Document:

EX-10.15

 Exhibit 10.15 
  

 
 CONSORTIUM AGREEMENT 

FOR THE PROJECT 
 Beta cell
preservation via antigen-specific immunotherapy in Type 1 Diabetes: Enhanced Epidermal Antigen Delivery Systems 
 “EE
ASI” 
 EC-GA n° 305305-2 

Type of funding scheme 

Collaborative Project – Small or medium-scale focused research project 

Work programme topics addressed 

HEALTH.2012.2.4.3-1: Innovative approach to manage diabetes. FP7-HEALTH-2012- INNOVATION-1 

This Consortium Agreement is based upon Regulation (EC) No1906/2006 of the European Parliament and of the Council of 18 December 2006 laying down
the rules for the participation of undertakings, research centres and universities in actions under the Seventh Framework Programme and for the dissemination of research results (2007- 2013) hereinafter referred to as “Rules for
Participation” and the Grant Agreement, adopted on June 25th 2012 hereinafter referred to as the “Grant Agreement or EC-GA” and Annex II adopted
on hereinafter referred to as “Annex II of the EC-GA” and is made on June 25th, 2012, hereinafter referred to as “Effective Date”. 

  
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 BETWEEN: 
  

									
	 Beneficiary

Number
	  	 Beneficiary
	  	 Acronym
	  	 Address
	  	 Legal representative

/ position

					
	1 COORD	  	Cardiff University	  	CU	  	30-36 Newport Road – Cardiff CF24 ODE - UK	  	Geraint W. Jones  
 Director of Research
and
Commercial
Division

					
	2	  	INSERM-Transfert SA	  	IT	  	7 Rue watt – 75013 Paris - France	  	Cécile Tharaud  
 CEO

					
	3	  	Midatech Group Ltd, UK	  	MID	  	4-5 Dunmore court, Abingdon OX13 6BH - UK	  	Stephane Jallat
					
	4	  	Nanopass Technologies	  	NPSS	  	3 Golda Meir ST., Nes Ziona 74036 - Israel	  	Yotam Levin  
 CEO

					
	5	  	Leiden University Medical Center	  	LUMC	  	Albinusdreef 2, Leiden 2333 ZA – The Netherlands	  	Drs. G.E. de Blécourt
/ managing director
Division 4
					
	6	  	King’s College London	  	KCL	  	Strand, London WC2R 2LS - UK	  	Paul Labbett
					
	7	  	Institut National de la Santé et de la Recherche Mé dicale, Marseille	  	Inserm	  	101, rue Tolbiac – 75654 Paris - France	  	Dominique Nobile  

Administrateur
Délégué Régional

					
	8	  	Linkoping University	  	LiU	  	Campus Valla, Linkoping 581 83 - Sweden	  	Christina Ekerfeldt

 hereinafter, jointly or individually, referred to as “Parties” or “Party” 

relating to the Project entitled “Beta cell preservation via antigen-specific immunotherapy in Type 1 Diabetes: Enhanced Epidermal Antigen Delivery
Systems”, in short “EE ASI”, hereinafter referred to as “Project”. 

  
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	 CONSORTIUM AGREEMENT
	  	 	1	  
		
	 SECTION 1 - DEFINITIONS
	  	 	4	  
		
	 SECTION 2 - PURPOSE
	  	 	7	  
		
	 SECTION 3 - ENTRY INTO FORCE, DURATION AND TERMINATION
	  	 	8	  
		
	 SECTION 4 - RESPONSIBILITIES OF PARTIES
	  	 	8	  
		
	 SECTION 5 - LIABILITY TOWARDS EACH OTHER
	  	 	13	  
		
	 SECTION 6 - GOVERNANCE
	  	 	15	  
		
	 SECTION 7 - FINANCIAL PROVISIONS
	  	 	25	  
		
	 SECTION 8 - FOREGROUND
	  	 	26	  
		
	 SECTION 9 - ACCESS RIGHTS
	  	 	31	  
		
	 SECTION 10 - NON DISCLOSURE OF INFORMATION
	  	 	34	  
		
	 SECTION 11 - MISCELLANEOUS
	  	 	35	  
		
	 SECTION 12 - SIGNATURE
	  	 	37	  
		
	 ATTACHMENT 1: CONSORTIUM AGREEMENT ACCESSION DOCUMENT
	  	 	46	  
		
	 ATTACHMENT 2 - LIST OF RESPECTIVE INCLUDED / EXCLUDED BACKGROUND
	  	 	47	  
		
	 ATTACHMENT 3 - LIST OF AFFILIATED ENTITIES
	  	 	50	  
		
	 ATTACHMENT 4 - LIST OF THIRD PARTIES FOR EXECUTION OF SECTION 8.2
	  	 	51	  
		
	 ATTACHMENT 5 - AGREEMENT FOR THE TRANSFER OF MATERIAL
	  	 	52	  
		
	 ATTACHMENT 6: CONSORTIUM BUDGET PLANS AS OF JANUARY 1ST 2011
	  	 	54	  

 WHEREAS: 
 The Parties,
having considerable experience in the field concerned, have submitted a Proposal for the Project to the Commission as part of the 7th Framework Programme of the European Community for Research,
Technological Development and Demonstration Activities under the funding scheme of “Collaborative Project”. The Parties wish to specify or supplement binding commitments among themselves in addition to the provisions of the EC-GA.

 NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS: 

  
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 SECTION 1 - DEFINITIONS 
  

	 	1.1	Definitions 

 Words beginning with a capital letter shall have the meaning defined either herein or in
the Rules for Participation or in the EC-GA including its Annexes without the need to replicate said terms herein. 
  

	 	1.2	Additional Definitions 

 “Access Rights means licences and user rights to foreground or
background to a Partner (And under Annex II and under Clause 27) 
 “Allocated Work” means the Project research work and the related
activities and services allocated to any of the Parties in accordance with the EC-GA, Annex 1; 
 “Background” means as provided for in
Annex II Section I Definitions; 
 “Beneficiary(ies)” as referred to in Annex II means a Party(ies) to this Agreement and shall also mean a
Partner as referred to in this Agreement; 
 “Chief Investigator” means Colin Dayan as appointed as the lead clinician for the purposes of
the Clinical Trials and Clinical Trials under Work Package 5, or in the event that Colin Dayan is no longer available to act as Chief Investigator for any reason then such other person appointed to be Chief Investigator; 

“Community Financial Contribution” means those funds received from the European Commission for the Project and distributed as appropriate by
the Coordinator to the Parties; 
 “Composite IMP Device” means that device which enables delivery of the IMP in the Clinical Trials and as
prepared and released by Midatech following receipt of the Midatech Product from Partner 3 and the IMP System from Partner 1 and Partner 6, both in combination as the MidaKing’s Product and the Nanopass Device from Partner 4, or such other
delivery IMP Device as may be prepared for the purposes of the Clinical Trials and which shall be Joint Foreground of the Parties to this Agreement in accordance with and pursuant to the provisions of this Agreement and the IP Plan; Nanopass’
participation in the Composite IMP Device is solely in the combination as is presented in the Composite IMP Device and not as a stand alone product. 

“Consortium Agreement” means this body text, its exhibit and its possible further amendments; 

“Consortium Body(-ies)” means the General Assembly, the Executive Committee, Work Package Teams; 

“Consortium Budget” means the allocation of all the resources in cash or in kind for the activities as defined in Annex I of the EC-GA or as
updated and approved by the General Assembly; 
 “Clinical Trials” means that element of the Work Package 5 which requires the recruitment
of and consent of Subjects; 
 “CRO/CTU” means the Company being the contract research organisation or the clinical trials unit, appointed
by the Sponsor and who is responsible for the day to day management of the Clinical Trials under Work Package 5; 

  
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 “Day(s)” means calendar day(s); 

“Defaulting Party” means a Party which is in breach of this Consortium Agreement and/or the EC-GA; 

“Data” means for the purposes of this Agreement any knowledge, information, scientific data, animal data, human data, personal data,
treatment response data, physical health data, diagnostic data, medical records data, raw Clinical Trials data, analysed Clinical Trials data, genetic information and any instructions designs reports and copies required to carry out the Project as
described in Annex I EC-GA, together with any results arising out of the use of Subject Samples and or Subject Data; 
 “Deliverable” means
reports and information, including progress reports and certified audit reports, referred to in the EC-GA and this Consortium Agreement that have to be delivered by the Parties via the Coordinator to the Commission. 

“Fair and Reasonable” means as stated and as referred to in Clause 7.1.1 of this CA and in Annex II Clause 34 and where reference is made to
‘appropriate conditions’ thereat, such appropriate conditions shall include such financial conditions more favourable than arms-length market conditions; 

“Foreground” means as defined in Annex II Section I Definitions; 

‘IP Plan’ means as referenced and required pursuant to ANNEX II SECTION 29 Point 2 and Section 6.4 of this Agreement namely an “the
plan for the use and dissemination of foreground”; 
 “King’s Product” means the peptide of proinsulin as
provided by Partner 6 being King’s College London or such other peptide of proinsulin as maybe provided via Partner 1 and Partner 6 or such other auto antigen/peptide combination obtained by Partner 1 and the provision of the same, under
licence to Partner 3 Midatech for integration with Midatech Device to form the MidaKing’s System and for further combination in to the Composite IMP Device with the Nanopass Device. 

“Joint Foreground” means Foreground generated for and during the course of the Project, where more than one Party has contributed to such
Foreground (not being to Sideground) and ownership in respect of such shall be joint and in such proportion to a Party’s contributing share in respect thereof and any commercialisation rights in respect thereof shall be negotiated on fair and
reasonable terms appropriate to the input of Party, as further clarified at Section 8.1 of this Agreement; 
 “Midatech Product” means
the IL-10 (system 1) developed under Work Package 2 of the Project and to be provided by Partner 3, to the Sponsor for the Sponsor and Partner 3 to work under Work Package 2 and for the Sponsor to prepare a Composite IMP Device to be used for the
purposes of the Project, pursuant the Protocol and pursuant to Work Package 5 as set out in Annex I EC-GA, whether System 1 NPs is either patentable or not; 

“MidaKing’s System” means the combination of the Midatech Product from Partner 3 and the King’s Product under the Project, being
Joint Foreground, for use in the Project, prior to the attachment of the Nanopass Device in respect of which, the Nanopass Device when in combination with MidaKing’s System is to form the Composite IMP Device. 

“Nanopass Device” means the micro needle delivery system in the commercial form MJ600 device, introduced under Work Package 2 of the Project
and to be provided by Partner 4 to the Sponsor for the Sponsor work on pursuant to Work Package 2 and to prepare a Composite IMP Device to be used pursuant to the Protocol for the purposes of the Project pursuant to Work Package 5 as set out in
Annex I EC-GA, whether micro needle delivery system is patentable or not; 

  
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 “Materials” means any and all samples including any information and/or Data in connection
therewith collected by a Party but in particular pursuant to Work Package 5 as described in Annex 1 EC –GA 305305-2; and shall include any animal material, animal samples, human genetic material, human biological samples, clinical biological
samples, animal biological samples, components, derivatives, modifications, portions, constructs and/ or separated material in respect of any thereof, save where such derivatives and/or modifications are Sideground. 

“Needed” means: 
  

	 	•	 	For the implementation of the Project, Access Rights are Needed if, without the grant of such Access Rights, carrying out the Allocated Work assigned to the recipient Party would be impossible, significantly delayed, or
require significant additional financial or human resources. 

  

	 	•	 	For Use of own Foreground: Access Rights are Needed if, without the grant of such Access Rights, the Use of own Foreground would be technically or legally impossible. 

“Partner” means where referred to in this Agreement a Party to this Agreement and beneficiary(ies) as referred to in Annex II of the EC-GA

 “Party” means those entities listed as the contracting entities to this Agreement and shall also mean Partner as referred to in this
Agreement and also beneficiary(ies) as referred to in Annex II of the EC_GA; 
 “Project” means the information, details and design of Work
Packages as set out in Annex I EC-GA No. 305305-2. 
 “Product(s)” means where any Composite IMP Device and/or other item, product,
device or treatment process and/or procedure, Foreground and/or Joint Foreground put to use as defined in Annex II and pursuant to the terms of this Agreement and Annex II EC-GA. 

QP means the person referred to in Article 48 of Directive 2001/83/EC or in Article 13(2) of Directive 2001/20/EC 

“Results” means the published data of the Project 

“Sideground” means data, results know-how and information, whether or not they can be protected which are generated by a Partner under the
Project but outside of the Project objectives and which are not needed for the undertaking and completing the Project or the research use of Foreground. Sideground specifically excludes Foreground. 

“Software” means sequences of instructions to carry out a process in, or convertible into, a form executable by a computer and fixed in any
tangible medium of expression. 
 “Sponsor” means Cardiff University who shall take overall responsibility for the conduct and management
of the Clinical Trials under Work Package 5 and for preparing all the relevant regulatory documentation and submissions and applications for approval and who shall be responsible for sub-contracting to and with a CTU or CRO for the day to day
management of the Clinical Trials. 
 “SAEs” means Serious Adverse Events as defined in the Protocol. 

“SUSARs” means Serious Unexpected Suspected Adverse Reaction as defined in the Protocol. 

  
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 “Subject” means those individuals from whom appropriate consent, as provided for and pursuant to
the Informed Consent provisions of Annex I EC-GA at Section 4.4.1, has been obtained for recruitment and inclusion in Work Package 5 and for the collection and use of Data in respect of and in connection with the same. 

“Subject Samples” means those Materials collected from a Subject who has consented to take part in the Clinical Trials pursuant to Work
Package 5 and pursuant to Annex 1 EC-GA Section 4.4.2 and the Safety provisions in relation thereto, as set out at Annex I EC-GA Section 4.7 and transferred to a Party for analysis for the purposes of the Clinical Trials. 

“Subject Data” means that Data collected from a Subject who has consented to take part in the Clinical Trials pursuant to Work Package 5 and
as referenced in Annex I EC-GA Section 4.4.3 and transferred to a Party for analysis for the purposes of the Clinical Trials. 
 “Trial Data
Set” means the raw data collected from Subjects and which is the source verification data for the purposes of any further trials and/or any regulatory requirements, together with the analysed data of the Clinical Trials under Work Package 5
and both of which shall be deemed to be Joint Foreground of the Parties and the Parties shall have joint ownership of the same. The Parties shall determine in accordance with the delegation of roles and responsibilities in respect of the Clinical
Trials, to whom the raw data from the Clinical Trials under WP 5 is being transferred to, if there is any doubt then it shall in the first instance be transferred to and collected by the Sponsor. 

“Use” means the direct or indirect utilisation of Foreground in further research activities involving third parties, other than those covered
by the Project, or for developing, creating and marketing a product, (such as the Composite IMP Device) or process, or for creating and providing a service. 
  

	 	•	 	direct utilisation is done by the Party owning the Foreground through, for example, further research or commercial or industrial exploitation in its own activities; 

 

	 	•	 	indirect utilisation is done by other Parties, for example, by licensing third parties. 

 Work Packages means
the programme of works contribution to the overall Project, to be undertaken by the Work Package Team appointed by a Party and where either a Party’s appointed Work Package Team undertakes the Work Programme on its own in or collaboration with
another Work Package Team, as appointed by another Party; 
 “Work Package Team” means those individuals, with the relevant expertise and
knowledge appointed by a Party to undertake the Work Package and contribute to the Project as a whole; 
 “Work Programme” means the Work Packages
undertaken as part of the Project and their association with each other as set out in the Gantt Chart in Annex I EC-GA No 305305-2. 
 SECTION 2 -
PURPOSE 
 The purpose of this Consortium Agreement is to specify with respect to the Project the relationship among the Parties, in particular
concerning the organisation of the Work Packages and the Allocated Work between the Parties, the management of the Project and the rights and obligations of the Parties concerning inter alia liability, Access Rights and dispute resolution.

  
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 SECTION 3 - ENTRY INTO FORCE, DURATION AND TERMINATION 

 

	 	3.1	Entry into force 

 a) An entity becomes a Party to this Consortium Agreement upon signature of this
Consortium Agreement by a duly authorised representative. 
 b) This Consortium Agreement shall have effect from the Effective Date identified at the
beginning of this Consortium Agreement. 
 c) A third party shall become a new Party to this Consortium Agreement upon signature of the “Accession
document” Attachment 1 by itself and the Coordinator. Such accession shall have effect from the date identified in the Accession document. 
  

	 	3.2	Duration and termination 

 This Consortium Agreement shall continue in full force and effect from its
Effective Date until complete fulfilment of all obligations undertaken by the Parties under the EC-GA and under this Consortium Agreement. However, this Consortium Agreement may be terminated in accordance with the terms of this Consortium Agreement
and Annex II of the EC-GA (EC-GA Article II.37. and II.38.). 
  

	 	3.3	Survival of rights and obligations 

 a) Section 10 relating to Confidentiality, shall survive the
expiration or termination of this Consortium Agreement as agreed upon in respective Sections. 
 b) Sections relating to Access Rights (9), Liability (5),
Applicable law (Section 11.7) and Settlement of disputes (Section 11.8) Business Plan Committee (6.4) Foreground (8) In relation to Trial and Clinical Trial Subjects (Section 4.1. i) and 4.4 .g) and 4.4. t), shall survive the expiration or
termination of this Agreement. 
 c) Termination shall not affect any rights or obligations of a Party leaving the Consortium incurred prior to the date of
termination, unless otherwise agreed between the General Assembly and the leaving Party. This includes the obligation to provide all input, Deliverables and/or Data and/or Materials and/or such other information and/or documents for the period of
its participation. 
 SECTION 4 - RESPONSIBILITIES OF PARTIES 
  

	 	4.1	General principles 

 a) Each Party undertakes to contribute to the efficient implementation of the
Project, and to cooperate, perform and fulfil, promptly and timely, all of its obligations under the EC-GA and this Consortium Agreement as may be reasonably required and in good faith. Each Party undertakes to notify promptly to the Coordinator,
any significant information, fact, problem or delay likely to affect the Project and the Coordinator shall if appropriate liaise with such relevant Party(ies) in order to resolving and/or mitigating and agreeing any such issues including the
revision of the Work Programme as set out in the Gantt Chart at Annex 1 EC-GA No. 305305-2. 

