Exhibit 10.1
WORLDWIDE LICENSE AGREEMENT
This WORLDWIDE LICENSE AGREEMENT (this "License Agreement"), effective as of
September 25, 2001 (the "Effective Date"), is between XXXXXX IMAGING S.P.A., an
Italian corporation having a principal place of business at Xxx Xxxxxx Xxxxx, x.
00, 00000 Xxxxx ("Bracco"), on one side; and EPIX MEDICAL, INC., a Delaware
corporation, having a principal place of business at 00 Xxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000, XXX ("EPIX"), on the other side. Bracco and EPIX may be
referred to separately as a "Party" or collectively as the "Parties."
RECITALS
WHEREAS, EPIX has certain rights under certain patents and patent
applications owned by The General Hospital Corporation, doing business as
Massachusetts General Hospital ("GH"), pursuant to an Amended and Restated
License Agreement dated July 10, 1995, as amended, between EPIX and GH;
WHEREAS, Bracco possesses certain rights relating to Licensed
Product(s) (defined below);
WHEREAS, the Parties are involved in several disputes now pending
before European and Japanese authorities with respect to Licensed Products and
Licensed Patents (defined below);
WHEREAS, the Parties have agreed to resolve the several disputes now
pending before European and Japanese authorities as more fully set forth in a
Settlement and Release Agreement dated September 25, 2001;
WHEREAS, EPIX is willing to xxxxx Xxxxxx a worldwide nonexclusive
sublicense under the Licensed Patents and a worldwide nonexclusive license under
the EPIX Patents (defined below); and
WHEREAS, Bracco is willing to accept from EPIX a worldwide nonexclusive
sublicense under the Licensed Patents and a worldwide nonexclusive license under
the EPIX Patents.
NOW THEREFORE, in consideration of the foregoing and the covenants and
promises contained in this License Agreement, the Parties hereto hereby agree as
follows:
ARTICLE 1
DEFINITIONS
For purposes of this License 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.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
1.1 "AFFILIATE" shall mean a corporation or other legal entity that
controls, is controlled by, or is under common control with a Party to this
License Agreement. For purposes of this definition, "control" means the
ownership, directly or indirectly, of more than fifty percent (50%) of the
outstanding equity securities of a corporation which are entitled to vote in the
election of directors or more than fifty percent (50%) interest in the net
assets or profits of an entity which is not a corporation. For the purposes of
this definition, Bracco Affiliates shall include those Affiliates that are, or
will become, Sublicensees of this Worldwide License Agreement and shall
initially include the entities identified on Exhibit 1 and any future similarly
organized Bracco Affiliates.
1.2 "BRACCO" shall mean Bracco identified as a Party above.
1.3 "BRACCO NET SALES" shall mean the amounts invoiced or otherwise
charged on the sales of Licensed Products by Bracco or its Affiliates to
Unaffiliated Third Parties in bona fide arms' length transactions: less (a)
trade, cash and quantity discounts, including charge backs, rebates, premiums,
allowances and any other deduction actually granted to the Unaffiliated Third
Parties; (b) sales and excise taxes and duties and any other governmental
charges imposed upon the importation, use or sale of the Licensed Products
actually charged to the Unaffiliated Third Parties; (c) freight, insurance and
other transportation charges actually charged to the Unaffiliated Third Parties;
(d) amounts repaid or credited by reason of rejections, defects, outdating,
price differences, recalls or returns, or because of retroactive price
reductions, or due to governmental laws or regulations requiring rebates
actually granted to the Unaffiliated Third Parties; and (e) a three percent (3%)
flat deduction to cover other expenses and deductions not otherwise accounted
for. Except pursuant to 1.3(e), any and all deductions used in the calculations
of Bracco Net Sales are allowable only to the extent that they have already been
included in the amounts invoiced or otherwise charged or granted on the sales of
Licensed Products by Bracco or its Affiliates to Unaffiliated Third Parties in
bona fide arms' length transactions. Calculations of Bracco Net Sales shall be
in accordance with generally accepted accounting standards of the countries in
which the Licensed Products are sold. No deductions of any kind whatsoever shall
be made in respect of sales of Licensed Products made prior to January 1, 2001,
as the royalties in respect of such sales have been determined solely in
accordance with Section 2.4(a) hereof.
1.4 "EPIX" shall mean EPIX identified as a Party above and any EPIX
Affiliate.
1.5 "EPIX PATENTS" shall mean any and all patents and patent
applications covering the Licensed Products, other than the Licensed Patents,
that are currently or may hereafter be owned, obtained, acquired, purchased by
or licensed to, with a right to sublicense, or in any way under the control or
at the disposal of EPIX, including any division, renewal, continuation,
continuation-in-part, extension, reissue, reexamination, substitution,
confirmation, registration, revalidation, supplementary protection certificate
or any extension or additions thereto.
1.6 "FDA APPROVAL" shall mean that a Licensed Product has been approved
for immediate nationwide sale by the U.S. Food and Drug Administration.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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1.7 "LICENSED PATENTS" shall mean all patents and patent applications
owned by GH listed on Exhibit 2 of this License Agreement and licensed to EPIX,
including any division, renewal, continuation, continuation-in-part, extension,
reissue, reexamination, substitution, confirmation, registration, revalidation,
supplementary protection certificate or any extension or additions thereto.
1.8 "LICENSED PRODUCTS" shall mean any pharmaceutical product or
formulation sold by Bracco or its Affiliates comprising the drug substance
having the chemical name (4-carboxy-5, 8, 11-tris
(carboxymethyl)-1-phenyl-2-oxa-5, 8, 11-triazatridecan-13-oato (5-)) gadolinate
(2-) dihydrogen, including but not limited to the product identified by Xxxxxx'x
trademark "MultiHance" and having the CAS Registry Number 127000-20-8; and
intermediates used in making, methods of preparing and methods of using such
product or formulation, that, absent the license provided in this License
Agreement, would be an infringement of a Valid Claim of the Licensed Patents.
