Exhibit 10.1
SETTLEMENT AND LICENSE
AGREEMENT
This Settlement and License
Agreement (this “ Agreement ”) is entered into
as of February 7, 2007, (the “ Effective Date
”) by and between CELSION CORPORATION , a corporation
organized and existing under the laws of the State of Delaware and
having its principal place of business at 10220-L Old Columbia
Road, Columbia, Maryland 21046 (“ Celsion ”),
and AMERICAN MEDICAL SYSTEMS, INC. (“ AMSI
”) and AMS RESEARCH CORPORATION (“ AMSRC
”), each a corporation organized and existing under the laws
of the State of Delaware and having their principal place of
business at 10700 Bren Road West, Minnetonka, Minnesota 55343 (AMSI
and AMSRC are herein individually and together referred to as
“ AMS ”). Celsion, AMSI and AMSRC are
collectively, the “ Parties ” and each
separately, a “ Party ”.
WHEREAS , Celsion is, in part, in the business of
developing, making, marketing and selling products, therapies and
technologies that use heat generated by microwave energy to treat
benign prostatic hyperplasia, including a product currently sold
under the brand Prolieve Thermodilation System
®
;
WHEREAS , on September 28, 2006, AMS commenced an
action against Celsion in the United States District Court for the
District of Delaware (the “ Court ”), Civil
Action No. 06-606-SLR (the “ Pending Action
”), alleging that Celsion infringed and is infringing
AMS’ U.S. Patent Nos. 5,220,927, 6,216,703, 7,089,064 and
7,093,601, which action remains pending;
WHEREAS , on November 16, 2006, Celsion filed
counterclaims for declaratory judgment in the Pending
Action;
WHEREAS , on September 27, 2006, the United States
District Court for the District of Minnesota dismissed a similar
patent infringement action filed by AMS on April 27,
2006,
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
against Celsion (Civil Action No. 06-1606
JMR/FLN) for lack of personal jurisdiction (the “ Prior
Action ” and together with the Pending Action, the
“ Action ”);
WHEREAS , Celsion denies that its products or other
business activities infringe AMS’ patents and is prepared to
defend against the Pending Action; and
WHEREAS , recognizing the costs, uncertainties and
burdens of litigation, Celsion and AMS desire finally and forever
to compromise, resolve and settle all asserted and unasserted
claims relating to the allegations in the Action on mutually
agreeable terms without admission of any liability by either, and
without admission as to the merits of any of the contentions of the
other.
NOW, THEREFORE
, for and in consideration of the
preambles set forth above and the mutual covenants, promises and
agreements contained herein, the Parties, intending to be legally
bound, do hereby agree as follows:
Article 1.
Definitions
In addition to terms defined
elsewhere in this Agreement, the following initially capitalized
terms, whether used in the singular or plural, shall have the
respective meanings set forth below:
Section 1.01 “
Affiliate ” shall mean any individual or entity which
(directly or indirectly) is controlled by, controlling or under
common control with a Party to this Agreement. For purposes of this
definition, the direct or indirect ownership of fifty percent
(50%) or more of the outstanding securities, membership
interests or partnership interests of or by an entity, or the right
to receive fifty percent (50%) or more of the profits or
earnings of or by an entity, or the right to control the management
or the board of directors or other governing body of or by
an
2
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
entity shall be deemed to constitute control.
“ AMS Parties ” shall mean AMSI, AMSRC and their
respective Affiliates.
Section 1.03 “
Average Sales Price ” shall mean the average invoiced
sales price at which the Celsion Parties have actually sold
Disposable Kits to non-Affiliate third parties during * including
in such calculation of average invoiced sales price the actual
sales price for any standard warranty sold for the Disposable Kits
but not including any rebates actually granted to a customer and
any reasonable and customary charges for taxes and shipping
actually collected by Celsion on behalf of third parties; provided
that, if the “Average Sales Price” as calculated is *
per Disposable Kit for * , the “Average Sales Price”
for that * shall be deemed * per Disposable Kit, and further
provided that, if the “Average Sales Price” as
calculated is * per Disposable Kit, the “Average Sales
Price” for that * shall be deemed * per kit.
