EXHIBIT 10.7
Dated 10 September 1997
PEPTIDE THERAPEUTICS LIMITED
-and-
UNIVERSITY OF MARYLAND, BALTIMORE
-and-
MEDEVA PLC
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ASSIGNMENT AND VARIATION AGREEMENT
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THIS ASSIGNMENT AND VARIATION AGREEMENT is made on this 10th day of September,
1997, (the "Effective Date") ("Agreement")
BY:
(1) PEPTIDE THERAPEUTICS LIMITED a company incorporated in England and
Wales (No. 2774777) whose registered office address is at 321 Cambridge
Science Park, Xxxxxx Xxxx, Xxxxxxxxx, XX0 0XX Xxxxxxx ("Peptide"); and
(2) UNIVERSITY OF MARYLAND, BALTIMORE of 000 X. Xxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxx 00000, XXX (the "University") formerly named UNIVERSITY OF
MARYLAND AT BALTIMORE; and
(3) MEDEVA PLC (No. 2086530) whose registered office address is at 00 Xx.
Xxxxx'x Xxxxxx, Xxxxxx XX0X 0XX Xxxxxxx ("Medeva").
WHEREAS
(A) In January 1991, Medeva and its affiliates acquired the exclusive rights
to use technology developed at the Wellcome Research Laboratories,
Beckenham, Kent in the field of attenuated mutants of Salmonella typhi for
human vaccines. These rights were licensed to Peptide by an agreement
dated 30 January 1997 ("Peptide Agreement").
(B) The University has the exclusive rights to use technology developed at its
Center for Vaccine Development ("CVD") in the field of []*
(C) By an Agreement of 20 September 1994 made between the University and
Medeva, University and Medeva agreed to collaborate in the further
development of []* ("The Principal Agreement").
(D) In or around May 1995, Medeva terminated the "Project" (as that term is
defined under the Principal Agreement) and the Principal Agreement fell
dormant.
(E) The parties have now agreed that Peptide take an assignment from Medeva of
the Principal Agreement on the terms and conditions and with the
modifications to the Principal Agreement and its schedules set out below.
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* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
1
IT IS AGREED as follows:
1 ASSIGNMENT OF THE PRINCIPAL AGREEMENT
1.1 In consideration of Peptide agreement to assume all the obligations and
liabilities of Medeva under the Principal Agreement from the Effective
Date, Medeva hereby assigns and Peptide hereby accepts the assignment of
the Principal Agreement on the terms herein (the "Assignment").
1.2 In consideration of (a) Peptide agreeing to accept the terms and
conditions of the Principal Agreement from the Effective Date and (b)
Medeva and Peptide accepting the terms and conditions of this Agreement,
the University hereby consents to the Assignment without further recourse
against Medeva for any reason whatsoever, []*.
1.3 With effect from the effective Date all contractual rights and obligations
under the Principal Agreement shall be enforceable exclusively between the
University and Peptide as fully as if Peptide had been an original party
to the Principal Agreement in place of Medeva from the Effective Date save
only that
1.3.1 the Principal Agreement shall be varied as set out in clause 2
1.3.2 for the avoidance of doubt it is accepted by University the
Termination of the Project by Medeva was valid and University
has no claim against Medeva in relation to its work under the
Project. Further, such termination of the Project by Medeva
shall have no effect upon the new project to be commenced by
Peptide with Medeva following the Effective Date.
2. VARIATIONS TO PRINCIPAL AGREEMENT
2.1 The main body of the Principal Agreement shall be varied as from the
Effective Date as follows:
2.1.1. The Recitals shall be deleted;
2.1.2 The definition for "Project Coordinator" shall be changed as
follows:
"Project Coordinator" means in the case of Peptide, Dr P Bedford,
and in the case of the University, Xx. X. Xxxxxx; or such other
person as a party may substitute from time to time by written
notice to the other party.
-----------------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
2
2.1.3 By this Agreement Medeva transfers to Peptide all rights assigned
or licensed to it under the Principal Agreement for the
bacterial salmonella typhoid strains known as CVD 908 and
CVD 906. Peptide acknowledges that the University owns Background
Intellectual Property Rights in CVD 908 and CVD 906.
Medeva's rights in such strains have been transferred from
Medeva to Peptide under the terms of this Principal Agreement
and this Assignment and Variation of Agreement. Medeva as a
result of the transfer of its rights in CVD 908 and CVD 906 will
have no further right to use them except under a separate
executed agreement between University and Medeva or under licence
from Peptide in respect of arrangements entered into under the
Peptide Agreement.
2.2 The Schedules to the Principal Agreement shall be varied as from the
Effective Date as follows:
2.2.1. Schedule 3 shall be replaced completely by the new Schedule 3
text set out in Schedule 1 to this agreement.
3. GENERAL
3.1 Save as set out in this Agreement, the Principal Agreement shall remaining
full force and effect save that it is assigned as from the Effective Date
from Medeva to Peptide.
3.2 University and Medeva agree that any Foreground Intellectual Property
developed under the Principal Agreement prior to the Effective Date shall
form part of the rights carried forward as Foreground Intellectual
Property under the Principal Agreement as assigned to Peptide.
3.3 Medeva shall pass control of all Foreground Technical Information received
from University to Peptide.
3.4 Medeva assigned to Peptide the rights granted under the Principal
Agreement with respect to University Background Technology Information
(BTI) and university Background Intellectual Property Rights (BIPR).
Medeva no longer has the right to use University BTI or University BIPR
save in respect of any arrangements entered into directly with University
of Peptide, including under licence pursuant to the Peptide Agreement.
3.5 All licences granted by University to Medeva and by Medeva to University
under the Principal Agreement terminate forthwith.
3.6 []*
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* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
3
[]*
3.7 University hereby releases Medeva from any and all liability arising out
of or relating to the Principal Agreement. Any liability arising from a
breach of the continuing obligation referred to in clause 3.6 above shall
be a liability arising under this Agreement.
3.8 Peptide will assume obligations for all the terms and conditions under the
Principal Agreement, and this Agreement, specifically for clause 16 -
Indemnity. Peptide's Indemnity obligations apply to actions and events
occurring on or after the Effective Date.
Signed by their duly authorised representatives to be effective as of 10th
September, 1997.
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
4
SCHEDULE I
Variations to and Replacements of Schedules
to the Principal Agreement
1. PHASE II CLINICAL TRIAL OF ATTENUATED SALMONELIA TYPHI ORAL LIVE VECTOR
VACCINE CVD 908-htrA.
Total Budget: $304,388
Payment Schedule: 4 equal instalments prior to treatment of each cohort
of 20 volunteers (80 volunteers total) or quarterly, whichever is sooner.
2.* OUTPATIENT VACCINATION OF VOLUNTEERS IN PREPARATION FOR CHALLENGE
Total Budget: $133,243
Payment Schedule: after recruitment but prior to vaccination of
volunteers.
3.* INPATIENT CHALLENGE OF VACCINATED VOLUNTEERS AND CONTROLS
Total Budget: $440,189
Payment Schedule: half in advance of challenge and half on successful
completion of inpatient follow-up period.
Studies dependent on successful establishment of challenge model.
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* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
5
SIGNED by a duly authorised officer )
for and on behalf of ) /s/ X.X. Xxxxxxx
PEPTIDE THERAPEUTICS LIMITED )
In the presence of:- )
X.X. Xxxxxxx
Signature of Witness: /s/ Xxxx Xxxxxxx
Name of Witness: Xxxx Xxxxxxx
Address: 00, Xxxxx Xxxx, Xxx, Xxxxx, XX
SIGNED by a duly authorised officer )
for and on behalf of ) /s/ X. X. Xxxxxxx
UNIVERSITY OF MARYLAND, BALTIMORE )
formerly named UNIVERSITY OF MARYLAND ) X. X. Xxxxxxx
AT BALTIMORE in the presence of:- )
Signature of Witness: /s/ Xxxx X. Xxxxx
Name of Witness: Xxxx X. Xxxxx
Address: [Illegible]
[Illegible]
Xxxxxxxxx, XX 00000
SIGNED by a duly authorised officer )
for and on behalf of ) Xx Xxxxx
MEDEVA PLC )
In the presence of:
Signature of Witness: /s/ X. Xxxxxx
Name of Witness X. Xxxxxx
Solicitor
Address: 00 Xx. Xxxxx'x Xx.
Xxxxxx, XX0
6
DATED 20th September 1994
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MEDEVA PLC
-and-
UNIVERSITY OF MARYLAND AT BALTIMORE
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BIPARTITE COLLABORATION AGREEMENT
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XXXXXXXX XXXX
Marcol House
000 Xxxxxx Xxxxxx
Xxxxxx X0X 0XX
Tel: 000-000 0000
TABLE OF CONTENTS
1. DEFINITIONS AND INTERPRETATION . . . . . . . . . . . . . . . . . . . . 1
2. OBLIGATIONS OF THE PARTIES . . . . . . . . . . . . . . . . . . . . . . 4
3. MANAGEMENT OF THE TYPHOID PROJECTS . . . . . . . . . . . . . . . . . . 6
4. FOREGROUND TECHNICAL INFORMATION AND FOREGROUND INTELLECTUAL
PROPERTY RIGHTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5. BACKGROUND TECHNICAL INFORMATION AND BACKGROUND INTELLECTUAL
PROPERTY RIGHTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6. OTHER INTELLECTUAL PROPERTY INTERESTS . . . . . . . . . . . . . . . . 15
7. ROYALTIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
8. CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
9. WARRANTIES AND LIABILITIES . . . . . . . . . . . . . . . . . . . . . 21
10. DURATION AND TERMINATION . . . . . . . . . . . . . . . . . . . . . . 23
11. ASSIGNMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
12. LAW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
13. FORCE MAJEURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
14. NOTICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
15. GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
16. INDEMNITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
SCHEDULE 1(a)
Background Intellectual Property Rights of Medeva
SCHEDULE 1(b)
Background Intellectual Property Rights of University
SCHEDULE 2(a)
Background Technical Information of Medeva
SCHEDULE 2(b)
Background Technical Information of University
SCHEDULE 3
Research Programme and Budget
SCHEDULE 4(a)
Third Party Arrangements known to Medeva
SCHEDULE 4(b)
Third Party Arrangements known to University
SCHEDULE 5
Materials Release Agreement
SCHEDULE 6
Confidential Disclosure Agreement
SCHEDULE 7
Adverse conditions to be covered
BIPARTITE COLLABORATION AGREEMENT
THIS AGREEMENT is made the 20th day of September 1994, by and between
MEDEVA PLC of 00 Xx Xxxxx'x Xxxxxx, Xxxxxx XX0X 0XX (hereinafter referred to as
"Medeva") of the first part
AND
UNIVERSITY OF MARYLAND AT BALTIMORE of 000 X. Xxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxx 00000, XXX (hereinafter referred to as the "University") of the second
part.