  
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 b) Each Party shall provide in due time all information reasonably required by a Consortium Body or by the
Coordinator to carry out its Allocated Work. 
 c) Each Party shall take reasonable measures to ensure the accuracy of any information, documentation, Data
and/or Materials it supplies to the other Parties. 
 d) Each Party shall ensure that its Allocated Work on the Project complies fully with all applicable
local, government and international laws, regulations and guidelines which are effective during the period of the EC-GA, including those governing health and safety, data protection, and where relevant, the use of human or animal subjects and good
clinical practice (including national legislation implementing the Parliament’s Directive 2001/20/EC on good clinical practice). In this regard, each Party shall maintain the confidentiality, in accordance with Section 10 of this
Consortium Agreement, of all Materials and Data relating to the use of human subjects, which is created or used in the course of the Project. 
 e) Each
Party shall secure all necessary approvals from the relevant research ethics committees before undertaking any part of the Project requiring ethics committee approval and shall, if required, obtain properly signed informed consent and
acknowledgement forms from any human subjects or their legal guardians who they will involve in the Project. Where any part of the Project takes place in a hospital, the Party involved shall first obtain all necessary approvals, indemnities and
agreements from that hospital. 
 f) When a Party (the “Provider”) sends Material and/or Data, except the IMP as defined above, to another
Party (the “Recipient”), a separate material transfer agreement, (an “MTA”), shall be concluded between the Parties to specify the conditions of such transfer of material. The material shall only be transferred if
it is Needed for the implementation of the Project, as defined in this Consortium Agreement. It shall only be transferred upon written request stating the purpose for which it is Needed and the material shall only be used for that purpose and for as
long as is necessary for that purpose. The Recipient will be entirely responsible for the use of the material and the Provider shall have no obligation or liability for the material, other than using reasonable endeavours to ensure the accuracy of
any information that it supplies. The Recipient shall not be entitled to transfer the material to any third party without the Provider’s prior written consent. A template of an MTA that shall be used for such transfers is included in
Attachment 5. Each Party using the template is responsible for ensuring that the MTA is completed correctly, adapted to the relevant situation and that it complies with all applicable rules, laws or regulations. 

g) The MTA as attached at Attachment 5 is compatible with the provisions in the Annex I EC-GA, namely the Specific Biological Studies at Section 4.4.2,
the Data Protection at Clause 4.4.3, Animal Work at Section 4.5 and Transportation of Samples and Devices at Section 4.7. The Parties hereby agree that in circumstances where there is a transfer of Data and/or Materials and/or Subject Data
and/or Materials then the MTA as attached at Attachment 5 will be used. 
 h) The Parties acknowledge that the Subject Sample under the Clinical Trials
pursuant to Work Package 5 are to be transferred from the Trial sites to Partner 6 and Partner 8 for analysis by Partner 6 and Partner 8 of the same. The analysis of the Subject Samples and the Subject Data and will be held by the Data Custodian and
Sample Custodian pursuant to Clause 4.4 and compiled on the Clinical Database, together with other such other results from the analysis of Material and/or Data . Any leftover Subject Samples from the Clinical Trials will be transferred and dealt
with in accordance with the Protocol. Neither Partner 6 or Partner 8 shall act as a store for human tissue after the termination or completion of the Project, for the duration of the Project, however the Materials and Subject Data and Subject
Samples will of course be collected, kept and used in accordance with the relevant ethical approvals and also the provisions of Annex I EC-GA Sections 4.4.1, 4.4.2, 4.5, and 4.7. 

  
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 i) In the event that pursuant to Annex II Section 37 or Annex II Section 38, a Party withdraws or in
circumstances where there is a defaulting Party, then the Party so leaving shall be required to transfer any and all physical Data and/or Materials to the Coordinator and ensure that any Access Rights required to be granted in respect of the same
are implemented pursuant to Section 7 and Section 8 of this CA. Provision to deal with the central storage of Materials, Data Subject Materials and/or Subject Data after the termination or completion of the Project is set out at Clause
4.4. 
  

	 	4.2	Breach 

 In the event a Consortium Body is informed of a breach by a Party of its obligations under this
Consortium Agreement or the EC-GA, (eg. A Party producing poor quality work) it will instruct the Coordinator to give written notice requiring that such breach be remedied within thirty (30) Days. If the breach is not remedied, the matter will
be taken to the General Assembly which may decide to declare the breaching Party to be a Defaulting Party and to decide on the consequences thereof. 
  

	 	4.3	Involvement of third parties 

 a) At principle, the Parties shall personally perform their respective
Allocated Work. However, upon clear justifications, the Parties can exceptionally involve third parties. 
 b) A Party that enters into a subcontract or
otherwise involves third parties (including but not limited to Affiliated Entities or Third Parties linked to Beneficiaries) in the Project remains solely responsible and liable for carrying out its relevant part of the Project and for such third
party’s compliance with the provisions of this Consortium Agreement and of the EC-GA. 
 c) It has to ensure that the involvement of third parties does
not affect the rights and obligations of the other Parties regarding Background and Foreground. 
 d) The Sponsor in its role as Sponsor, shall, in the
first instance, seek to appoint the CRO and the CRO shall be identified and appointed by and shall be a sub-contractor for the purposes of this Agreement. 

e) The manufacturer of the Midatech Product if not carried out by Midatech itself, shall be identified and appointed by and shall be a sub-contractor of
Partner 3, Midatech, for the purposes of this Agreement. 
 f) The manufacturer of the Nanopass Device if not carried out by Nanopass itself shall be
identified and appointed by and shall be a sub-contractor of Partner 4, Nanopass, for the purposes of this Agreement. 
 g) The manufacturer of the
King’s Product if not carried out by Cardiff University or King’s College London shall be identified and appointed by and shall be a sub-contractor of Partner 1, or Partner 6 as appropriate, for the purposes of this Agreement. 

h) The manufacturer of the MidaKing’s System shall be identified and appointed by and shall be a sub-contractor of Partner 3, Midatech, for the purposes
of this Agreement, with appropriate licences in place for the purpose. 
 i) The manufacturer of Composite IMP Device shall in the first instance, be
identified and appointed by Partner 3, Midatech and shall be a sub-contractor of Midatech for the purposes of this Agreement. 

  
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	 	4.4	In relation to Trial And Trial Subjects 

 a) Subject to the provisions set out at this Article 4.4 and in
accordance with Section 4.4.3 of the EC-GA Annex I, the Parties shall ensure that they shall not at any time disclose to any third party the name of any Subject unless required to do so by law and/or regulatory authority. 

b) For the avoidance of doubt, the Parties shall not under any circumstances disclose to any other Party any identifiable information relating to any Subject
unless it is in the interests of the health and safety of any Subject and then any such disclosure shall be for the intended purpose only and no other. 

c) Any Party who, in fulfilment of its obligations set out in Annex 1, EC-GA and in accordance with Annex I Section 4.4.1, Section 4.4.2,
Section 4.4.3, Section 4.5, and Section 4.7 thereof, is required to transfer to any other Party and/or to any third party any Data and/or Materials shall first effect the completion of a Material Transfer Agreement in the form set out
in Attachment 5. 
 d) It is agreed and recognised between the Parties that no Party shall under any circumstances undertake or instruct any third party to
undertake whether directly or indirectly any test, analysis or assay of any Data or Materials which have been transferred to them by another Party for the furtherance of the Project other than as provided for in Annex 1, EC-GA. All and any tests,
analysis or assays to be carried out on the Samples pursuant to Annex 1, EC-GA shall be conducted in accordance with all relevant and applicable regulations, guidelines and current good laboratory practices or accepted laboratory practices, where
applicable and as referred to at Annex I Section 4.3 and Section 4.7. 
 e) Any Party in possession of any Data or Materials shall ensure that
they are used in compliance with all applicable laws and governmental regulations and guidelines, including for the avoidance of doubt those laws and regulations relating to data protection issues and in accordance with Section 4.4.3 of Annex
1, EC-GA, , any applicable ethical approvals and law and regulations relating to informed consent as set out in Annex 1, EC-GA Section 4.4.2 and also any applicable ethical approvals and law and regulations relating to Annex 1, EC-GA
Section 4.4.2 Section 4.5 and Section 4.7 thereof. 
 f) The Sponsor shall act as the custodian of any Subject Samples in the first instance
during the course of the Trial and after the completion of the Trial the Sponsor and the Coordinator shall agree how and where any remaining Subject Samples shall be stored. All Parties shall cooperate and liaise to ensure that any transfer of
Subject Samples on the completion of the Trial, are transferred in accordance with all applicable regulations. The budget for this shall, if necessary and as appropriate, be allocated by Partner 1, the Coordinator and agreed between the Parties.

 g) The Sponsor shall act as the custodian of any Subject Data, in the first instance during the course of the Trial and after completion of the Trial the
Sponsor and the Coordinator shall agree how and where the Subject Data shall be stored. All Parties and all Parties shall ensure that any appointed sub-contractors third parties, including the CRO, involved in Subject Data collection, shall
cooperate and liaise to ensure that any transfer of Subject Data upon completion of the Trial are transferred in accordance with all applicable regulations and is transferred in a usable format. The budget for this shall, if necessary and as
appropriate be allocated by Partner 1, the Coordinator and agreed between the Parties. 
 h) The Sponsor shall ensure that all necessary and appropriate
insurance is in place to cover Subjects involvement in the Clinical Trials under Work Package 5 for the benefit of any Subject. 

  
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 i) The Partner 6, being the Party responsible for providing the IMP System, as manufactured under Work Package 5,
for the purposes of the Clinical Trials under Work Package 5, shall ensure that all necessary and appropriate insurance is in place to cover its liability in respect of the IMP System. The Sponsor being required to take out such necessary and
appropriate insurance in respect of the Composite IMP Device, as QP released as to regulatory release and used in the Clinical Trials. 
 j) The Partner 3,
being the Party responsible for providing the Midatech Product, as manufactured in accordance with GMP under Work Packages 2 and 5, for use of the Midatech Product for the purposes of the Clinical Trials under Work Package 5, shall ensure that all
necessary and appropriate insurance is in place to cover its liability in respect of the Midatech IMP. The Sponsor being required to take out such necessary and appropriate insurance in respect of the Composite IMP Device, as QP released and used in
the Clinical Trials. 
 k) The Partner 4, being the Party responsible for providing the Nanopass Device, as manufactured in accordance with GMP, under Work
Packages 2, 3 and 5, for the use of the Nanopass Device in the Composite IMP Device, for the purposes of the Clinical Trials under Work Package 5, shall ensure that all necessary and appropriate insurance is in place to cover its liability in
respect of the Nanopass Device for the purposes of delivery of the Nanopass Device to Midatech and up to the point of the production of the Composite IMP Device. 

I) The Sponsor being required to take out such necessary and appropriate insurance in respect of the Composite IMP Device, as QP released and used in the
Clinical Trials as a therapeutic IMP and Device. 
 m) The Party(ies) having input in to the design of the Protocol shall be responsible for the same and
the Sponsor shall put in place such insurance as is required to cover the implementation of the Protocol for the purposes of the Clinical Trial and any Party having such input shall provide written approval of the final Protocol. Any supply
agreement for the provision of the Composite IMP Device shall also be provide to Partner 1 and Partner 4 and Partner 5 and Partner 7 for their information and approval. 

n) Partner 1 in cooperation with Partner 6, shall be responsible for and with the benefit of appropriate licences, for the manufacture of the King’s
Product to the principles of GMP and the provision of the same to Partner 3, Midatech, for Midatech to combine with the Midatech Product to prepare the MidaKing’s System. The Parties undertake that there shall be no modification of the
King’s Product within the MidaKing’s System without the input and approval of Partner 6 and if necessary and appropriate Partner 1. The delivery of the Nanopass Device to Midatech shall be covered by way of a separate MTA to be implemented
after the signing of this Consortium Agreement and shall be drafted by Cardiff. 
 o) Partner 4, Nanopass, shall be responsible for the provision and
release of the Nanopass Device to Midatech for Midatech to prepare and QP release the Composite IMP Device. Midatech undertakes that there shall be no modification of the Nanopass Device without the input and approval of Partner 4, Nanopass. The
Nanopass Device is regulated under the Medical Device Directive 93/42/EEC and is CE certified. The Parties undertake that there shall be no modification of the Nanopass Device within the Composite IMP Device without the input and approval of Partner
4, Nanopass. The delivery of the Nanopass Device to Midatech shall be covered by way of a separate MTA to be implemented after the signing of this Consortium Agreement and shall be drafted by Cardiff. 

p) Partner 3, Midatech, shall be responsible for the Midatech Product and the provision of the QP release of Midatech Product, as to batch certification of
the same for the preparation of the MidaKing’s System and the Composite IMP Device and QP release of the Composite IMP Device. The Parties undertake that they shall be no modification of the Midatech Product without the input and approval of
Partner 3, Midatech. 

  
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 q) Composite IMP Device shall be prepared and manufactured by Partner 3, Midatech or their appointed manufacturer
and shall be QP released together with all necessary and appropriate insurance in place in respect of the Composite IMP Device as produced in its combined form and together with all necessary and appropriate certificates, documents and
Investigator’s Brochure to the distribution facility responsible for QP release of the Composite IMP Device, prior to the shipment of the Composite IMP Device to the relevant pharmaceutical unit identified as being responsible for the receipt
of the Composite IMP Device and QP as to technical release and onward distribution of the Composite IMP Device to the Trial Site for use in the Clinical Trial. 

r) The Sponsor shall be responsible for QP as to regulatory release. (This being a requirement of the role as Sponsor that the QP provides technical release
of the Composite IMP Device to the Sponsor and the Sponsor performs regulatory release for the purposes of the use of the Composite IMP Device at the Clinical Trial Sites.) 

s) The provision of the Nanopass Device and the Midatech Product and the Composite IMP Device is based on the applicable cGMP (current good manufacturing
practice) legislation in the European Union and specifically Directive 2001/20/EV (Clinical Trials Directive) and Rules and Guidance for Pharmaceutical Manufacturers and Distributors of: EU Guidelines on GMP, including annexes 13 and 16 (EU
Guidelines on GMP) and in accordance with the terms of any manufacturing licence and their respective valid MIA (IMP) MIA (IMD), and Medical Device Directive 93/42/EEC and including for the avoidance of doubt the requirement to retain samples of the
Composite IMP Device pursuant to Annex 13 and Directive 91/356 for two years after the end of the Trial. 
 t) In the event that the Sponsor, for whatever
reason, is no longer in a position to act as Sponsor, either voluntarily or otherwise, then any Data and/or Materials, including for the avoidance of doubt Participant Data and/or Participant Materials, then the Sponsor shall ensure that appropriate
and adequate provisions are in place and provided for to ensure the safety of such Data and/or Materials and where such Data and/or Materials are held in the indirect day to day care and control by a third party appointed by the Sponsor, including
any CRO/CTU if appointed by the Sponsor, then the Sponsor shall require the third party and/or any CRO/CTU, as appointed, to transfer any and all such Data and/or Material to the Sponsor to be dealt with in accordance with the provisions of this
Agreement. The Sponsor shall ensure that in any contract with the third party including any CRO/CTU as appointed shall require the third party and/or the CRO/CTU to liaise with the Sponsor and the Coordinator in order to give effect to the safe and
timely transfer and in a format that is useable to the Sponsor and the Coordinator, of any and all such information relation to the Project and/or the Clinical Trial including the Data and/or Materials. 

SECTION 5 - LIABILITY TOWARDS EACH OTHER 
  

	 	5.1	No warranties 

 a) In respect of any information, including Background and/or Foreground, and/or Data
and/or Materials supplied by one Party to another under the Project, no warranty or representation of any kind is made, given or implied as to the sufficiency or fitness for purpose, nor as to the absence of any infringement not deliberately made of
any proprietary rights of third parties. Therefore: 
  

	 	•	 	the recipient Party shall in all cases be entirely and solely liable for the use to which it puts such information Data and/or Materials; 

 

	 	•	 	no Party shall be liable in any case of infringement of proprietary rights of a third party resulting from any other Party (or its Affiliates) exercising its Access Rights. 

  
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	 	5.2	Limitations of contractual liability 

 a) A Party’s aggregate liability towards the other Parties
collectively shall be limited to the Party’s share of the Community Financial Contribution, as identified in Annex I of the EC-GA. 
 b) The
limitations of liability stated above (sect. 5.1 and 5.2.1) shall not apply in the case of liability caused by a wilful act and/or gross negligence of a Party, its Affiliated Entities or their employees, officers, or directors in the performance of
the said Party’s obligations under this Consortium Agreement, to the extent allowed by law. 
 c) The terms of this Consortium Agreement shall not be
construed to amend or limit any statutory liability. 
  

	 	5.3	Liability and Clinical Trials 

 a) The Midatech Product, as manufactured to the principles of GMP, under
Work Package 2 and the IMP System as manufactured to the principles of GMP under Work Package 5, as combined and manufactured under Work Package 5 to produce the MidaKing’s System 5 and when combined with the Nanopass Device as manufactured to
GMP, under work Packages 2 and 3 (together the Composite IMP Device) and the delivery of the same to the Clinical Trials sites for use in the Clinical Trials under Work Package 5 shall be detailed in an IMP and Device Supply Agreement” to be
drafted by the Sponsor of the Clinical Trials and shall be provided to the Party(ies) involved in the Clinical Trials as a Clinical Trials site for review and approval to ensure that all appropriate local government and local regulatory requirements
are met and shall then also be annexed to this Consortium Agreement at the appropriate time point, when the Clinical Trials design is finalised and Protocol agreed between the Parties. 

b) The Composite IMP Device Supply Agreement shall include appropriate provisions as to: 1) insurance for use of the Composite IMP Device in the Clinical
Trials, 2) shipping and QP release certifications to the relevant distribution units in the relevant countries providing sites for the Clinical Trials prior to onward delivery of the IMP and the Device to the trail site conducting the Clinical
Trials, 3) reporting of SUSAR/SAE provisions and an agreed form for the reporting of the same, 4) recall of the Composite IMP Device in the event of fault, 5) recall of the Midatech Product in the event of fault 6) recall of the Nanopass Device in
the event of fault, 7) recall of the IMP System in the event of fault 8) recall of the MidaKing’s System 9) disposal or return of the Composite IMP Device on early termination or completion of the Clinical Trials, 10) attachment of a draft or
agreed Protocol. 
 c) is agreed that no submission for regulatory approval following the preparation of a report pursuant to Del 5.1 under Work
Package 5 shall be made to the relevant authorities until an appropriate agreement is concluded between the Parties, if necessary in order to reflect (i) any Ownership of Foreground under the Project including the Clinical Trials Data Set
pursuant to a Annex II Section 26, and (ii) Protection of Foreground including the Trial Data Set pursuant to Annex II Section 28 and (iii) the Use of Foreground including the Trial Data Set pursuant to Annex II Section 29 and (iv) Dissemination of
the Results and/or Foreground including the Clinical Trials Data Set under Annex II Section 30 and (v) to ensure that any anticipated or know transfer assignment of Foreground including the Clinical Trials Data Set pursuant to Annex II section 27
shall enable another Party and other Parties to exercise their rights in accordance with Annex II Section 27 Point 2. 

  
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	 	5.4	Exclusion of liability 

 No Party shall be liable to any other Party for punitive damages, indirect or
consequential loss or similar damage such as, but not limited to, loss of profit, loss of revenue or loss of contracts. 
  

	 	5.5	Damage caused to third parties 

 Each Party shall be solely liable for any loss, damage or injury to
third parties resulting from the performance of the said Party’s obligations under this Consortium Agreement or from its use of Foreground or Background, provided, however, a Party shall not be responsible to the extent any loss, damage or
injury to third parties results from the gross negligence or wilful misconduct of another Party. 
  

	 	5.6	Force Majeure 

 No Party shall be considered to be in breach of this Consortium Agreement if such breach
is caused by force majeure. Each Party will notify the General Assembly of any force majeure as soon as possible. If the consequences of force majeure for the Project are not overcome within six (6) weeks after such notification, the transfer
of Allocated Work - if any - shall be decided by the General Assembly. 
 SECTION 6 - GOVERNANCE 

The organisational structure of the Consortium shall be as follows: 
  

	 	1-	Operational bodies and specific operational procedures applicable to each Consortium Bodies 

  

	 	•	 	the General Assembly (“GA”) is the decision-making body of the Consortium for the execution of the Project; 

The General Assembly will be permanently chaired by the Coordinator. 

Role. The GA is in charge of the overall direction and major decisions with regard to the Project and will principally guide the strategic
direction of the Work Programme. This will involve addressing the following matters: 
  

	•	 	Project and sub-Project status and compliance with the objectives of the Work Programme; 

  

	•	 	degree of integration through the Work Programme of Work Allocated activities; 

  

	•	 	termination of sub-Projects not complying with the objectives or EC /CA standards; 

  

	•	 	risk assessment and adoption of rescue plans. 

