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<PAGE>
EXHIBIT 10.1
TRANSFER AND LICENSE AGREEMENT
entered into by and between
OCTOPLUS N.V.
CHIENNA B.V.
ISOTIS INC.
and
ISOTIS N.V.
LOYENS & LOEFF N.V.
REF. #1027075-V8A
24 APRIL 2007
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
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TABLE OF CONTENTS
<TABLE>
<S> <C>
1. DEFINITIONS AND
INTERPRETATION.........................................................
4
2. TERMINATION
ACLA.......................................................................
5
3. TRANSFER AND
ASSIGNMENT................................................................
6
4. LICENSES FOR
ISOTIS....................................................................
7
5. OBLIGATIONS OF
ISOTIS..................................................................
9
6. OBLIGATIONS OF
OCTOPLUS................................................................
10
7.
CONSIDERATION..........................................................................
11
8. REPRESENTATIONS AND
WARRANTIES.........................................................
12
9.
CONFIDENTIALITY........................................................................
14
10. PENALTY ON MATERIAL
BREACH.............................................................
14
11. TERM AND
TERMINATION...................................................................
14
12. TRANSFER OF ISOTIS LICENSE
RIGHTS...................................................... 15
13.
INDEMNITY..............................................................................
15
14.
MISCELLANEOUS..........................................................................
17
15. APPLICABLE LAW /
JURISDICTION..........................................................
18
</TABLE>
Annexes
Annex 1.1 Definitions
Annex 2.4 License granted under the ISOTIS-Patents
Annex 3.1 PolyActive Rights B
Annex 3.2 PolyActive Rights A
Annex 3.3 PolyActive Name and Trademarks
Annex 5.5 Amended and Restated Supply Agreement between IsoTis
and Chienna
Annex 5.6 Production Equipment
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
2
<PAGE>
THE UNDERSIGNED:
1. the limited liability company OCTOPLUS N.V., incorporated
under the
laws of the Netherlands, having its registered offices at
Zernikedreef 12 (2333 CL) Leiden, the Netherlands,
hereinafter:
"OctoPlus", duly represented herein by Joost J.M. Holthuis and
Hans
C.H.L. Pauli, its statutory directors (statutair
directeuren);
2. the limited liability company CHIENNA B.V., incorporated
under the
laws of the Netherlands, having its corporate seat in Bilthoven
and
its registered offices at Zernikedreef 12 (2333 CL) Leiden,
the
Netherlands, hereinafter: "Chienna", duly represented herein
by
Joost J.M. Holthuis and Hans C.H.L. Pauli;
3. the company under foreign law ISOTIS INC., incorporated under
the
laws of Delaware, United States of America, having its
principal
office at 2 Goodyear Irvine, California, United Stares of
America,
hereinafter "IsoTis Inc.", duly represented herein by its
officers
Pieter Wolters and Rob Morocco;
and
4. the limited liability company ISOTIS N.V. incorporated under
the
laws of the Netherlands, having its corporate seat in Amsterdam
and
its registered offices at Professor Bronkhorstlaan 10 D (3723
MB)
Bilthoven hereinafter: "IsoTis N.V.", duly represented herein
by
IsoTis SA, its director.
(OctoPlus, Chienna, IsoTis and IsoTis N.V. jointly referred to
hereinafter as
the "PARTIES" and each individually as a "PARTY").
WHEREAS:
A. IsoTis Inc. and IsoTis N.V. (collectively hereinafter
referred to as:
"IsoTis") are companies specialized in developing and
manufacturing
techniques and products relating to, inter alia, tissue
regeneration.
B. Pursuant to the share purchase agreement dated 6 May 2003
(the "SPA")
between IsoTis N.V. as the seller and OctoShare B.V. (currently
a 100%
subsidiary of OctoPlus) as the buyer, OctoShare B.V. acquired
91.46 % of
the shares in the capital of Chienna B.V. ("CHIENNA"), a biotech
company,
specialized in developing and manufacturing techniques and
products
relating to drug delivery. On 1 September 2006, OctoPlus
acquired all
remaining shares in the capital of Chienna.
