SETTLEMENT & WORLDWIDE LICENSE AGREEMENT
CONFIDENTIAL
TREATMENT REQUESTED: Certain portions of this document have been
omitted pursuant to a request for confidential treatment and, where applicable,
have been marked with an asterisk (“[****]”) to denote where omissions have been
made. Note that one page of this exhibit contains omitted material pursuant
to
this request. The confidential material has been filed separately with the
Securities and Exchange Commission.
SETTLEMENT
& WORLDWIDE LICENSE AGREEMENT
AGREEMENT
(“Agreement”) made as of January 31, 2001, (the “Effective Date”), by and among
Xxxxxx International B.V. (“Bracco”), a Netherlands corporation having a place
of business at 3051 Strawinskylaan, 1077 ZX Amsterdam, Netherlands; Schering
Aktiengesellschaft (“Schering”), a German corporation having a place of business
at Xxxxxxxxxxxxx 000, 00000 Xxxxxx-Xxxxxxx, Xxxxxxx; and Alliance Pharmaceutical
Corp. (“Alliance”), a New York corporation having a place of business at 0000
Xxxxxxx Xxxx Xxxx, Xxx Xxxxx, Xxxxxxxxxx 00000. Bracco, Schering, and Alliance
may be referred to separately as a “Party” or collectively as the
“Parties”.
WHEREAS,
Bracco possesses intellectual property relating to the formulation method
of
preparing or use of Microbubbles (as this term is defined below);
WHEREAS,
Alliance possesses intellectual property relating to the formulation method
of
preparing or use of Microbubbles;
WHEREAS,
Schering possesses intellectual property relating to the formulation method
of
preparing or use of Microbubbles;
WHEREAS,
Schering and Alliance have entered into a License Agreement under which Alliance
granted to Schering an exclusive worldwide license with a right to sublicense
under the Alliance Patents as defined therein;
WHEREAS,
there is pending before the United States Patent and Trademark Office
Interference No. 104,427 between Bracco and Alliance; and
WHEREAS,
the Parties desire to settle the interference and all potential intellectual
property disputes relating to their future and planned activities involving
certain Products (as this term is defined below) or Microbubbles that have
been
or are currently being developed or may be developed in the future.
NOW,
THEREFORE, in consideration of the foregoing and the covenants and
acknowledgements and representations contained in this Agreement, the Parties
hereby agree as follows:
ARTICLE
I. DEFINITIONS
1.1. Definitions.
For
purposes of this Agreement, the terms defined in this Article shall have
the
meanings specified below. These terms are intended to encompass both the
singular and plural forms.
1
| 1.1.1 |
“Affiliate”
shall mean a person or an entity that controls, is controlled by,
or is
under common control with a Party to this
Agreement.
|
| 1.1.2 |
“Alliance”
shall mean Alliance as identified as a Party above and any Affiliate
of
Alliance.
|
| 1.1.3 |
“Alliance
Licensed Patents”
shall mean Licensed Patents which are owned, obtained, acquired,
purchased
by or licensed to, with a right to sublicense, or in any way under
the
control or at disposal of Alliance, except for Third Party patents
and
patent applications acquired after December 20, 2000 by Alliance
which,
prior to their acquisition and not as a result of the negotiations
leading
up to such acquisition, had been previously exclusively licensed
or
otherwise exclusively restricted to any Third
Party.
|
| 1.1.4 |
“BR-1”
shall mean a phospholipid-stabilized Microbubble formulation not
prepared
by freeze drying wherein the fluorine atoms contained in the Microbubbles
are in the form of SF6.
|
| 1.1.5 |
“BR-14”
shall mean a phospholipid-stabilized Microbubble formulation not
prepared
by spray drying wherein the fluorine atoms contained in the Microbubbles
are in the form of CF4,
C2F6,
C3F6,
C4F10
or
mixtures thereof.
|
| 1.1.6 |
“Bracco”
shall mean Bracco as identified as a Party above and any Affiliate
of
Bracco.
|
| 1.1.7 |
“Bracco
Licensed Patents”
shall mean Licensed Patents which are owned, obtained, acquired,
purchased
or licensed to, with a right to sublicense, or in any way under
the
control or at disposal of Bracco, except for Third Party patents
and
patent applications acquired after December 20, 2000 by Bracco
which,
prior to their acquisition and not as a result of the negotiations
leading
up to such acquisition, had been previously exclusively licensed
or
otherwise exclusively restricted to any Third
Party.
