MASTER SERVICES AGREEMENT

This Master Services Agreement (the “Agreement”) is made and entered into on 11th October, 2011, (the “Effective Date”), by and between DanDrit Biotech A/S, a Danish corporation, with offices at Høffdingsvej 34, 2500 Valby, Denmark (hereinafter referred to as “Client”) and Aptiv Solutions (UK) Ltd, together with its Affiliates, with offices at Hemel One, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 (hereinafter referred to as “Aptiv Solutions”), both hereinafter referred as a “Party” or collectively as the “Parties”.

 

Aptiv Solutions is engaged in the business of providing services related to the implementation and management of clinical development programs for the pharmaceutical, biotechnology and medical device industries; and

 

Client desires to engage Aptiv Solutions to perform such services in connection with certain pharmaceutical products under development by or under control of Client;

 

Therefore, in consideration of the premises and mutual promises and undertakings herein, the receipt and sufficiency of which are hereby acknowledged, the Parties intending to be legally bound do hereby agree as follows:

 

1.1	DEFINITIONS

 

	a.	Affiliates:      With respect to either Party, an Affiliate is any entity that is controlled by, controls, or is under common control with the Party named above.
	b.	Amendment: A written specification of changes to a Project Agreement that is agreed to by the Parties and authorized by signature of each Party’s authorized representative(s), in a format substantially similar to Exhibit B attached hereto.
	c.	Budget for Services: A component of a Project Agreement that delineates the estimated cost of the Services based upon the Project Specifications.
	d.	Institutional Review Board (“IRB”):   Any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of human subjects. The term has the same meaning as the phrase institutional review committee, independent ethics committee or ethics committee.

	e.	GCP or Good Clinical Practice: The standard defined in the ICH Harmonised Tripartite Guideline For Good Clinical Practice E6(R1) Current Step 4 version dated 10 June 1996 (including the Post Step 4 corrections) together with, for Services performed in the European Union, such other Good Clinical Practice requirements as are specified in Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 relating to medicinal products for human use and in guidance published by the European Commission pursuant to such Directive; and for Services performed in other jurisdictions, any analogous laws and/or regulations.
	f.	Institution: Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
	g.	Investigator(s): A person or persons responsible for the conduct of the clinical trial at a Trial Site. If a trial is conducted by a team of individuals at a Trial Site, the Investigator is the responsible leader of the team and may be called the principal investigator.
	h.	Milestone: An event associated with a specific date, for which a payment will be due, as set out in the Payment Schedule of any Project Agreement.
	i.	Pass-Through Budget: A component of a Project Agreement that outlines the estimated costs of Pass Through Expenses for goods and services incurred by Aptiv Solutions on behalf of Client, in connection with the performance of the Services.
	j.	Payment Schedule: A component of a Project Agreement that describes the timing of payments due to be made for Services delivered and Pass Through Expenses incurred.
	k.	Aptiv Solutions Project Manager: The Aptiv Solutions representative assigned to lead the Aptiv Solutions project team, act as the principal liaison between Aptiv Solutions and Client, and provide general oversight in the delivery of Services with regard to a specific Project Agreement.
	l.	Project Agreement: A written specification of Services to be performed by Aptiv Solutions under this Agreement, including the Project Specifications, Project Schedule, Contact Information, Budget for Services, Pass-Through Budget, and Payment Schedule
	m.	Project Schedule: A component of a Project Agreement that outlines the project milestones, estimated timelines and completion date for the Services based upon the Project Specifications.

	n.	Project Specifications: A component of a Project Agreement that outlines the specific Services to be provided, assumptions used in preparing the Budget for Services, Pass-Through Budget and Project Schedule, and assignment of project-related responsibilities between the Parties.
	o.	Services:   The services to be provided by Aptiv Solutions and its Subcontractors (if applicable) under this Agreement as specifically outlined in a Project Agreement or otherwise authorized by Client.
	p.	Study: A clinical trial performed at one or more investigative sites under the supervision of one or more Investigator(s) pursuant to a study protocol.
	q.	Subcontractor: An individual or company engaged by Aptiv Solutions to conduct some elements of a Project Agreement, including without limitation, clinical laboratories, patient recruitment services, interactive voice recognition systems and other services.
	r.	Trial Site(s): The location(s) where trial-related activities are actually conducted.

