Exhibit 10.5.4
Confidential portions of this
document have been omitted and filed separately with the Commission. The omitted portions
have been marked as follows: “***”.
Confidential
DEED OF CONSENT AND
NOVATION
This
Deed of Consent and Novation (this “Deed”) is entered into as of August
4, 2004 among Jagotec AG (“Jagotec”), Quintiles Transnational Corp.
(“Quintiles”), Quintiles Ireland Limited, an affiliate of Quintiles
(“QIreland”), Xxxxxxx Pharmaceuticals, Inc. (“Xxxxxxx”)
and BDY Acquisition Corp. (the “Buyer”), a wholly-owned subsidiary
of Xxxxxxx.
Recitals
A. Jagotec and Bioglan Pharma
Plc entered into the Licence and Manufacturing Agreement dated March 13, 2000
(the “Licence and Manufacturing Agreement”) regarding a pharmaceutical
product known as Solaraze®;
B. Jagotec and Bioglan Pharma Plc
entered into the Addendum Agreement dated December 28, 2000 (the “Addendum Agreement”);
C. Jagotec, Bioglan Pharma Plc and
QIreland entered into the Second Addendum dated December 20, 2001 (the “Second Addendum”);
D. Jagotec, Bioglan Pharma Plc,
Bioglan Pharma Inc. (now known as BPI New Corp.), QIreland and Quintiles entered into the
Deed of Variation and Novation dated December 20, 2001 (the “Deed of Variation and
Novation”) (the Licence and Manufacturing Agreement, the Addendum Agreement, the Second
Addendum, and the Deed of Variation and Novation are collectively referred to in this
Deed as the “Licence Documents”);
E. Bioglan Pharmaceuticals Company,
an affiliate of Quintiles, and QIreland plan to transfer and sell certain assets to the
Buyer, a company organized under the laws of Delaware, U.S.A. (the “Transaction”);
F. In connection with the
Transaction, Quintiles and its affiliates have requested that Jagotec consent to the
transfer of the Licence Documents to the Buyer and agree to certain matters as set forth
in this Deed; and
G. Jagotec agrees to consent to
certain other matters on the terms set forth in this Deed.
NOW, THEREFORE, the parties agree as
follows:
| (1) |
Jagotec
hereby consents, acknowledges and agrees to the following: |
| |
(a) |
QIreland
may assign and transfer all of its rights and obligations under the
Licence Documents to the Buyer at the closing of the Transaction (the
“Assignment Date”); provided, such assignment and transfer shall not
take place prior to Jagotec receiving the payment referred to in
clause 3 below and if for any reason that date |
| |
of
receipt is later than the date of the closing of the Transaction then that later
date shall be the Assignment Date: |
| |
(i) |
the
Buyer shall assume and be responsible for all liabilities and obligations
of QIreland arising after the Assignment Date, under the Licence Documents; |
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(ii) |
the Buyer
shall have and enjoy all the rights and benefits of QIreland under the Licence
Documents including without limitation under Section 7.1 of the Deed of
Variation and Novation. For the avoidance of doubt, the Licence Documents
provide Buyer with ***; |
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(iii) |
QIreland
releases and discharges Jagotec from all its obligations and liabilities
to QIreland under the Licence Documents which accrue in respect of acts or
omissions of Jagotec after the Assignment Date; |
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(iv) |
Jagotec
releases and discharges QIreland from all its obligations and liabilities
to Jagotec under the Licence Documents which accrue in respect of acts or
omissions of QIreland after the Assignment Date; |
| |
(v) |
QIreland
shall cease to be a party, and the Buyer shall become a party, to the
Licence Documents with respect to all rights and obligations of QIreland
under the Licence Documents arising after the Assignment Date; |
| |
(vi) |
Clause
11 and Schedule 1 of the Deed of Variation and Novation, regarding a
guarantee of Quintiles Transnational Corp., shall terminate and have no
further force or effect and shall not constitute an obligation of the
Buyer; and |
| |
(vii) |
the
assignment and novation envisaged by this Deed shall not constitute a
“termination” within the meaning of Clause 5.7 of the Licence and
Manufacturing Agreement as amended in the Second Addendum; |
| |
(b) |
The
parties acknowledge and agree that: |
| |
(i) |
any
obligation of QIreland owed to Jagotec pursuant to the terms of the
Licence Documents which remain undischarged at the Assignment Date shall
not be deemed to be waived by Jagotec by virtue of Clause 1(a)(iv) and |
| |
shall
remain obligations owed to Jagotec by QIreland, which for the
