Document:

EX-10.1

 

EXHIBIT 10.1

					
	 	 	 	 	 
	NGIN
	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

NEXT GENERATION HIV-1 IMMUNOGEN

INDUCING BROADLY REACTIVE

NEUTRALIZING ANTIBODIES

(“NGIN”)

Consortium Agreement

DISTRIBUTION LIST

	•	 	European Commission (EC)

	•	 	Consortium Contractors

ABOUT THIS DOCUMENT

Purpose

The purpose of this document is to amplify the standard contract (“Grant Agreement”) agreed between
the NGIN participants and the EC by setting out their individual duties and responsibilities, the
rules and responsibilities of committees and other groups and any key working procedures.

Authorship and Disclaimer

This document has been produced at the Fondazione Centro San Raffaele Del Monte Tabor based upon
different model agreements proposed by the European Commission. The model agreement was offered
for use at the sole discretion and on the sole responsibility of the using parties.

Readership

The EC and project participants

Cross References

(Project Proposal, Technical Annex of Grant Agreement)

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

This consortium agreement (“Consortium Agreement”) is made and entered by and among:

FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR whose registered office is at via Olgettina 60,
20132 Milan, Italy, represented by Dr. Renato BOTTI, General Manager , duly authorised for the
purposes hereof;

- Hereinafter referred to as “HSR”

and

ACADEMISCH ZIEKENHUIS BIJ DE UNIVERSITEIT VAN AMSTERDAM whose registered office is at Meibergdreef
9, 1105 AZ Amsterdam, the Netherlands, represented by Prof. Dr. Louise J. Gunning-Schepers, Chair
of the Executive Board and Dean, duly authorized for the purposes hereof;

- Hereinafter referred to as “AMC“

MEDICAL RESEARCH COUNCIL, whose main administrative office is at 20 Park Crescent, London W1B 1AL,
United, Kingdom, acting on behalf of its Human Immunology Unit, and represented by Dr. Anne-Marie
Coriat, Head of MRC Oxfordshire Centre or Mrs Sonja Townsend, External Funding Manager MRC
Oxfordshire Centre, duly authorized for the purposes hereof;

- Hereinafter referred to as “MRC”

ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI “FOND. G. PASCALE”; whose main administrative
office is at via Mariano Semmola 1, 80131 Napoli, Italy; represented by Prof. Mario Luigi
Santangelo, General Director, duly authorised for the purposes hereof;

- Hereinafter referred to as “INT-NA”

CYTOS BIOTECHNOLOGY AG ,  whose main administrative office is at Wagistrasse 25 ,  CH-8952
Zurich-Schlieren, Switzerland; represented by Dr. Martin Bachmann, Chief Scientific Officer, duly
authorised for the purposes hereof;

- Hereinafter referred to as “Cytos”

UNIVERSITA’ DEGLI STUDI DI MILANO, whose registered office is at Via Festa del Perdono 7, 20122
Milan, Italy, represented by Prof. Enrico Decleva, Rector, duly authorised for the purpose hereof;

- Hereinafter referred to as “UMIL”

AVARIS AB, whose main administrative office is at Fogdevreten 2, SE-171 65 Solna, Sweden;
represented by Dr. Mats Lake, CEO, duly authorised for the purposes hereof;

- Hereinafter referred to as “AVARIS”

STATENS SERUM INSTITUT, whose administrative office is at 5 Artillerivej, DK-2300 Copenhagen,
Denmark, represented by Dr Frank Espersen,Executive Vice- President or Dr. Nils Strandberg
Pedersen, President & Chief Executive Officer of Statens Serum Institut;

- Hereinafter referred to as “SSI”

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

COMMISSARIAT À L1ENERGIE ATOMIQUE, whose registered office is at Bâtiment Le Ponant D, 25, rue
Leblanc, Paris 15ème, France; represented by M Roger Genet acting as interim Head of the Life
Sciences Division and duly authorised for the purposes hereof;

hereinafter referred to as “ CEA”

KAROLINSKA INSTITUTET, whose registered office is at Nobels väg 5, 171 77 Stockholm, Sweden;
represented by Dr. Katarina Bjelke, Director of the Department of Research and Postgraduate
Education or Dr. Miles Davies, Head of Grants Office, duly authorised for the purposes hereof;

- Hereinafter referred to as “KI”

PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE, whose registered office is at Nationalestraat
155, B-2000 Antwerpen, Belgium; represented by Prof. Dr. Bruno Gryseels, Director, and/or Mrs.
Lieve Schueremans, General Administrator, duly authorised for the purposes hereof;

- Hereinafter referred to as “ITG“

NATIONAL BIOLOGICAL STANDARDS BOARD, whose registered office is at Blanche Lane, South Mimms,
Potters Bar, Hertfordshire EN6 3QG, England; represented by Victor Knight, Secretary to the Board /
Head of Finance, duly authorised for the purposes hereof;

- Hereinafter referred to as “NIBSC”

MYMETICS MANAGEMENT S.A.R.L. whose main administrative office is at 14 rue de la Colombière, 1260
Nyon, Switzerland: represented by Mr. Ernest Lübke, General Administrator, duly authorized for the
purposes hereof;

- Hereinafter referred to as “Mymetics”

LUNDS UNIVERSITET whose registered office is at Paradisgatan 5C, 221 00 LUND, Sweden, represented
by Mr Mattias Brattström, Head of Faculty Office, duly authorised for the purposes hereof;

- Hereinafter referred to as “ULUND”

UNIVERSITE PARIS DESCARTES — PARIS 5 whose registered office is at 12, rue de l’Ecole de Médecine,
75270 Paris cedex 07, France, represented by Mr Bruno Varet, Administrateur Provisoire, duly
authorised for the purposes hereof;

- Hereinafter referred to as “UPD

Hereinafter referred to individually or collectively as the “Contractor(s)”

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

TABLE OF CONTENTS

	 	 	 
	Preamble
	 	 
	Article 1

	 	- Duration
	Article 2

	 	- Definition
	Article 3

	 	- Purpose
	Article 4

	 	- Negotiations and signature of the Grant Agreement
	Article 5

	 	-Contractors’ obligations for the implementation of the Grant Agreement
	Article 6

	 	- Organisation of the Project
	Article 7

	 	- Financial provisions
	Article 8

	 	- Intellectual property rights, ownership and Access Rights
	Article 9

	 	- Liabilities of the Contractors
	Article 10

	 	- Default and Remedies — Withdrawal of a Contractor
	Article 11

	 	- Confidentiality
	Article 12

	 	- Force Majeure
	Article 13

	 	- No Partnership or Agency
	Article 14

	 	- Language
	Article 15

	 	- Applicable Law
	Article 16

	 	- Annexes, Conflicts and Inconsistencies
	Article 17

	 	- Assignments, Amendments
	Article 18

	 	- Mandatory statutory restrictions
	Article 19

	 	- Notices and other communication
	Article 20

	 	- Disputes
	Article 21

	 	- Counterparts
	Annex A

	 	- Notice Details
	Annex B

	 	- (List of Affiliated Entities)
	Annex C

	 	- (List of Background)
	Annex D

	 	- (Material Transfer Agreement)
	Annex E

	 	- Initial Project Officers and Members of the SC
	Annex F

	 	- List of Limitations and Restrictions with Respect to Access Rights
	Annex G

	 	- List of third Parties with Respect to Transferring Ownership of Foreground

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

Preamble

WHEREAS, in consideration of the REGULATION (EC) No 1906/2006 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), the Contractors, having considerable experience in the field
concerned, have submitted to the European Commission a joint Proposal for the Collaborative Project
entitled “ NEXT GENERATION HIV-1 IMMUNOGENS INDUCING BROADLY REACTIVE NEUTRALIZING ANTIBODIES”
(NGIN), under the Seventh RTD Framework Programme, Thematic Priority HEALTH -2007-2.3.2-6

WHEREAS the Contractors have decided and agreed to execute and perform the Grant Agreement (as such
term is defined in the above mentioned Regulation) awarded by the Commission for the Project as
consequence of the approval by the Commission of the submitted Proposal.

WHEREAS in case the provisions of this Consortium Agreement conflict with any of the rules
contained in the Rules of Participation or in the Grant Agreement, the latter shall apply and the
Consortium Agreement provision, or part of the provision, which is contradictory to the Rules of
Participation or the Grant Agreement shall be disregarded.

WHEREAS in consequence of the academic and scientific tasks and obligations imposed upon the
majority of the Contractors by law and/or academic statutes it is expressly understood that except
as specifically provided in the Grant Agreement or this Consortium Agreement, nothing is intended
to prevent or hamper any of the Contractors, jointly or severally, at its sole discretion and
outside this Consortium Agreement, in defining and carrying out separate research programmes in the
field as set forth in Annex I to the Grant Agreement, using materials and know-how proprietary to
such Contractors or lawfully obtained from any third party.

WHEREAS the Contractors in accordance with the provisions of the Commission contractual rules in
the Grant Agreement, Annex II General Conditions, Article II.2.4 (c) , wish to specify or
supplement, between themselves, the provisions of the anticipated Grant Agreement , with respect to
the carrying out thereof.

Therefore, the Contractors hereby agree as follows:

ARTICLE 1 – DURATION

This Consortium Agreement shall come into force as of:

- the date of its appropriate authorised signature by all the Contractors, but shall have
retroactive effect as from March 6, 2007 and,

- in case of an entity joining the Consortium after the date in which this Consortium
Agreement comes into force, such agreement shall come into force for such entity upon the date of
their signature of the “Accession of the Beneficiaries Form” to the Grant Agreement and the
Consortium Agreement , whichever is the earlier;

This Consortium Agreement shall continue in full force and effect until:

- the Commission decides not to offer a contract for the Project to the Consortium;

- upon a six (6) month period from the date of coming into force hereto, if the Grant Agreement has
not yet been signed by the Commission;

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

- cancellation of the Project by the Commission;

- termination of the entire Grant Agreement by the Commission;

- complete discharge of all obligations for the carrying out of the Project undertaken by the
Contractors under the Grant Agreement and this Consortium Agreement whichever is the earlier.

For the avoidance of doubt, in the event of termination for any of the above-listed reasons, the
provisions of Article 11 of this Consortium Agreement are to remain in force as described therein.

ARTICLE 2 — DEFINITIONS

2.1 GENERAL

The words bearing a capital letter in this Consortium Agreement shall have the same definition and
meaning as those contained in:

- the Rules for Participation REGULATION (EC) No 1906/2006 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).

- (OJEC L 391/1) or in the Grant Agreement, including its Annexes without the need to replicate
said terms herein.

For the avoidance of doubt, there shall be no need to replicate any definition shown in the Grant
Agreement herein and, any said definitions repeated in this Consortium Agreement have been so
repeated for ease of reference only.

2.2 ADDITIONAL DEFINITIONS

“Advisory Board” means the external advisory group established as set forth in Article
6.3.4 hereof

“Allocated Work” means the research work and the related activities and services allocated
either collectively to any Work Package or individually to any Contractor in accordance with:

	 	(i)	 	the Proposal before the signature of the Grant Agreement; or
	 
	 	(ii)	 	Annex I of the Grant Agreement as modified by any subsequently agreed in the
Implementation Plan, after the signature of the Grant Agreement.

“Community Financial Contribution” means the financial contribution provided by the
Community for the Project in accordance with Article 5 of the Grant Agreement

“Consortium Budget”  means the allocation of all the Community Financial Contribution for
the Project activities as defined in Annex I of the Grant Agreement.

“Defaulting Party” means a Contractor which is in breach of this Consortium Agreement or
the Grant Agreement and which has been identified as such by the Steering Committee.

“Deliverables” means reports, including progress reports and certified audit reports, as
well as any information, report, sample or material referred to in the Grant Agreement and in this
Consortium Agreement that have to be delivered to any member of the Management team, Work Package
PI’s and/or the European Commission.

“Ethical Management Committee”  means the internal advisory group established as set forth
in Article 6.3.5 hereof.

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

“Grant Agreement” means the European Contract HEALTH-F3-2007-201433 (including its
Annexes), signed by the Coordinator with the European Commission for the undertaking by the
Contractors of the Project. Grant Agreement also means, as applicable, any Grant Agreement
amendment. To avoid doubt, before its signature, Grant Agreement shall mean the model grant
agreement established by the Commission for the undertaking of collaborative projects under the
Community’s Seventh Framework Programme (FP7).

“Implementation plan” means the annual extrapolation and adjustment of the Project Plan
with respect to changes in Allocated Work and Consortium budget allocations to be prepared annually
for submission to and approval by the European Commission in accordance with the conditions of the
Grant Agreement.

“Management Team” means the administrative management group established by the Coordinator
as set forth in Article 6.3.3 hereof.

“needed for the implementation of the Project” means, in relation to the granting Access
Rights for the Project, that without the grant of such Access Rights carrying out the tasks
assigned to the recipient Contractor would be impossible, significantly delayed, or require
significant additional financial or human resources.

“needed for use” means, in relation to the granting Access Rights for Use, that without
the grant of such Access Rights the Use of the recipient Contractor’s own Foreground would be
technically or legally impossible.

“Project” means the collaborative project with the acronym “NGIN”, which will be
undertaken jointly by all Contractors and will receive funding from the European Community under
the Grant Agreement

“Project Plan” means the plan for undertaking the Project described in the Annex I of the
Grant Agreement.

“Steering Committee” means the project management and the decision-making body established
as set forth in Article 6.3.1 hereof

“Work Package” means any work package created by decision of the Steering Committee in
accordance with the provisions of this Consortium Agreement and the Annex I of the Grant Agreement.

“Work Package PI(s)” means the Contractor who will carry out the scientific coordination
of research activities undertaken by a specific Work Package.

ARTICLE 3 — PURPOSE

The purpose of this Consortium Agreement is to specify the organisation of the work between the
Contractors, to organise the management of the Project, to define the rights and obligations of the
Contractors, including, but not limited to, their liability and indemnification, to supplement the
provisions of the Grant Agreement concerning Access Rights and to set out rights and obligations of
the Contractors supplementing but not conflicting with those of the Grant Agreement.

ARTICLE 4 – NEGOTIATIONS AND SIGNATURE OF THE GRANT AGREEMENT

Without prejudice to the provisions of Article 6.3.2 relating to the role of the Coordinator, the
following shall apply.

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

4.1 PROPOSAL EVALUATION AND NEGOTIATIONS OF THE GRANT AGREEMENT

4.1.1 The Coordinator shall be responsible for the conduct of both the hearings of the Contractors
for evaluation of the Proposal before the panel of experts of the Commission and of negotiations of
the Proposal with the Commission, after completion of the hearings.

4.1.2 Each Contractor shall be kept fully informed of the progress of the evaluation of the
Proposal and of any negotiations and, as far as its Work Package is concerned, shall attend and
participate in the evaluation hearings and in the Grant Agreement negotiations only upon request
from the Coordinator.

4.1.3 The Coordinator shall put at the disposal of the Contractors all significant letters, emails,
faxes or documents relating to the evaluation and/or negotiations and shall also keep each
Contractor informed of everything relevant to its Work Package until the award of the Grant
Agreement.

4.1.4 The Coordinator shall not, without the prior written agreement of each relevant Contractor,
propose or accept any deviation or variation to the conditions or scope of said Contractor’s Work
Package.

4.1.5 In case the negotiations with the Commission result in conditions in the Grant Agreement
which substantially deviate from these of the Proposal and/or this Consortium Agreement, the
Contractors shall in good faith negotiate in view of adapting the conditions of this Consortium
Agreement to those of the Grant Agreement. For the avoidance of doubt, if any Contractor declares,
before their accession to the Grant Agreement, that they cannot accept the proposed changes they
shall be entitled to immediately withdraw from this Consortium Agreement.

4.2 SIGNATURE OF THE GRANT AGREEMENT

As per the Commission contractual rules, the Grant Agreement will enter into force upon signature
by the Coordinator and the Commission, on the day of the last signature.

The Coordinator shall therefore not sign the Grant Agreement unless and until all other Contractors
have approved in writing the contract terms and such approval shall not be unreasonably withheld or
delayed.

ARTICLE 5 – RESPONSABILITIES OF CONTRACTORS

Without prejudice to the provisions of Article 6.3.2 relating to the role of the Coordinator, the
following shall apply.

5.1 Without prejudice to any other obligations under the Grant Agreement and this Consortium
Agreement, the Contractors undertakes to use all endeavours and resources that are reasonably
necessary to ensure the efficient implementation of the Project and to cooperate, perform, fulfil,
promptly and in due time all their obligations so that the Project is carried out in accordance
with the terms and conditions of the Grant Agreement and this Consortium Agreement.

5.2 The Contractors shall provide the Coordinator with the Deliverables, including all information
and reports as the Coordinator requires in order to perform its duties under this Consortium
Agreement and under the Grant Agreement or as the Commission may request (and in such case the
relevant Contractor shall keep the Coordinator informed of any such request from the Commission).

5.3 On request of the Coordinator, all Deliverables, including information, and reports shall be
submitted in electronic form in RTF or PDF format, graphics in GIF or JPEG format or any other
format mutually agreed.