WHEREAS:
A) Medeva and its Affiliates have the exclusive rights to use technology
developed at the Wellcome Research Laboratories, Beckenham, Kent, U.K. in
the field of attenuated mutants of Salmonella typhi for human vaccines.
B) The University has the exclusive rights to use technology developed at its
Center for Vaccine Development ("CVD") in the field of attenuated mutants
of Salmonella typhi bacteria for human vaccines, and has the resources for
clinical trials of human vaccines.
C) The parties now wish to collaborate in the further development of
recombinant attenuated strains of Salmonella typhi for use as a single
dose oral typhoid vaccine and to agree to the terms and conditions
applicable to their collaboration.
NOW THEREFORE it is hereby agreed by and between the parties as follows:
1. DEFINITIONS AND INTERPRETATION
1.1 In this Agreement the following terms shall have the following meanings
unless the context requires otherwise:
(a) "Affiliate" means a company, partnership, or other entity which
directly or indirectly controls, is controlled by or is under common
control with the relevant party to this Agreement. "Control" means the
ownership of more than 50% of the issued share capital or the legal
power to direct or cause the direction of the general management and
policies of the entity in question.
(b) "Background Intellectual Property Rights" means Intellectual Property
Rights (as hereinafter defined) to be made available by a party for
use in the
and for the purposes of this Agreement "Animals" means all non-human
animals;
1
Typhoid Project (as hereinafter defined), pursuant to clause 2.2(c)
including those specified in Schedules 1(a) and 1(b) attached hereto.
(c) "Background Technical Information" means Technical Information (as
hereinafter defined) to be made available by a party for use in the
Typhoid Project pursuant to clause 2.2(c) including but not limited to
those specified in Schedules 2(a) and 2(b) attached hereto.
(d) "Core Typhoid Project" means the Typhoid Project as envisaged by the
research programme and budget set out in Schedule 3 hereto as amended
from time to time under the provisions of clause 2.2(b).
(e) "Field" shall mean the prevention or reduction in susceptibility to
infectious disease in human beings by administration to human beings
of a substance that induces immunity in human beings against such
disease;
For the avoidance of doubt Field shall exclude:-
(i) insofar as they relate exclusively to Animals;
(a) products and services for the treatment,
alleviation, prevention or control of
disease in, nuisance to or other adverse
conditions in Animals;
(b) products for production, improvement in
or for the economic management of Animals
by substances that are biologically
active in Animals;
and for the purposes of this Agreement "Animals"
means all non-human Animals;
(ii) products and services insofar as they relate
exclusively to or are exclusively for;
(a) the diagnosis of disease in human beings;
(b) the therapeutic treatment of disease in
human beings;
(c) vaccines for use by administration to
human beings for the treatment or
prophylaxis of all immuno deficiency
virus infections.
(f) "Foreground Intellectual Property Rights" means Intellectual
Property Rights (as hereinafter defined) obtained, discovered, found,
produced, made by or generated in the course of work on a Typhoid
Project.
2
(g) "Foreground Technical Information" means Technical Information (as
hereinafter defined) obtained, discovered, found, produced, made by or
generated in the course of work on a Typhoid Project.
(h) "Intellectual Property Rights" means patents, registered designs,
copyrights and trademarks and applications for any of the foregoing
and any form of protection afforded by law to ideas, concepts,
inventions and the right to apply for any of the foregoing.
(i) "Know-How" means any technical data and information arising directly
from or used in the course of a Typhoid Project which a party holds as
non-public and is capable of being employed in respect of a Second
Generation Product (as hereinafter defined) or process by which a
Second Generation Product is manufactured or used.
(j) "Net Sales" means the aggregate sales revenue of a Second
Generation Product (determined by gross invoice price) less all
reasonable relevant discounts, credits, transportation charges, excise
and other taxes and duties and with allowance made for returns and
replacements. For the purposes of calculating royalties due to the
University pursuant to this Agreement Net Sales shall include the
amounts referred to in the final sentence of clause 5.3(b) of this
Agreement.
(k) "Project Coordinator" means in the case of Medeva, Xx X X Xxxxxxxxx
and in the case of the University, Dr M Xxxxxx; or such other person
as a party may substitute from time to time by written notice to the
other party.
(l) "Project Management Committee" means, with respect to a Typhoid
Project, a Committee consisting of both Project Coordinators.
(m) "Proprietary Information" (sometimes referred to as "Confidential
Information") shall have the meaning set forth in clause 8 of this
Agreement.
(n) "Regulatory Agency" means a government body concerned with the
granting of marketing authorisation for human vaccines.
(o) "Second Generation Product" means any oral typhoid vaccine which is
derived from recombinant attenuated strains of Salmonella typhi
possessing; []*
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* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
3
(p) "Technical Information" means technical information, know-how,
show-how and data of any kind including but not limited to designs,
drawings, techniques, processes, formulae, reports, specifications,
procedures, instructions, substances and bacterial strains.
(q) "Typhoid Project" means a research programme to develop and/or work or
studies directed towards the development of a Second Generation
Product.
1.2 Where appropriate, words denoting a singular number only shall include the
plural and vice versa.
1.3 Reference to any statute or statutory provision or regulation includes a
reference to such statute, statutory provision or regulation as from time to
time amended, extended or re-enacted.
2. OBLIGATIONS OF THE PARTIES
2.1 (a) Each party undertakes to carry out its duties as defined in Schedule 3
in accordance with the timescales and costs detailed therein, or in
modifications or supplements to Schedule 3. The costs of work carried
out at or under the auspices of the University as specified in
Schedule 3, or in modifications or supplements to Schedule 3 shall be
borne by Medeva.
(b) Medeva shall have the right to monitor the clinical trials carried out
at or under the auspices of the University by having representatives
in attendance and shall have the right to audit (at reasonable times
and at its own expense) information associated with these trials.
(c) Medeva shall pay the University at quarterly intervals in advance one
quarter of the total budget for the year in which the quarter falls.
The total budget figure for the relevant year is the figure specified
as "TOTAL COSTS YEAR..." on page 1 of Schedule 3 (as the same may be
modified or supplemented from time to time in accordance with the
provisions of clause 2.2(b)).
(d) The provisions of 2.1(a) to (c) above shall apply mutatis mutandis
to any additional or new Schedule drawn up pursuant to clause 2.3, and
the work envisaged thereby.
2.2 The obligations of each party in order to carry out a Typhoid Project shall
be as follows:
(a) to communicate fully and promptly to the Project Coordinator of the
other party all such Foreground Intellectual Property Rights,
Foreground Technical
4
Information, Background Intellectual Property Rights and Background
Technical Information necessary for such other party to carry out its
part of such Typhoid Project;
(b) to comply with all reasonable requests and requirements of the Project
Management Committee consistent with the research programme and the
budget for such Typhoid Project and in the case of the Core Typhoid
Project the research programme and budget contained in Schedule 3;
Medeva shall have the right either directly or through the Project
Management Committee to give its prior approval to any decision
designed to initiate human clinical trials. Medeva shall be entitled
to make modifications to or to supplement the research programme and
budget contained in Schedule 3 provided that any changes to the budget
or to the scheduling of studies arising from such modifications or
supplements shall be subject to the consent of the University such
consent not to be unreasonably withheld or delayed.
(c) when the Project Management Committee decides to pursue any Second
Generation Product, to contribute to such Typhoid Project Background
Intellectual Property Rights and Background Technical Information
which (i) such party owns, (ii) such party is not prohibited from
contributing to such Typhoid Project pursuant to any written
agreements such party may have with a third party that is not an
Affiliate of such party, and (iii) is required for the construction,
evaluation and exploitation of the Second Generation Product in
question.
2.3 Where either party wishes to undertake work in relation to a Typhoid
Project other than the work as currently envisaged by Schedule 3 hereto (as the
same may be amended from time to time under the provisions of clause 2.2(b)),
that party shall notify the other through its Project Coordinator. If the
proposal is approved by both Project Coordinators a new document setting out the
details of the research programme and budget for such work shall be executed as
an additional Schedule to this Agreement.
2.4 In respect of the Core Typhoid Project, at least four (4) months prior
to expiration of []* from the date of this Agreement, the parties shall enter
into good faith negotiations to reach agreement upon a revised Schedule 3 for
the []* of the Core Typhoid Project.
2.5 On the completion of each study in the course of carrying out a Typhoid
Project the results of such study shall be submitted to the relevant Project
Management Committee and Medeva shall have sufficient time to review such
results before the parties embark on the next stage or further study within that
Typhoid Project unless Medeva has specifically agreed in writing to proceed with
such further work in advance of having the opportunity to review such results.
Medeva shall have the right to terminate such Typhoid
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
5
Project by notice in writing without proceeding to carry out any further study
or work or proceeding to commercialise a Second Generation Product. Medeva
shall be entitled to terminate a study in progress but if it does so Medeva
shall be liable, in accordance with clause 2.1(a) of this Agreement for the
costs of that study which at the time of termination have been committed to and
which have been or cannot avoid being incurred.
2.6 Medeva acknowledges that it has been provided by the University with the
bacterial salmonella typhi strains known as CVD 908 and CVD 906. Medeva
acknowledges that the University owns Background Intellectual Property Rights
in CVD 908 and CVD 906. Such strains have been provided to Medeva under the
terms of this Agreement and accordingly the agreements previously entered
into covering the provision of such strains and the work carried out
thereunder shall have no further force and effect upon the signing of this
Agreement. All Know-How, Technical Information and Intellectual Property
Rights arising from the work carried out pursuant to []* shall, for the
purposes of this Agreement, constitute Foreground Technical Information
and/or Foreground Intellectual Property Rights owned jointly by Medeva and
the University.