|
| 1.1.8 |
“Distributor”
shall mean any Third Party engaged solely in the shipping, transportation,
or distribution of any product, whether or not owned by a
Party.
|
| 1.1.9 |
“Imavist”
shall mean a phospholipid-stabilized Microbubble formulation not
prepared
by freeze drying wherein the fluorine atoms contained in the Microbubble
are in the form of C6F14.
|
| 1.1.10 |
“Imavist
II”
shall mean a phospholipid-stabilized Microbubble formulation not
prepared
by freeze drying wherein the fluoride atoms contained in the Microbubble
are in the form of C6F14 or any three fluoroether species or any
combination thereof to be named by Alliance within five years of
the
Effective Date of this Agreement.
|
2
| 1.1.11 |
“Joint
Development Parties”
shall mean any Third Party engaged in the development, manufacture,
sale,
use, exportation or importation of a Party’s
Product(s).
|
| 1.1.12 |
“Licensed
Patents”
shall mean all present and future patent and patent application
claims,
worldwide, that are directed to Microbubbles, formulations of
Microbubbles, intermediates used in making Microbubbles, methods
of
preparing Microbubbles or the use of Microbubbles in Ultrasound
Imaging
(including harmonic imaging) that cover a Product, method of preparing
a
Product or method of using a Product, provided that such patent
and patent
application claims shall not include those directed to (i) non-Ultrasound
Imaging uses of Microbubbles such as uses in drug delivery; gene
therapy;
sonothrombolysis; magnetic resonance imaging; and oxygen delivery,
and
(ii) Microbubbles with targeting ligands, peptides or chelates
and
formulations, intermediates for, methods of preparing and the use
of
same.
|
| 1.1.13 |
“Medical
Diagnostic Imaging Field”
shall mean any in
vivo
imaging of at least a portion of a patient, including but not limited
to
radiopharmaceutical, ultrasound, MRI, X-ray and light
imaging.
|
| 1.1.14 |
“Microbubbles”
shall mean microbubbles, microspheres, microballoons, microparticles
and/or microvesicles containing gas or gas
mixtures.
|
| 1.1.15 |
“Physiologically
Acceptable Gas”
shall mean a gas selected from air, nitrogen, oxygen, carbon dioxide,
helium, xenon or mixtures thereof.
|
| 1.1.16 |
“Products”
shall mean Imavist or Imavist II in the case of Alliance or Schering,
and
BR-1 or BR-14 in the case of
Bracco.
|
| 1.1.17 |
“Schering”
shall mean Schering as identified as a Party above and any Affiliates
of
Schering.
|
| 1.1.18 |
“Schering
Licensed Patents”
shall mean Licensed Patents which are owned, obtained, acquired,
purchased
by or licensed to, with a right to sublicense, or in any way under
the
control or at disposal of Schering, except for Third Party patents
and
patent applications acquired after December 20, 2000 by Schering
which,
prior to their acquisition and not as a result of the negotiations
leading
up to such acquisition, had been previously exclusively licensed
or
otherwise exclusively restricted to any Third
Party.
|
| 1.1.19 |
“Third
Party”
shall mean any entity other than Bracco, Alliance, or Schering,
including
any person or other entity that controls, is controlled by, or
is under
common control with that entity.
|
3
| 1.1.20 |
“Ultrasound
Imaging”
shall mean the in
vivo
imaging of at least a portion of a patient with ultrasound, including
but
not limited to harmonic imaging.
|
ARTICLE
II. WORLDWIDE
GRANT OF INTELLECTUAL PROPERTY RIGHTS
2.1. Bracco
hereby grants an irrevocable worldwide nonexclusive license to Schering and
Alliance under the Bracco Licensed Patents to make, have made, use, sell,
offer
to sell, import Imavist and/Imavist II, whether or not Imavist and/or Imavist
are combined with other elements and used outside the coverage of the Licensed
Patents. This license of the instant provision 2.1 includes the right to
sublicense such rights to current and future Distributors and Joint Development
Partners.
2.2. Schering
hereby grants an irrevocable worldwide nonexclusive license to Bracco under
the
Schering Licensed Patents to make, have made, use, sell, offer to sell, import
or export BR-1 and/or BR-14, whether or not BR-1 and/or BR-14 are combined
with
other elements and used outside the coverage of the Licensed Patents. This
license of the instant provision 2.2 includes the right to sublicense such
rights to current and future Distributors and Joint Development
Partners.
