AMENDMENT NO. 2 TO PRODUCT LICENSE AND ASSIGNMENT AGREEMENT
EXHIBIT 10.1
Confidential
Treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality
request. Omissions are designated as “***”. A complete
version of this exhibit has been filed separately with the Securities and
Exchange Commission.
AMENDMENT
NO. 2 TO
This
Amendment No. 2 to that certain Product License and Assignment Agreement (this
“Amendment”) is made and entered into as of February 14, 2008 by and between
CYTOGEN CORPORATION, a Delaware corporation having an address at 000 Xxxxxxx
Xxxx Xxxx, Xxxxx 0000, Xxxxxxxxx, Xxx Xxxxxx 00000, Xxxxxx Xxxxxx (“Cytogen”), and
INPHARMA AS, a Norwegian company having an address at Pb 2030 (Xxxxxxxxxx. 00),
0000 Xxxxxxx, Xxxxxx (“Inpharma”).
RECITALS
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A.
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Cytogen
and Inpharma entered into a Product License and Assignment Agreement dated
as of October 11, 2006, as amended as of August 30, 2007 (the “License
Agreement”).
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B.
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Cytogen
and Inpharma wish to amend the terms of the License Agreement as set forth
below in accordance with Section 9.05 of the License
Agreement.
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NOW,
THEREFORE, in consideration of the foregoing, the mutual covenants and
agreements herein contained and other good and valuable consideration, the
receipt and adequacy of which is hereby acknowledged, the Parties, intending to
be legally bound, hereby agree as follows:
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1.
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Any
defined terms utilized herein and not otherwise defined herein shall have
the meaning ascribed thereto in the License
Agreement.
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2.
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Section
2.04(a) of the License Agreement is hereby amended in its entirety as
follows:
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“(a) Inpharma
hereby grants to Cytogen the exclusive options to acquire the exclusive licenses
to market, distribute, sell and otherwise commercialize and Exploit the Product
in each of Europe and Asia (each an “Option” and together
the “Options”). The
Option for Europe and the Option for Asia shall each be exercisable by Cytogen
for eighteen (18) months after the Effective Date. Cytogen may
exercise either Option or both Options by delivering to Inpharma, before
expiration of such eighteen (18) month period: (a) written notice exercising the
Option (or both Options); and (b) the exercise price for the Option (or both
Options) being exercised, as set forth in Section 3.04, by wire transfer of
immediately available funds to an account designated by Inpharma.”
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3.
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Section
3.04 of the License Agreement is hereby amended in its entirety as
follows:
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1-PR/1377790.1
“Section 3.04 Option
Payments; Adjustment to Milestones and Royalties.
Cytogen
shall pay Inpharma the following consideration for the Option or both Options
granted under Section 2.04(a):
(a) As
consideration for the grant of the Options, on the Effective Date Cytogen shall
pay Inpharma a fee of *** (the “Upfront Option
Fee”). The exercise price for the Option for Asia shall
be ***, against which *** of the Upfront Option Fee shall be
credited. Cytogen may, at its sole discretion, exercise its Option
for either Europe or Asia and the fee set forth above in the immediately
foregoing two sentences shall be independent of each
other. Notwithstanding anything to the contrary herein, if Cytogen
exercises both Options, then, in lieu of the fees set forth in the second
sentence of this Section 3.04(a) and in Section 3.04(b) with respect to Asia, or
in Sections 3.04(c) and (d) with respect to Europe, Cytogen shall pay the fees
set forth in Section 3.04(g).
(b) If
Cytogen exercises the Option for Asia (but not the Option for Europe), future
milestone payments shall be payable by Cytogen to Inpharma as
follows:
(i) Cytogen
shall make a one-time additional payment of *** to Inpharma if and when Net
Sales to third parties in Asia equal or exceed *** in any Year for the first
time;
(ii) Cytogen
shall make a one-time additional payment of *** to Inpharma if and when Net
Sales to third parties in Asia reach *** in any Year for a second time;
and
(iii) Cytogen
shall pay to Inpharma *** of any upfront license fees and milestone payments
(but not royalties) received by Cytogen or its Affiliates in consideration of
the grant by Cytogen or its Affiliates of the license or equivalent right to
Exploit the Product in any country or countries in Asia, to the extent such
upfront license fees and milestone payments are in excess of the respective
amount paid by Cytogen to Inpharma for such rights pursuant to Section
3.04(a). For the purposes of this Section 3.04, the term “upfront
license fees” means any amount that is not metered on sales of the Product and
that is received by Cytogen or its Affiliates in connection with the grant of a
license or right to Exploit the Product within eighteen (18) months after the
grant of such right or license, less (x) any amount paid by Cytogen or its
Affiliates for related services that Cytogen or its Affiliates purchases from
the licensee; and (y) any amount paid by Cytogen or its Affiliates for any asset
received by Cytogen or its Affiliate from the licensee.
