Certain portions of this
exhibit have been
omitted based upon
a request for confidential
treatment. Omitted portions
have been separately filed
with the Securities and
Exchange Commission.
RESEARCH AGREEMENT
This Agreement is made by and between Osiris Therapeutics, Inc., a
Delaware, U.S.A. Corporation, having its business address at 0000 Xxxxxxxxx
Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000-0000 (hereinafter "OSIRIS") and the
Consorzio per la gestione del Centro Di Biotecnologie Avanzate, having its
principal offices at Xxxxx Xxxxxxx Xxxxx, 00000 Xxxxxx, Xxxxx (hereinafter the
"CBA").
SUBJECT
WHEREAS the parties to this Research Agreement (the "AGREEMENT") wish to
promote the increase of useful knowledge through research relating to tissue
regeneration based on the differentiation of mesenchymal stem and progenitor
cells;
WHEREAS with this aim in mind, the parties have previously signed a
letter of intent between them whereby the parties indicated their intention to
enter into a co-operation agreement with respect to research in the FIELD OF
RESEARCH as defined hereinbelow;
WHEREAS, OSIRIS desires to both fund certain work to be performed at
CBA in the FIELD OF RESEARCH, and to acquire rights to all research carried
out by CBA within the FIELD OF RESEARCH, whether or not funded by OSIRIS, on
the conditions set out under this AGREEMENT, such rights to be granted to
OSIRIS in accordance with a separate standard License Agreement attached
hereto as Exhibit A (the "LICENSE AGREEMENT");
WHEREAS, CBA desires to receive such funding and recognizes that the
right to acquire the rights to the work to be performed hereunder will be
granted to OSIRIS under this
AGREEMENT and in accordance with the LICENSE AGREEMENT.
WHEREAS, the parties therefore wish to establish in detail to which
specific projects in the FIELD OF RESEARCH Osiris wishes to contribute,
and on what basis CBA shall ensure that the relevant qualified staff shall
work on such specific projects.
WHEREAS, this Agreement is in conformity with Article 12 of the
Convention signed between CBA and the IST, the Istituto Nazionale per la
Ricerca sul Xxxxxx, or, the Institute for Cancer Research, which latter forms
part of the CBA consortium, and CBA shall therefore sign this Agreement both
on its and IST's behalf pursuant to the said Convention.
IT IS AGREED
1.0 DEFINITIONS
1.1 The term "AFFILIATE" as applied to OSIRIS, shall mean any
company or other legal entity other than OSIRIS, in whatever country
organized, controlling or controlled by OSIRIS. The term "control" means
possession of the power to direct or cause the direction of the management and
policies whether through the ownership of voting securities, by contract or
otherwise. The term "CBA AFFILIATE" as applied to CBA, shall mean any
company or other legal entity other than CBA, including by definition the
Institute for Cancer Research (the "INSTITUTE"), in whatever country
organized, controlling or controlled by CBA.
1.2 The term "AGREEMENT YEAR" shall mean the twelve month period
beginning on July 1, 1997 (the "EFFECTIVE DATE"), and each subsequent twelve
(12) month period thereafter.
1.3 The term "BACKGROUND TECHNOLOGY" shall mean any data, formulas,
inventions, process information or other information, materials and substances
belonging to the FIELD OF USE known to CBA through PRINCIPAL INVESTIGATOR on
the EFFECTIVE DATE and in and to which CBA has a transferable right, which
includes but is not limited to: MESENCHYMAL STEM CELLS
1.4 The term "FIELD OF RESEARCH" shall mean the isolation,
purification, expansion, characterization and use of human MESENCHYMAL STEM
CELLS in the laboratories of the PRINCIPAL INVESTIGATOR.
1.5 "FIELD OF USE" means the isolation, purification,
characterization, culture-expansion, clinical use and manufacture of
MESENCHYMAL STEM CELLS in cancer, orthopaedics and other tissue repair and
regeneration indications.
1.6 The term "INVESTIGATOR" shall mean PRINCIPAL INVESTIGATOR, CBA
or CBA AFFILIATE faculty members, graduate students, fellows, consultants or
employees of CBA or a CBA AFFILIATE who shall work under the direction of
PRINCIPAL INVESTIGATOR on the FIELD OF RESEARCH.
1.7 The term "LICENSED PRODUCT" shall mean any article, composition,
apparatus, substance, chemical, material, method, process or service the
manufacture, use or sale of which is covered by PATENT RIGHTS or which
incorporates or uses TECHNOLOGY.
1.8 "LICENSED SERVICE(S)" means the performance on behalf of a
third party of any method or the use of any product or composition, the
manufacture, use or sale of which is covered by PATENT RIGHTS or which
incorporates or uses TECHNOLOGY.
1.9 The term "LICENSED TERRITORY" shall mean all countries of the
world.
1.10 "MATERIAL" shall mean any material or substance which is
TECHNOLOGY.
1.11 The term "MESENCHYMAL STEM CELL" or "MSC" shall mean the:
[*CONFIDENTIALITY REQUESTED*]
1.12 The term "PATENT RIGHT(s)" shall mean (i) any patent application
or patent or equivalent thereof, anywhere in the world including, but not
limited to any division, continuation, or continuation-in-part, re-
examination, reissue or extension issuing thereon, which is owned by CBA and
contains one or more claims to any TECHNOLOGY.
1.13 The term "PRINCIPAL INVESTIGATOR" shall mean Xx. Xxxxxxx
Cancedda, a professor of the University of Genoa, at the Faculty of
Medicine, who has been appointed Laboratory Head under an agreement between
the University of Genoa and IST, and who is currently seconded by IST itself
to CBA.
1.14 "RESEARCH" shall mean the specific research in the FIELD OF
RESEARCH set out in more detail in Exhibit B, attached hereto, and such
other research as the parties shall decide, by mutual consent, to add to
Exhibit B hereto.
1.15 The term "RESEARCH TECHNOLOGY" shall mean any data, formulas,
process information or other information, material, substance, invention or
discovery, whether or not patentable, conceived or first actually or
constructively reduced to practice during the period when research is being
supported under this AGREEMENT solely or jointly by at least one INVESTIGATOR
which is in the FIELD OF RESEARCH or which is the direct result of RESEARCH.
1.16 "RETAINED RIGHTS" shall mean any rights retained by any
government research granting agencies and public bodies, and any retained
right of CBA to make, have made, provide and use LICENSED PRODUCT(S)
and LICENSED SERVICES for its non-profit, non-commercial research purposes, or
with LICENSED PRODUCT obtained from OSIRIS for the treatment or diagnosis of
patients by CBA. In such case, OSIRIS will make such LICENSED PRODUCT
available to CBA at its most favorable academic medical center discount for a
period of five (5) years following EU regulatory approval.
1.17 "TECHNOLOGY" means individually and collectively BACKGROUND
TECHNOLOGY and/or RESEARCH TECHNOLOGY.
2.0 RESEARCH PROJECT
2.1 In accordance with Paragraph 3.1 below, OSIRIS shall provide a
maximum of US: $ 1,000,000 (One million) in total research support (full
direct and indirect costs and expenses) to CBA in the annual installments
described in the detailed budget set out in Exhibit C hereto to support
RESEARCH in the FIELD OF USE from, July 1, 1997 to, June 30, 2000 in the
laboratories of the PRINCIPAL INVESTIGATOR. Subject to Paragraph 2.2 and
Article 3 below, the research support (direct and indirect expenses) for the
1997-1998 period from July 1, 1997 to June 30, 1998 shall be paid quarterly on
July 1st 1997, September 1st 1997, January 1st, 1998 and April 1st 1998, and
shall be paid in similar quarterly installments during each succeeding
AGREEMENT YEAR. OSIRIS and CBA will negotiate the terms and extension, if
any, to the RESEARCH, if applicable, for each one year period following the
initial term of the AGREEMENT as set out above (the "INITIAL TERM").
2.2 If PRINCIPAL INVESTIGATOR ceases to be employed by CBA, then
OSIRIS at
its option, may elect to continue the research funding so long as CBA provides
a suitable substitute, acceptable to OSIRIS, for the PRINCIPAL INVESTIGATOR
to supervise other INVESTIGATORS with respect to RESEARCH. Conversely,
OSIRIS may elect to terminate RESEARCH according to Paragraph 9.1 below, in
which event neither party shall be due any further sum from the other under
this Agreement. All terms under this AGREEMENT which apply to the PRINCIPAL
INVESTIGATOR shall apply in the same manner to any substitute for the
PRINCIPAL INVESTIGATOR.
2.3 The relationship between OSIRIS and CBA shall be exclusive.
CBA may not furnish MATERIAL under this AGREEMENT or the LICENSE AGREEMENT
attached hereto or enter into discussions with other commercial organizations
without the prior approval of OSIRIS.
2.4 To the extent practicable, OSIRIS shall submit joint research
applications with CBA in the FIELD OF USE for Italian Government and/or EU
research funding.
3.0 OBLIGATIONS OF CBA
3.1 Within sixty (60) days following the end of each AGREEMENT
YEAR, CBA shall provide OSIRIS with an accounting of the expenditure
of research funds for such year in accordance with CBA'S standard procedures
for such accounting. Any funds granted hereunder which have not been expended
by CBA within any such AGREEMENT YEAR shall continue to be used to fund
RESEARCH under this AGREEMENT during the following AGREEMENT YEAR. Any funds
which have not been expended upon termination of this AGREEMENT shall be
returned to OSIRIS.
3.2 During the period in which OSIRIS is funding research under
this AGREEMENT, CBA shall undertake to ensure that PRINCIPAL INVESTIGATOR
shall not seek or accept
funding from a commercial sponsor in the FIELD OF RESEARCH
without the prior written approval of OSIRIS but may accept funding from the
government, not-for-profit organizations and other universities.