Section 1.04 “
Celsion Parties ” shall mean Celsion and its
Affiliates.
Section 1.05 “
Current Products ” of a Party shall mean products and
components thereof commercially available from that Party or its
Affiliates at or before the Effective Date in the Technology Field,
which for Celsion is the Prolieve Thermodilation System (depicted
in Exhibit A ) (“ Celsion Current Products
”) and for AMS is the TherMatrx System (depicted in
Exhibit B ) (“ AMS Current Products ”).
For purposes of clarity, a product that qualifies as of the
Effective Date as a Current Product remains a Current Product even
if the business or assets relating to such product line are sold to
a permitted successor or assign to this Agreement.
Section 1.06 “
Days ” or “days” shall mean calendar
days.
3
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
Section 1.07 “
Dismissal Order ” shall mean an Order of the Court
dismissing the Pending Action in accordance with the provisions of
Article 6 below, which order has become final and no longer subject
to appeal or reconsideration.
Section 1.08 “
Disposable Kits ” shall mean the disposable catheter
kit component of the Licensed Products. Disposable Kits do not
include control units and other reusable apparatus or accessories
that are marketed for use in connection with the Licensed Products.
For the sake of clarity, the Disposable Kit component of the
Celsion Current Products is depicted in Exhibit A
hereto.
Section 1.09 “
Disposable Kit Sold ” shall mean a Disposable Kit that
has been invoiced to a non-Affiliate third party by a Celsion
Party, including Disposable Kits distributed for no consideration
(but excluding a reasonable number of Disposable Kits distributed
for no consideration solely for clinical trials and up to an
additional one hundred (100) Disposable Kits distributed for
no consideration).
Section 1.10 “
Excluded Technology ” shall mean products and methods
that are designed or intended for use with or constitute any of the
following:
|
|
(1)
|
a system or
therapy with integrated microwave and laser components;
|
|
|
(2)
|
Treatment
Catheters without an integrated compression balloon, such as the
integrated compression balloon in the existing Prolieve
Thermodilation ® System depicted in Exhibit A hereto;
or
|
|
|
(3)
|
Treatment
Catheters with an integrated temperature probe.
|
For the sake of clarity, while the
license and covenant not to sue granted to Celsion herein do not
cover Excluded Technology, nothing in this Agreement prohibits or
restricts Celsion or its permitted successors or assigns with
respect to Excluded Technology, and nothing in this Agreement
prohibits or restricts AMS or its permitted successors or assigns
from asserting claims against Excluded Technology.
4
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
Section 1.11 “
Including ” shall mean, whether or not capitalized,
including without limitation.
Section 1.12 “
Licensed Patent(s) ” shall mean (a) all of the
claims of AMS’ patents and applications existing or filed as
of the Effective Date that include subject matter directed to the
Technology Field, including all of the claims of the issued patents
listed on Exhibit C hereof (including the 927 Patent, the
703 Patent, the 064 Patent and the 601 Patent); and
(b) continuations, continuations in part (to the extent of the
part within the Technology Field and to the extent entitled to
priority before the Effective Date), divisionals, reexaminations,
reissuances, extensions and foreign counterparts of any of the
foregoing, provided , however , that “Licensed
Patent(s)” shall not include any patent that has expired or
has been invalidated or canceled or declared unenforceable or any
claims in any patent that have been invalidated, declared
unenforceable or canceled where all right to appeal any such order
of cancellation, unenforceability or invalidity has elapsed and the
order has become final. “Licensed Patent(s)” shall
include applications beneficially owned or controlled by an AMS
Party as of the Effective Date even if then pending in the name of
the inventors or another assignee and not yet formally assigned to
the AMS Party.
