regulatory responsibility of SPONSOR.

 

B.

Unless otherwise stated in the applicable Task Order, the Services will be conducted in compliance with MEDPACE SOPs and Policies, copies of which have been or will be provided to SPONSOR during the negotiation of the relevant Task Order.

 

 

C.

From time to time, SPONSOR may wish to enter into a Task Order with a MEDPACE Affiliate for Services under this Agreement (“Affiliate Task Order”), and such MEDPACE Affiliate may wish enter into the Affiliate Task Order with SPONSOR. Any such Affiliate Task Order must be in writing and signed by the parties to the Affiliate Task Order, and each signatory to an Affiliate Task Order is solely responsible for all obligations it undertakes under the Affiliate Task Order. For the purposes of a particular Affiliate Task Order, the Affiliate signing such Affiliate Task Order will be substituted for MEDPACE everywhere it appears in this Agreement, and the term “Affiliate Task Order” will be substituted for Task Order everywhere it appears in this Agreement.

 

 

D.

As used herein, “Affiliate” means in relation to a Party, any entity, directly or indirectly, controlling such Party, controlled by such Party, or under common control with such Party.  For purposes of this definition, “control” shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the activities, management or policies of such party, whether through the ownership of voting securities, by contract or otherwise.  Without limiting the foregoing, control shall be presumed to exist when a person, organization or entity (i) owns or directly controls fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (ii) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity.

 

 

E.

To avoid any doubt, the Parties agree that any and all regulatory filings and submissions that may be made with respect to the Services provided under this Agreement shall be (i) coordinated with and approved by SPONSOR in advance at all times, (ii) made solely in SPONSOR’s name, (iii) owned solely by SPONSOR.  The extent of MEDPACE’s responsibility for such filings and submissions shall be set out in the applicable Task Order.

 

F.

As part of the Services and as an accommodation to SPONSOR, MEDPACE may contract with third parties for the provision of services not customarily performed or provided by MEDPACE (“Pre-funded Vendors”).  While MEDPACE may contract with and/or facilitate the activities of such Pre-funded Vendors, MEDPACE does not undertake by virtue of this Agreement, the relevant Task Order or such third party contract, responsibility for the Pre-funded Vendor’s business, professional conduct, performance, or breaches by such Pre-funded Vendors.  MEDPACE’s responsibility with respect to such Pre-funded Vendors shall be to coordinate the services of such Pre-funded Vendors and to make payments after receipt of sufficient funds from SPONSOR (“Pre-funded Expenses”).   Pre - funded Expenses may include but are not limited to third party advance payments for investigator meetings, vendors, Study Site payments (“Study Site” shall mean the physical location at which a particular investigator conducts a study), and any payments to investigators, institutions, and site maintenance organizations for services performed that relate to a study.  In the event a Pre-funded Vendor requests indemnification with respect to the services performed under such Pre-funded Vendor’s contract, MEDPACE shall notify SPONSOR and SPONSOR enter into an indemnification agreement directly with such Pre-funded Vendors.  MEDPACE shall have no obligation with respect to the indemnity of a Pre-funded Vendors. The Parties acknowledge and agree that any Pre-funded Vendors (including but not limited to investigators, institutions or site management organizations) paid with Pre-funded Expenses in connection with the performance of Services under this Agreement or any Task Order shall not be considered the agent, employee or subcontractor of MEDPACE.

 

 

G.

Except as otherwise agreed by the Parties in writing, SPONSOR is and at all times remains, in all geographical regions where the Study is being performed, the “Sponsor” or “Legal Representative” of the Study pursuant to or applicable law.

 

A.

Each Task Order shall contain project timelines, milestones and/or target dates for completion of a project or a portion thereof, and all such schedules shall be reasonable for the Services to be provided.  The Parties shall, at all times, use their reasonable best efforts to comply with and perform their obligations in accordance with each Task Order.

 

 

B.