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
3
<PAGE>
C. On 6 May 2003, IsoTis N.V. and Chienna entered into the
Amended and
Restated License Assignment and Cross License Agreement (the
"ACLA"),
pursuant to which IsoTis N.V. transferred and assigned all
rights, title
and interest in the CHIENNA-Patents (as defined and listed in
Annex I(A)
to the ACLA) to Chienna and IsoTis N.V. was granted an
exclusive,
royalty-free, world wide license with the right to grant
sub-licenses
under the CHIENNA-Patents and all future patent and patent
applications
related to the CHIENNA-Patents for uses set forth in the
ACLA.
Furthermore, Chienna granted to IsoTis N.V. the right of first
refusal to
be granted an exclusive, world-wide license with the right to
grant
sub-licenses under all future patents and patent applications
that will
accrue to Chienna within three years after the effective date of
the ACLA,
being 6 May 2003.
D. In connection with the acquisitions of IsoTis N.V.'s shares
in the capital
of Chienna by OctoShare B.V. as laid down in the SPA, Chienna
has granted
to IsoTis N.V. an exclusive, royalty-free, world-wide license
with a right
to grant sub-licenses under the CHIENNA-Patents and all future
patents and
patent applications related to the Orthopedic Field.
E. Pursuant to the ACLA, Chienna is entitled to a royalty-free
exclusive
license with the right to grant sub-licenses under the
ISOTIS-Patents (as
defined and listed in Annex I(B) to the ACLA) and all future
patent and
patent applications related to the ISOTIS-Patents for uses set
forth in
the ACLA. Chienna is furthermore entitled to the right of first
refusal to
be granted an exclusive, world-wide license with the right to
grant
sub-licenses under all future patents and patent applications
that will
accrue to IsoTis N.V. within three years after the effective
date of the
ACLA, being 6 May 2003.
F. During the term of the ACLA, the CHIENNA-Patents and the
ISOTIS-Patents
have been partly abandoned and/or transferred. The patents
previously
referred to as CHIENNA-Patents are hereinafter referred to as
PolyActive
Rights B. The patents previously referred to as ISOTIS-Patents
are
hereinafter referred to as PolyActive Rights A.
G. By means of this Transfer and License Agreement (the
"AGREEMENT"), Parties
are prepared to terminate the ACLA under the terms and
conditions as set
out below.
NOW THEREFORE, THE PARTIES HAVE AGREED AS FOLLOWS:
1. DEFINITIONS AND INTERPRETATION
1.1 In this Agreement, save where the context otherwise requires
or the
Agreement otherwise provides, capitalized words and expressions
shall have
the meanings given to them in ANNEX 1.1.
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
4
<PAGE>
1.2 References to any time of the day are to the time in the
Netherlands
(CET).
1.3 Headings are inserted for convenience only and shall not
affect the
interpretation or construction of this Agreement.
1.4 All Annexes, Schedules and any other attachments to this
Agreement shall
form an integral part thereof and shall have the same force and
effect as
any other provisions of this Agreement.
2. TERMINATION ACLA
2.1 As of the Effective Date, Chienna and IsoTis N.V. terminate
the ACLA and
agree to the terms and conditions set forth in this
Agreement.
2.2 As of the Effective Date, pursuant to Article 2.1, the
Parties acknowledge
that IsoTis' licenses with the right to grant sub-licenses under
the
CHIENNA-Patents (article 3.1 and 3.2 ACLA) are terminated.
This
termination shall have no bearing on any abandonment and/or
transfer of
CHIENNA-Patents that occurred prior to the Effective Date.
2.3 If and in as far as IsoTis has granted sub-licenses under
the
CHIENNA-Patents, OctoPlus will take over the position of IsoTis
as
(sub-)licensor vis-a-vis the sub-licensee. Such substitution
shall be
effected by way of substitution of contract
(contractsoverneming) in
accordance with the applicable requirements of Dutch law
(including but
not limited to section 6:159 of the Dutch Civil Code). If and in
as far as
a sub-licensee will not cooperate to such substitution of
contract, IsoTis
N.V. remains the licensor vis-a-vis the sub-licensee, acting for
and on
behalf of OctoPlus.
