EXHIBIT 10.9
CONFIDENTIAL TREATMENT
EPIX Medical, Inc. has requested that the marked
portions of this document be accorded confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of
1934.
EXECUTION COPY
INTELLECTUAL PROPERTY AGREEMENT
This “Agreement” made
this 17th day of November, 2003 by and between Dr. Martin R. Prince
(hereinafter, “Prince”), an individual residing at
*****, and EPIX Medical, Inc., a corporation duly organized under
the laws of the State of Delaware and having a principal place of
business at 71 Rogers Street, Cambridge, Massachusetts USA
(hereinafter “EPIX”).
RECITALS
Prince is recognized for his
expertise in clinical magnetic resonance imaging and magnetic
resonance angiography and as the inventor of contrast-enhanced
magnetic resonance angiography techniques.
Prince and Dr. James F.M. Meaney
(hereinafter “Meaney”), an individual residing at
*****, are the inventors of certain inventions relating to bolus
chase magnetic resonance angiography.
Prince represents that he is the
owner of, and has the right to grant the discharges, releases,
promises and covenants not to sue under intellectual property
pertaining to magnetic resonance imaging and magnetic resonance
angiography that is the subject of this Agreement.
EPIX, by itself and/or through its
Affiliates, desires to obtain discharges, releases, promises and
covenants not to sue under the above-described intellectual
property rights to enable them to develop and commercialize
contrast agents used in magnetic resonance imaging and magnetic
resonance angiography on the terms set forth herein.
Prince desires to grant such
discharges, releases, promises and covenants not to sue on the
terms set forth herein.
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AGREEMENT
NOW, THEREFORE, in consideration of
the promises and mutual covenants set forth herein, the parties
agree as follows:
ARTICLE 1
DEFINITIONS
1.1
“Effective Date” means
the date first set forth above.
1.2
“Royalty Start Date”
means the date of the first Sale of an MR Contrast Agent
Product.
1.3
“Affiliate(s)” means any
entity which is or becomes directly or indirectly controlled by
EPIX, control being defined as (i) the direct or indirect ownership
of at least 50% of the stock entitled to vote upon election of
directors or persons performing similar functions, or (ii) direct
or indirect ownership of the maximum percentage of such stock
permitted by local laws or regulations in those countries where
fifty percent (50%) ownership by a foreign entity is not
permitted.
1.4
“CE-MRA” means
contrast-enhanced MR angiography.
1.5
“MR” means magnetic
resonance imaging and magnetic resonance angiography.
1.6
“MR Contrast Agent(s)”
means any contrast agent used in, or capable of use in CE-MRA
procedures.
1.7
“MR Imaging System(s)”
means any magnetic resonance transmission/receiving system,
inclusive of all hardware (for example, without limitation, imaging
coils) and software components, that is capable of performing
CE-MRA procedures.
1.8
“MR Injection
Product(s)” means any pump, tubing set, or like apparatus
that is designed for or advertised to be used in CE-MRA procedures
to administer, inject or infuse contrast agent(s) to a
patient. Notwithstanding the foregoing, a syringe that is
pre-filled with the MR Contrast Agent Product is not an MR
Injection Product.
1.9
“MR Contrast Agent
Product” means a product containing the MR Contrast Agent
currently designated by EPIX as MS-325. Expressly excluded
from this definition are all other MR Contrast Agents, and MR
Imaging Systems or any MR Injection Products, no matter how Sold,
provided, used or disposed of.
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1.10
“Prince MR Intellectual
Property” means any invention, improvement, trade secret,
patent, patent application, copyright and other intellectual
property rights to which Prince is able to grant the discharge,
release, promise and covenant not to sue herein as of the Effective
Date or thereafter during the term of this Agreement, which relate
to the manufacture, use, importation, advertisement, offer to Sell,
or Sale of any MR Contrast Agent Product.
1.11
“Prince Patents” means
the patents and patent applications included within the Prince MR
Intellectual Property, including, without limitation, the patents
and patent applications listed in Exhibit A and any and all
applications, continuation applications, continuation-in-part
applications, divisional applications, reissue applications,
reexamination applications, foreign counterparts or other statutory
rights arising from or based on such applications, anywhere in the
world.
1.12
“Third Party(ies)” means
any entity which is neither a party to this Agreement nor an
Affiliate of such a party.