  

	•	 	on an 18-month basis, adoption and any revision of the Work Programme of Work Allocated activities and budget shares; 

  

	•	 	inclusion and exclusion of Partners; nomination of a new coordinator if default; 

  

	•	 	amendment of terms of the Work Allocated activities’ of the Work Programme of the EC grant Agreement and of the CA; 

  

	•	 	review of publications, authorships, dissemination and intellectual property right issues; strategies to exploit the obtained Results. 

 

	•	 	establishment of the IAB, including the appointment, revocation of appointment and determination of the rules for selection of the experts; assessment of the report of the IAB. At least 2 bioethicists will be appointed
in the IAB. 

  
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 Composition. The GA consists of one principal contact point per Partner, backed by one authorised person
for signature of the institution he/she represents. 
 Meetings. The General Assembly will meet every 12 months from the start of the Project
execution: Five GA meetings will be regular physical meetings (kick-off, Month 12, 24, 36 and Final meeting). These meetings will be coupled with General Consortium meetings, which gather not only the Principal Investigators, but also all
personnel working on the Project, Work Package Team members in particular post-docs or PhD students hired thanks to the EC funds. Intermediate meetings (Month 6, 18, 30, 42) will be held electronically. Basically, the GA receives the minutes of the
ExCom for discussion and final validation by vote via emails or teleconference. 
 The GA meetings will be convened and prepared by the Coordinator with the
support of the PMT. The Coordinator will prepare in writing the agenda of the meetings and send it to each GA member at least 15 days before the meetings, with all relevant Background Information and supporting documents to any decision
proposed to be taken. For decision-making purposes, each GA member will have one vote. Quorum and majority requirements will be laid down in the CA. Minutes of General Assemblies will be prepared by the Coordinator and the PMT acting as
secretary, sent by the project manager (Work Package Leaders) to all members, and archived on the private website for allowing continuous access. 
  

	 	•	 	the Executive Committee (‘ExCom’) 

 The Executive Committee (ExCom), board of the WP leaders,
is the operational arm of the GA in charge of coordinating the implementation of the Project and other relevant activities supporting this research Work Programme. 

Role. 
 Vis-à-vis the GA, the ExCom will be in
charge of: 
  

	•	 	proposing and implementing the scientific orientations in the WPs (when needed, evaluated by the IAB); managing the implementation of the research Work Programme; providing alternatives for the existing research Work
Programme (rescue plans); monitoring milestones, deliverables and timelines, Partners’ performance; evaluating the quality of the performed research Project; 

 

	•	 	supporting the Coordinator in the preparation of the meetings and in the compilation of minutes; 

  

	•	 	preparing relevant documentation for the items to be approved by the GA including financial subventions per type of Work Package activities and per Partner; 

 

	•	 	drawing up proposals to the GA for additional agreements and amendment of its terms; 

  

	•	 	implementing and deciding on measures of controls and audit procedures in order to ensure the day-to-day coordination and monitoring of the Project activities; 

 

	•	 	compiling reports in case of the default of a Partner or the Coordinator to the GA; 

  

	•	 	assembling the reports (technical part) to be delivered to the EC and writing their general sections; 

  

	•	 	ensuring the optimal use and harnessing the generated knowledge within the scientific community and the public; 

  

	•	 	preparing competitive calls for the acceptance of new partners; 

 Vis-à-vis the overall project
management, the ExCom will be: 
  

	•	 	coaching and verifying the observance of the Work Programme by the Partners; 

  

	•	 	taking the decisions needed for the correct implementation of the Work Packages; and 

  

	•	 	approving and collecting the Project’s deliverables. 

  
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 Decisions by the ExCom will normally be taken by consensus, but where this is not feasible the principle of
majority voting of two thirds will apply. Decisions may be taken via audio- or video-teleconferences, or during physical meetings. The Work Package Leaders shall send meeting minutes to all the members of the ExCom within 15 calendar days and they
shall be considered as accepted if no member has objected to the Coordinator against the minutes within 15 calendar days. 
 Composition. The ExCom
consists of the Coordinator, one representative of the PMT, as well as each WP leader. Thus, the ExCom consists of five members with various profiles and experience: public academics, SME and larger pharmaceutical company background, which will give
a well balanced diversity of approaches to the same issue. Additional Partners can be invited depending on the agenda of the meeting. The EE-ASI Coordinator chairs the ExCom for the duration of the Project; the Project Manager will act as
vice-chair. The Additional Partners being members of EE-ASI Project who are invited to attend in an advisory capacity to assist in discussions of agenda items. 
  

							
	 Partner no.
	  	 Short name
	  	 ExCom member
	  	 Leadership / expertise

				
	1	  	CU	  	Colin Dayan	  	Coordinator, leader of WP4, co-leader of WP1 & WP6
				
	2	  	IT	  	 Jerome

Weinbach
	  	Leader of WP1&WP6, management and business aspects
				
	3	  	MID	  	Jan Mous	  	SME rep., leader of WP2, nanoparticle design, synthesis and clinical grade manufacture; nanoparticle toxicology
				
	4	  	NPSS	  	Yotam Levin	  	Leader of WP3 for microneedle design, GMP manufacture and testing

 Meetings. The ExCom will meet at least every 6 months, but additional meetings via teleconference or videoconference
may be held if required. The Project Manager shall convene the meetings with a notice period of 30 calendar days, and send the agenda and any supporting relevant documentation to all Partners 15 days before the meeting. The ExCom is the main
decision-drafting entity and will prepare all the management decisions needed to keep the Project focused on its objectives. All such decisions will be submitted to the GA for discussion and final approval. 

 

	 	•	 	the Work Package Teams and Leaders (‘WPT’) 

 There are as many WPTs as Work Packages (WP)
defined in the project. 
 Role. The role of the WPT vis-à-vis the ExCom will be: 

 

	•	 	to present scientific and financial progress reports on the advancement of the WPs; 

  

	•	 	to make proposals on the allocation of WP tasks, financial needs among the contractors; 

  

	•	 	to draft and validate project deliverables of the WP to be submitted to the EC; 

  

	•	 	to identify potential risk within the WP; and 

  

	•	 	to inform the ExCom of any other difficulty arising in connection with the WP. 

 Composition. Each WPT
for the purposes of the governance provisions of this Agreement is composed of one member per Partner participating in the relevant WP (see part B2.4: resources). The WP Leaders of each WPT have already been defined. The WP leader will chair the
WPT. They are responsible for the overall follow-up of the concerned Work Package and will ensure an efficient communication within the WPT, including the organisation and funding (R&D cost) of WPT meetings when necessary. To ease the
coordination process within the WP, each collaborative task defined in the WP is led by a task leader who reports to the WP Leader. 

  
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 Meetings. The WPT shall convene meetings at least every 3 months via teleconference or at any time upon
written request of the WP Leader or any member of the WPT if need be. 
 2 – Management team: 

 

	 	•	 	The Coordinator is the legal entity acting as the intermediary between the Parties and the Commission. The Coordinator shall, in addition to its responsibilities as a Party, perform the coordination tasks
assigned to it as described in the EC-GA and this Consortium Agreement. 

  

	 	•	 	A Project Manager assists the General Assembly and the Coordinator. 

  

	 	•	 	An Business Plan Committee, dealing with IP issues and exploitation strategy regarding the Project. 

  

	 	6.1	Operational procedures applicable to all Consortium Bodies 

 6.1.1 Representation in meetings

 Any member of the Consortium Bodies should be present or represented at any of its meeting. A member may appoint a substitute or a proxy to attend and
vote at any meeting and shall participate in a cooperative manner in the meetings. 
 All of the members of the Consortium Bodies may grant a power of
attorney to one of the other members to represent them as proxies, with a limit of one (1) proxy per member. 
 6.1.2 Preparation and
organisation of meetings 
 6.1.2.1 CONVENING MEETINGS 

The chairperson of a Consortium Body shall convene meetings of that Consortium Body: 
  

	 	•	 	for the General Assembly: ordinary meeting shall be held once (1) a year; 

  

	 	•	 	for the ExCom: ordinary meeting shall be held at least twice (2) a year. 

 Extraordinary meetings shall be
held at any time upon written request of one-third (1/3) of the members of the related Consortium Body and upon written request of a (1) member in case of emergency. 

6.1.2.2 NOTICE OF A MEETING 

The chairperson of a Consortium Body shall give prior notice in writing of a meeting to each member of that Consortium Body as soon as possible and within at
least thirty (30) Days prior to the meeting date and, for the extraordinary meetings, within at least fifteen (15) Days prior to the meeting date. 

  
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 6.1.2.3 AGENDA 

The Coordinator shall prepare in writing the agenda to each member of the relevant Consortium Body and send it with all relevant and supporting documentation
when sending the notice of the meeting. 
 Any agenda item requiring a decision by such Consortium Body must be identified as such on the agenda. 

Adding agenda items: 
 Any member of a Consortium Body may
add an item to the original agenda by prior written notification to all of the other members of that Consortium Body within ten (10) Days. 
 However,
during a meeting the members of a Consortium Body present or represented can unanimously agree to add a new item to the original agenda. 
 6.1.2.4
DECISION WITHOUT MEETING 
 Meeting can also be held by teleconference or other telecommunication means.

 Any decision may also be taken without a meeting by circulating to all members a written document which is then signed by the defined majority of members
in compliance with Section 0 of this Consortium Agreement. 
 Decisions shall only be executed once the relevant part of the minutes is accepted according
to Section 0 of this Consortium Agreement. 
 6.1.3 Quorum and voting rules 

Each member of a Consortium Body present or represented in the meeting shall have one (1) vote. 

Decisions concerning the fact that a Party is a Defaulting Party shall be taken unanimously. But, for decisions relating to the default of a Party and the
consequences, the vote of such Party shall not be required nor counted. 
  

	 	•	 	Regarding the General Assembly and the Executive Committee: 

 The General Assembly or the ExCom shall
not validly deliberate and decide unless a quorum of 6/9 of the members of either the GA members or the ExCom members are present or represented. 

Decisions by the ExCom will normally be taken by consensus, but where this is not feasible the principle of majority voting of two thirds will apply.
Decisions may be taken via audio- or video-teleconferences, or during physical meetings. 
 In case the quorum is not met, the General Assembly or the ExCom
members will be convened once again within no more than fifteen (15) Days from this date, with the same agenda and may validly deliberate and make vote even in the absence of quorum. Then all decisions shall be taken by a majority of two-third
(2/3) of the votes unless otherwise provided for in this Consortium Agreement. 
  

	 	•	 	Regarding the Work Package Team: 

 There is no quorum condition. 

  
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 Decisions shall be taken by a majority of two-thirds (2/3) of the votes unless otherwise provided for in
this Consortium Agreement. 
 6.1.4 Veto rights 

A Party who can show that its own work, time for performance, costs, liabilities, intellectual property rights or other legitimate interests would be severely
affected by a decision of a Consortium Body may exercise a veto with respect to the corresponding decision or relevant part of the decision. 
 When the
decision is foreseen on the original agenda, a member may only veto such a decision during the meeting. 
 When a decision has been taken on a new item
added to the agenda before or during the meeting, a member may veto such decision during the meeting and within fifteen (15) Days after the validated minutes of the meeting are sent. 

In case of exercise of veto, the members of the related Consortium Body shall make every effort to resolve the matter which occasioned the veto to the general
satisfaction of all its members. 
 A Party may not veto decisions relating to its identification as a Defaulting Party. The Defaulting Party may not veto
decisions relating to its participation and termination in the Project or the consequences of them. 
 A Party requesting to leave the Consortium may not
veto decisions relating thereto. 
 6.1.5 Minutes of meetings 

The chairperson of the Consortium Body shall produce written minutes of each meeting which shall be the formal record of all decisions taken. He shall send the
draft to the voting members (present or represented) within thirty (30) Days for the GA and within fifteen (15) Days as from the meeting. 
 The
minutes shall be considered as accepted if, within thirty (15) Days for the GA and for the ExCom from the receiving date, no member has objected in writing to the chairperson with respect to the accuracy of the draft of the minutes. 

In case of a persistent objection the point subject to debate shall automatically be registered on the agenda of the next meeting. 

The accepted minutes shall be sent as soon as possible to all of the members of the ExCom and the Coordinator, who shall safeguard them. If requested the
Coordinator shall provide authenticated duplicates to Parties. 
 Decisions shall only be executed once the relevant part of the minutes is accepted. 

 

	 	6.2	Coordinator 

 The position of Coordinator is entrusted to Prof C Dayan, Partner 1, Cardiff University,
who is assisted by the PMT (Partner 2, IT) for all coordination and grant management related tasks as described in WP1. The Coordinator is the intermediary between the Beneficiaries and the European Commission. Furthermore, the Coordinator is
vigilant in ensuring that the WP leaders deliver on time. 

  
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 Role. The role of the Coordinator to be stated in the CA will be: 

Vis-à-vis the European Commission, the coordinator will: 
  

	•	 	communicate all information in connection with the Project to the EC; 

  

	•	 	timely distribute the EC pre-financing to the Partners in proportion of their planned budgets; 

  

	•	 	obtain Certification on Financial Statements (CFS) by the Beneficiaries when necessary; 

  

	•	 	prepare and submit periodic accounts and reports as requested by the EC; 

  

	•	 	be responsible for the administration, preparation of minutes and chairing the GA and the ExCom, and follow-up of their decisions; 

  

	•	 	submit any request of amendment of the grant agreement to the EC with accompanying documents. 

Vis-à-vis the other Partners, the Coordinator will: 
  

	•	 	assess with the ExCom the Project Deliverables based on the reports, the supporting documents and CFS provided by the Partners; and 

The Coordinator shall not be entitled to act or to make legally binding declarations on behalf of any other Party. The Coordinator shall not enlarge its role
beyond the tasks specified in this Consortium Agreement and in the EC-GA. 
  

	 	6.3	Project Manager 

 The position of Project Manager is entrusted to INSERM TRANSFERT, represented by Jerome
Weinbach, senior project manager assisted by Marie Clotteau, project manager. 
 The Project Manager will be responsible for implementing at
Consortium-level all activities linked to the management of the financial and legal issues, together with the co-ordination of the knowledge management and other innovation-related activities comprising those as stated in the IP Plan for
dissemination and use. The IP Plan being made available in a timely manner so as to ensure the Partners can consult with their relevant IP managers. The IP Plan will include inter alia provisions to cover those matters as outlined at
Section 6.4 of this Agreement 
 The Project Manager will oversee the promotion of gender equality within the Consortium. The Project Manager will work
in close liaison with the Coordinator and other Partners and members of various Work Package Teams of the Consortium to ensure that the objectives of the Project are timely fulfilled, so as to alert in due time the General Assembly in case of delay
to implement Contingency Plans. 
  

	 	6.4	Business Plan Committee (“BPC”) 

 a) Each Party shall appoint one (1) representative,
having specialised competence regarding intellectual property right. IPUC shall be chaired by Mrs Teresa Bowen (Beneficiary #1 / Cardiff University), LSF Senior Contracts Officer or Eryl Cox Technology Transfer Officer of Partner No 1 Cardiff
University. 
 b) It shall meet as often as necessary, when intellectual property issues arise. It shall also initiate and implement EE ASI Intellectual
Property procedures and good practices, this being the IP PLAN as referenced and required pursuant to ANNEX II SECTION 29 Point 2 namely an “ the plan for the use and dissemination of foreground” 

The IP Plan will have considerations as to provision for the following matters 
  

	 	•	 	extension of the time of one year as set out in Annex II Section 34 Point 4 

  

	 	•	 	options provisions for a Party(ies) to commercialise a Product and/or process for the benefit of all Parties, including provision for recognition of Parties, including financial recognition attributable to Parties.

  
 21/54 

 c) Apportionment of percentage ownership and also any interests in rights on commercialisation of the same shall
be attributed and attributable on fair and reasonable terms, having and giving consideration to a Party’s input to any Background and/or Foreground and/or Joint Foreground both during to the term of the Project and also as at the date of the
determination of the same in readiness for any commercialisation of any Product and/or process. 
 d) It is acknowledged by the Parties that it may be an
SME who takes forward any commercialisation of a Product, however any decision as to which Party shall take forward the commercialisation, shall be determined at the time of such proposed commercialisation and any such decision shall be made by the
Business Plan Committee, (as is required to be approved by the Commission) and shall be made on the basis, as to which Party is viewed as being the most appropriate and best Party at that time, to take forward any commercialisation, in the interests
of all the Parties. 

  
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	 	6.5	External advisory committees 

 6.5.1 Independent Advisory Board (“IAB”) 

Due to the nature of the Project, an independent consultative body specifically addressing commercial, ethical and regulatory issues will be constituted at the
very beginning of the Project. This Independent Advisory Board (IAB) will be composed of 6 members chosen for their recognised expertise, 2 being experts in ethical and regulatory issues: 

 

			
	 Name of the expert
	  	 Expertise and background

	 Dr. med. Thomas Danne
  

Ethics, Childhood and Adolescent Diabetes
	  	Thomas is the Director of the Department of General Paediatrics and Endocrinology / Diabetology at the Kinderkrankenhaus auf der Bult, Hannover Medical School, which is the largest paediatrics diabetes centre in Germany. His
research interests include basic and clinical research in paediatric diabetology with special emphasis on new insulins, glucose sensors and insulin pumps. Dr Danne has published over 70 peer-reviewed papers and has contributed to several books. He
is the past President of the International Society for Paediatric and Adolescent Diabetes (ISPAD) and a member of the IDF’s Consultative Section for Childhood and Adolescent Diabetes (CSCAD), and past conference President of the German Diabetes
Association (DDG).
		
	 Prof Nikolaus Romani
  

Dendritic cells immunology
	  	Associate Professor, Dep. of Dermatology & Venerology, Innsbruck Medical University, Austria, Nikolaus studied biology at the University of Innsbruck where he obtained his PhD in 1983. After two years at the Rockefeller
University in Ralph Steinman’s laboratory (1987-88) he - together with Gerold Schuler - helped to make Innsbruck one of the first “dendritic cell strongholds” in the Old World. He became Associate Professor in 1990 and has been
involved in dendritic cell research at the Department of Dermatology of “Innsbruck Medical University” ever since.
		
	 Dr Roland Dobbelaer
  

Vaccinology, Clinical Trials, GMP production. Regulatory affairs.
	  	Roland holds a PhD in Biochemistry. In mid 2007 he retired as Head of the Section for Biological Standardisation of the Scientific Institute of Public Health in Brussels, where he was responsible for the National Control Authority
Batch Release of vaccines and plasma derivatives operating in the EU Network of Official Medicines Control Laboratories. In this capacity, Roland advised the Belgian Medicines Agency. As a member of the EU CHMP Biologies Working Party, he also
advised the European Authorities in matters of licensing and regulation of biologicals. Between 2006 and 2008, Roland chaired the following committees: WHO Expert Committee on Biological Standardisation (ECBS), CHMP Vaccines Working Party,
Biological Standardisation Steering Committee of the European Directorate for the Quality of Medicines (EDQM), and the European Pharmacopoeia Expert Group N° 15 on vaccines.
		
	 Prof Berent Prakken
 Cellular immunology,
antigen-specific immunotherapy in humans
	  	Berent is professor of Paediatrics with a special interest in immunology at the UMC Utrecht, the Netherlands and at the Willhemina Children’s Hospital Utrecht. He is a paediatric rheumatologist and trained in research in the
Netherlands and UC San Diego. His laboratory was the first to demonstrate CD4/CD25/FOXP3+ regulatory T cells in human autoimmunity and in recent years he has focused on optimal targets, route and setting for immune intervention in human immune
mediated disease and the development of biomarkers and technology for the characterization of antigen-specific T cells in humans.
		
