EXHIBIT 10.44
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE
BEEN MARKED TO INDICATE THAT CONFIDENTIAL INFORMATION HAS BEEN
OMITTED. CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL
INFORMATION. THE CONFIDENTIAL PORTIONS HAVE BEEN PROVIDED
SEPARATELY TO THE SECURITIES AND EXCHANGE
COMMISSION]
EXCLUSIVE LICENSE
AGREEMENT
This Exclusive License Agreement
(hereinafter called the “Agreement”) is made effective
the 2nd day of November, 2004, by and between Wisconsin Alumni
Research Foundation (hereinafter called “WARF”), a
nonstock, nonprofit Wisconsin corporation, and Inspire
Pharmaceuticals, Inc. (hereinafter called “Licensee”),
a corporation organized and existing under the laws of
Delaware.
WHEREAS, WARF and Yeda Research and Development Co. Ltd.
(hereinafter called “Yeda”) own certain inventions
described in the “Licensed Patents” defined below and
have entered into an agreement under which Yeda has granted to WARF
the exclusive right to grant, negotiate, execute, administer and
enforce licenses under the Licensed Patents for the benefit of WARF
and Yeda (collectively referred to hereinafter as the
“Licensors”); and
WHEREAS , WARF is willing to grant a license to Licensee
under any one or all of the Licensed Patents and Licensee desires a
license under all of them;
NOW, THEREFORE,
in consideration of the mutual
covenants and agreements set forth below, the parties covenant and
agree as follows:
Section 1. Definitions
.
For the purpose of this Agreement,
the Appendix A definitions shall apply.
Section 2. Grant .
A. License .
WARF hereby grants to Licensee on
behalf of the Licensors, and Licensee hereby accepts, subject to
the terms and conditions hereof, an exclusive license under the
Licensed Patents, with the right to grant sublicenses in accordance
with Section 2B below, to develop, make, have made, use, market,
distribute, import, offer for sale and sell Products in the
Licensed Field and Licensed Territory.
B. Sublicenses .
(i) Licensee may grant written
sublicenses to third parties with respect to the rights licensed
hereunder. Any agreement granting a sublicense shall state that the
sublicense is subject to the termination of this Agreement, but
that such Sublicensee shall have the right simultaneously with such
termination to obtain a license directly from WARF, and WARF shall
simultaneously grant such a license, under the terms and conditions
set forth in this Agreement. During the term of this Agreement,
Licensee shall have the same responsibility for the activities of
any Sublicensee as if the activities were directly those of
Licensee. Licensee shall provide WARF with the name, contact
information and address of each Sublicensee, as well as information
regarding the number of full-time employees of any such Sublicensee
to allow WARF to determine whether it can maintain its small entity
filing status for patent prosecution and maintenance
purposes.
Page 1 of 19
(ii) With respect to sublicenses
granted by Licensee under this Section 2B, Licensee shall pay to
WARF what Licensee would have been required to pay to WARF had
Licensee sold the amount of Products sold by such Sublicensee. In
addition, if Licensee receives fees or milestone payments in
consideration for the grant of rights under any sublicense, and
such amounts are not royalty payments based directly upon the
amount or value of Products sold by the Sublicensee, then Licensee
shall pay to WARF a percentage of such fee or milestone payments as
follows:
(a) [CONFIDENTIAL] of such
fee or milestone payments received under each sublicense agreement
entered into within [CONFIDENTIAL] of the date
hereof;
(b) [CONFIDENTIAL] of such
fee or milestone payments received under each sublicense agreement
entered into prior to the date that is [CONFIDENTIAL] from
the date hereof but subsequent to the date that is
[CONFIDENTIAL] from the date hereof; and
(c) [CONFIDENTIAL] of such
fee or milestone payments received under each sublicense agreement
entered into subsequent to the date that is [CONFIDENTIAL]
from the date hereof.
The parties agree that payments received by
Licensee as payment to or reimbursement for actual costs and
expenses, including direct, indirect and overhead allocations,
calculated in accordance with Licensee’s accounting practices
applied on a consistent basis in accordance with generally accepted
accounting principles, incurred in conducting research or other
activities on behalf of a Sublicensee as part of a research or
collaboration or other agreement, or payments received by Licensee
as consideration for services or goods provided to a Sublicensee,
shall not be considered as payments subject to the percentage
distribution set forth above. If goods provided by Licensee to its
Sublicensees are Products as defined under this Agreement, then any
payments received by Licensee for such goods shall be subject to
Section 4C. Licensee shall not receive from its Sublicensees
anything of value in lieu of cash payments in consideration for any
sublicense granted under this Agreement, without the express prior
written consent of WARF, such consent not to be unreasonably
withheld, conditioned or delayed.
C. Reservation of Rights
.
Licensors hereby reserve the right
to practice and use the inventions of the Licensed Patents solely
for Non-Commercial Research Purposes, and to grant non-profit
research institutions and governmental agencies non-exclusive
licenses under the Licensed Patents for Non-Commercial Research
Purposes, provided that such use shall specifically prohibit any
human use or clinical administration.