Section 1.13 “
Licensed Products ” shall mean Celsion Current
Products and Reasonable Modifications thereof developed,
manufactured, used, marketed, offered for sale, sold, imported,
licensed or distributed by or on behalf of a Celsion Party or a
permitted successor or assign under this Agreement, directly or
through their respective manufacturers, distributors, contractors,
resellers, and other intermediaries. “Licensed
Products” shall not include Excluded Technology.
Section 1.14 “
927 Patent ” shall mean United States Patent
No. 5,220,927 while it is in effect.
5
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
Section 1.15 “
703 Patent ” shall mean United States Patent
No. 6,216,703 while it is in effect.
Section 1.16 “
064 Patent ” shall mean United States Patent
No. 7,089,064 while it is in effect.
Section 1.17 “
601 Patent ” shall mean United States Patent
No. 7,093,601 while it is in effect.
Section 1.18 “
Product Related Activities : shall mean, research,
development, testing, scale-up, clinical, prototyping, trial,
sales, marketing and other business activities undertaken in the
process of creating, seeking approval for and commercializing
products.
Section 1.19 “
Reasonable Modifications ” shall mean improvements or
modifications to Current Products primarily to improve materials,
dimensions, software, manufacturability, quality or cost, provided
such improvements or modifications are consistent with the function
and treatment provided by the party’s Current Products as of
the Effective Date. For the sake of clarity, Reasonable
Modifications to a party’s current Treatment Catheter do not
include, for example, adding (in the case of AMS) or removing (in
the case of Celsion) an integrated compression balloon.
Section 1.20 “
Returned Products ” shall mean Disposable Kits
(1) returned by non-Affiliate third parties to whom the
Disposable Kits were sold and (2) for which Celsion has fully
refunded to the third party (or extended a credit for) all
consideration received for the returned Disposable Kits (with the
exception of reasonable and customary shipping or handling charges,
if applicable).
Section 1.21 “
Technology Field ” shall mean the field of microwave
therapy for treating benign prostatic hyperplasia
(“BPH”) and prostatitis.
6
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
Section 1.22 “
Treatment Catheters ” shall mean urethral catheters
for applying heat or microwave energy to prostatic
tissue.
Article 2. License Grant and
Other Covenants
Section 2.01 Subject
to the provisions herein, from the Effective Date, AMS, for itself
and its Affiliates, hereby grants to Celsion and its Affiliates a
perpetual, irrevocable (except for termination expressly permitted
in Section 6 of this Agreement), non-exclusive, worldwide
right and license under the Licensed Patents only within the
Technology Field (excluding Excluded Technology) to
(a) undertake Product Related Activities for Licensed Products
and (b) develop, make, have made, market, use, authorize
others to use, import, distribute, sell, have sold and offer to
sell Licensed Products, for the life of the Licensed Patents (the
“ License ”).
Section 2.02 Celsion
and its Affiliates may not sublicense the licensed rights granted
above, but may engage third party contractors, consultants,
outsourcers and agents to undertake Product Related Activities for
Licensed Products and to exercise the licensed rights on their
behalf such as, for example, in the manufacturing, assembly, sale,
importation and marketing of Licensed Products.
Section 2.03 AMS
represents that, as of the Effective Date, AMS is the sole owner of
all title and interest to each of the Licensed Patents.
Section 2.04 AMS
agrees (a) to provide to Celsion, promptly upon reasonable
written request, information regarding the status of the Licensed
Patents, including information on any new applications filed or
patents issued or abandoned anywhere and any adverse claims made by
third parties against any of the Licensed Patents, and (b) to
take commercially reasonable steps to prosecute and maintain in
effect the Licensed Patents.
7
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
Section 2.05 Celsion
and Affiliates will take commercially reasonable steps to comply
with the marking provisions of 35 U.S.C. §287 with respect to
Licensed Products and the Licensed Patents, consistent with
Celsion’s standard labeling practices.
