EXHIBIT 10.88
ASSIGNMENT AGREEMENT
(OF COLLABORATION AGREEMENT BETWEEN GENTA JAGO AND GENSIA)
This ASSIGNMENT AGREEMENT effective as of October 1, 1996 (this "AGREEMENT") is
entered into among GENSIA, INC., a Delaware corporation having a place of
business at 0000 Xxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000, X.X.X.
(hereinafter referred to as "GENSIA"), and GENTA JAGO TECHNOLOGIES B.V., a Dutch
company, having a place of business at Xxxxxxxxxxxx 00, XX-0000 Xxxxxxxx,
Xxxxxxxxxxx (hereinafter referred to as "GENTA JAGO"), and BRIGHTSTONE PHARMA,
INC., a Delaware corporation having a place of business at 000 XxxXxxxx Xxxxx,
Xxxx, Xxxxx Xxxxxxxx 00000, X.X.X. (hereinafter referred to as "BRIGHTSTONE")
and SKYEPHARMA PLC, an English public company, having a place of business at 000
Xxxxxxxxxx, Xxxxxx (hereinafter referred to as "SKYEPHARMA").
WITNESSTH:
WHEREAS, GENSIA and GENTA JAGO have entered into a certain
Collaboration Agreement dated as of January 22, 1993 (as amended as of October
7, 1994, and thereafter, hereinafter the "GJT Collaboration Agreement")
regarding the development of - inter alia - a GEOMATRIX(R) formulation of
Nifedipine (hereinafter the "Nifedipine Product"); and
WHEREAS, GENSIA and Jagotec AG, a Swiss corporation (hereinafter
"JAGOTEC") have entered into a certain License Agreement dated as of January 22,
1993 (as amended as of October 7, 1994 and thereafter; hereinafter the "License
Agreement") regarding manufacturing rights for - inter alia - the Nifedipine
Product; and
WHEREAS, GENSIA and JAGO Pharma AG, a Swiss corporation (hereinafter
"JAGO PHARMA") have entered into a certain Supply Agreement dated as of January
22, 1993 (as amended as of October 7, 1994 and thereafter; hereinafter the
"Supply Agreement") regarding the manufacturing and supply of - inter alia - the
Nifedipine Product; and
WHEREAS, GENSIA and Boehringer Mannheim Pharmaceuticals Corporation, a
Maryland corporation (hereinafter "BMPC") have entered into a certain License
and Collaboration Agreement dated as of October 10, 1994 (hereinafter the "BMCT
License and Collaboration Agreement") regarding the development and marketing of
the Nifedipine Product; and
WHEREAS, as the result of an internal corporate restructuring,
Boehringer Mannheim Corporation, Therapeutics Division ("BMCT"), succeeded to
the rights and obligations of BMPC under the BMCT License and Collaboration
Agreement;
WHEREAS, BRIGHTSTONE desires to assume, and GENSIA desires to assign to
BRIGHTSTONE, all of GENSIA's rights and obligations under the GJT Collaboration
Agreement as of the Effective Date (as defined below) and under the terms and
subject to the conditions of this Agreement; and
WHEREAS, GENTA JAGO is willing to consent to GENSIA's assignment and
BRIGHTSTONE's assumption of GENSIA's rights and obligations under the GJT
Collaboration Agreement, under the terms and subject to the conditions of this
Agreement; and
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WHEREAS, the GENTA JAGO and BRIGHTSTONE desire to amend certain
provisions of the GJT Collaboration Agreement as of the Effective Date as set
forth below.
NOW, THEREFORE, for and in consideration of the premises, mutual
covenants and agreements contained herein and intending to be legally bound
hereby, the parties hereby agree as follows:
ARTICLE 1
ASSIGNMENT, SUBSTITUTION AND RELEASE
As of the Effective Date and subject to the terms and conditions of
this Agreement,
1.1 GENSIA does assign and transfer to BRIGHTSTONE all of GENSIA's right,
title and interest in and to, and all of GENSIA's liabilities, duties
and obligations arising or becoming due on or after the Effective Date
under the GJT Collaboration Agreement;
1.2 BRIGHTSTONE does assume such right, title, interest, liabilities,
duties and obligations of GENSIA and does agree that it shall be
substituted for GENSIA under the GJT Collaboration Agreement and that
it will perform the obligations, liabilities and duties of GENSIA
arising or becoming due on or after the Effective Date thereunder in
accordance with the terms hereof and thereof;
1.3 SKYEPHARMA agrees to guarantee the performance of BRIGHTSTONE under the
GJT Collaboration Agreement as it will be amended concurrently
herewith; and
1.4 GENTA JAGO does consent to such assignment and substitution.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
2.1 Of Each Party to the Others. Each party hereby represents and warrants
to the other parties as follows:
(a) Corporate Existence. Such party is a corporation duly organized,
validly existing and in good standing under the laws of the state or
other jurisdiction in which it is incorporated.
