EXHIBIT 10.1

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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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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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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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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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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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- 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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“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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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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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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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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  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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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

23

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          NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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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          NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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.

25

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

26

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          NGIN   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
  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:
   

27

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          NGIN   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   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:

28

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          NGIN   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   CYTOS BIOTECHNOLOGY AG (CYTOS) 

By (signature):
Name: Dr. Martin Bachmann
Title: Chief Scientific Officer
Date:

29

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          NGIN   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   UNIVERSITA’ DEGLI STUDI DI MILANO (UMIL)

By (signature):
Name: Prof. Enrico Decleva
Title: Rector
Date:

30

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          NGIN   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   AVARIS AB (AVARIS)

By (signature):
Name: Dr. Mats Lake
Title: CEO
Date:

31

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          NGIN   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   STATENS SERUM INSTITUT (SSI)

By (signature):
Name: Dr Nils Strandberg Pedersen
Title: President, CEO
Date:

32

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          NGIN   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   COMMISSARIAT À L 1ENERGIE ATOMIQUE (CEA)

By (signature):
Name: M Roger GENET
Title: as interim Head of the Life Sciences Division
Date:

33

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          NGIN   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   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:

34

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          NGIN   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   PRINS LEOPOLD INSTITUUT VOOR TROPISCHE
GENEESKUNDE, (ITG)

By (signature):
Name: Prof. Dr. Bruno Gryseels
Title: Director
Date:

35

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          NGIN   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   NATIONAL BIOLOGICAL STANDARDS BOARD (NIBSC)

By (signature):
Name: Mr. Victor Knight
Title: Secretary to the Board /Head of Finance
Date:

36

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          NGIN   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   MYMETICS MANAGEMENT S.A.R.L (Mymetics)

By (signature):
Name: Mr. Ernest Lübke
Title: General Administrator
Date:

37

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          NGIN   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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          NGIN   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   UNIVERSITE PARIS DESCARTES- PARIS 5 (UPD)

By (signature):
Name: Prof. Bruno Varet
Title: Administrateur Provisoire
Date:

39

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

40

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

41

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

42

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

43

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

44

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

45

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

46

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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

47

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008   CONTRACTOR #13-
Mymetics:           NONE           CONTRACTOR #14 – ULUND:         LUAB
P.O. Box 117
221 00 LUND, Sweden         CONTRACTOR #15 — UPD:         NONE      

48

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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

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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NGIN   CONSORTIUM AGREEMENT   FINAL VERSION JANUARY 2008

- 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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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

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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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

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

52

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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

  •   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

53

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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

  •   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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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

               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.

55

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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

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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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

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

57

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      NGIN CONSORTIUM AGREEMENT FINAL VERSION JANUARY 2008

    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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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    

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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

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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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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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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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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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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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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

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