D. License to WARF
.
Licensee hereby grants WARF a
nonexclusive, royalty-free, irrevocable, paid-up license, with the
right to grant sublicenses solely to non-profit research
institutions and governmental agencies, to practice and use
“Improvements” for Non-Commercial Research Purposes,
provided that such use shall specifically prohibit any human use or
clinical administration. “Improvements” shall mean any
patented modification by Licensee during the term of this Agreement
of an invention described in the Licensed Patents that (1) would be
infringed by the practice of an invention claimed in the Licensed
Patents; or (2) if not for the license granted under this
Agreement, would infringe one or more Valid Claims of the Licensed
Patents. Licensee shall provide WARF with a written, enabling
disclosure of each such invention, unambiguously identifying it as
an invention governed by this paragraph, within six (6) months of
the issuance of a patent thereon.
Page 2 of 19
Section 3. Development
.
Licensee agrees to and warrants that
it has, or will obtain, the expertise reasonably necessary to
independently evaluate the inventions of the Licensed Patents and
to undertake the development of Products for sale in the commercial
market, and that it so intends to develop Products for the
commercial market. Further, the parties agree that Licensee has, as
of the date hereof, provided WARF with a development plan
encompassing at least the information set forth in Appendix E
describing the steps Licensee reasonably anticipates, consistent
with industry practice, as necessary to allow the inventions of the
Licensed Patents to be utilized to provide Products for sale in the
commercial market. The parties acknowledge that such plan may be
subject to change, as determined by Licensee in its sole and
reasonable discretion. In addition, within one (1) month following
the end of each annual period ending on December 31 until the Date
of First Commercial Sale of Products, Licensee will provide WARF
with a written Development Report summarizing Licensee’s
product development activities since the last Development Report
and any necessary adjustments to the development plan. If Licensee
fails to provide a written Development Report to WARF within
forty-five (45) days of receipt of written request from WARF as a
result of Licensee’s failure to provide the Development
Report to WARF within the required time period set forth above
(i.e., by January 31 for the prior calendar year), such failure
shall be deemed a material breach of a material covenant under this
Agreement. All development activities and strategies and all
aspects of product design and decisions to market and the like are
entirely at the discretion of Licensee, and Licensee shall rely
entirely on its own expertise and/or the expertise of
Licensee’s contractors and collaborators with respect
thereto. WARF’s review of Licensee’s development plan
is solely to verify the existence of Licensee’s commitment to
the development activity described in Appendix E hereto and to
assure compliance with Licensee’s obligations to utilize the
inventions of the Licensed Patents to commercialize Products for
the marketplace. WARF reserves the right to audit Licensee’s
records relating to development of Products as required hereunder.
Such record keeping and audit procedures shall be subject to the
procedures and restrictions set forth in Section 6 for auditing the
financial records of Licensee.
Section 4. Consideration
.
A. License Fee .
Licensee agrees to pay to WARF a
license fee of $150,000 within thirty (30) days of execution of
this Agreement.
B. Milestone Fees
.
Licensee agrees to pay to WARF the
amounts detailed below within thirty (30) days of the achievement
of the corresponding milestones.
|
|
|
|
|
Milestone
|
|
Milestone Fee
|
|
[CONFIDENTIAL]
|
|
$[CONFIDENTIAL]
|
|
|
|
|
[CONFIDENTIAL]
|
|
$[CONFIDENTIAL]
|
|
|
|
|
[CONFIDENTIAL]
|
|
$[CONFIDENTIAL]
|
|
|
|
|
[CONFIDENTIAL]
|
|
$[CONFIDENTIAL]
|
Page 3 of 19
Each milestone payment above shall
only be made once under this Agreement upon the initial
accomplishment of the relevant milestone in connection with the
first Product for which such milestone event occurs. Thus, a
maximum of $1,800,000 in potential milestones is payable during the
term of this Agreement.
C. Royalty; Combination Products;
Third Party Royalties .
(i) In addition to the Section 4A
license fee and Section 4B milestone fees, Licensee agrees to pay
to WARF a royalty calculated as [CONFIDENTIAL] of the
Selling Price of Products sold by or on behalf of Licensee in
jurisdictions in the Licensed Territory where the use or sale of
such Products would, but for the licenses granted hereunder,
infringe a Valid Claim of the Licensed Patents in that
jurisdiction. The royalty shall be deemed earned as of the earlier
of the date the Product is actually sold or otherwise transferred
for consideration, or the date an invoice is sent by Licensee. No
multiple royalty shall be payable because the manufacture, use,
sale or distribution of a Product is covered by more than one Valid
Claim. In addition, with respect to transfers of Products by,
between or among Licensee and Licensee’s affiliates or
Sublicensees, no royalty shall be due and payable where the
affiliate or Sublicensee will resell the Products and such resale
will be subject to the earned royalty calculation.
