Exhibit
4.13


 


__________________________________________________________


 


SERVICE
AGREEMENT


 


________________________________________________


 


By and between


 








	(1)	RECIPHARM PESSAC













 


and


 





	(2)	FLAMEL TECHNOLOGIES













 




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SERVICE
AGREEMENT


 


THIS SERVICE AGREEMENT (the “Agreement”)
is effective on December 1st, 2014 (the “Effective Date”) and is made by between:


 


RECIPHARM PESSAC, a French Société
par Actions Simplifiée under registration process and having its principal place of business at, rue Archimède,
33600 Pessac France, (“SUPPLIER”).


 


FLAMEL TECHNOLOGIES SA, registered
under the laws of France under registration number 379 001 530 and having its principal office at Parc Club du Moulin
à Vent, 33, avenue du Docteur Georges Lévy 69200 VÉNISSIEUX (“CUSTOMER”).


 


WHEREAS:


 


		(A)	CUSTOMER is engaged in the research
                                         and development of pharmaceutical products and wishes SUPPLIER to perform the Services
                                         (as hereinafter defined); and



 


		(B)	SUPPLIER is a contract research organisation
                                         specialised in the formulation, development and manufacturing of pharmaceutical products.



 


		(C)	The Parties entered into a transaction
                                         under various agreements and in particular a Master Agreement which with the Quality
                                         Assurance Agreement shall govern the overall relations between the Parties with regard
                                         to the Services to be provided by SUPPLIER to CUSTOMER under this Agreement and the relevant
                                         Project Agreement.



 


NOW, THEREFORE,
the Parties agree as follows:


 


		1.	DEFINITIONS
                                         AND INTERPRETATION



 


		1.1	In
                                         this Agreement:



 


“Affiliate(s)”
means any corporation or other entity that controls, is controlled by, or is under common control with, a Party. A corporation
or other entity shall be regarded as in control of another corporation or entity if it owns or directly or indirectly controls
more than 50% of the voting securities or other ownership interests of the other corporation or entity, or if it possesses, directly
or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity;


 


‘Applicable Laws’
means all relevant statutes, laws, directives, regulations, ordinances guidance notes and codes that apply to the Services
in the country where such Services are performed, and those specifically set out below, applicable to a Project or the Services
in force from time to time during this Agreement including applicable: (i) FDA Guidance Documents on current cGMP and compliance,
including the Guidelines on the Preparation of Investigational New Drug Products (Human and Animal) and the Draft Guidance for
Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production; (ii) Applicable European, US and
ICH cGMP and cGLP; and (iii) all other regulations specified in the relevant Project Agreement);


 


‘Arising Intellectual
Property’ shall have the meaning given in clause 6.1;


 


‘Background Intellectual
Property’ shall have the meaning given in clause 6.4;


 







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‘Business Day(s)’
means a day other than a Saturday, Sunday or a day on which banks are not open for business in France or the Country where
the Services will be performed under this Agreement and the related Project Agreement ;


 


‘Certificate of Analysis’
means SUPPLIER’s standard form certificate of analysis confirming the results of tests conducted on Service Materials;


 


‘cGMP’ means
the current good manufacturing practice requirements as applicable: (i) in the European Union; (ii) in the United States of America;
and (iii) in accordance with ICH requirements. As in force from time to time during the term of this Agreement;


 


‘Competent Authority/(ies)’
means a national or supra-national authority responsible for the control of medicinal products;


 


“Effective Date”
is defined in preamble of the Agreement;


 


‘External Costs’
means the amount paid by SUPPLIER or the SUPPLIER Affiliate for any Service specific materials, goods, supplies, and equipment
of any nature for providing the Service under the related Project Agreement when SUPPLIER or the related SUPPLIER Affiliate shall
have not the resources, capacity or ability to provide such part of the Service whatever this Person is deemed to be a subcontractor
or not, and any tax to be invoiced to CUSTOMER under Applicable Laws and Regulations;


 


“Force Majeure Event’
means, in relation to either Party, any circumstances beyond the reasonable control of that Party (including, without limitation,
fire, floods, embargoes, shortages, epidemics, quarantines, war, acts of God, acts, omissions or delays in acting by any governmental
authorities and any strike, lock-out or other form of industrial action or other form of action with respect to employment relationships);


 


‘cGLP’ means
the current Good Laboratory Practice being a set of principles that provides a framework within which laboratory studies are planned,
performed, monitored, recorded, reported and archived as applicable: (i) in the European Union; (ii) in the United States of America;
and (iii) in accordance with ICH requirements. As in force from time to time during the term of this Agreement;


 


‘Intellectual Property’
means all intellectual property rights, including (without limitation) patents, supplementary protection certificates, petty
patents, utility models, trademarks, database rights, rights in designs, copyrights (whether or not any of these are registered
or capable of being registered) and including all applications and the right to apply for registered protection of the foregoing
and all inventions, trade secrets, know-how, techniques and confidential information and other proprietary knowledge and information,
and all rights and forms of protection of a similar nature or having equivalent or similar effect to any of these which may subsist
anywhere in the world, in each case for their full term and together with any renewals or extensions;


  


‘Internal Costs’
means (i) fully allocated cost of a full time equivalent (“FTE”) for providing the Service under the related Project
Agreement, such fully allocated costs comprises direct costs incurred directly for the provision of the Services by SUPPLIER or
the SUPPLIER Affiliate under the related Project Agreement (including but not limited to labour, materials, goods and supplies)
and indirect costs specifically allocable to the provision of Services by Supplier or the SUPPLIER Affiliate under the related
Project Agreement (including but not limited to administrative labour costs, maintenance, insurance the part of depreciation allocated
to assets used in the provision of the related Services) ; such calculation being based upon accepted contract manufacturing industry
standards and generally accepted accounting principles ;


 




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‘Master Agreement’
means the agreement entered into by and between the Parties on Effective Date where the Parties have agreed upon, among other
things, overall conditions for providing the Services;


 


‘Materials’
means all compounds, materials and other substances supplied by CUSTOMER to SUPPLIER for use under a Project Agreement;


 


‘Parties’ means
CUSTOMER and SUPPLIER;


 


‘Party’ means
CUSTOMER or SUPPLIER as appropriate;


 


‘Permitted Recipients’
means those employees or contractors of the receiving Party who would reasonably require access of the Relevant Information
for the proper enjoyment or performance by that Party of its rights and obligations under this Agreement or a Project Agreement;


 


‘Project’ means
a specific project related to pharmaceutical development activities and the manufacturing of drug products for clinical use which
CUSTOMER and SUPPLIER agree to enter into under the terms of this Agreement and the relevant Project Agreement;


 


‘Project Agreement’
means each agreement made under this Agreement in accordance with clause 2 relating to a Project in the form set out in Appendix
1 to this Agreement;


 


‘Quality Agreement’
means a quality agreement setting out the Parties responsibilities for quality assurance under Applicable Laws;


 


‘Relevant Information’
means any data or information (whether or not recorded in a document, and whether or not marked as confidential), which is
disclosed by one Party to the other or is obtained by either Party from any information so disclosed or from any materials which
are made available by or on behalf of one Party to the other Party or is otherwise obtained by one Party, which are not publicly
known. Relevant Information shall include without limitation information relating to the business of either Party, including clinical
and product development plans, strategies, patent disclosures, patent applications, structures, models, techniques, know-how,
trade secrets, processes, compositions, formulations, compounds and apparatus relating to the same and proprietary information
related to the current, future, and proposed products or services of the disclosing Party, including for the avoidance of doubt
Service Data which shall be Relevant Information of CUSTOMER;


 


‘Service Data’
means all data and information produced as a result of the performance of the Services;


 


‘Service Materials’
means all materials produced as a result of the performance of the Services;


 


‘Services’
means the services to be performed by SUPPLIER pursuant to the relevant Project Agreement;


 


‘SOPs’ means
the relevant standard operating procedures to be used by SUPPLIER during the performance of the Services that have been approved
in writing by CUSTOMER; and



   




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‘Starting Fee’
means any applicable starting fee paid as a deposit for initiation of a Project as stated in the Project Agreement.