If at any time either Party anticipates a delay in meeting the timelines for a given Task Order as set forth in its Project Schedule, either due to changes to the Services requested by SPONSOR, or other causes beyond the control of such Party (such as FDA approval of a competitor’s NDA for the same drug, which may adversely affect patient enrollment), then the anticipating Party shall promptly notify the other Party in writing, specifying the reason for the delay and the anticipated effect upon the timelines, milestones or other deliverables.

 

A.

Service Fees:

 

 

B.

Pass Through Costs:

 

 

C.

Pre - funded Expenses:

 

 

D.

Payment Terms:

 

 

E.

Security:

 

 

A.

Acknowledgements:

 

 

B.

Representations and Warranties of MEDPACE:

 

 

i.

MEDPACE represents and warrants that it is duly organized, validly existing and in good standing in its jurisdiction of organization, and is in good standing and duly qualified to carrying on business including as contemplated by this Agreement.

 

ii.

MEDPACE represents and warrants that the execution, delivery and performance of this Agreement and each Task Order has been (and will be at the relevant time) validly authorized by all necessary corporate action and this Agreement and each Task Order represents (and will represent) the valid binding agreement of MEDPACE enforceable in accordance with its terms.  MEDPACE represents and warrants that the execution, delivery and performance of this Agreement and each Task Order does not and will not violate any organizational document governing MEDPACE, any agreement to which MEDPACE is a party, or any law or court or governmental order, holding or writ by which MEDPACE is bound.  MEDPACE further represents and warrants that it shall, and undertakes to, render the Services requested by SPONSOR in accordance with high professional standards, consistent with Good Clinical Practices and with the standard of care customary in the contract research organization industry.

 

iii.

MEDPACE represents and warrants that the personnel assigned to perform services rendered under this Agreement shall be qualified and professionally capable of performing the Services, shall be adequate to effectively perform the Services on the agreed upon schedule and shall devote such time as is necessary to perform the Services on such agreed upon schedule.  Upon request of SPONSOR, MEDPACE will provide SPONSOR with the credentials of all study personnel.

 

iv.

MEDPACE further represents, warrants and undertakes that it shall perform the Services in compliance with all applicable laws and regulations in the jurisdiction(s) in which the Services are performed, including, without limitation, the US Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and all future amendments thereto during the term.  In addition, MEDPACE undertakes to ensure that any materials provided by SPONSOR for the purpose of the performance of the Services pursuant to any Task Order shall be handled, transported, stored, used and disposed of in accordance with the laws and regulations.

 

v.

MEDPACE represents and warrants that there is no litigation, regulatory investigation or proceeding, administrative hearing or any other similar proceeding pending or to the best of its knowledge threatened against MEDPACE which could adversely affect MEDPACE’s ability to perform the Services.

 

C.

Representations and Warranties of SPONSOR

 

 

i.

SPONSOR represents and warrants that it is a corporation with its principal office and place of business at Hi-Tech Park 2/5 Givat Ram, PO Box 39098, Jerusalem, 91390, Israel, duly organized, validly existing and in good standing in its place of organization, and is in good standing in and duly qualified to do business.

 

ii.

SPONSOR represents and warrants that the execution, delivery and performance of this Agreement and each Task Order has been and will be validly authorized by all corporate action and this Agreement and each Task Order represents and will represent the valid binding agreement of SPONSOR enforceable in accordance with its terms.  The execution, delivery and performance of this Agreement and each Task Order does not and will not violate any organizational document governing SPONSOR, any agreement to which SPONSOR is a party, or any law or court or governmental order, holding or writ by which SPONSOR is bound.

 

iii.

SPONSOR represents and warrants that there is no litigation, regulatory investigation or proceeding, administrative hearing or any other similar proceeding pending or to the best of its knowledge threatened against SPONSOR which could adversely affect SPONSOR’s ability to perform under this Agreement or any Task Order.

 

A.

SPONSOR may terminate this Agreement without cause immediately upon giving the other Party notice of such termination, provided such termination shall not in and of itself affect any then uncompleted Task Order.