2.4 In as far as IsoTis has granted licenses under the
ISOTIS-Patents, other
than pursuant to the Amended and Restated Assignment and Cross
License
Agreement dated 6 May 2003, (see ANNEX 2.4), OctoPlus will take
over the
position of IsoTis as licensor vis-a-vis the licensee. Such
substitution
shall be effected by way of substitution of contract
(contractsoverneming)
in accordance with the applicable requirements of Dutch law
(including but
not limited to section 6:159 of the Dutch Civil Code). If and in
as far as
a licensee will not cooperate to such substitution of contract,
IsoTis
N.V. remains the licensor vis-a-vis the licensee, acting for and
on behalf
of OctoPlus.
2.5 As of the Effective Date, pursuant to Article 2.1, the
Parties acknowledge
that the right of first refusal granted to IsoTis to be granted
an
exclusive, world-wide license, with the right to grant
sub-licenses, under
all future patents and patent applications that will accrue
to
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
5
<PAGE>
Chienna within three (3) years after the effective date of the
ACLA, and
accompanying technical information, for the making, using,
selling,
developing etc. of materials intended for use as a medical
device, not
containing a biologically active agent (article 3.5 ACLA) is
terminated.
2.6 As of the Effective Date, pursuant to Article 2.1, the
Parties acknowledge
that Chienna's license with the right to grant sub-licenses
under the
ISOTIS-Patents (article 2.1 ACLA) is terminated.
2.7 As of the Effective Date, pursuant to Article 2.1, the
Parties acknowledge
that the right of first refusal granted to Chienna to be granted
an
exclusive, world-wide license, with the right to grant
sub-licenses, under
all future patents and patent applications that will accrue to
IsoTis
within three (3) years after the effective date of the ACLA,
and
accompanying technical information, for the making, using,
selling,
developing etc. of materials comprising a biologically active
agent
intended for release in vivo (article 2.3 ACLA) is
terminated.
3. TRANSFER AND ASSIGNMENT
3.1 As of the Effective Date, IsoTis N.V. transfers and assigns
to OctoPlus,
and OctoPlus accepts such transfer and assignment, any and all
rights,
title and interest in the PolyActive Rights B, defined and
listed in ANNEX
3.1. Any and all costs directly arising from the transfer of
the
PolyActive Rights B to OctoPlus will be for the account of
OctoPlus.
3.2 As of the Effective Date, IsoTis N.V. transfers (i) all
rights, title and
interest in intellectual property rights for which no
applications have
yet been filed and all patent and trademark applications
regarding the
PolyActive Rights A, defined and listed in ANNEX 3.2, and (ii)
all rights,
title and interest in intellectual property rights for which
no
applications have yet been filed and all patent and trademark
applications
regarding the PolyActive Rights B (together: "FUTURE IP") to
OctoPlus.
3.3 As of the Effective Date, IsoTis N.V. transfers and assigns
the PolyActive
Name and Trademarks as defined and listed in ANNEX 3.3 to
OctoPlus.
3.4 IsoTis N.V. hereby gives an irrevocable power of attorney to
OctoPlus to
make, do or execute all documents, acts, matters or writings
which
OctoPlus deems necessary or desirable to give full effect to
the
provisions of this transfer and assignment. For that purpose,
this
Agreement or extracts thereof may be registered with the
relevant
trademark, patent or other office(s) for the registration of
intellectual
property rights.
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
6
<PAGE>
3.5 For the event that for any part of any of the PolyActive
Rights B and/or
the Future IP this Agreement would not fully constitute full
transfer and
assignment of any and all rights, title and interest, and
additional
requirements would be necessary to that effect, IsoTis N.V.
hereby grants
to OctoPlus, and OctoPlus hereby accepts, the unlimited,
worldwide,
perpetual, royalty-free exclusive license to use and exploit
such
PolyActive Rights B and Future IP as of the Effective Date until
any and
all such additional requirements for full transfer and
assignment have
been executed and effectuated.