1.9 "NAMED ENTITIES" shall mean those entities involved in the
actions/disputes described in Exhibit 4 of the S/R Agreement, excluding EPIX and
GH.
1.10 "PRIME RATE" shall mean the prime rate of interest as published in
the Wall Street Journal on the first business day of each calendar quarter.
1.11 "S/R AGREEMENT" shall mean the Settlement and Release Agreement
entered into by EPIX, Bracco and GH on September 25, 2001.
1.12 "SUBLICENSEE" shall mean an Affiliate of Bracco who obtains a
sublicense under the Licensed Patents pursuant to Section 2.2 of this License
Agreement.
1.13 "TERRITORY" shall mean any country in the world in which a
Licensed Patent has issued and a Valid Claim is in effect. Exhibit 5 lists the
countries in which a Licensed Patent has issued with reference to the time of
execution of this Agreement.
1.14 "THIRD PARTIES" shall mean any entities other than EPIX, Bracco
or a Bracco Affiliate.
1.15 "UNAFFILIATED THIRD PARTIES" shall mean any Third Party and shall
include without limitation the joint venture partner, company or other entity
that also has non-controlling outstanding equity securities of a Bracco
Affiliate or has a non-controlling interest in the net assets or profits of an
entity which is a Bracco Affiliate, such as Eisai Ltd. Co. or Byk Xxxxxx Lomberg
Chemische Fabrik, GmbH or is a parent or affiliate of such entity.
1.16 "VALID CLAIM" shall mean a claim in an issued, unexpired Licensed
Patent as so provided for by this License Agreement, that, absent the license
provided in this License Agreement, would be infringed by the Licensed Products,
that (i) has not been finally cancelled, withdrawn, abandoned or rejected by any
administrative agency or other body of competent jurisdiction, (ii) has not been
revoked, held invalid, or declared unpatentable or unenforceable in
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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a decision of a court or other body of competent jurisdiction that is
unappealable or unappealed within the time allowed for appeal, (iii) has not
been rendered unenforceable through disclaimer or otherwise, or (iv) is not lost
through an interference proceeding.
1.17 "LICENSE AGREEMENT" shall mean this Worldwide License Agreement
between Bracco and EPIX, as of its Effective Date.
ARTICLE 2
WORLDWIDE NONEXCLUSIVE SUBLICENSE UNDER THE LICENSED PATENTS AND WORLDWIDE
NONEXCLUSIVE LICENSE UNDER THE EPIX PATENTS
2.1 GRANT OF LICENSE. EPIX hereby grants to Bracco, and Bracco hereby
accepts, a worldwide nonexclusive sublicense under the Licensed Patents and a
worldwide nonexclusive license under the EPIX Patents to conduct research and to
develop, use, make, have made, import or export, manufacture, have manufactured,
offer for sale, sell and/or have sold, advertise and promote the Licensed
Products in the Territory. It is agreed and understood that decisions regarding
such activities will be made by Bracco at its sole discretion. Bracco has
received approval for marketing Licensed Products in the Territory in the
countries of Austria, Belgium, France, Germany, Italy, Luxembourg, Sweden, The
Netherlands and the United Kingdom, and shall provide written notice to EPIX
within thirty (30) days from the approval date if and when Licensed Products are
approved for marketing in any other country in the Territory.
2.2 SUBLICENSES. Bracco shall have the limited right to grant
sublicenses under the Licensed Patents and the EPIX Patents as set forth in
Section 2.1 hereof solely to Xxxxxx'x Affiliates. Bracco has listed its current
Sublicensees on Exhibit 1 and shall provide EPIX with an updated list quarterly
of the names and addresses of all newly appointed Sublicensees.
2.3 UPFRONT AND LICENSE FEES. In consideration for the sublicense
granted in Section 2.1 and the right to grant sublicenses granted in Section 2.2
hereof, Bracco shall pay EPIX within thirty (30) days following the execution of
this License Agreement, but in no event later than September 27, 2001:
(a) a non-refundable license fee of $2,000,000;
(b) a fee of $3,000,000 as an advance payment for MultiHance FDA
Approval Milestone Payment subject to Section 2.5;
(c) a fee of $3,000,000 that is an advance payment to be treated as a
credit against the Threshold royalty payments pursuant to Section 2.4(b); and
(d) a fee of $1,000,000 that is an advance payment against future
royalty payments subject to Section 2.4(c).
2.4 ROYALTIES AND CREDIT AGAINST FUTURE ROYALTY PAYMENTS. In further
consideration of the license granted in Sections 2.1 and 2.2 hereof, Bracco
shall pay EPIX:
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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(a) $1,000,000 within thirty (30) days following the execution of this
License Agreement, but in no event later than September 27, 2001, as full,
non-refundable payment for royalties due on Bracco Net Sales prior to January 1,
2001;
(b) for the Licensed Products sold by Bracco or a Bracco Affiliate to
an Unaffiliated Third Party in the Territory that are covered by a Valid Claim
in such Territory (only one royalty shall be payable for each Licensed Product
irrespective of the number of Valid Claims in each country and payment of such
royalty for each Licensed Product shall end all further royalty obligations
therefor including, without limitation, any obligation of distributors or
customers of Bracco or its Affiliates), a royalty in an amount equal to:
(i) [ * ] of Bracco Net Sales for the first [ * ]
(hereinafter the "Threshold") of Bracco Net Sales
made on or after January 1, 2001, but, as a
consequence of the credit against future royalties
provided for in Section 2.3 (c), the actual royalty
to be paid shall be [ * ] of Bracco Net Sales until
the achievement of the Threshold, calculated as
follows:
Threshold Royalty Obligation: [ * ] x [ * ] = [ * ]
Less Pre-Payments: [ * ] - [ * ] = [ * ]
Threshold Calculated Royalty after Pre-Payments:
[ * ]:
Calculated Threshold Royalty Rate = [ * ] / [ * ] =
[ * ] [ * ]
(ii) [ * ] of Bracco Net Sales in excess of the Threshold.