	Steve Reed – Product development	  	Steve is the Founder, President, and CSO of the Infectious Disease Research Institute (IDRI), Professor of Medicine at Cornell University Medical College in New York and Research Professor of Pathobiology at the University of
Washington as well as a member of the Vaccine Development Steering Committee of the World Health Organization. He joined the Seattle Biomedical Research Institute in 1984 where he worked until founding IDRI in 1993. In 1994 he co-founded Corixa
Corporation (which was later sold to GlaxoSmithKline, GSK) where he served as Chief Scientific Officer until leaving in 2004. He also founded Dharma Therapeutics, co-founded Immune Design Corp in 2008. He has more than 230 original publications and
105 issued patents on diagnostics, vaccines, and therapeutics of infectious diseases and cancer.
		
	Dr Richard Insel, Type 1 diabetes patient organisations.	  	Dick is Chief Scientific Officer for Juvenile Diabetes Research Foundation, the leading charity for supporting research into type 1 diabetes worldwide. At JDRF he has responsibility for heading up the strategic direction and
oversight of all JDRF research projects. Prior to joining JDRF in 2003, he held various leadership positions at the University of Rochester Medical Center during a 26-year tenure there. He was the scientific co-founder of Praxis Biologies, a
biotechnology company established in 1983 and subsequently acquired by Wyeth, the global pharmaceutical and health care products company. Praxis Biologies was responsible for bringing a new vaccine to market that resulted in the virtual elimination
of the most common form of childhood meningitis among American infants and children.

  
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 The IAB will consider the multidisciplinary nature of ethical, regulatory, technical and strategic (exploitation)
issues raised by our antigen-specific immunotherapeutic approach in Type 1 Diabetes and in particular the use of Enhanced Epidermal Antigen Delivery Systems. The IAB will facilitate compliance with ethical requirements by providing guidance on
ethics and regulatory issues. Moreover, these experts will be responsible for keeping the Project Partners well-informed about any new ethical regulations relevant to our project. Actions will be taken in order to increase researchers’
awareness of ethical issues. 
 The ultimate goal of EE-ASI is to integrate an antigen delivery system supported by cutting-edge technology, which will be
tested in a first Clinical Trials towards the end of the Project. Therefore, we have populated our IAB with experts who can provide information and guidance on regulatory issues during the developmental stages of such an innovative therapy. Contacts
with the EMA Innovation Task Force (ITF) will be established to facilitate informal exchange of information from the very onset of this Project. 
 The IAB
will attend annual consortium meetings including the kick-off meeting. In advance of the meeting, the consortium Partners will send relevant questions and comments to the IAB so that they can prepare the topics for discussion. The Advisory Board
will monitor the work performed and advise the ExCom when necessary. A report from the Advisory Board will be included in the intermediate and final Project reports. The Advisory Board will ensure that the research performed by the EE-ASI Partners
is in accordance with the recommendations of the European group of Ethics. Another task of the IAB will be to comment / advise on our business and dissemination plans, helping reaching out to the scientific community and to interested groups in
society (general public, patient associations, legislation etc.) and to stimulate a meaningful dialogue on this topic. 
  

	 	•	 	The Data Safety Monitoring Board (DSMB) 

 Role. The DSMB will provide independent, competent, and
timely review of the data quality and of safety of our Clinical Trials. In their composition, SOPs, and decision-making, DSMB will have appropriate independence from political, social, institutional, professional, and market influences. Their
governing rules will promote independence in decision-making vis-à-vis the Sponsor. 
 The DSMB will have no direct relation with the ethicists of
our IAB. However, all amendments and revisions that received a positive feedback from IAB will be submitted to the DSMB, whether or not related to recommendations of the DSMB. Site-specific amendments may require special treatment. 

Composition. The independent Data Safety Monitoring Boards set-up is the responsibility of the Sponsor. 

Meetings and reports. The DSMB will meet at regularly defined intervals via teleconference to review and evaluate the quality of data collected during
the Clinical Trials and assess reports on cumulated serious adverse events, as per the DMSB chart developed for the Clinical Trials and provide advices to the Trial Steering Committee. When requested, emergency reviews of data for safety –
related issues may be requested by the Sponsor. After the conclusion of the review, the DSMB will provide recommendations to the Trial SC regarding the ongoing scientific and ethical integrity of the Clinical Trials based on the data reviewed and
the progress reports of the Clinical Trials in reference to the Clinical Trials Protocol. 

  
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 SECTION 7 - FINANCIAL PROVISIONS 
  

	 	7.1	General Principles 

 7.1.1 Distribution of the Community Financial Contribution 

The Community Financial Contribution received from the Commission to the Project shall be distributed by the Coordinator according to: 

 

	 	•	 	the Consortium Budget (See Attachment 6 of this Consortium Agreement), 

  

	 	•	 	under the condition of the Commission approving the corresponding Deliverables, including periodic reports required by the EC-GA; 

  

	 	•	 	Section 7.3 of this Consortium Agreement. 

 7.1.2 Justifying Costs 

In accordance with its own usual accounting and management principles and practices, each Party shall be solely responsible for justifying its costs with
respect to the Project towards the Commission. Neither the Coordinator nor any of the other Parties shall be in any way liable or responsible for such justification of costs towards the Commission. 

7.1.3 Funding principles 
 A Party that spends less
than its allocated share of the Consortium Budget will be funded from the Community Financial Contribution in accordance with its actual duly justified eligible costs only. A Party that spends more than its allocated share of the Consortium Budget
will be funded from the Community Financial Contribution only in respect of duly justified eligible costs up to an amount not exceeding that share. No other Party shall be liable for any costs of a Party, exceeding that Party’s budgeting of
such cost. 
 7.1.4 Financial Consequences for a leaving Party 

A Party leaving the Consortium shall refund all advance payments received except the amount of expended eligible costs accepted by the Commission. 

Furthermore a Defaulting Party shall, within the limits specified in Section 5.2 of this Consortium Agreement, bear any additional costs incurred by the
other Parties in order to perform the Defaulting Party’s incomplete tasks under the Work Plan. 
 7.1.5 Clinical Trials valuation 

In the course of the Project, the Sponsor shall valuate the Clinical Trials effective costs. With respect of the amounts identified, the Executive Committee
shall prepare and submit a Clinical Trials budget plan proposal to the General Assembly for its approval. For the avoidance of doubt, the Clinical Trials shall not start if the full financial covering is not ensured ie provided for. 

  
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	 	7.2	Budgeting 

 All resources made available for the Project shall be valued in accordance with the usual
accounting and management principles and practices of the respective Parties and shall be included in the Consortium Budget. 
  

	 	7.3	Payments 

 Payments to Parties from the Community Financial Contribution are the exclusive Allocated Work
of the Coordinator. In particular, the Coordinator shall: 
  

	 	•	 	notify the Party concerned promptly of the date and of the amount transferred to its bank account, giving the relevant references 

  

	 	•	 	perform diligently its Allocated Work in the proper administration of Community Financial Contribution 

 All
payments shall be made without undue delay by the Coordinator after receipt of Community Financial Contribution from the Commission in accordance with the accepted decisions of the General Assembly, which includes the payment schedule. 

The Coordinator is entitled to withhold any advances due to a Defaulting Party. The Coordinator is entitled to recover any advances already paid to a
Defaulting Party. 
 SECTION 8 - FOREGROUND 
 EC-GA
Article II.26. to Article II.29. shall apply to Foreground with the following additions: 
  

	 	8.1	Joint ownership 

 8.1.1 Principle 

a) According to Article II 26.2 of the EC-GA, but subject to the provisions of Clause 8.1.1 d) and Clause 8.1.1. e) and Clause 8.1.1 f) below, in case of joint
ownership of Foreground (“the Joint Foreground”) and when no joint ownership agreement (“the Intellectual Property Plan” as per Annex II Section 29 Point 2) has been concluded yet, each of the joint owners (“the
Joint Owner(s)”) shall with written consent be entitled to use the Joint Foreground as it sees fit, and to grant non-exclusive licenses to third parties under market conditions, without any right to sublicense, subject to the following
conditions: 
  

	 	•	 	at least forty-five (45) Days prior notice must be given to the other joint owner(s); (as per Annex II Section 30 Point 3 and Annex II Section 27 Point 2 

 

	 	•	 	and fair and reasonable compensation must be provided to the other joint owner(s). 

 b) The joint ownership
agreement, namely the IP Plan, pursuant to Annex II Section 2 Point 1 which must be concluded as soon as possible and at the latter upon the expiry date or the termination date of the Project, shall clearly state a fair and reasonable compensation
of the other Joint Owner(s). 

  
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 c) In any case the Joint Owners shall freely utilise the Joint Foreground for internal research activities, up to
and including preclinical studies, on a royalty free basis and without the prior consent of the other Joint Owners. 
 d) Foreground in the Trial Data Set
and the Composite IMP Device is deemed to be Joint Foreground owned by all the Parties and any ownership share shall be in accordance with a Party’s contribution in respect of the same and as reflected in the IP Plan. 

e) The Parties hereby agree that there shall be no ‘use’ of any Foreground and/or Joint Foreground, in terms of the marketing and/or
commercialisation of the Composite IMP Device or any process relating thereto, until Deliverable 5.5 has been prepared, reviewed and approved by the Parties, following which the Parties shall meet in order to agree how to implement the IP Plan in
respect of the Composite IMP Device. 
 f) The Parties hereby agree that there should be no ‘use’ of any Material, Data, Foreground and/or
Joint Foreground in terms of the marketing and/or commercialisation of the same, if such marketing and/or commercialisation of the same, would prejudice the integrity and/or efficacy of the Clinical Trials during the conduct of the Clinical Trials
and/or the production of any report of the Clinical Trials under DEL 5.1 DEL 5.2 and/or DEL 5.3. 
 g) In circumstances where a Party leaves the Consortium
or a Party’s involvement in the Project is terminated pursuant to Annex II Section 36, Annex II Section 37 and/or Annex II Section 38, the Parties recognise that pursuant to Clause 8.8.2.2, the leaving Party is required to grant
Access Rights to other Parties for the remainder of the Project, however the leaving Party shall (notwithstanding the provisions of Annex II Section 34 Paragraph 4) ensure prior to the end date of their participation, that the Access Rights as
provided for pursuant to Annex II Section 33 Paragraph 1 and Paragraph 2 and Section 34 Paragraph 1 and Paragraph 2 thereof, shall be granted to any relevant Party. 

h) In circumstances where a Party leaves the Consortium or a Party’s involvement in the Project is terminated pursuant to Annex II Section 36, Annex
II Section 37 and/or Annex II Section 38, the Parties recognise that pursuant to Clause 8.8.2.2, the leaving Party is required to grant Access Rights to other Parties for the remainder of the Project. The Parties acknowledge however that
the leaving Party, pursuant to Section 9 Clause 9.8.2.1.2 and Clause 9.8.2.1.1, no longer has the benefit of Access Rights to Foreground, accordingly where the leaving Party is a Joint Owner to Joint Foreground at the date of leaving, then the
leaving Party shall ensure, prior to end date of their participation in the Consortium and in circumstances where there is no transfer of Joint Foreground under Annex II Section 27, that the leaving Party’s interest in such Joint
Foreground is effectively assigned to the other Joint Owner(s) of such Joint Foreground and this request shall be deemed to be included in the provisions of Annex II Section 36 Paragraph 6. It would not necessarily follow however, as a
consequence that a leaving Party would not benefit under any IP Plan but it might be that a defaulting Party might not be viewed as being due a benefit under the IP Plan. 

i) In circumstances where a Party, who is the owner of Joint Foreground, intends to transfer it interest in such Joint Foreground, pursuant to Annex II
Section 27 Paragraph 1, then the transferring Party shall provide at least 45 days notice to the other Parties of the envisaged transfer. Following such notification, any other Joint Owner of the Joint Foreground may object within 30 days of the
notification or such other time limit as agreed in writing, to any envisaged transfer of ownership on the grounds that such transfer of Joint Foreground may adversely affect the commercial interests of other Joint Owners of such Joint Foreground or
such transfer is inconsistent with the IP Plan and the Parties shall met to agree how such Joint Foreground shall be protected and the commercial interests of all Joint Owners of Joint Foreground can be protected and/or is in accordance with any IP
Plan in place. 

  
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 j) For the avoidance of doubt Access Rights are still granted to a leaving Party until date of leaving but
not to a Defaulting Party whose contract has been terminated this is in accordance with Clause 9.8.2.1 below. “Access Rights” are as defined in Annex II Section 1. 

k) For the avoidance of doubt it is provided for under Annex II Section 33 that Access Rights to Foreground and Background shall be granted on a royalty
free basis to the other Parties if needed for the Project. 
 I) Under Annex II Section 34 where Access Rights are needed by a Party in order to
use their own Foreground or Background then such Access Rights are granted on a royalty free basis or under fair and reasonable conditions. Where Annex II Section 1 defines “use” as the “direct’ or indirect
utilisation of Foreground inter alia for “....developing, creating and marketing a product or process...” 
 m) It is recognised by the
Parties that the time limit of one year as stated at Annex II Section 33 will required to be extended in order to accommodate the requirements of the Project and therefore an extension of time to the one year provided in Annex II
Section 33 shall be extended and shall be discussed and agreed and provided for in the IP Plan 
 n) If a Party leaves the Consortium and terminates
their participation in this Agreement ie. the leaving Party then their percentage share of Foreground and/or Joint Foreground shall be and shall remain that as it stands at the date of the leaving Party leaving. Accordingly, if any new Foreground
and/or Joint Foreground is developed after the leaving Party has left then this will logically involve the dilution of the leaving Party’s original share. Any commercial rights including any royalty share or otherwise, attributable to the
Foreground and/or Joint Foreground at the time of commercialisation of the Foreground and/or Joint Foreground, shall be attributed on a fair and reasonable basis and on terms appropriate to both 1) the Parties remaining at the time of
commercialisation and 2) also to a leaving Party’s Background and Foreground input up to the date of the leaving. No reach through rights to Foreground and/or Joint Foreground going forward, shall be granted to a leaving Party and accordingly
therefore a leaving Party’s proportionate entitlement to Foreground and/or Joint Foreground shall not increase after the leaving Party has left. 

8.1.2 Clinical Database 
 a) The Clinical Database
to be delivered under Annex I of the EC-GA (DEL 5.3) shall be the Joint Foreground jointly owned by the Parties. The Sponsor and the Coordinator shall agree as to where the Clinical database is to be located and who shall provide the Clinical
Database, together with the provision of any specification, testing and approval of the same, prior to the commencement of the Clinical Trial. 
 b) The
Parties agree that the ExC shall administrate this Clinical Database on behalf of the Parties during the Project. This will be set out in the IP Plan to be concluded, as well as the appointment of the final administrator for the maintenance of the
Clinical Database for regulatory purposes (it may be that the final administrator is also the final recipient of any Data and/or Material of the Project and/or the final administrator of the Subject Samples and Subject Data and it shall be agreed as
between the Sponsor and the Coordinator as to whom the final administrator shall be and the Access Rights conditions stated in 9 below. 
 c) Neither the
Sponsor, nor the CI of any Clinical Trials, would have access to the Clinical Database during the currency of the Clinical Trials and all analysis of any Trial Data would be accessed by and any analysis thereof would be conducted by the Project
statistician and presentation of the same to the DSMB. It is then from this that the report pursuant to DEL5.3 would be prepared for regulatory purposes. 

  
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 d) If and where a Party is to sub-contract the commissioning, running, collation of data and management of the
Clinical Database to a named sub-contractor during the period of the Clinical Trials then any sub-contact shall state that the Clinical Database is to be owned by the Party under this Agreement (‘the Contractor’) and the Clinical Database
is held by the Contractor under the sub-contract agreement for the joint benefit and ownership of the Contractor and all the Parties to this Agreement. A Party shall at all times remain responsible for the act and/or omissions of it sub-contractor.

 e) If and where a Party is to sub-contract any part of their respective Work Package, then any sub-contact shall state that the sub-contracted work is to
be owned by the Party under this Agreement (‘the Contractor’) and the subcontracted work is held by the Contractor under the sub-contract agreement for the joint benefit and ownership of the Contractor and all the Parties to this
Agreement. A Party shall at all times remain responsible for the act and/or omissions of it sub-contractor. 
  

	 	8.2	Transfer of Foreground 

 a) Each Party may transfer ownership of its own Foreground, in all or in part,
following the procedures of the EC-GA Article II 27 during the Consortium Agreement. 
 b) It may identify specific third parties it intends to transfer
ownership of Foreground to in Attachment 4 (“list of the third parties for the execution of Section 8.2”) here enclosed to this Consortium Agreement. Any further modification of this Attachment shall be valid after
unanimous and favourable decision of the General Assembly, as set forth in Section 6 
 c) The other Parties hereby waive their right to object to a
transfer to listed third parties according to the EC-GA Article II.27.3. 
 d) The transferring Party shall, however, notify the other Parties of such
transfer and shall be responsible for ensuring that the rights of the other Parties will not be affected by such transfer. Any addition to Attachment (4) after signature of this Consortium Agreement requires a decision of the General Assembly.

 e) The Parties recognize that in the framework of a merger or an acquisition of an important part of its assets, a Party may be subject to
confidentiality obligations which prevent it from giving the full forty five (45) Days prior notice foreseen in EC-GA Article II 27.2. Notwithstanding the foregoing sentence, a Party shall always give not less than fourteen (14) Days prior
notice to the other Parties. 
  

	 	8.3	Dissemination 

 8.3.1 Publication 

Dissemination activities including but not limited to publications and presentations shall be governed by Article II.30 of the EC-GA. 

All Parties publishing on the EE-ASI project and their Foreground shall use as often as possible the EE ASI logo and graphical chart adopted by the
General Assembly at the start of the Project. Furthermore, all Parties shall acknowledge the EC support in these publications using the following sentence: 

  
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 This work is part of the EE ASI programme (Collaborative Project) supported by the European

 Commission under the Health Cooperation Work Programme of the 7th Framework Programme 

(Grant agreement n° 305305-2). 

The Parties acknowledge their common interest in publishing Foreground to obtain recognition within the scientific community and to advance the state of
scientific knowledge in their scientific field. The Parties also recognize their common interest in obtaining valid intellectual property protection and in protecting business interests. 

It is contemplated that the Foreground will jointly be published whenever applicable, notably in the respect for the fact that one such Foreground is
jointly-owned; however, the Parties each separately reserve the right to publish their own Foreground and Background. Authorship on joint publications will be based on academic standards and custom. 

The Party(ies) wishing to make a Publication or communication will provide a copy of such proposed abstract or publication manuscript (and a reasonably
detailed description of any such oral presentation or other public disclosure) to the other Parties, at least forty-five (45) days prior to the proposed date of submission of the publication to an editor: or communication. 

Following the above notification, a Party may object within thirty (30) Days to the proposed publication or communication if it considers that its
legitimate interests in relation its Foreground or Background could suffer disproportionately great harm. A Party may comment upon, but may not change, the conclusions of any such publication or communication. Each Party is entitled to demand that
its Confidential Information, Background and/or Foreground be deleted from any such publication or communication, or to delay disclosure if the information contained in the proposed publication or communication is the subject of intellectual
property protection. 
 In the event a dispute arises over a proposed publication or communication that cannot be settled amicably within two
(2) calendar months, the General Assembly shall mediate on the issue. If such dispute cannot be resolved for a further one (1) month, the Parties concerned shall be entitled to settle the dispute in accordance to Section 11.8 of this
Consortium Agreement. 
 Provided that all reasonable modifications have been implemented, none of the Parties concerned may withhold its consent to
publication or communication for a period longer than four (4) months from the date such publication or communication was first notified to the Parties. 