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

	5.4	 	Each Contractor undertakes:

	 	i.	 	to notify the Coordinator promptly of any delay in performance of their Allocated Work
or of any adverse event that may impact the Project;
	 
	 	ii.	 	to inform the Coordinator of relevant communications it receives from third parties in
relation to the Project;
	 
	 	iii.	 	to take reasonable measures to ensure the accuracy of any information, reagents or
materials it supplies to the other Contractors or under the Grant Agreement and to promptly
correct any error therein of which it is notified. The recipient Contractor shall be
responsible for the use to which it puts such information, reagents and materials;
	 
	 	iv.	 	not to use knowingly any proprietary rights of a third party for which such Contractor
has not acquired the corresponding right of use and/or to grant licenses in accordance with
the Grant Agreement and this Consortium Agreement;
	 
	 	v.	 	to act at all times in good faith and in a manner that reflects the good name, goodwill
and reputation of the other Contractors and in accordance with good scientific and business
ethics;
	 
	 	vi.	 	to participate in a co-operative manner to the meetings of the different Project bodies
under this Consortium Agreement and not to exercise veto rights, which are absolute,
inappropriately.

	5.5	 	Each Contractor undertakes:

	 	i.	 	to ensure that its 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 Grant Agreement including those governing health and safety, data
protection, and where relevant, the use of human subjects and good clinical practice
(including national legislation implementing the Parliament’s Directive 2001/20/EC on good
clinical practice). In this regard, each Contractor shall maintain the full
confidentiality of all samples and data relating to the use of human subjects, which is
created or used in the course of the Project.
	 
	 	ii.	 	to secure all necessary approvals from the relevant research ethics committees before
undertaking any part of the Project requiring ethics committee approval and 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 Contractor involved shall first obtain all necessary approvals,
indemnities and agreements from that hospital.

ARTICLE 6 — ORGANISATION OF THE PROJECT

6.1 GENERAL PRINCIPLES

The Project is structured by Work Packages allocated among the Contractors.
The Steering Committee shall handle major changes in Work Packages, particularly creation,
reallocation, or termination thereof.

6.2 EUROPEAN COMMISSION REPRESENTATIVE

The Commission may participate as an observer at all the meetings of the Steering Committee.

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

6.3 PROJECT BODIES

6.3.1 Steering Committee (SC)

The Steering Committee will be composed by one (1) representative from each Work Package (Members
of the Steering Committee) and is the main decision-making body. To avoid doubt, the initial
members of the SC are shown in Annex E. The Coordinator shall chair all meetings of the Steering
Committee. Each member of the SC shall have one (1) vote and may appoint a substitute to attend and
vote at any meeting of the Steering Committee.

The Coordinator shall convene ordinary meetings of the Steering Committee at least every twelve
(12) months and shall also convene extraordinary meetings at any time upon written request of any
Contractor in the case of an extraordinary situation.

The Coordinator shall give each of the members at least thirty (30) calendar days notice in writing
of such meetings or fifteen (15) calendar days notice in case of an emergency situation.

Any decision requiring a vote at a Steering Committee meeting must be identified as such on the
invitation.

Should a member suggest adding a discussion/decision to the proposed agenda, it shall do so in
writing to all other members (via Coordinator) at least seven (7) calendar days prior to the
meeting date.

However, any decision required or permitted to be taken by the Steering Committee may be taken in
accordance with the above (i) in meetings via teleconference and/or via email; (ii) without a
meeting with prior notice and/or (iii) without a vote, if, in any such (ii) and (iii) cases, a
consent in writing, setting forth the decision so taken, is signed by the representatives of the
Members having not less than the minimum number of votes that would be necessary to take such
decision at a meeting at which all Members entitled to vote on such decision were represented and
were voting, and provided the consent has been delivered for signature to all Member’s
representatives.

The Steering Committee shall be in charge of the overall direction and major decisions with regard
to the Project.

Such decisions shall encompass the following:

	 	i.	 	Allocating the Project’s budget in accordance with the Grant Agreement (including the
Project Plan shown in its Annex I as modified and agreed Implementation Plan), deciding
upon the allocation of the Community Financial Contribution for management of the Project,
and reviewing and proposing to the Contractors Consortium Budget transfers;
	 
	 	ii.	 	Deciding upon a change of the list of Affiliated Entity, when requested;
	 
	 	iii.	 	Making proposals to the Contractors for the review and/or amendment of terms of the
Grant Agreement and/or this Consortium Agreement;
	 
	 	iv.	 	Deciding to suspend all or part of the Project or to terminate all or part of the Grant
Agreement, or to request the Commission to terminate the participation of one or more
Contractors;
	 
	 	v.	 	In case of default of a Contractor deciding on actions to be taken against the
Defaulting Contractor (in accordance with Article 10), including a request to the
Commission for an audit or for the assistance of the Commission, and making proposals to
the other Contractors to assign the Defaulting Contractor’s incomplete Allocated Work, and
if appropriate to agree upon a new entity to join the Project for that purpose;
	 
	 	vi.	 	In case of default of the Coordinator in the performance of its tasks as a Coordinator,
deciding on actions to be taken and possible nomination of a new Coordinator;
	 
	 	vii.	 	Deciding upon the entering into the Grant Agreement and the Consortium Agreement of new
Contractors;

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

	 	viii.	 	Without prejudice to Article 8, setting procedures and policies in accordance with the
Grant Agreement, Annex II General Conditions — Part C for the management of the Foreground;
	 
	 	ix.	 	Deciding upon the designation of the deposit account and rules for the management of
the Community Financial Contribution and for the management budget rules in accordance with
Article 7 herein;
	 
	 	x.	 	Deciding upon major changes in Work Packages, particularly creation, reallocation, or
termination of Work Packages;
	 
	 	xi.	 	Deciding on technical roadmaps of the Project;
xii. Deciding upon the selection of additional expertise (Subcontractors);
	 
	 	xiii.	 	Without prejudice to the rules under Article 8, agreeing press releases and
publications by the Contractors or by the Commission or with the Commission with regard the
Project as per the Grant Agreement, Annex II General Conditions — Part A, Section 1,
Article II.12
	 
	 	xiv.	 	Supporting the Coordinator in preparing meetings with the Commission and related data
and Deliverables.

The Steering Committee shall not deliberate and decide validly unless a majority of two-thirds
(2/3) of its Members are present or represented. Where decisions are to be taken unanimously, all
Members must be present or represented at the meeting. In case of an equally split vote for
decisions requiring only a simple majority, the Coordinator has the deciding vote.
In the cases of sub paragraphs i to x, decisions shall be taken unanimously by all of the Members,
excluding the Defaulting Contractor (if it is a Member of the SC) as appropriate or excluding in
the iv) sub paragraph the Contractor(s) whose participation would be terminated.

In all other cases, decisions shall be taken by a simple majority of the votes of the
representatives in the Steering Committee, present or represented, provided always that a
Contractor whose Allocated Work, time for performance, costs or liabilities, or intellectual
property rights are adversely impacted or whose information is to be published, may veto such
decisions if such veto is duly and reasonably justified.
Subject to the veto rights shown above and the provisions of Articles 8.8.5 and of Article 20
herein, the Contractors agree to abide by all decisions of the Steering Committee.

The Coordinator shall draft the minutes of each meeting to formalize in writing all voting and
resulting decisions taken and shall dispatch them to all Members within fifteen (15) calendar days
of the concerned meeting.

The minutes shall be considered as accepted by the Members if, within seven (7) calendar days from
receipt thereof, no Member has intimated in writing to the Coordinator that the minutes do not
properly reflect the discussions and decisions of the relevant meeting. Where any such Member shall
have so intimated, the Coordinator shall have a further seven (7) days within which to issue
amended minutes, or to respond to such member explaining his/her refusal to do so. The Coordinator
shall promptly, after expiry of the said period, (or, where any Member shall have intimated that
the minutes are inaccurate, following resolution of such issue to the satisfaction of the
Coordinator, whose decision shall be final), forward a copy of the approved minutes to each
Contractor, not only to each Member.

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

6.3.2 Coordinator

The Coordinator shall be the intermediary between the Contractors and the Commission and shall
perform all tasks assigned to it as described in the Grant Agreement and hereunder. The Coordinator
will be supported in the management of such tasks, including the relationship between the
Contractors in respect of the Project, by the Coordinator’s representative, the Project
Co-coordinator and the Management Team. Whilst the initial individuals acting as the Coordinator’s
representative and the Project Co-coordinator have been named in the Proposal, they have also (for
convenience) been named in Annex E.

In particular, the Coordinator shall be responsible for:

	 	i.	 	Submitting all Deliverables, including reports and information, to the Commission;
	 
	 	ii.	 	The administration, preparation of minutes and provision of the chairman of the
Steering Committee, and follow-up of its decisions;
	 
	 	iii.	 	The transmission of any documents and information connected with the Project to and
between the Contractors concerned;
	 
	 	iv.	 	Withholding advance payments of the Community Financial Contribution and transferring
the sums allocated among the Contractors as per the Consortium Budget, as may be modified
by any Implementation Plan agreed in the Steering Committee and keeping related records
identifying what portion of the of the Community Financial Contribution has been allocated
and/or paid to each Contractor;
	 
	 	v.	 	Overseeing on a day-to-day basis the progress of the technical work under the Project;
	 
	 	vi.	 	Reviewing Deliverables at each agreed step under the Project Plan and advising the
Contractors of any delay in delivery that could not be remedied or any major discrepancy.

The Coordinator shall neither be entitled to act or to make legally binding declarations on behalf
of any other Contractor nor to enlarge its role beyond the one described herein and in the Grant
Agreement.

6.3.3 Management Team

The Management Team that will be established by the Coordinator, is essentially composed by the
members of the Grant Office and of the Research Administrative Office of the Coordinator, plus a
manager (Project Manager) and it shall provide the necessary support for day-to-day Project
administrative management for the Coordinator and all Consortium bodies as well as reporting
activities to the Commission. The Coordinator shall chair meetings of the Management Team. Whilst
the initial individual acting as the Project Manager has been named in the Proposal, they have also
(for convenience) been named in Annex E.

In particular the Management Team shall:

	 	(a)	 	Manage the administrative, legal, financial and other non-scientific aspects of the Project
in accordance with the provisions of the Grant Agreement and this Consortium Agreement;
	 
	 	(b)	 	Assist the Steering Committee in the steering, administration and management of the
Consortium (including monitoring Project activities, issuing reminders for task initiation or
completion, reporting etc.);
	 
	 	(c)	 	Assist the Coordinator in preparing Deliverables;
	 
	 	(d)	 	Assist the Steering Committee in implementing the competitive selection procedure for new
Consortium members;
	 
	 	(e)	 	Provide management support in relation to the activities for technical and/or exploitation
/ Dissemination issues, as applicable;

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	 	(f)	 	Assist the Contractors with individual advice and assistance with respect to Intellectual
Property Right (IPR) issues. This may include advice and assistance with respect to IPR
protection and potential commercialisation of Foreground. For the avoidance of doubt, it is
stated that any assistance and support provided by Management Team, with respect to
Foreground protection and exploitation, will be without prejudice to any dissemination and
exploitation services that the Contractors may individually have, and each Contractor shall
be free to rely on its own ways and contacts in order to protect and exploit its own
Background and Foreground in accordance with the Grant Agreement and the Consortium
Agreement, including any decision by the Contractor concerned to adopt standardised IPR
procedures.

6.3.4 External Advisory Board

An External Advisory Board will provide advice and external expertise on strategic direction to the
Steering Committee in respect of significant scientific issues affecting the Project. It will be
appointed by the Steering Committee during the first months of the Project.

The Board will be composed of maximum three (3) members, representing the wider HIV scientific
community. Members of the External Advisory Board will be invited in an advisory capacity to attend
a Steering Committee Meeting and at the annual project meetings, when necessary and they are
subject to appropriate confidentiality undertakings.

6.3.5 Ethical Management Committee

The Ethical Management Committee is an internal Project body consisting of representatives coming
from the ethic committees of each Contractor or in any case a representative appointed with special
expertise in animal experiments or clinical studies (one representative appointed by each of the
Contractors). The meeting of the Ethical Management Committee will be chaired by the Coordinator.

The Ethical Management Committee is the Consortium’s main working committee to ensure that all
Project activities follow the National, European and international ethical rules and guidelines of
the related WPs, with special regards in the design of animal experimentation and clinical studies
and is under the control of the Steering Committee and the contractual obligation.

The task of the Ethical Management Committee includes:

	 	•	 	control and review of ethical aspects of the Project
	 
	 	•	 	design rules in case the Project activities violate any ethical provisions of the Grant
Agreement or applicable National, European or international rules or guidelines
	 
	 	•	 	annual review of animal and clinical studies performed in the framework of the Project
	 
	 	•	 	preparation of an annual ethical implementation plan of the Project

ARTICLE 7 – FINANCIAL PROVISIONS

7.1 GENERAL PRINCIPLES

7.1.1 The Community Financial Contribution shall be distributed by the Coordinator according to:

- the Consortium Budget as described in the Project Plan as may be modified by any Implementation
Plan agreed in the Steering Committee,

- the approval of the corresponding Project reports by the Commission, and

- the provisions of payment shown in Article 7.3 herein.

7.1.2 Each Contractor shall in accordance with its own usual accounting and management principles
and practices, shall bear all its own costs incurred in connection with the performance of their
obligation s under this Consortium Agreement and the Grant Agreement, including costs incurred in
connection with

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the implementation of the Allocated Work. Any exchange rate gains or losses arising from currency
transactions within the Project will be the sole asset/liability of the individual Contractor
concerned.

7.1.3 A Contractor that spends less than its allocated share of the Consortium Budget, allocated to
it in accordance with Article 6.3.1.i of this Consortium Agreement, will be funded in accordance
with its actual duly justified eligible costs only.

A Contractor that spends more than its allocated share of the Consortium Budget, allocated to it in
accordance with Article 6.3.1.i of this Consortium Agreement, will be funded only in respect of
duly justified eligible costs up to an amount not exceeding that share.

7.1.4 A Contractor leaving the Consortium shall refund all advances paid to it from the Community
Financial Contribution except the amount of expended eligible costs accepted by the Commission.

Furthermore a Defaulting Contractor shall, within the limits specified in Article 10 of this
Consortium Agreement, bear any additional costs occurring to the other Contractors in order to
perform the Defaulting Contractor’s incomplete Allocated Work.

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 Contractors and shall be
recorded in the Consortium Budget.

7.2.1 Budgeted costs eligible for 100% reimbursement

These costs shall be budgeted in the Consortium Budget in the following order of priority:

	-	 	banking and transaction costs related to the handling of the Community Financial Contribution
by the Coordinator on behalf of the other Contractors
	 
	-	 	a reasonable cost of Contractors related to

	 	•	 	the delivery of certification of financial statements according to the Grant
Agreement
	 
	 	•	 	the certification of the financial/administrative methodology (unless the
methodology has already been used by the Contractor in a previous grant agreement
and has not changed) (Grant Agreement Annex II.14.1.e) and/or
	 
	 	•	 	the certification of the simplified method of calculation of a Contractor’s full
indirect eligible costs (Grant Agreement Annex II.15.2.a) if any

- costs related to competitive calls for new Contractors

- costs related to updating this Consortium Agreement

- costs related to the Consortium management activities undertaken by the Coordinator including
the Management Team, if any

- costs for Dissemination activities (including publication) and

- any other costs eligible for 100% reimbursement from the Community Financial Contribution

7.2.2 Budgeting of coordination costs

Costs for coordination of research which are not allowed as management cost according to Article
II.16.5 of the Grant Agreement, have to be budgeted separately, under the “research and
technological development activities” category

7.2.3 Budgeting of intellectual property protection costs

Costs for protection of Foreground have to be budgeted, even if it is not predictable which
Contractor will need such cost during the corresponding Consortium Budget period.

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7.3 PAYMENTS

Payments to the Contractors from the Community Financial Contribution are the exclusive tasks of
the Coordinator.

In particular, the Coordinator shall:

- notify the Contractor concerned promptly of the date and composition of the amount transferred to
its bank account, giving the relevant references

- perform diligently its tasks in the proper administration of the Community Financial Contribution
and in maintaining financial accounts

- undertake to keep the Community Financial Contribution separated from its normal business
accounts, its own assets and property, except if the Coordinator is not entitled to do so due to
statutory legislation or as a Public Body.

All payments due from the Community Financial Contribution shall be made without undue delay after
receipt by the Coordinator of the corresponding funds from the Commission in accordance with the
decisions of the allocation shown in Annex I of the Grant Agreement as may be modified by the
Steering Committee on the Consortium Budget, which includes the payment schedule.

Payments to Contractors will be handled according to the following modality:

All payments due for past performance of the Allocated Work approved by the Commission will be
compared with the advance payment already given to a Contractor for such past performance; the
difference will be balanced directly with the Contractor concerned.

Subject to any decision of the Steering Committee the Coordinator is entitled to withhold any
advances payment due to a Defaulting Contractor.

The Coordinator is entitled to recover any advances already paid to a Defaulting Contractor, except
the amount of expended eligible costs accepted by the Commission.