3.6 For the event that for any part of any of the PolyActive
Name and
Trademarks this Agreement would not fully constitute full
transfer and
assignment of any and all rights, title and interest, and
additional
requirements would be necessary to that effect, IsoTis N.V.
hereby grants
to OctoPlus, and OctoPlus hereby accepts, the unlimited,
worldwide,
perpetual, royalty-free exclusive license to use and exploit
such
PolyActive Name and Trademarks as of the Effective Date until
any and all
such additional requirements for full transfer and assignment
have been
executed and effectuated.
4. LICENSES FOR ISOTIS
IsoTis Licenses B and AB
4.1 Subject to the terms and conditions of this Agreement and
for the term of
this Agreement, OctoPlus grants to IsoTis and IsoTis accepts, as
from the
Effective Date, an exclusive, unlimited, world-wide,
perpetual,
royalty-free license, with the right to grant sub-licenses to
make, use,
sell, market and develop any PolyActive Rights B relating to
osseouschondral and/or osteochondral plugs, fillers, cement
restrictors,
or the like, including but not limited to SynPlug(TM) ("ISOTIS
LICENSE
B").
4.2 Subject to the terms and conditions of this Agreement and
for the term of
this Agreement, OctoPlus grants to IsoTis and IsoTis accepts, as
from the
Effective Date, an exclusive, unlimited, world-wide,
perpetual,
royalty-free license, with the right to grant sub-licenses to
make, use,
sell, market and develop any PolyActive Rights A and/or
PolyActive Rights
B related to the use of the PolyActive Technology in a medical
device to
be used to measure and/or monitor blood glucose ("ISOTIS LICENSE
AB").
4.3 The exclusivity mentioned in Article 4.1 and Article 4.2
means that
OctoPlus undertakes neither to grant any other license to third
parties to
use the PolyActive Rights B related to osseouschondral
and/or
osteochondral plugs, fillers, cement restrictors, or the like.
(e.g.,
SynPlug(TM), etc.) ("ISOTIS LICENSE B RIGHTS") and/or the use of
the
PolyActive Technology in a medical device to be used to measure
and/or
monitor blood glucose ("ISOTIS LICENSE AB RIGHTS"), nor to use
these
rights itself, for the same materials as specified in Article
4.1 or
Article 4.2 respectively. IsoTis acknowledges and accepts that
OctoPlus is
and will remain
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
7
<PAGE>
entitled to unrestrictedly use and (sub-)license PolyActive
Rights A,
PolyActive Rights B and PolyActive Technology for any and all
PolyActive
Rights B materials not directly relating to those specified in
Article
4.1, and the PolyActive Technology not related to the use in a
medical
device to measure and/or monitor blood glucose.
Right of first refusal
4.4 Subject to the terms and conditions of this Agreement,
OctoPlus
furthermore hereby grants to IsoTis, and IsoTis hereby accepts,
the right
of first refusal to be granted a license under all future
patents and
patent applications in connection with the PolyActive Technology
for the
non-exclusive use by IsoTis of the PolyActive Technology in the
Orthopedic
Field and/or for use as a medical device not containing a
biological
active agent(s). Such right will be subject to a royalty to be
negotiated.
4.5 With regard to IsoTis' right to grant sub-licenses as
referred to in
Articles 4.1, 4.2 and 4.4 IsoTis agrees and guarantees that it
shall bind
any sub-licensees, and warrants their compliance, to at least
the same
obligations which exist for IsoTis under this Agreement.
4.6 The Parties agree to execute such formal documents as may be
required for
the purpose of registering the abovementioned licenses in the
relevant
countries.