3.3 Beginning on the EFFECTIVE DATE of this AGREEMENT and thereafter
unless sooner terminated, CBA shall:
(i) Through the PRINCIPAL INVESTIGATOR conduct the RESEARCH,
and apply the funds paid by OSIRIS to support the expenses of RESEARCH
including for the employment of INVESTIGATORS hereinafter and shall use
reasonable efforts and diligence consistent with CBA'S professional standards
to achieve the goals for such RESEARCH;
(ii) promptly and systematically disclose TECHNOLOGY to
OSIRIS, and shall promptly advise OSIRIS of any invention which is
TECHNOLOGY in the manner specified in more detail in Article 8 below;
(iii) for the purpose of facilitating disclosure to OSIRIS of
TECHNOLOGY, permit duly authorized employees or representatives of OSIRIS to
visit the PRINCIPAL INVESTIGATOR'S laboratories at CBA where RESEARCH is
conducted at reasonable times and with reasonable notice;
(iv) promptly advise OSIRIS of any invention which is RESEARCH
TECHNOLOGY;
(v) at OSIRIS' request, provide OSIRIS with reasonable
research quantities of MATERIALS; and
(vi) advise, on a continuing basis, OSIRIS of the results of
the RESEARCH and at least once every four (4) months provide OSIRIS with
written progress reports concerning the RESEARCH. A final written report
setting forth in detail the results achieved under and pursuant
to such RESEARCH shall be submitted by CBA to OSIRIS within ninety (90) days
of termination of each AGREEMENT YEAR and of the RESEARCH. Such final report
shall include (1) a complete summary of all research carried out; (2) a
scientific assessment by the PRINCIPAL INVESTIGATOR of all research carried
out; and (3) detailed experimental protocols for the experiments performed in
the course of the research, it being understood that the latter protocols
shall not be sent to OSIRIS but shall be kept at CBA's premises and shall be
at the disposition of OSIRIS should its representatives wish to examine them
there..
(vii) ensure that all results of RESEARCH shall be the property
of CBA free of any third party rights and shall indemnify and hold OSIRIS
harmless from any claims for damages or of any other nature whatsoever raised
by third parties with respect to such results and shall undertake to ensure
that all non-employees of CBA working in their laboratories on RESEARCH or
collaborating with them on the research funded by OSIRIS hereunder sign the
Invention Agreement attached hereto as Exhibit D.
4.0 FACILITIES
CBA agrees to furnish such laboratory facilities and equipment and
secretarial support as it and OSIRIS shall, by mutual consent, determine
necessary for the RESEARCH and as set out in more detail in Exhibit C
hereto (the "FACILITIES"). Any addition or change to the FACILITIES as
set out in Exhibit C shall be agreed by mutual consent between the parties,
and shall be made by CBA at its own expense. Any equipment provided by
OSIRIS for CBA's use in the RESEARCH shall be subject to CBA's approval.
5.0 EMPLOYMENT OF INVESTIGATORS
5.1 The RESEARCH shall be carried out by those of the
INVESTIGATORS specifically indicated in Exhibit E hereto which shall include,
inter alia, the PRINCIPAL
INVESTIGATOR or Laboratory Head , other senior research staff,
research staff, research scientists, junior research scientists, graduate
students, a chief technician, junior technicians and technician students more
particularly described in Exhibit E hereto (respectively senior research
staff being referred to as the "Senior Research Staff ", research staff and
the chief technician being referred to as the "Research Staff", research
scientists being referred to as the "Research Scientists", and junior research
scientists, graduate students, junior technicians and technician students
being referred to as the "Fellowship Holders" ). CBA shall ensure that
each of the said INVESTIGATORS shall devote their time and energies to the
RESEARCH in accordance with the specific provisions set out in Exhibit E hereto.
5.2 PRINCIPAL INVESTIGATOR shall continue to be jointly appointed
by the University of Genoa and IST and seconded to CBA from IST, and CBA shall
pay him appropriate incentive payments from the funding provided by OSIRIS
with respect to the RESEARCH in conformity with applicable Italian law
currently in force and on the basis of the conditions provided for by the
entity(ies) by which PRINCIPAL INVESTIGATOR is appointed.
5.3 The Senior Research Staff shall be seconded to CBA in accordance
with certain specific conventions between CBA and IST or such other entity as
they are employed by, and CBA shall pay them appropriate incentive payments
from the funding provided by OSIRIS with respect to the RESEARCH in conformity
with applicable Italian law currently in force and on the basis of the
conditions provided for by the entity(ies) by which the Senior Research Staff
is appointed. They shall be subject to an appropriate non-competition
obligation under such contracts in the RESEARCH FIELD which shall apply
throughout the duration of the contracts and for a period of two years
following the termination of the contracts.
5.4 The Research Staff shall be seconded to CBA in accordance with
certain
specific conventions between CBA and IST or such other entity as they are
employed by and CBA shall pay them appropriate incentive payments from the
funding provided by OSIRIS with respect to the RESEARCH in conformity with
applicable Italian law currently in force and on the basis of the conditions
provided for by the entity by which the Research Staff is appointed. They
shall be subject to an appropriate non-competition obligation under such
contracts in the RESEARCH FIELD which shall apply throughout the duration of
the contracts and for a period of two years following the termination of the
contracts.
5.5 The Research Scientists shall be directly employed by CBA as
employees on a temporary basis. Under the employment contracts established
between the Research Scientists and CBA, the Research Scientists shall be
subject to an appropriate non-competition obligation in respect of the
restricted field of the specific project of the RESEARCH on which they shall
work. Such non-competition obligation shall apply throughout the duration of
their respective employment contracts, and for a period of one year following
termination of such employment contract, only as regards commercial
organizations conducting work similar to the RESEARCH FIELD, as opposed to
academic posts which they may be offered.
5.6 The Fellowship Holders shall carry out RESEARCH in return for
the award of a fellowship from CBA for the three (3) year duration of the
RESEARCH, which shall be provided from the funding provided by OSIRIS with
respect to the RESEARCH.
6.0 PUBLICATION
6.1 OSIRIS agrees that INVESTIGATORS engaged in the RESEARCH shall
be permitted to present or publish at their own choosing, methods and results
of the RESEARCH; provided, however, that OSIRIS shall have been furnished
copies of any abstract, proposed presentation, or publication thirty (30) days
prior to submission to scientific meeting organizers or
scientific publications.
6.2 Notwithstanding anything else to the contrary, CBA undertakes
that it shall not, and undertakes to ensure that PRINCIPAL INVESTIGATOR shall
not, publish or disclose to third parties TECHNOLOGY without supplying OSIRIS
with a copy of the material to be disclosed or published to third parties at
the time of submission for publication or disclosure so that OSIRIS may
evaluate such material to determine whether the material contains patentable
subject matter on which a patent application should be filed. OSIRIS shall
review the material within thirty (30) days of submission to OSIRIS.
6.3 At OSIRIS'S request, CBA will delay publication and/or
disclosure of TECHNOLOGY for an additional sixty (60) days in order to
enable the preparation and filing of a patent application in the United
States, Europe or other jurisdiction on any such patentable subject matter.
Notwithstanding anything to the contrary, CBA will not be required to withhold
publication of such material for a period which is more than ninety (90) days
after OSIRIS is first provided with the material to be disclosed or published.
6.4 Nothing in this Agreement shall entitle CBA to disclose to
others or publish any information disclosed to CBA by OSIRIS that is
confidential within the meaning of article 7.0 without the prior written
approval of OSIRIS.
7.0 CONFIDENTIALITY
7.1 The parties agree and undertake to keep confidential all and any
information, whether written or oral, which is imparted to them by the other
in confidence or which is confidential and which is acquired by one party in
connection with this Agreement or the research to be carried out under it
including, for the avoidance of doubt, all such information relating to the
activities, business or affairs or the other party ("CONFIDENTIAL
INFORMATION").
CONFIDENTIAL INFORMATION shall not be disclosed or revealed to
anyone except employees of the recipient who have a need to know the
information and who have entered into a secrecy agreement with the recipient
under which such employees are required to maintain confidential the
proprietary information of the recipient and such employees shall be advised
by the recipient of the confidential nature of the information and that the
information shall be treated accordingly. The recipient's obligations under
this Paragraph 7.1 shall not extend to any part of the information:
a. that can be demonstrated to have been in the public
domain or publicly known and readily available to the trade
or the public prior to the date of the disclosure; or
b. that can be demonstrated, from written records to have
been in the recipient's possession or readily available to the
recipient from another source not under obligation of secrecy
to the disclosing party prior to the disclosure; or
c. that becomes part of the public domain or publicly
known by publication or otherwise, not due to any unauthorized
act by the recipient.
d. that can be demonstrated, from written records, to have
been developed by the recipient independently of the disclosed
information.
7.2 The obligations of Paragraph 7.1 shall also apply to AFFILIATES
and/or SUBLICENSEES provided such information by OSIRIS. CBA'S, OSIRIS', and
AFFILIATES' obligations under Paragraph 7.1 shall extend until three (3) years
after the termination of this AGREEMENT. Notwithstanding the foregoing,
OSIRIS and AFFILIATES shall, with the prior consent of CBA, have the right to
disclose CONFIDENTIAL INFORMATION of CBA to a third party who undertakes
an obligation of confidentiality and non-use with respect to such information
at least as restrictive as the obligations under Paragraph 7.1.
8.0 PATENT AND OTHER RIGHTS AND LICENSE OPTIONS
8.1 CBA agrees to promptly notify OSIRIS of any invention, whether
or not patentable, made by or disclosed to CBA which is TECHNOLOGY
(hereinafter an "INVENTION") within thirty (30) days after receipt of an
invention disclosure from the inventor or draft of a manuscript and prior to
its submission for publication, in accordance with article 6 above. The
titles, serial numbers and other identifying data of patent applications
claiming an INVENTION shall become part of the PATENT RIGHTS, it being
understood between the parties, however, that, where such an INVENTION is
patentable, CBA shall decide whether or not to patent it at its discretion.