(c) The
exercise price for the Option for Europe shall be ***.
(d) If
Cytogen exercises the Option for Europe (but not the Option for Asia), Cytogen
shall pay to Inpharma *** of any sales milestone payments (but not royalties)
received by Cytogen or its Affiliates in consideration of the grant by Cytogen
or its Affiliates of the license or equivalent right to Exploit the Product in
any country or countries in Europe. The Parties agree that the sales
milestone payments receivable by Cytogen or its Affiliates for the grant of
rights in Europe shall be as follows:
1-PR/1377790.1
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(i) a
one-time additional payment of *** to Cytogen in the event net sales of the
Product by the licensee to unaffiliated third parties within Europe in any
twelve (12) month period reach *** for the first time;
(ii) a
one-time additional payment of *** to Cytogen in the event net sales of the
Product by the licensee to unaffiliated third parties within Europe in any
twelve (12) month period reach *** for the first time;
(iii) a
one-time additional payment of *** to Cytogen in the event net sales of the
Product by the licensee to unaffiliated third parties within Europe in any
twelve (12) month period reach *** for the first time;
(iv) a
one-time additional payment of *** to Cytogen in the event net sales of the
Product by the licensee to unaffiliated third parties within Europe in any
twelve (12) month period reach *** for the first time; and
(v) a
one-time additional payment of ***to Cytogen in the event net sales of the
Product by the licensee to unaffiliated third parties within Europe in any
twelve (12) month period reach *** for the first time.
(e) The
amounts payable by Cytogen to Inpharma under Sections 3.04(c) and (d) shall not
exceed *** in the aggregate.
(f) In
the event the Option for Europe or the Option for Asia is not exercised by
Cytogen and any of such Options expire, Cytogen shall provide to Inpharma the
identities and contact information of the parties that Cytogen contacted with
respect to licensing and/or marketing the Product in Europe or Asia, as
applicable.
(g) In
the event that Cytogen exercises both the Option for Europe and the Option for
Asia:
(i) Cytogen
shall pay the following amount to Inpharma in lieu of the amounts set forth
above for individual exercises of the Option for Europe or the Option for
Asia. The exercise price for both Options shall be (1) an initial
payment of five million dollars ($5,000,000), due within two (2) Business Days
after exercise, and (2) three (3) additional payments of five million dollars
($5,000,000), each due on the later of (x) each of the first, second and third
anniversaries of the exercise date and (y) April 1 in the calendar year in which
each such anniversary occurs, for a total payment of twenty million dollars
($20,000,000); provided, however, that, in the
event there is a Launch of a Generic Caphosol or CalPhos Mouth Rinse during the
three (3)-year period of such payments, any such payment not yet made as of the
date of such Launch shall be reduced by ***. In the event that any
such anniversary occurs on a day that is not a Business Day, such payment shall
be made on the next succeeding Business Day. For clarity, in the
event that Cytogen gives written notice to Inpharma exercising the Options
within the eighteen (18) month period set forth in Section 2.04(a), but does not
make the first payment of five million dollars ($5,000,000) within the two (2)
Business Day period set forth in this Section 3.04(g), then such exercise of the
Options shall be deemed to be ineffective.
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(ii) The
Parties acknowledge that (x) *** of the initial five million dollar ($5,000,000)
payment referenced in Section 3.04(g)(i)(1) and (y) *** of each of the three (3)
installment payments of five million dollars ($5,000,000) each referenced in
Section 3.04(g)(i)(2) shall be allocated to the acquisition of rights to the
Product for Europe and Asia, for a total such allocation of ***. The
parties acknowledge that the remainder of the consideration payable pursuant to
Section 3.04(g)(i) represents consideration for Inpharma’s termination of
Cytogen’s royalty and milestone payment obligations. The purchase
price allocation set forth in this Section 3.04(g)(ii) shall not in any way
affect the amounts payable by Cytogen for exercise of the Options, which are set
forth exclusively in Section 3.04(g)(i) above.