8.3.2 Publication of another Party’s Foreground or Background 

For the avoidance of doubt, a Party may not publish Foreground or Background of another Party, even if such Foreground or Background is amalgamated
with the Party’s Foreground, without the other Party’s prior written approval. 
 8.3.3 Thesis 

Notwithstanding the confidentiality and publication provisions, the Parties undertake to cooperate to allow the timely submission, examination, publication and
defence of any dissertation or thesis for a degree which includes their Foreground or Background. 
 8.3.4 Use of names, logos or
trademarks 
 In accordance with scientific customs, the Party’s contributions will be expressly reflected in all written or oral public disclosures
concerning Foreground by acknowledgment or co-authorship, as appropriate. An appropriate reference to the Community support must be included in all such disclosures and publications in accordance with the provision of Article II.30 of the EC-GA.

  
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 Notwithstanding the above, nothing in this Consortium Agreement shall be construed as conferring rights to use in
advertising, publicity or otherwise the name of the Parties or any of their logos or trademarks without their prior written approval. 
 SECTION 9 -
ACCESS RIGHTS 
  

	 	9.1	Background covered 

 a) In accordance with the provision of Article II.31 of the EC-GA, the Parties may
identify in the Attachment 2 the Needed Background to which they are ready to grant Access Rights, subject to the Sections of this Consortium Agreement and the EC-GA. Such identification may also be done by naming a specific department of a
Party. When including a part of Background to Attachment 2, the Party shall mention any existing or intended limitation to the relevant Access Right. 
 b)
The owning Party may add further Background to Attachment 2 during the Project by written notice to the General Assembly. For the avoidance of doubt, the owner is under no obligation to agree to addition to his Background to Attachment 2. 

c) addition, if a Party wishes to exclude specific Background, it shall also list such Background in the Attachment 2. 

d) In case a Party decides to withdraw included Background, and subject to the conditions stated in Section 9.4 and 9.5 above, the Party concerned shall
give written notice to the General Assembly. For avoidance of doubt in any case this withdrawal should not impair the implementation of the Project. 
 The
Parties shall remain owners of their Background. 
  

	 	9.2	Sideground generated 

 a) Ownership of Sideground belongs to the Party or the Parties who generated it.

 b) For the avoidance of doubt Sideground in the Nanopass Device and/or the Midatech Product and/or the IMP System shall belong to the Party who owns the
Background in respect of the same 
 c) For the further avoidance of doubt the Foreground in the MidaIMP System and the Composite IMP Device shall not be
Sideground but shall be Joint Foreground and shall be held in accordance with and pursuant to the IP Plan, which shall reflect the respective Parties, original contributions and input in respect of the same. 

 

	 	9.3	General Principles 

 a) Each Party shall bear sole responsibility for ensuring that its activities within
the Project do not knowingly infringe third party’s property rights. 

  
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 b) As provided in the EC-GA Article II.32.3. Parties shall inform the Consortium as soon as possible of any
limitation to the granting of Access Rights to Background or of any other restriction which might substantially affect the granting of Access Rights. Such limitation shall be mentioned in Attachment 2 with respect to the relevant Background. 

c) Access Rights granted under this Project expressly exclude any entitlement to grant sublicense unless expressly stated otherwise by the owning Party of the
Foreground or the Background. 
 d) All Access Rights shall be granted upon written request showing that the Access Rights are Needed. 

e) The granting of Access Rights may be made conditional on the acceptance of specific conditions aimed at ensuring that these Access Rights will be used only
for the intended purpose and that appropriate confidentiality obligations are in place. 
  

	 	9.4	Access Rights for implementation of the Project 

 Access Rights to Foreground and Background Needed by a
Party for the execution of its own Allocated Work under the Project shall be granted on a royalty-free basis. 
  

	 	9.5	Access Rights for Use 

 a) Access Rights to Foreground Needed by a Party for Use of its own Foreground
including for Use for third-party research shall be granted on fair and reasonable conditions. 
 b) A third party shall not be granted direct access to
Foreground or Sideground generated by other Parties unless those Parties explicitly agree to it. 
 c) Access Rights to Foreground for internal research
purposes, excluding research activities involving third parties and excluding activities with a commercial purpose, shall be granted on a royalty-free basis. 

d) Access Rights to Background Needed by a Party for Use of its own Foreground shall be granted on fair and reasonable conditions. 

 

	 	9.6	Access Rights for Affiliated Entities 

 a) Affiliated Entities, listed in Attachment 3 below have
Access Rights under the conditions of the EC-GA Article II.34.3. 
 b) Such Access Rights to Affiliated Entities shall be granted on fair and reasonable
conditions and upon written bilateral agreement. 
 c) Affiliated Entities which obtain Access Rights in return grant Access Rights to all Parties and
fulfil all confidentiality and other obligations accepted by the Parties under the EC-GA or this Consortium Agreement as if such Affiliated Entities were Parties. 

d) Access Rights may be refused to Affiliate Entities if such granting is contrary to the legitimate interests of the Party which owns the Background or the
Foreground. 

  
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 e) Access Rights granted to any Affiliated Entity are subject to the continuation of the Access Rights of the
Party to which it is affiliated and shall automatically terminate upon termination of the Access Rights granted to such Party. 
 f) Upon cessation of the
status as an Affiliated Entity, any Access Rights granted to such former Affiliated Entity shall lapse. Further arrangements with Affiliated Entities may be negotiated in separate agreements. 

 

	 	9.7	Additional Access Rights 

 For the avoidance of doubt any grant of Access Rights not covered by this
Consortium Agreement shall be at the absolute discretion of the owning Party and subject to such terms and conditions as may be agreed between the owning and receiving Parties. 

 

	 	9.8	Access Rights for Parties entering or leaving the Consortium 

 9.8.1 New Parties entering the
Consortium 
 All Foreground developed before the accession of the new Party shall be considered to be Background with regard to said new Party. 

9.8.2 Parties leaving the Consortium 
 9.8.2.1
ACCESS RIGHTS GRANTED TO A LEAVING PARTY 

9.8.2.1.1 Defaulting Party 
 Access Rights granted to a
Defaulting Party and such Party’s right to request Access Rights shall cease immediately upon receipt by the Defaulting Party of the formal notice of the decision of the General Assembly to terminate its participation in the Consortium. 

9.8.2.1.2 Non-defaulting Party 
 A Party leaving
voluntarily the Project with the other Parties’ consent shall have Access Rights to the Foreground developed until the effective date of the termination of its participation. The time limit for its right to request these Access Rights shall
start on the same date. 
 9.8.2.2 ACCESS RIGHTS TO BE GRANTED
BY ANY LEAVING PARTY 
 Any Party leaving the Project shall continue to grant Access Rights
pursuant to the EC-GA and this Consortium Agreement as if it had remained a Party for the whole duration of the Project. 
  

	 	9.9	Specific Provisions for Access Rights to Software 

 a) For the avoidance of doubt, the general Sections
for Access Rights provided for in this 0 are applicable also to Software. Parties’ Access Rights to Software do not include any right to receive source code or object code ported to a certain hardware platform or any right to receive respective
Software documentation in any particular form or detail, but only as available from the Party granting the Access Rights. 

  
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	 	9.10	Specific Provisions for Access Rights to the Clinical Database 

 b) For the avoidance of doubt, the
general provisions for Access Rights are applicable also to the Clinical Database. 
 c) Each Party, even the joint owners, shall have Access Rights to data
related to its own country in the Clinical Database, under the terms and conditions provided for in this 0 (from sect 9.1 to sect 9.7, included). 
 d) Any
additional duly requested Access Right shall be submitted to the prior agreement of the Coordinator and the Executive Committee, during the Project and shall be submitted to the prior agreement of Cardiff University and the joint owners after the
end of the Project. 
 SECTION 10 - NON DISCLOSURE OF INFORMATION 

a) All information in whatever form or mode of transmission, which is disclosed by a Party (the “Disclosing Party”) to any other Party (the
“Recipient”) in connection with the Project during its implementation and which has been explicitly marked as “CONFIDENTIAL”, or when disclosed orally, has been identified as confidential at the time of disclosure and has
been confirmed and designated in writing within fifteen (15) Days at the latest as confidential information by the Disclosing Party, is “Confidential Information”. 

b) The Recipients hereby undertake in addition and without prejudice to any commitment of non-disclosure under the EC-GA, for a period of five (5) years
after the termination or the expiry of the Project: 
  

	 	•	 	not to use Confidential Information otherwise than for the purpose for which it was disclosed; 

  

	 	•	 	not to disclose Confidential Information to any third party without the prior written consent by the Disclosing Party; 

  

	 	•	 	to ensure that internal distribution of Confidential Information takes place on a strict need-to-know basis; and 

  

	 	•	 	to return to the Disclosing Party on demand all Confidential Information which has been supplied to the Recipients including all copies thereof and to delete all information stored in a machine readable form. If needed
for recording the Recipients may however keep a copy for archival purposes only. 

 c) The Recipients shall be responsible for the fulfilment
of the above obligations on the part of their employees and shall ensure that their employees remain so obliged, as far as legally possible, during and after the end of the Project and/or after the termination of employment. 

The above shall not apply to information, if and in so far as the Recipient can prove that said information: 

 

	 	•	 	has become publicly available by means other than a breach of the Recipient’s confidentiality obligations; or 

  

	 	•	 	is communicated to the Recipient without any obligation of confidence by a third party who is in lawful possession thereof and under no obligation of confidence to the Disclosing Party; or 

 

	 	•	 	the disclosure or communication of which is foreseen by provisions of the EC-GA; or 

  

	 	•	 	is developed by the Recipient independently of any such disclosure by the Disclosing Party; or 

  

	 	•	 	was already known to the Recipient prior to disclosure. 

  
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 d) The Recipient shall apply the same degree of care with regard to the Confidential Information disclosed within
the scope of the Project as with its own confidential and/or proprietary information, but in no case less than reasonable care. 
 e) Each Party shall
promptly advise the other Party in writing of any unauthorised disclosure, misappropriation or misuse by any person of Confidential Information as soon as practicable after it becomes aware of such unauthorised disclosure, misappropriation or
misuse. 
 f) If any Party becomes aware that it will be required, or is likely to be required, to disclose Confidential Information in order to comply with
applicable laws or regulations or with a court or administrative order, it shall, to the extent it is lawfully able to do so, prior to any such disclosure 
  

	 	•	 	notify the Disclosing Party, and 

  

	 	•	 	and comply with the Disclosing Party’s reasonable instructions to protect the confidentiality of the information. 

g) However, disclosures due to national laws, national regulations or national court order can never constitute a breach of this Agreement. A Party is not
liable for such disclosure. 
 h) The confidentiality obligations under this Consortium Agreement and the EC-GA shall not prevent the communication of
Confidential Information to the Commission. 
 SECTION 11 - MISCELLANEOUS 
  

	 	11.1	Inconsistencies and severability 

 This Consortium Agreement consists of this body text and: 

 

	 	•	 	Attachment 1 – “Consortium Agreement Accession Document” 

  

	 	•	 	Attachment 2 – “List of respective included/excluded Background” 

  

	 	•	 	Attachment 3 – “List of Affiliated Entities” 

  

	 	•	 	Attachment 4 – “List of Third Parties for execution of Section 8.2” 

  

	 	•	 	Attachment 5 – “Agreement for Material Transfer” 

 In case this Consortium Agreement is
in conflict with the EC-GA, the terms of the latter shall prevail. 
 Should any provision of this Consortium Agreement become invalid, illegal or
unenforceable, it shall not affect the validity of the remaining provisions of this Consortium Agreement. In such a case, the Parties concerned shall be entitled to request that a valid and practicable provision be negotiated which fulfils the
purpose of the original Section. 

  
 35/54 

	 	11.2	No representation, partnership or agency 

 The Parties shall not be entitled to act or to make legally
binding declarations on behalf of any other Party. 
 Nothing in this Consortium Agreement shall be deemed to constitute a joint venture, agency,
partnership, interest grouping or any other kind of formal business grouping or entity between the Parties. 
  

	 	11.3	Notices and other communication 

 Any notice to be given under this Consortium Agreement shall be in
writing to the addresses and recipients as listed in the most current address list kept by the Coordinator. 
 Formal notices: If it is required in
this Consortium Agreement (Section 0 and Section 0) that a formal notice, consent or approval shall be given, such notice shall be signed by an authorised representative of a Party and shall either be served personally or sent by mail with recorded
delivery or telefax with receipt acknowledgement. 
 Other communication: Other communication between the Parties may also be effected by other means
such as e- mail with acknowledgement of receipt (e.g. minutes). 
 Any change of persons or contact details shall be notified immediately by the respective
Party to the Coordinator. The address list shall be accessible to all concerned. 
  

	 	11.4	Assignment and amendments 

 No rights or obligations of the Parties arising from this Consortium
Agreement may be assigned or transferred, in whole or in part, to any third party without the other Parties’ prior formal approval. 
 Amendments and
modifications to the text of this Consortium Agreement not explicitly listed in Section 11 require a prior written and separate agreement signed by all the Parties. 
  

	 	11.5	Mandatory statutory law 

 Nothing in this Consortium Agreement shall be deemed to require a Party to
breach any mandatory statutory law under which the Party is operating. 
  

	 	11.6	Language 

 This Consortium Agreement is drawn up in English, which language shall govern all documents,
notices, meetings, arbitral awards and processes relative thereto. 
  

	 	11.7	Applicable law 

 This Consortium Agreement shall be construed in accordance with and governed by the same
laws of that of the EC-GA: the Belgian law. 

  
 36/54 

	 	11.8	Settlement of disputes 

 All disputes arising out of or in connection with this Consortium Agreement,
which cannot be solved amicably, shall 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. 

The place of arbitration shall be Brussels (Belgium) if not otherwise agreed by the conflicting Parties. 

The award of the arbitration will be final and binding upon the Parties. 

Nothing in this Consortium Agreement shall limit the Parties’ right to seek injunctive relief or to enforce an arbitration award in any applicable
competent court of law. 
 SECTION 12 - SIGNATURE 

AS WITNESS: 
 Consortium Agreement for EE-ASI (EC-GA
No. 305305-2) Final Version Dated 13th day of JULY 2012 
 The Parties have caused this
Consortium Agreement to be duly signed by the undersigned authorised representatives in the day and year first above written. 
  

 
 Space intentionally left blank
– See the signatures on the following pages 

  
 37/54 

 « EE ASI » Project: 

 

					
	Cardiff University CU	  	
		
	 /s/ Geraint W. Jones
	 	
		
	Name / Position	 	Geraint W. Jones / Director of Research and Commercial Division

  
 38/54 

 « EE ASI » Project: 

 

							
	 INSERM-Transfert SA

 
  

/s/ Cécile THARAUD
	  	IT	  	 INSERM TRANSFERT

7 rue Watt - 75013 PARIS

Tél. : 01 55 03 01 00
 Fax :
01 55 03 01 60
	  	
				
	Name / Position	  	Cécile THARAUD / CEO	  	 SA au capital de 9 573 470 €      

SIRET 434 033 619 00025 - APE 731Z
	  	

  
 38/53 

 « EE ASI » Project: 

 

			
	Midatech Group Ltd, UK	  	MID
		
	Name / Position	  	Stephane Jallat Chief Financial Officer
		
	 /s/ Stephane Jallat
	  	
		
		  	13/07/2012

  
 40/54 

 « EE ASI » Project: 

 

					
	Nanopass Technologies	  	NPSS	  	
			
	Name / Position	  	Yotam Levin / CEO	  	
			
		  	 /s/ Yotam Levin
	  	
			
		  	 NanoPass Technologies Ltd.
 P.C.O.
512936212
	  	

  
 40/53 

 « EE ASI » Project: 

 

					
	Leiden University Medical Center	  	LUMC	  	
		
	 /s/ DRS. G.E. de Blécourt

Name / Position
	  	Drs. G.E. de Blécourt / Managing director Division 4
		
		  	 Mw. drs. G. E. de Blécourt

Managing Director Division 4
 Leiden University Medical
Center

  
 41/53 

 « EE ASI » Project: 

 

					
	King’s College London	  	KCL	  	
			
	 /s/ Paul Labbett
	  		  	
		
	Name / Position	  	Paul Labbett

  

			
	  
  

Paul Labbett
  

Director of Research Grants & Contracts
  

King’s College London
	  	

  
 42/54 

 « EE ASI » Project: 

 

			
	Institut National de la Santé et de la Recherche Médicale	  	Inserm

					
		
	Name / Position	  	Dominique Nobile / Directeur Délégué Régional

					
			
	 /s/ Dominique Nobile
	  	 Dominique Nobile

Délégué Régional Inserm

Provence-Alpes-Côte d’Azur

et Corse
	  	

  
 42/52 

 « EE ASI » Project: 

 

			
	Linkoping University	  	LiU
		
	 /s/ Curt Karlsson
	  	
		
	Name / Position	  	Curt Karlsson / Authorized representative

  
 45/54 

 ATTACHMENT 1: CONSORTIUM AGREEMENT ACCESSION DOCUMENT 

of a new Party to EE ASI Consortium Agreement, version [..., YYYY-MM-DD] (EC-GA n°305305-2). 

[OFFICIAL NAME OF THE NEW PARTY AS IDENTIFIED IN THE EC-GA] hereby consents to become a Party to the Consortium Agreement identified above and accepts
all the rights and obligations of a Party starting [date]. 
 Cardiff University (CU), 

hereby certifies that the Consortium has accepted in the meeting held on [date] the accession of [the name of the new Party] to the Consortium starting [date].

 This Accession document has been done into two (2) originals to be duly signed by the undersigned authorised representatives. 

 

					
	[Date and Place]	 		 	[Date and Place]
			
	[INSERT NAME OF THE NEW PARTY]	 		 	Cardiff University
			
	Signature(s)	 		 	Signature(s)
			
	Name(s)	 		 	Name(s)
			
	Title(s)	 		 	Title(s)

  
 46/54 

 Participating organisation #1 
  

			
	Organisation legal name	  	Cardiff University
	Organisation short name	  	CU

 Included: 

Professor Colin Dayan and identified members of the EE-ASI research group at CU have the expertise to conduct the research and the clinical studies including
in the areas as identified and set out in the relevant and appropriate Work Packages as detailed in EE-ASI Annex I Part B. 
 Accordingly for the purpose of
CU’s description of Background to be included under the Project, CU shall only grant Access Rights to such of its Background which CU considers and identifies as being necessary and appropriate to be introduced for the Project, for the purposes
only of CU’s performance in relation to the relevant to the Allocated Work to be undertaken by CU and/or relevant to the Allocated Work under Work Packages of the other Parties as described in Annex 1 of the EC-GA and where, in respect of such
Background, CU is free to provide such Access Rights to such Background and in respect of which CU shall, at all times, in its own discretion decide. Subject to the above, CU grants Access Rights to its Background which has been developed and/or
generated and/or acquired by Professor Dayan and his research group in relation to the specific Allocated Work under Work Packages in Annex 1 Part B, where such Background is required for the purposes only of relying on such Background for
the development of Foreground and/or Joint Foreground under the Project and/or under the provisions of Section 4.1 of the Consortium Agreement, where CU as a Party is required to provide in due time all information reasonably required by the
Consortium Body or by the Coordinator to carry out its Allocated Work under the Project. 
 Included Background at the time of entering in to the Consortium
Agreement shall be for: 
  

	 	1.	the Testing system for micro-needles in relation only to where such work has been conducted exclusively with Nanopass micro-needles in ex-vivo live human tissue models, pursuant to ethical approvals; 

 

	 	2.	necessary formulation and developmental work for the use of micro-needle systems based on ex-vivo live human tissue modelling; 

  

	 	3.	Results from the pre-application testing of laboratory work with Nanopass but only where such results were used for the purposes of validation of submission of the Grant Application in respect of the EE-ASI Project to
the Commission (but excluding any intellectual property in the Nanopass Device used to obtain those results); 

  

	 	4.	Results from the pre-application testing of laboratory work with Midatech but only where such results were used for the purposes of validation of submission of the Grant Application in respect of the EE-ASI Project to
the Commission (but excluding any intellectual property in the Midatech materials used to obtain those results); 

  

	 	5.	Only those Access Rights which are necessary and only required to be granted as between Cardiff and King’s solely for the purposes of the Project and only as is Needed, in order to permit King’s to complete
its Allocated Work. 

