DISTRIBUTION OPTION AGREEMENT
EXHIBIT 10.10
Execution Version
THIS DISTRIBUTION OPTION AGREEMENT (the “Agreement”), is made and entered into on
December 7, 2007 (the “Effective Date”), by and between (i) Boston Scientific Corporation,
a Delaware corporation (“BSC”), and (ii) Xxxx Medical, Inc., a California corporation
(“Xxxx”).
WHEREAS, each of Xxxx and BSC desires to enter into this Agreement to facilitate the
contemplated sale by Xxxx for cash of shares of its Series H Preferred Stock, no par value per
share;
WHEREAS, pursuant to the terms of that certain Agreement and Plan of Merger (the
“Merger Agreement”), dated as of October 13, 2004, by and among (i) BSC, (ii) RMI
Acquisition Corp. (the “Merger Sub”), a California corporation and a wholly-owned
subsidiary of Boston Scientific Scimed, Inc., a Minnesota corporation and a subsidiary of BSC
formerly known as Scimed Life Systems, Inc. (“Scimed”), (iii) Xxxx, and (iv) the members of
the Stockholder Representative Committee referred to therein, BSC has an exclusive option (the
“Company Option”) to acquire all of the outstanding capital stock, options, warrants and
other rights exercisable for, or instruments convertible into, shares of capital stock of Xxxx;
WHEREAS, if BSC exercises the Company Option, Xxxx, BSC and Merger Sub will consummate the
Merger described in the Merger Agreement, pursuant to which Merger Sub will merge (the
“Merger”) with and into Xxxx and Xxxx, as the surviving corporation in the Merger, will
become a wholly-owned subsidiary of Scimed;
WHEREAS, immediately following the execution and delivery of this agreement, BSC, Xxxx, Merger
Sub and the Stockholder Representative Committee intend to enter into an amendment to the Merger
Agreement (the “Amendment”) providing that, among other things, (i) upon the consummation
of an initial closing of a Qualified Equity Financing in which the Company receives aggregate net
cash proceeds (not subject to any contingencies) of no less than $10,000,000, the Company Option
shall be suspended until September 30, 2008, unless the Company has received aggregate net cash
proceeds (not subject to any contingencies) equal to no less than $25,000,000 in a Qualified Equity
Financing prior to such date (including such amounts received at such initial closing), in which
event the Company Option shall be suspended until the third anniversary of the
consummation of the initial closing of the Qualified Equity Financing (the date upon with the
Company Option shall no longer be suspended being referred to herein as the “Restoration
Date”), and (ii) upon the consummation by Xxxx at any time prior to the Restoration Date of
an initial public offering of shares of its capital stock resulting in the receipt by Xxxx of no
less than $50,000,000 in aggregate gross cash proceeds, the Company Option shall be terminated; and
WHEREAS, BSC is unwilling to enter into the Amendment unless this Agreement is executed and
delivered by the parties hereto.
NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements contained
herein, the parties hereby agree as follows:
1. Definitions. As used herein the following terms not otherwise defined have the
following respective meanings:
“Affiliate” shall mean, with respect to any person or entity, any person or entity
that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is
under common control with, such person or entity.
“business days” (whether such term is capitalized or not) shall mean any day
other than Saturday, Sunday or a legal holiday that banks located in Boston, Massachusetts are open
for business.
“Clinical Milestone” shall mean the date occurring ninety (90) days following
the delivery by Xxxx to BSC of each of (i) all material information (including, but not limited to,
all case report forms and all data concerning imaging, death, MI, ST and TLR) available to Xxxx
relating to the one year follow-up of at least 200 implanted resorbable drug coated stents of Xxxx
from a human clinical trial conducted in accordance with applicable laws and regulations (the
“Implanted Stents”), (ii) all material information (including, but not limited to,
core lab acute gain, late loss, and binary angiographic restenosis) relating to the 8-9 month
angiographic follow-up of at least 100 of such Implanted Stents, and (iii) all material information
relating to the 8-9 month IVUS of at least 40 of such Implanted Stents.
