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.
TABLE OF CONTENTS
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
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.
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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 X.X. Xxxxxxxx and Xxxx
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 X.X. Xxxxxxxx and Xxxx 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
Xxxxxx Xxxxxxx and Xxx 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 Xxxxxxxxxxxxxx 00 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.
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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.
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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.
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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.
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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.
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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
(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 License B and IsoTis License AB. At OctoPlus' request, IsoTis
shall disclose the identity of any party having access to the Device
Master File.
****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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Supply of PolyActive
5.5 IsoTis shall ensure uninterrupted supply of PolyActive through its own
Production Equipment, or through a third party supplier in accordance with
the articles 1 through 9 and 12 of the Amended and Restated Supply
Agreement between IsoTis and Chienna dated 6 May 2003, attached as ANNEX
5.5.
5.6 In the event IsoTis wishes to sell the Production Equipment to a third
party, IsoTis shall offer the Production Equipment (ANNEX 5.6) first to
OctoPlus for ****, ****. If OctoPlus decides not to acquire the Production
Equipment, IsoTis shall ensure uninterrupted supply of PolyActive by the
third party supplier under the terms and conditions as is currently the
case. If OctoPlus decides to purchase the Production Equipment, it shall
also receive the Device Master File for ****.
5.7 In the event the Production Equipment is sold to a third party, IsoTis
shall stipulate in the transfer agreement with the third party, (i) that
IsoTis maintains ownership of the Device Master File, and shall maintain
such Device Master File in good order. And (ii) failure to maintain the
Device Master File will allow OctoPlus to acquire the Production Equipment
for ****, ****.
5.8 IsoTis shall not provide PolyActive to any third party, outside the scope
of IsoTis License B and IsoTis License AB, save with the prior consent of
OctoPlus, and shall ensure that the third party who has acquired the
Production Equipment shall not do so either. IsoTis shall be fully
responsible for the correct performance of the prohibition to provide
PolyActive to any third party outside the scope of IsoTis License B and
IsoTis License AB by a party who has acquired the Production Equipment. In
case of any breach in the performance of this Article 5.8, IsoTis agrees
to pay to OctoPlus an immediately payable, non-reducible and
non-offsetable penalty of **** (****).
6. OBLIGATIONS OF OCTOPLUS
6.1 Notwithstanding the provision of Article 4.8, OctoPlus shall not make any
substantial amendments to the specification, description and/or claims of
any of the IsoTis License B Rights and/or IsoTis License AB Rights that
might affect IsoTis' rights under this Agreement, without IsoTis' consent,
which shall not unreasonably be withheld.
6.2 In connection with the obligations referred to in Article 6.1, OctoPlus
shall keep transparent maintenance-files and -records regarding the IsoTis
License B Rights and IsoTis License AB Rights. IsoTis shall be entitled
to, once a quarter of a year, inspect these maintenance-files
****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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and records of OctoPlus in respect of which the Parties shall provide each
other with full assistance and cooperation.
6.3 Within **** of the Effective Date, OctoPlus shall pay IsoTis any and all
outstanding amounts owed to IsoTis (if any) arising from OctoPlus' and/or
Chienna's obligations under the terms and conditions of the ACLA (e.g.
royalty and milestone payments owed to IsoTis). The Parties acknowledge
that OctoPlus' and/or Chienna's obligations under article 1.2 of the ACLA
survive the termination of the ACLA and become part of OctoPlus'
obligations under this Agreement.
7. CONSIDERATION
7.1 The total consideration for (i) the transfer of the PolyActive Rights B to
OctoPlus, (ii) the termination of IsoTis' license regarding the
CHIENNA-Patents, currently set forth as PolyActive Rights A, (iii) the
transfer of Future IP to OctoPlus and (iv) the transfer of the PolyActive
Name and Trademarks to OctoPlus shall consist of an up-front payment and
future royalty payments.
7.2 OctoPlus shall pay to IsoTis an up-front payment of EUR 1,250,000 (one
million two hundred and fifty thousand euros) on or prior to the Effective
Date.
7.3 OctoPlus shall pay to IsoTis a royalty of **** (****) of the milestone and
royalty-payments received by OctoPlus on sales of **** ("ROYALTY PAYMENTS
A") on a quarterly basis starting from the date of first commercial sale
of ****.