Except as otherwise provided for in this License Agreement, it is,
however, agreed and understood that royalties on Bracco Net Sales in any country
as provided for in this Section 2.4 shall be due to EPIX until the date of
expiration in such country of the last to expire Valid Claim of the Licensed
Patents covering the Licensed Products, with no royalties due thereafter on such
Bracco Net Sales.
(c) Beginning on the date following receipt by EPIX of the funds set
forth in Section 2.3(d) ($1,000,000) and continuing until December 31, 2004,
Bracco shall be granted a quarterly credit to royalties due pursuant to Section
2.4(b) equal to the amount set forth in Section 2.3(d) ($1,000,000) multiplied
by the Prime Rate plus [ * ] multiplied by the number of days such funds were
outstanding during the quarter divided by the total number of days in a year
(365).
EXAMPLE: $1,000,000 IS OUTSTANDING FOR THE THIRD QUARTER AND
PRIME RATE IS 7%
Calculation: ($1,000,000 x [ * ]) x (92/365) = [ * ] royalty
credit
In the event that the royalty credit calculated herein exceeds the actual
royalty due pursuant to Section 2.4(b), such excess shall be carried forward to
the next quarterly period and applied to
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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such future royalty due. In the event that an excess of such royalty credit
exists on December 31, 2004, EPIX shall, within ten (10) days after receipt of
the information from Bracco as set forth in Section 2.6, refund such excess to
Bracco.
(d) Beginning on January 1, 2005, Bracco shall have the right to offset
the amount set forth in Section 2.3 (d) (i.e. $1,000,000) against royalties due
to EPIX pursuant to Section 2.4(b).
2.5 MULTIHANCE FDA APPROVAL MILESTONE PAYMENT.
(a) Except as set forth in Section 2.5 (c), in the event that a
Licensed Product receives FDA Approval prior to June 30, 2003, and provided that
upon the receipt of such FDA approval, at least one Valid Claim covering such
approved Licensed Product is in full force and effect in the United States, then
the fee set forth in Section 2.3(b) shall be treated as a non-refundable license
fee as of the date of such FDA approval.
(b) Except as provided in Section 2.5 (c), in the event that FDA
Approval for a Licensed Product is not obtained prior to June 30, 2003, then
Bracco shall have the right to offset the amount set forth in Section 2.3(b)
(i.e., $3,000,000) against future royalties due pursuant to Section 2.4 (b) as
calculated on Exhibit 3 until either (i) the full offset of the $3,000,000 or
(ii) the date on which FDA Approval for a Licensed Product is received. It is
agreed, however, that, upon the receipt of FDA Approval for a Licensed Product,
provided that at the time of the FDA Approval at least one Valid Claim covering
such approved Licensed Product is in full force and effect in the United States,
then the fee set forth in Section 2.3(b) shall be treated as a non-refundable
license fee as of the date of such FDA Approval. If, at such FDA Approval date,
Bracco has offset any amounts pursuant to Section 2.3(b), then within ten (10)
days of the date such FDA Approval is received, Bracco will pay EPIX an amount
equal to the amount that Bracco has offset from royalties due through the date
of receipt of such FDA Approval pursuant to this Section 2.5(b). In the event
that the $3,000,000 has been offset in full, Bracco will pay EPIX $3,000,000.
(c) In the event that a decision of a court or other body of competent
jurisdiction determines the unenforceability or invalidity of all the claims of
the Licensed Patents covering the Licensed Products for which FDA Approval is
being sought in the United States prior to the date on which FDA Approval for
such Licensed Product is received, then (i) the payments made pursuant to
Section 2.3(b) shall not be treated as a non-refundable license fee as provided
for in Section 2.5(a) and (ii) Bracco shall be able to continue to take or
commence taking the offsets provided for in Section 2.5(b) until and unless at
least one claim covering the Licensed Products is ultimately reinstated in a
final appeal as a valid and enforceable claim, at which time Xxxxxx'x
obligations pursuant to the provisions of Sections 2.5(a) and (b) shall be
reinstated.
(d) Beginning on the date following receipt by EPIX of the funds set
forth in Section 2.3(b) ($3,000,000) and continuing until the earlier of FDA
Approval of a Licensed Product or June 30, 2003, Bracco shall be granted a
quarterly credit to royalties due pursuant to Section 2.4(b) equal to the amount
set forth in Section 2.3(b) ($3,000,000) multiplied by the Prime Rate
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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plus [ * ] multiplied by the number of days such funds were outstanding during
the quarter divided by the total number of days in a year (365).
EXAMPLE: $3,000,000 IS OUTSTANDING FOR THE THIRD QUARTER AND
PRIME RATE IS 7%
Calculation: ($3,000,000 x .[ * ]) x (92/365) = [ * ] royalty
credit
In the event that the royalty credit calculated herein exceeds the actual
royalty due pursuant to Section 2.4(b), such excess shall not be refundable by
EPIX during such quarter but, instead shall be carried forward to the next
quarterly period and applied to such future royalty due. In the event that an
excess of such royalty credit exists on December 31, 2005, EPIX shall within ten
(10) days of receipt of the information from Bracco as set forth in Section 2.6,
refund such excess to Bracco.