“Coronary Stent Product” shall mean Reva’s bioresorbable coronary
stent products and (i) any stent products subsequently developed by Xxxx that serve as line
extensions thereto, (ii) any associated products of Xxxx that are integral to the performance of
Reva’s bioresorbable coronary stent products or sold therewith as part of a kit, and (iii) any
Improvements or substitutes therefor.
“Corresponding Stent Product” shall mean, (i) with respect to any
Directly Competitive Resorbable Stent Product that is a coronary stent product, the Coronary Stent
Product, and (ii) with respect to any Directly Competitive Resorbable Stent Product that is a
peripheral vascular stent product, the Peripheral Vascular Stent Product.
“Direct Competitor” shall mean Medtronic, Xxxxxxx & Xxxxxxx Corporation and
Xxxxxx Laboratories and each of their respective Affiliates.
“Directly Competitive Resorbable Stent Product” shall
mean any bioresorbable coronary or peripheral vascular stent product, other than, (i) with respect
to a coronary stent product, the Coronary Stent Product, and, (ii) with respect to a peripheral
vascular stent product, the Peripheral Vascular Stent Product, in each case with approved
indications substantially similar to those of the Coronary Stent Product or Peripheral Vascular
Stent Product, as applicable.
“Effectiveness Time” shall be the moment in time immediately following the initial
closing of a Qualified Equity Financing, provided, that such closing results in the Company
actually receiving aggregate net cash proceeds (not subject to any contingencies) equal to no less
than $10,000,000.
“FDA” means the United States Food and Drug Administration, or any successor entity.
2
“Improvement” shall mean an addition, development, enhancement, update or other change
in any Product, including any extension of the label claims for any Product and any new design for
any Product.
“IVUS” shall mean intravascular ultrasound.
“MI” shall mean acute myocardial infarction.
“Jurisdiction” shall mean each country or other jurisdiction in the world;
provided, that the member states of the European Union shall each be considered a single
Jurisdiction for purposes hereof.
“Option Period” shall mean the period of time beginning as of the Effectiveness Time
and ending, unless otherwise terminated earlier pursuant to Section 3 hereof, on the date on which
the Clinical Milestone is achieved.
“Peripheral Vascular Stent Product” shall mean Reva’s bioresorbable
peripheral vascular stent products and (i) any stent products subsequently developed by Xxxx that
serve as line extensions thereto, (ii) any associated products of Xxxx that are integral to the
performance of Reva’s bioresorbable peripheral vascular stent products or sold therewith as part of
a kit and (iii) any Improvements or substitutes therefor.
“person” (whether such term is capitalized or not) shall mean an individual,
corporation, partnership, limited partnership, limited liability company, syndicate, person
(including, without limitation, a “person” as defined in Section 13(d)(3) of the Exchange Act),
trust, association or entity or government, political subdivision, agency or instrumentality of a
government.
“Product” shall mean any of the Coronary Stent Product or Peripheral Vascular Stent
Product.
“Product Approvals” shall mean, with respect to a Jurisdiction, all regulatory
approvals required for importation, exportation, promotion, pricing, marketing and sale of any
Product in such Jurisdiction.
“Qualified Equity Financing” shall mean the sale for cash of a new
series of Company Preferred Stock (as defined in the Merger Agreement) on or after the Effective
Date to a syndicate of investors led by a non-affiliated third party in a transaction which may
include one or more closings pursuant to which Xxxx shall actually receive aggregate net proceeds
(not subject to any contingencies) equal to no less than $25,000,000; provided,
however, that the initial closing (or first closing) of a Qualified Equity Financing shall
be deemed to have occurred at such time as the Company shall have received in an initial closing
(whether or not any subsequent closings actually take place) not less than $10,000,000 pursuant to
the terms and conditions set forth above.
“ST” shall mean stent thrombosis.
“TLR” shall mean target lesion revascularization.