Section 2.06 In
order to maintain separate identity between the Current Products
(and Reasonable Modifications thereof) being sold contemporaneously
in the marketplace by each of the Parties, each of AMS and Celsion
agrees from and after the Effective Date not to develop, make, use,
sell, offer for sale or import Treatment Catheters in the
Technology Field that are confusingly similar with respect to
protectable packaging features and external trade dress to the
Current Products available from the other Party as of the Effective
Date. In the event a party reasonably believes that a product of
the other in the Technology Field violates this Section, it shall
provide prompt written notice to the other, describing the nature
of the perceived violation and what in its view would cure the
violation. The Party receiving the notice shall have a period of
forty-five (45) days to investigate the allegation and respond
to the other Party in writing with either a denial of the
allegations, a request for further information or a proposed
curative course of action. If the party responding to the notice
requests further information, the Party who sent the notice shall
promptly provide it and the time to respond shall commence again
once the information is provided. If the curative action proposed
by the Party who received the notice is acceptable to the other
Party, the Party who received the notice shall have a reasonable
period of time to implement the curative actions, taking into
account factors such as the need for regulatory approvals for any
changes. In the event the Party who received the notice denies the
allegations and/or does not propose a remedy therefor that is
reasonably acceptable to the other Party, the Party who sent the
notice shall submit the matter to binding arbitration in accordance
with the arbitration provisions of Section 8.05 (and subject
to Section 6.02). The Parties will not,
8
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
pending the opinion of the arbitration panel,
seek interim relief. Each Party acknowledges and agrees that the
products in the Technology Field commercially available as of the
Effective Date from the other are not confusingly similar. For
purposes of this Section 2.06, AMSI and AMSRC shall be deemed
one Party.
Section 2.07 Except
as stated in this Section and in Article 6 below, while the License
is in effect, Celsion agrees not to challenge, or support or
participate in a challenge of, the validity or enforceability of
the Licensed Patents, including by initiating, participating or
supporting a request for reexamination of the Licensed Patents, or
by raising such claims in defense of a claim by AMS for a breach by
Celsion of the provisions of this Agreement. Notwithstanding any
other provision of this Agreement, the covenant in the prior
sentence shall not apply and Celsion shall be free to bring claims
and raise defenses (a) in connection with a claim by AMS for
infringement relating to the Licensed Products in the event that
AMS is seeking to terminate or has terminated the license grant in
Section 2.01 above, or (b) with respect to products other
than Licensed Products, including any Excluded Technology products,
or (c) in the event AMS breaches a material provision of the
Agreement such as the covenant not to assert or the release, or
(d) if compelled by law or court order (such as a
subpoena).
Section 2.08 Nothing
in this Agreement shall be construed as conveying any express or
implied license or right, to any patent owned, controlled or
licensed by a Party or its Affiliates, to any other Party, person
or entity, except as expressly and specifically set forth in this
Agreement.
Article 3.
Payments
Section 3.01 In
consideration of the license rights, releases and other covenants
and promises under this Agreement, Celsion shall pay the following
fees to AMS:
9
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
a.* in license fees due on the date
of execution and delivery of this Agreement by all Parties and
payable in full by February 20, 2007; and
b. Subject to Sections 3.02 and 3.03
below, a running royalty from * on Disposable Kits Sold of the
lesser of: (i) * of the * or (ii) * per Disposable Kit
Sold (the “ Royalty ”). The Royalty shall be
automatically reduced to the lesser of (i) * of the * , or
(ii) * per Disposable Kit Sold from and after the expiration
or final cancellation, abandonment or invalidation date of the 927
Patent.
Section 3.02 The
obligation to pay Royalties shall automatically cease and the
License granted in Section 2.01 shall become fully paid-up and
royalty-free from and after the earlier of (i) * ,
(ii) the expiration or cancellation, abandonment or
invalidation of all of the Licensed Patents, or (iii) the
prepayment of Royalties set forth in Section 3.03 below (such
date, the “ End of the Royalty Payment Term
”).