 All requests for Access Rights to CU Included Background shall be submitted in writing to Cardiff 

All requests for Access Rights for Use including Access Rights to Background Needed by a Party for Use of its own Foreground shall be submitted
in writing to Cardiff. 

 Excluded: 

Excluded Background 
 CU hereby excludes from its
obligation to grant Access Rights to any Background, including unpublished work, registered patents, patent applications, intellectual property rights, any improvements and/or modifications in relation to intellectual property rights, confidential
information, data, results, materials, know-how, information, protocols, patient information sheets, consent forms, methodologies, laboratory and know-how techniques, analysis, expertise to conduct clinical studies and/or in echocardiography
methodology, databases, software and hardware and their use, application and development, analytical and techniques, any of the above in relation to peptide immuno therapy and antigen presentation in the skin or studies of patients with Type 1
Diabetes, any of the above in relation to skin explants and viruses; any of the above in relation to animal models of diabetes pathogenesis; any of the above in relation to micro-needle design, manufacture or testing of therapeutic/vaccine delivery
or other application; any of the above in respect of CU as a whole: 
  

	 	•	 	which has been generated and/or developed and any information and/or data generated and/or developed by researchers, employees, agents, collaborators of CU who do not participate in or contribute to the Project;

  

	 	•	 	which has been generated and/or developed and any information and/or data generated and/or developed by researchers, employees, agents, collaborators of CU and third parties and/or collaborators and/or partners and is
therefore outside the Project; 

  

	 	•	 	resulting from CU research which was funded in full or in part consideration by industrial, commercial, charitable, military, government funders/sponsors or which CU by virtue of third party provisions and arrangements
is not entitled to grant Access Rights to; 

  

	 	•	 	developed by the research group involved in the Project on research topics which are not specifically and/or directly the subject of the Project activities as described in Annex I (“Description of Work”) of
the EC-GA. 

  

	 	•	 	CU also excludes from its obligations to grant Access Rights to any Background any data or information collected relating to the use of clinical dermatology and/or skin immunity such information in this Project.

  

	 	•	 	That Background which is not Needed by King’s, for the purposes of the Project and which is not Needed by King’s to enable King’s to complete its Allocated Work. 

 

	 	•	 	Where intellectual property is referred to herein it shall be deemed to include (but not by way of limitation) any and all intellectual and industrial property rights including without limitation, copyright, know-how,
patents, trade marks (whether registered or not), designs (whether registered or not), utility models, animal models, human models, applications for and rights to apply for any of the foregoing, rights to prevent passing off for unfair competition
and copyright, database rights and any other rights in any invention, discovery or process, in each case in the United Kingdom and all other countries in the world and together with all renewals and extensions 

	 	•	 	Where know-how is referred to herein it shall be deemed to include (but not by way of limitation) commercial information, inventions which may reasonably be of commercial interest to CU in the design, manufacture or
supply of any products and the marketing and exploitation of any licensed intellectual property. This includes (without limitation) descriptions of manufacturing processes, formulae or drawings relating to the design, development, manufacture,
assembly, repair, testing and use of the products. 

 Participating organisation #3 
  

			
	Organisation legal name	  	Midatech Group Ltd, UK
	Organisation short name	  	MID

 Included: 

Application number: WO/PCT/GB01/04633: 
 Title:
Nanoparticles 
 Application number: WO/PCT/GB2005/003791: 

Title: Nanoparticles Comprising Antigens and Adjuvants, and Immunogenic Structures 

Application number: WO/PCT/GB2011/000882: 
 Title:
Peptide-carrying Nanoparticles 
 Including all families relating to these Patents 

Excluded: 

 Participating organisation #4 
  

			
	Organisation legal name	  	Nanopass Technologies
	Organisation short name	  	NPSS

 Included: IP protecting MicronJet600TM and MicronJetTM microneedle technology for Use which explicitly
excludes any manufacturing rights. The rights granted are solely for the Project and in the field of the Project (Type1 Diabetes Immunotherapy). 

The results generated by Cardiff and NanoPass prior to the initiation of the Project. 

Excluded: Any use of any microneedle devices, optimization or modification, IP or knowhow, outside the Field, including Sideground or for any matter
outside the Project. 

 Participating organisation #5 
  

			
	Organisation legal name	  	Leiden University Medical Center
	Organisation short name	  	LUMC

 Included: 
 NONE

 Excluded: 
 Any and all pre-existing knowledge
of LUMC, unless agreed separately in writing otherwise. 

 Participating organisation #6 
  

			
	Organisation legal name	  	King’s College London
	Organisation short name	  	KCL

 Included: 

King’s College London grants access to Proinsulin KCL C19-A3, on a royalty-free basis, solely for the implementation of the of the Project and as is
Needed to permit another Beneficiary to complete its Allocated Work, subject to: 
 All requests for Access Rights being submitted in writing to
King’s College London 
 Access Rights shall only be granted upon the signature of a Material Transfer Agreement which be drafted to the
requirements of King’s College London ensuring protection of its Background and also compliance with requirements of any third parties. 

Excluded: 
 King’s College London
specifically excludes any access to Proinsulin KCL C19-A3 for Use, including Access Rights to Background Needed by a Party for Use of its own Foreground, unless otherwise agreed in a written separate agreement. 

Any granting of Access Rights for Use including Access Rights to Background Needed by a Party for Use of its own Foreground will require additionally
require the written agreement of the Wellcome Trust. 
 Furthermore, King’s College London hereby excludes from its obligation to grant Access
Rights to Background Knowledge all Background generated by King’s College London other than that generated by the members of the research group of Professor Mark Peakman who are directly involved in carrying out the Project. 

King’s College London also hereby excludes specifically from its obligation to grant Access Rights to Background to the following Background: 

 

	•	 	All data, samples, methodologies and know-how not generated through the direct participation in the Project or which King’s College London is not free to provide. 

 

	•	 	Databases and software not generated through the direct participation in the Project or which King’s College London is not free to provide. 

 

	•	 	All Background resulting from research carried out by the research group of Professor Mark Peakman, which was funded in full or in part by external organisations. 

King’s College London also hereby excludes from its obligation to grant Access Rights to Background all Background that has been and/or will be
derived outside the Project which King’s College London due to third party rights are not able to grant Access Rights to or for which King’s College London needs to get permission to grant Access Rights. 

 Participating organisation #7 
  

			
	Organisation legal name	  	Institut National de la Santé et de la Recherche Médicale
	Organisation short name	  	Inserm

 Included: 
 WP3:
Construction of the DNA sequence containing GAD and IL10 under the langerin or MHCII promoted Participant 7 has extensively characterized mouse MHCII genes (Analysis of the expression and function of class II major histocompatibility
complex-encoded molecules by DNA-mediated gene transfer. Germain and Malisse Annual Review of Immunology 4: 281-315) and the mouse Langerin gene (Dynamics and function of Langerhans cells in vivo: dermal dendritic cells colonize lymph node
areas distinct from slower migrating Langerhans cells. Kissenpfennig A, Henri S, Dubois B, Laplace-Builhe C, Perrin P, Romani N, Tripp CH, Douillard P, Leserman L, Kaiserlian D, Saeland S, Davoust J, Malissen B. Immunity. 22: 643-54 and
Disruption of the langerin/CD207 gene abolishes Birbeck granules without a marked loss of Langerhans cell function Kissenpfennig A, Ait-Yahia S, Clair-Moninot V, Stossel H, Badell E, Bordat Y, Pooley JL, Lang T, Prina E, Coste I, Gresser O,
Renno T, Winter N, Milon G, Shortman K, Romani N, Lebecque S, Malissen B, Saeland S, Douillard P, Mol Cell Biol. 25: 88-99), the promoter of which will be used to express the GAD and IL10 gene in a selected set of dendritic cells. Participant
7 masters all the recombineering techniques needed to develop the DNA constructs designed in the frame of WP3. 
 WP:4 Follow up the role of skin DC subset
upon skin application of microneedle: The participant 7 has developed a procedure and a 12 parameter flow cytometry approach to discriminate all DC subsets as well as all macrophages in different organs such as the skin, the muscle, thymus and
intestine. The participant has also characterized some specific functions for precise DC subsets. The current knowledge of participant 7 is described in the following papers: 1- Langlet C, Tamoutounour S, Henri S, Luche H, Ardouin L, Gregoire
C, Malissen B, Guilliams M. CD64 expression distinguishes monocyte-derived and conventional dendritic cells and reveals their distinct role during intramuscular immunization. J Immunol 2012. 188:1751-60; 2- Crozat K, Tamoutounour S,
Manh TP, Fossum E, Luche H, Ardouin L, Guilliams M, Azukizawa H, Bogen B, Malissen B, Henri S, Dalod M. Cutting edge: Expression of XCR1 defines mouse lymphoid-tissue resident and migratory dendritic cells of the CD8alpha+ type. J Immunol
2011.187:4411-5. 3- Luche H, Ardouin L, Teo P, See P, Henri S, Merad M, Ginhoux F, Malissen B. The earliest intrathymic precursors of CD8alpha(+) thymic dendritic cells correspond to myeloid-type
double-negative 1c cells. Eur J Immunol 2011. 41:2165-75; 4- Guilliams, M., Crozat, K., Henri, S., Tamoutounour, S., Grenot, P., Devilard, E., de Bovis, B., Alexopoulou, L., Dalod, M. and Malissen, B., Skin-draining lymph nodes contain
dermis-derived CD103- dendritic cells that constitutively produce retinoic acid and induce Foxp3+ regulatory T cells. Blood 2010. 115: 1958-1968. 5- Henri, S., Poulin, L. F., Tamoutounour, S., Ardouin, L., Guilliams, M., de
Bovis, B., Devilard, E., Viret, C., Azukizawa, H., Kissenpfennig, A. and Malissen, B., CD207+ CD103+ dermal dendritic cells cross-present keratinocyte-derived antigens irrespective of the presence of Langerhans cells. J Exp Med 2010. 207:
189-206, S181-186. 6- Crozat, K., Guiton, R., Guilliams, M., Henri, S., Baranek, T., Schwartz-Cornil, I., Malissen, B. and Dalod, M., Comparative genomics as a tool to reveal functional equivalences between human and mouse dendritic cell
subsets. Immunol Rev 2010. 234: 177-198. 7- Poulin, L F., Henri, S., de Bovis, B., Devilard, E., Kissenpfennig, A. and Malissen, B., The dermis contains langerin dendritic cells that develop and function independently of epidermal
Langerhans cells. J Exp Med 2007. 204: 3119-3131. 8- Kissenpfennig, A., Henri, S., Dubois, B., Laplace-Builhe, C., Perrin, P., Romani, N., Tripp, C. H., Douillard, P., Leserman, L., Kaiserlian, D., Saeland, S., Davoust, J. and
Malissen, B., Dynamics and function of Langerhans cells in vivo: dermal dendritic cells colonize lymph node areas distinct from slower migrating Langerhans cells. Immunity 2005. 22: 643-654. 

Excluded: 

 Participating organisation #8 
  

			
	Organisation legal name	  	Linkoping University
	Organisation short name	  	LiU

 Included: 

Excluded: 
 For avoidance of doubt, in addition to
the above mentioned (i.e the information to be provided by IKE) LiU exclude all; 
  

	•	 	Background developed by personnel, scientists or students at LiU not participating in the Project 

  

	•	 	Background developed by personnel, scientists or students at LiU participating in the Project which is outside the scope of the Project. 

 

	•	 	All Background in patents and current patent applications. 

  

	•	 	any unpublished work that we want to publish before disclosure to the project. 

  

	•	 	All Background that is covered under other specific research agreements and confidentiality agreements and therefore subject to third party rights. 

This represents the status at the time of signature of this Consortium Agreement.” 

 ATTACHMENT 3 - LIST OF AFFILIATED ENTITIES 

 

					
	 Beneficiary

Number
	  	 Beneficiary
	  	 Affiliated Parties

	1 COORD	  	Cardiff University	  	
			
	2	  	INSERM-Transfert SA	  	
			
	3	  	Midatech Group Ltd, UK	  	
			
	4	  	Nanopass Technologies	  	
			
	5	  	Leiden University Medical Center	  	
			
	6	  	King’s College London	  	
			
	7	  	Institut National de la Santé et de la Recherche Médicale, Marseille	  	
			
	8	  	Linkoping University	  	

  
 50/54 

 ATTACHMENT 4 - LIST OF THIRD PARTIES FOR EXECUTION OF SECTION 8.2 

 

					
	 Beneficiary

Number
	  	 Beneficiary
	  	 Third Parties

	1 COORD	  	Cardiff University	  	
			
	2	  	INSERM-Transfert SA	  	
			
	3	  	Midatech Group Ltd, UK	  	
			
	4	  	Nanopass Technologies	  	
			
	5	  	Leiden University Medical Center	  	
			
	6	  	King’s College London	  	
			
	7	  	Institut National de la Santé et de la Recherche Medicale, Marseille	  	
			
	8	  	Linkoping University	  	

  
 51/54 

 ATTACHMENT 5 - AGREEMENT FOR THE TRANSFER OF MATERIAL 

  
 52/54 

 Attachment 5: Materials and Data Transfer Agreement 

BETWEEN: 
  

	(1)	[NAME] whose registered office is at/with administrative offices at [ADDRESS] (“the Transferor”); and 

  

	(2)	[NAME] whose registered office is at/with administrative offices at [ADDRESS] (“the Recipient”); 

Jointly referred to as “Parties” or individually as “Party”. 

The Parties agree as follows: 
 Definitions:

  

			
	“Confidential Information”	 	Confidential Information means for the purposes of this Agreement any knowledge, information, data or experience and any drawings, computer programmes, instructions, designs or reports thereon and copies thereof (whether technical,
economic, commercial or of any other description) in any way connected with the Materials and/or Data and/or Results (whether orally or in writing) or which is obtained by either Party to this Agreement. All written Confidential Information shall be
marked as such by the Party disclosing, and all such information relayed orally shall be reduced to writing within fifteen (15) days. In the event however that Confidential Information is not marked as such but it is clearly intended by a Party to
be Confidential Information for the purposes of this Agreement then it shall be deemed to be Confidential Information which falls to be covered by the provisions of this Agreement.
		
	“Consortium Agreement”	 	the agreement between partners entitled EE-ASI with Grant number Agreement 305305-2 dated [DATE]
		
	“Contract Period”	 	Contract Period means from [DATE] to [DATE].
		
	“Data”	 	as defined in the Consortium Agreement.
		
	“Materials”	 	as defined in the Consortium Agreement.
		
	“Participant”	 	as defined in the Consortium Agreement.
		
	“Project”	 	as defined in the Consortium Agreement.
		
	 “Recipient’s Scientist”
	 	 Name
 Address:

Email address:
 Telephone number:

Fax number:

		
	“Results”	 	means any results whether or not patentable which relate to the research, tests or assays conducted by the Recipient in respect of the Materials and/or Data and form part of the Foreground, as defined in Annex II of the
EC-GA.
		
	 “Transferor’s Scientist”
	 	 Name:
 Address:

Email address:
 Telephone number:

Fax number:

	1.	The Parties are working on a collaborative project and are Parties to a Consortium Agreement with Cardiff University acting as the Project co-ordinator. The Recipient will carry out its analysis of Materials and/or Data
in accordance with the Project and shall receive the Materials and/or Data from the Transferor. The Recipient shall keep the Materials and/or Data in accordance with Clause 11 below and only use such Materials and/or Data in accordance with Articles
4.4, 4.5 and 4.7 of Annex 1, EC-GA. 

  

	2.	The Parties to this Agreement shall at all times have in mind and comply with the Project, in particular as detailed in Annex 1, EC-GA of the Project and provisions where applicable and appropriate relating to data
protection issues as set out in section 4.4.3 of Annex 1, EC-GA of the Project (“Data Protection”), and the following legislation [STIPULATE RELEVANT LEGISLATION EG DATA PROTECTION ACT 1998], the Human Tissue Act 2004 (if applicable),
law and regulations relating to informed consent and the requirements of section 4.4.1 Annex 1, EC-GA of the Project and the law and regulations relating to the use of animals in experiments and the requirements of section 4.5 of Annex 1, EC-GA of
the Project. 

  

	3.	The Parties to this Agreement hereby recognise that the EU Convention on Human Rights provides that, everyone has the right to respect for their private life, their home and correspondence. All staff employed by the
Parties are also subject to a Common Law Duty of Confidence which applies to all information on humans which is identifiable. The duty of confidentiality requires that, unless there is a statutory requirement or a sufficiently robust public interest
justification to use information that has been provided in confidence, then that information should only be used for purposes that the Participant has been informed about and has consented to. 

 

	4.	The Transferor undertakes that at all times it shall only transfer to the Recipient anonymised Materials and/or Data and the Recipient shall only use the Materials and/or Data for the purposes of the Project and in
accordance with sections 4.4 and 4.7 Annex 1 of the EC-GA and/or section 4.5 Annex 1, EC-GA of the Project Annex 1, EC-GA of the Project. 

  

	5.	The Transferor undertakes that it shall, where appropriate and necessary in accordance with section 4.2.1 of Annex 1 of the EC-GA, follow any and all relevant procedures and that
it shall ensure that any specific informed consent has been obtained prior to sending any Materials and/or Data to the Recipient. Furthermore, the Transferor shall retain, if necessary and appropriate, a record of such consent. 

 

	6.	Subject to the provisions set out at Article 4 of the Consortium Agreement, the Transferor shall ensure at all times that it does not, and shall procure that its employees do not, disclose to the Recipient or any third
party the name or any other identifiable information relating to any of the Participants which is in their possession unless such information is required by law and/or on the order of a regulatory authority with competent jurisdiction.

  

	7.	Without prejudice to the operation of any other provisions of the Consortium Agreement and/or section 4.4.3 of Annex 1 of the EC-GA, the Parties warrant to each other that in any event any “personal data”
relating to a Participant shall come into their possession or control (whether accidentally or otherwise) then the receiving Party shall comply with the Act in the management and retention of any information relating to the Participant and, in
particular, shall: 

  

	 	(a)	make no independent use of it whatsoever and act at all times in accordance with the Participant’s informed consent; 

	 	(b)	only process such personal data with the explicit, informed consent of the Participant; 

  

	 	(c)	ensure that all personal data is kept securely and in accordance with the requirements of the Act; 

  

	 	(d)	maintain all appropriate technical and organisational measures in place to guard against unauthorised or unlawful processing of personal data and against accidental loss, damage or destruction; 

 

	 	(e)	take all reasonable steps to ensure the reliability of its staff who will have access to such personal data; 

  

	 	(f)	not to export any personal data to any third party whatsoever and wheresoever 

  

	8.	The Parties shall indemnify one another and each Participant against any claims, proceedings, damages, losses, costs (including reasonable legal fees) and demands whatsoever and howsoever arising or incurred as a result
of any breach of section 4.4.3 Annex 1 of the EC-GA and for any action brought against a Party resulting from the other Party’s use of the Materials and/or Data. 