ARTICLE
III. WORLDWIDE
SETTLEMENT OF INTELLECTUAL PROPERTY DISPUTES
3.1. It
is the
intention of the Parties to settle any and all current and potential
intellectual property disputes pertaining to the Licensed Products so as
to
obtain freedom to market their respective Products and therefor the Parties
have
voluntarily entered into this Agreement. In that connection, the Parties
shall:
| 3.1.1 |
withdraw
all current oppositions brought against the Licensed Patents of
another
Party in countries foreign to the United
States;
|
| 3.1.2 |
refrain
from filing any future oppositions or other challenge against the
Licensed
Patents of another Party in countries foreign to the United
States;
|
| 3.1.3 |
refrain
from filing any requests for interference, reexamination or other
challenge against the Licensed Patents of another Party in the
United
States; and
|
| 3.1.4 |
in
the event an interference is declared by the United States Patent
and
Trademark Office (“PTO”), meet and cooperate in good faith to find a joint
settlement in a timely and efficient manner consistent with the
requirements of 35 U.S.C. § 135 and other applicable laws and
regulations.
|
3.2. In
order
to advance the resolution of PTO interference No. 104,427 (the “Interference”),
Bracco and Alliance counsel have met, exchanged information and determined
in
good faith and in order to resolve the Interference in just, timely and
efficient manner, to proceed as follows:
4
| 3.2.1 |
Alliance
will file three motions in the Interference, namely, (1) a motion
to
[****], (2) a motion to [****], and (3)
a motion to be
[****].
|
| 3.2.2 |
Bracco
will file papers in the Interference stating that it will not oppose
the
two motions set forth in Section 3.2.1 above and requesting entry
of an
adverse judgment against Bracco on Count
2.
|
| 3.2.3 |
Bracco
will file motions in the Interference [****] Xxxxxxxxx
AAA application, which claims are set forth in Exhibits B and C
annexed
hereto) and accompanying motions for
benefit.
|
| 3.2.4 |
Alliance
will file papers in the Interference stating that it will not oppose
the
motions set forth in Section 3.2.3 above and requesting entry of
an
adverse judgment against Alliance on the Proposed
Counts.
|
| 3.2.5 |
Bracco
and Alliance will generally cooperate in a reasonable manner in
filing the
motions and papers identified above. In this regard, Bracco and
Alliance
will file no other motions or other papers in the Interference
other than
those that are identified in Sections 3.2.1, 3.2.2, 3.2.3 and 3.2.4
above
and 3.3 below unless they are reasonably necessary to effectuate
the
above. If, however, after the Parties file these motions and papers,
the
PTO comes to some other judgment that does not include awarding
Alliance
judgment for Count 2 and either awarding Bracco judgment for the
Proposed
Counts or denying or dismissing the motions for the Proposed Counts
(e.g.,
the PTO sua sponte
corresponds some or all of the claims that make up Count 2 and
some or all
of the claims that make up the Proposed Counts to a single count
in the
original interference or in a new interference), then Bracco and
Alliance
will confer on an appropriate way to advance the resolution of
the
Interference. If agreement on such an appropriate way to advance
the
resolution cannot be reached, Bracco and Alliance will be free
to file any
motions or other papers to pursue any
outcome.
|
3.3. Bracco
and Alliance will file all agreements and understandings regarding the
Interference, including this Agreement, with the PTO as required by 35 U.S.C.
§ 135(c).
3.4. In
the event the [****] application, the [****]
application and/or an application claiming priority from the
[****] application or the [****] application
issues as a United States patent, Bracco will xxxxx [****]
under any such patent for any products or methods used outside of the Medical
Diagnostic Imaging Field. Notwithstanding the foregoing, the license set
forth
in this Section 3.4 shall not include any other Bracco patent or patent
application, even if the patent or patent application has claims that are
the
same or similar to the New Claims, provided that the patent does not issue
from
the [****] application, the [****] application
or an application that claims priority from the [****]
application or the [****] application.
5
3.5. Neither
Bracco nor Alliance will, in the future, assert an issue preclusion defense
in
any proceeding, other than an interference proceeding in the PTO, based upon
the
other Party requesting entry of an adverse judgment pursuant to Sections
3.2.2
and 3.2.4 above.