(b) Authorization and Enforcement of Obligations. Such party has the
corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder and 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 and binding
obligation, enforceable against such party in accordance with its
terms.
(c) Consents. All necessary consents, approvals and authorizations of
all governmental authorities and other persons required to be obtained
by such party in connection with this Agreement have been obtained.
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(d) No Conflict. The execution and delivery of this Agreement and the
performance of such party's obligations hereunder do not conflict with
or violate any requirement of applicable laws or regulations and do not
conflict with, or constitute a default under, any contractual
obligation of such party, except such conflicts that do not,
individually or in the aggregate, have a material adverse effect on
such party or do not materially adversely affect such party's ability
to perform its obligations under this Agreement.
2.2 Of GENSIA and GENTA JAGO to Each Other, SKYEPHARMA and BRIGHTSTONE.
Each of GENSIA and GENTA JAGO hereby represents and warrants to each
other, SKYEPHARMA and BRIGHTSTONE that, immediately prior to the
Effective Date, (a) the GJT Collaboration Agreement is in full force
and effect; (b) the GJT Collaboration Agreement has not been amended,
modified or altered (by amendment, side agreement or otherwise) other
than as described in the recitals to this Agreement, (c) all amounts
owing as of such date by GENSIA to GJT under the GJT Collaboration
Agreement have been paid in full; (d) it has not received any notice of
uncured past default under the GJT Collaboration Agreement, (e) there
exists no uncured default or event which (with only the passage of
time, the giving of notice or both) would constitute an uncured default
of a material obligation under the GJT Collaboration Agreement, other
than any default under the GJT Collaboration Agreement which directly
or indirectly derives from or relates to the same or a related
occurrence (or series of occurrences) which BMCT alleges (or may
allege) constitutes a default under the BMCT License and Collaboration
Agreement or the BMCT Amended License and Collaboration Agreement and
(f) to the best of its knowledge, there exists no pending litigation,
arbitration or similar proceeding to which it is a party, and it has
not received written notice of any threatened litigation, arbitration
or similar proceeding, relating to the GJT Collaboration Agreement or
the activities contemplated by the GJT Collaboration Agreement.
ARTICLE 3
RELEASES
3.1 Release of GENSIA. GENTA JAGO, BRIGHTSTONE and SKYEPHARMA do hereby
release, remise and forever discharge GENSIA and its officers,
directors, shareholders, employees and agents from (i) liabilities of
GENSIA resulting from acts of GENTA JAGO on or after the Effective Date
arising from the GJT Collaboration Agreement; and (ii) those
liabilities of GENSIA to GENTA JAGO, BRIGHTSTONE or SKYEPHARMA arising
from the GJT Collaboration Agreement which have accrued prior to the
Effective Date and are actually known by GENTA JAGO, BRIGHTSTONE or
SKYEPHARMA. In no event shall the foregoing release apply to
obligations and liabilities of GENSIA owing to third parties.
3.2 Release of GENTA JAGO, BRIGHTSTONE and SKYEPHARMA. GENSIA does hereby
release, remise and forever discharge each of GENTA JAGO, BRIGHTSTONE
and SKYEPHARMA and its officers, directors, shareholders, employees and
agents from any and all liabilities and obligations arising out of or
related to the GJT Collaboration Agreement which have accrued prior to
the Effective Date and are actually known by GENSIA. In no event shall
the foregoing release apply to obligations and liabilities of GENTA
JAGO, BRIGHTSTONE or SKYEPHARMA owing to third parties.