Aptiv Solutions, itself or through one of its Affiliates or Subcontractors (if applicable), will perform the Services as specified in this Agreement and any associated Project Agreement(s), in accordance with the terms and conditions of this Agreement. Aptiv Solutions will use reasonable efforts to perform the Services described in any Project Agreement issued hereunder and to meet all obligations and deadlines described in such Project Agreements. The Parties will agree on all Services to be provided and the performance of those Services will be authorized in writing through the execution of a Project Agreement. Aptiv Solutions will not begin work on any Services without an agreement in writing.

Client will have the overall responsibility for the studies at all times and will manage all study related tasks which have not been specifically delegated to Aptiv Solutions as described in each Project Agreement. Client will, at its expense and as applicable, supply the drug for the timely completion of the clinical studies described in each Project Agreement. Client agrees to keep Aptiv Solutions fully informed at all times of relevant information known to Client which might influence the conduct of the study and the provision of Services.

Client acknowledges that Aptiv Solutions will require documents, drug supplies, data, records and cooperation by Client, investigators, and/or third party suppliers in order to properly perform the Services, and that Aptiv Solutions will not be liable for the failure of Client or any third party involved in a Study to supply such information or data to Aptiv Solutions.

All responsibility for the conduct of the study will remain with Client as defined in 21 CFR 312.52 or Directive 2001/20/EC, as applicable.

Aptiv Solutions will provide Services as specified in one or more Project Agreements, which will be prepared in a format substantially similar to the Form of Project Agreement, attached hereto as Exhibit A. Each Project Agreement will include detailed information with respect to a specific project, including Project Specifications, Project Schedule, Budget for Services, Pass-Through Budget, and Payment Schedule. Project Agreements will become effective when signed by an authorized representative or representatives of both Parties as directed by the Project Agreements.

Any changes to a Project Agreement, including but not limited to changes to the Project Specifications, Project Schedule, Budget for Services or Pass-Through Budget, will be agreed upon by the Parties and documented in an Amendment to the Project Agreement in a form substantially similar to that attached hereto as Exhibit B. Client agrees that Aptiv Solutions will not perform any out-of-scope work described in an Amendment until it is approved in writing by both Parties.

 

In performing the Services, Aptiv Solutions will assign personnel who are adequately trained, qualified and experienced to conduct the work as specified in a Project Agreement. Client may make reasonable requests for replacement of assigned personnel for cause, such as unsatisfactory performance or interpersonal conflicts. Aptiv Solutions will promptly respond to any such request and make reasonable efforts to correct the situation in order to improve performance, or to provide a replacement, at its own expense, within a mutually agreeable timeframe. Aptiv Solutions will assign personnel at its sole discretion from one or more of its or its Affiliates offices located worldwide, as needed to perform the Services in accordance with the Project Agreement.

Aptiv Solutions may use Subcontractors to conduct some elements of a Project Agreement. For any project Aptiv Solutions will notify Client in advance if it intends to use Subcontractors and will not engage subcontractors not specifically approved by Aptiv Solutions.

The Parties agree that Aptiv Solutions will provide the operational systems, processes and standard operating procedures to be used in performance of the Services unless specified otherwise in the Project Specifications. All Services will be conducted in accordance with GCP and applicable laws and regulations, including but not limited to all relevant personal data protection legislation.

In the event that Client requires Aptiv Solutions to use Client’s information systems and associated processes, Client will be responsible for all costs associated with installation and operation of the systems, including costs for hardware and software licenses, and for training of Aptiv Solutions personnel assigned to the project in the use of Client system(s).

The Parties agree that the fees and other reimbursements that Aptiv Solutions will receive for performing the Services hereunder will be outlined in each Project Agreement and are subject to the following terms and conditions.