7.4 OctoPlus shall pay to IsoTis a royalty of **** (****) of the milestone and
royalty-payments received by OctoPlus on sales of **** ("ROYALTY PAYMENTS
B"), on a quarterly basis starting from the date of first commercial sale
of ****.
7.5 OctoPlus shall pay the Royalty Payments A and Royalty Payments B to IsoTis
for sales achieved during the remaining life of the relevant patents
listed in Annex 3.1 and Annex 3.2.
7.6 Payment of the consideration mentioned in this Article 7 by OctoPlus shall
be made by transfer to the account of IsoTis Inc for the respective
amounts on the respective payment dates as follows;
PAY 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.
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ROUTING & TRANSIT #: ****
SWIFT CODE: ****
FOR THE CREDIT OF: IsoTis Inc.
FINAL CREDIT ACCOUNT #: ****
BY ORDER OF: NAME OF SENDER
8. REPRESENTATIONS AND WARRANTIES
General
8.1 Each Party (i) is a corporation duly organized, validly existing and in
good standing under the jurisdiction in which it is incorporated; (ii) has
the corporate power and authority and the legal right to own and operate
its property and assets and to carry on its business as it is now being
conducted and (iii) is in compliance with all requirements of applicable
law, except to the extent that any non-compliance would not have a
material adverse effect on the properties, business, financial or other
condition of such party and would not materially adversely affect such
Party's ability to perform its obligations under this Agreement.
8.2 Each Party (i) has the corporate power and authority and the legal right
to enter into this Agreement and to perform its obligations hereunder and
(ii) has taken all necessary corporate action on its part to authorize the
execution and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly executed and delivered
on behalf of such Party, and constitutes a legal, valid, binding
obligation, enforceable against such Party in accordance with its terms.
8.3 The execution and delivery of this Agreement and the performance of each
Party's obligations hereunder (i) do not conflict with or violate any
requirement of applicable laws or regulations or any contractual
obligation of such Party and (ii) do not conflict with, or constitute a
default or require any consent under, any contractual obligation of such
Party.
Transfer and assignment
8.4 IsoTis represents and warrants that it has the full and unencumbered
ownership and the lawful right to transfer and assign the PolyActive
Rights B as defined and listed in Annex 3.1 to OctoPlus.
8.5 IsoTis represents and warrants that any and all fees due in respect of the
ISOTIS-Patents, currently set forth in Annex 3.1, including but not
limited to annuity fees, have been validly paid up to and including the
Effective Date.
8.6 IsoTis represents and warrants that it has the full and unencumbered
ownership and the lawful right to transfer and assign the Future IP to
OctoPlus.
****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.
12
8.7 IsoTis represents and warrants that it has the full and unencumbered
ownership and the lawful right to transfer and assign the PolyActive Name
and Trademarks as defined and listed in Annex 3.3 to OctoPlus.
8.8 IsoTis represents and warrants that it has full and unencumbered ownership
of the Device Master File.
8.9 IsoTis represents and warrants that it has full and unencumbered ownership
of the Production Equipment, which representation and warranty shall be
repeated at the time of transfer of the Production Equipment pursuant to
Article 5.6.
8.10 To the best of IsoTis knowledge, no claim is pending or threatened,
alleging that any rights regarding the PolyActive Technology owned or
licensed to IsoTis are invalid or unenforceable by IsoTis, and, to the
best of IsoTis' knowledge, there is no basis for any such claim, whether
pending or threatened. Nothing herein contained shall be construed as a
representation or warranty that the intellectual property rights
transferred to OctoPlus by IsoTis under this Agreement (i.e. the
PolyActive Rights B, the Future IP and the PolyActive Name and Trademarks)
are valid and can be issued and/or maintained in all circumstances, or
that use of such intellectual property rights is free from infringement or
violations of any third party's rights.
8.11 IsoTis N.V. and IsoTis Inc. are jointly and severally liable for the
performance of IsoTis under this Article 8.
IsoTis Licenses
8.12 Notwithstanding the above, nothing herein contained shall be construed as
a representation or warranty that the rights for the use of which the
IsoTis License B and the use of IsoTis License AB have been granted are
valid and can be issued and/or maintained in all circumstances, or that
use of the IsoTis License B Rights and the IsoTis License AB Rights is
free from infringement or violations on any third party's rights.
8.13 OctoPlus warrants that it has the lawful right to grant the IsoTis License
B and the IsoTis License AB.