2.6 STATEMENT AND REMITTANCE. Beginning with the calendar quarter
ending on March 31, 2001 and continuing on a country-by-country basis, until the
last to expire of the Licensed Patents, within sixty (60) days after the end of
each calendar quarter (except with respect to the quarters ended March 31 and
June 30, 2001, for which sums due shall be paid within thirty (30) days of the
execution of this License Agreement, but in no event later than September 27,
2001), Bracco shall send royalty payments to EPIX along with a detailed written
statement of all information relevant to the calculation of Bracco Net Sales and
royalty payments on a country-by-country basis, including the units of Licensed
Products sold and credits made as permitted in the relevant calendar quarter for
which royalties are payable and the amount of royalties due according to Section
2.4 above.
2.7 PAYMENT IN ESCROW. If a decision of a court or other body of
competent jurisdiction determines the unenforceability or invalidity of all of
the claims of the Licensed Patents in a country in the Territory resulting in
there being no Valid Claims remaining in that country covering the Licensed
Products, then the amount of royalties to be paid to EPIX by Bracco in respect
of Bracco Net Sales in that country pursuant to Section 2.4(b) thereafter will
be put in escrow by Bracco awaiting a final decision by a court from which no
appeal may be taken. In the event that the Threshold has not been achieved, only
the actual royalty of [ * ] will be payable into the escrow account. Any
royalties paid by Bracco to EPIX for any period during which a Valid Claim in a
country is in full force and effect, prior to an adjudication of invalidity or
unenforceability by a court or other body of competent jurisdiction, shall be
nonrefundable
2.8 RECORDS. Bracco and its Sublicensees shall keep accurate records
with respect to all Licensed Products sold hereunder in sufficient detail to
enable EPIX to determine the amount of royalties that are due and payable
hereunder. Records shall be kept at their principal place of business and be
open during reasonable business hours, for a period of three (3) years from the
end of the calendar year to which such royalties apply, for examination at EPIX'
expense by a certified public accountant selected by EPIX (subject to Xxxxxx'x
consent, such consent not to be unreasonably withheld or delayed), for the sole
purpose of verifying the correctness of calculations and classifications of
Bracco Net Sales under this License Agreement. Records per each calendar year
shall be audited only once. EPIX shall bear its own costs related to such
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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audit; provided, that, for any underpayments greater than five percent (5%) of
annual royalties payable by Bracco, Bracco shall pay EPIX the amount of
underpayment, together with interest at the Prime Rate plus five percent (5%),
as determined in accordance with Section 1.7 above, from the time the amount was
due and EPIX' out-of-pocket expenses related to the audit. For any underpayments
less than five percent (5%) of annual royalties payable found under this
Section, Bracco shall pay EPIX the amount of the underpayment plus interest at
the Prime Rate from the time the amount was due. Any overpayments by Bracco will
be refunded to Bracco or credited to future payments by Bracco to EPIX, at
Xxxxxx'x election. Any records or accounting information received from Bracco
shall be Confidential Information of Bracco for purposes of Article 4. Results
of any such audit shall be provided to both Parties and GH, and shall be
Confidential Information of Bracco for purposes of Article 4.
2.9 TERMS OF PAYMENTS. All payments shall be made in United States
dollars. Conversion of foreign currency to U.S. dollars shall be made at the
conversion rate existing in the United States (as reported in the Wall Street
Journal) on the last business day of the calendar quarter preceding the
applicable calendar quarter. If The Wall Street Journal ceases to be published,
then the rate of exchange to be used shall be that reported in such other
business publication of national circulation in the United States as the parties
reasonably agree. Each Party shall deduct any taxes which the Party is obligated
to pay and/or withhold in its country on the payments due under this License
Agreement and pay them to the proper authorities as required by applicable laws.
Calculations of such taxes shall be consistent with Exhibit 6, but in no event
shall such calculations be inconsistent with any change in the existing law.
Therefore, it is agreed and understood that any amount paid under this License
Agreement is net of any such tax. Each Party shall maintain official receipts of
payment of any such taxes and forward these receipts to the other within sixty
(60) days and shall provide reasonable assistance to the other Party in
obtaining any credit or refund of such taxes.
2.10 PAYMENTS' ACCOUNTS. The payments due by Bracco to EPIX according
to Section 2.3, 2.4 and 2.5 of this License Agreement shall be made by wire
transfer to EPIX using the following wiring instructions;
[ * ]
Credit to:
[ * ]
Further credit to;
[ * ]
2.11 EPIX PATENTS. Within ninety (90) days of the expiration of the
last to expire claim of the Licensed Patents covering the Licensed Products, the
Parties shall meet to discuss existing patents of interest to both Parties,
including but not limited to the EPIX Patents. In the event that Bracco
expresses an interest at the meeting in acquiring a license to any patents owned
or controlled by EPIX which otherwise haven't been exclusively licensed to a
Third Party, other than the EPIX Patents, the Parties shall negotiate in good
faith commercially reasonable terms
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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for such a license. With respect to the EPIX Patents only, in the event EPIX
believes that one or more of the EPIX Patents covers the Licensed Products, it
shall inform Bracco in writing at least ninety (90) days prior to the meeting
and Bracco shall inform EPIX at least fifteen (15) days prior to the meeting if
it wishes to continue its license to one or more EPIX Patents. In the event that
Bracco expresses its wishes to continue the license to one or more of the EPIX
Patents, the Parties shall negotiate in good faith commercially reasonable terms
for such a license. Bracco may continue the license to one or more of the EPIX
Patents at a royalty up to and including [ * ] of Bracco Net Sales of the
Licensed Products covered by the EPIX Patents PROVIDED THAT EPIX, at its sole
discretion, may reject any offer by Bracco to pay EPIX royalties of less than [
* ] of Net Sales of the Licensed Products. However, it is understood that EPIX
shall, at the request of Bracco, be obligated to continue the license granted
herein to the Epix Patents under the same terms and conditions herein, PROVIDED
THAT Bracco is willing to pay a royalty of [ * ] as the sole payment terms and
conditions. In the event that the Parties are unable to reach an agreement on
the terms for a continuation of the license for one or more EPIX Patents
pursuant to this Section 2.11 within ninety (90) days from the date of the
meeting, then the negotiation period shall be extended for an additional ninety
(90) days, after which time any and all licenses for EPIX Patents granted
hereunder shall immediately terminate if an agreement is not reached.