In the event that it decides not to patent any patentable INVENTION, it shall
grant OSIRIS the right to patent such INVENTION in return for a one-off
payment of US $5,000.
8.2 With respect to any invention made by or disclosed to CBA
referred to in Paragraph 8.1 above and which must be notified to OSIRIS in
accordance with that Paragraph and which is the direct result of RESEARCH,
OSIRIS shall be automatically granted an exclusive license subject to the
RETAINED RIGHTS under the PATENT RIGHTS and under TECHNOLOGY to make, have
made, use and sell the LICENSED PRODUCT(S) and to provide the LICENSED
SERVICE(S) in the LICENSED TERRITORY (collectively, the "RESEARCH RIGHTS").
The relevant RESEARCH RIGHTS shall automatically vest in OSIRIS under the
specific terms and conditions set out in the LICENSE AGREEMENT, in particular,
its clause 2, which shall constitute the entire agreement with respect to the
RESEARCH RIGHTS.
8.3 With respect to any invention made by or disclosed to CBA
referred to in Paragraph 8.1 above and which must be notified to OSIRIS in
accordance with that Paragraph and which is not the direct result of RESEARCH,
OSIRIS shall have an option to obtain an exclusive license
subject to the RETAINED RIGHTS under the PATENT RIGHTS and under TECHNOLOGY to
make, have made, use and sell the LICENSED PRODUCT(S) and to provide the
LICENSED SERVICE(S) in the LICENSED TERRITORY (collectively, the "RIGHTS").
8.4 Within 30 days of notification of an INVENTION in accordance
with Paragraph 8.1 above, OSIRIS shall notify CBA as to whether it wishes to
exercise the option referred to in Paragraph 8.2 above. Exercise of the
option shall automatically vest the relevant RIGHTS in OSIRIS under the
specific terms and conditions set out in the LICENSE AGREEMENT, which shall
constitute the entire agreement with respect to the RIGHTS.
9.0 TERMINATION
9.1 OSIRIS may terminate this AGREEMENT immediately by giving CBA
simple written notice thereof in the event of any breach of CBA of any of its
obligations under Paragraphs 3.1, 3.3, 6.0 and 8.1 of this AGREEMENT, or in
the event that OSIRIS decides to terminate this AGREEMENT in accordance with
Paragraph 2.2 above..
9.2 Without prejudice to Clause 9.1 above, either of the parties may
terminate this AGREEMENT for its breach by the other party, in the event that
the party in breach does not remedy such breach within sixty (60) days of
receiving written notice of the breach from the party which is not in breach.
9.3 In the event of early termination of this AGREEMENT under
Article 9.2 above, or under Article 9.1 above for breach of CBA, the following
provisions shall apply:-
(i) Where the termination is due to breach of the Agreement
by OSIRIS, OSIRIS shall pay all costs accrued by CBA as of the date of
termination including non-cancelable obligations for the term of this
Agreement, and non-cancelable payment obligations to all INVESTIGATORS
appointed before the effective date of termination specifically to work on the
RESEARCH funded by OSIRIS for a period of one year;
(ii) Where termination is due to breach of the Agreement by
CBA, CBA shall pay back all sums already paid to it by OSIRIS and not yet used.
10.0 NEGATION OF WARRANTY
10.1 CBA makes no representation other than those specified in this
Agreement. In particular, CBA MAKES NO EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF DATA OR
TECHNICAL INFORMATION DERIVED FROM THIS RESEARCH PROJECT OR OF ANY
TANGIBLE OR INTANGIBLE PROPERTY OR PROPERTY RIGHT.
11.0 ASSIGNMENT
This AGREEMENT shall be binding upon and inure to the benefit of the
respective parties and their permitted successors and assignees.
Notwithstanding the above, in the case of OSIRIS this AGREEMENT shall be
assignable by OSIRIS to any AFFILIATE of OSIRIS or other party with the
prior written consent of CBA, such consent not to be unreasonably withheld.
OSIRIS shall also have the right to assign this AGREEMENT to another party
without the consent of CBA in the case of the sale or transfer or merger or
consolidation of OSIRIS or sale or transfer by OSIRIS to that party of
all, or substantially all, of its assets or all or substantially all of the
portion of its assets to which this AGREEMENT relates, provided the assignee
undertakes to be bound by and perform the obligations of the assignor under
this AGREEMENT.
12.0 PUBLICITY
The COMPANY and CBA and their AFFILIATES and SUBLICENSEES shall not use
the names, likenesses, or logos of CBA or OSIRIS or any of their constituent
parts and affiliated
hospitals and companies, in any press releases, general publications,
advertising, marketing, promotional or sales literature without
prior written consent from an authorized official of OSIRIS or CBA, which
consent shall not be unreasonably withheld. OSIRIS shall, however, have the
right to use the name of CBA in agreements between OSIRIS and SUBLICENSEES,
in shareholder communications and news releases, and in any US Securities and
Exchange Commission (SEC) or comparable EU filing, fundraising documents and
the like and in any case where such use is required by law, rule or regulation.
13.0 NOTICES
Notices, invoices, payments and other communications hereunder shall be
deemed to have been made when delivered, sent by telex, or when mailed first
class, postage prepaid, or by commercial international courier service and
addressed to the party at the address given below, or such other address as
may hereafter be designated by notice in writing:
OSIRIS THERAPEUTICS, INC. 0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxx X. Xxxxx, President
and Chief Executive Officer
CC: Xxxxxx, Casati E Associati
X.xx Xxxxxxxx Xxxxxxxx XX, 00
00000 Xxxxxx, Xxxxx
Attn: Xxxx Xxxxxxx, Esq. and
Avv. Donatella De Xxxx
Xxxxxxx, Byrne, Bain, Gilfillan,
Cecchi, Xxxxxxx & Olstein
0 Xxxxxx Xxxx Xxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxxx X. Xxxxxxx, Esq.
CENTRO DI BIOTECNOLOGIE AVANZATE:
If administrative: Xxxxxxxx Xxxxx, M.D., Ph.D.
Chief Executive Officer
Consorzio per la gestione
Centro de Biotecnlogie Avanzate
Xxxxx Xxxxxxx Xxxxx 00
00000 Xxxxxx, Xxxxx
If technical: Xxxx. Xxxxxxx Cancedda, M.D.
Director
Laboratorio di Differenziazione
Cellulare
Centro di Biotecnologie Avanzate
Xxxxx Xxxxxxx Xxxxx 00
00000 Xxxxxx, Xxxxx
14.0 MISCELLANEOUS
14.1 CBA and OSIRIS agree that, in performing their activities as
regards the RESEARCH, INVESTIGATORS are acting as employees of CBA or the
INSTITUTE and nothing contained in this Agreement shall allow the
INVESTIGATORS to be or be deemed to be the agent or the employee of OSIRIS for
any purpose whatsoever.
14.2 This AGREEMENT shall be governed by and construed according to
the laws of Italy.
14.3 The parties shall make reasonable efforts to settle in an
amicable way any dispute that may arise between them in connection with this
AGREEMENT or the carrying out of the transaction contemplated herein.
14.4. Should either party consider it not possible to reach an
amicable settlement, then the dispute shall be resolved through arbitration
with a panel of three arbitrators.
14.5. The first arbitrator shall be appointed by the party initiating
the arbitration proceedings within its demand for arbitration to the other
party; the second arbitrator shall be appointed by the other party within 30
days from the date on which it has received notice of the
demand for arbitration; and the third arbitrator, as Chairman of the panel,
shall be designated by agreement of the first two arbitrators within 30 days
from the appointment of the second arbitrator or, failing such agreement, by
the President of the Court of Genoa, Italy, upon request of one party. The
President of the Tribunal of Genoa, Italy, upon request of one party, shall
also designate an arbitrator in the same manner if the party required to make
such appointment shall not have done so within the period of time specified
above.
14.6. The appointment of the arbitrator shall be carried out by
formally notifying it to the other party through the judicial officer.
14.7. In the event that more than two parties legitimately are party
to the arbitration proceedings, then the dispute shall be resolved by a panel
of three arbitrators appointed by agreement of the various parties to the
procedure or, failing such agreement, by the President of the Tribunal of
Genoa, Italy, upon request of one party.
14.8. The arbitration procedure shall be held in accordance with the
customary Italian Procedure Law.
14.9. The arbitrators shall come to a decision in accordance with
Italian Law ("arbitrato rituale di diritto") and within a term of 180 days
after their appointment be it by the parties, or by the President of Tribunal
of Genoa, Italy; the arbitrators' award shall not be subject to any form of
appeal or recourse.
14.10. The arbitration proceedings shall take place in Genoa, Italy and
shall be held in English.
14.11 This AGREEMENT includes Exhibits "A" through "E" as an integral
part hereof and it supersedes any prior agreement between the parties hereto
and constitutes the entire agreement of the parties with respect to its
subject matter. Any amendments hereto must be in writing and
signed by duly authorized representatives of both parties hereto.
The parties hereto have caused this AGREEMENT to be executed by duly
authorized representatives effective as of the later date indicated below.
OSIRIS THERAPEUTICS, INC. CONSORZIO PER LA GESTIONE
CENTRO DI BIOTECNOLOGIE AVANZATE
By:/s/ Xxxxx X. Xxxxx By: /s/ Xxxxxxxx Xxxxx
Name: Xxxxx X. Xxxxx Name: Xxxxxxxx Xxxxx, M.D., Ph.D.
Title: President & Chief Executive Officer Title: Chief Executive Officer
Date: _7/25/97_______________ Date: _7/15/97_________________
I have read, understand and agree to abide by the terms of this AGREEMENT.
By: /s/ Xxxxxxx Cancedda
Name: Xxxxxxx Cancedda, M.D.