(iii) Cytogen
shall be obligated to make the payments specified in Section 3.04(g)(i) and
Cytogen shall be relieved of any obligation to pay milestone payments or
royalties to Inpharma with respect to any country or countries in the
Territory. Accordingly, the following sections of the License
Agreement shall be of no further force or effect: Section 3.02, clause (i) of
Section 3.03, Section 3.05, Section 3.06, the second sentence of Section
3.07(b), Section 3.08, and Section 6.19. In addition, if Cytogen
exercises the Options, Section 6.02 shall be of no further force or effect but
Cytogen shall continue to report to the Licensors the steps it has taken towards
its plans for the Exploitation of the Product in the Territory, on or about
February 1 each year during the term of the License.”
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4.
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Section
8.01 of the License Agreement is hereby amended in its entirety as
follows:
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“Section 8.01 Termination of Agreement.
This
Agreement (and the License granted hereunder) may be terminated as
follows:
(a) by
mutual written agreement of Inpharma and Cytogen; or
(b) by
either Inpharma (with respect to Europe and Asia, on the one hand, and North
America, on the other hand, prior to the License becoming irrevocable pursuant
to Section 8.03 with respect to Europe and Asia, or with respect to the United
States, as applicable) or Cytogen, on written notice, if the other Party becomes
insolvent or seeks protection under any bankruptcy, receivership, trust deed,
creditors arrangement, composition or comparable proceeding, or if any such
proceeding is instituted against the other Party which proceeding remains
undismissed for a period of ***;
(c) by
either Inpharma (with respect to Europe and Asia, on the one hand, and North
America, on the other hand, prior to the License becoming irrevocable pursuant
to Section 8.03 with respect to Europe and Asia, or with respect to the United
States, as applicable) or Cytogen if the other Party has breached any material
obligation hereunder that remains uncured for a period of *** after written
notice and demand for cure thereof by the non-breaching Party, unless such
breach is not capable of cure, in which event the non-breaching Party may
terminate immediately.”
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5.
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Section
8.02 of the License Agreement is hereby amended in its entirety as
follows:
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“Section 8.02
Termination of License. In the event that Cytogen challenges the validity
of any Licensed Patents, including without limitation by disputing the validity
or enforceability of such Licensed Patent in any judicial or agency proceeding,
or by any interference or requested re-examination relating to such Licensed
Patents, Inpharma shall (with respect to Europe and Asia, on the one hand, and
North America, on the other hand, prior to the License becoming irrevocable
pursuant to Section 8.03 with respect to Europe and Asia, or with respect to the
United States, as applicable) have the right, in its sole discretion, to
terminate the License immediately on written notice to Cytogen; provided,
however, that the foregoing shall no in any manner limit or restrict Cytogen’s
performance of its obligations or exercise of its rights under this
Agreement.”
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6.
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Section
8.03 of the License Agreement is hereby amended in its entirety as
follows:
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“Section
8.03 Fully Paid Up License. Upon the expiration of the
last Valid Claim in the Licensed Patents, the License shall be fully paid-up,
irrevocable and continue in perpetuity; provided, however, that, in the event of
the exercise of both Options, then the License shall be fully paid-up,
irrevocable and continue in perpetuity (a) in the United States, upon Inpharma’s
receipt of all option exercise payments described in Section 3.04(g)(i)(2), and
(b) in Europe and Asia, upon Inpharma’s receipt of the initial payment
referenced in Section 3.04(g)(i)(1) (in each case, if such payment occurs prior
to the expiration of the last Valid Claim in the Licensed
Patents).”
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7.