ARTICLE 8 — INTELLECTUAL PROPERTY RIGHTS, OWNERSHIP AND ACCESS RIGHTS

8.1 GENERAL

Each Contractor is bound by the terms and conditions of the Grant Agreement, Annex II General
Conditions — Part C entitled “Intellectual Property Rights, Use and Dissemination” as hereby
complemented or modified or extended.

8.2 OWNERSHIP AND PROTECTION OF BACKGROUND

8.2.1 The Contractors agree that the Background available with and owned by each and every of the
separate Contractors (developed by their specific research groups directly participating in the
Project as specified in the positive list of Contractors  — Annex C — to this Consortium Agreement
and the Grant Agreement) needed for the implementation of the Project, has – in as far as
reasonably feasible and or possible – been described in Annex I to the Grant Agreement and listed
in Annex C of this Consortium Agreement.

8.2.2 Contractors agree that all other Background (to avoid of doubt any information, copyrights
and/or intellectual property rights held by the Contractors prior to their accession to the Grant
Agreement), that is not listed in Annex C, shall be considered as unnecessary for the
implementation of the Project and thereby will be excluded from any obligation to grant Access
Rights under the Grant Agreement and/or this Consortium Agreement.

8.2.3 The Background that is made available for the Project by the Contractor owning such
Background, will always remain the property of such providing Contractor

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8.3 OWNERSHIP AND PROTECTION OF FOREGROUND

8.3.1. Foreground shall be the property of the Contractor(s) generating it.

8.3.2. In case of joint ownership of Foreground, the provisions of Article II.26.2 of the Grant
Agreement shall apply.

8.3.3. The Contractors shall make reasonable endeavours to protect the Foreground arising out of
the execution of their respective Work Package under the Project, according to their own policy and
legitimate interests and in observance of their obligations under Article II.28.2 of the Grant
Agreement and this Article 8.3.

Each Contractor shall be entitled to protect its own Foreground under its own name and at its sole
expense unless specifically agreed otherwise between the Contractors concerned.

Such Contractor shall always inform the Coordinator and the other Contractors in a timely fashion
and, where necessary, under an appropriate confidential, non-disclosure Agreement of any patent
filing or other application or agreement for the protection of the Intellectual Property Rights
in relation to the Foreground.

8.3.4 In the case where a Contractor (“Originator”) would decide at its sole discretion that it
does not intend to seek adequate and effective IPR protection of certain of its Foreground from the
Project, then, the Originator shall inform in writing the other Contractors, through the
Coordinator, of such decision and any Contractor interested in applying to obtain and maintain
such protection shall advise the Originator through the Coordinator, of such interest and in
writing within one (1) month of receipt of relevant notice. The Contractor/s interested in so
applying, shall then strive to set up between them and the Originator appropriate agreements in
order to do so.

Should no other Contractor show an interest to so apply, no Dissemination activities related to
such Foreground may take place before the Commission has been informed by the Coordinator. The
Coordinator shall inform the Commission at the latest forty-five (45) calendar days before the
intended Dissemination. The foregoing shall be without prejudice to the Access Rights of all
Contractors that will remain unaffected.

8.3.5 The Contractors acknowledge that all patent applications relating to Foreground must include
the statement shown in Article II.28.2 of the Grant Agreement.

8.4 TRANSFER OF FOREGROUND

Each Contractor may transfer ownership of its own Foreground to any third party, but only after
prior written communication to all the other Contractors, in accordance with Article II.27.1 of the
Grant Agreement. The other Contractors hereby waive their right to object to such transfer to the
third parties listed in Annex G, according to Article II.27.3 of the Grant Agreement, provided the
transferring Contractor ensure the Access Rights of the other Contractors will not be adversely
affected by such transfer.

The transferring Contractor shall, however, always notify the other Contractors of such transfer
and shall ensure that the rights of the other Contractor will not be affected by such transfer.

8.5 DISSEMINATION

Dissemination activities, including but not restricted to written publications and oral
presentations directly arising from the Project shall be governed by Article II.30 of the Grant
Agreement as

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supplemented by this Article 8.5. Authorship on publications will be based on academic standards
and custom.

The Contractors acknowledge their common interest in publishing Foreground to obtain recognition
and to advance the state of Foreground in the field as set forth in Annex I to the Grant Agreement.
The Contractors also recognise their common interest in obtaining valid intellectual property
protection and in protecting their legitimate interests.

The Contractor or Contractors wishing to make a publication, whether written or oral, concerning
Foreground developed within the Consortium will provide the other Contractors with a copy of the
abstract or manuscript and a reasonably detailed description at the earliest possible time, but in
any event within at least 30 (thirty) calendar days prior to any public disclosure of such
Foreground in whichever format.

For the avoidance of doubt, a Contractor may not publish or communicate Foreground generated by
another Contractor or any Background of such other Contractor, even if such Foreground or
Background is amalgamated with such Contractor’s Foreground, without the other Contractor’s prior
written approval.

For the avoidance of doubt, for the period of secrecy reasonably needed for a preparation and
submission of a successful patent application, there cannot be any publication during such period
without prior written approval of the Contractor(s) owning such Foreground. In any case after the
patent application and before release into the public domain, any publication is subject to prior
written approval of the Contractor(s) owning Foreground and/or Background.

If any Contractor has reasonably shown within thirty (30) calendar days of notification that its
legitimate interests in relation to its Foreground or Background could suffer disproportionately
great harm and if the Contractors have not agreed on other measures, the Contractor intending to
disseminate shall take the appropriate step of deleting such other Contractor’s Foreground or
Background from the intended dissemination.

Dissemination activities including but not restricted to publications and presentations shall be
governed by Article II.30 of the Grant Agreement.

Nothing in this Consortium Agreement shall be construed as conferring rights on a Contractor to use
in advertising or publicity, including any release to the press, the name of another Contractor or
any of their logos, without the corresponding Contractor’s prior written approval.

8.6 DISSERTATION OR THESIS

The Contractors 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.

8.7 USE AND DISSEMINATION OF REAGENTS

In accordance with the provisions shown in the Grant Agreement and in this Consortium Agreement
relating to the granting of Access Rights, all reagents jointly or solely generated by the
Contractors within the Project will be made available only to the Contractors, if needed for the
Implementation of the Project. Subject to any corresponding limitations or restrictions, such
Access Rights will be granted under the Material Transfer Agreement (MTA), enclosed as Annex D
Reagents generated by a single Contractor may be distributed for any other purposes by such
Contractor under its own MTA or license agreements, provided that such agreements guarantee
maintenance of Access Rights to all Contractors in accordance with the Grant Agreement and this
Consortium Agreement.

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To avoid of doubt, except as otherwise specifically allowed under the Grant Agreement and this
Consortium Agreement each Contractor will not license, assign or otherwise transfer to any third
party his proprietary rights in either the research involving the reagents or the intellectual
property, or in any invention potentially evolving therefore, which was jointly developed with one
or more Contractors under this Project.

8.8 ACCESS RIGHTS

8.8.1 General principles

As provided in Article II.32.3 of the Grant Agreement, Contractors 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. All such limitations
and restrictions shall be recorded in Annex F herein as soon as reasonably possible after their
notification.

Access Rights will be granted in accordance with Part C, Section 2 of the Grant Agreement, as
supplemented by this Article 8.8 and Annex F herein, and will expressly exclude any rights to
sublicense unless expressly stated otherwise. To avoid doubt, the granting of any Access Rights
shall be subject to any written corresponding limitations or restrictions.

Access Rights shall be free of any administrative transfer costs.

Access Rights are granted on a non-exclusive basis, if not otherwise agreed in writing by all the
Contractors according to Article II.32.7 of the Grant Agreement.

Foreground and Background shall be used only for the purposes for which Access Rights to it have
been granted.

All Access Rights shall only be granted upon written request. Subject to the provisions of Article
8.7 herein, the granting of Access Rights shall be made conditional on the acceptance of specific
conditions in a written bilateral agreement between the Contractors concerned.

The requesting Contractor must clearly show that the requested Access Rights are either Needed For
Implementation of the Project or are Needed For Use.

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 Contractor and subject to such terms and
conditions as may be agreed between the owning and receiving Contractors.

All the requests for Access Rights shall be made up to one (1) year after a) the end of the
Project; or b) termination of Contractors by the owner of the Background or Foreground concerned.

8.8.2 Identification of Background

The Contractors shall identify in the Annex C the Background to which they are ready to grant
Access Rights, subject to the provisions of this Consortium Agreement and the Grant Agreement. Such
identification shall also be done by naming a specific research group of a Contractor.

The owning Contractor shall add further Background to the Annex C during the Project, by written
notice to the Steering Committee.

The Contractors agree that all Background not listed in Annex C shall be explicitly excluded from
Access Rights.

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8.8.3 Access Rights needed for Implementation of the Project

The Contractors agree that, upon written request, the Access Rights on Foreground and Background
Needed For the Implementation of the Project by a Contractor shall be granted on a royalty-free
basis to that Contractor.

8.8.4 Access Rights Needed for Use

Access Rights to Foreground if Needed For Use of a Contractor’s own Foreground shall be granted,
upon written request:

- in general on fair and reasonable market conditions to and by all Contractors, subject to a
bilateral agreement between the Contractors concerned;

- on royalty-free conditions in the case of further research activities which only include:

	 	•	 	internal non-commercial research activities and teaching activities and
	 
	 	•	 	third-party non-commercial research activities, provided the third party does
not have direct Access Rights to Foreground from the Project generated by other
Contractors.

Access Rights to Background Needed For Use of a Contractor’s own Foreground shall be granted, upon
written request stating the extent of the Access Rights needed and provide reasonable evidence on
its Needs, on fair and reasonable market conditions to and by all Contractors, subject to a
bilateral agreement between the Contractors concerned, except when the Contractor owning the
background is not able to grant Access Rights Needed For Use due to third party rights, or other
limitations or restrictions that prevent the granting of such rights.

8.8.5 Disputes on Access Rights and/or ownership of proprietary rights in and to Background,
Foreground, Inventions or matters pertaining to joint Intellectual Property 

In the event of a dispute between Contractors with respect to Access Rights Needed for the
Implementation of the Project or Needed for Use, the following procedure shall apply:

the Contractor involved shall first submit the matter to the Steering Committee for settlement
through mediation. Upon receiving notice of any such dispute, the Steering Committee shall appoint
a Panel of three (3) technology transfer representatives of the Contractors, who are not involved
in such dispute, in order to mediate in the subject matter, and to analyse, report and advice on
same. A final relation of the dispute will be submitted by the Panel to the Steering Committee for
its advisory decision. A member of the Steering Committee, who is associated with any of the
Contractors in dispute, shall not participate in its deliberations or vote on its advisory
decision. The decision of the Steering Committee shall– unless otherwise agreed in writing — be
considered and valuated by all Contractors concerned. In case the Contractors involved,
notwithstanding the work of the Panel and the decision of the Steering Committee, fail to reach an
amicable settlement, the dispute shall be finally settled in accordance with the Article 20 herein.

8.8.6 Affiliated Entity Access Rights

When an Affiliated Entity has Access Rights according to the Article II.34.3. of the Grant
Agreement, than the condition stated in this Consortium Agreement will equally apply to this
Affiliated Entity.

Affiliated Entities shall in return grant Access-Rights to all Contractors and fulfil all
confidentiality and other obligations accepted by the Contractors under the Grant Agreement or this
Consortium Agreement as if such Affiliated Entities were Contractors. Access Rights granted to any
Affiliated Entity are subject to the continuation of the Access Rights of the Contractor of which
it is an Affiliated Entity, and shall automatically terminate upon termination of the Access Rights
granted to such Contractor.

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.

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8.8.7 Access Rights for Contractors entering or leaving the Consortium

8.8.7.1 New Contractors entering the Consortium

All Foreground developed before the Accession of the new Contractor shall be considered to be
Background with regard to said new Contractor.

8.8.7.2  Contractors leaving the Consortium

Access Rights granted to a Defaulting Contractor and such Contractor’s right to request Access
Rights shall cease immediately upon receipt by the Defaulting Contractor of the decision of the
Steering Committee to terminate its participation in the Consortium.

A Contractor leaving voluntarily the Consortium and with the other Contractors’ consent shall have
the right to request Access Rights to the Foreground developed until the date of the termination of
its participation, which is Needed for Use of such withdrawing Contractor’s own Foreground.

The time-limit for its right to request these Access Rights shall be as shown in Article II.34.4 of
the Grant Agreement and shall start on the same date.

For avoidance of doubt any Contractor leaving the Project shall continue to have the obligation to
grant Access Rights pursuant to the Grant Agreement and this Consortium Agreement as if it had
remained a Contractor for the whole duration of the Project.

ARTICLE 9  — LIABILITIES OF THE CONTRACTORS

9.1 NO IMPLIED WARRANTY

No warranty or representation of any kind is made, given or implied as to the sufficiency or
fitness for purpose of any information or materials supplied under the Project or, subject to
Article 5.4 (iv) herein, as to the absence of any infringement of any proprietary rights of third
parties. The recipient Contractor shall in all cases be entirely and solely liable for the use to
which it puts such information and materials.

9.2 EXCLUSION OF INDIRECT DAMAGES

Subject always to such other undertakings and warranties as are provided for in this Consortium
Agreement and the Grant Agreement, each Contractor agrees to assume all of the financial
consequences of its liability in all cases its liability is asserted on the basis of damage caused
to the other Contractors in the scope of such first Contractor’s performance of this Consortium
Agreement.

No Contractor shall be responsible to any other Contractor 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.

A Contractor’s aggregate liability towards the other Contractors collectively in respect of any and
all claims made under this Consortium Agreement, shall not exceed the amount of the Contractor’s
share of of the Community Financial Contribution.

The exclusions and limitations of liability stated above shall not apply in the case of damage
caused by a wilful act or gross negligence.

The terms of this Consortium Agreement shall not be construed to amend or limit any statutory
liability.

9.3 LIABILITY TOWARDS THIRD PARTIES

Each Contractor shall be solely liable for any loss, damage or injury to third parties resulting
from the performance of the said Contractor’s obligations under this Consortium Agreement or from
its use of Foreground or Background.

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9.4 LIABILITY FOR SUBCONTRACTORS

Each Contractor that enters into a subcontract or otherwise involves third parties in the Project
shall remains fully responsible for the performance of any part of its Work Package, or for the
performance of its obligations under the Grant Agreement and this Consortium Agreement. In any case
appointment of a Subcontractor shall be subject to the approval of the Steering Committee.

Therefore said Contractor shall ensure that (i) such subcontracts or involved third parties fully
comply with the requirements of the Grant Agreement and this Consortium Agreement; (ii) the other
Contractors’ Access Rights are fully preserved; and (iii) the said subcontractor(s) and/or involved
third party(ies) shall have no access to any other Contractor’s Foreground or Background without
the latter’s prior written consent.

ARTICLE 10 — DEFAULTS AND REMEDIES – WITHDRAWAL OR EXCLUSION OF A CONTRACTOR

10.1 GENERAL PRINCIPLE

Any Contractor may request to terminate its participation in the Grant Agreement and the Consortium
Agreement, by giving three (3) months written notice of termination to the other Contractors, by
registered mail with acknowledgement of receipt, indicating the reasons for termination.
 

The Steering Committee may object to such termination by a unanimous vote of the members present or
represented, minus the vote of the withdrawing Contractor (if it is a Member of the SC), indicating
the reasons for objection, within a period of forty-five (45) calendar days from receipt of
notification. To avoid doubt the consent to the termination of the participation of a Contractor
shall not be unreasonably withheld by the Steering Committee.

If the Steering Committee agrees, the Coordinator shall inform the Commission by registered mail
with acknowledgement of receipt in accordance with the provisions of the Grant Agreement. The
Commission has forty-five (45) calendar days from receipt to issue an objection.

Where the Consortium disagrees, the Coordinator shall submit to the Commission a request for
assistance, in accordance with the provisions of the Grant Agreement.

10.2 DEFAULT AND REMEDIES

The withdrawing Contractor agrees to treat as confidential all Confidential Information, as defined
in Article 11 hereinafter, received from another Contractor, for a period of five (5) years from
the date of its withdrawal, and agrees not to apply for any patent or other proprietary right over
any other Contractor’s information it may have had knowledge of in connection with its
participation in the Project, without the corresponding Contractor’s prior written permission.
Any Contractor withdrawing from the Consortium:

       - keeps its entitlement to royalties generated by the Use (excluding in respect of rights
granted for further research activities on a royalty-free basis under Article 8.8.4 herein) by
Contractors, other co-owners or third parties of the Foreground produced in the scope of the
Project of which it is the owner or co-owner. In respect of jointly owned Foreground, share of
royalties will be calculated proportionally to the withdrawal Contractor’s co-ownership share, or
pursuant to the corresponding co-ownership agreement(s) or licence(s) concluded prior to its
withdrawal;

       - shall return all equipment or materials provided by the other Contractors, or destroy them
upon their written request, at its own costs.

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Within the financial limits shown in Article 9.2 herein, the withdrawing Contractor shall pay:

- any possible procedure fees to select a new Contractor(s) to carry out the withdrawing
Contractor’s incomplete Allocated Work; in an amount determined by the Steering Committee;

- a financial compensation if the withdrawal adversely affects the conduct of the Project, in an
amount determined and justified by the Steering Committee. To avoid doubt, the maximum
fees/compensation payable by a withdrawing Contractor under the preceding paragraph shall be
limited to the amount of the Community Financial Contribution received by the withdrawing
Contractor since the beginning of the Project plus relinquishment of any further payments
originally allocated to such Contractor from the Community Financial Contribution.
 