2.7 The parties acknowledge that in the course of carrying out work on a
Typhoid Project it may become impracticable or impossible to continue due to
information indicating that the proposed Second Generation Product is not safe
or efficacious. In such circumstances if appropriate amendments or variations to
the research programme and budget are not agreed by the parties as soon as
practicable following the availability of the relevant information, the
relevant Typhoid Project shall terminate and payments to the University in
accordance with the approved budget for that Typhoid Project shall cease 3
months from the date upon which the Typhoid Project is so terminated or earlier
if mutually agreed.
3. MANAGEMENT OF THE TYPHOID PROJECTS
3.1 The following provisions of this clause 3 apply to all Typhoid Projects
individually.
3.2 Meetings of the Project Management Committee shall normally be held at
quarterly intervals and otherwise as may be deemed necessary or desirable by the
parties. Meetings shall review the progress of Typhoid Project work performed to
date and objectives for the following months. No meetings shall be held unless
both members of the Project Management Committee (or an authorised delegate) for
that Project or work attend either by personal appearance or by teleconference
call.
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
6
3.3 Each party shall submit to the other party:
(a) Progress reports at least ten days prior to each Project Management
Committee meeting, which shall include, but not be limited to, details
of strains, materials, reagents and protocols developed during the
course of such Typhoid Project work.
(b) Brief quarterly updates.
(c) On completion of sufficient clinical trials to support a product
licence application, a full report detailing all work carried out on
such Typhoid Project and results obtained. Such reports shall be
prepared to standards suitable for submission to Regulatory Agencies.
3.4 The University shall submit to Medeva annual statements of expenditure on
such Typhoid Project. The form of such statements shall be approved by Medeva
but in any event shall contain sufficient information to enable the items of
expenditure to be compared with the various budgeted items of expenditure:
(i) in the case of the Core Typhoid Project in Schedule 3, as the same may
be modified or supplemented from time to time in accordance with the
provisions of clause 2.2(b); and
(ii) in the case of any other Typhoid Project in the additional Schedule to
be executed pursuant to the provisions of clause 2.3.
3.5 At intervals of no less than 12 months, the University, at the request of
Medeva shall allow Medeva or its agents reasonable access to such information as
they may reasonably require to audit the University's expenditure statements for
up to the preceding 3 years. Such agents, if any, shall be accountants who are
familiar with financial recordkeeping practices for institutions receiving
United States government grants, and shall be subject to the approval of the
University, which approval shall not be unreasonably withheld or delayed. Such
access shall be granted only at the University's place of business and only
during the regular business hours of the University. The University undertakes
to ensure that all relevant information which Medeva or its agents may
reasonably require to carry out such audit is maintained at the University's
place of business or is positioned there at the time of such audit. The expense
of such audit shall be borne by Medeva.
4. FOREGROUND TECHNICAL INFORMATION AND FOREGROUND INTELLECTUAL PROPERTY
RIGHTS
4.1 Each party undertakes to monitor Foreground Technical Information with
respect to Second Generation Products for material which may be eligible for
Intellectual Property Rights protection and to notify promptly the other party
thereof.
7
4.2 All Foreground Technical Information and Foreground Intellectual Property
Rights shall be owned by the party or parties which first develop such
Foreground Technical Information or Foreground Intellectual Property Rights.
4.3 (a) In respect of Foreground Technical Information or Foreground
Intellectual Property Rights owned solely or jointly by the
University, the University hereby grants or agrees to grant to Medeva
a worldwide, royalty-bearing (in accordance with the provisions of
clause 7), irrevocable (subject to the provisions of clause 10)
licence to use such Foreground Technical Information and Foreground
Intellectual Property Rights within the Field, subject to the
provisions of this clause 4 and of clause 6. Medeva shall be the
University's exclusive licensee of such Foreground Technical
Information and Foreground Intellectual Property Rights within the
Field, subject to the provisions of this clause 4.
(b) Medeva hereby grants or agrees to grant to the University, subject
always to the University adhering to the provision of clause 9.2, a
worldwide, royalty-free, irrevocable (subject to the provisions of
clause 10) license to use Foreground Technical Information and
Foreground Intellectual Property Rights which Medeva owns exclusively
or jointly with the University for the sole purpose of education and
academic research but not for any work done for the benefit of an
organisation which has an interest in commercially exploiting or
authorising the commercial exploitation of such work.
(c) Such licences shall take effect as of the date that the relevant
Foreground Technical Information or Foreground Intellectual Property
Rights shall come into existence.
4.4 Initial Patent Protection will be sought on all Foreground Intellectual
Property Rights unless Medeva considers that initial patent protection should
not be sought, in which case the provisions of clause 4.6(a) shall apply. The
procedure for obtaining initial patent protection for Foreground Intellectual
Property Rights, up to and including UK and US priority applications, shall be
implemented by the Project Management Committee for the relevant Typhoid
Project. Such Project Management Committee may appoint either the patent
department of Medeva or an independent chartered patent agent or patent attorney
to undertake any such work under the instructions of such Project Management
Committee. For Foreground Intellectual Property Rights owned exclusively or
jointly by the University, the University shall have the right to approve such
patent agent or patent attorney such approval not to be withheld or delayed.
Where necessary the parties shall jointly or severally execute any power of
attorney or other document to enable such patent agent or patent attorney to
perform its duties hereunder efficiently. If the relevant Project Management
Committee shall
8
take such steps to obtain initial patent protection the costs of obtaining such
protection, including the costs of the first filing, shall be borne by Medeva.
4.5 (a) All costs, charges and expenses incidental to or consequent upon any
form of legal action concerning the prosecution and/or defence of the
Foreground Intellectual Property Rights including proceedings for the
revocation of any Foreground Intellectual Property Rights or for the
grant of a compulsory licence thereunder shall be borne and paid by
Medeva.
(b) If Medeva decides to commence any proceedings (including counterclaims
and actions for declaratory judgment) in respect of alleged
infringement of any of the Foreground Intellectual Property Rights,
all costs, charges and expenses incidental to or consequent upon such
proceedings shall be borne and paid by Medeva, the right to direct and
settle such proceedings shall belong to Medeva and all damages and
other sums recovered in such proceedings and any other benefit of the
judgment and order therein shall belong to Medeva.
(c) The University agrees that Medeva shall have the right to use the
University's name in any proceeding brought by Medeva pursuant to
clause 4.5(a) and (b) so that such proceeding may be conducted by
Medeva in the name of the University if appropriate. Medeva shall
notify the University prior to the use of the University's name in any
proceeding pursuant to this clause 4.5(c). The University further
agrees to sign such documents and do whatever may be necessary and
advisable to further the conduct of such proceeding in the name of
Medeva and/or the University.
(d) If Medeva commences a proceeding in the name of the University
pursuant to clause 4.5(c) and the University is subsequently
countersued in such proceeding or if the University is sued by
original action relating or arising from Medeva's use of the
Foreground Intellectual Property Rights, Medeva at its cost shall
defend the University and its Regents, officers, employees and agents
in such countersuit and shall indemnify the University and its
Regents, officers employees and agents against any and all losses
incurred by them as a result of such countersuit.
4.6 (a) In the event that Medeva chooses not to pursue patent protection in
the US Patent Office, European Patent Office or Japanese Patent Office
for any Foreground Intellectual Property Right owned exclusively or
jointly by the University, within six months of its receipt of notice
from the University regarding the existence of such Foreground
Intellectual Property
9
Right, Medeva shall notify the University of its decision, and the
University may thereafter elect to pursue protection for such
Foreground Intellectual Property Rights in such Patent Offices at its
own expense and, in such circumstances, clauses 4.5(a) and (b) shall
not apply. Where, in the circumstances referred to above, the
University obtains a granted patent the provisions of clause 4.6(c)
below shall apply.
(b) If Medeva pursues protection efforts in any country with respect to
any Foreground Intellectual Property Rights owned exclusively or
jointly by the University, and thereafter chooses to abandon such
protection efforts in that country, it shall notify the University of
its decision, and the University may thereafter elect to pursue
protection in such Patent Office for such Foreground Intellectual
Property Rights at its own expense and, in such circumstances, clauses
4.5(a) and (b) shall not apply. Where, in the circumstances referred
to above, the University obtains a granted patent the provisions of
clause 4.6(c) below shall apply.
(c) Where in the circumstances referred to in 4.6(a) and (b) above, the
University is successful in obtaining a granted patent as a
consequence of Medeva choosing not to pursue such patent protection or
abandoning its efforts to obtain such protection, the University shall
notify Medeva in writing that such a patent has been granted and that
such notification is made under this clause 4.6(c). Within ninety (90)
days of notification under this clause 4.6(c), Medeva may choose to
reimburse the University its reasonable costs of obtaining such
granted patent and the Intellectual Property Rights covered under such
granted patent will be part of this Agreement. If Medeva chooses not
to reimburse the University its reasonable costs of obtaining such
granted patent within such ninety (90) day period, Medeva shall have
no ownership right in such patent(s) and the University shall be
entitled to licence such patent rights to other entities which are not
parties to this Agreement, subject to the provisions of clause 6 of
this Agreement. In such circumstances clauses 4.5(a) and (b) shall
not apply.
4.7 Each party shall have the right to review and comment upon any applications
filed for Foreground Intellectual Property Rights prior to filing; provided,
however, that the Project Management Committee may approve the filing of an
application for Foreground Intellectual Property Rights prior to the receipt of
comments from each party (but subsequent to giving notice to each party of such
intent to file and providing each party with a draft of the proposed filing) if
the Project Management Committee reasonably deems that such filing is necessary
to prevent the loss of rights with respect
10
to the subject matter of such filing to non-parties to this Agreement. Each
party shall cooperate with the other with respect to preparation of applications
and further pursuit of Foreground Intellectual Property Rights.
4.8 (a) Medeva as exclusive or joint owner of any foreground Technical
Information or Foreground Intellectual Property Rights shall be
entitled, at any time, to use the same for its own profit without
accounting to the University (except for the payment of royalties
due pursuant to this Agreement), and shall have the right to assign
or licence such Foreground Technical Information or Foreground
Intellectual property Rights. Medeva shall notify the University as
soon as practicable following any such assignment and/or granting of
any licence of the fact that such assignment or licence has been
entered into and the identity of the assignee or licensee.