 

	9.	The Materials and/or Data shall be transferred by the Transferor Scientist to the Recipient Scientist as agreed mutually between the parties and shall be provided by or sent by the Transferor Scientist for the attention
of the Recipient Scientist. The Materials are experimental in nature, and the Transferor makes no expressed or implied warranties of safety, merchantability or fitness of the Materials for a particular purpose. 

 

	10.	Nothing in this Agreement shall affect the Intellectual property Rights owned by a Party prior to the Project or generated outside of the Project (“Background Rights”). Any and all results (including all
intellectual property rights) created or arising using or analysing the Materials and/or Data pursuant to the Project, arising out of Recipient’s use or analysis of the Materials and/or Data shall be treated in accordance with section 8 of the
Consortium Agreement. 

  

	11.	It is hereby recognised and agreed between the Parties that the Recipient will keep the Materials at the laboratory of the Recipient Scientist in accordance with section 4 of Annex 1, EC-GA of the Project.

  

	12.	The Transferor shall fully indemnify the Recipient in respect of the failure of any relevant procedures relating to the obtaining of specific informed consent under Clause 5 of this Agreement and/or in accordance with
section 4.4.1 of Annex 1 of the EC-GA. For the avoidance of doubt the Recipient shall not be liable for the content or the subject matter of the consent form and/or any patient information sheet which relates to Recipient’s use of the Materials
and/or Data under and as detailed in Annex 1, EC-GA of the Project. 

  

	13.	Any and all use of Results, commercial or otherwise, is subject to section 8 of the Consortium Agreement. 

  

	14.	Any Confidential Information provided by either party shall be at all times treated in accordance with Article 10 of the Consortium Agreement. 

 

	15.	Nothing in this Agreement shall be construed as: 

  

					
	16.	 	(a)	 	a warranty or representation by the Transferor that the use of the Materials and/or Data is not infringing or will not infringe any patents or proprietary rights of third parties;

  

	 	(b)	an agreement by the Transferor to bring or prosecute actions or suits against third parties for infringement of any rights. 

	17.	The Recipient shall collect, keep, use and deal with all Materials and/or Data in accordance with Section 4 of Annex 1 of the EC-GA during the Project and at the end of the
Project. 

  

	18.	Any publication of any Results is subject to the provisions of Article 8 of the Consortium Agreement. 

  

	19.	Other than as granted herein, no other right or licence is granted or implied herewith. 

  

	20.	Nothing in this Agreement shall be deemed to make any Party liable to any other Party other than for loss or damage caused as a result of gross negligence and wilful misconduct. 

 

	21.	This Agreement does not create any right enforceable by any person who is not a Party to it. 

  

	22.	This Agreement shall be effective upon countersignature and shall continue in effect for the full duration of the Project period unless sooner terminated in accordance with the provisions of Clause 23 of this Agreement.

  

	23.	In the event that either Party hereto shall commit any breach of or default in any of the terms or conditions of this Agreement, and also shall fail to remedy such default or breach within thirty (30) days after
receipt of written notice thereof from any non-defaulting Party, the non-breaching Party may, at its option terminate this Agreement by sending notice of termination in writing to the other Party to such effect and such termination shall be
effective as of the date of the receipt of such notice. 

  

	24.	In the event that a Party’s participation in the Consortium Agreement is terminated, then this Agreement shall be deemed to be terminated. 

 

	25.	In the event of termination of this Agreement, the Materials and the Data shall be dealt with in accordance with the Consortium Agreement and sections II.37 and II.38 of Annex II of the EC-GA. 

 

	26.	Termination of this Agreement for any reason shall not affect the rights and obligations of the Parties accrued prior to the effective date of termination of this Agreement. No termination of this Agreement shall effect
or release any Party’s rights, obligations and duties under Clauses 2, 3, 6, 7, 8, 11, 12, 13, 14, 17, 18, 19, 20, 21, 22, 23, 25, 26 and 27. 

  

	27.	This Agreement shall be governed and construed according to the laws of Belgium whose courts have non-exclusive jurisdiction. 

 Agreed by the Parties through their authorised signatories: 

 

			
	For and on behalf of [TRANSFEROR]
		
	Name:	 	  

		
	Title:	 	  

		
	Signature:	 	  

		
	Date:	 	  

	
	For and behalf of [RECIPIENT]
		
	Name:	 	  

		
	Title:	 	  

		
	Signature:	 	  

		
	Date:	 	  

 ATTACHMENT 6: CONSORTIUM BUDGET PLANS AS OF JANUARY 1ST 2011 

Caution: These plans are MAXIMUM costs and may evolve at the end of each reporting period set in the GA, pending on actual performance of each
Beneficiary and revision of the programme of activities by the EE ASI ExCom. 

  
 54/54 

 A3: 

Budget Breakdown 
  

							
	Project Number 1	  	305305	  	Project Acronym 2	  	EE-ASI

 One Form per Project 
  

																																					
	
Participant number in this project 11
	  	Participant
short name	  	Fund.
%12	 	  	Ind. costs13	  	Estimated eligible costs (whole duration of the project)	 	  	Total
receipts	 	  	Requested
EU
contribution	 
	  	  	  	  	RTD /
Innovation
(A)	 	  	Demonstration
(B)	 	  	Management
(C)	 	  	Other
(D)	 	  	Total
A+B+C+D	 	  	  
	 1
	  	CU	  	 	75.0	  	  	T	  	 	2,453,301.60	  	  	 	0.00	  	  	 	50,000.00	  	  	 	40,000.00	  	  	 	2,543,301.60	  	  	 	0.00	  	  	 	1,929,975.00	  
	 2
	  	IT	  	 	50.0	  	  	S	  	 	0.00	  	  	 	0.00	  	  	 	264,068.00	  	  	 	122,803.00	  	  	 	386,871.00	  	  	 	0.00	  	  	 	386,871.00	  
	 3
	  	MID	  	 	75.0	  	  	S	  	 	1,333,334.00	  	  	 	0.00	  	  	 	9,000.00	  	  	 	50,000.00	  	  	 	1,392,334.00	  	  	 	0.00	  	  	 	1,059,000.00	  
	 4
	  	NPSS	  	 	75.0	  	  	T	  	 	1,000,000.00	  	  	 	0.00	  	  	 	7,200.00	  	  	 	50,000.00	  	  	 	1,057,200.00	  	  	 	0.00	  	  	 	807,200.00	  
	 5
	  	LUMC	  	 	75.0	  	  	T	  	 	400,000.00	  	  	 	0.00	  	  	 	0.00	  	  	 	15,000.00	  	  	 	415,000.00	  	  	 	0.00	  	  	 	315,000.00	  
	 6
	  	KCL	  	 	75.0	  	  	T	  	 	754,433.60	  	  	 	0.00	  	  	 	3,000.00	  	  	 	15,000.00	  	  	 	772,433.60	  	  	 	0.00	  	  	 	583,825.00	  
	 7
	  	INSERM	  	 	75.0	  	  	T	  	 	711,342.40	  	  	 	0.00	  	  	 	0.00	  	  	 	20,612.80	  	  	 	731,955.20	  	  	 	0.00	  	  	 	515,000.00	  
	 8
	  	LIU	  	 	75.0	  	  	T	  	 	493,334.40	  	  	 	0.00	  	  	 	2,000.00	  	  	 	15,000.00	  	  	 	510,334.40	  	  	 	0.00	  	  	 	387,000.00	  
	 Total
	  		  				  		  	 	7,145,746.00	  	  	 	0.00	  	  	 	335,268.00	  	  	 	328,415.80	  	  	 	7,809,429.80	  	  	 	0.00	  	  	 	5,983,871.00	  

 Note that the budget mentioned in this table is the total budget requested by the Beneficiary and associated Third Parties.EX-10.16

 Exhibit 10.16 

MEDPDATED 9th JULY 2013 

NOVA LABORATORIES LIMITED 

AND 
 Q
CHIP LIMITED 
  

 
 SUPPLY
AGREEMENT 
  
  

 SUPPLY AGREEMENT 

Date: 9th JULY 2013 

Parties: 
  

	(1)	NOVA LABORATORIES LIMITED a company incorporated in England under number 2875110, whose registered office is at Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YF (“Nova”).

  

	(2)	Q Chip Limited a company incorporated in England, whose principal place of business is at Oddfellows House, 19 Newport Road, Cardiff CF240AA U.K. (“the Customer”) 

 

	1	INTERPRETATION 

  

	1.1	In this agreement: 

 “BATCH” means the technology transfer process and each batch of the Product
manufactured by Nova for the Customer in accordance with each Purchase Order (i.e. engineering, demo, media fills and clinical batches: 
 “BMR”
means the batch manufacturing record further described in clause 6 below; 
 “BUSINESS DAY” means Monday to Friday (excluding normal public
holidays in England) between the hours of 9am and 5pm; 
 “CONSUMABLES” means the consumable products and supplies required by Nova to manufacture
the Products other than the Starting Materials; 
 “CUSTOMER TECHNOLOGY EQUIPMENT” means the machinery and equipment required by Nova for the use
of Customer Technology in the manufacture of the Product; 
 “CUSTOMER TECHNOLOGY IMPROVEMENTS” means any development, enhancement or derivative
of the Customer Technology developed either by Customer or Nova; 
 “CUSTOMER TECHNOLOGY” means Customer’s proprietary microsphere
manufacturing platform, including CUSTOMER TECHNOLOGY IMPROVEMENTS; 
 “DOCUMENT” includes, in addition to a document in Writing, a map, plan,
design, drawing, picture or other image, or any other record of any information in any form; 
 “EQUIPMENT” means the specialist tools, machinery
and equipment required for use in connection with the manufacture of the Products that are not ordinarily provided by Nova, excluding Customer Technology Equipment; 

“FORCE MAJEURE” means in relation to either party, any circumstances beyond the reasonable control of that party (including, without limitation, any
strike, lock-out or other industrial action); 

  
 2 

 “INTELLECTUAL PROPERTY” means any patent, copyright, registered design or unregistered design right and
any application for any of the foregoing, any rights in respect of confidential information and any other intellectual property right; 
 “PURCHASE
ORDER” means the purchase order sent by the Customer to Nova in the form set out in the Schedule; 
 “PRICE” means the price for each Batch
and any Equipment as specified in the Quotation; 
 “PRODUCT” means the product or products to be manufactured by Nova for the Customer as
detailed further in the Technical Specification for each product; 
 “QUOTATION” means the quotation sent by Nova to the Customer as described
further in clause 2.4; 
 “STARTING MATERIALS” means the constituent materials for the Product as detailed further in the Technical Specification.

 “TECHNICAL SPECIFICATION” means the specification to which each Product will be manufactured; 

“TERM” shall mean the period of 5 years; 
 “TRADE
MARKS” means the registered trade marks of the Customer that apply to the Customer’s business and Customer Technology or specifically to the Products; 

“WRITING”, and any similar expression, includes facsimile transmission and comparable means of communication, but not electronic mail: 

 

	1.2	The headings in this agreement are for convenience only and shall not affect its interpretation. 

  

	2	SUPPLY OF SERVICES 

  

	2.1	Nova has facilities and expertise in the manufacture of pharmaceutical and medical products and devices and the Customer owns Customer Technology and wishes Nova to manufacture the Product in Batches on the terms of
this Agreement. 

  

	2.2	Nova and Customer have agreed outline prices for each Batch as outlined in Quotation SP/2013/05/01. 

  

	2.3	The Customer shall send to Nova the Technical Specification for each Batch and in response Nova shall provide a detailed Quotation for each Batch. 

 

	2.4	The Quotation shall contain: 

  

	 	2.4.1	the Price; 

  

	 	2.4.2	a responsibilities schedule: 

  

	 	2.4.3	the date by which the Starting Materials, if they are to be supplied by Customer, must by received by Nova; 

  

	 	2.4.4	the anticipated date for the completion of each Batch; and 

  
 3 

	 	2.4.5	details of any Equipment Nova will purchase on the Customers behalf in accordance with clause 5. 

  

	2.5	If the Customer accepts the Quotation for a Batch, the Customer shall send to Nova a Purchaser Order. 

  

	2.6	Nova shall not initiate manufacture of a Batch until requested to do so by Customer. 

  

	2.7	Nova shall promptly advise Customer of any potential overruns on costs and slippage in terms of timescales. In this event an amendment to a Quotation shall be discussed with Customer and submitted to Customer in
writing. On receipt of written approval of an amendment to a Quotation from Customer, Customer shall raise a Purchase Order. 

  

	2.8	Upon receipt of the Purchaser Order for a Batch, and the Starting Materials, Nova shall produce each Batch in accordance with the Quotation and the Technical Specification. 

 

	2.9	Nova shall send to the Customer a BMR in respect of each Batch, which shall be sent by electronic mail after the time of delivery of each Batch and subsequently by CD-ROM. 

 

	2.10	The production of each Batch requires the Customer Technical Equipment, Consumables (which shall be supplied by Nova at no additional cost to the Customer) the Starting Materials (which shall, unless specified
otherwise, be supplied by the Customer at no additional cost to Nova) and the Equipment. 

  

	3	CONSUMABLES 

  

	3.1	The Technical Specification shall detail the specifications of all Consumables. 

  

	3.2	Nova shall source all Consumables required for the manufacture of each Product from their approved and audited suppliers. Should Nova wish to use alternative suppliers of Consumables, these should be agreed with
Customer prior to placement of an order. 

  

	3.3	Nova shall, where appropriate, obtain all certificates and assurances in relation to the quality of the Consumables as Nova may be able to obtain, which in the event of a failure in the production of any Batch shall be
made available to the Customer by Nova upon receiving a request in Writing. 

  

	4	STARTING MATERIALS 

  

	4.1	The Customer, or if the Starting Materials are to be provided by Nova, Nova shall ensure that: 

  

	 	4.1.1	the specification of the Starting Materials is in accordance with the Technical Specification; 

  

	 	4.1.2	the Starting Materials are delivered to Nova on a Business Day; 

  
 4 

	 	4.1.3	the Starting Materials are delivered to Nova with full storage instructions contained in a delivery note that is attached to the outside of the packaging of the Starting Materials; and 

 

	 	4.1.4	the quantity of the Starting Materials is in accordance with the Quotation or the Purchase Order. 

  

	 	4.1.5	the Starting Materials are delivered to Nova free of charge with all duties, taxes and carriage paid. 

  

	4.2	Nova shall store the Starting Materials in accordance with the requirements of GMP and the Customer’s storage instructions as provided in accordance with clause 4.1.3. 

 

	5	EQUIPMENT 

  

	5.1	If the production of the Products requires any Equipment Nova shall detail the Equipment in the Quotation. 

  

	5.2	Nova shall: 

  

	 	5.2.1	source the Equipment from reputable suppliers at the best price reasonably obtainable; 

  

	 	5.2.2	maintain and service the Equipment; 

  

	 	5.2.3	use the Equipment solely for the purposes of producing the Product. 

  

	5.3	The Customer shall, upon payment of any charges in respect of the Equipment, be the legal and beneficial owner of the Equipment. 

  

	5.4	The Customer shall be responsible for the cost of all repairs to the Equipment including routine maintenance and servicing of the Equipment. 

 

	5.5	Nova is entitled to use the Equipment for the duration of the production of each Product that requires the Equipment and shall not be in breach of this Agreement for failing to produce any Batch if the Customer removes
the Equipment from Nova’s premises. 

  

	5.6	Nova shall, in so far as they are able, pass to the Customer the benefit of any warranty or guarantee obtained when the Equipment is purchased. 

 

	5.7	The cost of any Equipment required by Nova that is not covered by a Quotation shall be submitted to Customer for approval in accordance with clause 2.7 of this Agreement, prior to purchase of such Equipment

  

	5.8	Customer shall provide Customer Technology Equipment to Nova and shall be responsible for the repairs and the cost of all repairs to such. 

 

	5.9	Nova shall use Customer Technology Equipment only for the manufacture of Batches of Product as provided for under this Agreement. 

  
 5 

	6	TESTING 

  

	6.1	Nova shall complete all testing and quality control that is contained in the Technical Specification. 

  

	6.2	Nova shall record contemporaneously in the BMR all testing and quality control procedures that are undertaken. 

  

	6.3	Nova shall notify Customer of any failure of any testing or quality control with 24 hours of such a result being generated. 

  

	6.4	Testing and quality control that cannot be undertaken by Nova shall, with Customer’s consent, be outsourced to Nova’s approved and audited providers. Should Nova wish to use alternative providers, these should
be agreed with Customer prior to outsourcing. 

  

	6.5	The Customer may request Nova to amend the BMR and Nova shall accommodate the Customers request so far as they are able to do so without affecting the integrity of the BMR. 

 

	6.6	Nova’s charges for the time spent in making any amendments to the BMR is payable by the Customer in addition to the Price at Nova’s published charging rates applicable at the date the Customers requests the
amendment in accordance with clause 6.5 above. 

  

	7	POSTPONEMENT AND CANCELLATION 

  

	7.1	Once written agreement has been received by Nova to commence manufacture of a Batch, the Customer may cancel or postpone the production of any Batch or Batches upon giving notice in Writing to Nova. 

 

	7.2	The Customer acknowledges that upon receipt of the Purchase Order for a Batch, Nova will allocate resources for the production of each Batch and will incur costs as a result of doing so. 

 

	7.3	If the Customer exercises its right to cancel or postpone the production of any Batch, Nova will use reasonable endeavours to reallocate the resources from this production to another project. 

 

	7.4	If Nova is not able to reallocate its resources in accordance with clause 7.3 above, Nova may (at Nova’s sole discretion) charge the Customer a fee excluding the cost of any Equipment (“the
Cancellation/Postponement Fee”) as follows: 

  

	 	7.4.1	cancellation more than 3 months before manufacture of a Batch, Nova shall charge no more than 10% of the Price for that Batch; 

  

	 	7.4.2	cancellation between 1 and 3 months before manufacture of a Batch, Nova shall charge no more than 50% of the Price for that Batch; 

  

	 	7.4.3	cancellation less than 1 month before manufacture of a Batch, Nova shall charge no more than 75% of the Price for that Batch; 

but nothing in this clause 7.4 shall remove the Customers liability to pay in full the cost of purchasing and maintaining the Equipment. 

  
 6 

	7.5	The Customer acknowledges that the Cancellation/Postponement Fee is not a penalty but is a reasonable assessment of the costs incurred by Nova as a direct result of the Customers cancellation or postponement.

  

	8	LICENCES, APPROVALS AND INFORMATION 

  

	8.1	For the duration of this Agreement Nova shall use all reasonable endeavours to maintain in full force and affect all licences, consents and approvals that Nova may require from any government or governmental authority
to carry out its obligations under this Agreement and to produce the Products in accordance with the Technical Specification and, where applicable EU and US cGMP. 

 

	8.2	The Customer shall, for each Batch, provide to Nova in writing all information relating to the use of that Batch, indicating whether it is for use in preclinical studies, for use in human trials or is to become licensed
for general use. 

  

	8.3	The Customer shall indemnify and hold Nova harmless from all claims and all direct, indirect or consequential liabilities (including loss of profits, loss of business, depletion of goodwill and similar losses), costs,
proceedings, damages and expenses (including legal and other professional fees and expenses) awarded against, or incurred or paid by Nova as a result of or in connection with any breach of clause 8.2 above. 

 

	9	DELIVERY 

  

	9.1	Delivery of each Batch shall be made by the Customer arranging collection of the Batch from Nova’s premises at any time after Nova has notified the Customer that the Batch is ready for collection or, if some other
place for delivery is agreed by Nova, by Nova delivering the Batch to that place. 