3.6. The
licenses set forth in this Agreement shall not be affected in any way by
any
outcome of the Interference.
ARTICLE
IV. FIRST
RIGHT OF NEGOTIATION
4.1. If
Alliance’s license of Imavist to Schering is terminated, Alliance will give
Bracco a first right of negotiation for any rights to Imavist returned to
Alliance as a result of such termination, which right of negotiation will
be for
ninety (90) days starting at the time Alliance informs Bracco that it desires
a
development/marketing partner for Imavist II.
4.2. Alliance
hereby grants to Bracco, subject to any rights of Schering, a first right
of
negotiation for worldwide rights (e.g., development and marketing) to Imavist
II
which right of negotiation will be for a one hundred and twenty (120) day
period
starting at the time Alliance informs Bracco that it desires a development
marketing partner for Imavist II.
ARTICLE
V. EFFECT
OF AGREEMENT ON THIRD PARTIES
5.1. Nothing
in this Agreement shall be construed to (1) obligate any Party to bring any
action against any Third Party based on such Party’s Licensed Patents, or (2)
limit or affect a Party’s right to bring any action against any Third Party
based on such Party’s Licensed Patents.
5.2. Nothing
in this Agreement shall be construed to (1) obligate any Party to negotiate
with
or obtain licenses from any Third Party, or (2) limit or affect a Party’s rights
to negotiate or obtain licenses from any Third Party.
ARTICLE
VI. FEES,
PAYMENTS, ROYALTIES, WARRANTIES, INDEMNIFICATION
6.1. No
party
shall have any obligation to make any payments to the other Parties pursuant
to
this Agreement. Each Party shall bear its own costs and expenses, including,
without limitation, its attorneys fees, relating to any action to be taken
or
having been taken in respect to this Agreement.
6.2. Each
Party makes the following warranties and representations to the other
Parties:
| 6.2.1 |
each
Party is a corporation duly organized and validly existing and
in good
standing under the laws of the state or country in which it is
organized
and has all requisite power and authority to enter into and perform
this
Agreement and the transactions contemplated hereby and to require
its
Affiliates to abide by its terms and
conditions;
|
6
| 6.2.2 |
all
requisite corporate actions on the part of each Party has been
completed
for the authorization of the execution and delivery of this Agreement
and
the performance of the transactions contemplated
hereunder.
|
| 6.2.3 |
this
Agreement is, and such other transactions will be, valid and binding
obligations of each Party enforceable in accordance with their
respective
terms; and
|
| 6.2.4 |
the
execution, delivery and performance of this Agreement and the consummation
of transactions contemplated hereby do not and will not violate
the
provisions of any Party’s certificate of incorporation or bylaws or
similar type documents or the provisions of any note, indenture,
lease,
license permit or other instrument or obligation or violate any
law,
order, rule or regulation applicable to
it.
|
6.3. No
Party
makes any warranties or representations, either express or implied, concerning
the scope, validity or enforceability of its respective Licensed
Patents.
6.4. No
party
shall have any obligation to indemnify any other Party for any lawsuit arising
in connection with Imavist, Imavist II, BR-1 or BR-14, or the Schering, Alliance
or Bracco Licensed Patents.
6.5. No
Party
makes any warranties or representations, either express or implied, or assumes
any responsibility whatsoever with respect to the manufacture, use or sale
or
other disposition by any other Party of that Party’s Product, even if that
Party’s Product makes use of any inventions claimed in the Licensed Patents of
another Party.
ARTICLE
VII. DURATION
7.1. The
term
of the license granted from Bracco to Schering and Alliance set forth in
Section
2.1 above and the Schering and/or Alliance obligations set forth in Section
3
above shall start at the Effective Date and shall last until Imavist and
Imavist
II are no longer under development or planned for development, undergoing
regulatory approval, or being manufactured, sold or prepared for sale by
either
Schering or Alliance.
7.2. The
term
of the license granted from Schering and/or Alliance to Bracco set forth
in
Sections 2.2 and 2.3 above and the Bracco obligations set forth in Section
3
above shall start at the Effective Date and shall last until BR-1 and
BR-14 are
no
longer under development or planned for development, undergoing regulatory
approval, or being manufactured, sold or prepared for sale by
Bracco.