(b) Medeva as licensee of any Foreground Technical Information or
Foreground Intellectual Property Rights shall be entitled, at any
time, to use the same subject always to the provisions of this
Agreement. Medeva may make use of the Foreground Technical
Information for its own profit without accounting to the University
(except for the payment of royalties due pursuant to this Agreement)
but subject to the provisions of this clause 4, and Medeva shall
have the right to assign its interest or grant sub-licenses to such
Foreground Technical Information. Medeva shall notify the University
as soon as practicable following any such assignment and/or granting
of any sub-licence of the fact that such assignment or sub-licence
has been entered into and the identity of the assignee or
sub-licensee.
(c) If Medeva sub-licenses or assigns its interest in any Foreground
Technical Information or Foreground Intellectual Property Rights it
shall ensure that any sub-licensee or assignee agrees to be bound by
the terms and conditions of this Agreement, and shall ensure that
any such sub-licence or assignment is granted or made on terms
consistent in all respects with the terms and conditions of this
Agreement and any act or omission by any sub-licensee or assignee
which would, if done or omitted to be done by Medeva, be a breach of
this Agreement shall be deemed to be a breach of this Agreement by
Medeva.
5 BACKGROUND TECHNICAL INFORMATION AND
BACKGROUND INTELLECTUAL PROPERTY RIGHTS
5.1 (a) Subject to the provisions of this clause 5 and of clause 4, clause
6, and of clause 7, the University hereby grants to Medeva within
the Field the
11
following rights with respect to Background Technical Information
and Background Intellectual Property owned exclusively or jointly by
the University:
(i) An exclusive worldwide licence under Background Intellectual
Property Rights, Background Technical Information and Know-How
to make, have made, use, lease, and sell (including the right
to assign and sub-licence) an htrA deletion (ahtrA) in
CVD908 (hereinafter "ahtrACVD908") or an htra deletion
(ahtrA) in CVD906 (hereinafter "ahtrACVD906").
(ii) An exclusive worldwide licence under Background Intellectual
Property Rights, Background Technical Information and Know-How
to make, have made, use, lease and sell including the right to
assign and sub-licence) a Second Generation Product
containing a min deletion (min) plus a htrA mutation
(hereinafter "min htrA).
(iii) A non-exclusive worldwide licence under Background
Intellectual Property Rights, Background Technical Information
and Know-How to make, have made, use, lease, and sell
(including the right to assign and sub-licence) a Second
Generation Product containing a min delection (amin) is CVD908
(hereinafter aminCVD908).
(iv) An exclusive, worldwide, royalty-bearing (in accordance with
clause 7), irrevocable (subject to the provisions of clause
10) licence under Background Intellectual Property Rights to
make, use and sell products within the Field.
Notwithstanding the above licenses the University acknowledges
that the hteX mutation is the property of Medeva and the license
as granted in (i) and (ii) above applies purely in relation to the
use of CVD908 and/or CVD906 and min deletions. No license is
required by Medeva in respect of aro and htrA deletions and/or
mutations the rights in which are the property of Medeva. The
University also acknowledges that the information and rights
relating to the combinations of CVD908, CVD906 and htrA deletions
and/or mutations for the purposes of this Agreement are foreground
Technical Information or foreground Intellectual Property Rights
held exclusively by Medeva.
(b) Licences of the University's Background Technical Information and
Background Intellectual Property
12
Rights to Medeva shall take effect as of the date that the
University becomes obligated to contribute such Background Technical
Information and/or Background Intellectual Property Rights to the
relevant typhoid Project.
5.2 (a) Medeva shall have a right to file in the name of the University
applications for patents, inventor's certificates and other property
rights in the United States and foreign countries relating to the
University's Background Technical Information and Background
Intellectual Property Rights relevant to that Typhoid Project and
any improvements, modifications and variations thereto, including
but not limited to the right to file, register, prosecute and
maintain patents and patent applications. The University will
cooperate and execute all documents in connection with the filing
and/or prosecution of said applications. Medeva will reimburse to
the University its reasonable costs and expenses of such
co-operation.
(b) With respect to the University's Background Technical Information
and Background Intellectual Property Rights the provisions of clause
5.2(a) above shall be exercised by Medeva by providing to and/or
consulting with the University in respect of its exercise of such
rights and allowing the University to submit the relevant
applications for patents and other matters referred to above to the
relevant patent attorneys and where necessary Medeva shall request
the University to engage the patent attorneys and/or agents referred
to in clause 5.2(c) below subject to Medeva bearing the reasonable
costs thereof. If at any time the University shall fail to deal in a
reasonable and expeditious manner with the submission for and
prosecution and maintenance of such rights Medeva shall have the
right to deal with all such matters directly itself.
(c) Medeva shall engage patent attorneys and/or agents to prosecute such
applications, and Medeva shall. pay the legal expenses and
governmental fees including maintenance fees. The University shall
have the right to approve such patent attorneys and/or agents, such
approval not to be unreasonably withheld or delayed. Medeva shall
have exclusive control of the prosecution of all such applications,
including discretion as to the amendment of claims, appeal of final
rejections, and abandonment of any application. In the event that
Medeva chooses to abandon any such application, it will notify the
University of its decision to abandon, and the University may
thereafter elect to continue prosecution of said application at its
own expense. Medeva will notify the University at least 90 days
before discontinuing support of any application and will pay all
expenses
13
or fees accrued in connection with the application until the
expiration of said notice.
(d) Medeva shall keep the university informed as to the status of the
applications which it has filed and will provide the University with
copies of all patent applications, office actions and materials
relevant to the applications.
5.3 (a) Medeva shall have the right, at its own expense, to enforce
patents and other property rights against persons infringing the
University's Background Technical Information or Background
Intellectual Property Rights in any country. The University agrees
that Medeva shall have the right to use the University's name in any
such action, suit, or proceeding so that such action, suit, or
proceeding may be conducted by Medeva in the name of the University
if appropriate. The University further agrees to sign such documents
and do whatever may be necessary and advisable to further the
conduct of such action, suit, or proceeding in the name of Medeva
and/or the University.
(b) If Medeva commences any proceedings (including counterclaims and
actions for declaratory judgment) in respect of any alleged
infringement of any of the University's Background Technical
Information or Background Intellectual Property Rights, all costs,
charges and expenses incidental to or consequent upon such
proceedings shall be borne and paid by Medeva, the right to direct
and settle such proceedings shall belong to Medeva and all damages
and other sums recovered in such proceedings and any other benefit
of the judgment and order therein shall belong to Medeva. In
calculating any royalties due to the University pursuant to clause 7
of this Agreement, Net Sales shall include any damages received in
lieu of sales revenues (after deduction of all reasonable costs,
charges, and expenses incidental to or consequent upon the recovery
of such damages and the proceedings relating thereto) which may be
received by or distributed to Medeva pursuant to this clause 5.3(b),
and clause 4.5(b) and 5.3(a).
(c) Medeva shall also have the right, at its own expense, to defend
(including, at its discretion, the taking of appeals) any action,
suit, or proceeding instituted against the University and/or Medeva
based on any claim that practice of the University's Background
Technical Information or Background Intellectual Property Rights
constitutes an infringement of any letters patent or other rights of
any other person.
(d) If Medeva commences a proceeding in the name of the University
pursuant to clause 5.3(a) or 5.3(b) and
14
the University is subsequently countersued in such proceeding or if
the University is sued by original action with respect to Medeva's
use of University Background Technical Information or Background
Intellectual Property Rights, Medeva shall defend the University and
its Regents, officers, employees and agents in such countersuit and
shall indemnify the University and its Regents, officers, employees
and agents against any and all losses incurred by them as a result
of such countersuit.
6. OTHER INTELLECTUAL PROPERTY INTERESTS
6.1 Subject, to all other provisions of this Agreement, Medeva hereby grants to
the University a licence to use Background Technical Information and Background
Intellectual Property Rights belonging to Medeva for the sole purpose of
education and academic research (which shall not include any work done for the
benefit of an organisation which has an interest in commercially exploiting or
authorising the commercial exploitation of such work).
6.2 In respect of licenses granted by or to one party under technical
Information or Intellectual Property Rights pursuant to this Agreement the other
party shall at the request and cost of that party execute and do all such deeds,
acts, matters and things as are requisite for securing official registration or
recordation of such licences in any jurisdiction where such registration or
recordation is desired by that party.
6.3 Medeva represents and warrants to the University that the royalty
arrangements described in Schedule 4(a) are, to the best of its knowledge and
belief at the date of execution of this Agreement, the only royalty payments
which may become due as a result of the sale of a Second Generation Product. The
University represents and warrants to Medeva that the royalty arrangements
described in Schedule 4(b) are, to the best of its knowledge and belief at the
date of execution of this Agreement, the only royalty payments which may become
due as a result of the sale of a Second Generation Product. Each party
undertakes to inform the other party of any additional third party royalties
promptly after identifying that such royalties may be applicable to a Typhoid
Project or to a Second Generation Product arising from such Typhoid Project.
6.4 (a) In the event of CVD wishing to collaborate with or undertake
work on or utilising Salmonella typhi strains or antigens for any
commercial entity not party to this Agreement using Background
Technical Information, Background Intellectual Property Rights,
Foreground Technical Information or Foreground Intellectual Property
Rights owned exclusively by the University, the University must
first offer in writing to Medeva the right of first refusal to
perform such collaboration or undertake such work with the
University in lieu of such third party commercial entity, upon terms
and conditions that are the same in all material respects as those
offered by
15
the University to such entity. Medeva shall have the right to
participate in and fund all or part of the work proposed pursuant to
this clause 6.4(a). In the event that Medeva decides not to
participate within 90 days of its receipt of such written offer the
University shall be entitled to proceed with such collaboration or
undertake such work with the third party commercial entity upon
terms and conditions that are the same in all material respects as
those contained in the written offer to Medeva, provided that Medeva
shall be entitled to such royalties and/or payments as may be fair
and reasonable under the circumstances. If Medeva makes no response
within said 90 days it shall be assumed that Medeva does not wish to
so participate provided that Medeva has been notified that the
relevant written offer is made by the University under this clause
6.4(a).