ARTICLE 3
WARRANTIES & REPRESENTATIONS
3.1 Each Party makes the following warranties and representations to
the other Parties:
- CORPORATE POWER. Each Party is a corporation duly
organized, 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 License Agreement and
the transactions contemplated hereby and to require
its Affiliates to abide by its terms and conditions.
- DUE AUTHORIZATION. The execution, delivery and
performance of this License Agreement have been duly
authorized by all necessary corporate action on the
part of each Party; no consent of any Third Party is
needed to enter into this License Agreement.
- BINDING AGREEMENT. This License Agreement is and
shall be a legal and valid obligation binding upon
each of the Parties, enforceable in accordance with
their respective terms.
- NO CONFLICT. None of the Parties has or will enter
into any agreement that would interfere with the
rights, licenses and privileges granted under this
License Agreement. The execution, delivery and
performance of this License Agreement and the
consummation of the transactions contemplated hereby
do not and will not violate the provisions of any
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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Party's certificate of incorporation or bylaws or
similar type documents or the provisions of any note,
lease, license permit or other instrument or
obligation or violate any law, order, rule or
regulation applicable to it or conflict with any
agreement, instrument or understanding, oral or
written, to which it is a Party or by which it may be
bound, nor violate any material law or regulation of
any court, governmental body or administrative or
other agency having jurisdiction over it.
3.2 EPIX WARRANTIES & REPRESENTATIONS. EPIX represents and warrants to
Bracco that:
(i) it has a valid interest in the Licensed Patents and,
subject to the rights of the U.S. Government under 35
U.S.C. Sections 202, et seq., has the exclusive right
to sublicense such Licensed Patents to other
entities, including Bracco;
(ii) it has not assigned, conveyed or otherwise encumbered
and will not do so for the life of this License
Agreement by any written or oral agreement or
otherwise any interest in the Licensed Patents or the
EPIX Patents in a way that would preclude, diminish
or limit Xxxxxx'x ability to use the Licensed Patents
or EPIX Patents to practice, exploit and benefit from
the manufacture, use or sale of Licensed Products;
(iii) to its knowledge after reasonable inquiry, no person
has asserted or made any claim or challenge to GH's
right to license the Licensed Patent rights to EPIX
or any claim or challenge to EPIX' right to
sublicense the Licensed Patents;
(iv) it has not transferred any rights in any of the
currently pending litigations or oppositions to an
Affiliate or another entity, that it will not apply
for or request from Bracco, its Affiliates, any Named
Entities or any other legal body any reimbursement of
legal fees or court costs related to any legal
proceeding described therein;
(v) it has made a full, complete and accurate disclosure
of all non-privileged written material in their
possession and not publicly available regarding the
ownership, validity and enforceability of the
Licensed Patents to Bracco; and
(vi) it has no patents or patent applications pending or
issued or license rights that cover the formulations
of the Licensed Products, nor to the best of its
knowledge, intermediates used in making Licensed
Products, methods of preparing Licensed Products or
methods of using Licensed Products for magnetic
resonance imaging the liver or central nervous system
other than those set forth on Exhibit 2 hereof.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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3.3 BRACCO WARRANTIES & REPRESENTATIONS. Bracco represents and warrants
to EPIX that:
(i) it has the full authority and necessary power of
attorney to act and execute the S/R Agreement on
behalf of its Affiliates and has the full authority
to terminate, in their entirety, all current actions
or legal proceedings instituted by all the Named
Entities with regard to all litigations or actions in
disputes with EPIX and GH, and the S/R Agreement is
binding and enforceable with respect to Bracco and
its Affiliates;
(ii) to its knowledge after reasonable inquiry, the terms
of all sublicense agreements between Bracco and its
Sublicensees under Section 2.2 are in all material
respects not inconsistent with the terms and
conditions of this License Agreement; and
(iii) it has not transferred any rights in any of the
currently pending litigations or oppositions to an
Affiliate or another entity, that it will not apply
for or request from EPIX, GH or any legal body any
reimbursement of legal fees or court costs related to
any legal proceeding described therein.
ARTICLE 4
CONFIDENTIALITY
4.1 During the term of this License Agreement and for a period of five
(5) years following the expiration or earlier termination hereof, each Party
shall maintain in confidence the information received by the other Party,
including but not limited to that relating to the terms and conditions of this
License Agreement, and shall not disclose, use or grant the use of such
information of the other Party, except on a need-to-know basis to such Party's
or its Affiliates' directors, officers and employees, and such Party's
consultants and collaborators, to the extent such disclosure is reasonably
necessary in connection with such Party's activities as expressly authorized by
this License Agreement. To the extent that disclosure to any person is
authorized by this License Agreement, prior to disclosure, a Party shall advise
such person of the confidential nature of such information and not to disclose,
use or grant the use of the information of the other Party except as expressly
permitted and under this License Agreement. The confidentiality obligations
under this Section 4.1 shall not apply to the extent that a Party is required to
disclose information by applicable law, regulation or order of a governmental
agency or a court of competent jurisdiction.