Title: Professor Date: 7/15/97
Exhibit A
LICENSE AGREEMENT
This Agreement is made by and between Osiris Therapeutics, Inc.,
a Delaware, U.S.A. corporation (hereinafter "OSIRIS") having its principal
place of business at 0000 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000-0000, and the
Consorzio per la gestione del Centro Di Biotecnologie Avanzate, having its
principal offices at Xxxxx Xxxxxxx Xxxxx 00, 00000 Xxxxxx, Xxxxx (hereinafter
the "CBA").
SUBJECT
WHEREAS, OSIRIS and CBA have entered into a separate Research Agreement
(the "RESEARCH AGREEMENT"), which grants OSIRIS automatic rights to certain
work, and an option to obtain rights to other research carried out in the
FIELD OF RESEARCH (as defined hereinafter) under this License Agreement (the
"AGREEMENT"); and
WHEREAS, CBA desires to receive such funding and recognizes that the
rights to the work to be performed hereunder will be granted to OSIRIS under
the RESEARCH AGREEMENT and the AGREEMENT.
WHEREAS, CBA is interested in licensing PATENT RIGHTS (hereinafter
defined) to facilitate the distribution of useful products and the utilization
of new clinical methods, but does not intend to commercially develop,
manufacture or distribute any such products or methods; and
WHEREAS, OSIRIS desires to commercially develop, manufacture, use and
distribute such products and processes covered by PATENT RIGHTS throughout the
world;
WHEREAS, this Agreement is in conformity with Article 12 of the
Convention signed between CBA and the IST, the Istituto Nazionale per la
Ricerca sul Xxxxxx, or, the Institute for Cancer Research, which latter forms
part of the CBA consortium, and CBA shall therefore sign this Agreement both
on its and IST's behalf pursuant to the said Convention.
NOW THEREFORE in consideration of the mutual promises and other good and
valuable consideration, the parties agree as follows:
IT IS AGREED
SECTION 1 - DEFINITIONS
1.1 The term "AFFILIATE" as applied to OSIRIS, shall mean any
company or other legal entity other than OSIRIS, in whatever country
organized, controlling or controlled by OSIRIS. The term "control" means
possession of the power to direct or cause the direction of the management and
policies whether through the ownership of voting securities, by contract or
otherwise. The term "CBA AFFILIATE" as applied to CBA, shall mean any company
or other legal entity other than CBA, including by definition the Institute
for Cancer Research (the "INSTITUTE"), in whatever country organized,
controlling or controlled by CBA.
1.2 The term "AGREEMENT YEAR" shall mean the twelve month period
beginning on [July 1, 1997] (the "EFFECTIVE DATE"), and each subsequent twelve
(12) month period thereafter.
1.3 The term "BACKGROUND TECHNOLOGY" shall mean any data, formulas,
inventions, process information or other information, materials and substances
belonging to the FIELD OF USE known to CBA through PRINCIPAL INVESTIGATOR on
the EFFECTIVE DATE and in and to which CBA has a transferable right, which
includes but is not limited to MESENCHYMAL STEM CELLS.
1.4 "EFFECTIVE DATE" of this License Agreement shall mean the later
of the date first appearing on this AGREEMENT or July 1, 1997.
1.5 "FIELD OF RESEARCH" shall mean the isolation, purification,
characterization and use of human MESENCHYMAL STEM CELLS in the laboratories
of the PRINCIPAL INVESTIGATOR.
1.6 "FIELD OF USE" means the isolation, purification,
characterization, culture-expansion, clinical use and manufacture of
MESENCHYMAL STEM CELLS in cancer., orthopaedics and other tissue repair and
regeneration indications.
1.7 The term "INVESTIGATOR" shall mean PRINCIPAL INVESTIGATOR,
CBA or CBA AFFILIATE faculty members, graduate students, fellows, consultants
or employees of
CBA who shall work under the direction of PRINCIPAL INVESTIGATOR on the FIELD
OF RESEARCH.
1.8 The term "LICENSED PRODUCT" shall mean any article, composition,
apparatus, substance, chemical, material, method, process or service the
manufacture, use or sale of which is covered by PATENT RIGHTS or which
incorporates or uses TECHNOLOGY or which incorporates or uses a MATERIAL.
1.9 "LICENSED SERVICE(S)" means the performance on behalf of a third
party of any method or the use of any product or composition, the manufacture,
use or sale of which is covered by PATENT RIGHTS or which incorporates or uses
TECHNOLOGY or which incorporates or uses a MATERIAL.
1.10 The term "LICENSED TERRITORY" shall mean all countries of the
world.
1.11 The term "MESENCHYMAL STEM CELL" or "MSC" shall mean the:
[*CONFIDENTIALITY REQUESTED*]
1.12 "NET SALES" subject to Paragraph 5.9 shall mean gross sales
revenues received by OSIRIS or an AFFILIATE from the sale of LICENSED
PRODUCT(S) less trade discounts allowed, refunds, returns and recalls,
rebates, transportation and transportation-related insurance costs, itemized
on a xxxx or invoice, and sales taxes. In the event that OSIRIS, an AFFILIATE
or SUBLICENSEE sells a LICENSED PRODUCT in combination with other ingredients
or components which are not LICENSED PRODUCT(S) (such other ingredients or
components being "Other Items"), then the NET SALES for purposes of royalty
payments on the combination shall be calculated as follows:
(a) If all LICENSED PRODUCT(S) and Other Items contained in
the combination are available separately, the NET SALES for purposes of
royalty payments will be calculated by multiplying the NET SALES of the
combination by the fraction A/(A+B), where A is
the separately available price of all LICENSED PRODUCT(S) in the combination,
and B is the separately available price for all Other Items in the combination.
(b) If the combination includes Other Items which are not
sold separately (but all LICENSED PRODUCT(S) contained in the combination are
available separately), the NET SALES of the combination multiplied by the
fraction A/C, where A is as defined above and C is the invoiced price of the
combination.
(c) If the LICENSED PRODUCTS contained in the combination are
not sold separately, the NET SALES for such combination shall be NET SALES
multiplied by D/C where C is defined above and D is the fair market value of
LICENSED PRODUCTS in the combination. The fair market value will be
determined by negotiation between the parties; should the parties fail to
reach an agreement, the issue will be brought for a finding to arbitration in
accordance with the rules of customary Italian Procedural Law relating to
arbitrations, as set forth in Clause 8 below.
The term "Other Items" does not include solvents, diluents,
carriers, excipients, or the like used in formulating a product.
1.13 "NET SERVICE REVENUES" shall mean actual revenues received for
the performance of LICENSED SERVICE less sales and/or use taxes imposed upon
and with specific reference to the LICENSED SERVICE, trade discounts allowed,
refunds and rebates. If a LICENSED SERVICE is offered in combination with
another service or services, NET SERVICE REVENUES for purposes of
determining royalties on the LICENSED SERVICE shall be calculated by
multiplying the NET SERVICE REVENUES (as defined above, but
applied to the combination services), by the fraction A/(A+B), where A is the
invoice price of the LICENSED SERVICE and B is the invoice price of the
other service or services in the combination if sold separately.
1.14 "MATERIAL" shall mean any material or substance which is
TECHNOLOGY.
1.15 The term "PATENT RIGHT(s)" shall mean any patent application or
patent or equivalent thereof, anywhere in the world including, but not limited
to any division, continuation, or continuation-in-part, re-examination,
reissue or extension issuing thereon, which is owned by CBA and contains one
or more claims to any TECHNOLOGY.
1.16 The term "PRINCIPAL INVESTIGATOR" shall mean Xx. Xxxxxxx
Cancedda a professor of the University of Genoa, at the Faculty of Medicine,
who has been appointed Laboratory
Head under an agreement between the University of Genoa and IST, and who is
currently seconded by IST itself to CBA.
1.17 "RETAINED RIGHTS" shall mean any rights retained by any
government research granting agencies and public bodies, and any retained right
of CBA to make, have made, provide and use LICENSED PRODUCT(S) and LICENSED
SERVICES for its non-profit, non-commercial research purposes, or with
LICENSED PRODUCT obtained from OSIRIS for the treatment or diagnosis of
patients by CBA. In such case, OSIRIS will make such LICENSED PRODUCT
available to CBA at its most favorable academic medical center discount for a
period of five (5) years following EU regulatory approval.
1.18 "RESEARCH AGREEMENT" means the Research Agreement by and
between CBA and OSIRIS dated as of the date of this AGREEMENT.
1.19 The term "RESEARCH TECHNOLOGY" shall mean any data, formulas,
process information or other information, material, substance, invention or
discovery, whether or not patentable, conceived or first actually or
constructively reduced to practice during the period when research is being
supported by OSIRIS under the RESEARCH AGREEMENT solely or jointly by at
least one INVESTIGATOR which is in the FIELD of RESEARCH or which is the
direct result of research funded in whole or in part by OSIRIS pursuant to the
RESEARCH AGREEMENT.
1.20 The term "SUBLICENSEE" shall mean any non-AFFILIATE licensed by
OSIRIS to make, have made, import, use or sell any LICENSED PRODUCT or
LICENSED SERVICE.
1.21 "TECHNOLOGY" means individually and collectively BACKGROUND
TECHNOLOGY and/or RESEARCH TECHNOLOGY.
1.22 "VALID CLAIM" shall mean a claim of an issued patent which has
not lapsed or become abandoned or been declared invalid or unenforceable by a
court of competent jurisdiction or an administrative agency from which no
appeal can be or is taken.
SECTION 2 - GRANTS OF LICENSES
2.1 Subject to the terms and conditions of this AGREEMENT, CBA
hereby grants to OSIRIS an exclusive license, subject to any RETAINED RIGHTS
under the PATENT RIGHTS and under TECHNOLOGY to make, have made, use and sell
the LICENSED PRODUCT(S) and to provide the LICENSED SERVICE(S) in the LICENSED
TERRITORY.