  

	9.2	Any dates quoted for delivery of each Batch are approximate only and Nova shall not be liable for any delay in delivery of the Batch however caused. Nova shall make reasonable efforts to comply with the delivery dates
agreed with the Customer and shall notify Customer as soon as is reasonably possible of any delays and revised delivery dates. Time for delivery shall not be of the essence of the Agreement unless previously agreed by Nova in Writing. The Batch may
be delivered by Nova in advance of the quoted delivery date on giving reasonable notice to the Customer. 

  

	9.3	If the Customer fails to take delivery of the Batch or fails to give Nova adequate delivery instructions at the time stated for delivery (otherwise than by reason of any cause beyond the Customer’s reasonable
control or by reason of Nova’s fault) then, without limiting any other right or remedy available to Nova, Nova may: 

  

	 	9.3.1	store the Batch until actual delivery and charge the Customer for the reasonable costs (including insurance) of storage; 

  

	 	9.3.2	after a period of 6 months from the date upon which the Customer has been notified of the Batch being available for delivery, Nova may destroy that Batch without incurring any liability to the Customer.

  
 7 

	9.4	Destruction of any Batch in accordance with clause 9.3.2 shall not negate to Customers liability to pay the Price for the Batch destroyed and any storage charges incurred in accordance with clause 9.3.1.

  

	10	TERMS OF PAYMENT 

  

	10.1	Subject to any special terms agreed in Writing between the Customer and Nova, Nova may invoice the Customer for the Price of each Batch as specified in the Purchase Order for the Batch on or at any time after production
of that Batch. 

  

	10.2	The Price does not include Value Added Tax for which the Customer shall be additionally liable at the appropriate rate from time to time. 

 

	10.3	Unless otherwise agreed in writing the Price does not include delivery and all costs or charges in relation to packaging all of which amounts the customer shall pay in addition when it is due to make payment.

  

	10.4	The Customer shall pay the Price together with any Value Added Tax and delivery and packaging costs (without any other deduction) within 30 days of the invoice date or immediately on receiving a BMR by e-mail, whichever
is the later and Nova shall be entitled to recover the Price, notwithstanding that delivery may not have taken place and the property in the Batch has not passed to the Customer. The time of payment of the Price shall be of the essence of this
Agreement. Receipts for payment will be issued only on request. 

  

	10.5	If Customer disputes any amounts under any invoice from Nova, such dispute shall be resolved in accordance with the provisions of this Agreement. 

 

	10.6	If following discussion between the Customer and Nova, and resolution of any dispute in accordance with clause 10.5 of this Agreement the Customer fails to make any payment on the due date then, without limiting any
other right or remedy available to Nova, Nova may: 

  

	 	10.6.1	cancel the contract or suspend any further deliveries to the Customer; 

  

	 	10.6.2	appropriate any payment made by the Customer to any Batch (or the goods supplied under any other contract between the Customer and Nova) as Nova may think fit (notwithstanding any purported appropriation by the
Customer); and 

  

	 	10.6.3	charge the Customer interest (both before and after any judgment) on the amount unpaid, at the rate of 4 per cent per annum above HSBC Bank Plc base rate from time to time, until payment in full is made (a part of
a month being treated as a full month for the purpose of calculating interest). 

  

	11	INTELLECTUAL PROPERTY AND TRADE MARKS 

  

	11.1	The Customer authorises Nova: 

  

	 	11.1.1	to use any Intellectual Property of the Customer in respect of Customer Technology and Product; and 

  
 8 

	 	11.1.2	to apply the Trade Marks to the Product; 

 solely for the purposes of exercising its rights and
performing its obligations under this Agreement. 
  

	11.2	Subject to clause 11.1, Nova shall have no rights in respect of any Intellectual Property of the Customer or any of the Trade Marks, and Nova shall not use any of the Intellectual Property except for the purposes
specified in clause 11.1 and otherwise in accordance with this Agreement. 

  

	11.3	Nova shall use the Trade Marks on or in relation to the Product in the form and manner specified by the Customer from time to time, and not otherwise. 

 

	11.4	All artwork supplied by the Customer from time to time for use in relation to the Product or its labelling and packaging, and all Intellectual Property in respect of it, shall belong exclusively to the Customer.

  

	11.5	Nova shall at the request and expense of the Customer take all such steps as the Customer may reasonably require to assist the Customer in maintaining the validity and enforceability of any Intellectual Property
referred to in clause 11.1 or 11.4 and the Trade Marks, and shall enter into such formal licences as the Customer may reasonably request for this purpose. Nova shall not represent that it has any title in or right of ownership to any of the
Intellectual Property or Trade Marks or do or suffer to be done any act or thing which may in any way impair the rights of the Customer in any of the Intellectual Property or Trade Marks or bring into question the validity of its registration.

  

	11.6	If any claim is made against Nova that the manufacture or sale of the Product infringes the Intellectual Property or other rights of any third party, the Customer shall, except to the extent that the claim is due to the
default of Nova, indemnify Nova against all damages or other compensation awarded against Nova in connection with the claim or paid or agreed to be paid by Nova in settlement of the claim and all legal or other expenses incurred by Nova in or about
the defence or settlement of the claim. Nova shall notify the Customer forthwith after becoming aware of the claim, and take all action reasonably requested by the Customer to avoid, compromise or defend the claim and any proceedings in respect of
the claim, subject to Nova being indemnified and secured to its reasonable satisfaction against all costs and expenses which may be incurred in so doing. 

  

	12	IMPROVEMENTS AND MODIFICATIONS 

  

	12.1	Any and all Customer Technical Improvements developed under this Agreement by either party shall be owned by Customer. 

  

	12.2	The Customer shall provide Nova with details of any Customer Technology Improvements developed by the Customer which it wishes to be incorporated into the Product or any other modification which it wishes to be made to
the Product from time to time; 

  
 9 

	12.3	Nova shall provide the Customer with details of any Customer Technology Improvement which is made or developed by Nova while performing its obligations under this Agreement;. 

 

	12.4	The title to and all Intellectual Property rights in respect of any Customer Technology Improvement made, developed or acquired by either party shall belong to Customer. 

 

	12.5	Nova shall not unreasonably withhold its consent to the incorporation into the Product of any Customer Technology Improvements. 

  

	12.6	Where the incorporation of any Customer Technical Improvement referred to in this clause 12 or any other modification to the Product which is agreed between the Customer and Nova requires any amendment to the Technical
Specification, Nova shall, as soon as practicable, submit to the Customer an amended Quotation and the Customer shall send to Nova a new Purchase Order. 

  

	13	CONFIDENTIALITY 

  

	13.1	Neither party shall, either during the period of this Agreement or at any subsequent time, disclose to any other person any information disclosed to it by the other party under this Agreement, including information on
Customer Technology and shall use its best endeavours to keep this information confidential (whether marked as such or not), except as provided by clause 13.2 or 13.3. 

 

	13.2	Any confidential information referred to in clause 13.1 may be disclosed to: 

  

	 	13.2.1	any contractor of or supplier to the party in question of the Equipment under a written confidentiality agreement; 

  

	 	13.2.2	any governmental or other authority or regulatory body; or 

  

	 	13.2.3	any directors or employees of the party in question to such extent only as is necessary for the purposes of this Agreement or as required by law, subject in each case (other than under clause 13.2.2) to the party in
question first obtaining (and submitting to the other a copy of) a Written undertaking from the person to whom the disclosure is made, as nearly as practicable in the terms of this clause, to keep it confidential and to use it only for the purposes
for which the disclosure is made. 

  

	13.3	Any confidential information referred to in clause 13.1 may be used by the receiving party for any purpose, or disclosed by that party to any other person, to the extent only that it is at the date of this Agreement or
subsequently becomes public knowledge through no fault of the party in question, provided that in so doing that party does not disclose any part of the confidential information which is not public knowledge. 

 

	13.4	Any confidential information referred to in clause 13.1 may, with the written consent of the disclosing party, be used by the receiving party for its own purposes, provided that in doing so that party does not disclose
any part of the confidential information which is not public knowledge. 

  
 10 

	14	WARRANTIES AND LIABILITIES 

  

	14.1	Nova warrants to the Customer that it has the corporate power, authority, proper consents and permits, financial capacity and legal right to enter into and perform its obligations under this Agreement; and that
Nova’s obligation under this Agreement will be provided using reasonable skill and care and suitably qualified staff and, as far as reasonably possible, in accordance with the Technical Specification and at the intervals and within the times
referred to in the Quotations. 

  

	14.2	Where Nova supplies Consumables in connection with this Agreement, Nova does not give any warranty, guarantee or other term to their quality, fitness for purpose of otherwise, but shall, where possible, assign to the
Customer the benefit of any warranty, guarantee or indemnity given by the supplier of the Consumables to Nova. 

  

	14.3	Nova shall indemnify Customer against all claims that relate to any breach of warranty or obligation under this agreement by Nova. 

  

	14.4	Nova shall have no liability to the Customer for any loss, damage, costs, expenses or other claims for compensation arising from: 

  

	 	14.4.1	the Starting Materials being delivered by the Customer at a time that is not a Business Day; 

  

	 	14.4.2	the Starting Materials not being clearly labelled; 

  

	 	14.4.3	the Starting Materials not having their storage instructions available in accordance with clause 4.1.3; 

  

	 	14.4.4	the Starting Materials differing from the Technical Specification in any way; 

  

	 	14.4.5	the quality of Starting Materials not being in accordance with the Quotation; 

  

	 	14.4.6	any contamination of the Starting Materials not caused by Nova; 

  

	 	14.4.7	the late arrival or non-arrival of the Starting Materials; 

  

	 	14.4.8	the Technical Specification being incomplete, incorrect, inaccurate, illegible, out of sequence or in the wrong form; 

  

	 	14.4.9	any other fault of the Customer; or 

  

	 	14.4.10	any fault or failure that is attributed to the Consumables. 

  
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	14.5	Nova shall have no liability to the Customer in respect of accidental damage or loss to the Starting Materials or to each Batch except when the accidental damage or loss is attributable to Nova, in which circumstance
Nova shall, providing that Customer replaces the Starting Materials, remanufacture the Batch free of charge; and: 

  

	 	14.5.1	The Customer shall, at its own expense, insure or self insure the Starting Materials against all risks (including but not limited to accidental damage and loss) from the time of dispatch from the Customers premises up
to and including the commencement of production of the Batch in which the Starting Materials are being used; and 

  

	 	14.5.2	The Customer shall also insure, or self insure, at its own expense, each completed Batch (including but not limited to accidental damage and loss) from the completion of production of each Batch. 

 

	14.6	Except in respect of death or personal injury caused by Nova’s negligence or as expressly provided in this Agreement, Nova shall not be liable to the Customer. Customer shall, except to the extent that the claim is
due to the default of Nova, indemnify Nova against all third party claims that may be asserted against the use of the Product. 

  

	14.7	Nova shall for the period that this Agreement is in force and for a period of 12 months subsequently, maintain general liability insurance cover of a minimum of £1 million, and provide such insurance policy
to Customer 

  

	14.8	A claim by the Customer which is based on any defect in the quality or condition of a Batch or its failure to correspond with the Technical Specification shall (whether or not delivery is refused by the Customer) be
notified to Nova within 7 days of the BMR being sent by Nova to the Customer by electronic mail or (where the defect or failure was not apparent on reasonable inspection) within 3 Business Days after discovery of the defect or failure and in any
event before 6 months after the BMR is sent by Nova to the Customer by electronic mail. If delivery is not refused, and the Customer does not notify Nova accordingly, the Customer shall not be entitled to reject the Batch and Nova shall have no
liability for such defect or failure, and the Customer shall be bound to pay the price as if the Batch had been delivered in accordance with this Agreement. 

  

	14.9	Where a valid claim in respect of any of the Batch which is based on a defect in the quality or condition of the Batch or its failure to meet the Technical Specification is notified to Nova in accordance with this
Agreement, Nova shall discuss with Customer the best course of action. Depending on the outcome of these discussions Nova shall rework or remanufacture the Batch (or the part in question) free of charge or, refund to the Customer the Price (or
proportionate part of the Price) in which case Nova shall have no further liability to the Customer. 

  

	14.10	The Customer shall, for each Batch, provide to Nova in writing all information relating to the use of that Batch, indicating whether it is for use in preclinical studies, for use in human trials or is to become licensed
for general use. 

  
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	14.11	The Customer shall indemnify and hold Nova harmless from all claims and all direct, indirect or consequential liabilities (including loss of profits, loss of business, depletion of goodwill and similar losses), costs,
proceedings, damages and expenses (including legal and other professional fees and expenses) awarded against, or incurred or paid by Nova as a result of or in connection with any breach of clause 14.10 above. 

 

	15	FORCE MAJEURE 

  

	15.1	If either party is affected by Force Majeure it shall promptly notify the other party of the nature and extent of the circumstances in question. 

 

	15.2	Notwithstanding any other provision of this Agreement, neither party shall be deemed to be in breach of this Agreement, or otherwise be liable to the other, for any delay in performance or the non-performance of any of
its obligations under this Agreement, to the extent that the delay or non-performance is due to any Force Majeure of which it has notified the other party, and the time for performance of that obligation shall be extended accordingly.

  

	15.3	If the Force Majeure in question prevails for a continuous period in excess of 5 months, the parties shall enter into bona fide discussions with a view to alleviating its effects, or to agreeing on such alternative
arrangements as may be fair and reasonable. 

  

	16	DURATION AND TERMINATION 

  

	16.1	This Agreement shall come into force immediately and, subject to the following provisions of this clause 16, shall continue in force for the Term and thereafter unless or until terminated by either party giving to the
other party not less than 3 months’ Written notice. 

  

	16.2	If Nova fails to maintain its licensees consents and approvals in accordance with clause 8, the Customer may at its option terminate this Agreement forthwith by giving Written notice to Nova. 

  
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	16.3	Either party shall be entitled forthwith to terminate this Agreement by giving Written notice to the other if: 

  

	 	16.3.1	the other party commits any continuing or material breach of any of the provisions of this Agreement and, in the case of such a breach which is capable of remedy, fails to remedy the breach within 30 days after receipt
of a Written notice giving full particulars of the breach and requiring it to be remedied; 

  

	 	16.3.2	an encumbrancer takes possession or a receiver is appointed over any of the property or assets of the other party; 

  

	 	16.3.3	the other party makes any voluntary arrangement with its creditors or becomes subject to an administration order; 

  

	 	16.3.4	the other party goes into liquidation (except for the purposes of an amalgamation, reconstruction or other reorganisation and in such manner that the company resulting from the reorganisation effectively agrees to be
bound by or to assume the obligations imposed on that other party under this agreement); or 

  

	 	16.3.5	the other party ceases, or threatens to cease, to carry on business. 

  

	16.4	For the purpose of clause 16.3.1, a breach shall be considered capable of remedy if the party in breach can comply with the provision in question in all respects other than as to the time of performance (provided that
time of performance is not of the essence). 

  

	16.5	Any waiver by either party of a breach of any provision of this Agreement shall not be considered as a waiver of any subsequent breach of the same or any other provision. 

 

	16.6	The rights to terminate this Agreement given by this clause 16 shall not prejudice any other right or remedy of either party in respect of the breach concerned (if any) or any other breach. 

 

	16.7	On the termination of this Agreement for any reason, Nova shall return to the Customer at the Customers expense all unused Starting Materials, Customer Technology Equipment and any Equipment in which title has passed to
the Customer. 

  

	16.8	Subject to clause 16.7, on the termination of this agreement for any reason Nova shall: 

  

	 	16.8.1	subject to clauses 13.3 and 13.4, ease to manufacture the Products or to use, either directly or indirectly, any of the Intellectual Property referred to in clause 11.1 and forthwith return to the Customer any Documents
in its possession or control which contain or record any part of any of the Intellectual Property and Customer confidential information detailed in clause 13.1; 

  
 14 

	 	16.8.2	cease to use any of the Trade Marks; and 

  

	 	16.8.3	consent to the cancellation of any formal licence granted to it, or of any record of it in any register, in respect of any Intellectual Property of the Customer or any of the Trade Marks. 

 

	16.9	The provisions of clause 13 shall continue in force in accordance with its terms, notwithstanding termination of this agreement for any reason. 

 

	17	NATURE OF AGREEMENT 

  

	17.1	This Agreement is personal to the parties and neither of them may, without the Written consent of the other, assign, mortgage, charge (otherwise than by floating charge) or dispose of any of its rights, or sub-contract
or otherwise delegate any of its obligations, under this Agreement, except in the case of a transfer to a bona fide purchaser of the whole of the business of the party in question, and subject to the purchaser first entering into a Written agreement
with the other party to comply with the obligations of the transferor party as if it were a party to this Agreement. 

  

	17.2	Nothing in clause 17.1 above shall prevent Nova from subcontracting any repairs and maintenance of the Equipment as Nova may (at its sole discretion) deem appropriate. 

 

	17.3	Nothing in this Agreement shall create, or be deemed to create, a partnership between the parties. 

  

	17.4	This Agreement contains the entire agreement between the parties with respect to its subject matter, supersedes all previous Agreements and understandings between the parties, including the Technical Agreement and may
not be modified except by an instrument in Writing signed by the duly authorised representatives of the parties. 

  

	17.5	Each party acknowledges that, in entering into this Agreement, it does not do so on the basis of or rely on any representation, warranty or other provision except as expressly provided in this Agreement, and accordingly
all conditions, warranties or other terms implied by statute or common law are excluded to the fullest extent permitted by law. 

  

	17.6	The parties acknowledge that it is not their intention that any third party shall be entitled to enforce any term of this Agreement which may confer a benefit on that third party, whether any such entitlement would, but
for this provision, arise under the Contracts (Rights of Third Parties) Act 1999 or otherwise. 

  

	17.7	If any provision of this Agreement is held by any court or other competent authority to be void or unenforceable in whole or part, the other provisions of this Agreement and the remainder of the affected provisions
shall continue to be valid. 

  

	17.8	Any dispute, difference or disagreement concerning this Agreement shall, in the first instance, be referred to each Party’s chief executive (or their nominee) who will seek to resolve the issue within 30 days.

  
 15 

	17.9	This Agreement shall be governed by and construed in all respects in accordance with the laws of England, and the parties agree to submit to the exclusive jurisdiction of the English courts. 

  
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	18	NOTICES AND SERVICE 

  

	18.1	A notice to be given by either party to the other may be given by hand or sent (by first class pre-paid post, facsimile transmission or comparable means of communication excluding electronic mail) to the other party at
the address referred to in clause 18.4. 

  

	18.2	A notice given by post under clause 18.1 which is not returned to the sender as undelivered shall be deemed to have been given on the second day after the envelope containing it was so posted; and proof that the
envelope containing any such notice or information was properly addressed, and sent by first class, pre-paid post, and that it has not been so returned to the sender, shall be sufficient evidence that such notice or information has been duly given.

  

	18.3	A notice or other information sent by facsimile transmission or comparable means of communication (excluding electronic mail) shall be deemed to have been duly sent on the date of transmission, provided that a
confirming copy is sent by first class pre-paid post to the other party at the address referred to in clause 18.4 within 24 hours after transmission. 

  

	18.4	A notice or other information or any legal proceedings concerning or arising out of this agreement shall be addressed to the company secretary of the party in question at its registered office, or to such other officer
at such other address as may be notified by the party concerned in Writing from time to time. 

  
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	Executed By	 		 	
					
	Signature:	 	/s/ Andrew Robinson	 		 		 	
	Name:	 	Andrew Robinson, on behalf of Nova Laboratories Limited	 		 		 	
	Position:	 	Head of Group Finance	 		 		 	

  

									
					
	Signature:	 	/s/ Tim Sparey	 		 		 	
	Name:	 	Tim Sparey, on behalf of Q Chip Limited	 		 		 	
	Position:	 	CEO

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