avoidance of doubt shall include all royalty obligations due from
QIreland in respect of any period prior to the Assignment Date; and |
| |
(ii) |
any
obligations of Jagotec owed to QIreland pursuant to the terms of
the Licence Documents which remain undischarged at the Assignment
Date shall not be deemed to be waived by QIreland by virtue of
Clause 1(a)(iii) and shall remain obligations owed by Jagotec to
QIreland. |
| |
(c) |
Notwithstanding
clause 18 of the Licence and Manufacturing Agreement, the Buyer shall be
entitled to assign and transfer any and all of its rights and obligations
under the Licence Documents, without Jagotec’s consent, to an Associated
Company (as such term is defined in the Licence and Manufacturing Agreement)
of the Buyer, provided that prior written notice of such assignment is given
to Jagotec; |
| |
(d) |
In
the event that the Buyer shall have entered into any arrangement
pursuant to clause 1(c) above whereby the Buyer shall have assigned the
benefit of the Licence Documents to any Associated Company of the Buyer,
the Buyer shall not allow any transaction or event to take place whereby
such Associated Company shall cease to be an Associated Company of the
Buyer without first ensuring that the benefit of the Licence
Documents shall prior to any such transaction or event be
assigned by such Associated Company to the Buyer or assigned to
another Associated Company of the Buyer; |
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(e) |
In
the event of an assignment pursuant to clause 1(c) or (d), this Deed
shall be binding upon such assignee but no such assignment or transfer
shall relieve the Buyer of any of, and the Buyer shall remain
responsible for, its obligations under the Licence Documents. In such
circumstances the Buyer (or any such other Associated Company, as the
case may be, to which such benefit shall be assigned) shall at the same
time as any such assignment execute an agreement in substantially the
same terms as this Deed; and |
| |
(f) |
The
Licence Documents constitute all of the agreements, arrangements or
understandings with respect to the subject matter thereof; the Licence
Documents have not been amended or modified; the Licence Documents are
in full force and effect and, to the knowledge of Jagotec, QIreland and
Quintiles are in compliance with the Licence Documents and no breach or
default has occurred thereunder, and no event has occurred and no
circumstance exists that would constitute a breach or default. |
(2) Without limiting the provisions
of the Licence Documents in any manner, Jagotec confirms and agrees that the term “Patent
Rights” as defined in the Addendum Agreement
includes the patents and patent
applications as shown in the attached schedule 2, and that Jagotec is owner of such
patents and patent applications.
(3) In consideration for Jagotec
consenting to the assignment and novation of the Licence Documents to the Buyer,
Quintiles agrees to pay to Jagotec a consent fee of Five Million United States Dollars
(US $5,000,000) at or prior to the closing of the Transaction. Prior to execution of this
Deed, QIreland’s obligation to pay all royalties and other fees under the Licence
Documents due in respect of sales in 2001, 2002, 2003 and the first quarter of 2004 has
been fulfilled. There is no known outstanding dispute with respect to royalties or other
fees under the Licence Documents. However, no royalty audit pursuant to Clause 4.4 of the
Licence and Manufacturing Agreement has yet taken place and the statements made in this
clause are without prejudice to Jagotec’s rights pursuant to the Licence and
Manufacturing Agreement including those contained in Clause 4.4
(4) Prior to or following the
Assignment Date, each party agrees to execute and deliver such other agreements,
documents and instruments, and to do and take such other acts or actions, as any other
party to this Deed shall reasonably request for the purpose of carrying out the intent of
this Deed, including without limitation in order to carry out or further evidence the
assignment and transfer of all of QIreland’s right, title and interest in, to and under
Licence Documents to the Buyer.
(5) This Deed shall be binding upon
the parties hereto and their successors and assigns and shall inure to the benefit of
such parties and their permitted successors and assigns. The parties do not intend that
any term of this Deed shall be enforceable solely by virtue of the Contracts (Rights of
Third Parties) Xxx 0000 by any person who is not a party to this Deed.