2.2 OSIRIS may sublicense others under this AGREEMENT provided that
it gives prior notice of the fundamental elements of any sub-license which it
may wish to enter into to CBA and CBA does not raise substantial objections to
such proposed sub-license within 60 days of the date of such notice and shall
provide a copy of each sublicense agreement to CBA after it is executed.
2.3 OSIRIS shall have the right to extend its license rights granted
under Paragraph 2.1 above to its AFFILIATES; however, such AFFILIATES must
agree in writing to be bound by the terms of this AGREEMENT with a copy of
such agreement furnished to CBA after it is executed.
SECTION 3 -OBLIGATIONS OF CBA REGARDING MATERIALS
3.1 During the period in which OSIRIS holds a license, CBA, and CBA
shall ensure that the PRINCIPAL INVESTIGATOR shall not, without OSIRIS'S prior
written approval, distribute or knowingly allow any MATERIALS to be
distributed to for-profit entities or persons known to be employed thereby or
consulting or performing research therefor other than under a license
permitted under this AGREEMENT.
3.2 CBA shall have the right, and CBA may allow PRINCIPAL
INVESTIGATOR to transfer MATERIALS to (i) not-for-profit entities or persons
known to be affiliated therewith, or (ii) to any person or entity, if required
by a journal in connection with a publication or if required by Government
rules and/or regulations, provided that such entities or persons sign a
Material Transfer Agreement in accordance with the terms set out in Annex A
hereto. CBA shall ensure that the PRINCIPAL INVESTIGATOR shall notify
OSIRIS before any such distribution is made.
3.3 Prior to distribution of any such MATERIALS, CBA and OSIRIS
shall use reasonable efforts to consider the patentability of such MATERIALS
and cooperate to file, where appropriate, PATENT RIGHTS protecting such
MATERIALS prior to their distribution.
SECTION 4 - DEVELOPMENT OF LICENSED PRODUCTS AND SERVICES
4.1 For each PATENT RIGHT, OSIRIS agrees to exercise reasonable
efforts and to take effective steps, within a reasonable time to (i) identify
product candidate(s) which are LICENSED PRODUCT(S) (ii) perform pre-clinical
animal and toxicological studies for each
identified product candidate, (iii) conduct clinical studies aimed at
obtaining FDA and/or EU regulatory approval for each identified product
candidate and (iv) develop and commercialize each such product; provided
however, a LICENSED PRODUCT need not be identified and developed for a
PATENT RIGHT if a similar product is being developed under another PATENT
RIGHT. OSIRIS'S obligations under this paragraph shall take into account the
stage of development thereof and regulatory consideration and requirements.
The efforts of a SUBLICENSEE, an AFFILIATE, a collaborator and research
funded under this AGREEMENT shall be considered as efforts of OSIRIS.
4.2 If, as to a specific LICENSED PRODUCT, OSIRIS fails to exercise
reasonable efforts as required by Paragraph 4.1, as its sole and exclusive
remedy CBA may convert OSIRIS'S license with respect thereto to non-exclusive
rights and licenses; provided however that, if in good faith, OSIRIS has
pursued development of such LICENSED PRODUCT and in good faith OSIRIS
intends to pursue development of such LICENSED PRODUCT, and reasonably
appears to have the ability to do so, and thereafter in good faith does
continue to do so, OSIRIS'S performance obligation will have been fulfilled.
4.3 OSIRIS may market and sell LICENSED PRODUCT(S) and LICENSED
SERVICE(S) to third parties at a sales price determined by OSIRIS in its sole
discretion.
4.4 After a NDA, PLA or BLA has been obtained from the FDA, OSIRIS
shall exercise commercially reasonable efforts to market a product included in
LICENSED PRODUCTS in the US and worldwide, provided that OSIRIS has obtained
regulatory approval in a particular foreign country or region.
4.5 In the event that a third party notifies CBA that it desires to
develop and market a LICENSED PRODUCT which is not being researched and/or
developed and/or marketed by OSIRIS, an AFFILIATE or SUBLICENSEE, CBA shall
notify OSIRIS in writing thereof. If OSIRIS does not notify CBA within ninety
(90) days of such written notice that OSIRIS or an AFFILIATE or SUBLICENSEE
intends to develop such LICENSED PRODUCT and does not initiate such
development in accordance with the provisions of Paragraph 4.1 hereof within a
reasonable time thereafter, CBA shall enter into good faith negotiations with
such third party for granting a sublicense for such LICENSED PRODUCT unless
the granting of such sublicense would have a potential adverse commercial
effect upon marketing and/or selling of a LICENSED PRODUCT which is being
researched, developed, or sold pursuant to this AGREEMENT.
SECTION 5 - LICENSE PAYMENTS, ROYALTIES AND RESEARCH MILESTONES
5.1 For each new invention after the initial AGREEMENT YEAR for
which an original (i.e., not continuational or divisional) US Patent
application is filed, OSIRIS shall pay to [*CONFIDENTIALITY REQUESTED*] within
sixty (60) days following such filing.
5.2 OSIRIS shall pay to CBA one of the following royalties which
shall be due and payable sixty (60) days after June 30 and December 31 for
LICENSED PRODUCTS sold or LICENSED SERVICES provided in the respective
half-year period:
(a) (i) [*CONFIDENTIALITY REQUESTED*] of NET SALES of
LICENSED PRODUCTS or NET SERVICE REVENUE of LICENSED SERVICES which are
[*CONFIDENTIALITY REQUESTED*] of NET SALES of LICENSED PRODUCTS or NET
SERVICE REVENUE of LICENSED SERVICES in the case of
[*CONFIDENTIALITY REQUESTED*], sold or provided by OSIRIS or an AFFILIATE
licensed under this AGREEMENT which in the country where made, sold or
provided are covered by a VALID CLAIM included in PATENT RIGHTS; (ii)
[*CONFIDENTIALITY REQUESTED*] of NET SALES of LICENSED PRODUCTS for
therapeutics and [*CONFIDENTIALITY REQUESTED*] of NET SALES of LICENSED
PRODUCTS in case of [*CONFIDENTIALITY REQUESTED*] in all other countries; it
being understood that, in the case of any LICENSED PRODUCTS or LICENSED
SERVICES which shall, in the future, be covered by a VALID CLAIM included in
PATENT RIGHTS for which registration has been requested but not yet granted,
the royalty amounts provided for under (ii) above shall be paid until the
grant of the PATENT RIGHTS, and, if and when such PATENT RIGHTS are granted,
those royalty amounts provided for under (i) above shall apply from the date
of such grant, and shall also be paid retroactively for the period from the
date at which registration of such PATENT RIGHTS was requested to the date of
such grant.
(b) (i) [*CONFIDENTIALITY REQUESTED*] received by OSIRIS
from a SUBLICENSEE for LICENSED PRODUCTS sold or LICENSED SERVICES provided
by such SUBLICENSEE which in the country where made, sold or provided are
covered by a VALID CLAIM included in PATENT RIGHTS; (ii)
[*CONFIDENTIALITY REQUESTED*] received by OSIRIS from a SUBLICENSEE for
LICENSED PRODUCTS sold or LICENSED SERVICES provided by such SUBLICENSEE in
all other countries.
5.3 In the event royalties are due hereunder with respect to a
LICENSED SERVICE solely because such service involves the use of a LICENSED
PRODUCT, for the
purposes of calculating royalties hereunder, NET SALES for the LICENSED
PRODUCT and/or NET SERVICE REVENUES for the LICENSED SERVICE shall be
based on the price of the LICENSED PRODUCT, respectively, in arm's length
transactions. If no such transactions have taken place, such price shall be
determined by mutual agreement of the parties and if such agreement is not
reached within sixty (60) days, either party shall have the right to submit a
determination of price to binding arbitration in accordance with Section 8
below.
5.4 OSIRIS shall provide to CBA within sixty (60) days of the end
of each June 30 and December 31, after the market introduction of LICENSED
PRODUCTS or LICENSED SERVICES in any country of the LICENSED TERRITORY, a
written report to CBA of the amount of LICENSED PRODUCTS sold, and LICENSED
SERVICES sold, the total NET SALES and NET SERVICE REVENUES of such LICENSED
PRODUCTS and LICENSED SERVICES, and the running royalties due to CBA as a
result of NET SALES and NET SERVICE REVENUES by OSIRIS, AFFILIATES and
SUBLICENSEES. Payment of any such royalties due shall accompany such report.
So long as OSIRIS, an AFFILIATE or a SUBLICENSEE is developing a LICENSED
PRODUCT under this AGREEMENT, a report shall be submitted at the end of every
June 30 and December 31 after the EFFECTIVE DATE of this AGREEMENT and will
include a full written report describing OSIRIS'S, AFFILIATE'S or
SUBLICENSEE'S technical efforts under Section 7.
5.5 OSIRIS shall make and retain, for a period of three (3) years
following the period of each royalty report required by Paragraph 5.4, true
and accurate records, files and books of account containing all the data
reasonably required for the full computation and verification of sales and
other royalty related information required in Paragraph 5.4. Such books and
records shall be in accordance with generally accepted accounting principles
consistently applied. OSIRIS shall permit the inspection and copying of such
records, files and books of account by CBA or its agents during regular
business hours upon ten (10) business days' written notice to OSIRIS. Such
inspection shall not be made more than once each calendar year. All costs of
such inspection and copying shall be paid by CBA, provided that if any such
inspection shall reveal that an underpayment error has been made in the amount
equal to ten percent (10%) or more of such payments in a calendar year, such
costs shall be borne by OSIRIS. OSIRIS shall include in any agreement with its
AFFILIATES or SUBLICENSEES which permits such party to make, use or sell
the LICENSED PRODUCT(S) or provide LICENSED SERVICES, a provision requiring
such party to retain records of sales of LICENSED PRODUCT(S) and records of
LICENSED SERVICES and other information
as required in Paragraph 5.4 and permit the CBA to inspect such records as
required by this Paragraph 5.5.