 

 

B.

SPONSOR may terminate any Task Order without cause immediately upon giving MEDPACE notice of such termination.  As soon as practicable, after receipt of such notice, the Parties shall cooperate in good faith to agree on a plan to expeditiously conclude activities with respect to such matter.  MEDPACE shall transfer to SPONSOR all case report forms, study files, and other data and information in any and all formats available, including electronic format and computer files and programs, in MEDPACE’s possession.

 

C.

MEDPACE may terminate a Task Order only if SPONSOR has defaulted on its obligations thereunder and has not cured such default within fifteen (15) days after receipt of written notice if the default is the failure to pay MEDPACE any amount due thereunder or within thirty (30) days after receipt of written notice in the event of any other default, provided, however, that where SPONSOR is making diligent, good faith efforts to cure such default but requires additional time to complete such cure, SPONSOR will notify MEDPACE in writing of its request for additional time and the parties will negotiate in good faith an appropriate extension to such period, provided, further, that SPONSOR shall be entitled to an extension of at least fifteen (15) days if the parties fail to reach agreement in respect of an appropriate extension.  As soon as practicable, after receipt of such notice, the Parties shall cooperate in good faith to agree on a plan to expeditiously conclude activities with respect to such matter.  MEDPACE shall transfer to SPONSOR all case report forms, study files, and other data and information in any and all formats available, including electronic format and computer files and programs, in MEDPACE’s possession.

 

 

D.

In the event of any termination of a Task Order before completion, SPONSOR agrees to pay MEDPACE for all Services rendered pursuant to the unfinished Task Order prior to such termination and any non-cancelable expenses incurred in connection with MEDPACE’s performance of Services thereunder to the extent such expenses cannot be reasonably mitigated.  As soon as reasonably practicable following receipt of a termination notice, MEDPACE shall submit an itemized accounting of Services performed, expenses incurred pursuant to performance of the Services, non-cancelable expenses incurred by MEDPACE relating to any unfinished Task Order, and payments received in order to determine a balance to be paid by either Party to the other.  Such balance shall be paid within 30 days of receipt of such an itemized accounting by SPONSOR.

 

 

E.

The following sections shall survive any expiration of termination of this Agreement: 8 [Confidentiality], 9 [Rights in Property], 10 [Patent Rights], 11 [Publicity], 14 [Indemnification], 15 [Limitation of Liability and Insurance], 16 [Inspections and Audit] and 18 [Non-Solicitation].

 

A.

SPONSOR, may provide confidential information to MEDPACE during the course of this Agreement.  All information provided by SPONSOR or its clients, and any and all data collected and/or generated by MEDPACE during the course of performance of the Services is deemed to be the confidential information of SPONSOR (“SPONSOR Confidential Information”).  MEDPACE shall not disclose SPONSOR Confidential Information to any third party, or use SPONSOR Confidential Information for any purpose other than for the benefit of SPONSOR pursuant to the terms of this Agreement, without the prior written consent of SPONSOR.

 

 

i.

MEDPACE shall ensure by binding written agreement that its employees, agents, and independent contractors (approved in advance and in writing by SPONSOR) who are involved in the provision of the Services (herein “MEDPACE Representatives”) shall comply with the provisions of Article 8 of this Agreement.  MEDPACE shall disclose SPONSOR Confidential Information only to those MEDPACE Representatives who reasonably need to know SPONSOR Confidential Information to enable MEDPACE to perform its obligations under this Agreement.  MEDPACE shall remain responsible to SPONSOR for all acts and omissions of MEDPACE Representatives with respect to their use of the SPONSOR Confidential Information.

 

ii.

MEDPACE shall exercise due care, but no less than a reasonable degree of care, to prevent the unauthorized disclosure and use of SPONSOR Confidential Information associated with the Services.  In the event that MEDPACE learns of any such unauthorized disclosure and use, it shall immediately (a) notify SPONSOR thereof, and (b) take all necessary actions to ensure that such disclosure and use is terminated.

