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Exhibit 10.43
AMENDMENT NO. 7 TO LICENSE & OPTION
AGREEMENT
THIS AMENDMENT NO. 7 TO THE LICENSE & OPTION AGREEMENT
("Amendment No. 7") is made and entered into this 27
th day of December,
2006 (the "Amendment No. 7 Effective Date") by and between
Oscient Pharmaceuticals Corporation ("OSCIENT"), a Massachusetts
corporation, having a principal place of business at 1000 Winter
Street, Suite 2200, Waltham, Massachusetts 02451, and LG Life
Sciences, LTD ("LGLS"), a corporation organized under the laws of
the Republic of Korea, having a principal place of business at LG
Twin Tower, 20 yoido-dong, Youngdungpo-gu, Seoul, 150-721, Republic
of Korea. LGLS and OSCIENT may be referred to herein individually
as a "Party" and collectively as the "Parties".
W I T N E S S E T H
WHEREAS, LGLS and GeneSoft Pharmaceuticals, Inc. entered into a
certain License and Option Agreement dated October 22, 2002
and amended said License and Option Agreement by Amendment
No. 1 dated November 21, 2002, Amendment No. 2 dated
December 6, 2002, Amendment No. 3 dated October 16,
2003, Amendment No. 4 dated March 31, 2005, Amendment
No. 5 dated February 3, 2006, and Amendment No. 6
dated February 3, 2006 (as amended, the "License");
WHEREAS, Genesoft merged into Genesoft Pharmaceuticals, LLC
(then Guardian Holdings, LLC ("Guardian")) on February 6, 2004
and the benefits of and obligations under the License were assigned
to Guardian, and then, Guardian assigned all of its right, title
and interest in, to and under the License to OSCIENT;
WHEREAS, OSCIENT is about to enter into a Partnership agreement
with Menarini (as defined below) for Menarini’s marketing of
the Product in the European Territory (as defined below)
immediately after the execution of this Amendment No. 7 based
on and in accordance with the License; and the Parties desire to
amend the License to, among other things, provide certain terms and
conditions necessary for such Partnership deal between OSCIENT and
Menarini and amend the supply price, royalty rate and milestones
related to sales of the Product; and
WHEREAS, the terms used herein with capital initial letters and
not otherwise defined shall have the same meanings as set forth in
the License.
NOW THEREFORE, in consideration of the premises, and other good
and valuable consideration, the sufficiency of which is hereby
acknowledged, the Parties agree as follows:
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1.
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Section 1.36 shall be deleted in its
entirety and replaced with the following:
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1.36 "Territory" means the United
States of America, Canada, Mexico, France, Germany, the United
Kingdom, Luxembourg, Ireland, Italy, Spain, Portugal, Belgium, the
Netherlands, Austria, Greece, Sweden, Denmark, Finland, Norway,
Iceland, Switzerland, Andorra, Monaco, San Marino, Vatican City,
Poland, Czech Republic, Slovakia, Slovenia, Hungary, Estonia,
Latvia, Lithuania, Liechtenstein, Malta, Cyprus, Romania, Bulgaria,
Croatia, Serbia and Montenegro, Bosnia and Herzegovina, Albania and
the Former Yugoslav Republic of Macedonia.
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2.
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A new Section 1.46 shall be inserted to
define "Centralized Procedure" as follows:
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1.46 " Centralized Procedure
" shall mean the centralized procedure for obtaining a Marketing
Authorization in the European Union as set forth in Regulation (EC)
726/2004.
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3.
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A new Section 1.47 shall be inserted to
define "European Territory" as follows:
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Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
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Confidential
1.47 " European Territory "
means France, Germany, the United Kingdom, Luxembourg, Ireland,
Italy, Spain, Portugal, Belgium, the Netherlands, Austria, Greece,
Sweden, Denmark, Finland, Norway, Iceland, Switzerland, Andorra,
Monaco, San Marino, Vatican City, Poland, Czech Republic, Slovakia,
Slovenia, Hungary, Estonia, Latvia, Lithuania, Liechtenstein,
Malta, Cyprus, Romania, Bulgaria, Croatia, Serbia and Montenegro,
Bosnia and Herzegovina, Albania and the Former Yugoslav Republic of
Macedonia.
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4.
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A new Section 1.48 shall be inserted to
define "Major Countries" as follows:
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1.48 " Major Countries "
shall mean each of France, Germany, Italy, Spain and the United
Kingdom.
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5.
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A new Section 1.49 shall be inserted to
define "Marketing Authorization" as follows:
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1.49 " Marketing
Authorization " shall mean an authorization issued by the
European Medicines Agency, or any other national, regional, state
or local regulatory agency in the European Territory with the
relevant regulatory authority, necessary to market and sell the
Product in the European Territory or in any country in the European
Territory.
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6.
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A new Section 1.50 shall be inserted to
define "Menarini" as follows:
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1.50 " Menarini " means Menarini
International Operations Luxembourg SA at Avenue de la Gare, 1,
L-1611 Luxembourg GD and any of its Affiliates.