5.6 OSIRIS agrees that in the event any LICENSED PRODUCT shall be
sold to an AFFILIATE, then the royalty due hereunder shall be based on the
higher of (i) NET SALES of the LICENSED PRODUCT to the AFFILIATE or (ii) the
NET SALES of the AFFILIATE from the resale of such LICENSED PRODUCT. In the
event any LICENSED PRODUCT or LICENSED SERVICE shall be sold to other than an
AFFILIATE for partial or full future compensation then such future
compensation when received shall be included in NET SALES for the purpose of
paying royalties hereunder.
5.7 All payments under this AGREEMENT shall be made in US Dollars.
5.8 To the extent royalty is owed to a third party for patents held
by that party covering the making, using or selling of a LICENSED PRODUCT or
LICENSED SERVICE in a particular country, the royalty due to CBA under
Paragraph 5.2 for such LICENSED PRODUCT or LICENSED SERVICE in such country
will be[*CONFIDENTIALITY REQUESTED*] such royalty paid to such third party;
however, in no event shall such royalty due to CBA for such LICENSED PRODUCT
or LICENSED SERVICE be [*CONFIDENTIALITY REQUESTED*].
5.9 Any tax required to be withheld by OSIRIS under the laws of any
foreign country for the account of CBA, shall be promptly paid by OSIRIS for
and on behalf of CBA to the appropriate governmental authority, and OSIRIS
shall use its best efforts to furnish CBA with proof of payment of such tax.
Any such tax actually paid on CBA'S behalf shall be deducted dollar for dollar
from royalty payments due CBA.
5.10 Only one royalty shall be due and payable for the manufacture,
use and sale of a LICENSED PRODUCT or a LICENSED SERVICE irrespective of
the number of patents or claims thereof which cover the manufacture, use or
sale of such LICENSED PRODUCT or LICENSED SERVICE.
SECTION 6 - PATENT INFRINGEMENT
6.1 Each party will notify the other promptly in writing when any
infringement of the PATENT RIGHTS by another is uncovered or suspected.
6.2 OSIRIS shall have the first right to enforce any patent within
PATENT RIGHTS against any infringement or alleged infringement thereof, and
shall at all times keep CBA
informed as to the status thereof. OSIRIS may, in its sole
judgment and at its own expense, institute a suit against any such infringer
or alleged infringer and control, settle, and defend such suit in a manner
consistent with the terms and provisions hereof and recover, for its account,
any damages, awards or settlements resulting therefrom, subject to Paragraph
6.4. CBA shall reasonably cooperate in any such litigation at OSIRIS'S
expense.
6.3 If OSIRIS elects not to enforce any patent within the PATENT
RIGHTS, then it shall so notify CBA in writing within six (6) months of
receiving notice that an infringement exists, and CBA may, in its sole
judgment and at its own expense, take steps to enforce any patent and control,
settle, and defend any suit that it brings in a manner consistent with the
terms and provisions hereof, and recover, for its own account, any damages,
awards or settlements resulting therefrom.
6.4 Any recovery by OSIRIS under Paragraph 6.2 shall be deemed to
reflect loss of commercial sales, and OSIRIS shall pay to CBA fifteen percent
(15%) of the recovery net of all reasonable costs and expenses, associated
with each suit or settlement, actually borne by OSIRIS. One-half (1/2) of the
costs and expenses incurred by OSIRIS pursuant to Paragraph 6.2 shall be
credited against royalties payable by OSIRIS to CBA hereunder in connection
with sales in the country of such legal proceedings; provided, however, that
any such credit under this Paragraph 6.4 shall not exceed fifty percent (50%)
of the royalties otherwise payable to CBA with regard to sales in the country
of such action in any one calendar year, with any excess credit being carried
forward to future calendar years, and also provided that OSIRIS shall
reimburse to CBA one half of the costs recovered from the counterpart in any
such legal proceedings, always within the limits of the amount actually
credited against royalties.
6.5 In the event that litigation against OSIRIS is initiated by a
third party charging OSIRIS with infringement of a patent of the third party
in a country as a result of the manufacture, use or sale by OSIRIS of a
LICENSED PRODUCT or LICENSED SERVICE in that country, OSIRIS shall promptly
notify CBA in writing thereof. One-half (1/2) of the costs and expenses
incurred by OSIRIS pursuant to this Paragraph 6.5 shall be credited against
royalties payable by OSIRIS to CBA hereunder in connection with sales in the
country of such legal proceedings, provided, however, that any such credit
under this Paragraph 6.5 shall not exceed fifty percent (50%) of the royalties
otherwise payable to CBA with regard to sales in the country of such action in
any one calendar year, with any excess credit being carried forward to future
calendar years.
6.6 In the event of a judgment in any suit in which a court of
competent jurisdiction rules that the manufacture, use or sale by OSIRIS in a
country of a LICENSED PRODUCT or LICENSED SERVICE covered by a PATENT RIGHT in
that country has infringed a third party's patent requiring OSIRIS to pay
damages or a royalty to said third party in that country, or in the event of a
settlement of such suit requiring damages or back royalty payments to
be made, payments due to CBA under Paragraph 5.2 of this AGREEMENT arising
from the applicable LICENSED PRODUCT or LICENSED SERVICE shall be
correspondingly reduced in that country by the amounts due under the
requirement of such judgment or under the terms of such settlement. The
royalty payment after taking into consideration any such reduction under this
Paragraph 6.6 shall not be reduced by more than fifty percent (50%) in any one
calendar year, with any excess credit being carried forward to future calendar
years.
6.7 In any infringement suit against a third party, should either
party hereto institute to enforce the PATENT RIGHTS pursuant to this
AGREEMENT, then the other party hereto shall, at the request of the party
initiating such suit, cooperate in all respects and, to the extent possible,
have its employees testify when requested and make available relevant records,
papers, information, samples, specimens, and the like. All reasonable out-of-
pocket costs incurred in connection with rendering cooperation requested
hereunder shall be paid by the party requesting cooperation.
SECTION 7 - PATENT RIGHTS AND CONFIDENTIAL INFORMATION
7.1 (a) OSIRIS shall have the right at its cost and expense to
file, prosecute and maintain patent applications and patents which are PATENT
RIGHTS in CBA'S or IST'S name through patent counsel selected by OSIRIS who
shall consult with and keep CBA advised with respect thereto: such patent
applications which are PATENT RIGHTS and filed in CBA's or IST's name shall,
however, always have been filed previously in Italy in accordance with
applicable Italian law currently in force prior to any filing of them in any
other country in which they are patentable. For the purposes of the above,
CBA shall notify OSIRIS as to whether any such patent application should be
filed in CBA's, or in IST's name.
(b) In any country where OSIRIS elects not to have a patent
application filed or to pay expenses associated with filing, prosecuting, or
maintaining a patent application or
patent which is a PATENT RIGHT, CBA may file, prosecute, and/or maintain a
patent application or patent at its own expense and for its own exclusive
benefit.
(c) For patent applications in PATENT RIGHTS that are jointly
owned by CBA and OSIRIS since they relate to INVENTIONs which are the result
of the work of inventors from both OSIRIS and CBA (the "JOINT PATENT RIGHTS"),
OSIRIS shall file, prosecute and maintain all such patents and patent
applications and OSIRIS shall be licensed thereunder. Title to all such
patents and patent applications shall reside jointly in CBA and OSIRIS.
(d) The parties shall first consult with each other as to the
advisability, preparation, filing, prosecution and maintenance of such
applications and patents. Each party shall keep the other advised as to all
developments with respect to all patent applications and patents included in
PATENT RIGHTS, it being understood that whichever of the parties first
receives correspondence concerning such patent applications and patents shall
forward copies thereof to the other party. In any event, OSIRIS shall, in
accordance with Paragraph 7.1(a) above, be responsible for maintaining all
files with respect to such applications and patents, except as provided under
this Article 7, and shall maintain at its principal offices for review by CBA:
(i) copies of all official correspondence from the US Patent Office or from a
patent office in any other country within a reasonable time after receipt; and
(ii) copies of all substantive papers to be filed in the US Patent Office or a
patent office in any other country a reasonable time prior to filing to
provide sufficient time to comment thereon.
7.2 OSIRIS agrees that all packaging containing individual LICENSED
PRODUCT(S) sold by OSIRIS, AFFILIATES and SUBLICENSEES will be marked with the
number of the applicable patent(s) licensed hereunder in accordance with each
country's patent laws.
7.3 The parties agree and undertake to keep confidential all and any
information, whether written or oral, which is imparted to them by the other
in confidence or which is confidential and which is acquired by one party in
connection with this Agreement or the research to be carried out under it
including, for the avoidance of doubt, all such information relating to the
activities, business or affairs or the other party ("CONFIDENTIAL
INFORMATION"). The information shall not be disclosed or revealed to anyone
except employees of the recipient who have a need to know
the information and who have entered into a secrecy agreement with the
recipient under which such employees are required to maintain confidential the
proprietary information of the recipient and such employees shall be advised
by the recipient of the confidential nature of the information and that the
information shall be treated accordingly. The recipient's obligations under
this Paragraph 7.3 shall not extend to any part of the information:
a. that can be demonstrated to have been in the
public domain or publicly known and readily
available to the trade or the public prior to the
date of the disclosure; or
b. that can be demonstrated, from written
records to have been in the recipient's possession
or readily available to the recipient from another
source not under obligation of secrecy to the
disclosing party prior to the disclosure; or
c. that becomes part of the public domain or
publicly known by publication or otherwise,
not due to any unauthorized act by the recipient.
d. that can be demonstrated, from written
records, to have been developed by the recipient
independently of the disclosed information.
The obligations of this Paragraph 7.3 shall also apply to AFFILIATES and/or
SUBLICENSEES provided such information by OSIRIS. CBA'S, OSIRIS'S,
AFFILIATES', and SUBLICENSEES' obligations under this Paragraph 7.3 shall
extend until five (5) years after the termination of this AGREEMENT.