 

 

B.

MEDPACE may provide confidential information to SPONSOR during the course of this Agreement (“MEDPACE Confidential Information”).  MEDPACE Confidential Information shall include but is not limited to standard operating procedures, pricing, and financial information provided by MEDPACE or its Affiliates to SPONSOR during the course of performance of the Services, and any non-public information pertaining to MEDPACE’s business practices or other proprietary information.  SPONSOR shall not disclose MEDPACE Confidential Information to any third party, or use MEDPACE Confidential Information for any purpose other than for those set forth under this Agreement or a Task Order, without the prior written consent of MEDPACE.

 

 

i.

SPONSOR shall ensure by binding written agreement that its employees, agents, and approved independent contractors involved in the Services shall comply with the provisions of Article 8 of this Agreement.  SPONSOR shall disclose MEDPACE Confidential Information only to those of its employees, agents, and independent contractors who reasonably need to know MEDPACE Confidential Information.

 

ii.

SPONSOR shall exercise due care, but no less than a reasonable degree of care, to prevent the unauthorized disclosure and use of confidential information associated with the Services.

 

 

C.

This confidentiality and non-disclosure provision shall not apply to:

 

 

i.

Information which was known by the Party receiving such information (the “Receiving Party”) before the date hereof or which is independently discovered, after the date hereof, without the aid, application or use of the confidential information, as evidenced by written records;

 

ii.

Information which is in the public domain on the date hereof or subsequently becomes publicly available through no fault or action of the Receiving Party; or

 

iii.

Information, which is disclosed to the Receiving Party by a third party, authorized to disclose it.

 

 

D.

If the Receiving Party is requested to disclose the Confidential Information of the other Party (the “Disclosing Party”) or the substance of this Agreement in connection with a legal or administrative proceeding or otherwise to comply with a requirement under applicable law, the Receiving Party will give the Disclosing Party prompt notice of such request so that the Disclosing Party may seek an appropriate protective order or other remedy, or waive compliance with the relevant provisions of this Agreement.  The Disclosing Party must notify the Receiving Party within 10 days that it intends to take action in response to the request for disclosure.  If the Disclosing Party seeks a protective order or other remedy, the Receiving Party, at the Disclosing Party’s expense, will cooperate with and assist the Disclosing Party in such efforts.  Failure of the Disclosing Party to intervene shall not relieve the obligations to maintain confidentiality except in so far as the Receiving Party must comply with the terms of such process compelling disclosure.

 

 

E.

Each Party acknowledges that any violation or threatened violation of the foregoing provisions may cause irreparable injury to the other Party, entitling the other Party to seek injunctive relief in addition to all other legal remedies.

 

A.

All materials, documents, data, laboratory samples, medical imaging data, software and information of every kind and description supplied to MEDPACE by SPONSOR or any of SPONSOR’s clients, or prepared, developed, or generated by MEDPACE or the MEDPACE Representatives pursuant to this Agreement (collectively, the “Results”), (except for the pre-existing MEDPACE procedural manuals, personal data, methods, procedures, and policies) are and shall be the sole and exclusive property of SPONSOR.  Further, all Results, and all rights subsisting therein and related thereto, shall be and remain the exclusive property of SPONSOR.  SPONSOR shall have the sole right to make whatever use SPONSOR deems desirable of the Results.  MEDPACE shall not, without the prior written consent of SPONSOR, publish, disseminate, or otherwise disclose to any third party any Results (except such disclosure as may be required by law, in which event MEDPACE shall notify SPONSOR thereof in advance), or use any Results for any purpose other than the performance of this Agreement.  Any inventions or other intellectual property, including without limitation patent rights, trade secrets, protectable copyrights and trademarks, that may evolve from the Results shall belong solely to SPONSOR, and MEDPACE agrees to assign its rights in all such inventions and/or other intellectual property to SPONSOR consistent with the obligations set forth in Article 10 below.  MEDPACE further agrees to perform such further acts and execute such further documents as may be reasonably necessary to carry out and give full effect to the foregoing arrangements.