4.2 The Parties agree that press releases and other announcements to be
made by either of them in relation to this License Agreement shall be subject to
the written consent of the other Party, which consent shall not be unreasonably
withheld or delayed, except to the extent that any such press release is
required to be made by law and the consent of the other Party is not obtained
after reasonable efforts to do so. EPIX intends to issue a press release
immediately
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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following the execution of this License Agreement, the form and content of which
shall be in the form and in the substance similar to the one attached to this
License Agreement as Exhibit 4.
ARTICLE 5
INDEMNIFICATION
5.1 With respect to each Licensed Product:
(a) Bracco (the "Indemnifying Party") hereby agrees to save, defend and
hold EPIX and its officers, directors, consultants, agents and employees (the
"Indemnified Party") harmless from and against any and all suits, claims,
demands, liabilities, expenses and/or losses, including reasonable attorneys
fees (collectively, "Losses" or "Loss") from a Third Party claim, resulting from
or arising out of the research, development, use, import or export, manufacture,
sale, advertisement or promotion of a Licensed Product, except to the extent
such Losses result from or arise out of the inaccuracy of any representation or
warranty of EPIX set forth in this License Agreement, or the negligence or
willful misconduct of EPIX, in which case EPIX hereby agrees to save, defend and
hold Bracco and its officers, directors, consultants, agents and employees
harmless from any and all such Losses. Under these circumstances, EPIX shall be
the Indemnifying Party, Bracco and its officers, directors, consultants, agents
and employees shall be considered the Indemnified Party and the provisions of
Section 5.1(b) shall apply accordingly.
(b) Each Indemnified Party agrees to give the Indemnifying Party prompt
written notice of any Loss or discovery of fact upon which such Indemnified
Party intends to base a request for indemnification under this Section 5.1. Each
Party shall furnish promptly to the other copies of all papers and official
documents received in respect of any Loss. With respect to any Loss relating
solely to the payment of money damages and which will not result in the
Indemnified Party becoming subject to the injunctive or other relief and as to
which the Indemnifying Party shall have acknowledged in writing the obligation
to indemnify the Indemnified Party hereunder, the Indemnifying Party shall have
the sole right to defend, settle or otherwise dispose of such Loss, on such
terms as the Indemnifying Party, in its sole discretion, shall deem appropriate.
The Indemnifying Party shall obtain the written consent of the Indemnified
Party, which shall not be unreasonably withheld or delayed, prior to ceasing to
defend, settling or otherwise disposing of any Loss if as a result thereof the
Indemnified Party would become subject to injunctive or other equitable relief
or any remedy other than the payment of money, which payment would be the
responsibility of the Indemnifying Party. The Indemnifying Party shall not be
liable for any settlement or other disposition of a Loss by the Indemnified
Party which is reached without the written consent of the Indemnifying Party.
The reasonable costs and expenses, including reasonable fees and disbursements
of counsel incurred by the Indemnified Party in connection with any Loss, shall
be reimbursed on a quarterly basis by the Indemnifying Party, without prejudice
to the Indemnifying Party's right to contest that it is ultimately not to be
obligated to indemnify the Indemnified Party.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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The Indemnified Party acknowledges and agrees that in case any
potential Loss arises, it shall refrain from taking any action of any nature
whatsoever, including without limitation contacting the opposing Third Party,
the opposing Third Party's lawyer or making any public declaration on the
matter, without having previously obtained the Indemnifying Party's written
approval.
5.2 If Bracco becomes aware that a Third Party may be infringing one or
more claims of the Licensed Patents or the EPIX Patents, Bracco shall give
prompt written notice to EPIX describing to its best information the product it
believes may be infringing such Patents and its impact on Bracco or Bracco
Affiliate sales of the Licensed Products in a particular country. In the event,
and after consultations between Bracco and EPIX, from a reasonable business and
scientific judgment, such infringement represents a serious competitive threat
to the manufacture, use and/or sale of the Licensed Products under the Licensed
Patents or the EPIX Patents, EPIX shall enforce the Licensed Patents or the EPIX
Patents.
ARTICLE 6
DURATION AND TERMINATION
6.1 DURATION. This License Agreement shall come into effect as of the
Effective Date and shall remain in full force and effect in each country in the
Territory until the date of expiration in such country of the last to expire of
any patent that is a Licensed Patent and that contains a Valid Claim that covers
a Licensed Product.
6.2 TERMINATION OF THIS LICENSE AGREEMENT. This License Agreement may
be terminated by either EPIX or Bracco upon thirty (30) days notice in the event
of (i) a material breach by the other Party or (ii) bankruptcy, insolvency,
dissolution or winding up of the other Party (a "Bankruptcy Event"), except, in
the case of a petition in bankruptcy filed involuntarily against a Party, if
such petition is dismissed within sixty (60) days of the date of its filing. No
Party shall have the right to terminate this License Agreement for a material
breach without first giving written notice to the other Party setting forth in
such notice the details of the material breach and giving such other Party the
right to cure such breach within thirty (30) days (ten (10) days in the case of
a failure to make a payment on time). In the event that such other Party
believes that the breach set forth in the notice has not occurred or is not a
material breach, such other Party shall give written notice to the notifying
Party of the basis for its position within such thirty (30) day period. In the
event there is a dispute between the Parties as to whether a breach has
occurred, no Party shall have the right to terminate this License Agreement
without first following the procedures for dispute resolution set forth in
Sections 7.4, 7.5 or 7.6. In no event shall any dispute as to the infringement
of a Valid Claim of any Licensed Patent in any country or as to the validity or
enforceability of a Valid Claim of any Licensed Patent be deemed a material
breach of this License Agreement.