The parties acknowledge that some projects may be executed in more than one country, and that the currencies used by those countries may vary, and may fluctuate in value during the term of this Agreement. Any such Project Agreements will contain a notation of the Base Exchange Rate for all currencies other than US Dollars in which costs for Services will be incurred. If at any time during the term of a Project Agreement the Base Exchange Rate for Services specified in a foreign currency has fluctuated more than 3%, plus or minus, Aptiv Solutions will calculate a foreign currency exchange adjustment for those Services.

The adjustment will be calculated by comparing the Base Exchange Rate with the Wall Street Journal foreign currency exchange spot rate on the last business Friday before each invoice is issued. Any resulting decrease in costs will be credited to Client and any resulting increase in costs will be invoiced to Client. Aptiv Solutions reserves the right to charge a handling fee of up to five percent (5%) of the Pass Through Expenses. In the event Aptiv Solutions incurs a pass through cost in a currency other than U.S. Dollars, the Parties shall determine the amount payable based on the relevant conversion rate as reported on Oanda.com on the invoice date.

Unless earlier terminated according to Section 4.2, 4.3, or 4.4 below, this Agreement will remain in effect for an initial term of two (2) years from the Effective Date, and thereafter will renew automatically unless either Party notifies the other Party of termination of the Agreement no later than sixty (60) days prior to renewal hereof. In the event of non-renewal by either Party, the term of this Agreement applicable under any outstanding Project Agreement will continue until completion of the Services described in such Project Agreement or termination of the Project Agreement.

The Client may terminate the Agreement or any Project Agreement issued hereunder for any reason upon sixty (60) days written notice to Aptiv Solutions. Should Client terminate this Agreement or a Project Agreement without cause, the termination process and associated fees will be as follows:

reasonably set by Client sixty (60) days, this Agreement may be terminated by Client. Client will pay Aptiv Solutions for all Services properly rendered and Pass Through Expenses incurred. As soon as practicable following receipt of notice of termination under this Section 4.3, Aptiv Solutions will submit an itemized accounting of Pass Through Expenses and costs incurred, costs anticipated, and payments received in order to determine a balance to be paid by either Party to the other. Such balance will be paid by Client within thirty (30) days of completion of work.

If in the reasonable assessment of Aptiv Solutions, its continued performance of the Services contemplated by this Agreement or any Project Agreement could constitute a potential or actual violation of legal, regulatory, ethical or scientific standards, then Aptiv Solutions may terminate this Agreement or any Project Agreement by giving written notice stating the effective date (which may not be less than sixty [60] days from the notice date) of such termination. The parties shall use all reasonable efforts to rectify the alleged violation prior to the end of the sixty (60) day notice period.

Each of the Parties represents, warrants and covenants to the other that: (a) it is a corporation duly incorporated, validly existing and in good standing; (b) it has taken all necessary actions on its part to authorize the execution, delivery and performance of the obligations undertaken in this Agreement, and no other corporate actions are necessary with respect thereto; (c) it is not a party to any agreement or understanding and knows of no law or regulation that would prohibit it from entering into and performing this Agreement; (d) when executed and delivered by it, this Agreement will constitute a legal, valid and binding obligation of it, enforceable against it in accordance with this Agreement’s terms; (e) it is duly licensed, authorized or qualified to do business and is in good standing in every jurisdiction in which a license, authorization or qualification is required for it to perform its obligations under this Agreement; and (f) it will not enter into any other agreements which would interfere or prevent performance of the obligations described herein.

All data (including without limitation, written, printed, graphic, video and audio material, and information contained in any computer database or computer readable form) generated by Aptiv Solutions in the course of conducting the Services (the “Data”) and related to the Services will be Client’s property. Any copyrightable work created in connection with performance of the Services and contained in the Data will be considered work made for hire, whether published or unpublished, and all rights therein will be the property of Client as employer, author and owner of copyright in such work.

Aptiv Solutions understands and agrees that the underlying rights to the intellectual property and materials that are the subject of each Project Agreement, including, without limitation, all intellectual property rights in Client’s drug candidates or products, are owned solely by Client.