 

 

B.

SPONSOR acknowledges that all computer programs, software, applications, databases, proposals and other documentation generally used by MEDPACE and not directly related to, derived from or developed solely for SPONSOR are the exclusive and confidential property of MEDPACE or the third parties from whom MEDPACE has secured the right of use.  SPONSOR agrees that any improvement, alteration or enhancement to MEDPACE systems, software, applications or processes which are developed or implemented during the course of any Services performed hereunder, without the use of any SPONSOR data, information, materials or Confidential Information (or derivatives thereof) or Results, shall be the property of MEDPACE.

 

A.

MEDPACE shall not make any public announcements, presentations, disclosures and/or publications concerning this Agreement or the subject matter hereof without the prior written consent of SPONSOR, unless required by applicable law or government agency.

 

 

B.

SPONSOR may not use MEDPACE’s name, logo or trademark in any public communication, release, notice or other publication without the express prior written consent of MEDPACE; provided, however, that SPONSOR may do so in order to comply with applicable laws, regulations and filing obligations of stock exchanges.

 

A.

MEDPACE shall make available to SPONSOR relevant records, programs and data which is the subject of a Task Order in accordance with the arrangements to be agreed in the relevant Task Order.

 

 

B.

SPONSOR shall have the right to monitor the operations of MEDPACE hereunder, and SPONSOR and or its designated representatives shall have the right to visit any of the facilities, upon reasonable advance written notice, where MEDPACE is performing any of the Services and during such visits to inspect the work being done and materials used, to observe the procedures being followed, and to examine the books, records and other data relevant to the Services.  If any regulatory agency requests to inspect any books, records, data of MEDPACE relating to the Services, MEDPACE shall immediately notify SPONSOR.

 

C.

MEDPACE shall use industry-standard commercially reasonable efforts, including, but not limited to, periodic backup of computer files (in accordance with MEDPACE’s SOPs), to prevent the loss or alteration of SPONSOR’s study data, Confidential Information, documentation, and correspondence, including secure, off-site redundancy storage.  MEDPACE shall in all respects comply with any Food and Drug Administration regulations concerning the maintenance, creation and storage of records, including electronic records.

 

 

D.

MEDPACE shall transfer study materials, documents and correspondence to SPONSOR in accordance with the arrangements (which shall include frequency of such transfer) set out in the applicable Task Order.  MEDPACE shall have the right to retain one copy of any study materials, documentation, and correspondence necessary solely to meet regulatory or MEDPACE’s own internal audit requirements, so long as it continues to maintain the confidentiality requirements of Article 8.

 

A.

SPONSOR shall indemnify, defend and hold harmless MEDPACE from and against any and all damages, losses, liabilities, costs or expenses (collectively “Damages”), resulting or arising from any third-party claims, demands, assessments, actions, suits, investigations or proceedings (collectively “Claims”), relating to or arising from or in connection with this Agreement or the Services under any Task Order (including but not limited to any Damages arising from or in connection with any study, test, device, product or potential product to which this Agreement relates), to the extent such Claims or Damages have not resulted from MEDPACE’s negligence, willful misconduct, or breach of any applicable law or material breach of this Agreement or any Task Order by MEDPACE.

 

 

B.

MEDPACE agrees to indemnify, defend and hold harmless SPONSOR from and against any and all Damages resulting or arising from third-party Claims relating to or arising from or in connection with the Services under any Task Order to the extent that such Claims or Damages are determined to have resulted from the negligence, , or willful misconduct of MEDPACE or a breach of any applicable federal, state or local law or a material breach of this Agreement or any Task Order by MEDPACE.

 

 

C.

Any party providing indemnification under this Agreement shall have the right to control the defense and settlement of any Claims or Damages.  The indemnified party shall have the right to obtain separate legal counsel at its own expense if it so chooses.  The indemnifying party shall not unreasonably withhold consent for settlement and the indemnified party shall reasonably cooperate in the defense of any Claims or Damages and provide prompt notice to the indemnifying party of any Claims or Damages for which indemnification is sought.