Notwithstanding the foregoing, OSIRIS, AFFILIATES and/or SUBLICENSEES
shall have the right to disclose CONFIDENTIAL INFORMATION of CBA to a third
party who undertakes an obligation of confidentiality and non-use with respect
to such information at least as restrictive as the obligations under this
Paragraph 7.3.
SECTION 8 - TERM AND TERMINATION
8.1 This AGREEMENT shall expire in each country on the date of
expiration of the last to expire patent included with PATENT RIGHTS in that
country or, if no patents are issued, ten (10) years from the EFFECTIVE DATE
of this AGREEMENT at which time OSIRIS shall have a fully paid up
noncancellable license to all TECHNOLOGY with respect to which it has
exercised the option under Article 8 of the Research Agreement.
8.2 Any matter or disagreement arising under Paragraphs 1.13 (c),
5.3, 4.1 or 4.2 shall be submitted to the arbitration procedure set out under
Section 9 below.
8.3 Except as provided in Paragraphs 4.1 and 4.2 above, upon breach
or default of any of the terms and conditions of this AGREEMENT, the
defaulting party shall be given written notice of such default in writing and
a period of ninety (90) days after receipt of such notice to respond in
writing to the notice of default or breach. If the default or breach is not
corrected within an additional ninety (90) day period, the party not in
default shall have the right to terminate this AGREEMENT.
8.4 OSIRIS may terminate this AGREEMENT for all or some of the
licenses granted herein under in any country under any PATENT RIGHT, for any
reason, upon giving CBA ninety (90) days written notice. In such case, the
provisions of Paragraph 8.1 shall not be applicable and CBA shall have the
right to freely use all those PATENT RIGHTS covered by such termination.
8.5 Termination shall not affect CBA'S right to recover unpaid
royalties or fees or reimbursement for patent expenses incurred, if any,
pursuant to Paragraph 7.1 prior to termination. Upon termination all rights
in and to the licensed technology (including PATENT RIGHTS) shall revert to
CBA at no cost to CBA.
8.6 Upon any termination of this AGREEMENT, OSIRIS at its option,
shall be entitled to finish any work-in-process which is completed within six
(6) months of termination of this AGREEMENT and to sell any completed
inventory of a LICENSED PRODUCT covered by this AGREEMENT which remains on
hand as of the date of the termination, so long as OSIRIS pays to CBA the
royalties applicable to said subsequent sales in accordance with the same
terms and conditions as set forth in this AGREEMENT.
8.7 In the event that this AGREEMENT and/or the rights and licenses
granted under this AGREEMENT to OSIRIS are terminated, any sublicense granted
under this AGREEMENT shall remain in full force and effect as a direct license
between CBA and the
SUBLICENSEE under the terms and conditions of the sublicense agreement,
subject to the SUBLICENSEE agreeing to be bound directly to CBA under such
terms and conditions of the sublicense as well as all the relevant duties and
obligations of a licensee under this AGREEMENT (other than royalty and other
payment obligations which shall be paid in accordance with the sublicense
provided that CBA receives a [*CONFIDENTIALITY REQUESTED*] of the
SUBLICENSEE'S NET SALES) within thirty (30) days after CBA provides
written notice to the SUBLICENSEE of the termination of OSIRIS'S rights and
licenses under this AGREEMENT, provided further that CBA'S obligations under
such sublicense are no greater than currently existing under this AGREEMENT.
At the request of OSIRIS, CBA will acknowledge to a SUBLICENSEE, CBA'S
obligations to the SUBLICENSEE under this paragraph.
SECTION 9 - MISCELLANEOUS
9.1 All notices pertaining to this AGREEMENT shall be in writing and
sent certified mail, return receipt requested, to the parties at the following
addresses or such other address as such party shall have furnished in writing
to the other party in accordance with this Paragraph 9.1:
CENTRO DI BIOTECNOLOGIE AVANZATE:
If administrative: Xxxxxxxx Xxxxx, M.D., Ph.D.
Chief Executive Officer
Consorzio per la gestione
Centro de Biotecnologie Avanzate
Xxxxx Xxxxxxx Xxxxx 00
00000 Xxxxxx, Xxxxx
If technical: Xxxx. Xxxxxxx Cancedda, M.D.
Director
Laboratorio di Differenziazione Cellulare
Centro di Biotecnologie Avanzate
Xxxxx Xxxxxxx Xxxxx 00
00000 Xxxxxx, Xxxxx
OSIRIS THERAPEUTICS, INC.: Osiris Therapeutics, Inc.
0000 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxx X. Xxxxx, President
CC: Xxxxxx, Casati E Associati
X.xx Xxxxxxxx Xxxxxxxx XX, 00
00000 Xxxxxx, Xxxxx
Attn: Xxxx Xxxxxxx, Esq. And
Avv. Proc. Donatella De Xxxx
Xxxxxxx, Byrne, Bain, Gilfillan, Cecchi,
Xxxxxxx & Olstein
0 Xxxxxx Xxxx Xxxx
Xxxxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxxx X. Xxxxxxx, Esq.
9.2 All written progress reports, royalty and other payments, and
any other related correspondence shall be in writing and sent to CBA at the
address noted above, or such other addressee which CBA may designate in
writing from time to time. Checks are to be made payable to CBA.
9.3 This AGREEMENT shall be binding upon and inure to the benefit of
and be enforceable by CBA and its successors and permitted assigns. This
AGREEMENT is binding upon and shall inure to the benefit of OSIRIS, its
successors and assignees and shall not be assignable to another party without
the written consent of CBA, which consent shall not be reasonably withheld,
except that OSIRIS shall have the right to assign this AGREEMENT to another
party without the consent of CBA in the case of the sale or transfer or merger
or consolidation of OSIRIS or sale or transfer by OSIRIS to that party of all,
or substantially all, of its assets or all or substantially all of the portion
of its assets to which this AGREEMENT relates, provided the assignee
undertakes to be bound by and perform the obligations of the assignor under
this AGREEMENT.
9.4 In the event that any one or more of the provisions of this
AGREEMENT should for any reason be held by any court or authority having
jurisdiction over this AGREEMENT, or over any of the parties hereto to be
invalid, illegal or unenforceable,
such provision or provisions shall be reformed to approximate as nearly as
possible the intent of the parties, and if unreformable, shall be divisible
and deleted in such jurisdictions; elsewhere, this AGREEMENT shall not be
affected.
9.5 The parties shall make reasonable efforts to settle in an
amicable way any dispute that may arise between them in connection with this
Agreement or the carrying out of the transaction contemplated herein.
9.6. Should either party consider it not possible to reach an
amicable settlement, then the dispute shall be resolved through arbitration
with a panel of three arbitrators, in particular, as regards any matter or
disagreement arising under Paragraphs 1.13 (c), 5.3, 4.1 or 4.2.
9.7. The first arbitrator shall be appointed by the party initiating
the arbitration proceedings within its demand for arbitration to the other
party; the second arbitrator shall be appointed by the other party within 30
days from the date on which it has received notice of the demand for
arbitration; and the third arbitrator, as Chairman of the panel, shall be
designated by agreement of the first two arbitrators within 30 days from the
appointment of the second arbitrator or, failing such agreement, by the
President of the Court of Genoa, Italy, upon request of one party. The
President of the Tribunal of Genoa, Italy, upon request of one party, shall
also designate an arbitrator in the same manner if the party required to make
such appointment shall not have done so within the period of time specified
above.
9.8. The appointment of the arbitrator shall be carried out by
formally notifying it to the other party through the judicial officer.
9.9. In the event that more than two parties legitimately are party
to the arbitration proceedings, then the dispute shall be resolved by a panel
of three arbitrators appointed by agreement of the various parties to the
procedure or, failing such agreement, by the President of the Tribunal of
Genoa, Italy, upon request of one party.
9.10. The arbitration procedure shall be held in accordance with the
customary Italian Procedure Law.
9.11. The arbitrators shall come to a decision in accordance with
Italian Law ("arbitrato rituale di diritto") and within a term of 180 days
after their appointment be it by the parties, or by the President of Tribunal
of Genoa, Italy; the arbitrators' award shall not be subject to any form of
appeal or recourse.
9.12. The arbitration proceedings shall take place in Genoa, Italy and
shall be held in English.
9.13. This Agreement shall be governed by and constructed according to
the laws of Italy.
9.14 OSIRIS and its AFFILIATES and its SUBLICENSEES shall not use the
names, likenesses, or logos of CBA or any of its constituent parts and
affiliated hospitals and companies, in any press releases, general
publications, advertising, marketing, promotional or sales literature without
prior written consent from an authorized official of CBA, which consent shall
not be unreasonably withheld. OSIRIS shall, however, have the right to use
the name of CBA in agreements between OSIRIS and SUBLICENSEES and in any SEC
filing (including but not limited to 8K statements), fundraising documents and
the like and in any case where such use is required by law, rule or regulation.