8.14 In no event shall OctoPlus be liable for any incidental or consequential
damages resulting from the exercise of the IsoTis License B or IsoTis
License AB or the use of the IsoTis License B Rights, the IsoTis License
AB Rights or the rights granted to IsoTis pursuant to Article 4.4.
8.15 In no event shall IsoTis be liable for any incidental or consequential
damages resulting from
****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.
13
OctoPlus' exercise of the intellectual property rights transferred to
OctoPlus by IsoTis under this Agreement (i.e. PolyActive Rights B and
Future IP and the PolyActive Name and Trademarks).
9. CONFIDENTIALITY
9.1 During as well as after the term of this Agreement, any information that
shall have been communicated by either Party to the other in confidence or
which by its nature ought to be regarded as confidential ("CONFIDENTIAL
INFORMATION"), shall be treated by the receiving Party as confidential,
unless and until the same is published by the communicating Party, or is
contained in a published patent specification, or is in the public domain
or generally known in the industry, or results from the normal performance
of any rights under this Agreement (including but not limited to
disclosure by sale of products), or in any other comparable circumstances,
provided that the disclosure has in all cases been made bona fide.
9.2 The Parties shall impose on all third parties that are working with or for
them which may have access to Confidential Information the same
obligations as are imposed on the Parties pursuant to this Article.
10. PENALTY ON MATERIAL BREACH
Each Party agrees to pay the other Party an immediately payable, non-reducible
and non-offsetable penalty of **** (****) in respect of any material breach of
the obligations referred to in Articles 5, 6, 7, 8 and/or 9, which material
breach the breaching Party has failed to remedy within **** after service of a
written notice requiring such remedy, without prejudice to the other Party's
rights to full compensation for damage.
11. TERM AND TERMINATION
11.1 This Agreement effectively replaces the ACLA and shall be effective as of
1 April 2007 (the "EFFECTIVE DATE") and shall continue in force until the
duration of the last to expire of any of the rights licensed to IsoTis
under this Agreement, adding the period of any extension of any of these
rights.
11.2 In case of termination of the licenses granted to IsoTis under this
Agreement, IsoTis shall no longer be entitled to market and sell materials
under the rights licensed to it under this Agreement and will immediately
refrain from further use and/or exploitation of these rights, in as far as
such rights are still in force. IsoTis shall furthermore refrain from
further use of any
****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.
14
technical information regarding the rights licensed to it and shall
immediately return any and all such technical information in its
possession or control to OctoPlus.
11.3 Termination or expiration of this Agreement shall not release either Party
of obligations incurred prior thereto and/or any obligation which by its
term or its nature is intended to remain in force after expiration.
11.4 Termination or expiration of this Agreement shall have no effect on the
transfer and assignment of the PolyActive Rights B, the Future IP and the
PolyActive Name and Trademarks as set out in Article 3.
12. TRANSFER OF ISOTIS LICENSE RIGHTS
12.1 Notwithstanding the provision of Article 6, if, during the term of this
Agreement, OctoPlus transfers any right, title interest in, or claims to
any of the IsoTis License B Rights or the IsoTis License AB Rights to a
third party or a subsidiary ("TRANSFEREE"), OctoPlus guarantees to IsoTis
the substitution of Transferee in its place as a Party to this Agreement
in connection with the transferred rights. In the event of transfer to a
subsidiary, OctoPlus remains liable towards IsoTis for due compliance by
the Transferee of the relevant obligations under this Agreement.
12.2 The substitution as referred to in Article 12.1 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).
13. INDEMNITY
13.1 IsoTis Inc. and IsoTis N.V. shall jointly and severally indemnify, hold
harmless and defend OctoPlus and Chienna, their respective directors,
officers, employees, volunteers and agents against any and all claims
(including but not limited to claims for bodily injury, death or property
damage), suits, losses, damage, costs, fees, liability (including but not
limited to product liability), penalties, fines, judgments and expenses
(including court costs and attorneys' fees) that they may incur, suffer,
become liable for, or that may be asserted or claimed against them as a
result of the development, manufacture, sale, distribution and use of any
service or product derived, in whole or in part, by the IsoTis or IsoTis'
sub-licensees from any rights provided to IsoTis under IsoTis License B,
IsoTis License AB and/or the right of first refusal set forth in Article
4.4, except to the extent arising from the willful misconduct or
negligence of OctoPlus and Chienna seeking indemnification or its
employees or agents.