1.13
“EPIX Licensee(s)” means
any entity that is authorized by EPIX to Sell the MR Contrast Agent
Product to a customer/user in any country of the world.
Currently, the only EPIX Licensees are Berlex Laboratories, Inc.
(hereinafter “Berlex”), a company having its principal
place of business at 340 Changebridge Road, Montville, New Jersey,
and Schering AG (hereinafter “Schering”), a company
having its principal place of business at Müllerstrasse 178,
D-13342 Berlin, Germany.
1.14
“Sell” means to sell,
lease, or otherwise transfer or convey an MR Contrast Agent
Product. A commercially reasonable number of units of MR
Contrast Agent Product that are provided, free of charge, to Third
Parties as samples for promotional purposes shall be deemed not to
have been Sold for purposes of determining the royalty payable
hereunder. “Sold”, “Sale”, and other
forms of “Sell” shall have the same meaning.
1.15
“Net Sales” means the
gross amount invoiced or otherwise charged a customer by EPIX (or
its Affiliates) or EPIX Licensees for a MR Contrast Agent Product
Sold by EPIX (or its Affiliates) or EPIX Licensees in any country
of the world, less the following amounts: (a) insurance,
transportation, taxes, customs brokers fees and customs duties
provided such deductions are paid by EPIX (or its Affiliates) or
EPIX Licensees and listed on the invoice; (b) allowances or credits
to customers in the ordinary course of business in connection with
the sale of an MR Contrast Agent Product on account of outdating,
recall, market withdrawal, rejection, or return of such MR Contrast
Agent Product, (c) credited allowances to such
independent
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customers for such MR Contrast Agent
Product which were spoiled, damaged, out-dated or returned; (d)
freight and insurance costs charged to such customers; (e) quantity
and promotional discounts actually allowed and taken; (f) sales,
use, value added, and other taxes or governmental charges (such as
customs duties) incurred in connection with the sale, exportation
or importation of the MR Contrast Agent Product in finished
packaged form; (g) charge back payments and/or rebates or other
fees provided to distributors, wholesalers, or other purchasers and
managed health care organizations or federal, state and local
governments, their agencies, purchasers and reimbursers, including
reimbursements to social security organizations; and (h)
volume-related customer program costs which are required by the
customer and which are independent of marketing
initiatives.
The parties recognize that (a)
customers may include persons in the chain of commerce, who enter
into agreements with a seller as to price even though title to the
MR Contrast Agent Product does not pass directly from the seller to
such customers, and even though payment for such MR Contrast Agent
Product is not made by such customers directly to the seller; and
(b) in such cases chargebacks paid by EPIX (or its Affiliates) or
EPIX Licensees to or through a Third Party (such as a wholesaler)
can be deducted by EPIX (or its Affiliates) or EPIX Licensees
from gross revenue in order to calculate Net Sales. Any
deductions listed above which involve a payment by EPIX (or its
Affiliates) or EPIX Licensees shall be taken as a deduction against
aggregate sales for the quarter in which the payment is
made.
Net Sales will be accounted for in
accordance with international accounting standards consistently
applied. In any instance where the calculation of Net Sales
according to international accounting standards differs materially
from GAAP such that the result of such calculation under
international accounting standards would cause EPIX (or its
Affiliates) or EPIX Licensees to improperly account for such
revenue under GAAP, EPIX will provide Prince with any and all
information requested by Prince regarding the calculation of Net
Sales to enable Prince to comply with GAAP in recognizing revenue
from such Net Sales.
Where a MR Contrast Agent Product is
transferred by EPIX (or its Affiliates), through one or more
Affiliates or EPIX Licensees for Sale to a customer/user, only the
Sale to such customer/user shall be included in the Net
Sales. For example, where a MR Contrast Agent Product is
transferred by (i) EPIX to Berlex or Schering (whether through one
or more Affiliates of EPIX) for Sale to a customer/user, or (ii)
Mallinckrodt to EPIX or Berlex or Schering for Sale to a
customer/user, only the Sale to such customer/user shall be
included in the Net Sales.
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Notwithstanding the foregoing, the
Net Sales for any calendar quarter shall be no less than the net
sales of MR Contrast Agent Product by EPIX Licensees for the
corresponding calendar quarter as reported (i) by EPIX Licensees to
EPIX (or its Affiliates) or (ii) by EPIX in publicly available
documentation (such as, for example, the Quarterly and/or Annual
Reports).