6.3 In the event that Bracco or Bracco Affiliate challenges the
validity or enforceability of a Valid Claim of any Licensed Patent, then (i) all
amounts paid or payable to EPIX under Sections 2.3(a), 2.3(b), 2.3(c), 2.3(d)
and 2.4 (a) shall be immediately due, payable
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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and non-refundable and, if already paid shall be non-refundable, and (ii) the
royalty rate under Section 2.4(b) shall be [ * ] as of the date such challenge
was commenced.
6.4 CONSEQUENCES OF TERMINATION OF LICENSE AGREEMENT.
6.4.1 EXISTING OBLIGATIONS. (a) Other than for termination of this
License Agreement pursuant to Section 6.2(i), the expiration or termination of
this License Agreement for any reason shall not relieve the Parties of any
obligation that accrued prior to such expiration or termination.
(b) Notwithstanding anything to the contrary, in case of
termination of this License Agreement for any reason whatsoever but for the
termination by EPIX pursuant to Section 6.2(i), if Bracco upon termination has
still, in part or in full, a credit towards EPIX with respect to the fees paid
by Bracco pursuant to Section 2.3(b), 2.3 (c) and Section 2.3(d), then, subject
to the terms of Section 6.3 hereof, EPIX shall refund Bracco any such fee or a
portion thereof not yet offset by Bracco as well as any excess credit royalties
pursuant to Sections 2.4 (c), 2.5 (b) and 2.5 (d).
(c) Any refund or reimbursement of any amounts by EPIX to Bracco
under the terms of this Agreement shall be net of any taxes paid by or withheld
on behalf of EPIX at the time of the initial payment of such amounts by Bracco
to EPIX. To the extent that EPIX is able to obtain a refund of such paid or
withheld taxes, EPIX shall pay such refunded amounts to Bracco.
6.4.2 DISPOSITION OF INVENTORY OF THE LICENSED PRODUCTS. (i) Bracco may
dispose of its inventory of the Licensed Products on hand as of the effective
date of termination, and may fill any orders for the Licensed Products accepted
prior to the effective date of termination, for a period of twenty-four (24)
months after the effective date of termination and (ii) within thirty (30) days
after disposition of such inventory and fulfillment of such orders (and in any
event within twenty-four (24) months after termination), Bracco will forward to
EPIX a final report containing the details required by Section 2.6 hereof and
pay EPIX royalties due on all Bracco Net Sales payable for such period.
6.4.3 EFFECT OF TERMINATION BY BRACCO. In the event that this License
Agreement is terminated by Bracco pursuant to the terms hereof or EPIX has
breached this License Agreement pursuant to Section 6.2.(i), Bracco shall be
entitled to claim from EPIX in a court of competent jurisdiction all damages or
other relief which would otherwise be available to Bracco at law or in equity.
6.4.4 EFFECT OF TERMINATION BY EPIX. In the event that this License
Agreement is terminated by EPIX pursuant to the terms hereof or Bracco has
breached this License Agreement pursuant to Section 6.2.(i), EPIX shall be
entitled to claim from Bracco in a court of competent jurisdiction all damages
or other relief which would otherwise be available to EPIX at law or in equity.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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6.5 SURVIVAL. The following Sections shall survive termination of the
License Agreement: Articles 4 and 5, and Sections 6.4, 6.5, 7.1, 7.4, 7.6, 7.11,
7.12 and 7.13.
ARTICLE 7
MISCELLANEOUS
7.1 NOTICES. All notices required pursuant to this License 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 for documents other than with respect to service of
process, or registered or certified mail (return receipt requested, postage
prepaid) to the following addresses or facsimile numbers:
If to EPIX: EPIX Medical, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Attention: Chief Executive Officer
Facsimile: 000-000-0000
With a copy to: Mintz, Levin, et al
Xxx Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxx, Esq.
Facsimile: 617-542-2241
If to Bracco: Xxxxxx S.p.a.
Via E. Folli 50
20134 Milan
Attention: Group Business Development
Facsimile: 011-39-02-2177-2781
With a copy to: Xxxxxx Xxxxx Xxxxxxx & Naftalis
000 Xxxxx Xxxxxx
Xxx Xxxx, X.X. 00000
Attention: Xxxxxxxx X. Xxxx, Esq.
Facsimile: 000- 000-0000
Either Party may change its designated address and facsimile number by notice to
the other Party in the manner provided in this Section. Service of Process by
confirmed facsimile transmission is not permitted.
7.2 ASSIGNMENT. This License Agreement may not be assigned by either
Party without the prior written consent of the other Party, except that either
Party may assign this License Agreement to any of its Affiliates or to a
successor in connection with the merger, consolidation, or sale of all or
substantially all of its assets or that portion of its business pertaining to
the subject matter of the License Agreement, with prompt written notice to the
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
-15-
other Party of any such assignment. This License Agreement shall inure to the
benefit of and be binding upon the Parties and their respective lawful
successors and assignees.
7.3 FORCE MAJEURE. Neither Party shall be held liable or responsible to
the other Party nor be deemed to have defaulted under or breached this License
Agreement for failure or delay in performing any term of this License Agreement
when such failure or delay is caused by or results from causes beyond the
reasonable control of the affected Party, including but not limited to fire,
floods, embargoes, war, acts of war (whether war is declared or not), riots,
strikes, lockouts or other labor disturbances, lawsuits, acts of God, or acts,
omissions or delays in acting by any court, governmental authority or the other
Party.