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7.
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Section 2.5 shall be deleted in its entirety
and replaced with the following:
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2.5 Costs of Development. All
Development expenses shall be borne by OSCIENT; provided that, LGLS
shall reimburse OSCIENT for 50% of all amounts paid to Menarini by
OSCIENT for all reasonable and verifiable regulatory development
expenses incurred by Menarini in the European Territory; provided
that in no event such reimbursement payments by LGLS shall exceed
$[*] in the aggregate. With respect to any such regulatory
development expenses to be reimbursed by LGLS, OSCIENT shall
provide LGLS with a copy of the statement prepared by Menarini
setting forth in detail such development expenses incurred by
Menarini in the relevant quarter and proof of payment of such
expenses by OSCIENT, such as receipt or payment slip. LGLS shall
reimburse OSCIENT as provided for in this Section 2.5 within
thirty (30) days of its receipt of all such statements and
proofs. OSCIENT shall cause Menarini to keep complete and accurate
books and financial records pertaining to such costs and expenses
of regulatory development. LGLS shall have the right, at its
discretion, to annually audit all such books and records of OSCIENT
and Menarini upon advance notice to OSCIENT, and OSCIENT shall duly
cooperate with LGLS. OSCIENT shall also cause Menarini to duly
cooperate with LGLS with respect to such audit.
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8.
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A new Section 4.3(d)(iii) shall be inserted
as follows:
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4.3 Co-Promotion.
(d)(iii) Upon Oscient entering into a Partnership in the
European Territory with Menarini, LGLS’ option under
subsection 4.3(a) above with respect to the European Territory
shall terminate and no longer be exercisable.
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9.
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Section 5.1(a)(ii) shall be deleted in its
entirety and replaced with the following:
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Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed separately with the
Commission.
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Confidential
(a) (ii) Following the expiration or
termination of the Initial Period and until the expiration or
termination of the License (the "Remaining Period"), LGLS shall
supply to OSCIENT, and OSCIENT shall exclusively purchase from
LGLS, all of OSCIENT’s requirements of API; provided
that OSCIENT’s obligation to exclusively purchase API to
be supplied in Mexico, Canada or the European Territory shall
expire on the last to expire of the LGLS Patents and GLAXO Patents
claiming or covering such Product in Mexico, Canada or the European
Territory, as the case may be. Notwithstanding anything herein to
the contrary, OSCIENT agrees that it shall exclusively purchase
from LGLS all its requirements of API for Mexico, Canada, and/or
the European Territory, as the case may be, so long as and to the
extent that OSCIENT continues to supply API or Final Product in
Mexico, Canada or the European Territory irrespective of any expiry
of LGLS Patents and GLAXO Patents.
LGLS shall not sell and shall procure that its Affiliates,
sublicensees and distributors shall not sell, Final Product or API
to any Third Party for use or resale in the European Territory so
long as and to the extent that OSCIENT exclusively purchases from
LGLS all its requirements of API and OSCIENT’s sublicensees
and distributors exclusively purchases from OSCIENT all their
requirements of API.
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10.
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A new Section 5.2(iv) shall be inserted as
follows:
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5.2 Supply Price.
(iv) Notwithstanding anything to the contrary in
Section 5.2(iii), the API supply price to OSCIENT for use by
Menarini or its Affiliates or subcontractors in Finished Product
marketed, sold and distributed in the European Territory shall be
$[*] per kg irrespective of the volume of API purchased by OSCIENT
after the grant of Marketing Authorization in at least one country
in the European Territory is obtained. Prior to obtaining the
Marketing Authorization in at least one country in the European
Territory, the API supply price to OSCIENT for use by Menarini or
its Affiliates shall be (A) prior to January 1, 2008, the
same as the supply price to OSCIENT for the US, and (B) on or
after January 1, 2008, $[*] per kg up to an aggregate of [*]
kg with any additional amounts to be purchased at the then current
supply price to OSCIENT for the US.
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11.
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A new Section 5.6.4 (i) shall be
inserted as follows:
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(i) OSCIENT acknowledges and agrees that all API
for use by Menarini shall be manufactured by LGLS. OSCIENT shall
ensure that all such API shall be delivered to Menarini directly.
OSCIENT shall forward to LGLS all purchase orders for API placed by
Menarini at least 90 days prior to the date upon which LGLS is
requested to ship such API. OSCIENT shall use best efforts to
ensure that all API delivered to Menarini shall be used in the
European Territory only and that such API shall not be shipped,
distributed or otherwise be used in any way whatsoever and
howsoever outside the European Territory.
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12.
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Section 10.2 shall be deleted in its
entirety and replaced with the following:
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10.2 Milestone Payments.
(i) Following the achievement of each milestone set forth below,
OSCIENT shall owe a non-refundable milestone payment to LGLS in the
amount and at the times set forth below. Each milestone payment
shall be due only once, notwithstanding the number of Products
actually
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Portions of this exhibit have been omitted
pursuant to a confidential treatment request. An unredacted version
of this exhibit has been filed sep
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