(6) This Deed may be executed in any
number of counterparts, each of which when executed and delivered shall be deemed to be
an original and all of which counterparts taken together shall constitute one and the
same instrument. The exchange of copies of this Deed and of executed signature pages by
facsimile transmission or by email transmission in portable digital format, or similar
format, shall constitute effective execution and delivery of this Deed. Signatures of the
parties transmitted by facsimile, or by email in portable digital or similar format shall
be deemed to be their original signatures for all purposes.
(7) In consideration of Jagotec
entering into this Deed, Xxxxxxx hereby gives in favour of Jagotec the guarantee in the
terms set out in schedule 1.
(8) Each party to this Deed
represents and warrants to the other parties that: (a) it is duly organized, validly
existing, and in good standing under the laws of the jurisdiction in which it is
organized, with full corporate power and authority to execute, deliver and perform
this Deed; and (b) this Deed constitutes the legal, valid and binding obligation of
it, enforceable against it in accordance with the terms of this Deed. Jagotec
represents and warrants to the other parties that it is an Associated Company of
SkyePharma Plc. The Buyer and Xxxxxxx represents and
warrants to the other parties that
the Buyer is an Associated Company of Xxxxxxx, and that the Buyer is incorporated in the
U.S.A.
(9) If any provision of this Deed is
or becomes illegal, invalid or unenforceable in any jurisdiction, that shall not affect:
| |
(a) |
the
legality, validity or enforceability in that jurisdiction of any other
provision of this Deed; or |
| |
(b) |
the
legality, validity or enforceability in any other jurisdiction of any
other provision of this Deed. |
(10) The rights of each party under
this Deed:
| |
(a) |
may
be exercised as often as necessary; |
| |
(b) |
are
cumulative and not exclusive of its rights under the general law; |
| |
(c) |
may
be waived only in writing and specifically; and |
| |
(d) |
shall
not be deemed waived solely by any delay in exercise or non-exercise
of any such right. |
(11) This Deed constitutes the
entire agreement relating to the subject matter of this Deed and supersedes all prior
negotiations, documents, agreements, statements and understandings.
(12) In the event that the Buyer or
other party shall have entered into any arrangement pursuant to clause 1(c) whereby
the Buyer shall have assigned the benefit of the Licence Documents to any Associated
Company of the Buyer or pursuant to clause 1(d) and such assignment results in any set
off or deduction whatsoever including, without limitation, any deduction of taxes,
charges or other duties that may be required by law, the sums paid under this Deed
or under the Licence Documents shall be grossed up such that the payment made shall be
as if it had been made in full without any such set-off or deduction provided that
Jagotec agrees to cooperate in taking all reasonably necessary steps to take advantage
of all double taxation treaties that may be available.
(13) This Deed is governed by and
shall be construed in accordance with English law.
(14) The parties agree that the
courts of England shall have jurisdiction to settle any disputes which may arise in
connection with this Deed and that any judgment or order of an English court in
connection with this is conclusive and binding on them and may be enforced against
them in the courts of any other jurisdiction.
(15) Jagotec, Quintiles, and the
Buyer undertake to, at all times, maintain an agent for service of process in England.
Such agent shall be:
| |
(a) |
in
relation to Jagotec: |
| |
SkyePharma
Plc, 000 Xxxxxxxxxx, Xxxxxx X0X 0XX for the attention of the Company Secretary |
| |
(b) |
in
relation to the Buyer: |
| |
The
London Law Agency Limited, Temple Xxxxxxxx, 00 Xxxxxx Xxxxxxxx, Xxxxxx, Xxxxxxx XX0X OHP
for the attention of the Buyer’s Secretary |
| |
(c) |
in
relation to Quintiles: |
| |
Quintiles
Transnational Corp.
c/o Quintiles, Ltd.
Xxxxxxx Xxxxx
Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxx XX00 0XX
Attn: Xxxxxxxx XxxXxxxxx, Vice President
of Legal and Quality Services |
or such other address as is notified
hereunder to the other of such parties in writing. Further, each of Jagotec, Quintiles,
and the Buyer undertake not to revoke the authority of the above and, if for any reason
any such agent no longer serves as agent for them, they shall promptly appoint another
such agent and advise the other parties accordingly.