7.4 ARBITRATION CLAUSE. In the event of a dispute between the Parties
arises out of or in connection with this License Agreement, the appropriate
officers or managers of the Parties shall meet within thirty (30) days after
notice of such dispute in a first attempt to settle through good faith
negotiations. In the event the Parties are unable to resolve such dispute, upon
the mutual consent of the Parties, such dispute may be finally settled by and
remanded to the exclusive jurisdiction of the American Arbitration Association
and a panel of three Arbitrators, appointed one by Bracco and one by EPIX, and a
third who is appointed by agreement of the first two Arbitrators or, in the
absence of such agreement, by the American Arbitration Association, who shall
act as President. The Party raising the dispute shall request the arbitration
and shall notify the other Party at the same time of the name of its own
appointed Arbitrator as provided for herein. The Party receiving such request
and notice shall within 30 (thirty) days of said notice appoint their own
Arbitrator as provided for herein and notify the other Party thereof. The
American Arbitration Association shall also proceed with the appointment of any
Arbitrator if any Party required to proceed with such an appointment shall not
have done so within the aforesaid 30 (thirty) day period. The Arbitration shall
be held in accordance with the Commercial Rules of the American Arbitration
Association and take place in New York, NY. Notwithstanding the above, without
resort to arbitration in the first instance, either Party shall have the right
to bring suit against the other Party to resolve the dispute as provided in
Section 7.6 below.
7.5 AMENDMENT AND WAIVER. This License Agreement may be amended,
supplemented, or otherwise modified only by means of a written instrument signed
by both Parties. Any waiver of any rights or failure to act in a specific
instance shall relate only to such instance and shall not be construed as an
agreement to waive any rights or fail to act in any other instance, whether or
not similar.
7.6 APPLICABLE LAW, JURISDICTION AND SERVICE OF PROCESS. This License
Agreement shall be governed by and construed in accordance with the laws of the
State of New York, without giving effect to the choice of law provisions
thereof. Any legal action or proceeding with respect to this License Agreement
shall be brought in the United States District Court for Southern District of
New York, if there is federal jurisdiction, or in the state courts for the State
of New York, in the Borough of New York. By execution and delivery of this
License Agreement, each of the Parties hereto accepts for itself and in respect
of its property, generally and unconditionally, the jurisdiction of the
aforesaid courts.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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7.7 SEVERABILITY. In the event that any provision of this License
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
License Agreement to preserve their original intent.
7.8 ENTIRE AGREEMENT. This License Agreement in conjunction with the
S/R Agreement constitutes the entire agreement between the Parties with respect
to the subject matter hereof and supersedes all prior agreements or
understandings between the Parties relating to the subject matter hereof.
7.9 HEADINGS. The captions to the several Articles and Sections hereof
are not a part of this License Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections hereof.
7.10 EXPORTS. The Parties acknowledge that the export of technical
data, materials or products is subject to the exporting Party receiving any
necessary export licenses and that the Parties cannot be responsible for any
delays attributable to export controls which are beyond the reasonable control
of either Party. EPIX and Bracco agree not to export or reexport, directly or
indirectly, any information, technical data, the direct product of such data,
samples or equipment received or generated under this License Agreement in
violation of any applicable export control laws or governmental regulations.
Bracco agrees to obtain similar covenants from their licensees, Sublicensees and
contractors with respect to the subject matter of this Section 7.10.
7.11 COUNTERPARTS. This License Agreement may be executed in two or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
7.12 INDEPENDENT CONTRACTORS; NEGATION OF PARTNERSHIP. The relationship
of EPIX and Bracco established by this License Agreement is that of independent
contractors, and nothing contained in this License Agreement shall be construed
to give either Party the power to direct or control the day-to-day activities of
the other, or allow one Party to create or assume an obligation on behalf of the
other Party for any purpose whatsoever. This License Agreement is not intended
to create a partnership between EPIX and Bracco for United States federal income
tax purposes for any state or local jurisdiction in the United States, or for
any country other than the United States. Therefore, there is no requirement in
the United States to file Form 0000, Xxxxxx Xxxxxx Partnership Return of Income,
or any similar state or local income tax return in any political subdivision, of
the United States, or any similar tax document in any country other than the
United States in regard to the contractual relationship described in this
License Agreement.
7.13 AMBIGUITIES. The Parties acknowledge and agree that: (i) each
Party reviewed and negotiated the terms and provisions of this License Agreement
and have contributed to its revision; (ii) the rule of construction to the
effect that any ambiguities are resolved against the drafting Party shall not be
employed in the interpretation of this License Agreement; and (iii) the terms
and provisions of this License Agreement shall be construed fairly as to all
Parties hereto and not in favor of or against any Party, regardless of which
Party was generally responsible for the preparation of this License Agreements.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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IN WITNESS WHEREOF, the undersigned have duly executed and delivered
this License Agreement as of the date first above written.
XXXXXX IMAGING S.P.A. EPIX MEDICAL, INC.
By: /s/ Xxxxx Xxxxxx By: /s/ Xxxxxxx X. Xxxx
--------------------------- ------------------------------
Title: Chairman Title: CEO
------------------------ ---------------------------
Date: September 25, 2001 Date: September 24, 2001
------------------------ ---------------------------
Exhibits Attached:
Exhibit 1: List of Current Bracco Affiliates and Current Sublicensees
Exhibit 2: List of Patents
Exhibit 3: Calculation of Offset to Royalties Pursuant to Section 2.5(b)
Exhibit 4: Press Release
Exhibit 5: List of Countries having Issued Licensed Patents
Exhibit 6: Accountants' Letter regarding tax calculations
THE FOREGOING EXHIBITS HAVE BEEN OMITTED AND WILL BE FURNISHED SUPPLEMENTALLY TO
THE COMMISSION UPON REQUEST.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act.
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