 


		1.2	Any
                                         reference in this Agreement to:



 





	 	(a)	“person” includes companies, firms or other organisations;
	 	 	 
	 	(b)	an Appendix is a reference to an Appendix to this Agreement; or
	 	 	 
	 	(c)	a clause is a reference to a clause of this Agreement.
	 	 	 
	 	(d)	The words “in particular”, “include”, “included” and “including”
    are to be construed without limitation to the generality of the preceding words.







 





In this Agreement, words importing
the singular shall include the plural and vice versa.


 


		2.	STRUCTURE
                                         OF THIS AGREEMENT AND PROJECT AGREEMENTS



 


		2.1	In
                                         consideration of the mutual promises and covenants set forth in this Agreement and for
                                         other good and valuable consideration, the receipt and sufficiency of which is hereby
                                         acknowledged, CUSTOMER appoints SUPPLIER on a non-exclusive basis (if not agreed otherwise
                                         in a specific Project Agreement) to provide the Services to CUSTOMER and SUPPLIER agrees
                                         to make its best commercial effort to accept and undertake such appointment on the terms
                                         and conditions set out in this Agreement.



 


		2.2	The
                                         Parties agree to conclude a separate Project Agreement for each Project to which the
                                         general conditions of this Agreement are applicable unless otherwise specifically agreed
                                         in the relevant Project Agreement. Where Services to be performed pursuant to a Project
                                         Agreement include clinical or cGMP activities the Parties agree to negotiate in good
                                         faith and to enter into a separate Quality Agreement as soon as practicable following
                                         the Effective Date. In case of any conflict between this Agreement and the provisions
                                         of a Project Agreement and/or a Quality Agreement, the provisions of this Agreement shall
                                         prevail if the conflict is not solely of a technical/quality nature where the Quality
                                         Agreement or the Project Agreement shall prevail. In the event that a conflict could
                                         reasonably be interpreted as both legal/commercial and technical/quality in nature then
                                         this Agreement shall prevail. In case of any conflict between a Project Agreement and
                                         a Quality Agreement the provisions of the Project Agreement shall prevail if the conflict
                                         is not solely of a quality nature where the Quality Agreement shall prevail.



 


		2.3	Each
                                         Project Agreement will include detailed information concerning a given Project, including
                                         without limitation a description of the Services to be provided, the names of certain
                                         of the individuals providing the Services (as applicable), Project milestones and completion
                                         dates, a budget, a payment schedule related to the Project, all of which will be signed
                                         by an authorised representative of each Party.









 


		2.4	In
                                         order to comply with the terms and conditions of the Master Agreement, the Parties agree
                                         to identify for each Project and shall allocate in each Project Agreement the Internal
                                         Costs and the External Costs of SUPPLIER in the Price for the Services. The Parties shall
                                         take into consideration any amendment to this allocation for each Change Order as referred
                                         to in clause 3.2 herein.



 


		2.5	Furthermore,
                                         CUSTOMER has no right to receive deliverables or other Services specified in Project
                                         Agreements that have not been executed by authorised representatives of both Parties.
                                         No work will be performed by SUPPLIER until both Parties have signed a Project Agreement,
                                         subject to the terms and conditions set out in this Agreement.










 




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		3.	PERFORMANCE
                                         OF SERVICES



 


			In respect of each Project:



 


		3.1	SUPPLIER
                                         agrees to use its best commercial efforts to perform the Services applying its reasonable
                                         professional standards in its performance of the Services and using its best commercial
                                         efforts to meet the timelines in accordance with:



 


	 	(a)	this Agreement and the relevant Project Agreement;
	 	(b)	the Quality Agreement;
	 	(c)	any other reasonable instructions given by CUSTOMER in writing;
	 	(d)	the SOPs; and
	 	(e)	all Applicable Laws.


 


		3.2	It
                                         is recognised that during a Project delay, changes, variations, or modifications to the
                                         Project Agreement may become advisable because of results observed, or at CUSTOMER’s
                                         request (“Amendment”). Any Amendment proposed by either SUPPLIER or
                                         CUSTOMER shall be notified to the other Party in writing and SUPPLIER will generate and
                                         provide to CUSTOMER a change order, substantially in the form attached hereto as Appendix
                                         2 (“Change Order”), with a cost and time estimate for implementing
                                         the proposed Amendment. The revised cost estimate will be based on the rates specified
                                         in the original Project Agreement. SUPPLIER shall not effect any Amendment until authorised
                                         representatives of both Parties have agreed and signed the Change Order. SUPPLIER shall
                                         not unreasonably withhold, delay or condition consent to any Change Order.



 


		3.3	SUPPLIER
                                         shall ensure that the Services are performed by employees who possess relevant skills,
                                         experience, and qualifications.



 


		3.4	SUPPLIER
                                         shall within reasonable time advise CUSTOMER in writing of the occurrence of any event
                                         that may materially delay or affect the performance of the Services or the progress of
                                         a Project.



 


		4.	DATA
                                         AND REPORTS



 


		4.1	The
                                         Service Data shall be the sole property of CUSTOMER.



 


		4.2	SUPPLIER
                                         agrees during the term of this Agreement and the relevant Project Agreement and thereafter,
                                         unless otherwise agreed in writing with CUSTOMER, to maintain the original records of
                                         the Service Data securely and in accordance with Applicable Laws.



 








		4.3	SUPPLIER
                                         shall maintain as confidential the Service Data and all information relating thereto
                                         supplied by CUSTOMER pursuant to this Agreement. SUPPLIER shall disclose the Service
                                         Data and information relating thereto only to those of its employees who need to know
                                         such information or be in possession of the Service Data for the purpose of performing
                                         the Services in relation to the Project in question and are bound by confidentiality
                                         terms no less onerous than those imposed on SUPPLIER under this Agreement.



 


		4.4	In
                                         a timely manner with regard to the nature of the related Services, with best SUPPLIER
                                         endeavours to do it within sixty (60) days of completion of the Services, SUPPLIER shall
                                         submit to CUSTOMER a report on the Services in a format approved by and acceptable to
                                         CUSTOMER, such approval and acceptance not to be unreasonably withheld, and in accordance
                                         with the requirements of the Project Agreement. Upon receipt of the report, CUSTOMER
                                         shall be entitled to discuss the contents thereof with SUPPLIER and to receive such further
                                         information as CUSTOMER may reasonably require.