 

 

Neither Aptiv Solutions, its Affiliates nor any of their respective Subcontractors will acquire any rights of any kind whatsoever with respect to Client’s drug candidates or products as a result of conducting Services hereunder. All rights to any know-how, trade secrets, developments, discoveries, inventions or improvements (whether or not patentable) conceived or reduced to practice in the performance of work conducted under this Agreement by Aptiv Solutions’ or its Affiliates’ employees, or independent contractors, either solely or jointly with employees, agents, consultants or other representatives of Client (the “Intellectual Property”), will be owned solely by Client. Aptiv Solutions, its Affiliates and their respective employees and Subcontractors will sign and deliver to Client all writings and do all such things as may be necessary or appropriate to vest in Client all right, title and interest in and to such Intellectual Property. Aptiv Solutions will promptly disclose to Client any such Intellectual Property arising under this Agreement. Client may, in its sole discretion, file and prosecute in its name and at its expense, patent applications on any patentable inventions within the Intellectual Property. Upon the request of Client, and at the sole expense of Client, Aptiv Solutions will execute and deliver any and all instruments necessary to transfer its ownership of such patent applications to Client and to enable Client to file and prosecute such patent applications in any country.

Notwithstanding the foregoing, Client agrees that Aptiv Solutions possesses or may in the future possess analytical methods, computer technical expertise and software, which have been independently developed by Aptiv Solutions and which will remain the sole and exclusive property of Aptiv Solutions, except to the extent that improvements or modifications include, incorporate or are based upon Client’s information. Improvements or enhancements made to Aptiv Solutions’ processes or methods which are independently developed incidental to the provision of Services hereunder will remain the sole property of Aptiv Solutions. Client may use this information of Aptiv Solutions free of charge for interpretation purposes or regulatory authorities’ purposes or for any purposes required for the achievement of the scope and objectives of a Project Agreement. Any improvement on information of Client will remain the sole property of Client.

 

To the extent applicable, Client and Aptiv Solutions will comply with all applicable national and international laws, regulations and guidelines relating to protection of the personal information of study subjects, including the European Commission Directive 95/46/IC as it relates to the protection of the personal information of EU/EEA study subjects, and the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Client may use, refer to and disseminate reprints of scientific, medical and other published articles which disclose the name of Aptiv Solutions consistent with applicable international copyright laws, provided such use does not constitute an endorsement of any commercial product or service by Aptiv Solutions. Neither Party will disclose publicly or utilize in any advertising or promotional materials or media the existence of this Agreement or its association with the other except to the party’s Affiliates, or use of the other Party’s name or the name of any of the other Party’s Affiliates, divisions, subsidiaries, products or investigations without the prior written permission of the other Party, provided however, that Aptiv Solutions may use the name of Client in its list of customers and may use Client’s logo or trademarks on proposals and presentation specifically prepared for Client. Further, either Party may make such public disclosures as it determines, based on advice of counsel, are reasonably necessary to comply with laws or regulations.

Aptiv Solutions’ liability for direct damages hereunder will not exceed the total fees payable by Client to Aptiv Solutions under the applicable Project Agreement. In no event will Aptiv Solutions be liable to Client for any indirect, incidental, special, or consequential damages or lost profits arising out of or related to its provision of Services to Client, even if Aptiv Solutions has been advised of the possibility of such damages, except to the extent that such damages result from the gross negligence, recklessness or intentional misconduct of Aptiv Solutions, its employees, independent contractors or agents.

Notwithstanding anything to the contrary in this Agreement or in any Project Agreement, the Parties agree that Aptiv Solutions shall not be liable for: (1) the lack of efficacy or complications associated with any product under study outside of Aptiv Solutions control, or (2) the act of any principal investigator, sub-investigator, clinical research associate, nurse, nurse-practitioner, pharmacist, or any other employee or consultant licensed to practice medicine or employed by or under agreement with any hospital, clinic, nursing service, site management organization, or other entity which is contracted to be a Trial Site for any study conducted pursuant to this Agreement, even if Aptiv Solutions shall pay, compensate, select, train, contract with or otherwise interact with any of the foregoing.