(b) In the event of the University wishing to collaborate with or
undertake work on or utilising (i) Salmonella typhi strains or
antigens used in a Typhoid Project using Background Technical
Information, Background Intellectual Property Rights, or (ii)
Salmonella typhi strains or antigens whether or not used in a
Typhoid Project using Foreground Technical Information or Foreground
Intellectual Property Rights; in both cases owned jointly by the
University and Medeva for any commercial entity not a party to this
Agreement the University must first obtain the written consent of
Medeva. Moreover, the University shall offer in writing to Medeva
the right of first refusal to perform such collaboration or
undertake such work with the University in lieu of such third party
commercial entity, upon terms and conditions that are the same in
all material respects as those offered by the University to such
entity. Medeva shall have the right to participate in and fund all
or part of the work proposed pursuant to this clause 6.4(b). Medeva
shall have 90 days from its receipt of the University's written
offer to notify the University (i) whether it wishes to participate
in the collaboration or work and/or (ii) whether or not it consents
to the University undertaking the collaboration or work with such
commercial entity not party to this Agreement. In the event that
Medeva decides not to participate but gives its written consent,
then as a term of such consent; Medeva shall be entitled to such
royalties and/or payments as may be fair and reasonable under the
circumstances. If Medeva makes no response within said 90 days its
consent shall be assumed provided that Medeva has been notified that
the written offer is made under this clause 6.4(b).
(c) No such rights to collaborate or undertake work are available to the
University in respect of any Foreground or Background Technical
Information or
16
Foreground or Background Intellectual Property Rights in which the
University does not have an ownership interest.
6.5 Following execution of this Agreement any bacterial strains or other
materials (excluding products intended for use by customers of Medeva) covered
by this Agreement shall only be released to third parties under a Materials
Release Agreement the form of which shall be as that appended as schedule 5 of
this Agreement. Provided, however, that the University may modify the form of
the Materials Release Agreement as required by policies of third parties which
are academic institutions if the third parties agree to make absolutely no
commercial or non-academic use of the materials without the prior consent of
both parties to this Agreement. Each party shall, promptly upon releasing any
materials covered by this Agreement, send to the other party a copy of the
Materials Release Agreement executed by the recipient of such materials.
6.6 (a) Medeva recognises that it is the policy of the University that the
results (including Technical Information and related Intellectual
Property Rights) of the work of the University employees and
students engaged in the Project ("the Researchers") must be
publishable. Medeva agrees that Researchers shall be permitted to
present at symposia and national or regional professional meetings,
and to publish in journals, theses, dissertations, and otherwise,
the methods and results of work carried out by the Researchers in
respect of the Typhoid Project.
(b) Medeva shall be furnished with accurate and complete copies of any
proposed publication or transcript of any proposed presentation at
least sixty (60) days in advance of the submission of such proposed
publication or presentation to a journal, editor, or other third
party or in the case of an oral presentation at least sixty (60)
days prior to the date of such presentation. Medeva shall have
forty-five (45) days after receipt of said copies to object to such
proposed presentation or publication either because there is
patentable subject matter which needs protection and/or there is
confidential information of Medeva contained in the proposed
publication or presentation.
(c) Any confidential information of Medeva identified by Medeva shall be
deleted from the proposed publication or presentation unless Medeva
consents to its inclusion (such consent not to be unreasonably
withheld) or unless Medeva agrees to treat the confidential
information as patentable information, as set forth in the following
paragraph.
(d) In the event that Medeva objects to a Researcher's publication or
presentation due to the proposed disclosure of patentable
information, the Researcher shall refrain from making any
publication or
17
presentation including that patentable information for (a) one year
from date of receipt of the objection, if the patentable information
was developed by Medeva, or (b) ninety days from date of receipt of
the objection, if the patentable information was developed by
Researchers solely or in collaboration with personnel of Medeva. The
delay in publication or presentation is to permit Medeva to file
patent application(s) with the US Patent and Trademark Office, UK
and/or other patent office(s) directed to the patentable subject
matter contained in the proposed publication or presentation.
(e) Following publication by Researcher(s) or the University, Medeva
shall have the right to freely publish, reproduce, and use any such
publication subject to the terms and conditions set forth herein,
and subject to any copyright interest of entities that are not
parties to this Agreement.
7. ROYALTIES
7.1. The University shall be entitled to fair and reasonable payments from
Medeva in respect of its commercialisation of Second Generation Products and/or
its commercial use or licensing of Background Technical Information, Background
Intellectual Property, Foreground Technical Information and Foreground
Intellectual Property Rights of the University. Such payments shall be
determined on a royalty basis of []* of Net Sales in the relevant jurisdictions.
7.2 Payments made to the University under this clause 7 shall be payable,
based on Net Sales in each country in which royalty payments are due, from
the commencement of commercial exploitation (defined as the sale of []* for
purposes other than clinical or regulatory testing uses) in that country of
the Second Generation Product or product as defined in paragraph 5.1(a)(iv)
(in this clause 'product') in question:
(a) where the product is subject to Foreground or Background
Intellectual Property Rights in the form of patent claim(s) which
are owned by the University and licensed to Medeva until the expiry
or revocation of all relevant patent claim in that country in which
such patent exists; or
(b) where the product is not covered by a patent claim(s) but is
comprised of Foreground or Background Technical Information owned by
the University, or of Foreground or Background Intellectual Property
Rights which are owned by the University, until Background or
Foreground such Technical Information has entered into the public
domain, or for a period of ten years from the date of commencement
of commercial exploitation (as defined above in this clause 7.2) in
any country of the EEC or the USA whichever is the
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
18
earlier.
7.3 Royalties shall be payable by Medeva to the University in United States
dollars by cheque or by electronic funds transfer to an account designated by
the University. To the extent sales may have been made by Medeva in a foreign
country such royalties shall be first determined in the currency in which the
sales to which the royalties relate are made and then if necessary converted to
their equivalent in United States dollars. The exchange rate to be used for the
purposes of conversion into United States dollars will be the most favourable
rate which Medeva can reasonably obtain from its bankers from time to time and
upon the day upon which funds are converted.
7.4 To the extent that statutes, laws, codes or government regulations
(including currency exchange regulations) shall prevent or limit royalty
payments by Medeva in any country Medeva shall render to the University annual
reports of sales in respect of which royalties are earned in such country. All
monies due and owing to the University as provided in such annual reports shall
be deposited by Medeva in a local bank in such country in an account to be
designated by the University in writing or alternatively paid to the University
or deposited in its account as directed in writing by the University in any
other country where such payment or deposit is lawful under such currency
restrictions.
7.5 Interest shall be due on payments to the University required by any
paragraph of this clause 7 that are more than thirty (30) days late, interest to
accrue at the rate of []*
7.6 Royalties shall be due from Medeva with respect to Net Sales by Medeva, its
Affiliates, its licensees, sub-licensees, assignees and any other party selling
Second Generation Products with the direct authorisation of Medeva provided
however that in respect of each individual product royalty shall only be payable
once, such payment arising on the first arms length sale of such individual
product.
7.7 (a) During the term of this Agreement and for three (3) years
thereafter Medeva shall keep and require each assignee, sub-licensee
and Affiliate selling Second Generation Products by authorisation of
Medeva to keep complete true and accurate records containing all
particulars that may be necessary to enable royalties payable to the
University hereunder to be determined and shall permit the said
records to be inspected at any time during normal business hours and
upon reasonable notice by an independent auditor appointed by the
University for such purposes and acceptable to Medeva. Medeva shall
not unreasonably withhold its acceptance of such auditor.
(b) The auditor shall report to the University only the amount of
royalty payable to the University in the period under consideration.
The audit shall be at
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
19
the University's expense unless the audit shows an under-payment of
royalty due to the University of 10% or more for any six months
royalty period (ending on either 30 June or 31 December) in the one
year period preceding the audit, in which case the audit expense
shall be borne by Medeva.
(c) Within ninety (90) days from each 30 June and 31 December of each
year, Medeva shall deliver to the University a report of the Total
Net Sales and the calculation of royalty due to University for the
six month period concerned.
(d) With each report submitted Medeva shall pay to the University the
royalties due and payable for the period covered by the report. Such
reports and payments shall be sent to the University at its address
set out in clause 14 or such other address that may be notified in
accordance with the provisions of that clause.
8. CONFIDENTIALITY
8.1 Any and all knowledge, know-how, show-how, practice, process or other
information including Background and Foreground Technical Information, Know-How,
and Intellectual Property Rights, disclosed or submitted to either party by the
other or arising in the course of a Typhoid Project shall be Proprietary
Information and/or Confidential Information and, subject to the provisions of
clauses 6.6 and 8.5, shall be received and maintained by the receiving party,
which in the case of Medeva shall include its Affiliates, in strict confidence
and shall not be disclosed to any third party. Neither party shall use the
other's Proprietary Information and/or Confidential Information for any purpose
other than the purposes of or as contemplated by this Agreement; provided,
however, that prior to any disclosure to a party's employees and in the case of
the University the Researchers in the course of such use, each employee or
Researcher shall be apprised of the duty to maintain in strict confidence the
Proprietary Information and/or Confidential Information and not to use it for
any purpose other than in accordance with this Agreement and the University
shall ensure that each such Researcher shall sign a confidentiality agreement in
the form attached as Schedule 6. The University's obligation to have such
agreement by Researchers shall be effective upon execution of this Agreement.
8.2 Nothing contained herein will in any way restrict or impair either party's
right to use, disclose, or otherwise deal with the other party's Proprietary
Information and/or Confidential Information which:
(a) at the time of its receipt is generally available in the public
domain, or thereafter becomes available to the public through no act
of the receiving party; or
20
(b) was independently known prior to receipt thereof, or was made
available to such receiving party as a matter of lawful right by a
third party.
8.3 The above obligations for confidentiality shall survive termination of this
Agreement for any reason whatsoever. With respect to each item of Proprietary
Information and/or Confidential Information, such obligations for
confidentiality shall survive until such item ceases to be confidential or 5
years from the date of termination of this Agreement, whichever is the earlier.
8.4 Each party will notify the other of any subpoena or judicial order seeking
protection or discovery of the other party's Proprietary Information and/or
Confidential Information.
8.5 Medeva acknowledges that the University, as a public agency, is subject to
Maryland laws regarding access to public information. In general, those Laws
permit the University to withhold from disclosure specific details of research
projects as well as trade secrets and/or confidential commercial information
received from other parties. Medeva asserts that their Proprietary Information
and/or Confidential Information consists of trade secrets or confidential
commercial information and the University agrees to oppose disclosure of the
Proprietary Information and/or Confidential Information in the event of a public
information request seeking the Proprietary Information and/or Confidential
Information. The University will notify Medeva of any such requests pursuant to
this clause 8.5 and will allow Medeva to participate in the opposition to the
request to the extent permitted by law.