 

A.

SPONSOR shall have the right, upon at least ten (10) days’ prior written notice to MEDPACE, to examine the standard operating procedures, facilities, books, records, papers, files and documentation, including computer files, data bases and records, at MEDPACE’s facilities and the facilities of clinical investigators contracted by MEDPACE to determine the adequacy of such records, to ensure the Services are being performed in accordance with the approved Task Orders and applicable regulations and/or to examine the financial records of MEDPACE as may be reasonably necessary to verify out-of-pocket expenses incurred during the performance of the Services.  Such inspections and audits shall be conducted during normal business hours.

 

 

B.

MEDPACE shall provide reasonable assistance, including making available members of its staff and providing access to all requested records, to facilitate such inspections and audits.

 

 

C.

MEDPACE shall take all reasonable steps required by SPONSOR to cure any deficiencies found in any audit, inspection or investigation.

 

 

D.

The obligations herein shall survive termination for a period of 7 years.

 

A.

MEDPACE hereby represents, warrants, and certifies that neither it nor any of its officers, directors, owners, principals or employees has been or will be at any relevant time hereunder debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or similar local law.  In the event that any such party becomes debarred, MEDPACE shall notify SPONSOR in writing immediately, and upon SPONSOR’s request, such individual shall cease to be involved in the provision of the Services.

 

B.

MEDPACE hereby represents, warrants, and certifies that it has not and shall not use in any capacity the services of any individual, corporation, partnership, or association which has been debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or similar local law.  In the event MEDPACE becomes aware of or receives notice of the debarment of any individual, corporation, partnership, or association providing services to MEDPACE, which relate to the Services being provided under this Agreement, MEDPACE shall notify SPONSOR in writing immediately, and upon SPONSOR’s request, such individual shall cease to be involved in the provision of the Services.

 

A.

Except as set forth herein, neither Party shall assign this Agreement or any Task Order except with the express prior written consent of the other Party.

 

 

B.

Notwithstanding anything contained herein, a Party may assign this Agreement and/or any Task Order to an Affiliate, and SPONSOR may assign this Agreement and/or any Task Order to a successor in interest to such Party or in the event of a merger or acquisition; in any such event, the Party so assigning shall notify the other Party in writing thereof.

 

A.

MEDPACE may subcontract any portion of the Services hereunder to an Affiliate without the prior written consent of SPONSOR provided MEDPACE remains liable for the performance of any such Affiliate, such subcontracting shall not derogate from MEDPACE’s obligations under this Agreement, and MEDPACE provides prompt written notice of such arrangement to MEDPACE.

By: 

John Wynne

Title: 

Executive Director

Business Development Support

Signature: 

By: 

Nadav Kidron

Title: 

CEO

 

1.

Scope of Work.  MEDPACE shall perform the services described in the Scope of Work, attached hereto as Appendix 1, in accordance with the Project Schedule, attached hereto as Appendix 2 and any other documents attached to and specifically referenced in this Task Order (“Services”).

 

2.

Compensation.  For performance of these Services, SPONSOR shall pay to MEDPACE an amount equal to the Project Budget set forth in Appendix 3, which amount shall be payable pursuant to the Payment Schedule set forth in Appendix 4.  The Project Budget is provided for cost analysis purposes.  It is agreed that all fees are fixed prices unless the underlying assumptions (including, but not limited to, trial duration, number of sites/patients, services provided) change and all such changes shall be documented in a Contract Amendment.  After staff are assigned, costs are incurred based upon allocation of staff capacity.

 

3.

Transfer of Obligations.  Sponsor Obligations transferred to MEDPACE by SPONSOR (consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D) are identified in Appendix 5.

 

4.

MSA. The provisions of the Master Services Agreement are hereby expressly incorporated by reference into and made a part of this Task Order.