DanDrit agrees to maintain at all times during the lifetime of this agreement a valid product liability insurance and general liability insurance as described in Dandritt’s current insurance policy, attached hereto as Appendix C..

Aptiv Solutions and Client are independent contractors. Nothing in this Agreement will be construed to create the relationship of partners, joint venturers, or employer and employee between Aptiv Solutions and Client or Aptiv Solutions’ employees. Neither Party, nor its employees, or independent contractors will have authority to act on behalf of or bind the other Party in any manner whatsoever unless otherwise authorized in this Agreement or a specific Project Agreement or in a separate writing signed by both Parties.

Neither Party, during the term of this Agreement and for twelve months thereafter, will, without the prior written consent of the other Party, directly or indirectly solicit for employment or contract, attempt to employ or contract with or assist any other entity in employing, contracting with or soliciting for employment or contract any employee or executive who is at that time employed/contracted by the other Party and who had been employed/contracted by the other Party in connection with one or more Project Agreements issued hereunder. Provided, however, that the foregoing provision will not prevent either Party from conducting solicitation via a general advertisement for employment that is not specifically directed to any such employee or from employing any such person who responds to such solicitation.

Except as otherwise provided, all communications and notices required under this Agreement will be mailed by first class mail or sent via nationally recognized overnight courier to the addresses set forth below, or to such other addresses as the Parties from time to time specify in writing.

If the performance of this Agreement by Aptiv Solutions or Client is prevented, restricted, interfered with or delayed (either totally or in part) by reason of any cause beyond the control of the Parties (including, but not limited to, acts of God, flood, sabotage, explosion, disease, weather, war, insurrection, terrorism, civil strike, failures to obtain requested governmental visas, work permits or other authorizations, governmental laws and regulations imposed after the fact, power failures, riots or extensive power failure), the Party so affected will, upon giving notice to the other Party as soon as is practical, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected Party will use reasonable efforts to avoid or remove such causes of non-performance and will continue performance whenever such causes are removed. In the event such failure continues for a period of sixty (60) days or more, either Aptiv Solutions or Client may terminate the applicable Work Order by giving written notice thereof to the other Party

This Agreement will be governed in all respects by the general principle of international commercial law (“Lex mercantoria”), and only if a solution cannot be found in such general accepted principles the laws of England shall apply.

If any of the provisions or a portion of any provision of this Agreement is held to be unenforceable or invalid by a court of competent jurisdiction, the validity and enforceability of the enforceable portion of any such provision and/or the remaining provisions will not be affected thereby.

Neither Party may assign this Agreement without the prior written consent of the other Party, which consent will not be unreasonably withheld; provided, however, that either Party may assign this Agreement without consent to a successor in interest to substantially all of the business of that Party to which the subject matter of this Agreement relates upon delivery to the other Party of notice of such assignment.

No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances will be deemed to be construed as a further or continuing waiver of such term, provision or condition or of any other term, provision or condition of this Agreement.

This Agreement, including all Exhibits, Project Agreements, and associated Amendments hereto contains the full understanding of the Parties with respect to the Services and supersedes all existing Agreements and all other oral, written or other communications between the Parties concerning the subject matter hereof. This Agreement will not be modified in any way except in writing and signed by a duly authorized representative of Client and an authorized officer of Aptiv Solutions.

The Parties hereto confirm that this Agreement as well as any other documents relating hereto, including notices, have been and shall be drawn up in the English language.

This Agreement may be executed in several counterparts, each of which will be deemed an original but all of which will constitute one and the same instrument. To the extent that counterparts are in a language other than English, the English language version shall control.

In the event a dispute relating to this Agreement or any Project Agreement arises between the Parties, the Parties will use all reasonable efforts to resolve the dispute through direct discussions for a period of thirty (30) business days. The senior management of each Party is committed to respond to any such dispute. Subsequent to such thirty-day period either Party may resort to binding arbitration procedures under the rules of the London Court of International Arbitration (LCIA) The Unless otherwise agreed between the parties the arbitration will be conducted in London, England,

Each party has participated fully in the review and revision of this Agreement. Any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not apply in interpreting this Agreement. The language in this Agreement shall be interpreted as to its fair meaning and not strictly for or against any party.