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ARTICLE 4
INDEMNIFICATION
4.1 Indemnification Provision. Each of SKYEPHARMA, BRIGHTSTONE AND GENTA
JAGO severally agree to indemnify GENSIA and hold GENSIA harmless from
and against all losses, liabilities, damages and expenses, including
reasonable attorneys' fees and costs, incurred as a result of any
claim, demand, action or other proceeding arising from the acts or
omissions of SKYEPHARMA, BRIGHTSTONE AND GENTA JAGO, respectively,
under the GJT Collaboration Agreement accruing on and after the
Effective Date. GENTA JAGO further agrees to indemnify GENSIA and hold
GENSIA harmless from and against all losses, liabilities, damages and
expenses, including reasonable attorneys' fees and costs, arising from
liabilities and obligations of GENSIA to GENTA JAGO arising out of or
related to the GJT Collaboration Agreement which liabilities and
obligations have accrued prior to the Effective Date and are actually
known by GENTA JAGO; provided, however, that in no event shall
SKYEPHARMA, BRIGHTSTONE OR GENTA JAGO indemnify GENSIA in respect of
obligations and liabilities of GENSIA owing to third parties. GENSIA
agrees to indemnify GENTA JAGO and hold GENTA JAGO harmless from and
against all losses, liabilities, damages and expenses, including
reasonable attorneys' fees and costs, arising from liabilities and
obligations of GENTA JAGO to GENSIA arising out of or related to the
GJT Collaboration Agreement which liabilities and obligations have
accrued prior to the Effective Date and are actually known by GENSIA;
provided, however, that in no event shall GENSIA indemnify GENTA JAGO
in respect of obligations and liabilities of GENTA JAGO owing to third
parties. GENSIA agrees to indemnify SKYEPHARMA, BRIGHTSTONE or GENTA
JAGO and hold each of them harmless from and against all losses,
liabilities, damages and expenses, including reasonable attorneys' fees
and costs, arising from liabilities and obligations of GENSIA owing to
third parties related to the GJT Collaboration Agreement, provided,
however, that the foregoing indemnification shall not apply to losses,
liabilities, damages and expenses of the indemnified parties incurred
as a result of the operation of the first sentence of this Section 4.1.
The foregoing notwithstanding, in no event will any party hereto be
required to indemnify another party hereunder for any loss, liability,
damage or expense to the extent it is caused by acts of such
indemnified party constituting gross negligence or willful misconduct
or constituting a breach of this Agreement.
4.2 Procedure. A party (the "Indemnitee") that intends to claim
indemnification under this Section 4 shall promptly notify the
indemnifying party (the "Indemnitor") of any claim, demand, action or
other proceeding in respect of which the Indemnitee intends to claim
such indemnification, and the Indemnitor shall have the right to
participate in, and, to the extent the Indemnitor so desires, jointly
with any other Indemnitor similarly noticed, to assume the defense
thereof with counsel selected by the Indemnitor, provided, however,
that an Indemnitee shall have the right to retain its own counsel, with
the fees and expenses to be paid by the Indemnitee. The indemnity
obligations under this Section 4 shall not apply to amounts paid in
settlement of any claim, demand, action or other proceeding if such
settlement is effected without the consent of the Indemnitor, which
consent shall not be unreasonably withheld. The failure to deliver
notice to the Indemnitor within a reasonable time after the
commencement of any such action, if prejudicial to its ability to
defend such action, shall relieve such Indemnitor of any liability to
the Indemnitee under this Section 4, but the omission so to deliver
notice to the Indemnitor will not relieve it of any liability that it
may have to any Indemnitee otherwise than under this Section 4. The
Indemnitor may not settle the action or otherwise consent to an adverse
judgment in such action that diminishes the rights or interests of the
Indemnitee without the express written consent of the Indemnitee, which
consent shall not be unreasonably withheld. The Indemnitee, its
employees
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and agents shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any action, claim or liability
covered by this indemnification.
ARTICLE 5
AMENDMENTS TO THE GJT COLLABORATION AGREEMENT
The GJT Collaboration Agreement is hereby amended as follows:
5.1 The reference to GENTA JAGO in the ingress of the GJT Collaboration
Agreement:
JOBEWOL INVESTMENTS BV (proposed to be renamed GENTA JAGO
TECHNOLOGIES BV), a Dutch corporation ("Technologies"), having
a place of business located at Xxxxxxxxxxxx 00, XX-0000
Xxxxxxxxx, Xxxxxxxxxxx,
shall be deleted and replaced by the following:
GENTA JAGO TECHNOLOGIES BV, A DUTCH COMPANY ("TECHNOLOGIES"),
HAVING A PLACE OF BUSINESS AT XXXXXXXXXXXX 00, XX-0000
XXXXXXXX, XXXXXXXXXXX,
5.2 In Section 1.2, the qualifying threshold of voting stock or other
ownership interest shall be increased from at least forty percent (40%)
to MORE THAN FIFTY PERCENT (50%).