  





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		4.5	CUSTOMER
                                         shall inform SUPPLIER of any non-conformance within thirty (30) days after receipt of
                                         the report for the applicable Services. If CUSTOMER fails to deliver such notice, CUSTOMER
                                         shall be deemed to have accepted any and all Services, unless CUSTOMER can demonstrate
                                         that such non-conformance was not identifiable between the time of delivery and acceptance
                                         within the thirty (30) days notice period. Any Services that do not adequately comply
                                         with the Project Agreement, if such failure is due to acts or omissions of SUPPLIER,
                                         shall at CUSTOMER’s discretion either: (i) be repeated at SUPPLIER expense if reasonable;
                                         or (ii) the cost of the Services shall be refunded by SUPPLIER to CUSTOMER and the Minimum
                                         Yearly Volume is not increased by such refunded amount for the Year where the related
                                         Service is recorded as referred to in the Master Agreement. In such event, any disputes
                                         over conformance shall be referred to an independent laboratory to be appointed by agreement
                                         between SUPPLIER and CUSTOMER. Except in the case of fraud or manifest error on the part
                                         of such independent expert, the decision of such independent expert will be binding upon
                                         the Parties and the cost of such determination shall be paid by the Party in error. In
                                         case the Parties are not able to agree on appointment of the independent expert, the
                                         Parties agree to submit the dispute to administered expertise proceedings in accordance
                                         with the Rules for Expertise of the International Chamber of Commerce



 


		5.	MATERIALS



 


		5.1	CUSTOMER
                                         will provide SUPPLIER with amounts of Materials necessary in the opinion of CUSTOMER
                                         for the performance of the Project in question. If applicable, CUSTOMER will furnish
                                         SUPPLIER with safety data sheets for the Materials and, where available, certificates
                                         of analysis. CUSTOMER will also provide SUPPLIER with such information concerning the
                                         Materials as CUSTOMER deems necessary to perform the Services, including, but not limited
                                         to, information concerning the stability of the Materials, their storage, transportation
                                         and applicable health, safety and environmental requirements.



 


		5.2	Upon
                                         termination of the Services in relation to the Project in question, any remaining Materials
                                         or Service Materials will be promptly returned to CUSTOMER (reasonably incurred costs
                                         in effecting such return shall be borne by CUSTOMER), or, at CUSTOMER’s written
                                         option, destroyed by SUPPLIER at CUSTOMER costs and charges, and if CUSTOMER requires
                                         the destruction of the remaining Materials or Service Materials, SUPPLIER shall provide
                                         to CUSTOMER reasonable documentary evidence of such destruction.



 





		5.3	SUPPLIER
                                         shall use the Materials or Service Materials only for the purposes of the Project in
                                         question and in accordance with Applicable Laws.



 


		5.4	SUPPLIER
                                         shall ensure that access to the Materials and Service Materials is restricted to its
                                         own personnel or contractors in its own laboratories. SUPPLIER shall not transfer the
                                         Materials, Service Materials or any part thereof outside such laboratories, other than
                                         to deliver to CUSTOMER, without CUSTOMER’s prior written consent, which shall not
                                         unreasonably withheld, nor use the Materials other than in the due performance of the
                                         Services in relation to the Project in question.



 








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		5.5	SUPPLIER
                                         shall retain any remaining Materials or Service Materials under appropriate conditions
                                         for a period of three years after submission of the final report of the Services to CUSTOMER
                                         in accordance with clause 4.4. CUSTOMER shall reimburse SUPPLIER for its reasonably incurred
                                         cost and expense arising from such retention. The Service Materials shall be the property
                                         of CUSTOMER and SUPPLIER will contact CUSTOMER at the end of such three year period for
                                         CUSTOMER’s instructions as to the Service Materials. Notwithstanding the provisions
                                         of this clause, SUPPLIER shall retain and store samples of all Service Material released
                                         by SUPPLIER’s quality department under a Project Agreement for such period as required
                                         by regulatory obligations prescribed by Applicable Laws.



 


		5.6	If
                                         at the written request of CUSTOMER any Materials or Service Materials are disposed of
                                         or delivered to CUSTOMER, by SUPPLIER in accordance with such written request in accordance
                                         with clause 5.5, SUPPLIER shall be relieved by CUSTOMER of any further responsibility
                                         for such Materials or Service Materials with respect to the activities performed in relation
                                         to such Materials or Service Materials after the said disposal or delivery, including
                                         any claims made against CUSTOMER by third parties.



 


		5.7	All
                                         Materials shall be delivered by CUSTOMER to SUPPLIER DPP (Delivered Duty Paid) Incoterms
                                         2010 at SUPPLIER’s premises designated into the Project Agreement. CUSTOMER shall
                                         provide SUPPLIER with advance notice in writing of the anticipated date of delivery.
                                         CUSTOMER shall contract with the carrier for all Materials.



 


		5.8	Delivery
                                         of all Service Materials by SUPPLIER to CUSTOMER or such third party as may be specified
                                         by CUSTOMER shall, at CUSTOMER’s cost and expense, be delivered Ex Works SUPPLIER’S
                                         Pessac plant or SUPPLIER Affiliate plant, Incoterms 2010 unless otherwise specifically
                                         agreed in the related Project Agreement.



 


		5.9	In
                                         respect of delivery by SUPPLIER of any Service Materials required hereunder to be produced
                                         in accordance with cGMP, SUPPLIER will supply at the time of delivery a Certificate of
                                         Analysis and any other required supporting regulatory documents relating to such Service
                                         Materials.



 


		6.	INTELLECTUAL
                                         AND PHYSICAL PROPERTY



 


		6.1	All
                                         Intellectual Property, other than the SUPPLIER Property (as defined below), arising as
                                         a result of the Services performed by or on behalf of either of the Parties including,
                                         without limitation, the Intellectual Property in the Service Data (“Arising
                                         Intellectual Property”) shall be the sole and exclusive property of CUSTOMER
                                         and SUPPLIER assigns any rights it may have in Arising Intellectual Property to CUSTOMER.









 


		6.2	CUSTOMER
                                         acknowledges that SUPPLIER possesses certain Intellectual Property relating to, laboratory
                                         analyses, analytical methods, manufacturing processes, procedures, and techniques which
                                         have been independently developed by SUPPLIER, or a third Party, without the benefit
                                         of any Materials, Service Materials, CUSTOMER’s Intellectual Property, or the Arising
                                         Intellectual Property (the “SUPPLIER Property”). CUSTOMER agrees that
                                         any SUPPLIER Property or improvements thereto which are created, modified or developed
                                         by SUPPLIER pursuant to this Agreement and which do not exclusively relate to the Materials,
                                         Service Materials, CUSTOMER’s Intellectual Property, are the sole and exclusive
                                         property of SUPPLIER. Any such improvements shall be treated as, and included within
                                         the definition of, SUPPLIER Property.







 




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		6.3	CUSTOMER
                                         hereby grants to SUPPLIER for the term of the Agreement a royalty free, non-exclusive,
                                         worldwide, limited licence to use such of CUSTOMER’s Intellectual Property, as
                                         is disclosed by CUSTOMER to SUPPLIER, to the extent the same are useful or necessary
                                         for the performance of the Services. This licence terminates on the completion of the
                                         Services as provided in the related Project Agreement upon provision of the final report
                                         as referred to in clause 4.4 hereinabove. Nothing in this Agreement or any Project Agreement
                                         constitutes a grant of any right or licence under such Intellectual Property except for
                                         the foregoing.


 





		6.4	Nothing
                                         in this Agreement shall affect SUPPLIER’s or CUSTOMER’s ownership of any
                                         Intellectual Property existing prior to the commencement of the Services or created outside
                                         the Services (“Background Intellectual Property”).



 


		6.5	Without
                                         limiting the foregoing, CUSTOMER reserves all rights and title (including ownership)
                                         in the physical property of the Materials and Service Materials. SUPPLIER shall hold
                                         all Materials and Service Materials to CUSTOMER’s order and shall not do or permit
                                         to be done anything incompatible with CUSTOMER’s right and title in the Materials
                                         and Service Materials. SUPPLIER further acknowledges that CUSTOMER holds the Intellectual
                                         Property including, for the avoidance of doubt, the Background Intellectual Property
                                         and Arising Intellectual Property, in the Materials or Service Materials including without
                                         limitation an ownership interest in patents and pending patent applications that cover
                                         compositions, methods and/or uses of the Materials or Service Materials of CUSTOMER.