8.6 Medeva acknowledges that under University of Maryland System policy the
University undertakes to use reasonable efforts to maintain the confidentiality
of Proprietary Information/Confidential Information but cannot accept Liability
if such efforts fail.
9. WARRANTIES AND LIABILITIES
9.1 Each party:
(a) undertakes to use all reasonable endeavours to ensure the accuracy
of all Background and Foreground Technical information and
Intellectual property Rights provided by it pursuant to this
Agreement and in the event of any error therein, promptly upon being
notified of the same, or of the same coming to its notice, to use
all reasonable endeavours to supply the appropriate corrections;
(b) warrants its right to disclose such Background and Foreground
Technical Information and Intellectual Property Rights;
(c) Warrants that it has full corporate power and authority to enter
into this Agreement and to enter into the transactions and
arrangements contemplated
21
hereby and to perform its obligations under this Agreement in
accordance with the terms contained herein; and
(d) warrants that neither the execution of this Agreement nor the
consummation of the transactions referred to or contemplated herein
shall contravene the terms of that party's constitution or the terms
of any third Party arrangements, that no registration, consent or
approval or other action by administrative or government authority
is required in connection with the execution, delivery and
performance of this Agreement, and that this Agreement when executed
by both parties and delivered will constitute the valid and binding
obligations of such party.
9.2 The parties recognise that inventions, copyrightable works and other
proprietary information sometime arise from research sponsored in whole or in
part by agencies of the Federal Government. Nonetheless, the University
represents and warrants to Medeva that (1) all activities pertaining to the
research and basic development of CVD 906 and CVD 908 up to the point of
clinical trials in human subjects have been conducted by the University
without the assistance of any direct government contract or government grant
funds, and (2) CVD 906 and CVD 908 are provided herein free from claim,
encumbrances, and restrictions of any nature whatsoever by any other person,
subject to any rights that the United States government may have. The
University further agrees to take whatever steps are necessary to prevent
rights in any Foreground Technical Information and any Foreground
Intellectual Property Rights from arising in, or inuring to the benefit of,
any person not a party to this Agreement, subject to any rights that the
United States government may have.
9.3 (a) Medeva represents and warrants to the University that it or its
Affiliates owns all right, title and interest to all the Background
Intellectual Property Rights described in Schedule 1(a). The
University represents and warrants to Medeva that it owns all right,
title and interest to all the Background Intellectual Property
Rights described in Schedule 1(b), subject to any rights that the
United States government may have in such Background Property
Rights.
(b) Medeva represents and warrants to the University that it or its
Affiliates owns all right, title and interest to all Background
Technical Information described in Schedule 2(a). The University
represents and warrants to Medeva that it owns all right, title and
interest to all Background Technical Information described in
Schedule 2(b), subject to any rights that the United States
government may have in such Background Technical Information.
9.4 The provisions of this clause 9 shall survive the
22
termination of this Agreement for any reason whatsoever.
10. DURATION AND TERMINATION
10.1 This Agreement shall be deemed to have become effective as of the date that
it is signed, and shall continue in respect of any Typhoid Project, subject to
the provisions of this clause 10, Clause 2.5 and clause 2.7 until the completion
of that Typhoid Project, as determined by unanimous vote of such Project
Management Committee for that Typhoid Project, or until otherwise determined by
written agreement of the parties.
10.2 (a) If Medeva having due regard for its usual business considerations,
wishes to withdraw from that Typhoid Project in addition to its
rights under clause 2.5 it may do so upon written notice to the
University of its termination of interest. Upon termination under
this clause the provision of clause 10.4 below shall apply.
(b) No party shall be entitled to utilise or take advantage of any right
to withdraw from a Typhoid Project while such party is in "default"
in respect of that Typhoid Project under clause 10.3.
10.3 In the event of either party ("the party in default");
(a) being in material breach of its obligations under this Agreement
which if capable of remedy is not remedied within 60 days of notice
from the other party requiring that it be remedied, or
(b) being or becoming bankrupt or insolvent or making any assignment for
the benefit of its creditors or having a receiver, administrator, or
administrative receiver or manager appointed in respect of its
undertaking or any of its assets or (otherwise than as a solvent
entity for the purpose of and followed by a merger or reorganisation
whereunder its successors shall be fully and effectually bound by
its obligations hereunder) commencing to be wound up,
then, and without prejudice to any other rights or remedies of either party, the
party not in default shall have the right by notice to the party in default to
terminate this Agreement and the termination shall take effect (i) in
relation only to the Typhoid Project or Typhoid Projects in respect of which the
default occurs in the case of a material breach under 10.3(a) above; or, (ii) if
the material breach relates to the Agreement as a whole or in the case of
termination under clause 10.3(b) above the termination shall apply to all
Typhoid Projects. In such event the following provisions of this clause 10.3
shall apply either to the relevant Typhoid Project or Typhoid Projects or to all
Typhoid Projects as the case may be.
23
(c) The party in default shall make available to the other party (i) any
Foreground Technical Information and Foreground Intellectual
Property Rights generated by the party, and (ii) any Background
Technical Information and Background Intellectual Property Rights
which are owned by such party in default, which are necessary for
the purposes referred to in clauses 10.3(e) and (g) below and which
the party in default is not prohibited from making available to the
other party due to written agreements, existing as of the date of
the termination notice delivered to such party pursuant to clause
10.3(a) or (b), with any third party that is not an Affiliate of
such party in default;
(d) The party in default's rights under clause 4 and clause 6 to own or
utilise any Foreground Intellectual Property Rights and Foreground
Technical Information shall cease;
(e) The other party's rights under clause 4 and clause 6 to utilise any
of such party in default's Foreground Intellectual Property Rights
and Foreground Technical Information shall survive and remain in
effect, and such rights shall remain subject to any royalty
obligations and other restrictions contained in clause 4 and clause
7;
(f) The party in default's rights under clause 5.1 or clause 6.1, as the
case may be, to utilise any of the other party's Background
Intellectual Property Rights and Background Technical information
shall cease;
(g) The other party's rights under clause 5.1(a) and (iv) or clause 6.1
as the case may be, to utilise any of such party in default's
Background Intellectual Property Rights and Background Technical
Information shall survive and remain in effect, without regard to
the restrictions contained in clauses 5 and 6 (except for clause
6.4). In the event that the University is the party in default the
royalty obligations in clause 7 shall be modified so that the
University shall only be entitled to a royalty of 1% of Net Sales
from the date of such default in respect of Net Sales in the
country(ies) where the University holds a granted patent which would
be infringed by the use, sale or offer to sell of the Second
Generation Product concerned. In such circumstances Medeva shall be
entitled to retain all royalties payable to the University (without
prejudice to any other rights which Medeva may have at law or under
this Agreement) up to an amount equal to the damages, losses, costs
and liabilities which arise directly or indirectly as a result of
the University's default.
24
(h) Where the University is the party in default Medeva's rights under
clauses 5.1(a)(ii) and (iii) shall continue and survive subject to
the payment of royalty in accordance with the obligations in clause
7.
(i) The provisions of clauses 1, 2.6, 4.5(c) and (d), 5.3, 6.1, 6.4(c),
6.6, 8, 9, 10, 11, 15.3 and 16 shall survive any such default by any
of the parties.
10.4 Upon termination of this Agreement for any cause other than default under
clause 10.3;
(a) Each party participating in a Typhoid Project shall make available
to the other party participating in that Typhoid Project (i) any
Foreground Technical Information and Foreground Intellectual
Property Rights generated by such party in the course of that
Typhoid Project, and (ii) any Background Technical Information and
Background Intellectual Property Rights which are owned by such
party, which are necessary to exploit any Foreground Technical
Information or Foreground Intellectual Property Rights generated by
any of the parties in such Project, and which such party is not
prohibited from making available to the other parties due to written
agreements, existing as of the date of the termination, with any
third party that is not an Affiliate of such party.
(b) Each party's rights under clause 4 and clause 6 to utilise any
Foreground Intellectual Property Rights and Foreground Technical
Information existing as of the date of termination shall survive
such termination, and such rights shall remain subject to any
royalty obligations and other restrictions contained in clause 4,
clause 6 and clause 7;
(c) Each party's rights under clause 5.1 or 6.1, as the case may be, to
utilise any of the other party's Background Intellectual Property
Rights and Background Technical Information required to be made
available hereunder to such party prior to the date of termination
shall survive such termination, and such party may continue to
utilise such Background Intellectual Property Rights and Background
Technical Information subject to any royalty obligations and other
restrictions contained in clause 4, clause 6 and clause 7; and
(d) The provisions of clauses 1, 2.6, 4.5(c) and (d), 5.3, 6.1, 6.4(c),
6.6, 8, 9, 10, 11, 15.3 and 16 and this 10.4 shall survive any such
termination of this Agreement.
25
11. ASSIGNMENT
The University shall not assign, sub-licence, mortgage or charge any of its
right, licences or obligations under this Agreement (save as expressly provided
for herein), or grant rights hereunder or otherwise delegate the performance of
its obligations without the prior written consent of Medeva, which consent shall
not be unreasonably withheld. Medeva may, in good faith, assign its rights and
the performance of its obligations and may grant sub-licences without consent
subject to the limitations imposed by other clauses of this Agreement. In
granting any sub-licence hereunder Medeva shall ensure that the terms upon which
such sub-licences are granted contain provisions relating to the payment of
royalty consistent with the provisions of clause 7 of this Agreement and Medeva
shall take appropriate steps in the case of any breach of such provisions by
such sub-licensees.
12. LAW
(a) This Agreement shall be governed by and construed in accordance with
the laws of State of Maryland (U.S.A) without regard to the
principles of conflicts of law, except that any issues regarding the
licence by Medeva of Background Intellectual Property Rights shall
be governed by English Law.
(b) In any suit arising pursuant to or relating to this Agreement to
which the University is a party, the parties to this Agreement agree
that: (i) the Federal and State Courts in the State of Maryland
located in Baltimore City or Baltimore County shall have personal
jurisdiction over each of them; (ii) such Courts shall have
jurisdiction over the subject matter of any such suit; and (iii)
such Courts shall be a proper venue for any such suit.