Section 3.03 Celsion
shall have the right to prepay all the Royalties payable under this
Agreement at any time prior to the End of the Royalty Payment Term
on a discounted net present value basis using (i) a mutually
agreed to discount rate of * and (ii) * (a) * or
(b)
10
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
* (the “ Prepaid Royalty ”).
An example of the calculation of the Prepaid Royalty is provided in
Exhibit D , which assumes the following for simplicity:
(1) * (2) * (3) * (4) * . Celsion shall
exercise the prepayment option by providing written notice thereof
to AMS including its calculation of the Prepaid Royalty (the
“ Prepayment Notice ”). The Parties agree that
the Prepaid Royalty, if this option is exercised by * shall be no
less than * . Thereafter, the Prepaid Royalty shall be * . Celsion
shall pay the Prepaid Royalty to AMS within thirty (30) days
of the date of its Prepayment Notice unless AMS notifies Celsion in
writing within fifteen (15) days of the date of the Prepayment
Notice that it disagrees with the calculation of the Prepaid
Royalty. Failure of AMS to provide timely notice of disagreement
shall constitute acceptance of the calculation of the Prepaid
Royalty. The Parties shall endeavor expeditiously and in good faith
to resolve any disagreements regarding the calculation of the
Prepaid Royalty. If the Parties shall have been unable to agree on
the amount of the Prepaid Royalty by the end of a thirty
(30) day period from the date of the Prepayment Notice, the
Parties shall engage an arbitrator to resolve the disagreement and
determine on an expedited basis the Prepaid Royalty as of the date
of the Prepayment Notice, with each side sharing equally in the
costs and expenses of the arbitrator and the proceedings. The
arbitrator shall have experience in royalty audits and calculations
and the decision of the arbitrator shall be final and binding. Upon
determination of the Prepaid Royalty after a dispute, Celsion shall
pay the Prepaid Royalty if it
11
* The asterisk denotes that confidential
portions of this exhibit have been omitted in reliance on Rule
24b-2 of the Securities Exchange Act of 1934, as amended. The
confidential portions have been submitted separately to the
Securities and Exchange Commission.
still wishes to pre-pay the Royalties based on
the amount calculated by the arbitrator, and AMS shall provide a
receipt thereof.
Section 3.04 Only
one Royalty is payable per Disposable Kit Sold regardless of
whether such product embodies, uses or practices one or more claims
in the Licensed Patents. Royalties are non-refundable (provided
that a Dismissal Order has been entered and subject to the
provisions of this Agreement relating to termination). Royalties
not paid when due shall bear interest from the due date at the rate
of * . Celsion shall be entitled to off-set royalties paid on
Returned Products against subsequent Royalty payments.
Section 3.05 Until
the End of the Royalty Payment Term, Celsion will pay the Royalties
* for Disposable Kits Sold during * . At that time, Celsion shall
furnish to AMS a statement showing the volume of Disposable Kits
Sold during * (including Disposable Kits distributed for no
consideration) and the calculation of the amount of Royalties due.
Until the End of the Royalty Payment Term, such statements shall be
furnished to AMS whether or not there are any Disposable Kits Sold
during * . AMS’ designated representative from a public
accounting firm shall have the right, not more than once in each
contract year during business hours with thirty
(30) days’ prior written notice to audit, at the place
where they are typically located, the relevant books and records of
Celsion and any Affiliates selling Licensed Products in order to
verify the accuracy of Royalties paid under this Agreement for the
current contract year and the two years before. Such representative
shall execute a confidentiality and non-disclosure agreement
acceptable to Celsion and the Affiliates in order to protect
information that is made available to the representative. The
representative shall not use
12
* The asterisk denotes that confidential
portions of