4.7 For the duration of licenses granted in Articles 4.1, 4.2
and 4.4, IsoTis
shall have full access to, and the right to use, any and all
technical
information available to OctoPlus during the term of this
Agreement,
directly relating to the licensed rights (including but not
limited to
descriptions of manufacturing processes, recipes, formulae,
R&D reports
and test reports), reasonably necessary or desirable to enable
IsoTis to
exercise licenses granted under the Articles 4.1, 4.2 and 4.4.
IsoTis
acknowledges and agrees that such technical information is
Confidential
Information within the meaning of Article 9.1, and that it shall
only use
such technical information to exercise its licenses granted
under Articles
4.1, 4.2 and 4.4.
OctoPlus' rights
4.8 OctoPlus may freely transfer any of the PolyActive Rights B
to a third
party, provided that the license rights granted to IsoTis in
Article 4.1,
4.2 and 4.4 are respected and maintained by such third party.
Furthermore,
OctoPlus may freely abandon or allow to lapse any of the
PolyActive Rights
B, irrespective of the license rights granted to IsoTis pursuant
to
Articles 4.1, 4.2 and 4.4, but OctoPlus must provide reasonable
written
notice to IsoTis so as to allow IsoTis to pick up the
maintenance and/or
prosecution of such PolyActive Rights B.
4.9 OctoPlus reserves the right to:
(a) use the IsoTis License B Rights, the IsoTis License AB
Rights and
the PolyActive Technology for educational and research purposes,
as
long as it is agreed to by IsoTis in writing, such agreement not
to
be unreasonably withheld;
****Certain confidential information contained in this document,
marked with
four asterisks, has been omitted and filed separately with the
Securities and
Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of
1934, as amended.
8
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(b) publish or otherwise disseminate any information about the
IsoTis
License B Rights, IsoTis License AB Rights and the
PolyActive
Technology, for as long as such publication or dissemination
does
not undermine any of IsoTis' rights under this Agreement, as
long as
it is agreed to by IsoTis in writing, such agreement not to
be
unreasonably withheld; and
(c) allow other non-profit institutions to use the IsoTis
License B
Rights, IsoTis License AB Rights and the PolyActive Technology
for
educational and non-commercial research purposes in their
facilities, as agreed to by IsoTis in writing, such agreement
not to
be unreasonably withheld.
IsoTis IP
4.10 All intellectual property rights developed under the
licenses granted to
IsoTis pursuant to this Agreement shall vest in IsoTis, but only
to the
extent that they are directly related to the specific fields of
attention
specified in Article 4.1, 4.2 and 4.4 ("ISOTIS IP"). To the
extent that
the IsoTis IP covers any other fields of attention than those
specified in
Article 4.1, 4.2 and 4.4, OctoPlus is hereby granted an
exclusive,
unlimited, world-wide, perpetual, royalty-free license, with the
right to
grant sub-licenses, to use the IsoTis IP in these other fields.
The
Parties acknowledge that the IsoTis IP shall in no event impede
the
pharmaceutical development services, drug delivery technologies
and/or
product development activities of OctoPlus.
5. OBLIGATIONS OF ISOTIS
5.1 IsoTis recognizes that the name, logo and marks of OctoPlus
represent
valuable assets of those entities and that substantial
recognition and
goodwill are associated with such assets. IsoTis hereby agrees
that
neither it nor any of its direct or indirect group companies
shall use the
name, logo, or marks of OctoPlus, without the prior written
authorization
of OctoPlus.
Device Master File
5.2 IsoTis ensures that at the Effective Date the Device Master
File is
up-to-date. IsoTis ensures that all future relevant data will be
submitted
on a timely basis in order to maintain the Device Master
File.
5.3 IsoTis furthermore ensures OctoPlus' uninterrupted
reasonable access to
the Device Master File.
5.4 IsoTis undertakes not to disclose the contents of the Device
Master File
to any third party without OctoPlus' prior consent, save for
any
governmental agencies, any parties that are involved in the
manufacturing
of PolyActive on behalf of IsoTis, any parties that are involved
in the
manufacture, sales, and development of materials and/or products
related
to IsoTis Lic
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