9.15 CBA warrants that it has good and valid title to its interest in
the inventions claimed under PATENT RIGHTS with the exception of certain
retained rights of any government, or public body. In addition, CBA warrants
that it has not licensed or assigned any right or interest in or to PATENT
RIGHTS to any third party, and the granting of such rights to OSIRIS hereunder
does not require the consent of a third party; and CBA is not aware as of the
EFFECTIVE DATE of this AGREEMENT of
any legal or contractual restriction which would inhibit its ability to
perform the terms and conditions imposed on it by this
AGREEMENT. CBA does not warrant the validity of any patents or that practice
under such patents shall be free of infringement. EXCEPT AS EXPRESSLY SET
FORTH IN THIS PARAGRAPH 9.14, OSIRIS, AFFILIATES AND SUBLICENSEES AGREE THAT
THE PATENT RIGHTS ARE PROVIDED AS IS, AND THAT CBA MAKES NO REPRESENTATION
OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCT(S) AND
LICENSED SERVICES INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL
VIABILITY. CBA DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCT(S) AND
SERVICES LICENSED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL
WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY
PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS
AGREEMENT, CBA ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON
THE PART OF CBA AND INVESTIGATORS, FOR DAMAGES, INCLUDING BUT NOT LIMITED
TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS' AND
EXPERTS' FEES, AND COURT COSTS (EVEN IF CBA HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), WHICH DAMAGES ARISE OUT OF
OR RESULT FROM THE MANUFACTURE, USE, OR SALE OF THE PRODUCT(S) AND
SERVICES LICENSED UNDER THIS AGREEMENT. OSIRIS, AFFILIATES AND
SUBLICENSEES ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR
DAMAGE CAUSED BY A PRODUCT AND SERVICE MANUFACTURED, USED OR SOLD
BY OSIRIS, ITS SUBLICENSEES AND AFFILIATES WHICH IS A LICENSED PRODUCT OR
LICENSED SERVICE AS DEFINED IN THIS AGREEMENT.
9.16 OSIRIS shall defend and hold CBA, their present and former
trustees, officers, inventors of PATENT RIGHTS, agents, faculty, employees
and students harmless as against any third-party judgments, fees, expenses, or
other costs arising from or incidental to any product liability or other
lawsuit, claim, demand or other action for personal injury including death or
property damage brought as a consequence of the practice of the inventions of
LICENSED PRODUCTS or LICENSED SERVICES by OSIRIS or its AFFILIATED COMPANIES
or its SUBLICENSEES or those operating for its account or third parties who
purchase LICENSED PRODUCTS(S) or LICENSED SERVICES from any of the foregoing
entities whether or not CBA or said inventors, either jointly or severally, is
named as a party defendant in any such lawsuit, except those which arise from
the gross negligence or willful misconduct of any of parties indemnified
hereunder. Practice of the inventions covered by LICENSED PRODUCT(S) and
LICENSED SERVICES, by an AFFILIATE or an agent or a SUBLICENSEE or a third
party on behalf of or for the account of OSIRIS or by a third party who
purchases LICENSED PRODUCT(S) and LICENSED SERVICES from OSIRIS, shall be
considered OSIRIS'S practice of said inventions for purposes of this Paragraph
9.15. The obligation of OSIRIS to defend and indemnify as set out in this
Paragraph 9.15 shall survive the termination of this AGREEMENT. OSIRIS shall
have the sole right to defend, settle and compromise any claim or action
indemnified hereunder. OSIRIS shall be promptly notified of any claim, suit,
demand or action which is to be indemnified hereunder.
9.17 Prior to initiating the first commercial sale of any LICENSED
PRODUCT or LICENSED SERVICE as the case may be in any particular county,
OSIRIS, AFFILIATES and/or SUBLICENSEES shall establish and maintain product
liability or other appropriate insurance coverage with respect to LICENSED
PRODUCT(S) and LICENSED SERVICES, which coverage
shall be similar to that maintained by companies at a stage of development
similar to OSIRIS for similar products, provided that such insurance is
available on terms, conditions and costs which are commercially reasonable
and prudent under the circumstances. Upon CBA'S request, OSIRIS will furnish
CBA with a Certificate of Insurance for each product liability insurance
policy obtained.
9.18 This AGREEMENT constitutes the entire understanding between
the parties with respect to the obligations of the parties with respect to the
subject matter hereof, and supersedes and replaces all prior agreements,
understandings, writings, and discussions between the parties relating to said
subject matter.
9.19 This AGREEMENT may be amended and any of its terms or conditions
may be waived only by a written instrument executed by the authorized
officials of the parties or, in the case of a waiver, by the party waiving
compliance. The failure of either party at any time or times to require
performance of any provision hereof shall in no manner affect its right at a
later time to enforce the same. No waiver by either party of any condition or
term in any one or more particular instances shall be construed as a further
or continuing waiver of such condition or term or of any other condition or
term.
9.20 Upon termination of this AGREEMENT for any reason, Paragraphs
7.3, 8.1, 8.4, 8.5, 8.6, 9.6, 9.7, 9.8, 9.9 (to the extent OSIRIS, AFFILIATES
and/or SUBLICENSEES are selling or providing LICENSED PRODUCTS or LICENSED
SERVICES under the licenses granted under this agreement) and this Paragraph
9.13 shall survive termination of the AGREEMENT.
IN WITNESS WHEREOF, the respective parties hereto have executed this
AGREEMENT by their duly authorized officers on the date appearing below
their signatures.
CONSORZIO PER LA GESTIONE OSIRIS THERAPEUTICS, INC.
CENTRO DE BIOTECNOLOGIE AVANZATE
By: /s/ Xxxxxxxx Xxxxx By: /s/ Xxxxx X. Xxxxx
Name: Xxxxxxxx Xxxxx, M.D., Ph.D. Name: Xxxxx X. Xxxxx
Title: Chief Executive OfficerTitle: President and CEO
Date:_7/15/97______________ Date:_7/25/97_________
I have read, understand and agree to abide by the terms of this AGREEMENT.
By:_/s/ Xxxxxxx Cancedda___
Xxxxxxx Cancedda, M.D.
Title:_Professor_____________ Date:_7/15/97_______________
ANNEX A
MATERIAL TRANSFER AGREEMENT
From: xxxx. Xxxxxxx Cancedda,
Centro di Biotecnologie Avanzate
Xxxxx Xxxxxxx Xxxxx, 00
00000 Xxxxxx, Xxxxx
Fax: x00 00 0000000
e-mail: xxxxxxxx@xxxxx.xxx.xxxxx.xx
To:
Date:
Re: General terms for the transfer of materials
Dear dr. ...........,
in order to avoid conflict of interest, and because of potential commercial
applications for some of the material that are distributed by our laboratory,
we ask each investigator who requests material (cells, antibodies, DNA probes,
and others) to agree to condition as specified below. Please complete, sign,
make a copy for your record and return the original to me
xxxx. Xxxxxxx Cancedda
-------------------------------------------------------------------------------
Please indicate the material(s) requested:
The material(s) requested will be used in this lab for studies concerning:
My institution is non-profit, and I will not be responsible for preventing
the material(s) or its derivatives to be used for commercial purposes.
I will be responsible for preventing the material(s) form being passed on to
other investigators outside my authority.
I will send you a copy of each abstract or paper in which we include
information about the materials(s).
Signature:
Title:
Address:
Fax:
e-mail:
Date:
EXHIBIT B
RESEARCH PROPOSAL
[*CONFIDENTIALITY REQUESTED*]
MAIN REFERENCES
Agematsu K, Nakahori Y. Recipient origin of bone marrow-derived fibroblastic
stromal cells during all periods following bone marrow transplantation. Br J
Haematol 79:359-365, 1991.
Allay J, Xxxxxx J, Haynesworth SE, Xxxxx XX, Xxxxxxx XX, Xxxxxx XX, Xxxxxx XX.
Retroviral transduction of marrow derived mesenchymal precursors. Blood 82
(suppl.l):477a, 1993.
Xxxxx XX, Dexter TM, Xxxxxxx XX. Marrow biology and stem cells in colony-
stimulating factors: Molecular and Cellular Biology (Eds. Dexter TM, Xxxxxxx XX,
Xxxxx XX) Xxxxxx Dekkes, New York pp 1-38, 1990.
Andlesaria P, Kase K, Xxxxxxxx J, Xxxxxxx CA, Xxxxxxxxx MA, Xxxxxx IA,
XxxxXxxxxx XX, Xxx XX, Xxxxxxxxxxx XX. Engraftment of a clonal bone marrow
stromal cell line in vivo stimulates hematopoietic recovery from total body
irradiation. Proc Natl Acad Sci USA 84:7681-7685, 0000
Xxxxxxxxx XX, Xxxxx X, Xxxxxxx XX. Origin of bone marrow stromal cells and
haemopoietic chimerism following boine marrow transplantation determined by in
situ hybridization. Br J Cancer 61:385-389, 1990.
Xxxxxxx XX, Xxxxx XX, Xxxxxxxx G, et al. Successful autografting in chronic
myeloid leukemia after maintenance of marrow in culture. Bone Marrow Transplant
4:345 351, 1989
Xxxxxxx XX, Xxxxxxx T, Xxxxx-Xxxx J. The origin of the hematopoietic
microenvironment in continuous bone marrow culture. Exp Hematol 10:367-372, 1982
Xxxxxxxxx, X.X. Osteogenic stem cells and the stromal system of bone and marrow.
Clin. Orthop. 240:279-280. 1989.
Xxxxxxxxxx X.X., Xxxxxxxxx X.X., Xxxxxxxx X.X. Articular cartilage: composition,
structure, response to injury and methods of facilitating repair, in: Articular
Cartilage and Knee Function: Basic Science and Arthroscopy, 19-55, Raven Press,
New York. 1990
EXHIBIT C
RESEARCH BUDGET
[*CONFIDENTIALITY REQUESTED*]
EXHIBIT D
INVENTION AGREEMENT
I soggetti sott indicati che a qualunque titolo, differente da rapporto di
dipendenza (a titolo meramente esemplificativo e non esaustivo: borsisti,
dottorandi, contrattisti, studenti, frequentatori ed altro), svolgono la
Laboratorio......................riconoscono che la tiolarita
di tutte le invenzioni, risulatati, prodotti, procedimenti, sviluppi e diritti
brevettuali e non, che derivano nel xxxxx xxxxx ricerca svolat dagli stessi
presso il Laboratorio ............................ Appartengono
all'ente da cui il Laboratorio ........................dipende.
FIRMA
NOME
QUALIFICA
DATA
EXHIBIT E
FACILITIES
[*CONFIDENTIALITY REQUESTED*]
EXHIBIT F
RESEARCH PERSONNEL
[*CONFIDENTIALITY REQUESTED*]