****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.
15
13.2 Promptly after receipt by OctoPlus and/or Chienna of a notice of the
commencement of any action related to the rights granted to IsoTis in
Articles 4.1, 4.2 and/or 4.4 (including any governmental action or
investigation and actions against IsoTis or OctoPlus and/or Chienna) (a
"THIRD PARTY CLAIM"), OctoPlus and/or Chienna will deliver to IsoTis a
written notice of the commencement of a Third Party Claim. The failure to
notify IsoTis within a reasonable time of a Third Party Claim will not
affect OctoPlus' and/or Chienna's right to indemnification under this
Article 13 if:
a. OctoPlus and/or Chienna seeking indemnification does not know (and
reasonably could not be expected to know) of the Third Party Claim
or the facts on which it is based; or
b. IsoTis is not materially prejudiced as a result of the failure.
13.3 If OctoPlus and/or Chienna make a claim for indemnification under this
Article 13, IsoTis shall be entitled to assume the defense of the Third
Party Claim with counsel selected by IsoTis and reasonably satisfactory to
OctoPlus and/or Chienna. IsoTis must obtain the prior written consent of
OctoPlus and/or Chienna named as a party in the Third Party Claim (which
will not be unreasonably withheld) for any settlement where as a result
OctoPlus and/or Chienna reasonably could become subject to injunctive or
other equitable relief or any remedy other than the payment of money by
IsoTis. IsoTis may settle all other Third Party Claims in its discretion
with a full release of OctoPlus and/or Chienna and no admission of
criminal liability.
13.4 If IsoTis assumes the defense of a Third Party Claim, IsoTis will not be
liable to OctoPlus and/or Chienna making the claim for indemnification for
legal expenses subsequently incurred by OctoPlus and/or Chienna in
connection with the defense of the Third Party Claim unless:
a. IsoTis has failed to defend, contest or otherwise protest against
the Third Party Claim in a timely manner; or
b. a conflict of interest exists making separate representation of
OctoPlus and/or Chienna necessary or appropriate.
13.5 If IsoTis assumes the defense, OctoPlus and/or Chienna will have the right
to participate in the defense and employ counsel at its own expense
separate from the counsel employed by IsoTis. IsoTis will be liable for
the reasonable fees and expenses of counsel employed by OctoPlus and/or
Chienna for any period during which IsoTis has not assumed the defense of
the Third Party Claim and for any period in which a conflict of interest
exists such that separate representation of OctoPlus and Chienna is
necessary or appropriate. If IsoTis chooses to defend any Third Party
Claim, the Parties to this Agreement shall cooperate in the defense or
prosecution of the Third Party Claim.
13.6 The indemnification requirements of this Article 13 will survive the
termination of this Agreement for as long as IsoTis is sub-licensing the
rights licensed to it under this Agreement.
****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.
16
IsoTis will ensure that any indemnification of OctoPlus and/or Chienna by
a sub-licensee will survive the termination of the applicable sub-license
agreement.
14. MISCELLANEOUS
14.1 Any notice or other communication under or in connection with this
Agreement shall be in writing and shall be delivered personally or sent by
air mail prepaid recorded delivery or by facsimile to the Party due to
receive the notice addressed to such Party at its address indicated below,
or to such other address as the addressee shall have last furnished in
writing to the addressor and (except as otherwise provided in this
Agreement) shall be effective upon receipt by the addressee.
If to OctoPlus: OctoPlus N.V.
Attn. Mr. J.J.M. Holthuis
Xxxxxxxxxxxx 00
0000 XX Xxxxxx
with a copy to: Loyens & Loeff N.V.
Attn. Ms. A.N. Xxxx
X.X. Xxx 0000
0000 XX Xxxxxxxxx
If to Chienna: Chienna B.V.
Attn. [INPUT OCTOPLUS]
Xxxxxxxxxxxx 00
0000 XX Xxxxxx
with a copy to: Loyens & Loeff N.V.
Attn. Ms A.N. Xxxx
X.X. Xxx 0000
0000 XX Xxxxxxxxx
If to IsoTis: IsoTis Inc.
Attn. Xxxxxx Xxxxxxx
2 Goodyear
Xxxxxx, Xxxxxxxxxx 00000
XXX
14.2 This Agreement and any agreements to be entered into pursuant to it
constitute the entire agreement between the Parties and supersedes all
prior agreements or understandings,
****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.
17
whether in writing or orally, between the Parties, unless explicitly
otherwise agreed herein. No variation of this Agreement shall be valid or
effective unless in writing and executed by each Party, unless explicitly
agreed otherwise herein.