The withdrawing Contractor is required to honour its financial commitments contracted prior to the
effective date of its withdrawal from the Project.

The withdrawing Contractor is required to refund all advances paid to it from the Community
Financial Contribution except the amount legitimately spent for the performance of its Allocated
Work, with appropriate justifications.

The withdrawing Contractor agrees to provide justifications in connection with the period during
which it participated in the Project and any other element required to prepare the corresponding
Deliverables, even after the date of its withdrawal from the Project.

The Contractors agree to endeavour to complete ongoing doctoral dissertations commenced in the
scope of the Project, under the best possible conditions.
 

The relevant consequences of the withdrawal of a Contractor are the same for its Affiliated
Entity(ies).

10.3 EXCLUSION OF A CONTRACTOR

The exclusion of a Contractor may be decided and approved by the Steering Committee by an
unanimously vote of the members present or represented, minus the vote of the concerned Contractor
(if it is a Member of the SC), and pursuant to the terms set forth in the Grant Agreement.

The exclusion of a Contractor has the same consequences as a withdrawal, except the financial
consequences. The excluded Contractor shall pay the following costs:

	 	-	 	the procedure fees to select a new Contractor(s) to carry out the Project; in an amount
determined by the Steering Committee;
	 
	 	-	 	damages to compensate the consequences of the exclusion affecting the conduct of the
Project, including losses suffered by the Contractors. This financial compensation shall be
payable only if the concerned Contractor is excluded on the basis of a default in the
execution of its commitments under the Grant Agreement and the Consortium Agreement.

ARTICLE 11– CONFIDENTIALITY 

All information in whatever form or mode of transmission, which is disclosed by a Contractor (the
“Disclosing Contractor”) to any other Contractor (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 as such by the Disclosing Contractor within thirty (30) days at the latest as
confidential information shall be considered to be “Confidential Information”.

The Recipients hereby undertake in addition and without prejudice to any commitment of
non-disclosure under the Grant Agreement, during the Project and for a period of five (5) years
thereafter:

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

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- not to disclose Confidential Information to any third party without the prior written consent of
the Disclosing Contractor;

- to ensure that internal distribution of Confidential Information by a Recipient shall take place
on a strict need-to-know basis; and

- to either destroy or return to the Disclosing Contractor on demand all Confidential Information
which has been supplied to or acquired by the Recipients including all copies thereof and to delete
all information stored in a machine readable form. If needed for the recording of ongoing
obligations, the Recipients may however keep an archive copy.

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

The Recipient shall not be liable for disclosure or use of Confidential Information, if and in so
far as the Recipient can show that:

- the Confidential Information is or has become publicly available
by means other than a breach of the Recipient’s confidentiality obligations under the Grant
Agreement and this Consortium Agreement;

- the Disclosing Contractor subsequently informs the Recipient that the Confidential Information is
no longer confidential;

- the Confidential Information has been 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 Contractor;

- the disclosure or communication of the Confidential Information is foreseen by provisions of the
Grant Agreement;

- the Confidential Information, at any time, has been developed by the Recipient completely
independently of any such disclosure by the Disclosing Contractor; or

- the Confidential Information was already known to the Recipient prior to disclosure without any
restrictions on disclosure; or

- the Confidential Information is needed to be communicated by the Recipient to comply with
applicable Government Laws or Regulations.

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.

Each Recipient shall promptly advise the Disclosing Contractor 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.

If any Recipient 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 Contractor, and comply with the Disclosing Contractor’s reasonable
instructions to protect the confidentiality of the information.

The confidentiality obligations under this Consortium Agreement and the Grant Agreement shall not
prevent the communication of Confidential Information to the Commission required by the Grant
Agreement

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ARTICLE 12 — FORCE MAJEURE 

No Contractor shall be considered to be in breach of this Consortium Agreement if such breach is
caused by Force Majeure. Each Contractor will notify the Steering Committee of any Force Majeure
event as soon as reasonably possible. Upon such notification the Steering Committee shall examine
in good faith the possible transfer of Allocated Work affected by such Force Majeure event. If the
event of Force Majeure is not overcome within six (6) calendar weeks after such notification, the
transfer of tasks – if any- shall be decided by the Steering Committee.

ARTICLE 13 — NO PARTNERSHIP OR AGENCY

The Contractors shall not be entitled to act or to make legally binding declarations on behalf of
any other Contractor. 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 Contractors.

ARTICLE 14 — LANGUAGE

This Consortium Agreement is drawn up in English which language shall govern all documents, notices
and meetings for its performance and application and/or extension or in any other way relative
thereto.

ARTICLE 15 — APPLICABLE LAW

This Consortium Agreement and all clauses in the Grant Agreement affecting the rights and
obligations between the Contractors shall be construed in accordance with and governed by the laws
of Belgium.

ARTICLE 16 — ANNEXES, CONFLICTS AND INCONSISTENCIES
 

This Consortium Agreement consists of:
 

This body text
 

Annex A Notice Details
 

Annex B (List of Affiliated Entity)
 

Annex C (Positive List of Background)
 

Annex D MTA
 

Annex E Initial Project Officers and Members of the SC
 

Annex F List of Limitations and Restrictions with Respect to Access Rights
 

Annex G List of third Parties with Respect to Transferring Ownership of Foreground

In case this Consortium Agreement is in conflict with the Grant Agreement, the terms of the latter
shall prevail. In case of conflicts between the Annexes and the body text of this Consortium
Agreement, 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 Contractors concerned shall be entitled to request that a valid and practicable provision
be negotiated which fulfils the purpose of the original provision.

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ARTICLE 17 — ASSIGNMENTS, AMENDMENTS

Except where specifically allowed under this Consortium Agreement no rights or obligations of the
Contractors arising from this Consortium Agreement may be assigned or transferred, in whole or in
part, to any third party without the other Contractors’ prior written formal approval.

All amendments and modifications to this Consortium Agreement require documents duly signed by all
Contractors.

ARTICLE 18 — MANDATORY STATUTORY RESTRICTIONS

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

ARTICLE 19 — NOTICES AND OTHER COMMUNICATION

If it is required in this Consortium Agreement that a formal notice, consent or approval shall be
given, such notice shall be signed by an authorised representative of a Contractor and shall either
be served personally or sent by mail with recorded delivery or telefax with receipt acknowledgement
or e-mail with acknowledgement of receipt to the appropriate representative(s) of the
Contractor(s) concerned at their addresses listed in the most current address list, attached to
this Agreement (Annex A).Notices as required under this Consortium Agreement or the Grant Agreement
shall be forwarded to the other Contractors via the Coordinator.

Other notices required under this Consortium Agreement or the Grant Agreement to the other
Contractors shall be forwarded via the Steering Committee or the Management Team.

Communication between the Contractors that is not required to be taken in a formal form may also be
effected by other means such as e-mail. Any change of persons or contact details shall be notified
immediately by the respective Contractor to the Coordinator.

ARTICLE 20 — DISPUTES

The Contractors agree to first use reasonable endeavours to try to amicably settle any dispute
arising among them in relation to the implementation of the Grant Agreement and/or of this
Consortium Agreement and for such purpose, to bring the dispute at the appropriate Project body
level. To avoid doubt, disputes concerning the Need For Access Rights shall be mediated, in first
instance, in accordance with Article 8.8.5 herein.

Failing to reach an amicable settlement, the dispute arising out of or in connection with the
present Consortium Agreement 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.

The language to be used in the arbitral proceedings shall be English.

ARTICLE 21: COUNTERPARTS

This Consortium Agreement may be executed in any number of counterparts, each which shall be deemed
an original, but all of which shall constitute one and the same instrument. The Coordinator and
every other Contractor shall each sign two (2) counterparts. The Coordinator shall send copies of
all the signed counterparts to each Contractor within sixty (60) calendar days of their receipt of
all such signed counterparts from the other Contractors.

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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

	 	 	 
	Authorised to sign on behalf of

	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)
	 
	 	 
	By (signature):
	 	 
	Name: Dr. Renato Botti
	 	 
	 
	 	 
	Title: General Manager
	 	 
	Date:
	 	 
	 
	Authorised to sign on behalf of

	 	ACADEMISCH ZIEKENHUIS BIJ DE UNIVERSITEIT VAN AMSTERDAM (AMC)
	 
	 	 
	By (signature):
	 	 
	Name: Prof. Louis J. Gunning-Schepers
	 	 
	 
	 	 
	Title: Dean and Chairman of the Board
	 	 
	Date:
	 	 

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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

	 	 	 
	Authorised to sign on behalf of

	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)
	 
	 	 
	By (signature):
	 	 
	Name: Dr. Renato Botti
	 	 
	 
	 	 
	Title: General Manager
	 	 
	Date:
	 	 
	 
	 	 
	Authorised to sign on behalf of

	 	MEDICAL RESEARCH COUNCIL (MRC)
	 
	 	 
	By (signature):
	 	 
	Name: Dr. Anne-Marie Coriat
	 	 
	 
	 	 
	Title: Head of MRC Oxfordshire Centre
	 	 
	Date:
	 	 
	 
	 	 
	Or
	 	 
	 
	 	 
	By (signature):
	 	 
	Name: Mrs Sonja Townsend
	 	 
	 
	 	 
	Title: External Funding Manager MRC
	 	 
	Date:
	 	 

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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI “FOND. G. PASCALE” (INT-NA)

By (signature):

Name: Prof. Mario Luigi Santangelo

Title: General Manager

Date:

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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	CYTOS BIOTECHNOLOGY AG (CYTOS) 

By (signature):

Name: Dr. Martin Bachmann

Title: Chief Scientific Officer

Date:

29

 

 
					
	 	 	 	 	 
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	 	CONSORTIUM AGREEMENT
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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	UNIVERSITA’ DEGLI STUDI DI MILANO (UMIL)

By (signature):

Name: Prof. Enrico Decleva

Title: Rector

Date:

30

 

					
	 	 	 	 	 
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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	AVARIS AB (AVARIS)

By (signature):

Name: Dr. Mats Lake

Title: CEO

Date:

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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	STATENS SERUM INSTITUT (SSI)

By (signature):

Name: Dr Nils Strandberg Pedersen

Title: President, CEO

Date:

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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	COMMISSARIAT À L 1ENERGIE ATOMIQUE (CEA)

By (signature):

Name: M Roger GENET

Title: as interim Head of the Life Sciences Division

Date:

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	 	CONSORTIUM AGREEMENT
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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	KAROLINSKA INSTITUTET (KI)

By (signature):

Name: Dr. Katarina Bjelke

Title: Director of the Department of Research and Postgraduate Education

Date:

Or

By (signature):

Name: Dr. Miles Davies

Title: Head of Grants Office

Date:

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	 	CONSORTIUM AGREEMENT
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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	PRINS LEOPOLD INSTITUUT VOOR TROPISCHE GENEESKUNDE, (ITG)

By (signature):

Name: Prof. Dr. Bruno Gryseels

Title: Director

Date:

35

 

					
	 	 	 	 	 
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	 	CONSORTIUM AGREEMENT
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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	NATIONAL BIOLOGICAL STANDARDS BOARD (NIBSC)

By (signature):

Name: Mr. Victor Knight

Title: Secretary to the Board /Head of Finance

Date:

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	 	CONSORTIUM AGREEMENT
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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	MYMETICS MANAGEMENT S.A.R.L (Mymetics)

By (signature):

Name: Mr. Ernest Lübke

Title: General Administrator

Date:

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	LUNDS UNIVERSITET (ULUND)

By (signature):

Name: Mr Mattias Brattström

Title: Head of Faculty Office

Date:

38

 

					
	 	 	 	 	 
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	 	CONSORTIUM AGREEMENT
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IN WITNESS WHEREOF, the Contractors have executed this Consortium Agreement in two original copies.

			
	Authorised to sign on behalf of	 	FONDAZIONE CENTRO SAN RAFFAELE DEL MONTE TABOR (HSR)

By (signature):

Name: Dr. Renato Botti

Title: General Manager

Date:

			
	Authorised to sign on behalf of	 	UNIVERSITE PARIS DESCARTES- PARIS 5 (UPD)

By (signature):

Name: Prof. Bruno Varet

Title: Administrateur Provisoire

Date:

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ANNEX A:

Notice Details

1-HSR:
For Scientific matters

Dr. Gabriella Scarlatti

Viral Evolution and Transmission Unit

DIBIT — Fondazione Centro San Raffaele del Monte Tabor

Via Olgettina 58, 20132 Milan, Italy

Tel: 0039 022643 4906 (dir) or 2821 (Assistant)

Email:scarlatti.gabriella@hsr.it

For Administrative/Financial matters

Dr. Maria Rosa Pedrazzi

Via Olgettina 60, 20132, Milan

Tel: 0039 022643 4845/3921 

Email:pedrazzi.mariarosa@hsr.it 

For IPR/Contractual matters

Dr. Paola Rebagliati

Via Olgettina 60, 20132, Milan

Tel: 0039 022649 4942

Email:rebagliati.paola@hsr.it

2-AMC:
For Scientific matters

Prof Dr Hanneke Schuitemaker

AMC at the University of Amsterdam

Dept Experimental Immunology

Meiberdreef 15, 1105 AZ Amsterdam, the Netherlands

Tel: 0031 20 5668590

Email: h.schuitemaker@amc.uva.nl

For Administrative/Financial matters

Mr Erik Veenstra

P.O. Box 22660, 1100 DD Amsterdam

Email: e.j.veenstra@amc.uva.nl

Tel: 0031 205667681

Fax: 0031 206915462

Email : e.j.veenstra@amc.uva.nl

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3-MRC:

For Scientific matters

Dr Guillaume Stewart-Jones

MRC Human Immunology Unit

Weatherall Institute of Molecular Medicine

John Radcliffe Hospital

Oxford OX3 9DS, UK

Tel: 0044 1865514419

Email: guillaume@strubi.ox.ac.uk

For Administrative/Financial matters

Mrs Sonja Townsend

External Funding Manager

MRC Center Oxfordshire

MRC Harwell

Didcot

Oxfordshire OX11 0RD, UK

Tel: 0044 (0) 1235841065

Email: So.townsend@har.mrc.ac.uk

For IPR/Contractual matters

Dr Atul Kotecha

Contracts Manager

MRC Center Oxfordshire

MRC Harwell

Didcot

Oxfordshire OX11 0RD, UK

Tel: 0044 (0) 1235841035

Email: a.kotecha@har.mrc.ac.uk

4-INT-NA:

For Scientific Matters

Dr. Luigi Buonaguro

Via Mariano Semmola 1

80131 Napoli, Italy

Tel: 0038 081 5903609

Email: irccsvir@unina.it

Email: lbuonaguro@tin.it

For Administrative Matters

Dr. Domenico Bisogni

Head of Research Administration Unit

Tel: 0039 081 5903294

Email: domenicobisogni@tiscali.it

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5-CYTOS:

For Scientific Matters

Dr. Till Alexander Röhn

Cytos Biotechnology AG   

Wagistrasse 25  

CH-8952 Zurich-Schlieren, Switzerland 

Tel: 0041 44 7334656

Email: till.roehn@cytos.com

For Administrative Matters

Dr. Gary Jennings

Cytos Biotechnology AG  

Wagistrasse 25 

CH-8952 Zurich-Schlieren

Tel: 0041 44 7334642

Email: gary.jennings@cytos.com

For IP Contractual MAtters

Dr. Martin Sperrle

Cytos Biotechnology AG   

Wagistrasse 25   

CH-8952 Zurich-Schlieren,

Tel: 0041 44 733713

Email: martin.sperrle@cytos.com

6-UMIL:

For Scientific Matters

Professor Mario Clerici, MD

Chair of Immunology

Milano University Medical School

Dipartimento di Scienze e Tecnologie Biomediche LITA

Via F.lli Cervi, 93, 20090 Segrate, Italy

Tel: +39 02 5031 9679

Fax: +39 02 5031 9677

Email: mario.clerici@unimi.it

For ADMINISTRATIVE & IP Contractual MAtters

Dr. Carlo Claudio Villa

Ufficio Contratti e Convenzioni di Ricerca Istituzionale

Università degli Studi di Milano

Via Festa del Perdono 7

20122 Milan, Italy

Tel.: 0039 02 5031 2756

Fax: 0039 02 5031 2750

Email: carlo.claudio.villa@unimi.it

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7-AVARIS:

For Scientific Matters

Dr. Anna-Lena Spetz,

Center for Infectious Medicine, F59

Karolinska Institutet

Dept. of Medicine Karolinska Huddinge

S-141 86 Stockholm, Sweden

Tel: 0046 8 5858 2272

Mobile:0046 70 7471303

Fax:0046 8 746 7637

Email: anna-lena.spetz@ki.se

8-SSI:

FOR SCIENTIFIC MATTERS

Dr. Anders Fomsgaard

Department of Virology

Statens Serum Institut

5 Artillerivej

DK-2300 Copenhagen S

Denmark

Tel: +45 3268 3460

Mobile: +45 4063 4638

Fax: +45 3268 3148

E-mail: afo@ssi.dk

FOR ADMINISTRATIVE AND ECONOMICAL MATTERS:

Vibeke Fonsholt

Department of Economy, build 202

Statens Serum Institut

5 Artillerivej

DK-2300 Copenhagen S

Denmark

Tel: +45 3268 3129

FOR IP CONTRACTUAL MATTERS

Erik Elm Olsen / Lars Toft

Corporate Affairs

Statens Serum Institut

5 Artillerivej

DK-2300 Copenhagen S

Denmark

Tel: +45 3268 3053

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9-CEA:

For ADMINISTRATIVE & IP Contractual Matters

Frederic ELIES

Commissariat à l’Energie Atomique

Direction Juridique et du Contentieux

Service Central de la Propriété Industrielle et des Accords

CEA/Saclay — Bât. 446 — 91191 Gif-sur-Yvette cedex

Tel: 0033 (0)1 69 08 80 50

-Fax: 0033 (0)1 69 08 83 36 

E-mail: frederic.elies@cea.fr

10-KI:

For Scientific Matters 

Professor Jan Albert

SMI/MTC

Nobelsväg 18

SE 171 82 Stockholm, Sweden

Tel: 0046 8 4572605

Fax 0046 8 337272

Email : jan.albert@smi.ki.se

For Administrative Matters

Mrs Christina Bergehed-Bonnevier

Nobelsväg 16 Box 280

SE 171 77 Stockholm, Sweden

Tel: 0046 8 52487140

Fax 0046 8 304276

11-
ITG

For Scientific Matters

Dr. Helen Donners

Institute of Tropical Medicine

Department of Microbiology, Unit Virology

Nationalestraat 155

B-2000 Antwerpen, Belgium

Tel: 0032 3 247 6631

Fax 0032 3 247 6333

Email: hdonners@itg.be

For Administrative Matters

Yvette Baeten

Head of Research Administration Unit

Tel: 0032 3 247 6319

Fax: 0032 3 247 6333

Email: ybaeten@itg.be

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12-
NIBSC

For Scientific Matters

Dr. Harvey Holmes

National Institute for Biological Standards & Control

Blanche Lane

South Mimms

Potters Bar

Hertfordshire EN6 3QG, England

Tel: 0044 1707 641000

Fax: 0044 1707 641051

Email : hholmes@nibsc.ac.uk

For Administrative Matters

Dr. Victor Knight

National Institute for Biological Standards & Control

Blanche Lane

South Mimms

Potters Bar

Hertfordshire EN6 3QG, England

Tel: 0044 1707 641218

Fax: 0044 1707 641060

Email: vknight@nibsc.ac.uk

13-
Mymetics

For Scientific Matters

Dr. Sylvain Fleury

Chief Scientific Officer

Mymetics Management Sàrl

14 rue de la Colombière

1260 Nyon

Tel: 0041 216925758

Fax: 0041223631311

For Administrative Matters

Mr. Ernest Lübke

Mymetics Management Sàrl

14 rue de la Colombière

1260 Nyon

Tel: 0041 223631308

Fax: 0041 223631311

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14
— ULUND

For Scientific Matters

Prof. Eva-Maria Fenyö

P.O. Box 117

221 00 LUND

Sweden

For Administrtive Matters

Ms. Anette Welin

Division of Clinical Genetics

P.O Box 117

221 00 LUND

Sweden

Tel: + 46 46 17 33 61

Fax: + 46 46 13 10 61

E-mail: Anette.welin@med.lu.se

15
— UPD

For Scientific Matters

Dr. Morgane BOMSEL

Entrée muqueuse du VIH et Immunité muqueuse (CNRS UMR 8104, INSERM U567)

Département de Biologie Cellulaire

Institut Cochin

Université Paris Descartes

22, rue Méchain

75014 — Paris, France

Phone:  0033 1 40516497

Fax:  0033 1 40516454

Email: bomsel@cochin.inserm.fr

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ANNEX
B:

LIST of AFFILIATED ENTITIES

CONTRACTOR
#1 – HSR:

NONE

CONTRACTOR
#2 – AMC:

NONE

CONTRACTOR
#3 – MRC:

NONE

CONTRACTOR
#4- INT-NA:

NONE

CONTRACTOR
#5- CYTOS:

NONE

CONTRACTOR
#6- UMIL:

NONE

CONTRACTOR
#7- AVARIS:

HANS-GUSTAF
LJUNGGREN

STEVE APPLEQUIST

Center for Infectious Medicine, F59 — Karolinska Institutet

Dept. of Medicine Karolinska Huddinge

S-141 86 Stockholm, Sweden

CONTRACTOR
#8- SSI:

NONE

CONTRACTOR #9- CEA:

NONE

CONTRACTOR
#10- KI:

NONE

CONTRACTOR
#11- ITG:

NONE

CONTRACTOR
#12 – NIBSC:

NONE

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	CONTRACTOR #13- Mymetics:
	 	 	 	 
	 
	NONE	 	 	 	 
	 
	CONTRACTOR #14 – ULUND:	 	
	 	 
	 
	
LUAB

P.O. Box 117
221 00 LUND, Sweden	 	
	 	 
	 
	CONTRACTOR #15 — UPD:
	 		 	 
	 
	NONE
	 		 	 

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ANNEX C:

POSITIVE LIST OF BACKGROUND

CONTRACTOR
#1- HSR

Immunobiology of HIV Unit will provide :

synthesis of Gp41 fragments (GIKQLQARILAVERYLKDQ or QARILAV) to be introduced in VLPs or virosomes.
Gp41 fragments will be synthesized by the solid-phase Fmoc method, using an Applied Biosystem model
433 A peptide synthesizer. After peptide assembly, resin bound peptides will be deprotected and
purified to greater 95% purity by semipreparative reverse-phase high performance liquid
chromatography (RP-HPLC). This Unit will also purify serum and mucosal IgG and IgA from immunized
animals through affinity purification methods (HPLC) with CnBr or Jacalin coupled Sepharose
respectively.

Biological Materials:

	 	1)	 	QARILAV peptide
	 
	 	2)	 	GIKQLQARILAVERYLKDQ peptide
	 
	 	3)	 	Serum IgG and IgA from immunized animals
	 
	 	4)	 	Mucosal IgG and IgA from immunized animals

1) Synthesis of peptides:

Technical description:

- Fields, G. B., and R. L. Noble. 1990. Solid phase peptide synthesis utilizing
9-fluorenylmethoxycarbonyl amino acids. Int J Pept Protein Res 35:161-214

- King, D. S., C. G. Fields, and G. B. Fields. 1990. A cleavage method which minimizes side
reactions following Fmoc solid phase peptide synthesis. Int J Pept Protein Res 36:255-66.

Assay used in:

- Lopalco, L., C. Barassi, C. Pastori, R. Longhi, S. E. Burastero, G. Tambussi, F. Mazzotta, A.
Lazzarin, M. Clerici, and A. G. Siccardi. 2000. CCR5-reactive antibodies in seronegative partners
of HIV-seropositive individuals down-modulate surface CCR5 in vivo and neutralize the infectivity
of R5 strains of HIV-1 In vitro. J Immunol 164:3426-33.

- Pastori, C., B. Weiser, C. Barassi, C. Uberti-Foppa, S. Ghezzi, R. Longhi, G. Calori, H. Burger,
K. Kemal, G. Poli, A. Lazzarin, and L. Lopalco. 2006. Long-lasting CCR5 internalization by
antibodies in a subset of long-term nonprogressors: a possible protective effect against disease
progression. Blood 107:4825-33

- Clerici, M., C. Barassi, C. Devito, C. Pastori, S. Piconi, D. Trabattoni, R. Longhi, J. Hinkula,
K. Broliden, and L. Lopalco. 2002. Serum IgA of HIV-exposed uninfected individuals inhibit HIV
through recognition of a region within the alpha-helix of gp41. Aids 16:1731-41.

2) Immunoglobulin purification

Technical description:

- Harlow E. and Lane D. 1988 Storing and purifying antibodies in Antibodies: A laboratory manual.
Ed. Cold Spring Harbor Laboratories:283-318.

Assay used in:

- Clerici, M., C. Barassi, C. Devito, C. Pastori, S. Piconi, D. Trabattoni, R. Longhi, J. Hinkula,
K. Broliden, and L. Lopalco. 2002. Serum IgA of HIV-exposed uninfected individuals inhibit HIV
through recognition of a region within the alpha-helix of gp41. Aids 16:1731-41

- Barassi C, Soprana E, Pastori C, Longhi R, Lillo F, Grasso M, Marenzi, C, Lazzarin A, Siccardi
A.G, Lopalco L. Induction of murine mucosal CCR5-reactive antibodies as anti-HIV strategy. 2005 J
Virol. 79:6848-6858

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- Bomsel M, Pastori C,, Tudor D, Claudia Pastori2,
Alberti C, Garcia S, Mei H, Ferrari D, Lazzarin
A, Lopalco L. Mucosal anti-CCR5 human antibodies inhibit mucosal HIV infectivity by blocking
HIV-1 transport across human epithelial cells. 2007 AIDS 21:13-22.

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

Unit of Human Virology: will provide:

	 	1.	 	Know-how on the performance of specific assays for the evaluation of anti-HIV-1
envelope antibodies, including test of antibody-mediated neutralization in primary human
PBMC or continuous cell lines (e.g., PM1) acutely infected with a wide variety of primary
HIV-1 isolates, HIV-1 envelope-mediated cell fusion assays based on a wide variety of
primary HIV-1 envelopes expressed either by recombinant vaccinia systems or by persistently
infected PM1 cells, as well as surrogate assays evaluating binding to the native,
oligomeric HIV-1 envelope trimer expressed on the surface of persistently infected PM1
cells.
	 
	 	2.	 	Know-how on the structural aspects of the HIV-1 envelope as well as the definition and
characterization of broadly conserved neutralization epitopes.
	 
	 	3.	 	Know-how on the design, synthesis and engineering into appropriate expression vectors
(e.g., vaccinia vectors) of native or mutagenized HIV-1 envelope glycoproteins for
expression in mammalian cells and immunization of small animals or nonhuman primates.
	 
	 	4.	 	Availability of a series of modified HIV-1 envelopes bearing rational alterations aimed
at better exposing conserved neutralization epitopes that are kept in a cryptic or
partially occluded conformation in the native trimer. The envelopes are available both as
DNA plasmids and engineered into vaccinia vectors for in vitro studies and in vivo
immunization.
	 
	 	5.	 	Know-how on small-rodent immunization using DNA or vaccinia vectors and monitoring of
specific antibody responses

Viral Evolution and Transmission Unit will provide:

	 	1.	 	Biological materials from HIV infected individuals collected during 1990-2007 and
during project duration.
	 
	 	2.	 	HIV strains from HIV infected patients collected during years 1990-2007 and during
project duration.
	 
	 	3.	 	Techniques as described in:

	 	–	 	Scarlatti et al PNAS 1993

	 	–	 	Scarlatti et al JID 1993

	 	–	 	Scarlatti et al Nat Med 1997

	 	–	 	Ripamonti et al AIDS Res Human Retroviruses in press

	 	4.	 	Know-how on the performance of specific assays for the evaluation of neutralizing
antibodies in single round infection of primary cells.

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

CONTRACTOR
#2- AMC

NONE

CONTRACTOR #3-MRC

MRC Background shall be restricted to the information and materials generated by the MRC Human
Immunology Unit research group led by Dr Guillaume Stewart-Jones

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CONTRACTOR #4- INT-NA:

The viral oncogenesis and immunotherapy unit will share:

	 	A.	 	know how on preparation of virus-like particles (VLP) in a baculovirus expression
system for the surface presentation of conformational proteins/epitopes to the immune
system in order to elicit neutralizing antibodies;
	 
	 	B.	 	preparation of novel glycoproteins presenting HIV-1 broadly neutralizing epitopes;
	 
	 	C.	 	immunization (intraperitoneal and intranasal) studies in small animal model (mice) and
serological evaluation of elicited (systemic and mucosal) humoral response;

Techinques used in:

	 	1.	 	Buonaguro, L., Buonaguro, F.M., Tornesello, M.L., Mantas, D., Beth-Giraldo, E.,
Wagner, Michelson, S., Prevost, M.-C., Wolf, H., Giraldo, G.: High efficient production
of Pr55gag Virus-like Particles expressing multiple HIV-1 epitopes, including a gp120
protein derived from an Ugandan HIV-1 isolate of subtype A. Antiviral Research, 49:
35-47, 2001
	 
	 	2.	 	Buonaguro, L., Racioppi, L., Tornesello, M.L., Arra, C., Visciano, M.L.,
Biryahwaho, B., Sempala, S.D.K., Giraldo, G. and Buonaguro, F.M.: Induction of
neutralizing antibodies and CTLs in Balb/c mice immunized with virus-like particles
presenting a gp120 molecule from a HIV-1 isolate of clade A (HIV-VLPAs). Antiviral
Research, 54: 189-201, 2002.
	 
	 	3.	 	Buonaguro, L., Visciano, M.L., Tornesello, M.L., Tagliamonte, M., Biryahwaho, B.
and Buonaguro, F.M.: Induction of systemic and mucosal cross-clade neutralizing
Antibodies in Balb/c mice immunized with HIV-1 clade A Virus-Like Particles administered
by different routes of inoculation. J. Virol., 79: 7059-7067, 2005.
	 
	 	4.	 	Buonaguro, L., Devito, C., Tornesello, M.L., Schröder, U., Wahren, B, Hinkula, J.
and Buonaguro, F.M.: DNA–VLP prime–boost intra-nasal immunization induces cellular and
humoral anti-HIV-1 systemic and mucosal immunity with cross-clade neutralizing activity.
Vaccine, 25: 5968-5977, 2007.

CONTRACTOR #5- CYTOS:

With respect to Background needed for the implementation of the Project as indicated in 8.2.1. of
the Consortium Agreement, and, thus, Background which would justify inclusion within Annex C
(Positive List of Background) thereof, please note that we have, at the present time, not
identified any such Background.

CONTRACTOR #6 – UMIL: 

NONE

CONTRACTOR #7- AVARIS:

1. Flagellin EPO 05740503.7 for use only to produce antibodies and/or vaccine against HIV.

2. Know-how IPR and future IPR including but not limited to future patents and patent applications
on or relating to certain HIV immunogen design to produce neutralizing antibodies emerging from the
project Auto/AlloCell-HIV under the Sixth Framework Programme, to the extent permitted by joint
owners and third parties (e.g. rights holders), see Annex F, and for use only to produce antibodies
and/or

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vaccine against HIV. For the avoidance of doubt, the Contractors hereby, by signing the
Consortium
Agreement, agree to include such later-filed IPRs (in accordance with this section) in the
definition of Background (therefore not constituting Foreground).

CONTRACTOR #8 – SSI:

Statens Serum Institut may on individually basis grant Access Rights to Background generated only
wholly by the research group of Dr. Anders Fomsgaard who are directly involved in carrying out the
project comprising: Know-how on rabbit, mouse and guinea pig immunizations using DNA, viral vectors
and/ or protein in adjuvants and monitoring of specific antibody responses. For the sake of
clarity, no Access Rights can be granted to SSI’s proprietary adjuvant technology CAF01.

CONTRACTOR #9 – CEA:

NONE

CONTRACTOR #10- KI:

Karolinska Institutet may grant Access Rights to Background generated by the Professors Britta
Wahren, Francesca Chiodi and Jan Albert, who are directly involved in carrying out the project.
Karolinska Institutet hereby excludes specifically from its obligation to grant Access Rights to
Background to the following Background:

	 	•	 	Antiviral composition. Combination of FLT/FLG and antiviral nucleosides.

PCT/SE99/00909:

DNA modification

PCT/SE91/00071:

Monoclonal antibodies against HIV

	 	•	 	Biological materials

	1.	 	060801 – uc = under construction:
	 
	2.	 	Component name
	 
	3.	 	pKCMVrev,tat,nef original and mutagenized/optimized
	 
	4.	 	pKCMVgp160B
	 
	5.	 	pKCMVgp160A
	 
	6.	 	pKCMVgp160C
	 
	7.	 	pKCMLgp160D uc
	 
	8.	 	pKCMVRT, RTmut
	 
	9.	 	series of RT mutations relevant to drug induced mutations
	 
	10.	 	pKCMV polyepitope resistance mutations
	 
	11.	 	pKCMVp37gagB
	 
	12.	 	pKCMVp37gagA
	 
	13.	 	pKCMVp37gagC
	 
	14.	 	pKCMVp37B/ires/fcu-1 uc
	 
	15.	 	series of pKCMV and bicistronic vectors with Hgranzyme B uc
	 
	16.	 	series of pKCMV neftat and mutations
	 
	17.	 	pKCMVCCR5
	 
	18.	 	pKCMVDC-sign uc
	 
	19.	 	pKCMVCXCR4
	 
	20.	 	pKCMV6, 66, wt CEA series
	 
	21.	 	pKCMV GFP
	 
	22.	 	pKCMV

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	 	•	 	Priority filings under consideration:

HIV-1/Murine leukemia Model

	 	•	 	Materials in biobank or for research purposes at KI/SMI

Biological materials from HIV infected individuals collected at SMI during 1985-2007.