 


		7.	PAYMENT
                                         and invoicing



 


		7.1	The
                                         Parties agree and undertake to determine the price for the Services in accordance with
                                         applicable provisions of the Master Agreement and such price for each Service shall be
                                         allocated in accordance with clause 2.4 hereinabove.



 


		7.2	The
                                         Parties shall set forth in the related Project Agreement the payment schedule for the
                                         Services and the amount of the Starting Fee, if any. All prices are exclusive of applicable
                                         sales taxes, which shall be paid by CUSTOMER at the prevailing rate.



 


		7.3	All
                                         invoices shall be payable in full within thirty (30) days after receipt of the invoice.
                                         CUSTOMER shall pay invoices and payments of undisputed invoice shall be made within thirty
                                         (30) days following the date of issue of the invoice. If the undisputed invoice is not
                                         paid within this timeframe, penalty interest plus recovery charges shall be charged to
                                         CUSTOMER in accordance with the Applicable Laws.



 





		8.	FACILITY
                                         VISITS



 


		8.1	SUPPLIER
                                         shall give access to its premises to CUSTOMER and its authorised representatives or licensees
                                         for the exclusive purpose to observe the progress of the implementation of the Services
                                         in a specific Project. Such access should be requested by CUSTOMER upon reasonable prior
                                         written notice from CUSTOMER and during normal business hours and at CUSTOMER costs.
                                         CUSTOMER may visit any of the premises used by SUPPLIER for the provision of the Services
                                         in the relevant Project, talk with SUPPLIER personnel and inspect and copy all files,
                                         records, books, proofs, models and all preparatory materials which CUSTOMER may reasonably
                                         require to verify that SUPPLIER is in compliance with its obligations under this Agreement,
                                         including the relevant Project Agreement where it is possible to do so without breaching
                                         any obligation of confidentiality, Applicable Law or regulatory requirement.



 








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		8.2	All
                                         information disclosed or ascertained by CUSTOMER in connection with any audit or examination
                                         or in connection with any correspondence between SUPPLIER and any Competent Authorities
                                         that is not Relevant Information of CUSTOMER will be deemed to constitute Relevant Information
                                         of SUPPLIER, and CUSTOMER will not disclose this to any third party or use such information
                                         for any purpose other than conducting the foresaid audit or inspection under this Clause
                                         8. SUPPLIER shall provide all such reasonable assistance and facilities in connection
                                         with the inspection as CUSTOMER may reasonably require. SUPPLIER also agrees to allow
                                         representatives of applicable Competent Authorities to enter and inspect any of its premises
                                         used by SUPPLIER for the provision of the Services.



 


		8.3	SUPPLIER
                                         shall permit any Competent Authority to visit any of the premises used by SUPPLIER for
                                         the provision of the Services. SUPPLIER shall, as soon as reasonably possible, inform
                                         CUSTOMER of any intended inspection of SUPPLIER premises by any Competent Authority where
                                         such inspection relates to the Services or processes and procedure relating to such Services.
                                         CUSTOMER shall have the right, but not the obligation, if allowed by the Competent Authority,
                                         to be present at any such inspection or regulatory action provided such inspection or
                                         action directly relates to any Project or Services. SUPPLIER shall as soon as reasonably
                                         possible inform CUSTOMER of any adverse comments, finding or reports related to SUPPLIER
                                         or its premises relating to any Services from any such Competent Authority and to the
                                         extent that such information is capable of being disclosed by SUPPLIER without breaching
                                         any obligation of confidentiality, Applicable Law or regulatory requirement, shall provide
                                         CUSTOMER with a copy of any written report from any such Competent Authority and details
                                         of any adverse comments, findings or reports within five (5) Business Days of receipt.
                                         SUPPLIER shall as soon as reasonably possible answer on deficiencies identified during
                                         audit by CUSTOMER or any Competent Authority of such premises. SUPPLIER shall advise
                                         CUSTOMER on a regular basis as to the status of any corrective action, where it is possible
                                         to do so without breaching any obligation of confidentiality, Applicable Law or regulatory
                                         requirement, including, but not limited to, providing CUSTOMER with copies of any relevant
                                         correspondence with the respective Competent Authority. For the avoidance of doubt the
                                         Confidentiality provisions at Clause 15 of this Agreement shall apply to any audit by
                                         CUSTOMER or any Competent Authority.



 


		8.4	The
                                         personnel of either Party visiting the premises of the other Party shall at all times
                                         conform to the regulations and restrictions in respect of access to restricted areas,
                                         conduct, safety and working conditions provided that such are drawn to the attention
                                         of the visitors.



 


		9.	REPRESENTATIVES



 


		9.1	SUPPLIER’s
                                         project representative in relation to a Project shall be as identified in the relevant
                                         Project Agreement, where SUPPLIER wishes to change the project representative for any
                                         reason it shall inform CUSTOMER of its nominated substitute.



 


		9.2	CUSTOMER’s
                                         representative in relation to a Project shall be as identified in the relevant Project
                                         Agreement, or such other person nominated by CUSTOMER from time to time.



 


		10.	WARRANTIES,
                                         LIABILITY AND INDEMNITY



 


		10.1	SUPPLIER
                                         warrants and represents to CUSTOMER that:



 


		10.1.1	it
                                         has the necessary permits, facilities, third party contractors and skilled personnel
                                         that may be reasonably anticipated to be necessary for a contract research organisation
                                         to provide the Services.



 










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		10.1.2	it
                                         will use its best commercial efforts to perform the Services as set forth in the Project
                                         Agreements, and any Quality Agreement in compliance with this Agreement and SOPs and
                                         all Applicable Laws;



 


		10.1.3	SUPPLIER
                                         owns or has the right to use any Intellectual Property to be used for to the due provision
                                         of the Services and that it has the right and title to give CUSTOMER unrestricted use
                                         of the Service Materials and Service Data, provided by SUPPLIER to CUSTOMER pursuant
                                         to the Services; and



 


		10.1.4	to
                                         the best of its knowledge, the Intellectual Property of SUPPLIER used in the Services
                                         does not infringe third party Intellectual Property.



 


		10.2	CUSTOMER
                                         warrants and represents to SUPPLIER that:



 


		10.2.1	CUSTOMER
                                         has the right to enter into this Agreement;



 


		10.2.2	CUSTOMER
                                         has and shall at all times throughout the term of this Agreement have the right to supply
                                         the Materials to SUPPLIER and the necessary rights to licence or permit SUPPLIER to use
                                         the same for the purpose of the Services and, if applicable, CUSTOMER’s testing
                                         of such Materials, shall at the time of delivery to SUPPLIER comply with cGMP;



 


		10.2.3	CUSTOMER
                                         owns or has the unrestricted right to use any Intellectual Property to be used pursuant
                                         to this Agreement and each Project Agreement and that it has the right and title to give
                                         SUPPLIER licence to use such Intellectual Property for the provision of the Services;
                                         and



 


		10.2.4	any
                                         of the Materials, Relevant Information and Intellectual Property to be provided or allowed
                                         access to by CUSTOMER hereunder and not owned by CUSTOMER are licensed to CUSTOMER under
                                         a licence which will permit their use by SUPPLIER to perform the related Services.