3
The following table sets forth certain other defined terms and the section of this Agreement
in which the meaning of each such term appears:
| Defined Term | Section | |||
“Agreement”
|
Preamble | |||
“Amendment”
|
Preamble | |||
“BSC”
|
Preamble | |||
“Company Option”
|
Preamble | |||
“Effective Date”
|
Preamble | |||
“Foreign Jurisdiction”
|
1.2 | |||
“Implanted Stents”
|
1, “Clinical Milestone” | |||
“Merger”
|
Preamble | |||
“Merger Agreement”
|
Preamble | |||
“Merger Sub”
|
Preamble | |||
“Negotiation Period”
|
1.3(b) | |||
“Option”
|
1.1 | |||
“Option Exercise Notice”
|
1.1 | |||
“Qualified Equity Financing”
|
Preamble | |||
“Restoration Date”
|
Preamble | |||
“Xxxx”
|
Preamble | |||
“Scimed”
|
Preamble | |||
2. Option to Distribute Products.
2.1 Distribution Options. Xxxx hereby grants to BSC an exclusive right with respect
to each Jurisdiction on an exclusive basis (in each case, an “Option”), exercisable in each
case in BSC’s sole discretion at any time during the Option Period, to sell, market and distribute
Products in such Jurisdiction. BSC may exercise the Option with respect to any Jurisdiction by
delivering written notice (each an “Option Exercise Notice”) to Xxxx at any
time during the Option Period. Notwithstanding the foregoing, from and after such time, if any,
that BSC first sells, markets or distributes any Directly Competitive Resorbable Stent Product in
any Jurisdiction, then each Option shall become an option to obtain nonexclusive rights in such
Jurisdiction solely with respect to the applicable Corresponding Stent Product and all exclusive
arrangements in such Jurisdiction shall become nonexclusive in such Jurisdiction solely with
respect to such Corresponding Stent Product.
2.2 Exclusive Distribution Right. Xxxx hereby agrees that at all times prior to the
expiration or termination of the Option Period, it will not market, sell or distribute any Product
in any Jurisdiction or enter into any agreement or take any other action (including but not limited
to, (i) granting any third party the right, or otherwise permitting any third party, to sell,
market or distribute any Product in any Jurisdiction, (ii) entering into any distribution agreement
with any third party in respect of any Product, and (iii) transferring or licensing to any third
party any proprietary rights or other intellectual property) that would prevent or hinder BSC from
exercising any Option; provided, however, that notwithstanding anything to the
contrary in this Section 2, if BSC sells, markets or distributes any Directly Competitive
Resorbable Stent
4
Product in any Jurisdiction, then Xxxx shall be entitled to market, sell and
distribute the applicable Corresponding Stent Product in such Jurisdiction, or grant other parties
the right to do so, in each case on a non-exclusive basis. Notwithstanding anything to the
contrary herein, if (x) Xxxx receives Product Approval in respect of any Jurisdiction, or any
country or territory within a Jurisdiction (in the case of the European Union), outside of the
United States (each a “Foreign Jurisdiction”) with respect to any Product prior to
the submission by Xxxx to the FDA of an application for Product Approval in the United States with
respect to such Product, and (y) BSC does not deliver to Xxxx an Option Exercise Notice with
respect to such Product and such Foreign Jurisdiction prior to the ninetieth (90th) day following
receipt by BSC of a written inquiry from Xxxx (which written inquiry may not be delivered to BSC
until after such time as Xxxx has obtained Product Approval in respect of such Product and such
Foreign Jurisdiction) inquiring whether BSC intends to exercise the Option with respect to such
Product and such Foreign Jurisdiction or BSC delivers an Option Exercise Notice with respect to
such Product and such Foreign Jurisdiction but BSC and Xxxx are unable to agree upon the terms of a
definitive distribution agreement prior to the expiration of the Negotiation Period, then Xxxx may
sell, market and distribute such Product in such Foreign Jurisdiction directly or through any third
party that is not a Direct Competitor, provided, however, that any and all
distribution, reseller or similar agreement(s) entered into between Xxxx and any such third party
shall be terminable, without cost or penalty to BSC, on no more than ninety (90) days’ written
notice.