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Section
8.04(a) of the License Agreement is hereby amended in its entirety as
follows:
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“Section
8.04 Procedure upon Termination or Expiration.
(a) In
the event of termination of this Agreement and the License:
(i)
Cytogen shall promptly cease all Exploitation of the Product and destroy all of
its inventory of the Product, unless both Options have been exercised and the
License has become irrevocable pursuant to Section 8.03;
(ii) Any
sublicenses of the Licensed Intellectual Property granted by Cytogen shall
automatically terminate, provided however if Cytogen has sublicensed any of its
rights under this Agreement, any sublicenses of the License Intellectual
Property granted by Cytogen shall survive termination of this Agreement only as
set forth in Section 8.04(c) below; and
(iii)
Within ***, Cytogen shall deliver to Inpharma a written report of Net Sales and
all amounts due to Inpharma for the period before termination, and all such
undisputed amounts hereunder shall be immediately due and payable; provided,
however, that, in the event of the exercise of the Option, then this clause
(iii) shall be of no force or effect.”
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8.
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Insert
new Section 8.04(c):
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“Any
sublicense shall survive termination of this Agreement if the sublicensee
complies with the following: (i) if Cytogen has exercised the Option for
Europe only, or Asia only, and has sublicensed its rights to the Product
in such Option Territory to a sublicensee, such sublicense shall survive
if Cytogen has paid the exercise price for the applicable Option set forth
in Section 3.04, and the sublicensee shall assume in writing any
outstanding obligations of Cytogen pursuant to this Agreement with respect
to the applicable Option Territory, including without limitation the
obligation to pay any amounts due to Inpharma under Section 3.04 of this
Agreement and remaining unpaid; (ii) if Cytogen has exercised the Options
for both Europe and Asia and Cytogen has sublicensed its rights for Europe
and/or Asia to one or more sublicensees, such sublicense(s) shall survive
if Cytogen has made the initial payment referenced in Section
3.04(g)(i)(1) and such sublicensee(s) shall assume in writing any other
outstanding obligations of Cytogen pursuant to this Agreement with respect
to Europe and/or Asia, as applicable; (iii) if Cytogen has exercised the
Options for both Europe and Asia and Cytogen has sublicensed its rights
for the United States to a sublicensee, such sublicense shall survive if
Cytogen has made the payments referenced in Section 3.04(g)(i)(2) or if
such sublicensee shall assume in writing the obligation to make any
remaining payments referenced in Section 3.04(g)(i)(2) and any other
outstanding obligations of Cytogen pursuant to this Agreement with respect
to the United States; (iv) if Cytogen has sublicensed its rights to the
Product in the United States and Cytogen has not exercised both Options,
Cytogen’s sublicense shall survive if the sublicensee shall assume in
writing any outstanding obligations of Cytogen applicable to the Initial
Territory, including without limitation the obligation to pay any amounts
due to Inpharma under Section 3.02 and 3.03 remaining unpaid;
and (v) if both Options have been exercised and Cytogen has sublicensed
its rights for Europe and Asia to a single sublicensee and such sublicense
survives termination in accordance with clause (ii) of this Section 8.03,
Cytogen’s sublicensee for Europe and Asia shall have the option (unless
Cytogen has separately sublicensed the rights to the Product for the
United States to a third party and such sublicense survives such
termination) to expand its license to include the United States on the
terms and conditions (including without limitation the obligation to pay
to Inpharma any remaining payments under Section 3.04(g)(i)(2)) set forth
in this Agreement.”
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9.
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Except
as expressly provided in this Amendment, all other terms, conditions and
provisions of the License Agreement shall continue in full force and
effect as provided therein. Any reference to the License Agreement in any
instrument or agreement shall mean and include the License Agreement as
amended by this Amendment. In the event of any conflict between
the terms of the License Agreement and the terms of this Amendment, the
terms of this Amendment shall govern and
control.
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10.
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The
License Agreement and this Amendment constitute the entire understanding
between the parties, except as expressly set forth herein, and supersede
any contracts, agreements or understanding (oral or written) of the
parties with respect to the subject matter hereof. No term of
this Amendment may be amended except upon written agreement of the
parties.
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11.
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This
Amendment may be executed by facsimile or “.pdf” file and in one or more
counterparts, each of which will be deemed an original but all of which
together will constitute one and the same
instrument.
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[remainder
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IN
WITNESS WHEREOF, Cytogen and Inpharma have entered into this Amendment effective
as of the date first written above.
CYTOGEN
CORPORATION
By /s/ Xxxxx X. Xxxxx
Xxxxx
X. Xxxxx
President
and Chief Executive Officer
INPHARMA
AS
By /s/ Xxxxxxx X. Xxxxxx
Xxxxxxx
X. Xxxxxx
President
and Chief Executive Officer
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