 


		10.3	SUPPLIER
                                         hereby indemnifies and holds harmless CUSTOMER and each of its directors and officers
                                         (the “CUSTOMER Parties”) against any and all losses, demands, claims,
                                         liabilities, damages, costs and expenses (including but not limited to court costs and
                                         reasonable documented attorney’s fees and expenses together with any applicable
                                         taxes thereon) that the CUSTOMER Parties have suffered or incurred directly in consequence
                                         of the following:






 


		10.3.1	the
                                         infringement or breach of any third party rights including Intellectual Property by SUPPLIER,
                                         except to the extent that any infringement is caused by the acts or omissions of CUSTOMER
                                         other than in accordance with this Agreement.



 


		10.3.2	a
                                         material inaccuracy due to the fault of SUPPLIER in a Certificate of Analysis such that
                                         the results of the analytical tests identified in the relevant Project Agreement were
                                         materially incorrect.



 


		10.3.3	the
                                         misrepresentation, negligence or material breach of obligations under this Agreement
                                         or any Project Agreement, breach of statutory duty or intentional misconduct of SUPPLIER
                                         or any of its directors, officers, employees, or permitted sub-contractors, assignees
                                         or agents, in particular but not limited to the failure of Service Materials released
                                         by SUPPLIER to comply with Applicable Laws, and






 










    	EXECUTION COPY	Page 11 of 24



    	 



    

 



		10.3.4	any
                                         loss or damage to the Materials or Service Materials due to SUPPLIER’s negligence
                                         or wilful misconduct or fire or any other natural disaster at SUPPLIER’s Facility
                                         as covered under SUPPLIER’s insurance.



 


		10.4	CUSTOMER
                                         hereby indemnifies and holds harmless SUPPLIER and each of its directors and officers
                                         and testing laboratories (the “SUPPLIER Parties”) against any and
                                         all losses, demands, claims, liabilities, damages, costs and expenses (including but
                                         not limited to court costs and reasonable documented attorney’s fees and expenses
                                         together with any applicable taxes thereon) that the SUPPLIER Parties may or have suffered
                                         or incurred in consequence of the following:



 


		10.4.1	the
                                         infringement or breach of any third party rights including Intellectual Property by CUSTOMER,
                                         except to the extent that any infringement is caused by the acts or omissions of SUPPLIER
                                         other than in accordance with this Agreement.



 


		10.4.2	the
                                         misrepresentation, negligence, material breach of obligations under this Agreement or
                                         any Project Agreement, breach of statutory duty or intentional misconduct of CUSTOMER
                                         or any of its directors, officers, employees, or permitted sub-contractors, assignees
                                         or agents.



 


		10.5	The
                                         Party (the “Indemnitee”) that intends to claim indemnification under
                                         this clause 10 shall:



 


		10.5.1	promptly,
                                         and in any event within fifteen (15) Business Days of it receiving notice of the claim,
                                         demand, threat or action, notify the other Party (the “Indemnitor”)
                                         in writing in general terms of any claim, demand, threat or action which has or has the
                                         potential to give rise to the Indemnitee seeking to rely on and claim the benefit of
                                         the indemnification together with notification of the Indemnitee's intention to rely
                                         on such indemnity, provided that, failure to give such notice shall not relieve the Indemnitor
                                         of its indemnification obligations except and only to the extent such failure actually
                                         and materially prejudices the ability of the Indemnitor to defend against such claims;



 


		10.5.2	not
                                         prejudice any defence to any claim or attempt to settle or compromise such claim;



 


		10.5.3	subject
                                         to its other rights and obligations and compliance with the procedures set out in this
                                         clause 10 permit the Indemnitor to have overall control of the conduct of the negotiations
                                         and the proceedings including any counterclaim subject the Indemnitor having duly appointed
                                         experienced attorneys who will professionally and thoroughly defend and prosecute any
                                         claim that gives rise to an indemnity claim;






 


		10.5.4	cooperate
                                         as reasonably requested by the Indemnitor, at the Indemnitor's expense, in the conduct
                                         of such claim (and any counterclaim); and



 


		10.5.5	have
                                         the right (at the Indemnitor's expense) to instruct independent counsel and participate
                                         in all proceedings and negotiations whether named or not as a party in the claim or proceedings.



 


		10.6	The
                                         Indemnitor shall not settle or consent to an adverse judgement in any such claim, demand,
                                         action or other proceeding that adversely affects the rights or interests of any Indemnitee
                                         or imposes additional obligations (financial or otherwise) on such Indemnitee, without
                                         the prior express written consent of such Indemnitee (such consent to be at the Indemnitee's
                                         sole discretion).



 


		10.7	The
                                         Parties shall promptly and in good faith discuss ways, whether by modifications to the
                                         Services, licensing or otherwise, to settle or overcome a claim under the indemnities.
                                         In the event that formal legal proceedings are commenced the Parties shall use their
                                         best endeavours to conduct such discussions expeditiously.









 




    	EXECUTION COPY	Page 12 of 24



    	 



    

 



		10.8	Without
                                         prejudice to this clause 10 neither Party shall be liable to the other Party for any
                                         loss or damage howsoever caused (even if foreseeable or in the contemplation of SUPPLIER
                                         or CUSTOMER) in respect of:



 


		10.8.1	loss
                                         of profits, business, business opportunities or revenue; or



 


		10.8.2	special,
                                         indirect or consequential loss.



 


		10.9	Any
                                         and all liability of SUPPLIER to CUSTOMER howsoever arising in respect of this Agreement
                                         or any Project Agreement and its performance shall for each Project be limited to an
                                         amount equal to one hundred (100) % of the amount to be reasonably received by SUPPLIER
                                         from CUSTOMER under the relevant Project Agreement.



 


		10.10	Nothing
                                         in this Agreement or any Project Agreement shall purport or attempt or serve to exclude
                                         or restrict any liability for: (i) death or personal injury resulting directly from either
                                         Party's negligence in its performance of the Services; or (ii) liability for any fraud
                                         or fraudulent misrepresentation.



 


		11.	DURATION
                                         OF AGREEMENT AND PROJECT AGREEMENTS



 


		11.1	This
                                         Agreement shall come into force on the Effective Date and shall continue in force until
                                         expiry of all the rights and obligations hereunder unless terminated earlier in accordance
                                         with its terms and subject to the respective rights and obligations of the Parties under
                                         the Master Agreement.



 


		11.2	The
                                         duration of each Project shall be set out in the relevant Project Agreement.



 


		12.	TERMINATION



 


		12.1	The
                                         termination of this Agreement is subject to the provisions of the Master Agreement, especially
                                         with regard to the Initial Term as referred to in said Master Agreement and such clause
                                         related to the Minimum Yearly Volume.



 


		12.2	Without
                                         prejudice of the provisions of the Master Agreement related to the Minimum Yearly Volume
                                         and without prejudice to any other rights or remedy it may have, either Party may terminate
                                         any Project Agreement, as follows:






 


		12.2.1	if
                                         the other Party is in material breach of the Agreement or relevant Project Agreement
                                         and, in the case of a breach capable of a remedy, the breach is not remedied within twenty
                                         (20) Business Days of the other Party receiving notice specifying the breach and requiring
                                         its remedy. Save that termination of the Agreement pursuant to this Clause 12.2.1 where
                                         a Party is only in material breach of a Project Agreement shall only be permitted where
                                         such material breach has a detrimental effect on such Party’s abilities to meet
                                         its obligations under other Project Agreements; or



 


		12.2.2	immediately
                                         if the other Party becomes insolvent or if an order is made or a resolution is passed
                                         for the winding up of the other Party (other than voluntarily for the purpose of solvent
                                         amalgamation or reconstruction) or if an administrator, administrative receiver or receiver
                                         is appointed in respect of the whole or any part of the other Party’s assets or
                                         business or if the other Party makes any composition with its creditors or takes or suffers
                                         any similar or analogous action in any jurisdiction to occur.