2.3 Negotiation of Agreement.
(a) If BSC exercises any Option(s), negotiations will begin as soon as reasonably practicable
thereafter and the parties shall negotiate in good faith to enter into a mutually acceptable
definitive distribution agreement with respect to such Option(s), which shall be prepared by BSC in
a form reasonably acceptable to Xxxx, with customary terms and provisions, including without
limitation, customary provisions relating to indemnification and representations and warranties
covering, among other things, ownership, manufacturing, regulatory approvals, product quality, no
liabilities, infringement and Intellectual Property coverage. In addition to such customary
provisions, such definitive distribution agreement shall also include provisions that (i) Xxxx
shall be obligated to meet all legal and regulatory requirements, as well as BSC quality standards,
with respect to the design, development, and manufacturing of all Products and will contain all
quality control provisions from BSC’s then current standard supplier quality agreement, (ii) the
transfer price for Products shall be equal to *** percent (***%) of BSC’s average selling price
for such Products, (iii) the term of such distribution agreement shall not be less than five (5)
years, (iv) BSC shall not be required to make any payments, other than payments of the
aforementioned transfer price for Products, with respect to the sale, marketing or distribution of
Products, (v) BSC shall be the exclusive distributor of the Products at all times during the term
of such distribution agreement so long as BSC does not commence the selling, marketing or
distributing of any Directly Competitive Resorbable Stent Product, with any such distribution
agreement becoming non-exclusive with respect to (x) any Jurisdiction and (y) the applicable
Corresponding Stent Product, at such time as BSC first sells, markets or distributes any Directly
Competitive Resorbable Stent Product in such Jurisdiction, and (vi) BSC shall have sole discretion
over all marketing and sales decisions relating to the Products.
| *** | Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. |
5
(b) If BSC and Xxxx are unable to agree upon the terms of a definitive distribution agreement
through good faith negotiations with respect to any Option within ninety (90) days of BSC’s
exercise of such Option (the “Negotiation Period”), or if BSC delivers at any time
written notice to Xxxx that it elects not to exercise any Option, then Xxxx shall be permitted to
sell, market and distribute Products in the Jurisdiction pertaining to any such Option itself or
offer the right to sell, market and distribute Products in the Jurisdiction pertaining to any such
Option to a third party, provided that, in the case of any such offer made to any such
third party, the terms of such offer, and of any definitive agreement establishing such third
party’s right to sell, market and distribute Products, shall not be materially more favorable than
the most favorable terms offered by Xxxx to BSC at any time after the date of this Agreement and
prior to the end of the Negotiation Period regarding BSC’s right to sell, market and distribute
Products in the Jurisdiction pertaining to any such Option.
2.4 Due Diligence. During any negotiation period for a distribution agreement
contemplated by this Section 2, subject to the parties entering into a confidentiality agreement in
form and substance reasonably acceptable to Xxxx, BSC shall be provided the opportunity to perform
reasonable financial, legal, business and other due diligence regarding the Products. BSC shall
not be required to enter into any distribution agreement with respect to any Option under any
circumstances where it is not satisfied, in its sole discretion, with the results of such due
diligence review. Xxxx shall provide BSC with reasonable cooperation in such due diligence review,
including, allowing BSC access to its books, records, facilities and personnel.
3. Term and Termination.
3.1 Term. This Agreement shall commence on the Effective Date and shall continue in
full force and effect until the termination or expiration of the Option Period; provided,
however, that (i) this Agreement may be terminated earlier in accordance with the
provisions of this Section 3 and (ii) this Agreement shall continue in full force and effect at all
times during any Negotiation Period.
3.2 Termination by BSC. BSC may terminate this Agreement, for any reason or no
reason, at any time from and after the Effective Date by written notice to Xxxx.
3.3 Survival of Certain Terms. The provisions of Sections 2.3(b), 3 and 4 of this
Agreement shall survive the termination of this Agreement for any reason. All other rights and
obligations of the parties, other than those rights that shall have then accrued, shall cease upon
termination of this Agreement.