Given the worldwide scope of this
Agreement, the impracticality of monitoring by EPIX of the movement
of the MR Contrast Agent Product through international markets and
the impracticality of establishing a value for pro-rata use in
CE-MRA (if any), it is agreed and recognized that paying royalties
on all Sales of MR Contrast Agent Product, as a whole, is fair and
reasonable, representing a balance between the concerns and
interests of both parties and resulting in a convenience for
EPIX.
1.16
“Third Party Price”
means the average amount paid by all Third Parties for the MR
Contrast Agent Product in arms-length transactions during the
calendar quarter corresponding to the royalty period of any royalty
report, provided there are substantial Sales of such MR Contrast
Agent Product to Third Parties during the royalty period. In
the event of a dispute regarding whether there have been such
substantial Sales, the parties agree to first meet and negotiate in
good faith with the expectation of determining a Third Party
Price.
1.17
“Confidential
Information” means any information disclosed by one party to
the other, pursuant to this Agreement, which is in written,
graphic, machine readable or other tangible form and is marked
“Confidential”, “Proprietary” or in some
other manner to indicate its confidential nature.
Confidential Information may also include oral information
disclosed by one party to the other provided that such information
is designated as confidential at the time of disclosure and reduced
to a written summary by the disclosing party, within thirty (30)
days after its oral disclosure, which is marked in a manner to
indicate its confidential nature and delivered to the receiving
party. Notwithstanding the foregoing limitations, all sales
and similar reports and records provided by EPIX to Prince
hereunder, or to which Prince or its designee may gain access
pursuant to Article 4, are hereby deemed to be Confidential
Information of EPIX.
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ARTICLE 2
DISCHARGE, RELEASE, AND COVENANT
2.1
Subject to the terms and conditions
of this Agreement, Prince hereby discharges, releases, promises and
covenants not to sue, threaten to sue or otherwise disturb EPIX,
and its Affiliates, and any EPIX Licensee, subcontractor, supplier,
distributor, vendor, reseller, purchaser, or user of the MR
Contrast Agent Product, acquired directly or indirectly from EPIX
(or its Affiliates) or an EPIX Licensee in any country in the
world, for any claim or cause of action based upon (i) the Prince
MR Intellectual Property and (ii) the manufacture, use, Sale,
advertisement, offer for Sale, importation, lease, or otherwise
transfer or disposition of the MR Contrast Agent Product, whether
such claim or cause of action is presently known or unknown.
This covenant not to sue is personal in nature and limited to EPIX,
its Affiliates, any successor(s) to EPIX, and any EPIX Licensee,
subcontractor, supplier, distributor, vendor, reseller, purchaser,
or user of the MR Contrast Agent Product.
2.2
Prince hereby grants to EPIX, and
its Affiliates and any EPIX Licensee, a non-exclusive, license,
without the right to sublicense, under U.S. Patent ***** to make,
have made, use, offer to Sell, Sell, import, export and otherwise
transfer the MR Contrast Agent Product during the term of this
Agreement. Nothing in this Agreement shall be construed as
expressly, impliedly, or otherwise granting a license, of any kind
or type, under the Prince Patents other than U.S. Patent
*****.
2.3
Nothing contained in this Agreement
shall be construed as:
(a)
a warranty or representation by
Prince as to the validity, enforceability, and/or scope of any one
of the Prince Patents; or
(b)
imposing on Prince any obligation to
institute legal action for infringement of any one of the Prince
Patents, or to defend a legal action brought by a Third Party in
relation to any one of the Prince Patents; or
(c)
imposing on Prince any obligation to
file application(s) or other intellectual property registration(s)
related to the Prince MR Intellectual Property, or to secure or
maintain in force any one of the Prince Patents; or
(d)
imposing on Prince any obligation to
furnish any technical information or know-how.
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ARTICLE 3
COMPENSATION AND RELATED OBLIGATIONS
3.1
In consideration of the license,
discharges, releases, promises and covenants not to sue granted
herein, EPIX agrees to pay Prince:
(a)
***** ($ *****), the payment being
due and payable within two (2) weeks of the Effective Date of the
Agreement; and
(b)
commencing with the Royalty Start
Date, a royalty equal to ***** percent (*****%) of Net
Sales.