13. FORCE MAJEURE
The parties shall not be responsible for failure to perform any of the
obligations imposed by this Agreement, provided such failure shall be occasioned
by fire, flood, explosion, lightning, windstorm, earthquake, subsidence of soil,
failure or destruction, in whole or in part, of machinery or equipment, or
failure of supply of materials, discontinuity in the supply of power,
governmental interference, civil commotion, riot, war, strikes, labour
disturbance, transportation difficulties, labour shortage, death, disability, or
unavailability of key research personnel, or any cause beyond the reasonable
control of the parties.
26
The affected party shall notify the other party as soon as practicable of the
occurrence of any of the above events. Both parties shall make every reasonable
effort to minimise the effect of force majeure upon the performance of the
Agreement.
The affected party shall notify the other party as soon as practicable of the
cessation of the relevant event. If either party shall be excused from
performance of any of its obligations for a continuous period of six (6) months
or more then the unaffected party may terminate this Agreement by seven (7)
days notice in writing provided that the relevant events continue throughout the
notice period.
14 NOTICES
Any notice, claim, demand or other communication given hereunder to be effective
shall be in writing and transmitted by certified mail, postage prepaid, or by
carrier providing a receipt of delivery to the recipient, at the addressee
stated below. Either party may notify the other in the manner set forth above at
the following addresses (or such other addresses as either party may notify to
the other in accordance with the provisions of this clause):
UNIVERSITY Xxxxx X Xxxxxx, Ph.D.
Assistant Vice President for
Technology Development
UMAB
Fifth Floor
000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
and copy by FAX to: 000-000-0000
copy to; Xxxxx Xxxxxxxx
Senior University Counsel
Second Floor
000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
and copy by FAX to: 000-000-0000
and to: Xx Xxxxx X Xxxxxx
UMAB
School of Medicine
9th Floor - MSTF Building
00 Xxxxx Xxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
and copy by FAX to: 000-000-0000
27
MEDEVA Mr R Xxxxxxx Xxxxxx
Medeva International
Xxxxx Xxxxx
Xxxxxx Xxxx
Xxxxxxxxxxx
Xxxxxx XX00 0XX
and copy by fax to: (00 00 000 0000)
and shall be deemed to be duly given when delivered if delivered by courier or
certified mail, postage prepaid; or when sent, if transmitted by telex or
facsimile transmission (receipt automatically confirmed) during normal business
hours of recipient.
15. GENERAL
15.1 This Agreement (which includes the content of all schedules hereto)
embodies and sets forth the entire agreement and understanding of the parties
and supersedes all prior oral or written agreements, understandings or
arrangements relating to the subject matter of this Agreement. Neither party
shall be entitled to rely on any agreement, understanding or arrangement which
is not expressly set forth in this Agreement.
15.2 This Agreement shall not be amended, modified, varied or supplemented
except in writing signed by duly authorised representatives of the parties.
15.3 In the event that either party requires the other party to execute any
further document which may be reasonably required for the purpose of recording
or memorialising any licence granted hereunder, the party receiving such request
shall promptly execute such further document provided that the terms of such
document are substantially similar to the terms of the licence granted herein
and do not operate to modify, amend or supplement in any way the terms of the
licence granted herein.
15.4 No failure or delay on the part of either party hereto to exercise any
right or remedy under this Agreement shall be construed or operated as a waiver
thereof nor shall any single or partial exercise of any right or remedy under
this Agreement preclude the exercise of any other right or remedy or preclude
the further exercise of such right or remedy as the case may be. The rights and
remedies provided in this Agreement are cumulative and are not exclusive of any
rights or remedies provided by law.
15.5 Any announcement, disclosure or publicity relating to a Typhoid Project or
the contents of this Agreement shall not be made by either party hereto without
first obtaining the written approval of the other. Nothing shall restrict a
party from making any disclosure of a Typhoid Project or the contents of this
Agreement as required by law or regulation, nor, in response to third party
enquiries, from acknowledging the existence of this Agreement as a
28
development agreement in respect of attenuated strains of Salmonella Typhi for
human vaccines.
15.6 Nothing herein shall constitute the relationship of employer and employee
or any partnership, and it is expressly agreed that neither party hereto will
hold itself out as an agent of the other party.
15.7 This Agreement shall inure to the benefit of and be binding upon the
parties hereto, their successors and permitted assigns. Nothing in this
Agreement, expressed or implied, is intended to confer upon any person, other
than the parties hereto, any rights or remedies under or by reason of this
Agreement.
15.8 The invalidity or unenforceability of any provision of this Agreement shall
not affect the other provisions hereof, and the Agreement shall be construed in
all respects as if such invalid or unenforceable provisions were omitted.
Furthermore, upon the request of either party hereto, the parties to this
Agreement shall add, in lieu of such invalid or unenforceable provisions,
provisions as similar in terms to such invalid or unenforceable provisions may
be possible and legal, valid and enforceable.
15.9 The captions to the clauses contained in this Agreement are for reference
only, they do not form a substantive part of this Agreement, and shall not
restrict or enlarge any substantive provision of this Agreement.
15.10 This Agreement may be executed in any number of counterparts, each of
which shall be considered an original but all of which shall constitute the
Agreement by and among the parties.
16. INDEMNITY
(a) Medeva shall indemnify and defend the University, the University
of Maryland System, and the State of Maryland the the officers,
agents, servants, employees and regents of the foregoing
(collectively, the "State entities") against any and all claims
or liabilities to third parties, including expenses and costs of
claims and suits, for any such third parties' loss, damage,
injury, or loss of life, if such claims or liabilities (a) arise
from commercial sale of any Second Generation Product
manufactured by Medeva or through an assignment, licence, or
sub-licence from Medeva; (b) arise from negligence of Medeva or
its officers, servants or agents or third parties acting on
behalf of or under authorisation from Medeva in the performance
of this Agreement; or (c) arise out of the use by Medeva or its
officers, servants or agents or any third party acting on behalf
or under authorisation from Medeva of products or processes
licensed to Medeva by the University. Researchers shall not be
deemed to be "officers, servants or agents" of Medeva or "third
parties acting on behalf of or under authorisation from Medeva"
with respect to their work on a Typhoid
29
Project.
(b) As a condition of indemnification by Medeva under this clause 16,
the University shall promptly notify Medeva in writing upon the
University's receipt or notification of any claims or liabilities
described herein and shall co-operate fully with Medeva in the
defence of such claims and liabilities. Medeva shall have the
conduct of all matters and proceedings relating to such claims
and liabilities and may assert all defences available to the
State entities, including the defences of governmental, sovereign
and statutory immunity.
(c) This clause shall not be construed to require Medeva to indemnify
the State entities with respect to: (1) claims or liabilities
that are attributable to the fault or negligence of the
University, a Researcher, or another State entity, unless Medeva
is more at fault or negligent as compared to the University, the
Researcher or the State entity; or (2) claims or liabilities
arising from the use of technology or intellectual property
rights by a licensee of the University as permitted by this
Agreement; or (3) claims or liabilities arising out of the
negligent administration of any product or claims or liabilities
for medical malpractice where the negligent administration or
medical malpractice is carried out (whether as part of a clinical
trial or otherwise) by or on behalf of a State entity or a
permitted licensee of the University.
(d) In no event will Medeva be liable pursuant to this Agreement for
damages caused by the University's failure to perform its
responsibilities under this Agreement unless the University's
failure is caused by Medeva.
(e) In addition to the foregoing, Medeva agrees that (subject to
16(c) above) should any clinical trials volunteers suffer adverse
affects from the utilisation of any vaccine in accordance with
the established protocol under a Typhoid Project, Medeva will be
responsible for paying for all costs incurred by such clinical
trial volunteers and/or CVD as a result of the adverse effects of
the use of the vaccine as outlined in Schedule 7, Adverse
Conditions to be covered or as agreed by the parties in respect
of future Typhoid Projects.
30
(f) Provided that there is no breach of this clause 16 by Medeva,
University will not bring any suit or claim against Medeva as a
defendant or as a third party defendant in connection with
personal injury claims arising from or related to participating
in clinical trials which are asserted by or on behalf of
volunteers.
Signed by their duly authorised representatives to be effective as of 20th
September 1994.
31
SCHEDULE 1(a)
Background Intellectual Property Rights of Medeva
Schedule 1(a) - Medeva's Background Intellectual Property Rights
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
32
SCHEDULE 1(b)
Background Intellectual Property Rights of University
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
33
SCHEDULE 2(a)
Background Technical Information of Medeva
NONE
34
SCHEDULE 2(b)
Background Technical Information of University
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
35
SCHEDULE 3
Research Programme and Budget
36
INVESTIGATIONAL PLAN FOR CLINICAL STUDIES
OF []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
ROLLUP OF COSTS, BY YEAR
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
TABLE 1a, CORE COSTS, []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
TABLE 1b, CORE COSTS, []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
TABLE 1c, CORE COSTS, []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
TABLE 3a, CORE COSTS, []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
TABLE 2b, CORE COSTS, []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
TABLE 2c, CORE PERSONNEL COSTS, []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
CLINICAL STUDIES WITH []*
TABLE , []*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
CENTER FOR VACCINE DEVELOPMENT
MEDEVA PLC
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
SCHEDULE 4(a)
Third Party Arrangements known to Medeva
Arrangements pursuant to which third party rights arise in respect of Background
Intellectual Property Rights and Background Technical Information:-
6.3(a) - Medeva
The Licence granted pursuant to this Agreement under Medeva's Background
Intellectual Property Rights which are set out in Schedule 1(a) is subject to
the payment of a royalty of [ ] *depending upon interpretation of terms of
the Licence the rate may be [ ] *on net sales to the Wellcome Foundation
Limited and ultimately by them to Lynxvale Limited, the employer of the
original inventor. Net sales are classified as the gross sales of product
which makes use of the invention the subject of the aforementioned Background
Intellectual Property Rights and which is covered by a valid claim in any
patent granted in respect of such rights less actual credit allowances for
spoiled, damaged, outdated and returned products and for retroactive price
reductions and less the amounts of trade and cash discounts not already
credited at the time of invoice, transportation and handling charges payable
and all sales taxes, excise taxes, use taxes or import/export duties actually
paid and less all other invoiced allowances and adjustments actually credited
to customers.
------------------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
37
SCHEDULE 4(b)
Third Party Arrangements known to University
NONE
38
SCHEDULE 5
Materials Release Agreement
To: [A]
Re: [supply of X]
Thank you for your recent request concerning the above material (hereinafter
called "the Sample") for experimental use. I am pleased to inform you that we
are able to release to you the Sample and certain information including safety
data relevant thereto. However, in order to protect our commercial interests
and to fulfil our obligations under relevant laws and obligations the Sample
will be released to you under the following conditions:
1. The Sample is provided for experimental use only in animals or in vitro
and must not be administered to humans.