5.3 Section 1.11 shall be deleted in its entirety and replaced by the
following new Section:
1.11 "GEOMATRIX(R) TECHNOLOGY" SHALL MEAN THE ORAL CONTROLLED-RELEASE
DRUG DELIVERY AND RELATED TECHNOLOGY LICENSED TO TECHNOLOGIES BY
JAGOTEC AG WHICH UTILIZES A HYDROPHILIC DRUG-CONTAINING MATRIX TABLET
WHICH CONTROLS THE RELEASE OF THE DRUG THROUGH THE USE OF ONE OR MORE
BARRIER LAYERS, TOGETHER WITH ALL IMPROVEMENTS THEREON AND THERETO.
5.4 Section 2.5 shall be deleted in its entirety and replaced by the
following new Section:
2.5 RIGHTS TO GEOMATRIX(R) TECHNOLOGY. TECHNOLOGIES REPRESENTS AND
WARRANTS THAT IT HAS THE EXCLUSIVE RIGHT AND LICENSE FOR SALE AND USE
IN THE FIELD UNDER THE PATENT RIGHTS, THE GEOMATRIX(R) TECHNOLOGY AND
THE KNOW-HOW NECESSARY AND REQUIRED TO GRANT THE LICENSES UNDER ARTICLE
6.1 BELOW, AND THAT IT HAS THE RIGHT TO GRANT THE LICENSES HEREUNDER.
5.5 Section 14.4 shall be amended by the following new sub-section
14.4 TERMINATION OF THE LICENSE AGREEMENTS.
14.4.1 IN THE EVENT THAT THE LICENSE AGREEMENT IS TERMINATED PRIOR TO
THE EXPIRATION OF THE LAST TO EXPIRE OF THE PATENTS LICENSED TO
TECHNOLOGIES IN THE TERRITORY, THEN JAGOTEC SHALL GRANT A DIRECT
LICENSE TO BRIGHTSTONE WHEREUNDER THE SAME LICENSE RIGHTS AS ARE
GRANTED UNDER THE LICENSE AGREEMENT TO TECHNOLOGIES ARE DIRECTLY
GRANTED TO BRIGHTSTONE. IN THIS EVENT JAGOTEC SHALL ASSUME ALL RIGHTS
AND OBLIGATIONS OF TECHNOLOGIES UNDER THIS AGREEMENT AND SHALL PROMPTLY
CURE ALL DEFAULTS OF TECHNOLOGIES UNDER THIS AGREEMENT, IF ANY.
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14.4.2 NOTWITHSTANDING ANYTHING CONTAINED IN THIS SECTION 14.4, NO
ACTION TAKEN BY JAGOTEC AND/OR BRIGHTSTONE TO CONTINUE OR NOT TO
CONTINUE THE LICENSE SHALL RELIEVE TECHNOLOGIES FROM ANY LIABILITY FOR
ANY UNCURED DEFAULTS UNDER THIS AGREEMENT OR THE LICENSE AGREEMENTS,
AND SUCH ACTION BY JAGOTEC AND/OR BRIGHTSTONE SHALL BE WITHOUT
PREJUDICE TO ANY OTHER RIGHTS OR REMEDIES JAGOTEC AND/OR BRIGHTSTONE
MAY HAVE IN LAW OR EQUITY.
5.6 In Section 20.1, the notice addresses to BRIGHTSTONE and Technologies
are amended as follows:
If to BRIGHTSTONE: BRIGHTSTONE PHARMA INC.
000 XxxXxxxx Xxxxx
Xxxx, XX 00000, X.X.X.
att: Xxxxxx X. Xxxxxx, Xx.
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with copies to: SKYEPHARMA PLC
000 Xxxxxxxxxx
Xxxxxx X0X 0XX, Xxxxxxx
att: Company Secretary
and: XXXXXXXXXXXX XXXXX & XXXXXXXXXXX
Xxxxxxxxxxxxxxxx 0
X.X. Xxx 0000
XX-0000 Xxxxxx, Xxxxxxxxxxx
att: Xx. Xxxxxx X. Xxxxxxxxxxxx
If to TECHNOLOGIES: GENTA JAGO TECHNOLOGIES BV
Swiss Branch
Xxxxxxxxxxxx 00
XX-0000 Xxxxxxxx
att: Management Committee
with copies to: remains unchanged
5.7 Section 20.6 (Non-Competition) shall be deleted in its entirety.
ARTICLE 6
CONFIDENTIALITY
6.1 For a period of ten years from the Effective Date, GENSIA shall
maintain in confidence and shall not use in any way information and
data resulting from or related to the development of the Products under
the GJT Collaboration Agreement and, to the extent not included in the
foregoing, information supplied by GENTA JAGO and marked "Confidential"
(collectively the "Information").