ARTICLE
VIII. CONFIDENTIALITY
8.1. Each
Party will maintain the other Party’s information in confidence. No party will
disclose the contents of this Agreement to any other person or entity and
each
Party will retain in confidence the terms and conditions of this Agreement,
except as necessary to comply with law or the valid order of a court or agency
of competent jurisdiction of a state or federal authority; or to the extent
necessary in any action, suit or proceeding to enforce this Agreement or
to
their respective Affiliates, banks, auditors, accountants, lawyers, and any
other representative of a Party who has a good faith need to know, provided
that
any such person or entity to whom disclosure is made must be advised of the
confidentiality of the information disclosed and agree to keep such information
confidential.
7
8.2. No
public
statements of any kind pertaining to this Agreement may be made except as
required by law, such as that enforced by the Securities Exchange Commission
of
the United States of America.
ARTICLE
IX. MISCELLANEOUS
9.1. Notice.
All
notices or communications required pursuant to this Agreement shall be in
writing and shall be deemed to have been duly given upon the date of receipt
if
delivered by hand, international overnight courier, confirmed facsimile
transmission, or registered or certified mail (return receipt requested,
postage
prepaid) to the following addressees or facsimile numbers:
| 9.1.1 |
For
Alliance:
|
Alliance
Pharmaceutical
0000
Xxxxxxx Xxxx Xxxx
Xxx
Xxxxx, XX 00000
XXX
Attn:
President
Facsimile:
x0-000-000-0000
| 9.1.2 |
For
Bracco:
|
Xxxxxx
Imaging
S.p.A.
Xxx
Xxxxxx Xxxxx 00
00
000
Xxxxxx, XXXXX
Attn:
Director, Intellectual Property
Facsimile:
x00-00-0000-0000
| 9.1.3 |
For
Schering:
|
Xxxxxxxx
Xxxxxxxxxxxxxxxxxx
00000
Xxxxxx
Xxxxxxx
Attn:
Legal Department
Facsimile:
x00-00-0000-0000
9.2. Choice
of Law:
The
Parties agree that this Agreement shall be governed by the laws of the State
of
New York without reference to conflict of laws principles.
9.3. Entire
Agreement:
This
Agreement, including all Exhibits attached hereto and all documents delivered
concurrently herewith,. set forth all the licenses, covenants, premises,
agreements, warranties, representations, conditions, and understandings between
the Parties hereto and supersede all prior agreements and understandings
between
the Parties relating to the subject matter hereof. This Agreement, including,
without limitation, the Exhibits attached hereto, is intended to describe
the
full extent of the legally enforceable undertakings of the Parties
hereto.
8
9.4. Severability:
In the
event that any provision of this Agreement shall, for any reason, be held
to be
invalid or unenforceable in any respect, such invalidity or unenforceability
shall not affect any other provision hereof, and the Parties shall negotiate
in
good faith to modify the Agreement to preserve their original
intent.
9.5. Amendment
and Waiver:
This
Agreement may be amended, supplemented, or otherwise modified only be means
of a
written instrument signed by all Parties. Any waiver of any rights or failure
to
act in a specific instance shall relate only to such instances and shall
not be
construed as an agreement to waive any rights or fail to act in any other
instance, whether or not similar.
9.6. Headings:
The
sections and paragraph headings contained herein are for the purposes of
convenience only and are not intended to define or limit the contents of
said
sections or paragraphs.
9.7. Counterparts:
This
Agreement may be signed in counterpart, each of which shall be deemed to
be an
original. Signatures shall be provided by facsimile transmission, with original
signatures following by mail.
9.8. Assignment:
Neither
this Agreement nor the licenses granted herein may be assigned to any Third
Party. No Party shall assign, by operation of law or otherwise, any Licensed
Patents to a Third Party without such Third Party agreeing to be bound in
writing by the licenses granted hereunder.
IN
WITNESS WHEREOF, the undersigned Parties have duly executed and delivered
this
Agreement as of the date first written above.
|
Alliance
Pharmaceutical Corp.
By:
/s/
Xxxxx X.
Xxxxxxx
Name:
Xxxxx X. Xxxxxxx
Title:
Vice President & General Counsel
Date:
31 Jan 2001
Schering
Aktiengellschaft
By:/s/
X. X.
Xxxx
Name:
X. X. Xxxx
Title:
Head of SBK, DG & RP
Date:
31.1.2001
|
for
and on behalf of
Xxxxxx
International B.V.
By:
Xxxxxx Holding BV
Name:
Xxxxx Xxxxxx
Title:
Managing Director
Date:
31.01.01
|
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