3.4 Effect of Termination. The parties acknowledge that upon termination of this
Agreement as permitted under, and in accordance with the terms of this Section 3, no party shall
have the right to recover any claim with respect to any losses suffered by such party in connection
with such termination, except to the extent that such losses arise out of or are related to a
breach of the agreements or covenants hereunder of another party hereto prior to or contemporaneous
with such termination.
3.5 Termination for Insolvency. This Agreement shall terminate without notice (a)
upon the institution by or against BSC of insolvency, receivership or bankruptcy proceedings
6
or any
other proceedings for the settlement of a party’s debts, which proceedings are not abandoned,
dismissed or otherwise terminated within thirty (30) calendar days after the commencement thereof,
(b) upon BSC’s making an assignment for the benefit of creditors, or (c) upon BSC’s dissolution or
ceasing to do business.
4. Miscellaneous.
4.1 Governing Law; Consent to Jurisdiction. This Agreement shall be governed by, and
construed in accordance with the laws of the Commonwealth of Massachusetts applicable to contracts
executed in and to be performed in that state, without reference to conflict of laws principles.
EACH OF BSC AND XXXX HEREBY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE STATE COURTS
OF THE COMMONWEALTH OF MASSACHUSETTS AND TO THE JURISDICTION OF THE UNITED STATES DISTRICT COURT
FOR THE COMMON WEALTH OF MASSACHUSETTS FOR THE PURPOSE OF ANY ACTION OR PROCEEDING ARISING OUT OF
OR RELATING TO THIS AGREEMENT, AND EACH OF BSC AND XXXX HEREBY IRREVOCABLY AGREES THAT ALL CLAIMS
IN RESPECT TO SUCH ACTION OR PROCEEDING MAY BE HEARD AND DETERMINED EXCLUSIVELY IN ANY
MASSACHUSETTS STATE OR FEDERAL COURT SITTING IN THE CITY OF BOSTON. EACH OF BSC AND XXXX AGREES
THAT A FINAL JUDGMENT IN ANY ACTION OR PROCEEDING SHALL BE CONCLUSIVE AND MAY BE ENFORCED IN OTHER
JURISDICTIONS BY SUIT ON THE JUDGMENT OR IN ANY OTHER MANNER PROVIDED BY LAW. EACH OF BSC AND XXXX
IRREVOCABLY CONSENTS TO THE SERVICE OF THE SUMMONS AND COMPLAINT AND ANY OTHER PROCESS IN ANY OTHER
ACTION OR PROCEEDING RELATING TO THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, ON BEHALF OF
ITSELF OR ITS PROPERTY, BY THE PERSONAL DELIVERY OF COPIES OF SUCH PROCESS TO SUCH PARTY. NOTHING
IN THIS SECTION 4.1 SHALL AFFECT THE RIGHT OF ANY PARTY TO SERVE LEGAL PROCESS IN ANY OTHER MANNER
PERMITTED BY LAW.
4.2 Assignability and Binding Effect. This Agreement constitutes the entire agreement
among the parties with respect to the subject matter hereof and supersedes all prior agreements and
undertakings, both written and oral, among the parties, or any of them, with respect to the subject
matter hereof. This Agreement shall not be assigned by operation of law or otherwise, except that
(a) BSC may assign all or any of its rights hereunder to any Affiliate of BSC; provided,
that no such assignment to an Affiliate shall relieve BSC of its obligations hereunder, and (b) BSC
may assign all of its rights and obligations hereunder to a person that acquires all of the capital
stock, or substantially all of the assets, of BSC or of its interventional cardiology business
unit; provided, that such person assumes BSC’s obligations under this Agreement, in
writing, and agrees to be bound by and comply with all of the terms and conditions hereof.
4.3 Counterparts. This Agreement may be executed and delivered (including by
facsimile transmission) in one (1) or more counterparts, and by the different parties hereto in
separate counterparts, each of which when executed and delivered shall be deemed to be an
original but all of which taken together shall constitute one (1) and the same agreement.