 







    	EXECUTION COPY	Page 13 of 24



    	 



    

 



		13.	EFFECTS
                                         OF TERMINATION



 


		13.1	Upon
                                         termination of this Agreement, SUPPLIER shall immediately provide to CUSTOMER the Relevant
                                         Information disclosed by SUPPLIER to CUSTOMER and the Service Data and any copies thereof,
                                         and the Materials and the Service Materials.



 


		13.2	The
                                         provisions of clauses 1 (Definitions) 4 (Data and Reports) 5 (Materials) 6 (Intellectual
                                         and Physical Property) 8.2 (Information relating to dealings with Competent Authorities)
                                         10 (Warranties, Liability and Indemnity) 11 (Confidentiality) 13 (Effects of Termination)
                                         16.10 (Governing Law) shall survive termination of this Agreement and any Project Agreement.



 


		13.3	At
                                         the request of CUSTOMER and provided that the termination is not due to CUSTOMER breaching
                                         this Agreement, SUPPLIER shall, if reasonably possible, complete any outstanding Project
                                         subject to the terms of this Agreement (mutatis mutandis) and the relevant Project Agreement
                                         notwithstanding the termination of this Agreement.



 


		14.	NATURE
                                         OF AGREEMENT



 


		14.1	Neither
                                         Parties shall assign, transfer or sub-contract any of its rights or obligations under
                                         this Agreement or any Project Agreement without obtaining the prior written consent of
                                         the other Party; except that, either Party may assign the benefit or burden of this Agreement
                                         to any Affiliate without the need to obtain such consent.



 


		14.2	The
                                         Parties are independent contractors and none of the provisions of this Agreement shall
                                         be deemed to constitute a partnership or joint venture between the Parties. No Party
                                         shall have any authority, nor hold itself out as having any such authority, to bind any
                                         other Party in any way.



 


		14.3	Save
                                         where specifically stated to the contrary in this Agreement or in any Project Agreement,
                                         each Party shall bear its own costs in entering into and performing its obligations under
                                         the Agreement and any Project Agreement.



 


		14.4	Each
                                         Party warrants to the other that it has the authority to enter into this Agreement and
                                         any Project Agreement and perform its obligations thereunder.






 


		14.5	This
                                         Agreement and each Project Agreement are govern by the Master Agreement for the duration
                                         of said Master Agreement and subject to the provisions of the Master Agreement contain
                                         the entire agreement between the Parties with respect to its subject matter, supersedes
                                         all previous agreements or understandings with respect thereto, and may not be modified
                                         except by an instrument in writing signed by the duly authorised representatives of the
                                         Parties.



 


		14.6	No
                                         failure or delay by either Party in exercising any of its rights under this Agreement
                                         or a Project Agreement shall be deemed to be a waiver of that right, and no waiver by
                                         either Party of a breach of any provision of this Agreement or the relevant Project Agreement
                                         shall be deemed to be a waiver of any subsequent breach of the same or any other provision.



 



    	EXECUTION COPY	Page 14 of 24



    	 



    

 





		14.7	If
                                         any provision of this Agreement is held to be invalid, illegal or unenforceable, in any
                                         respect, then, to the fullest extent permitted by Applicable Laws and if the rights or
                                         obligations of any Party will not be materially and adversely affected: (a) such provision
                                         will be given no effect by the Parties and shall not form part of this Agreement; (b)
                                         all other provisions of this Agreement shall remain in full force and effect; and (c)
                                         the Parties will use their best efforts to negotiate a provision in replacement of the
                                         provision held invalid, illegal or unenforceable that is consistent with Applicable Laws
                                         and achieves, as nearly as possible, the original intention of the Parties. To the fullest
                                         extent permitted by Applicable Laws, the Parties waive any provision of Applicable Laws
                                         that would render any provision in this Agreement invalid, illegal or unenforceable in
                                         any respect.



 


		14.8	All
                                         notices required under the terms of this Agreement or any Project Agreement shall be
                                         in writing and shall be validly given if sent by recorded delivery mail or courier service
                                         to the respective person as set out below, or such person as may be notified by one Party
                                         to the other in writing from time to time. All notices shall be deemed to have been received
                                         three (3) Business Days after they are sent.



 


	 	For:
    CUSTOMER	FLAMEL
    TECHNOLOGIES


 


	 	Address:	Parc Club du Moulin à Vent
	 	33, avenue du Docteur Georges Lévy
	 	69200 VÉNISSIEUX, FRANCE


 


	 	For the attention of:	Président Directeur Général
	 	With a copy to:	Sr. Vice President, General Counsel



 


	 	For: SUPPLIER	RECIPHARM PESSAC



 


	 	Address:	rue Archimède, 33600 PESSAC, France
	 	Facsimile:	+ 33 5 56 36 58 91
	 	For the attention of:	Président
	 	 	 
	 	With a copy to:	RECIPHARM AB (publ)



 


	 	Address	Lagervägen 7, SE-136 50 Jordbro, Sweden
	 	Facsimile:	0046 8 81 87 03
	 	For the attention of:	Legal


 


		15.	INSURANCE



 


		15.1	During
                                         the duration of this Agreement, and for three (3) years thereafter, each Party represents
                                         and warrants to the other Party that it has insurance coverage with a reputable insurance
                                         company of a type and amount typical in the pharmaceutical business and industry sufficient
                                         to secure the performance of its obligations hereunder.



 


		15.2	Each
                                         Party shall provide evidence of such insurance whenever reasonably requested by the other
                                         Party. The Parties covenants and agrees not to do or to omit any matter or thing which
                                         may prejudice or render voidable such insurance.



 


		15.3	Any
                                         Materials supplied by CUSTOMER shall be and at all times remain at the risk of CUSTOMER,
                                         and CUSTOMER shall insure such Materials to their full replacement value while on SUPPLIER’s
                                         premises unless and until they are incorporated into Service Material or destroyed as
                                         a result of the Services.



 


		16.	CONFIDENTIALITY



 


		16.1	In
                                         consideration of one Party (the “Disclosing Party”) making available
                                         its Relevant Information to the other (the “Recipient Party”), the
                                         Recipient Party hereby undertakes that it shall, and shall procure that each of its Permitted
                                         Recipients shall:



 







    	EXECUTION COPY	Page 15 of 24



    	 



    

 





		16.1.1	treat
                                         and safeguard as private and confidential all the Relevant Information of the Disclosing
                                         Party;



 


		16.1.2	use
                                         the Relevant Information of the Disclosing Party only during the duration of this Agreement
                                         and the relevant Project Agreement for those purposes reasonably necessary for or anticipated
                                         under this Agreement and without prejudice to the generality of the foregoing, not use
                                         any Relevant Information of the Disclosing Party to obtain any commercial advantage over
                                         the Disclosing Party;



 


		16.1.3	ensure
                                         the proper and secure storage of all Relevant Information of the Disclosing Party applying
                                         standards of care reasonably expected and no less stringent than standards applied to
                                         protection of the Recipient Party's own confidential information;



 


		16.1.4	not
                                         at any time without the Disclosing Party’s prior written consent disclose or reveal,
                                         whether directly or indirectly any of the Relevant Information of the Disclosing Party
                                         to any person whatsoever save its Permitted Recipients, and then only on a limited need
                                         to know basis, who shall be informed by it of the confidential nature of the Relevant
                                         Information and of the confidentiality terms of this Agreement and for whom it hereby
                                         accepts full responsibility in the event that any such person shall breach the duty of
                                         confidence imposed upon them; and



 


		16.1.5	not
                                         at any time have any discussion, correspondence or contact with any third party concerning
                                         the Relevant Information of the Disclosing without the prior written consent of the Disclosing
                                         Party.