This Project Agreement is made and entered into on <Month> <Day>, <Year>, the Effective Date, by and between <Client>, a corporation of ______________ with offices at <Location> (hereinafter referred to as “Client”) and Aptiv Solutions (UK) Ltd, together with its Affiliates, with offices having its place of business at Hemel One, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7YU, UK (hereinafter referred to as “Aptiv Solutions”).

WHEREAS, Client and Aptiv Solutions have entered into that certain Master Services Agreement for dated the <day> of <month>, 201_ (hereinafter referred to as the “Agreement”); and

WHEREAS, pursuant to the Agreement, Aptiv Solutions has agreed to perform certain Services in accordance with Project Agreements from time to time entered into by the Parties, as more fully provided in Section 2 of the Agreement, and Client and Aptiv Solutions now desire to enter into such a Project Agreement.

WHEREAS, Aptiv Solutions and Client desire that Aptiv Solutions provide certain Services with respect to a  ___________________, (the “Study”) for the study of the drug <device>_________________________(“Study Drug”) as set out in the Protocol titled:  _____________, which is incorporated herein by reference.

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the parties hereby agree as follows:

1.      Project Specifications.   Aptiv Solutions will perform the services described in the Project Specifications, attached hereto as Appendix A, in accordance with the Project Schedule, attached hereto as Appendix B and any other documents attached to this Project Agreement (“Services”).

2.      Compensation. For performance of these Services, Client will pay to Aptiv Solutions the amounts described in the Budget for Services and Pass-Through Budget set forth in Appendix C, which amounts will be payable pursuant to the Payment Schedule set forth in Appendix D.

2.1.         A payment plan inclusive of a down payment element of twenty percent (20%) of the total budget estimate, inclusive of Pass Through Expenses will be included in the Payment Schedule. The down payment is considered as an advance payment and shall be taken into account with the final payment(s) upon completion of the Services.

2.2.         Down payment invoices are due immediately upon signature of this Project Agreement. All payments are to be made in accordance with the Agreement and due within thirty (30) days of invoice date.

3.      Designated Contact Person.  The Aptiv Solutions Project Manager <or other designation for this project> who will oversee the Services in accordance with the Master Agreement, is:

4.      Term and Termination. The term of this Project Agreement will commence upon its execution by Aptiv Solutions and Client and will continue until completion of the Services described in Appendix A, provided, however, that either Party may terminate this Project Agreement in accordance with Section 4, Term and Termination, of the Agreement.

5.      Incorporation by Reference; Conflict. The provisions of the Agreement are hereby expressly incorporated by reference into and made a part of this Project Agreement. In the event of a conflict between the terms and conditions of this Project Agreement and those of the Agreement, the terms of the Agreement will take precedence and control; provided however, in event of conflicts between the Project Agreement and the Agreement, Sections 3.0 Payment,

WHEREAS, under the terms of a certain Master Services Agreement (the “Agreement”), dated the                                                           day of                             , 201_ by and between the parties, Client agreed to retain Aptiv Solutions, and Aptiv Solutions agreed to be retained by Client, to perform the Services as more particularly described in the Agreement pursuant to the terms of Project Agreements to be issued from time to time;

WHEREAS, the Parties hereto have entered into certain additional agreements with respect to modification of the Project Agreement, and which they desire to memorialize in this Amendment #_;

NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions hereinafter set forth, the parties hereto agree as follows:

1.      Project Specifications. The Services to be provided by Aptiv Solutions pursuant to the Agreement are hereby amended by inclusion of the Services described in Amendment Appendix      , “Additional Project Specifications”, which is attached hereto and incorporated herein by reference.

2.      Project Schedule. The Project Schedule, attached to the Agreement as Appendix               , is hereby stricken and replaced by the Amended Project Schedule, attached hereto as Amendment Appendix    , “Amended Project Schedule”, which is incorporated herein by reference.