14.3 The invalidity or unenforceability of any provision of this Agreement
shall not affect the validity or unenforceability of any other provision
of this Agreement. Any such invalid or unenforceable provision shall be
replaced or be deemed to be replaced by a provision that is considered to
be valid and enforceable and which interpretation shall be as close as
possible to the intent of the invalid or unenforceable provision.
14.4 No Party shall assign or transfer or purport to assign or transfer any of
its rights or obligations under this Agreement without the prior written
consent of the other Party, which consent will not unreasonably be
withheld.
14.5 A Party to this Agreement may be excused from any performance required
herein if such performance is rendered impossible or unfeasible due to any
catastrophe or other major event beyond its reasonable control, including,
without limitation, war, riot, and insurrection; laws, proclamations,
edicts, ordinances, or regulations; strikes, lockouts, or other serious
labor disputes; and floods, fires, explosions, or other natural disasters.
When such events have abated, the non-performing Party's obligations
herein shall resume.
14.6 Timing and contents of any press releases in connection with the Agreement
will be mutually agreed by the Parties.
15. APPLICABLE LAW / JURISDICTION
15.1 This Agreement and any agreements to be entered into pursuant to it shall
in all respects be governed by and construed in accordance with the Laws
of the Netherlands.
15.2 Any dispute arising out of or in connection to this Agreement shall be
exclusively referred to and settled by the competent court in Amsterdam,
the Netherlands.
****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.
18
IN WITNESS WHEREOF
This Agreement has been executed and signed in duplicate in Leiden on 24 April
2007.
- Signature page follows -
****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.
19
OCTOPLUS N.V. CHIENNA B.V.
/s/ Joost X.X. Xxxxxxxx /s/ Joost X.X. Xxxxxxxx
-------------------------- --------------------------
Joost X.X. Xxxxxxxx Joost X.X. Xxxxxxxx
its: director its: director's director
date: date:
/s/ Hans C.H.L. Pauli /s/ Hans C.H.L. Pauli
--------------------------- ---------------------------
Hans C.H.L. Xxxxx Xxxx C.H.L. Pauli
its: director its: director's director
date: date:
ISOTIS INC. ISOTIS N.V.
/s/ Xxxxxx Xxxxxxx /s/ Xxxxxx Xxxxxxx
--------------------------- ---------------------------
Xxxxxx Xxxxxxx IsoTis SA, represented by Xxxxxx Xxxxxxx
its: CEO its: director
date: Irvine CA date: Irvine CA
April 24, 2007 April 24, 2007
/s/ Rob Morocco /s/ Rob Morocco
--------------------------- ---------------------------
Rob Morocco IsoTis SA, represented by Rob Morocco
its: CFO its: director
date: April 24, 2007 date: April 24, 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.
20
ANNEX 1.1 DEFINITIONS
ACLA Shall mean the Amended and Restated Assignment
and Cross License Agreement between IsoTis
and Chienna B.V. dated 6 May 2003.
Agreement Shall mean this Transfer and License agreement,
including all Annexes hereto.
Annex Shall mean an annex to this Agreement.
Article Shall mean an article of this Agreement.
Chienna Shall mean Chienna B.V., having its corporate seat in
Bilthoven and its registered offices at
Zernikedreef 12 (2333 CL) Leiden, the Netherlands.
CHIENNA-Patents Shall mean the patents and patent applications
defined and listed in Annex I(A) to the ACLA.
Confidential Information Shall have the meaning given to it in Article 9.1.
Device Master File Shall mean the Food and Drug Administration (FDA)
Master File on PolyActive(TM) having formal FDA
number ****. The first FDA filing of MAF
PolyActive(TM) was done by IsoTis N.V. in February
2001 to the FDA Center for Devices and Radiological
Health of the FDA. An update and amendment thereof
was issued to the FDA by IsoTis N.V. in June 2006.
Effective Date Shall have the meaning given to it in Article 11.1.
Future IP Shall mean all developed intellectual property,
patents and patent applications regarding
the PolyActive Rights A and B.
IsoTis IsoTis Inc. and its related company IsoTis N.V..