 


		16.2	The
                                         obligations in this Agreement regarding Relevant Information do not apply to information:



 


		16.2.1	which,
                                         at the time of its disclosure by the Disclosing Party, was wholly available to the public
                                         and could be obtained without reference to the Relevant Information by any person with
                                         no more than reasonable diligence;



 


		16.2.2	which
                                         becomes generally available to the public after such disclosure otherwise than by reason
                                         of a breach of any of the undertakings in this Agreement or any breaches of confidence
                                         by the Recipient Party or its Permitted Recipients;



 


		16.2.3	which
                                         is, at the time of such disclosure and as evidenced by the Recipient Party's written
                                         records, lawfully already within its possession; or



 


		16.2.4	to
                                         the extent that the Recipient Party or any of its Permitted Recipients is compelled to
                                         disclose the Relevant Information by law or by any stock exchange or other Competent
                                         Authority having jurisdiction over it or them (but, for the avoidance of doubt, only
                                         to that extent).



 


		16.3	Other
                                         than the limited and restricted rights of use set out in this clause 11 nothing in this
                                         Agreement or any Project Agreement intends to or has the effect of granting any right,
                                         title, licence or interest in or to the Recipient Party or Permitted Recipients in respect
                                         of the Disclosing Party's Relevant Information.



 


		16.4	If
                                         the Recipient Party or any of its Permitted Recipients becomes compelled to disclose
                                         any Relevant Information of confidentiality or a breach or threatened breach or becomes
                                         apparent or becomes aware of any misuse of the Relevant Information, the Recipient Party
                                         shall inform the Disclosing Party in writing of such obligation or fact as soon as possible
                                         after it is informed, or becomes aware, of it and if possible, before any Relevant Information
                                         is disclosed, so that (if the Disclosing Party in its absolute discretion shall see fit)
                                         a protective order or other appropriate remedy may be sought. The Recipient Party agrees
                                         to assist and co operate (and shall procure that each of its Permitted Recipients shall,
                                         as appropriate, assist and co-operate) in any action which the Disclosing Party may decide
                                         to take. The Recipient Party shall notify the Disclosing Party prior to each disclosure
                                         of Relevant Information if it is under any obligation which would or might compel it
                                         to disclose any Relevant Information and subsequent to such disclosure it shall not voluntarily
                                         assume any such obligation.






 




    	EXECUTION COPY	Page 16 of 24



    	 



    

 





		16.5	Except
                                         as otherwise provided for in this Agreement or the relevant Project Agreement or otherwise
                                         required by law or administrative authorities, neither CUSTOMER nor SUPPLIER shall disclose
                                         any terms or conditions of this Agreement or any Project Agreement to any third party
                                         without the prior written consent of the other Party.



 


		16.6	Upon
                                         termination or expiry of this Agreement or the relevant Project Agreement or at the request
                                         of the Disclosing Party, the Recipient Party shall promptly return to the Disclosing
                                         Party any and all Relevant Information (including copies of documents, computer records
                                         and records on all other media) then in its possession or under its control except where
                                         such Relevant Information is covered under surviving licence rights between the Parties,
                                         or, at the Disclosing Parties option and request, destroy any and all Relevant Information,
                                         and if the Disclosing Party requires the destruction of the remaining Relevant Information,
                                         the Recipient Party shall provide to the Disclosing Party written confirmation of such
                                         destruction.



 


		16.7	The
                                         provisions of this clause shall survive termination of this Agreement for a period of
                                         seven (7) years.



 


		16.8	The
                                         Parties agree not to advertise, disclose or publish in any way the existence of this
                                         Agreement or any Project Agreement without the other Party’s prior written consent
                                         such consent not to be unreasonably withheld. Save that CUSTOMER may make such a disclosure
                                         in respect of any negotiations or due diligence exercises with a view to entering into
                                         a contractual relationship, in such circumstances SUPPLIER’s consent shall not
                                         be required.



 


		16.9	The
                                         name of a Party or the names of any of its staff shall not be used for any advertising,
                                         promotional, or other public purposes by the other Party without the prior written consent
                                         of the first Party.



 


		16.10	The
                                         Recipient Party acknowledges that disclosure or distribution of the Relevant Information
                                         or any part of it or use of the Relevant Information or any part of it contrary to the
                                         terms of this Agreement may cause irreparable harm for which damages at law may not be
                                         an adequate remedy, and agrees that the provisions of this Agreement prohibiting disclosure
                                         or distribution of the Information or use contrary to the provisions hereof may be specifically
                                         enforced by a court of competent jurisdiction in addition to any and all other remedies
                                         available at law or in equity.



 


		16.11	For
                                         the avoidance of doubt SUPPLIER shall treat the Service Data as Relevant Information
                                         of CUSTOMER.



 


		16.12	If
                                         the Disclosing Party is a listed company, the Relevant Information may contain unpublished
                                         information that could affect the market value of the share of the Disclosing Party.
                                         Therefore, the Recipient Party shall inform each individual who will have access to the
                                         Relevant Information that he or she may be subject to applicable rules relating to insider
                                         trading.



  




    	EXECUTION COPY	Page 17 of 24



    	 



    

 





		17.	FORCE
                                         MAJEURE



 


		17.1	In
                                         the event any Party is delayed or hindered in or prevented from the performance of any
                                         act required hereunder by reason of a Force Majeure Event, then performance of such act
                                         will be excused for the period of such delay, provided however, that such Party shall
                                         exert its reasonable efforts to overcome such Force Majeure Event and to resume performance
                                         of its obligations in a timely manner.



 


		17.2	Notice
                                         of the commencement and ending of such Force Majeure Event will be provided by such Party
                                         to the other Party within ten (10) Business Days. Any timeline or milestone obligations
                                         of such Party affected by the Force Majeure Event will be extended for a period of time
                                         equal to the number of days of the delay, provided however that, but subject to subject
                                         to the provisions of the Master Agreement, especially with regard to the Initial Term
                                         as referred to in said Master Agreement and such clauses related to the Minimum Yearly
                                         Volume, in the event that a Party is unable to overcome any Force Majeure Event within:
                                         (i) sixty (60) Business Days, the other Party may terminate Project Agreements under
                                         which the affected Services are being provided or, beyond the Initial Term, terminate
                                         this Agreement if all Project Agreements have been terminated. In case the Project Agreement
                                         is then terminated by CUSTOMER because SUPPLIER is unable to overcome the related Force
                                         Majeure Event, the Minimum Yearly Volume for the Year where the related Project Agreement
                                         is recorded as referred to in the Master Agreement shall be reduced by the price for
                                         the related Project Agreement.



 


		18.	Governing
                                         Law and Disputes 



 


		18.1	The
                                         interpretation and construction of this Agreement and each Project Agreement shall be
                                         governed by the substantive laws of France.



 


		18.2	In
                                         the event that agreement on a matter cannot be reached within thirty (30) days (or sooner,
                                         if required), the Parties shall first try to settle their differences amicably between
                                         themselves. Any Party may initiate such informal dispute resolution by sending written
                                         notice of the dispute to the other Party, and within thirty (30) days after such notice,
                                         appropriate representatives of the Parties shall meet for attempted resolution by such
                                         bona fide negotiations.