6.2 The obligation not to disclose or use Information shall not apply to
any part of such Information that (a) is or becomes patented, published
or otherwise part of the public domain other than by acts of GENSIA or
its Affiliates or sublicensees in contravention of this Agreement, (b)
is disclosed to GENSIA or its Affiliates or sublicensees by a Third
Party, provided that such Information was not obtained by such Third
Party directly or indirectly on a confidential basis, (c) prior to
disclosure to GENSIA was already in possession of GENSIA or its
Affiliates or sublicensees, provided such Information was not obtained
directly or indirectly from GENTA JAGO under the GJT Collaboration
Agreement, or (d) is disclosed in a press release agreed to by all
parties hereto. GENSIA agrees that it shall not, directly or
indirectly, perform research and development on, promote, sell or
distribute another sustained release formulation of Nifedipine in the
Territory, provided, however, that the foregoing non-competition
obligation shall not apply to GENSIA in the event of a change of
control (as defined in Section 13.2.4 of the License and Collaboration
Agreement between GENSIA and BMCT).
6.3 Furthermore, GENSIA shall not disclose to any third party any of the
terms or conditions of the GJT Collaboration Agreement or this
Agreement without the prior written consent of the other parties
hereto, except where and to the extent required by applicable law.
Notwithstanding the foregoing, prior to the Effective Date, the parties
hereto shall agree on the substance of
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information to describe the terms of this transaction, which
information may be disclosed by GENSIA without the consent of the other
parties hereto.
ARTICLE 7
CLOSING, CONDITION PRECEDENT AND EFFECTIVE DATE
7.1 The closing of the transaction contemplated hereby ("Closing") shall
take place at the offices of Xxxxx Xxxx LLP, counsel for BMCT, 000
Xxxxxxxxxx Xxxxxx, X.X., Xxxxxxxxxx, X.X., or at such other place as
the parties may agree at 1:00 p.m. EST on February 24, 1997, provided
that the following conditions precedent have been fulfilled:
(a) GENSIA, JAGOTEC, BRIGHTSTONE and SKYE PHARMA shall have agreed
upon and duly executed an assignment agreement (hereinafter
the "JAGOTEC Assignment") providing for the assignment of all
of GENSIA's rights and obligations under the License Agreement
to, and the assumption thereof by, BRIGHTSTONE under terms and
conditions reasonably acceptable to all parties thereto; and
(b) GENSIA, JAGO PHARMA, BRIGHTSTONE and SKYE PHARMA shall have
agreed upon and duly executed an assignment agreement
(hereinafter the "JAGO PHARMA Assignment") providing for the
assignment of all of GENSIA's rights and obligations under the
Supply Agreement to, and the assumption thereof by,
BRIGHTSTONE under terms and conditions reasonably acceptable
to all parties thereto; and
(c) GENSIA, BMCT, BRIGHTSTONE and SKYE PHARMA shall have agreed
upon and duly executed an assignment agreement (hereinafter
the "BMPC Assignment") providing for the assignment of all of
GENSIA's rights and obligations under the BMPC Agreement to,
and the assumption thereof by, BRIGHTSTONE under terms and
conditions reasonably acceptable to all parties thereto.
7.2 Provided that the Closing shall take place as provided hereinbefore,
the "Effective Date" of this transaction shall be October 1, 1996.
ARTICLE 8
MISCELLANEOUS
8.1 This Agreement embodies the entire understanding among the parties
hereto and supersedes any prior representations, agreements,
arrangements or understandings among them regarding the subject matter
hereof, including but not limited to the letter of intent dated October
17, 1996. There are no representations, agreements, arrangements or
understandings, oral or written, among the parties hereto regarding the
subject matter hereof which are not fully expressed herein.
8.2 No change, modification, extension, termination or waiver of this
Agreement, or any provision herein contained, shall be valid unless
made in writing and duly signed by authorized representatives of the
parties hereto.
8.3 This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement effective as
of the date first written above.
GENSIA, INC.
/s/Xxxxx X. Xxxx
---------------------------------
By: Xxxxx X. Xxxx
Its: Chairman, President and CEO
GENTA JAGO Technologies B.V.
/s/ /s/Xxxxxx X. Xxxxx
--------------------------------- ---------------------------------
By: By: Xxxxxx X. Xxxxx, Ph.D.
Its: Managing Director Its: Managing Director
BRIGHTSTONE PHARMA INC.
/s/
---------------------------------
By:
Its: President
SKYE PHARMA PLC
/s/
---------------------------------
By:
Its: Chairman