HIV strains from HIV infected patients collected at SMI during years 1985-2007).

US patent 6846637 Issued 25 January 2005 (F. Chiodi)

EPO application 99931070.9;Application allowed; EP patent will be EP 1087993 (F.Chiodi)

CONTRACTOR #11- ITG: 

Materials in biobank or for research purposes 

Some biological material (plasma, cells and HIV strains) from HIV infected individuals collected at
ITG during 1985-2007.

Some biological materials (plasma, cells and HIV strains) from HIV infected individuals that
will be collected by ITG during the run time of this project.

CONTRACTOR #12 — NIBSC:

NONE

CONTRACTOR #13- Mymetics:

Mymetics Corp. owns the IP on the virosome technology in the field of HIV and malaria. Meanwhile,
Mymetics Corp. grants to Mymetics Management Sàrl, a Swiss subsidiary of Mymetics Corps, the right
to use its Background under certain restrictions for performing the project described into the NGIN
Consortium Agreement (FP7). Mymetics Corp. hereby excludes from its obligation to grant Access
Right to its Background acquired by its various academic and private collaborators related to
research programs on antigen designs, antigen production, virosome, vaccine development and
production. These exclusions especially concern the collaboration with Dr Morgane Bomsel (UPD,
contractor no.15) on the development of a virosome-based mucosal vaccine against HIV, based on the
gp41 antigen, and Dr. Erwann Loret (Marseille University, France)..
These exclude especially the following patents

	 	•	 	Various granted IP on the virosomes technology and all its improvements
	 
	 	•	 	Recent international PCT applications:

	 	1.	 	PCT/IB2005/001180: INSERM/ Inventors: Morgane Bomsel, Daniela Tudor «
Neutralizing anti-gp41: IgA  with a long CDR3H »
	 
	 	2.	 	PCT/IB2005/001182: INSERM/ Inventors: Morgane Bomsel, Daniela Tudor/ Mymetics
: en cours de dépot : n° BR-78776.  « Neutralizing anti-gp41 engineered loop IgAs 
» 
	 
	 	3.	 	PCT/IB 2006.000466 INSERM/Mymetics/Pevion/ Inventors:  M. Bomsel, S. Fleury,
R. Zubrigen « Virosomes like vesicules comprising GP41 derivate antigen »

	 	•	 	Coming new IP on virosomes containing other HIV antigens, in addition to gp41. These IP
do no include the gp120 antigens, which is part of the NGIN consortium.
	 
	 	•	 	Virosomes are biosynthetic vesicles representing reconstituted empty influenza virus
envelope that serve as delivery system for vaccination
	 
	 	•	 	Virosome® technology already approved in 43 Countries
	 
	 	•	 	High safety profile in human and very stable
	 
	 	•	 	Virosomes are very efficient carriers for peptides & proteins for vaccination
	 
	 	•	 	Virosomes have an adjuvant potential that strongly promotes blood and mucosal
responses into a majority of vaccinated animals and subjects, which is unique

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	 	•	 	There are already two human marketed vaccines using the virosome technology: the
Inflexal (influenza vaccine) marketed since 1997 with more than 35 million doses sold and
the Epaxal (hepatitis A vaccine) marketed since 1994 with more than 3.0 million doses sold.

Mymetics Management Sàrl will be responsible for conducting the aspect of the project that consists
to use its Background for

	 	•	 	Formulating and producing virosome-based vaccines
	 
	 	•	 	Grafting immunogenic and promising antigens at the surface of virosomes.
	 
	 	•	 	Monitoring the coupling of the antigen to virosomes
	 
	 	•	 	Quantification of bound antigens to virosome surface

Protein or peptide graftings onto virosomes will be performed in Pevion Biotech facilities in Bern
(Switzerland), which acts as a sub-contractant for Mymetics Management Sàrl. Mymetics Sàrl and
Pevion will do their best to successfully graft the HIV antigens onto virosomes, using their
Background for the Implementation of the Project.

Animal pre-immunization with inactivated influenza virus is highly recommended for optimal
vaccination outcomes
Mymetics Management Sàrl might also provide some Background on mucosal immunity and protocol
designs for targeting the mucosal compartment.

CONTRACTOR #14-ULUND

	 	1.	 	Plaque reduction assays for HIV and SIV neutralisation. 

Technical description: 

               Shi Y, Albert J, Francis G, Holmes H, and Fenyö EM. A new cell line-based neutralisation assay
for primary HIV-1 isolates. AIDS Res Hum Retroviruses 18:957-967, 2002.

               Nordqvist A and Fenyö EM. Plaque reduction assays for human and simian immunodeficiency virus
neutralisation. Human Retrovirus Protocols. Ed: Tuofu Zhu. Humana Press Chapter 26:273-285, 2005.

Assays used in: 

               Shi Y, Brandin E, Vincic E, Jansson M, Blaxhult A, Gyllensten K, Moberg L, Brostrom C, Fenyo
EM, Albert J. Evolution of human immunodeficiency virus type 2 coreceptor usage, autologous
neutralization, envelope sequence and glycosylation. J Gen Virol. 86:3385-96, 2005.

               Lauren A, Thorstensson R, Fenyo EM. Comparative studies on mucosal and intravenous
transmission of simian immunodeficiency virus (SIVsm): the kinetics of evolution to neutralization
resistance are related to progression rate of disease. J Gen Virol. 87:595-606, 2006.

               Ripamonti C, Leitner T, Laurén A, Karlsson I, Pastore A, Cavarelli M, Antonsson L, Plebani A,
Fenyö EM and Scarlatti G. Biological and genetic evolution of HIV-1 in two siblings with different
patterns of disease progression. AIDS Res Hum Retroviruses, in press.

	 	2.	 	Quantitative assay for HIV and SIV co-receptor usage 

Infectivity assay on GHOST(3) cells engineered to express CCR1, CCR2b, CCR3, CCR5, CXCR4, CXCR6 and BOB. 

Technical description:

               Vödrös D and Fenyö EM. Quantitative evaluation of HIV and SIV co-receptor use with GHOST(3)
cell assay. Human Retrovirus Protocols. Ed: Tuofu Zhu. Humana Press Chapter 26:333-342, 2005.

Assay used in:

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               Vödrös D, Tscherning-Casper C, Navea L, Schols D, De Clercq E, and Fenyö EM. Quantitative
evaluation of HIV-1 coreceptor use in the GHOST(3) cell assay. Virology 291:1-11, 2001.

               Vödrös D, Thorstensson R, Biberfeld G, Schols D, De Clercq E, and Fenyö EM. Coreceptor usage
of sequential isolates from cynomolgus monkeys experimentally infected with Simian immunodeficiency
virus (SIVsm). Virology 291:12-21, 2001.

               Lauren A, Vodros D, Thorstensson R, Fenyo EM. Comparative studies on mucosal and intravenous
transmission of simian immunodeficiency virus (SIVsm): evolution of coreceptor use varies with
pathogenic outcome. J Gen Virol. 87:581-94, 2006.

               Shi Y, Brandin E, Vincic E, Jansson M, Blaxhult A, Gyllensten K, Moberg L, Brostrom C, Fenyo
EM, Albert J. Evolution of human immunodeficiency virus type 2 coreceptor usage, autologous
neutralization, envelope sequence and glycosylation. J Gen Virol. 86:3385-96, 2005.

	 	3.	 	Assays for mode of CCR5 use by HIV and SIV 

Infectivity assays on U87.CD4 cell lines expressing chimeric CXCR4/CCR5 receptors (FC-1, FC-2
and FC-4b) were used in:

               Karlsson I, Antonsson L, Shi Y, Karlsson A, Albert J, Leitner T, Olde B, Owman C and Fenyö EM.
HIV biological variability unveiled: frequent isolations and chimeric receptors reveal
unprecedented variation of coreceptor use. AIDS 17:2561-2569, 2003.

               Karlsson I, Antonsson L, Shi Y, Öberg M, Karlsson A, Albert J, Olde B, Owman C, Jansson M and
Fenyö EM. Coevolution of RANTES sensitivity and mode of CCR5 receptor use by HIV-1 of R5 phenotype.
J Virol 78:11807-11815, 2004.

               Lauren A, Vincic E, Hoshino H, Thorstensson R, Fenyo EM. CD4-independent use of the CCR5
receptor by sequential primary SIVsm isolates. Retrovirology. 4:50, 2007.

               Ripamonti C, Leitner T, Laurén A, Karlsson I, Pastore A, Cavarelli M, Antonsson L, Plebani A,
Fenyö EM and Scarlatti G. Biological and genetic evolution of HIV-1 in two siblings with different
patterns of disease progression. AIDS Res Hum Retroviruses, in press.

All cell lines included under point 1 or 2 of this background are available from the repository
at NIBSC. Transfer of cell lines included under point 3 to NIBSC is in progress. 

CONTRACTOR #15 — UPD:

International  PCT on May, 2cd, 2005 : n° PCT/IB2005/001180: INSERM/ Inventeurs/ Inventors:
Morgane Bomsel, Daniela Tudor IV « Neutralizing anti-gp41: IgA  with a long CDR3H »

International PCT on May, 2cd, 2005 : n° PCT/IB2005/001182: INSERM/ Inventeurs/ Inventors:
Morgane Bomsel, Daniela Tudor/ Mymetics : en cours de dépot : n° BR-78776.  « Neutralizing
anti-gp41 engineered loop IgA s » 

International PCT on March, 2cd, 2006 : n° PCT/IB 2006.000466 INSERM/Mymetics/Pevion
Inventeurs/ Inventors:  M. Bomsel, S. Fleury, R. Zubrigen IV « Virosomes like vesicules comprising
GP41 derivate antigen »

Investigation of the molecular and cellular mechanisms of HIV entry at mucosal sites via simple
epithelial cells and dendritic cells. Definition of receptors and entry pathways. In particular the
group has pioneered the description of HIV transcytosis across simple epithelia and its
intracellular inhibition by neutralising IgA specific for HIV envelope. Investigation of the
humoral immunity in HIV infected and highly exposed but resistant individuals, especially at
mucosal sites. Characterisation of HIV receptor at mucosal sites and of neutralising mucosal IgA.

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In collaboration with Mymetics, elaboration of a mucosal vaccine against HIV based on gp41
conserved peptides and the virosomes technology as vaccine-carrier.

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ANNEX D:

MATERIAL TRANSFER AGREEMENT (“MTA”) AMONG CONSORTIUM

PARTICIPANTS FOR THE IMPLEMENTATION OF THE NGIN PROJECT

The Institute    
               
              
   
      (the Institute) is willing to provide   
               
              
              
            
    (the Investigator) of your Institution
              
             
          
    (the Recipient) with certain reagents known as
           
         , said reagents and progeny (“Progeny” shall mean all unmodified
descendants from the Original Materials, such as virus from virus, cell from cell, or organism from
organism) thereof (referred to herein collectively as the Material) and unmodified derivatives
(including but not limited to recombinant constructs, cultures, subcultures, mutations, or other
products prepared by the Recipient that contain the Material or a portion thereof, referred to
herein as the Derivatives) upon the terms and conditions set forth herein.

NOW THEREFORE, intending to be legally bound, the parties hereto hereby agree as follows:

	1.	 	The Material furnished to the Investigator pursuant to this MTA and Derivatives thereof will
be maintained within the sole possession and control of the Investigator and his staff and
will be used solely by the Investigator, his staff and students for the purpose of undertaking
research and/or educational activities allocated to the Investigator under the collaborative
project entitled “Next Generation HIV-1 Immunogens inducing broadly reactive Neutralising
antibodies” (NGIN)..

	2.	 	The Contractors acknowledge that they are participating in the NGIN project as part of a
consortium (Consortium) and that the Consortium has entered into (i) an agreement with the
European Community (Grant Agreement) and (ii) an agreement with each other (Consortium
Agreement) in respect of the NGIN Project. The Contractors further acknowledge that use of
the Material and Derivatives by the Recipient shall be governed by this MTA plus all
applicable provisions of the Grant Agreement and Consortium Agreement.

	3.	 	Institute grants the Recipient a non-exclusive royalty free license to use the Material and
Derivatives solely for the scientific research and educational activities of the Recipient
within the NGIN Project (as described in the Annex I of the Grant Agreement). The Material is
provided to Recipient for use only in laboratory animals or in vitro experiments. THE MATERIAL
AND/OR OR DERIVATIVES WILL NOT BE USED IN HUMANS.

	4.	 	The Material, Derivatives, and any information relating to the Material that may be disclosed
to the Investigator by the Institute (the Information) are being provided to and accepted by
the Recipient WITHOUT ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR
ANY OTHER WARRANTY, EXPRESSED OR IMPLIED. The Institute and its directors, officers,
employees, students or agents assume no liability and make no representations in connection
with the Material or the Derivatives or the Information or their use by the Investigator or
the Recipient. The Recipient hereby agrees to defend, indemnify and hold harmless the
Institute and its directors, officers, employees and agents from and against any liability or
claim arising from any use of the Material or the Derivatives by the Investigator and the
Recipient. Without limiting the foregoing, the Institute makes no representations as to
testing of the Material for the presence or

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	 	 	absence of any pathogens, and the Investigator and the Recipient assume all risk of harm with
respect to any such pathogens.
	 
	5.	 	Except as otherwise specifically allowed under the Grant Agreement or under this Consortium
Agreement, the Recipient or Investigator (as appropriate) will not license, assign or
otherwise transfer to any Third Party any interest in the research involving the Material and
Derivatives, or in the intellectual property or invention that might emerge therefore,
developed under the Project in common with one or more Contractors.
	 
	6.	 	Title to the Material, Derivatives, Information and all associated patent rights and other
proprietary rights therein are retained by the Institute. No right or license is granted with
respect to the Material, any Derivatives, or the Information, except as expressly set forth
herein.
	 
	7.	 	If use of the Material, Derivatives or any relevant Information under this MTA result in the
Investigator or any staff or students of the Recipient under the Investigator’s supervision,
becoming a co-inventor of an invention, discovered in joint research between the Recipient
and a Institute’s researcher (determined in accordance with applicable law governing
inventorship), the Recipient and the Institute agree that neither Contractor will license or
otherwise commercialise any such invention in the absence of an agreement to be negotiated in
good faith by the parties hereto, providing for, inter alia, the sharing of royalty income.
	 
	8.	 	Confidentiality and publication provisions shown in Article 8 and 11 of the Consortium
Agreement shall apply.
	 
	9.	 	Effective Date, Termination Date and Survival

	 	9.1	 	This MTA will be effective upon final signature of this MTA and will terminate, if not
differently agreed in writing between the Contractors concerned, at the end of the NGIN
Project. Articles 4, 6, 7 and 8will survive any termination of this MTA. To avoid doubt,
any applicable provisions of the Grant Agreement and the Consortium Agreement shall also
survive any termination of this MTA.
	 
	 	9.2	 	Upon termination, either by mutual consent, breach of this MTA by Recipient or subject
to article 9.1 of this MTA, Recipient and/or Recipient Investigator will immediately return
any remaining Material and Information, in any form whatsoever or destroy the Material and
all copies of Information, and will furnish to Institute a certificate attesting to such
return or destruction. To avoid doubt, the Recipient will also destroy all Derivatives or
remain bound by the terms of this MTA as they apply to Derivatives.