[signature page follows]
[Signature page to Deed
of Consent and Novation]
IN WITNESS WHEREOF, the parties
hereto, through their respective authorized representatives below, have duly executed and
delivered this document as a Deed as of the date set forth above.
| Executed
as a deed by JAGOTEC AG: |
)
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Director
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/s/ [ILLEGIBLE]
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Director
or Secretary |
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/s/ [ILLEGIBLE]
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Executed
as a deed by QUINTILES
IRELAND LIMITED: |
)
) |
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Director |
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/s/ [ILLEGIBLE]
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Director
or Secretary |
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/s/ [ILLEGIBLE]
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Executed
as a deed by QUINTILES
TRANSNATIONAL CORP.: |
)
) |
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Director |
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/s/ [ILLEGIBLE]
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Director
or Secretary |
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/s/ [ILLEGIBLE]
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Executed
as a deed by XXXXXXX
PHARMACEUTICALS, INC.:
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)
)
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Director
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/s/ [ILLEGIBLE]
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Director
or Secretary |
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/s/ Xxxx X.
Xxxxxxxx
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| Executed as
a deed by BDY ACQUISITION CORP.: |
)
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Director
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/s/ [ILLEGIBLE]
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Director
or Secretary |
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/s/ [ILLEGIBLE]
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SCHEDULE 1
The Guarantee
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Xxxxxxx
Pharmaceuticals, Inc. (“Xxxxxxx”) irrevocably and unconditionally: |
| |
(a) |
guarantees
to Jagotec as principal obligor the due and punctual performance and
observance by the Buyer of all of its obligations under this Deed; and |
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(b) |
undertakes
to indemnify Jagotec against all losses, damages, costs and expenses
incurred by Jagotec arising from any failure by the Buyer to perform
and/or observe any of its obligations under this Deed, |
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(together
this “Guarantee”). |
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This
Guarantee is to be a continuing security which shall remain in full force and
effect until all of the obligations of the Buyer under this Deed shall have
been fulfilled or shall have expired in terms of this Deed (which ever is the
sooner) and this Guarantee is to be in addition, and without prejudice to, and
shall not merge with any other right, remedy, guarantee, indemnity or security
which Jagotec may now or hereafter hold in respect of all or any of the
obligations of Buyer under this Deed. |
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The
liability of Xxxxxxx under this Guarantee shall not be affected, impaired or
discharged by reason of any act, omission, matter or thing which but for this
provision might operate to release or otherwise exonerate Xxxxxxx from its
obligations hereunder including, without limitation: |
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(a) |
any
amendment, variation or modification to, or replacement of this Deed, |
| |
(b) |
the
taking, variation, compromise, renewal, release, refusal or neglect to
perfect or enforce any rights, remedies or securities against the
Buyer or any other person; |
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(c) |
any
time or indulgence or waiver given to, or composition made with the
Buyer or any other person; or |
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(d) |
the
Buyer becoming insolvent, going into receivership or liquidation or
having an administrator appointed. |
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This
Guarantee shall continue in full force and effect notwithstanding: |
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(a) |
that
any purported obligation of the Buyer or any other person to Jagotec
(or any security therefor) becomes wholly or partly void, invalid or
unenforceable for any reason whether or not known to Jagotec or
Xxxxxxx; or |
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(b) |
any
incapacity or any change in the constitution of, or any amalgamation
or reconstruction of, the Buyer or Xxxxxxx or any other matter
whatsoever. |
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This
Guarantee shall constitute the primary obligations of Xxxxxxx and Jagotec
shall not be obliged to make any demand on the Buyer before enforcing its
rights against Xxxxxxx under this Guarantee. |
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No
delay or omission of Jagotec in exercising any right, power or privilege
under this Guarantee shall impair such right, power or privilege or be
construed as a waiver of such right, power or privilege nor shall any single
or partial exercise of any such right, power or privilege preclude any
further exercise thereof or the exercise of any other right, power or
privilege. |
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If
at any time any one or more of the provisions of this Guarantee is or becomes
invalid, illegal or unenforceable in any respect under any law, the validity,
legality and enforceability of the remaining provisions hereof shall not be
in any way affected or impaired thereby. |
This Deed is governed by and shall
be construed in accordance with English law.