 


		18.3	Except
                                         as set forth in clause 4.5 herein above, if the representatives of the Parties empowered
                                         to settle a dispute are not able to close the dispute within forty (40) days from the
                                         date of the written notice, the Parties shall then refer the dispute to proceedings under
                                         the ICC Mediation Rules. If the dispute has not been settled pursuant to the said Rules
                                         within sixty (60) days following the filing of a Request for Mediation or within such
                                         other period as the Parties may agree in writing, such dispute shall thereafter be finally
                                         settled under the Rules of Arbitration of the International Chamber of Commerce by one
                                         or more arbitrators appointed in accordance with the said Rules of Arbitration.



 


		19.	Counterparts
                                         



 


		19.1	This
                                         Agreement is executed in two (2) counterparts, each of which shall be deemed an original
                                         and all of which taken together shall be deemed to constitute one and the same instrument.



 







    	EXECUTION COPY	Page 18 of 24



    	 



    

 





IN WITNESS
WHEREOF, the Parties have executed this Agreement on the Effective Date.


 





	SIGNED for and on behalf
    of  SUPPLIER	 	SIGNED for and on behalf
    of CUSTOMER
	 	 	 
	 	 	 
	Signature	 	Signature
	 	 	 
	Name:	 	Name:
		 	 
	Title:	 	Title:
	 	 	 
	Signature	 	Signature
	 	 	 
	Name:	 	Name:
	 	 	 
	Title:	 	Title:




  




    	EXECUTION COPY	Page 19 of 24



    	 



    

 


APPENDIX
1


 


PROJECT
AGREEMENT


 


THIS
PROJECT AGREEMENT (the “Project Agreement”) is effective on [201YMMDD] (the “Effective
Date”) and is made by between:


 


		(1)	Recipharm X [INSERT APPLICABLE
                                         COMPANY], registered under the laws of [INSERT COUNTRY] under registration number [INSERT
                                         NUMBER] and having an office at [INSERT ADRESS], (“SUPPLIER”).



 


		(2)	FLAMEL TECHNOLOGIES SA, a
                                         French Société Anonyme with the registered number 379 001 530
                                         and having its principal office at Parc Club du Moulin à Vent, 33, avenue du Docteur
                                         Georges Lévy 69200 VÉNISSIEUX (“CUSTOMER”).



 


WHEREAS:


 


		(A)	The Parties entered into a Service
                                         Agreement on [INSERT DATE] (the “Service Agreement”).



 


		(B)	Clause 2.2 of the Service Agreement
                                         provides that Project Agreements specifying the details of Services may be entered into
                                         pursuant to the Service Agreement.



 


		(C)	The Parties wish to enter into this
                                         Project Agreement subject to the Service Agreement.



 


NOW THEREFORE, the Parties agree as follows:


 


		I.	This Project Agreement shall be incorporated
                                         by reference and made a part of the Service Agreement with effect from the Project Effective
                                         Date.



 


		II.	The Parties agree to follow all other
                                         terms and conditions of the Service Agreement which shall be unchanged and shall continue
                                         in full force and effect.



 


		III.	Capitalised terms utilised herein
                                         and not otherwise defined shall have their respective meanings set forth in the Service
                                         Agreement.



 





	IV.	The scope of Services is hereinafter
    set forth:










 





	i)	Scope
    of Work




 


There will be no Appendix A;
each service provided in the proposed Appendix A as provided by Seller shall have to be inserted in an appropriate and separate
Project Schedule as scope of the Work.


 










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	ii)	Designated Personnel






 


	Title	 	Title of work to be entered
	SUPPLIER	 	Name	 	Phone

        (Fax)

        Email

	 	 	 	 	 
	Project Representative	 	Insert project contact names	 	Insert project contact fax/phone/email
	 	 	 	 	 
	Add others as required	 	Insert project contact names	 	Insert project contact fax/phone/email
	 	 	 	 	 
	CUSTOMER	 	Name	 	Phone

        (Fax)

        Email

	 	 	 	 	 
	Project Representative	 	Project personnel will be entered	 	Contact fax/phone/email will be entered.
	 	 	 	 	 
	Add others as required	 	Insert project contact names	 	Insert project contact fax/phone/email
	 	 	 	 	 
	Invoice forwarded to:	 	Insert project contact name	 	Insert address


 


	iii)	Timeline/Project Milestones/Deliverables








 





Key timings, deliverables and milestones are
the following


 


See comment in Scope of Works


  





	iv)	Allocation
    of Responsibilities/Necessary Approvals







 


Same comments that for scope of Works


 





	v)	Budget/Payment
    Terms







 


Same comments that for scope of Works


This section will determine any associated
costs, payment (against milestones), payments based on agreed outputs. This will reflect the proposals made and agreed per the
quotation in response to CUSTOMER’s Invitation to tender. It will also cover any specific agreed purchases including
materials and equipment if applicable. 


 





	vi)	Project Related
    Documents







 


Same comments that for scope of Works.
This will detail the appropriate documentation to be provided by the Parties pursuant to the Project Agreement.


 


	Document	 	Comment
	Description	 	Any additional comments/requirements


 





	vii)	Special Terms
    & Conditions







 


To cover any special terms not addressed in
the above sections.


 


For the avoidance of doubt, all terms of the
Service Agreement remain in force without modification, in particular those relating to Intellectual Property rights, Confidentiality
and Non Infringement of third party rights.


 










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IN WITNESS WHEREOF, the following have
caused this Project Agreement to be executed by their respective duly authorised representatives effective as of the day and year
stated above.


 





	SIGNED for and on behalf
    of SUPPLIER [...] 	 	SIGNED for and on behalf
    of CUSTOMER [...]
	 	 	 	 
	 	 	 
	Signature	 	 	Signature	 
	 	 	 	 	 
	Name:	 	 	Name:	 
	 	 	 	 	 
	Title:	 	 	Title:	 
	 	 	 	 	 
	 	 	 
	Signature 	 	Signature
	 	 	 
	Name:	 	 	Name:	 
	 	 	 	 	 
	Title:	 	 	Title:	 




  




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APPENDIX
2


 


CHANGE
ORDER


 


	CHANGE ORDER FORM
	 
	 
		 
	PROJECT AGREEMENT NUMBER:	 
	 	 
	PROJECT NAME/DESCRIPTION:	 
	 	 
	RECIPHARM CONTACT PERSON:	 
	 	 
	DATE OF REQUEST:	PREPARED BY:
	 	 	 


 


	BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST BELOW:
	 
	 
	IMPACT (estimated effort and/or timeline):
	 
	 
	ESTIMATED COST: 
	 
	Payment Terms:
	 
	Amendment:
	 
	This Change Order constitutes an Amendment to the Service Agreement effective on [YYYYMMDD]
    (“Service Agreement”) and the Project Agreement as stated above between [CUSTOMER] and Recipharm X and shall apply
    only to the scope of Services listed herein or attached hereto.  In all other respects the terms and conditions
    of the Service Agreement and the relevant Project Agreement shall remain in full force and effect and shall be applied to
    this Amendment.


 


	SUPPLIER	FLAMEL TECHNOLOGIES
	 	 
	 	 
	(Signature)	(Signature)
	 	 
	(Date)	(Date)


 







    	EXECUTION COPY	Page 23 of 24



    	 



    

 


appendix
3


 


Quality
Agreement





 










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