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	CONSORTIUM AGREEMENT 	FINAL VERSION JANUARY 2008

Very truly yours,

To be signed by the Investigator of
Institute:

Agreed and accepted this:

   
             
     day of        
              2007

	 	 	 	 	 
	By
	 	 	 	 
	 

	 	 	 	 
	 

	 	SIGNATURE OF INVESTIGATOR
	 	 
	Name
	 	 	 	 
	 

	 	 	 	 
	 

	 	TYPED NAME OF INVESTIGATOR	 	 
	Title
	 	 	 	 
	 

	 	 	 	 
	 

	 	TITLE OF INVESTIGATOR	 	 
	 
	 	 	 	 
	To be signed by the Investigator
of the Recipient:	 	 
	 
	Agreed and accepted this:	 	 
	 
	 	 	 	 
	                    

	 	 day of                     2007	 	 

	 	 	 	 	 
	By
	 	 	 	 
	 

	 	 

SIGNATURE OF INVESTIGATOR
	 	 
	Name
	 	 	 	 
	 

	 	 	 	 
	 

	 	TYPED NAME OF INVESTIGATOR	 	 
	Title
	 	 	 	 
	 

	 	 	 	 
	 

	 	TITLE OF INVESTIGATOR	 	 

 

To be signed by the Authorized
Representative of the Institute:

Agreed and accepted this:

       day of                      2007

	 	 	 	 	 
	By
	 	 	 	 
	 

	 	 

SIGNATURE OF REPRESENTATIVE
	 	 
	Name
	 	 	 	 
	 

	 	 	 	 
	 

	 	TYPED NAME OF REPRESENTATIVE	 	 
	Title
	 	 	 	 
	 

	 	 	 	 
	 

	 	TITLE OF REPRESENTATIVE	 	 
	 
	 	 	 	 
	To be signed by the
Authorized Representative of the Recipient:	 	 
	 
	Agreed and accepted this:	 	 
	 
	 	 	 	 
	___ day

	of                      2007	 	 

	 	 	 	 	 
	By

	 	 

	 	 
	
Name

	 	 

SIGNATURE OF REPRESENTATIVE
	 	 
	 

	 	 	 	 
	 

	 	TYPED NAME OF REPRESENTATIVE	 	 
	Title
	 	 	 	 
	 

	 	 	 	 
	 

	 	TITLE OF THE REPRESENTATIVE	 	 

59

 

					
	 	 	 	 	 
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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

ANNEX E

INITIAL PROJECT OFFICERS AND MEMBERS OF THE SC

The initial Project Officers will be:

	 	 	 
	Coordinator:

	 	- G. Scarlatti
	Co-coordinator:

	 	- H. Schuitemaker
	Project Manager:

	 	- P. Biswas

The initial members of the Steering Committee will be:

	 	 	 	 	 	 	 	 	 
	Contractor	 	Work Package leader	 	Contractor	 	Deputy/Substitute
	1

	 	(HSR)
	 	G. Scarlatti* (WP 7)
	 	(AMC)
	 	H. Schuitemaker (WP 7)
	2

	 	(AMC)
	 	H. Schuitemaker (WP 1)
	 	(MRC)
	 	G. Stewart-Jones (WP1)
	3

	 	(INT-NA)
	 	L. Buonaguro (WP 2)
	 	(Cytos)
	 	T. A. Rohn (WP 2)
	4

	 	(UNIMI)
	 	M. Clerici (WP 3)
	 	(AVARIS)
	 	A.-L. Spetz (WP3)
	5

	 	(SSI)
	 	A. Fomsgaard (WP 4)
	 	(CEA)
	 	R. Le Grand (WP 4)
	6

	 	(KI)
	 	J. Albert (WP5)
	 	(ITG)
	 	H. Donners (WP 5)
	7

	 	(NIBSC)
	 	H. Holmes (WP 6)	 	 	 	 

 

			
	*	 	Denotes chairperson of SC

60

 

					
	 	 	 	 	 
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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

ANNEX F

LIST OF LIMITATIONS AND RESTRICTIONS WITH RESPECT TO ACCESS RIGHTS

CONTRACTOR #1 – HSR:

HSR hereby gives formal notice it has restrictions and incompatible obligations that mean it will
not be able to grant Access Rights Needed For The Implementation Of The Project to HSR Background
to a for-profit member of the Consortium on a royalty-free basis. Subject to Article II.33.2 of
the Grant Agreement the HSR hereby confirms that it will be able to provide for-profit members of
the Consortium with such Access Rights on Fair and Reasonable Conditions.

Also HSR hereby informs the Consortium of the following limitation and restriction to the granting
of Access Rights. Thus, HSR hereby excludes any and all obligation to grant Access Rights to:
all Background generated by the Fondazione Centro San Raffaele del Monte Tabor other than that
generated by the research team of Dr. Gabriella Scarlatti (included the research group of Dr. Lucia
Lopalco and Prof. Paolo Lusso), reported in the Annex C of this Consortium Agreement. In any case
the access rights to the Background of the research team of Dr. Gabriella Scarlatti (included the
research group of Dr. Lucia Lopalco and Prof. Paolo Lusso) will be guarantee only for the
implementation of the Project only.

HSR Unit also hereby gives formal notice it may be required to obtain materials/information from
third parties for use in the Project as outlined in Annex I of the Grant Agreement. Access to such
materials/information by HSR Unit may be conditional on HSR accepting terms and conditions that are
not compatible with the Grant Agreement or this Consortium Agreement. Whilst HSR will use all
reasonable efforts to ensure that said materials/information can be obtained on terms compatible
with the HSR’s obligations under this the Grant Agreement and this Consortium Agreement, HSR cannot
guarantee such an outcome. Therefore, access to said materials/information (or HSR Foreground
arising from the use of such materials/information) by the other Contractors may be conditional on
the other Contractors’ acceptance of said third party terms and conditions.

In any case the Access Rights to the Background listed in Annex C will be guaranteed only for the
Implementation of the Project.

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

CONTRACTOR #2- AMC:

AMC hereby gives formal notice it may be required to obtain materials/information from third
parties for use in the Project as outlined in Annex I of the Grant Agreement. Access to such
materials/information by AMC may be conditional on AMC accepting terms and conditions that are not
compatible with the Grant Agreement or this Consortium Agreement. Whilst AMC will use all
reasonable efforts to ensure that said materials/information can be obtained on terms compatible
with the AMC’s obligations under this the Grant Agreement and this Consortium Agreement, AMC cannot
guarantee such an outcome. Therefore, access to said materials/information (or AMC Foreground
arising from the use of such materials/information) by the other Contractors may be conditional on
the other Contractors’ acceptance of said third party terms and conditions.

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The following know-how is excluded from the obligation to grant Access Rights:

1. Any and all know-how that exists or is henceforth developed within AMC, but outside of the group
of Prof. Dr. H. Schuitemaker.

2. Any and all know-how that exists or is henceforth developed within the research group listed
above but that does not relate to the subject matter of the Project NGIN or that is patented and/or
that is not freely available.

CONTRACTOR #3 - MRC:

MRC hereby gives formal notice it has restrictions and incompatible obligations that mean it will
not be able to grant Access Rights Needed For The Implementation Of The Project to MRC Background
to a for-profit member of the Consortium on a royalty-free basis. Subject to Article II.33.2 of
the Grant Agreement and any applicable restrictions shown below, the MRC hereby confirms
that it will be able to provide for-profit members of the Consortium with such Access Rights on
Fair and Reasonable Conditions.

MRC hereby gives formal notice it will be required to obtain materials/information from third
parties for use in the Project as outlined in Annex I of the Grant Agreement. Access to such
materials/information by MRC may be conditional on MRC accepting terms and conditions that are not
compatible with the Grant Agreement or this Consortium Agreement. Whilst MRC will use all
reasonable efforts to ensure that said materials/information can be
obtained on terms compatible with the MRC’s obligations under this the Grant Agreement and this Consortium Agreement, MRC cannot
guarantee such an outcome. Therefore, access to said materials/information (or MRC Foreground
arising from the use of such materials/information) by the other Contractors may be conditional on
the other Contractors’ acceptance of said third party terms and conditions.

CONTRACTOR #4 – INT-NA:

INT-NA hereby gives formal notice it has restrictions and incompatible obligations that mean it
will not be able to grant Access Rights Needed For The Implementation Of The Project to HSR
Background to a for-profit member of the Consortium on a royalty-free basis. Subject to Article
II.33.2 of the Grant Agreement the INT-NA hereby confirms that it will be able to provide
for-profit members of the Consortium with such Access Rights on Fair and Reasonable Conditions.
INT-NA hereby informs the Consortium that the following know-how is excluded from the obligation to
grant Access Rights: all Background and know-how that exists or is henceforth developed within the
research group that does not relate to the subject matter of the Project NGIN or that is patented
and/or that is not freely available. In any case the access rights to the Background of the
research team of Dr. Luigi Buonaguro will be guarantee for the implementation of the Project only.

INT-NA hereby gives formal notice it may be required to obtain materials/information from third
parties for use in the Project as outlined in Annex I of the Grant Agreement. Access to such
materials/information by INT-NA may be conditional on INT-NA accepting terms and conditions that
are not compatible with the Grant Agreement or this Consortium Agreement. Whilst INT-NA will use
all reasonable efforts to ensure that said materials/information can be obtained on terms
compatible with the INT-NA’s obligations under this the Grant Agreement and this Consortium
Agreement, INT-NA cannot guarantee such an outcome. Therefore, access to said materials/information
(or INT-NA Foreground arising from the use of such materials/information) by the other Contractors
may be conditional on the other Contractors’ acceptance of said third party terms and conditions.

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

CONTRACTOR #5- CYTOS:

CYTOS hereby informs the Consortium of the following limitation and restriction to the granting of
Access Rights. Thus, CYTOS hereby excludes any and all obligation to grant Access Rights to:

– All technology and know-how associated with the production of virus-like particles (VLPs).

– All technology and know-how involving covalent coupling of antigens and/or molecules to VLPs.

– All technology and know-how involved in the packaging of immunostimulatory nucleic acid sequences
and substances within VLPs.
- All analytical techniques and know-how involved in and involving
the above technologies and processes.

– All
technologies and know-how relating to the application of ’
Immunodrugs(TM) and/or other VLPs,
including without limitation to humans and/or non-humans and/or relating to the use to Cytos’
Immunodrugs(TM) and/or other VLPs as therapeutic, prophylactic and/or diagnostic tools and/or
products. 

– ALL TECHNOLOGIES AND KNOW-HOW TO WHICH THE GRANTING OF ACCESS RIGHTS WOULD VIOLATE THE TERMS AND
CONDITIONS OF A PARTY BEING IN A CONTRACTUAL RELATIONSHIP WITH
CYTOS.

Furthermore, CYTOS hereby excludes any and all obligation to grant Access Rights to know-how and
/or other intellectual property rights that are disclosed and/or protected in any patent
application filed by CYTOS or a party being in contractual relationship with CYTOS Moreover, CYTOS
hereby excludes any and obligation to grant Access Rights to know-how and /or other intellectual
property rights that are described and/or will be described in any patent application already filed
or will be filed by CYTOS or a party being in contractual relationship with CYTOS.

CONTRACTOR #6 – UMIL:

 
NONE

CONTRACTOR #7- AVARIS:

Avaris is a company operating very closely to academic institutions, e.g. Karolinska Institutet,
which is also a party to this Consortium Agreement. Several of the scientists and personnel who are
participating in the project on behalf of Avaris are also participating in the project on behalf of
Karolinska Institutet. Avaris has also participated in certain projects with Lund University which
is also a party to this Consortium Agreement, and Avaris has jointly with Lund University developed
certain innovations relating to HIV immunogen designs to produce neutralizing antibodies and/or
vaccine against HIV. Thus, the IPR situation of Avaris is complex. For the avoidance of doubt and
with reference to the foregoing, Avaris hereby gives formal notice that its grant of Access Rights
to any intellectual property rights whatsoever constituting Foreground or Background, is granted
with the same limitations as those applicable to Avaris’ rights.

Avaris hereby gives formal notice that it will not be able to grant Access Rights Needed for the
Implementation of The Project to Avaris Background to a for-profit member of the Consortium on a
royalty-free basis. Subject to Article II.33.2 of the Grant Agreement Avaris hereby confirms that
it will be able to provide for-profit members of the Consortium with such Access Rights on Fair and
Reasonable Conditions.

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

Avaris informs the Consortium of the following specific limitations and restrictions to the
granting of Access Rights. Thus, Avaris hereby makes the following carve out from its grant of
Access Rights:

	 	•	 	All Background acquired by Avaris’ various academic and private collaborators related to
research programs on Flagellin and HIV vaccine. These exclusions especially concern
(without limiting the aforesaid) the collaboration with Karolinska Institutet in general
and specifically in this Project and with Lund University in general and specifically
within the Auto/AlloCell-HIV project under the Sixth Framework Programme.
	 
	 	•	 	Any and all know-how and Background that exists or is henceforth developed within Avaris
but that does not relate to the subject matter of the Project NGIN or that is patented
and/or that is not freely available.

Avaris hereby informs (without limiting the aforesaid), in accordance with the Grant Agreement
Article II.32.3, that due to third party rights Avaris is limited and/or restricted to grant Access
Rights to the following Background:

	 	•	 	Background that has been and/or will be created and developed by personnel and/or
scientists and/or students at Karolinska Institutet and or other institutions not directly
involved in the Project.
	 
	 	•	 	Background that has been, and/or will be derived outside the Project.

Avaris also hereby gives formal notice that it may be required to obtain materials/information from
third parties for use in the Project. Access to such materials/information by Avaris may be
conditional on Avaris accepting terms and conditions that are not compatible with the Grant
Agreement or this Consortium Agreement. Whilst Avaris will use all reasonable efforts to ensure
that said materials/information can be obtained on terms compatible with Avaris’ obligations under
the Grant Agreement and this Consortium Agreement, Avaris cannot guarantee such an outcome.
Therefore, Access Rights to said materials/information (or Avaris Foreground arising from the use
of such materials/information) by the other Contractors may be conditional on the other
Contractors’ acceptance of said third party terms and conditions.

In any case the Access Rights to the Background listed in Annex C will be guaranteed only for the
Implementation of the Project.

CONTRACTOR #8- SSI:

SSI hereby gives formal notice it may be required to obtain materials/information from third
parties for use in the Project as outlined in e.g. Annex I of the Grant Agreement. Access to such
materials/information by SSI may be conditional on SSI accepting terms and conditions that are not
compatible with the Grant Agreement or this Consortium Agreement. Whilst SSI will use all
reasonable efforts to ensure that said materials/information can be obtained on terms compatible
with the SSI’s obligations under this Grant Agreement and this Consortium Agreement, SSI cannot
guarantee such an outcome. Therefore, access to said materials/information (or SSI Foreground
arising from the use of such materials/information) by the other Contractors may be on conditional
of the other Contractors’ acceptance of said third party terms and conditions.

In addition hereto, SSI hereby excludes any and all obligation to grant Access Rights to:

Any and all know-how that exists or is henceforth developed within SSI, but outside of the group of
Dr. A. Fomsgaard.

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	 	FINAL VERSION JANUARY 2008

Plasmids and recombinant viral vectors for immunisation encoding codon-optimized HIV-1 envelope
genes from strains Bx08, SSI 1. and SSI 2, and DNA constructs for production of recombinantly
expressed proteins.

Any and all know-how that exists or is henceforth developed within the research group listed above
but that does not relate to the subject matter of the Project NGIN or that is patented and/or that
is not freely available.

– All technology and know-how associated with the production of the adjuvans CAF 01 and derivatives
herof.

– All technology and know-how involving coupling of antigens and/or molecules to CAF 01.

– All technology and know-how involved in the packaging of immunostimulatory molecules and
substances within CAF 01.

– All analytical techniques and know-how involved in and involving the above technologies and
processes.

– All technologies and know-how relating to the application of CAF 01and/or other CAF 01, including
without limitation to humans and/or non-humans and/or relating to the use to CAF 01 and/or other
CAF 01 derivatives as therapeutic and/or prophylactic products.

(all the technology, know.how, material within CAF01, and adjivants reported upon hereinafter
referred collectively as “SSI material / adjuvant CAF 01”
(All the technology, know.how, material within CAF01, and adjuvant, reported upon, hereinafter
referred collectively as “SSI material / adjuvant CAF 01”)

– ALL TECHNOLOGIES AND KNOW-HOW TO WHICH THE GRANTING OF ACCESS RIGHTS WOULD VIOLATE THE TERMS AND
CONDITIONS OF A PARTY BEING IN A CONTRACTUAL RELATIONSHIP WITH SSI.   

Furthermore, SSI hereby takes the right to exclude any and all obligation to grant Access Rights to
know-how and /or other intellectual property rights that are disclosed and/or protected in any
patent application filed by SSI or a party being in contractual relationship with SSI. Moreover,
SSI hereby excludes any and obligation to grant Access Rights to know-how and /or other
intellectual property rights that are described and/or will be described in any patent application
already filed or will be filed by SSI or a party being in contractual relationship with SSI.

If a contractor may wish to use the SSI material/adjuvant CAF 01 (described in Annex F) in the
Consortium Agreement and the relevant department under SSI or third party accept this (conditions
to be negotiated between the parties), all rights reserves to any new patent, background or
foreground knowledge or other know-how in which the SSI material/ adjuvant is considered to be a
part of wholly or partly, the ownership shall be deemed to be the property of SSI.

It is a precondition for the use of and transfer of any SSI material/adjuvant CAF01 mentioned in
this Annex F that SSI use its own standard MTA wording. For clarification if conflict the SSI MTA
for this specific transfer shall be used and have priority above the Consortium standard MTA.

Any access rights may only be given by prior written permission from the SSI Business Development
and SSI Department of Corporate Affairs.

CONTRACTOR #9: CEA: 

NONE

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

CONTRACTOR #10- KI:

Karolinska Institutet hereby informs, in accordance with the Grant Agreement Article II.32.3, that
due to third party rights Karolinska Institutet is limited and/or restricted to grant access rights
to the following Background:

1 – Background that has been and/or will be created and developed by personnel and/or scientists
and/or students at Karolinska Institutet not directly involved in the
Project.

2 – Background that has been, and/or will be derived outside the project, which Karolinska
Institutet due to third party rights is not able to grant access rights to.

CONTRACTOR #11- ITG: 

NONE

CONTRACTOR #12 — NIBSC:

NONE

CONTRACTOR #13 –Mymetics:

Mymetics Corp. has restrictions and obligations that prevent it from granting Access Rights Needed
For The Implementation Of The Project to a for-profit member of the NGIN Consortium on a
royalty-free basis. However, Mymetics Corp. hereby confirms that it will be able to provide
for-profit members of the Consortium with such Access Rights on Fair and Reasonable Conditions.