****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.
21
IsoTis Inc. Shall mean IsoTis Inc., having its principle office
located at 0 Xxxxxxxx, Xxxxxx, Xxxxxxxxxx, Xxxxxx
Xxxxxx of America.
IsoTis IP Shall have the meaning given to it in Article 4.10
IsoTis N.V. Shall mean IsoTis N.V., having its corporate seat in
Amsterdam and its registered offices at Professor
Xxxxxxxxxxxxxx 00 D (3723 MB) Bilthoven.
IsoTis License AB Shall have the meaning given to it in Article 4.2.
IsoTis License AB Rights Shall have the meaning given to it in Article 4.3.
IsoTis License B Shall have the meaning given to it in Article 4.1.
IsoTis License B Rights Shall have the meaning given to it in Article 4.3.
ISOTIS-Patents Shall mean the patents and patent applications
defined and listed in Annex I(B) to the ACLA.
IsoTis SA Shall mean IsoTis SA, having its principle office located at
0 Xxx xx Xxxxxxxxx, 0000 Xxxxxxxx, Xxxxxxxxxxx.
OctoPlus Shall mean OctoPlus N.V., having its
registered offices at Zernikedreef 12 (2333
CL) Leiden, the Netherlands.
Orthopedic Field Shall mean that part of the OctoPlus' patents
and patent application which relate to a
therapeutic application to the musculoskeletal
system, including bone, cartilage, joints,
related connective tissues, ligaments,
tendons and nerves.
Party Shall mean a party to this Agreement; "Parties" means every
Party.
PolyActive Shall mean a biodegradable (amphiphilic) poly(ether-ester)
multiblock copolymer based on PEGT and PBT.
****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.
22
PolyActive Name and Trademarks Shall mean the name and trademark applications
and registrations as defined in Annex 3.3.
PolyActive Rights A Shall mean the PolyActive Rights A as
defined and listed in Annex 3.2, consisting of
the CHIENNA-Patents but not including all
previously abandoned and/or transferred
patents and patent applications.
PolyActive Rights B Shall mean the PolyActive Rights B as
defined and listed in Annex 3.1, consisting of
the ISOTIS-Patents but not including (1) all
previously abandoned and/or transferred
patents and patent applications; (2) ****
(****); and (3) ****(****).
PolyActive Technology Shall mean a drug delivery system controlling the
release of biologically active molecules, which is
based on PolyActive. Products based on PolyActive
Technology can be used for both local and systemic
administration, and have applications in
pharmaceutics and medical technology.
Production Equipment Shall mean the equipment of IsoTis, used for the
production of the PolyActive as set forth in Annex 5.6.
Royalty Payments A Shall have the meaning given to it in Article 7.3.
Royalty Payments B Shall have the meaning given to it in Article 7.4.
SPA Shall mean the Share Purchase Agreement
between IsoTis and OctoPlus regarding the
shares in the capital of Chienna B.V. dated 6 May 2003.
****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.
23
Third Party Claim Shall have the meaning given to it in Article 13.2.
Transferee Shall have the meaning given to it in Article 12.1.
****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.
24
ANNEX 2.4 LICENSE GRANTED UNDER THE ISOTIS-PATENTS
CellCoTec Agreement [separate document]
****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.
25
ANNEX 3.1 POLYACTIVE RIGHTS B
TITLE PATENTS PATENT APPLICATION - PUBLICATION NUMBER
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
****
**** ****
****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.
26
ANNEX 3.2 POLYACTIVE RIGHTS A
PATENT APPLICATION -
TITLE PATENT NUMBER PUBLICATION NUMBER
**** ****
****
****
****
****
**** ****
****
****
****
****
**** ****
****
****
****
****
**** ****
****
****
****
**** ****
****
**** ****
****
****
****
**** ****
****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.
27
ANNEX 3.3 POLYACTIVE NAME AND TRADEMARKS
POLYACTIVE(R)
REGION/COUNTRY REG. NUMBER
-------------- -----------
**** ****
**** ****
**** ****
**** ****
**** ****
****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.
28
ANNEX 5.5 AMENDED AND RESTATED SUPPLY AGREEMENT BETWEEN ISOTIS AND CHIENNA
[separate document]
****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.
29
ANNEX 5.6 PRODUCTION EQUIPMENT
ISOTIS
APPARATUS APP. NR.
--------- --------
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
****
****
****
****
****
****
QC EQUIPMENT
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
**** ****
PRODUCTION RELATED 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.
30