7
4.4 Titles and Subtitles. The descriptive headings contained in this Agreement are
included for convenience of reference only and shall not affect in any way the meaning or
interpretation of this Agreement. Whenever the word “include,” “includes,” or “including” appears
in this Agreement, it shall be deemed in each instance to be followed by the words “without
limitation”.
4.5 Notices. All notices, claims and demands hereunder, and all other communications
which are required to be given in writing pursuant to this Agreement, shall be in writing and shall
be given (and shall be deemed to have been duly given upon receipt) by delivery in person or
facsimile (received at the facsimile machine to which it is transmitted prior to 5 p.m., local
time, on a business day for the party to which it is sent, or if received after 5 p.m., local time,
as of the next business day) or by registered or certified mail (postage prepaid, return receipt
requested) to the respective parties at the following addresses (or at such other address for a
party as shall be specified in a notice given in accordance with this Section 4.5):
if to BSC:
Boston Scientific Corporation
Xxx Xxxxxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Financial Officer
Facsimile: 000-000-0000
Xxx Xxxxxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Financial Officer
Facsimile: 000-000-0000
with a copy to:
Boston Scientific Corporation
Xxx Xxxxxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Assistant General Counsel
Facsimile: 000-000-0000
Xxx Xxxxxx Xxxxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Assistant General Counsel
Facsimile: 000-000-0000
if to Xxxx:
XXXX Medical, Inc.
0000 Xxxxxx Xxxxx, Xxxxx X
Xxx Xxxxx, XX 00000
Attention: President
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
0000 Xxxxxx Xxxxx, Xxxxx X
Xxx Xxxxx, XX 00000
Attention: President
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to:
Xxxxxx Xxxxxx White & XxXxxxxxx LLP
0000 Xx Xxxxx Xxxxxxx Xxxxx, 0xx Xxxxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
0000 Xx Xxxxx Xxxxxxx Xxxxx, 0xx Xxxxx
Xxx Xxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
8
4.6 Fees and Expenses. All costs and expenses incurred in connection with this
Agreement by Xxxx shall be paid by Xxxx. All costs and expenses incurred in connection with this
Agreement by BSC shall be paid by BSC.
4.7 Amendments and Waivers. Any term of this Agreement may be amended or waived
(either generally or in a particular instance and either retroactively or prospectively), only with
the written consent of BSC and Xxxx.
4.8 Severability. If any term or other provision of this Agreement is invalid,
illegal or incapable of being enforced by any rule of applicable law, or public policy, all other
conditions and provisions of this Agreement shall nevertheless remain in full force and effect so
long as the economic or legal substance of the matters referred to herein are not affected in any
manner materially adverse to any party. Upon such determination that any term or other provision
is invalid, illegal or incapable of being enforced, the parties hereto shall negotiate in good
faith to modify this Agreement so as to effect the original intent of the parties as closely as
possible in a mutually acceptable manner in order that the matters referred to herein are
consummated as originally contemplated to the fullest extent possible.
4.9 Specific Enforcement. The parties hereto agree that irreparable damage would
occur in the event that any provision of this Agreement was not performed in accordance with the
terms hereof and that the parties shall be entitled to specific performance of the terms hereof, in
addition to any other remedy at law or equity.
[The remainder of the page is intentionally left blank.]
9
IN WITNESS WHEREOF, the parties have executed this Distribution Option Agreement as an
instrument under seal as of the date first above written.
| BSC: BOSTON SCIENTIFIC CORPORATION |
||||
| By: | /s/ Xxx Xxxxxxx | |||
| Name: | Xxx Xxxxxxx | |||
| Title: | Executive Vice President and Group President, Cardiovascular | |||
| XXXX: XXXX MEDICAL, INC. |
||||
| By: | /s/ Xxxxxx X. Xxxxxxx | |||
| Name: | Xxxxxx X. Xxxxxxx | |||
| Title: | President | |||