Mymetics Corp. hereby gives formal notice that it will use all reasonable efforts to ensure that
said virosome technology in HIV field will remain available to the NGIN Consortium for the granting
period in the event that Mymetics Corp. sells its technology to a third party.

Mymetics Corp. hereby gives formal notice it will not provide information on its virosome
technology to third parties for use in the Project as outlined in Annex I of the Grant Agreement.
Access to such information from Mymetics Corp. may be conditional on Mymetics Corps. accepting
terms and conditions that are not compatible with the Grant Agreement or this Consortium Agreement.
Whilst Mymetics Corp. will use all reasonable efforts to ensure that said information can be
obtained on terms compatible with the Mymetics Corps’ obligations under this the Grant Agreement
and this Consortium Agreement, Mymetics Corp. cannot guarantee such an outcome. Therefore, access
to said information (or Mymetics Corp. Foreground arising from the use of such information) by the
other Contractors may be conditional on the other Contractors’ acceptance of said third party terms
and conditions.

CONTRACTOR #14 – ULUND:

Lund University hereby informs, in accordance with the Grant Agreement Article II.32.3, that due to
third party rights Lund University is limited and/or restricted to grant access rights to the
following Background:

1 – Background that has been and/or will be created and developed by personnel and/or scientists
and/or students at Lund University not directly involved in the
Project.

2 – Background that has been, and/or will be derived outside the project, which Lund University due
to third party rights is not able to grant access rights to.

CONTRACTOR #15 -UPD:

NONE

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	 	CONSORTIUM AGREEMENT
	 	FINAL VERSION JANUARY 2008

ANNEX G

LIST OF THIRD PARTIES WITH RESPECT TO TRANSFERRING OWNERSHIP OF FOREGROUND

CONTRACTOR #1- HSR: 

FRAUNHOFER INSTITUT BIONEDIZINISCHE TECHNIK

Enshelmer Strabe 48

66386, St. Ingbert, Germany

IATEC BV

Pietersbergweg 9, 1105 BM Amsterdam

The Netherlands

HSR hereby informs, in accordance with the Grant Agreement Article II.32.3, that due to third party
rights HSR is limited and/or restricted to grant access rights to the
following Background:

1 – Background that has been and/or will be created and developed by personnel and/or scientists
and/or students at HSR not directly involved in the Project.

2 – Background that has been, and/or will be derived outside the project, which HSR due to third
party rights is not able to grant access rights to.

CONTRACTOR #2 -AMC: 

NONE

CONTRACTOR #3- MRC:

NONE

CONTRACTOR #4 – INT-NA:

NONE

CONTRACTOR #5 – CYTOS:

NONE

CONTRACTOR #6 – UMIL: 

NONE

CONTRACTOR #7 – AVARIS: 

Gilead Sciences, Inc.

GLAXOSMITHKLINE (GSK)

Novartis

CONTRACTOR #8 – SSI:

SSI hereby informs, in accordance with the Grant Agreement Article II.32.3, that due to third party
rights SSI is limited and/or restricted to grant access rights to the following Background:

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Background that has been and/or will be created and developed by personnel and/or scientists and/or
students at SSI not directly involved in the Project.

Background that has been, and/or will be derived outside the project, which SSI due to third party
rights is not able to grant access rights to.

If a contractor may wish to use the SSI material / adjuvant CAF 01 in the Consortium Agreement and
the relevant department under SSI or third party accept this (conditions to be negotiated between
the parties), all rights reserves and any new patent, background or foreground knowledge or other
know-how in which the SSI adjuvant is considered to be a part of wholly or partly, the ownership
shall be deemed to be SSI property.

All the technology, know.how, material within CAF01, and adjuvant, reported upon, hereinafter
referred collectively as “SSI material / adjuvant CAF 01”)

It is a precondition for the use of and transfer of any SSI material / adjuvant CAF 01 that SSI use
it’s own standard MTA wording. If conflict the SSI MTA shall be used and have priority above the
Consortium standard MTA.

CONTRACTOR #9- CEA:

NONE

CONTRACTOR #10 – KI: 

NONE

CONTRACTOR #11- ITG: 

The Institute of Tropical Medicine hereby informs, in accordance with the Grant Agreement Article
II.32.3, that due to third party rights the Institute of Tropical Medicine is limited and/or
restricted to grant access rights to the following Background:

1 – Background that has been and/or will be created and developed by personnel and/or scientists
and/or students at the Institute of Tropical Medicine not directly
involved in the Project.

2 – Background that has been, and/or will be derived outside the project, which the Institute of
Tropical Medicine due to third party rights is not able to grant access rights to.

CONTRACTOR #12- NIBSC:

NONE

CONTRACTOR #13- MYMETICS:

Mymetics hereby informs, in accordance with the Grant Agreement Article II.32.3, that due to third
party rights Mymetics is limited and/or restricted to grant access rights to the following
Background:
1 – Background that has been and/or will be created and developed by collaborators and/or
scientists from Mymetics and it’s network not directly involved in the NGIN Project.

CONTRACTOR #14- ULUND: 

NONE

CONTRACTOR #15 -UPD:

NONE

68technest_10qsb-ex1008.htm

    Exhibit 10.8

     

     

    TECHNEST
HOLDINGS, INC.

    
      SEVERANCE
AGREEMENT

      

      This
Severance Agreement ("Agreement") is entered into as of December 31, 2007, by
and between Technest Holdings, Inc., a Delaware corporation with its principal
offices located at 10411 Motor City Drive, Suite 650, Bethesda, Maryland 20817
(the "Company"), and Joseph P. Mackin, an individual residing in Quincy,
Massachusetts  (the "Executive").

       

      WHEREAS,
the Executive is currently employed as Chief Executive Officer and President of
the Company;

       

      WHEREAS,
in consideration of the services rendered and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged by
the Company, the Company is willing to provide, subject to the terms of this
Agreement, certain payments to the Executive upon the Sale (as defined
below);

       

      NOW,
THEREFORE, in consideration of the mutual covenants and agreements set forth
herein, the parties agree as follows:

       

      

      1.  Continuing
Employment.  Until the Trigger Date (as defined below), the
Executive shall continue in his role as the Chief Executive Officer and
President of the Company and shall continue as a member of the Board of
Directors of the Company.  As the Chief Executive Officer and
President of the Company, the Executive shall continue to devote his full time
during normal business hours to rendering services to the Company hereunder, and
shall exert all reasonable efforts in the rendering of such services, consistent
with his past efforts.  In the event that the Executive voluntarily
resigns as Chief Executive Officer and/or President of the Company prior to the
Trigger Date, then the Company shall have no obligations to the Executive, and
you shall have no rights, under this Agreement with respect to Section 3
hereof.

       

      2. Change of
Role on Trigger Date.  The Executive
shall automatically resign (without any further action on his part) as Chief
Executive Officer and President of the Company effective as of the Trigger
Date.  For these purposes, the “Trigger Date” shall
be the closing date of the sale of all the outstanding capital stock of the
Company’s wholly owned subsidiary E-OIR Technologies, Inc. (the “Sale”)  pursuant
to that certain Stock Purchase Agreement dated as of September 10, 2007 by and
among EOIR Holdings LLC, E-OIR Technologies, Inc. and the Company (the “Stock Purchase
Agreement”).

       

      3.  Severance
Pay.

       

      (a)  Initial Severance
Pay.  Subject to the Executive’s continuing compliance
following the Trigger Date, with the provisions of Section 5 (Confidential
Information), Section 7 (Intellectual Property Rights) and Section 9
(Non-Competition) of the Employment Agreement dated as of March 13, 2006 between
the Executive and the Company (the “Employment
Agreement”) and to the Executive’s compliance with Section 8(e)
(Surrender of Records and Property) of the Employment Agreement, the Company
will make an initial severance payment to the Executive in a total gross amount
of $350,000, which amount is the equivalent of the Executive’s annual base
salary for one year (the “Annual Base
Salary”).  Such payment will be made in a lump sum and shall be
payable no later than ten (10) business days after the Trigger
Date.

       

      
        
           

        

        
          
          

          
            

          

        

        
           

        

      

      

       

      (b)  Contingent Severance
Pay. In the
event that the Company is paid the Contingent Purchase Price (as such term is
defined in the Stock Purchase Agreement), then the Executive shall be entitled
to receive a contingent severance payment in a total gross amount that is the
equivalent of the gross amount of the Executive’s Annual Base Salary for the
remainder of the Executive’s term of employment as specified in the Employment
Agreement, which assuming a Trigger Date of December 31, 2007 would total
$785,833.  Such payment will be made in a lump sum contemporaneously
with the Company’s receipt of the Contingent Purchase Price.  If the
Contingent Purchase Price is not paid, then the Executive shall not receive any
payment pursuant to this Section 3(b).

       

      (c)  Withholdings.  The Company may
deduct from any and all payments described in this Section 3, such legally
required withholdings, payments and/or deductions as may be
required.

       

      (d)  Benefits.  As
of the Trigger Date, he Executive agrees that he is forgoing and is no longer
entitled to any benefits or insurance coverage by the Company, if any currently
being provided to the Executive.

       

      (e) Termination of Employment
Agreement. Other than as provided herein, the Employment Agreement shall
terminate as of the Trigger Date.

       

      4.  Release.  The Executive and
all his successors, assigns and heirs hereby release, forever discharge and
covenant not to sue the Company, its predecessors, successors, subsidiaries,
affiliates, assigns, agents, and any of their present or former directors,
officers, employees or shareholders, from any and all claims, demands, damages
or liability of any nature whatsoever prior to the date of this Agreement, known
or unknown, which Executive has or may have, including, but not limited to,
claims arising under the Employee Retirement Income Security Act of 1974
(“ERISA”), claims for breach of contract or wrongful termination, claims for
equity awards, claims for severance or termination pay, claims for alleged
discrimination under federal, state or local law, including, but not limited to,
Title VII of the Civil Rights Act of 1964, as amended, 42 U.S.C. § 2000e, et
seq., the Age Discrimination In Employment Act (“ADEA”), 29 U.S.C. § 621 et
seq., the Americans With Disabilities Act, 42 U.S.C. § 12111, et seq., and any
other federal, state, foreign or local laws, statutes, regulations, or
ordinances, as well as rights under any and all common law causes of action.
Consistent with the terms of this Paragraph, Executive further agrees to refrain
from bringing, prosecuting or arbitrating any claim, demand or cause of action,
either at law or in equity, against the Company as the result of any act or
omission by the Company occurring up to and including the date of his execution
of this Agreement.

       

      
        
           

        

        
          - 2
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      5.   Indemnification.

       

      5.1  In
the event that the Executive is made, or threatened to be made, a party to any
action or proceeding, whether civil or criminal, by reason of the fact that the
Executive was a director, officer, employee, or member of a committee of the
Board or served any other corporation, partnership, joint venture, trust, the
Executive benefit plan or other enterprise in any capacity at the request of the
Company, or resulting from any of the Executive’s actions in any of the
foregoing roles (a “Proceeding”) the Executive shall be indemnified by the
Company and the Company shall advance the Executive’s related expenses to the
fullest extent permitted by law (including without limitation, damages, costs
and reasonable attorney fees), as may otherwise be provided in the Company’s
Articles of Incorporation and Bylaws as incurred and will start prior to any
judicial proceeding. The Company further covenants not to amend or repeal any
provisions of the Articles of Incorporation or Bylaws of the Company in any
manner which would adversely affect the indemnification or exculpatory
provisions contained therein as they pertain to acts. The provisions of this
Section are intended to be for the benefit of, and shall be enforceable by, each
indemnified party and the Executive’s heirs and representatives. If the Company
or any of its successors or assigns (i) shall consolidate with or merge into any
other corporation or entity and shall not be the continuing or surviving
corporation or entity of such consolidation or merger or (ii) shall transfer all
or substantially all of its properties and assets to such person, then and in
each such case, proper provisions shall be made so that the successors and
assigns of the Company shall assume all of the obligations set forth in this
Section 5.1.

       

      5.2  If
any Proceeding shall be brought or asserted against the Executive, the Executive
shall promptly notify the Company in writing, and the Company shall assume the
defense thereof, including the employment of counsel reasonably satisfactory to
the Executive and the payment of all fees and expenses incurred in connection
with defense thereof; provided, that the failure of the Executive to give such
notice shall not relieve the Company of its obligations or liabilities pursuant
to this Section 5, except (and only) to the extent that such failure shall have
prejudiced the Company.

       

      The
Executive shall have the right to employ separate counsel in any such Proceeding
and to participate in the defense thereof, but the fees and expenses of such
counsel shall be at the expense of the Executive unless: (1) the Company has
agreed in writing to pay such fees and expenses; or (2) the Company shall have
failed promptly to assume the defense of such Proceeding and to employ counsel
reasonably satisfactory to the Executive in any such Proceeding; or (3) the
named parties to any such Proceeding (including any impleaded parties) include
both the Executive and the Company, and the Executive shall have been advised by
counsel that a material conflict of interest is likely to exist if the same
counsel were to represent the Executive and the Company (in which case, if the
Executive notifies the Company in writing that it elects to employ separate
counsel at the expense of the Company, the Company shall not have the right to
assume the defense thereof and the reasonable expense of such counsel for the
Executive shall be at the expense of the Company).  The Company shall
not be liable for any settlement of any such Proceeding effected without its
written consent, which consent shall not be unreasonably
withheld.  The Company shall not, without the prior written consent of
the Executive, effect any settlement of any pending Proceeding in respect of
which any Executive is a party, unless such settlement includes an unconditional
release of the Executive from all liability on claims that are the subject
matter of such Proceeding.

       

      
        
           

        

        
          - 3
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      Subject
to the terms of this Section 5, all fees and expenses of the Executive
(including reasonable fees and expenses to the extent incurred in connection
with investigating or preparing to defend such Proceeding in a manner not
inconsistent with this Section) shall be paid to the Executive, as incurred,
within thirty days of written notice thereof to the Company (regardless of
whether it is ultimately determined that an Executive is not entitled to
indemnification hereunder; provided, that the Company may require the Executive
to undertake to reimburse all such fees and expenses to the extent it is finally
judicially determined that the Executive is not entitled to indemnification
hereunder).

       

       

      6.  Miscellaneous.

       

      (a)  Notices.  Any
notice or other communication required or permitted hereunder shall be in
writing and shall be deemed given when delivered personally or sent by facsimile
transmission (with confirmation) or, if sent by regular mail, three days after
the date of deposit in the United States mails to the addresses set forth above
or to such other address as either party may from time to time provide to the
other by notice as provided in this section.

       

      (b)  Entire
Agreement.  This Agreement constitutes the entire agreement and
understanding between the Company and the Executive, and supersedes all prior
negotiations, agreements, arrangements, and understandings, both written or
oral, between the Company and the Executive with respect to the subject matter
of this Agreement.

       

      (c)  Waiver or
Amendment.  The waiver by either party of a breach or violation
of any term or provision of this Agreement by the other party shall not operate
or be construed as a waiver of any subsequent breach or violation of any
provision of this Agreement or of any other right or remedy.  No
provision in this Agreement may be amended unless such amendment is set forth in
a writing that specifically refers to this Agreement and is signed by the
Executive and the Company.

       

      (d)  Governing
Law.  This Agreement shall be governed by and construed in
accordance with the laws of the State of Nevada without regard to its conflict
of laws rules.

       

      (e)  Assignment.  This
Agreement shall inure to the benefit of, and shall be binding upon, each of the
Company and the Executive and their respective heirs, personal representatives,
legal representatives, successors and assigns.

       

      (f)  Severability.  The
invalidity of any one or more of the words, phrases, sentences, clauses or
sections contained in this Agreement shall not affect the enforceability of the
remaining portions of this Agreement or any part hereof.  If any part
of this Agreement shall be declared invalid by a court of competent
jurisdiction, this Agreement shall be construed as if such invalid part had not
been inserted.

       

      
        
           

        

        
          - 4
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      (g)  Section
Headings.  The section and subsection headings contained in
this Agreement are for reference purposes only and shall not affect any way the
meaning, construction or interpretation of any or all of the provisions of this
Agreement.

       

      (h)  Counterparts.  This
Agreement may be executed in any number of counterparts and by the separate
parties hereto in separate counterparts, each of which shall be deemed to
constitute an original and all of which shall be deemed to be one and the same
instrument.

       

      (i)  Authority to
Execute.  The undersigned officer represents and warrants that
he or she has full power and authority to enter into this Agreement on behalf of
the Company, and that the execution, delivery and performance of this Agreement
have been authorized by the Board of Directors of the Company.  Upon
the Executive's acceptance of this Agreement by signing and returning it to the
Company, this Agreement will become binding upon the Executive and the
Company.

       

      
        
           

        

        
          - 5
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      IN
WITNESS WHEREOF, the parties have executed this Agreement as of the day and year
first written above.

       

      
        	
                EXECUTIVE

              	 
      	
                TECHNEST
      HOLDINGS, INC.

              
	 	 	 
	 	 	 
	
                    
      /s/ Joseph P.
      Mackin                            
      

                Joseph
      P. Mackin

              	 
      	
                By:    Gino M.
      Pereira                                           
      

                Gino
      M. Pereira

                Chief
      Financial Officer

              

      

      

       

       

       

       

       

       

       

       - 6 -

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