Executed
as a deed by XXXXXXX
PHARMACEUTICALS, INC.
on
August 4, 2004: |
)
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Director
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/s/ [ILLEGIBLE]
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Director
or Secretary |
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/s/ Xxxx X.
Xxxxxxxx
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SCHEDULE 2
Patent Rights
“Treatment of
Conditions and Disease” - Solaraze I
|
| Country |
|
Application No. |
|
Publication No. |
|
Status |
|
|
| Canada |
|
612307 |
|
1340994 |
|
Granted |
|
|
| USA |
|
08/465,335 |
|
5,811,410 |
|
Granted |
|
|
| USA |
|
08/286,263 |
|
5,827,834 |
|
Granted |
|
|
| USA |
|
08/462,615 |
|
5,830,882 |
|
Granted |
|
|
| USA |
|
08/462,147 |
|
5,852,002 |
|
Granted |
|
|
| USA |
|
08/462,614 |
|
5,914,314 |
|
Granted |
|
|
| USA |
|
08/462,148 |
|
5,929,048 |
|
Granted |
|
|
| USA |
|
08/461,124 |
|
5,932,560 |
|
Granted |
|
|
| USA |
|
08/462,154 |
|
5,985,850 |
|
Granted |
|
|
| USA |
|
08/744,852 |
|
5,985,851 |
|
Granted |
|
|
| USA |
|
08/461,565 |
|
6,048,844 |
|
Granted |
|
|
| USA |
|
07/675,908 |
|
6,069,135 |
|
Granted |
|
|
| USA |
|
08/460,978 |
|
6,194,392 |
|
Granted |
|
|
“Formulation
Containing Hyaluronic Acid” - Solaraze II
|
| Country |
|
Application No. |
|
Publication No. |
|
Status |
|
|
| Canada |
|
2061703 |
|
2061703 |
|
Granted |
|
|
| Canada |
|
2089621 |
|
|
|
Pending |
|
|
| Mexico |
|
930904 |
|
209917 |
|
Granted |
|
|
| USA |
|
08/467,171 |
|
5,942,498 |
|
Granted |
|
|
| USA |
|
08/467,995 |
|
5,977,088 |
|
Granted |
|
|
| USA |
|
08/466,713 |
|
5,990,096 |
|
Granted |
|
|
| |
|
|
|
|
|
|
|
|
| USA |
|
08/018,754 |
|
6,103,704 |
|
Granted |
|
|
| USA |
|
08/352,697 |
|
6,114,314 |
|
Granted |
|
|
| USA |
|
08/466,714 |
|
6,140,312 |
|
Granted |
|
|
| USA |
|
08/467,994 |
|
6,218,373 |
|
Granted |
|
|
| USA |
|
08/468,330 |
|
6,147,059 |
|
Granted |
|
|
| USA |
|
08/474,732 |
|
6,087,344 |
|
Granted |
|
|
| USA |
|
08/466,715 |
|
6,136,793 |
|
Granted |
|
|
“Treatment of Disease
Employing Hyaluronic Acid and NSAIDs” - Solaraze III
|
| Country |
|
Application No. |
|
Publication No. |
|
Status |
|
|
| Canada |
|
2061566 |
|
2061566 |
|
Granted |
|
|
| Canada |
|
2089635 |
|
|
|
Pending |
|
|
| Mexico |
|
930905 |
|
|
|
Pending |
|
|
| USA |
|
07/838,675 |
|
5,639,738 |
|
Granted |
|
|
| USA |
|
08/018,508 |
|
5,792,753 |
|
Granted |
|
|
| USA |
|
08/468,329 |
|
5,824,658 |
|
Granted |
|
|
| USA |
|
08/290,848 |
|
5,910,489 |
|
Granted |
|
|
| USA |
|
08/466,774 |
|
5,914,322 |
|
Granted |
|
|
| USA |
|
08/466,778 |
|
5,962,433 |
|
Granted |
|
|
| USA |
|
08/466,775 |
|
6,017,900 |
|
Granted |
|
|