3.2
In the event that the MR Contrast
Agent Product is Sold during a calendar quarter under circumstances
where the selling price is not established on an arms-length basis,
Net Sales shall be calculated using the Third Party Price of such
MR Contrast Agent Product. If there is no Third Party Price
for such MR Contrast Agent Product, the parties shall immediately
determine an appropriate royalty base for such MR Contrast Agent
Product. In the event that a resolution is not reached, the
dispute shall be resolved according to the resolution procedure of
paragraph 13.2.
3.3
In further consideration of the
license, discharges, releases, promises and covenants granted
herein, EPIX agrees to provide to Prince, or another designated in
writing by Prince, ***** Dollars ($*****) worth of MR Contrast
Agent Product per year calendar commencing on the earlier of (i)
the day that the FDA issues final approval of the use of MR
Contrast Agent Product for a CE-MRA procedure or indication, or
(ii) the day the MR Contrast Agent Product becomes commercially
available, and continuing each calendar year thereafter until
expiration or termination of the Agreement. The number of
Doses to be provided for each calendar year will be determined by
dividing ***** by the Third Party Price per Dose as of the first
day of such year. EPIX will provide Prince with an invoice
promptly after the first day of the year setting forth the number
of Doses to be delivered to Prince during such year and the method
by which the number of doses was determined, including without
limitation, the Third Party Price per Dose. Such Doses shall
be deemed not to have been Sold for purposes of determining the
royalty payable under this Agreement. One (1) dose of MR
Contrast Agent Product is equal to the largest commercially
available volume of MR Contrast Agent Product, within a container,
for administration to one (1) patient. For example, where the
largest commercially available volume of MR Contrast Agent within a
container for administration to one (1) patient is a vial or
syringe containing one hundred milliliters
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(100ml) of MR Contrast Agent
Product, one dose of MR Contrast Agent Product is one hundred
milliliters (100ml).
3.4
EPIX shall deliver the MR Contrast
Agent Product referenced in paragraph 3.3 of this Agreement to a
place in North America as designated by Prince within ninety (90)
days of written notice. Each dose shall be delivered to
Prince in accordance with industry “best practices” and
shall be packaged in a separate container in the same manner and
material(s) (for example, without limitation, vial or syringe) as
commercially available to bona fide customers/users. In the
event that the MR Contrast Agent Product is available in more than
one type or form of container, Prince shall have the option, at his
sole discretion, to designate the type or form of container.
To facilitate storage of such MR Contrast Agent Product, Prince
may, at his sole discretion, specify delivery of the MR Contrast
Agent Product of paragraph 3.3 in prorated amounts at monthly or
quarterly intervals.
3.5
Notwithstanding paragraph 3.3, in
the event that Prince, in any calendar year, requests delivery of
fewer Doses than were indicated on the invoice provided to Prince
by EPIX for such calendar year, then the difference between the
number of Doses indicated on the invoice and the number of Doses
actually requested in that calendar year shall be added to the
number of Doses available to be requested by Prince in a subsequent
year under the conditions of paragraph 3.4. Further, in the
event that the last year of the term of this Agreement is not a
full calendar year, EPIX shall deliver to Prince, under the same
terms and conditions as set forth in paragraphs 3.3 and 3.4, a
pro-rated amount of MR Contrast Agent Product plus any increase
based on a carry over of a non-requested amount from previous
year(s).
3.6
Prince shall not Sell directly or
indirectly (for example, through another) the MR Contrast Agent
Product provided by EPIX to Prince pursuant to paragraphs 3.3 - 3.5
of this Agreement. Notwithstanding the foregoing, MR Contrast
Agent Product of paragraphs 3.3 - 3.7 that is used in a CE-MRA
procedure by Prince, or his employers or employees, which is
invoiced and/or charged to a Third Party, shall not be considered
as Sold to such Third Party for the purposes of this paragraph 3.6
nor for the purposes of determining the royalty payable under this
Agreement.
3.7
Prince agrees to comply with all
applicable laws and regulations pertaining to the use, handling,
storage, disposal, administration, billing, recordkeeping and sale
of the MR Contrast Agent Product provided by EPIX hereunder.
Without limiting the generality of the foregoing, Prince will
properly disclose accurate pricing information relating to the MR
Contrast A
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