2. Use of the Sample is restricted to the experimental protocol or to the
field of the research which you have already notified to us in writing.
Prior to the commencement of experimental work with the Sample ("the
Work") you will advise us, if you have not already done so, of the names
of the person or persons conducting the Work.
3. Access to the Sample will be restricted to your own personnel in your
own laboratories, namely, [X], or to such other laboratory within your
organization which you specify to us in writing and to which we confirm
that we have no objection. Neither the Sample nor any sub-unit nor
derivative thereof may be transferred from such laboratories without our
prior written consent.
4. We reserve title in the property of the Sample supplied. The transfer of
the Sample to you does not constitute a license of any kind (except as
provided for explicitly in Paragraph 2) nor does such transfer convey to
you any of our property rights in such material.
5. You will ensure that all persons involved in the conduct of the Work are
made aware of the terms of this Agreement and agree to comply with it.
6. The Sample and all information with respect thereto supplied by us
pursuant to this Agreement must be maintained as confidential by you and
your laboratory or organization as the case may be. Within your
laboratory or organization information supplied by us pursuant to this
Agreement shall only be released to the persons referred to in this
Agreement, and to other persons who have legal need to know of the
information; provided that all such persons shall agree to be bound by
the terms of this Agreement prior to their receipt of the Sample and/or
information.
39
7. You will be responsible for ensuring that there is no disclosure of the
Work to any third party verbally, in writing or otherwise without your
obtaining our prior written consent.
8. As soon as possible after the conclusion of the Work and/or upon the
termination and/or expiry of this Agreement (whichever will first occur)
you will send to us a written summary report of the Work.
9. Neither you nor your laboratory or organization nor any person or
persons within it or involved in the conduct of the Work shall make any
commercial or other use of the sample or any sub-unit or derivative
thereof or any information with respect thereto supplied by us pursuant
to this Agreement, or the results of the Work, unless such commercial or
other use is permitted by us in writing and governed by a further
written agreement to which we are a party.
10. You understand that any patent or other property right arising from the
Work shall be our property, and you shall assign any such patent or
property right to us and execute any documents necessary to effectuate
such assignment promptly upon our request.
11. At the conclusion of the Work and/or termination and/or expiry of this
Agreement whichever is earlier, you will at our option arrange for the
destruction to our complete satisfaction or the return to us of any
remaining portion of the Sample, any sub-unit or derivative thereof and
any information relating thereto. Such return shall be in accordance
with our specific instructions or otherwise in a receptacle and/or
packaging previously approved by us.
12. We shall not be responsible for any personal injury or property damage
suffered in the course of the Work, whether such injury or damage is
suffered by your laboratory or organization, the personnel engaged in
the Work, or any other persons or entities.
13. Subject to the continuing obligations contained herein, this Agreement
shall be in effect throughout the duration of the Work and for a period
of ten (10) years from the date of completion of the Work.
14. This Agreement shall be governed by and interpreted in accordance with
the laws of the State of Maryland (USA), without regard to the
principles of conflicts of laws or (in accordance with English law.)
If you will please indicate acceptance of the above conditions by signing and
dating the duplicate of this letter and returning it to [z] at the above
address we will arrange for delivery of the Sample.
40
We would advise you that we will update the safety data during the
continuance of this Agreement insofar as further relevant information becomes
known to us during that period and you hereby undertake to comply fully with
any such updates.
Should you require further information in this matter, please write directly
to [z] at the above address.
Yours sincerely
________________________
For and on behalf of [B]
Date:___________________
________________________
Accepted and agreed
For and on behalf of [A]
41
SCHEDULE 6
----------
Confidential Disclosure Agreement
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This Agreement, made and entered into this ___ day of __________, 19__,
by and between, MEDEVA PLC and the UNIVERSITY OF MARYLAND AT BALTIMORE,
(hereinafter "RESEARCH COLLABORATORS"), and [employee name]___________________
_____________________ having an address at ___________________________________
______________________________________________________________________________
_____________________ (hereinafter "XYZ").
XYZ, who is an employee or student of University of Maryland at
Baltimore ("UMAB") will be working on a research project undertaken by the
RESEARCH COLLABORATORS relating to SALMONELLA TYPHI (hereinafter "THE
PROJECT"). In the course of XYZ's activities in support of THE PROJECT, XYZ
(a) will develop information proprietary to the RESEARCH COLLABORATORS and
(b) will receive oral and written disclosures of information developed by the
RESEARCH COLLABORATORS (collectively hereinafter "INFORMATION"). In
consideration of employment by UMAB and/or the opportunity to work with the
INFORMATION, and other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, XYZ agrees to the following:
1. Subject to the terms and conditions of this Agreement XYZ will keep
confidential, and will prevent disclosure, directly or indirectly, of, all
INFORMATION received by XYZ (whether by means of written or oral disclosure
or otherwise), except with the prior written consent of RESEARCH
COLLABORATORS, their employees or agents, and will not use any INFORMATION
received from RESEARCH COLLABORATORS except as may be necessary for the
benefit of THE PROJECT. This Agreement conveys no right or licence for XYZ to
use the INFORMATION other than as expressly recited herein. ALL INFORMATION
received by XYZ, together with all copies thereof and all materials relating
thereto, including but not limited to reports, papers, surveys, letters,
drawings, computer printouts and software relating to the INFORMATION, will
be returned promptly to RESEARCH COLLABORATORS upon request. XYZ will follow
any procedures established by UMAB with respect to preventing disclosure of
INFORMATION.
2. Obligations of XYZ under Paragraph 1 hereof shall not apply to any
information which XYZ can prove was: (i) independently known to XYZ prior to
disclosure of such information to XYZ by RESEARCH COLLABORATORS, so long as
such information was not acquired directly or indirectly from RESEARCH
COLLABORATORS; (ii) lawfully obtained after the date of this Agreement by XYZ
from a third party (other than RESEARCH COLLABORATORS) having the legal right
to transmit the same; or (iii) which is generally available to the public or
which becomes generally available to the public through no act or fault of XYZ.
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3. No liability shall arise under this Agreement due to XYZ's
disclosure of INFORMATION made pursuant to judicial or governmental order,
provided that XYZ notifies RESEARCH COLLABORATORS as soon as possible and in
any event prior to such disclosure and cooperates with RESEARCH COLLABORATORS
in the event they elect to contest legally and avoid such disclosure.
4. Obligations of XYZ hereunder shall be in effect throughout the
duration of THE PROJECT and shall continue for a period of five (5) years
from the date at which UMAB's activities regarding THE PROJECT have concluded.
5. XYZ understands that under UMAB policy XYZ is required to use
reasonable efforts to protect the INFORMATION. XYZ shall exercise at least
the same degree of care as UMAB normally takes to preserve and safeguard its
own proprietary information, and in any event shall take reasonable measures
to maintain the confidentiality of the INFORMATION. XYZ acknowledges that any
RESEARCH COLLABORATOR may bring action against XYZ, at law or in equity, to
bar disclosures by XYZ in violation of this Agreement, and/or to recover
damages caused by XYZ as a result of disclosures in violation of this
Agreement.
6. All INFORMATION transferred to or developed by XYZ pursuant to
this Agreement shall be and/or remain the property of the party or parties
disclosing such information to XYZ, and none of the proprietary rights in
such information shall be conveyed to XYZ by means of such transferal.
7. XYZ shall not export directly or indirectly any INFORMATION or any
products utilizing any such INFORMATION to any country (or citizen of such
country) for which the U.S. Government or any agency thereof, at the time of
export, requires an export licence or other government approval, without
first obtaining the express written consent of RESEARCH COLLABORATORS and
without first obtaining necessary consent to do so from such agencies of the
U.S. Government as shall be required by the applicable statutes and
regulations then in effect.
8. In the event that any of the INFORMATION is or becomes the subject
of any patent application, patent, copyright application or copyright, XYZ
agrees and understands that RESEARCH COLLABORATORS will have all the rights
and remedies available to them under the law as a result of said patent
applications, patents, copyright applications or copyrights, and that
disclosure of such INFORMATION to XYZ does not in any way affect those
rights and remedies.
9. This Agreement contains our entire understanding with respect to
matters contained herein. It may not be changed or modified orally, but only
by an instrument in writing, signed by the parties hereto, which states that
it is an amendment to this Agreement.
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10. Failure to insist upon strict compliance with any of the terms,
covenants or conditions of this Agreement shall not be deemed a waiver of
such terms, covenants or conditions, nor shall any waiver or relinquishment
of any right or power hereunder at any one time or more times be deemed a
waiver or relinquishment of such right or power at any other time or times.
11. The invalidly or unenforceability of any provision of this Agreement
shall not effect the other provisions hereof, and the Agreement shall be
construed in all respects as if such invalid or unenforceable provisions were
omitted. Furthermore, upon the request of any party hereto, the parties to
this Agreement shall add, in lieu of such invalid or unenforceable
provisions, provisions as similar in terms to such invalid or unenforceable
provisions as may be possible and legal, valid and enforceable.
12. This Agreement shall not be assigned by any party hereto without
the express prior written consent of the other parties.
13. This Agreement shall be governed by the laws of the State of
Maryland, without regard to the principles of conflicts of laws.
UNIVERSITY OF MARYLAND AT BALTIMORE
FOR RESEARCH COLLABORATORS
By
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--------------------- Title
XYZ -----------------------------
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SCHEDULE 7
Adverse conditions to be covered
Coverage
For the duration of the clinical study and for a period of three (3) years
afterward.
Conditions
Acute abdomen (including appendicitis, mesenteric adenitis, perforation,
peritonitis)
cholecyatitis
nonspecific febrile illness not due to other obvious causes (only for 90 days
post vaccine)
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For and on behalf of MEDEVA PLC
Date: Sept. 8th, 1994
/s/ X.X. Xxxxxx
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X.X. Xxxxxx (Name)
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Director (Title)
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For and on behalf of UNIVERSITY OF MARYLAND AT BALTIMORE
Date: 9.20; 1994
/s/ XXXXX X XXXXXX DM
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XXXXX X XXXXXX DM; DPhil (Name)
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President (Title)
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