(ii) Notwithstanding the foregoing
or anything to the contrary in this Agreement, in the event that
Products are sold by Licensee as part of a combination or bundled
product, the Selling Price of such combination/bundled product, for
the purposes of determining royalty payments due under this
Agreement, shall be determined by multiplying the Selling Price (as
defined on Appendix A) of the combination/bundled product by the
fraction A/(A+B), where A is the average sale price of the Product
when sold separately in finished form and B is the average sale
price of the other product(s) or system sold separately in finished
form, so that A+B is the average sale price of the product(s). In
the event that such average sale price cannot be determined for
both the Product and such other product(s) or system(s) in
combination, the Selling Price for the purposes of determining
royalty payments with respect to such combination or bundled
product shall be commercially reasonable and determined by good
faith negotiation between WARF and Licensee.
(iii) Notwithstanding the foregoing,
in addition to and without limitation of any reduction in royalties
pursuant to Section 4C(ii) above, if Licensee makes payments to one
or more independent third parties during any calendar year to
obtain or maintain a license or similar right under intellectual
property owned by such independent third party as determined in
good faith by Licensee, after consultation with WARF, to be
reasonably necessary to avoid infringement thereof by the
manufacture, use, or sale of Products, or to reasonably avoid
infringement-related litigation with respect to such patent(s),
then Licensee may deduct [CONFIDENTIAL] of such third party
payments from royalties payable to WARF with respect to that
calendar year, provided that such deduction does not exceed
[CONFIDENTIAL] of the royalties payable to WARF under this
Agreement during any such calendar year.
Page 4 of 19
D. Minimum Royalty
.
Licensee further agrees to pay to
WARF a minimum royalty of $10,000 per calendar year, or pro rated
portion thereof for each partial calendar year, during which this
Agreement is in effect starting in calendar year 2008, against
which any earned royalty paid for the same calendar year will be
credited. The minimum royalty for a given year shall be due at the
time payments are due for the calendar quarter ending on December
31. It is understood that the minimum royalties will apply on a
calendar year basis, and that sales of Products requiring the
payment of earned royalties made during a prior or subsequent
calendar year shall have no effect on the annual minimum royalty
due WARF for any given calendar year.
E. Patent Fees and Costs
.
(i) Licensee also agrees to
reimburse the Licensors for all reasonable, documented costs
associated with the filing, prosecution and maintenance of the
Licensed Patents. Licensee shall pay to WARF $67,353.32 within
thirty (30) days of execution of this Agreement to reimburse the
Licensors for the previously-incurred expenses incurred with
respect to the Licensed Patents. Licensee shall pay to WARF all
reasonable, documented future expenses associated with the filing,
prosecution and maintenance of the Licensed Patents within thirty
(30) days of receiving an invoice from WARF with respect
thereto.
(ii) WARF shall keep Licensee
advised as to the maintenance of all Licensed Patents by promptly
forwarding to Licensee copies of all official correspondence
received or provided to the corresponding patent office relating
thereto (including, but not limited to, patent applications, Office
Actions, responses, etc.). Licensee shall have the right to advise
WARF as to such maintenance; and further, Licensee shall have the
right to make reasonable requests to WARF as to the conduct of such
maintenance; provided, however, that Licensee understands and
agrees that WARF has the sole and final authority to make final
decisions.
(iii) WARF will maintain the
Licensed Patents until WARF makes a good faith determination, in
consultation with Licensee, that continued maintenance is
unnecessary. If WARF makes such a good faith determination to
abandon a Licensed Patent, WARF shall provide Licensee written
notice of WARF’s intent to abandon such patent at least
ninety (90) days in advance of any applicable statutory deadline.
In such event, Licensee shall have the right to continue
maintenance of said patent, at its own expense, on behalf of WARF,
Yeda and Licensee, to the extent allowed under applicable law, by
providing written notice thereof to WARF within such ninety (90)
day period.
F. Accounting; Payments;
Taxes .
(i) Amounts owing to WARF under
Sections 2B and 4C shall be paid on a quarterly basis, with such
amounts due and received by WARF on or before the sixtieth
(60 th ) day following the end of the
calendar quarter ending on March 31, June 30, September 30 or
December 31 in which such amounts were earned. The balance of any
amounts which remain unpaid more than thirty (30) days after they
are due to WARF shall accrue interest until paid at the rate of the
lesser of one percent (1%) per month or the maximum amount allowed
under applicable law. However, in no event shall this interest
provision be construed as a grant of permission for any payment
delays.
(ii) Except as otherwise directed,
all amounts owing to Licensors under this Agreement shall be paid
in U.S. dollars to WARF at the address provided in Section 16(a).
For converting any royalty payments on Selling Prices made in a
currency other than U.S. dollars, Selling Prices shall first be
determined in the currency of the country in which they are earned
and shall be converted each calendar quarter into an account in
U.S. dollars at the average of the bid and ask prices reported in
the Wall Street Journal as of the close of the last business day of
such calendar quarter in which such royalty is due. If the last day
of such calendar quarter is not a business day, then the closest
preceding business day shall be used for such calculation. All such
converted Selling Prices
Page 5 of 19
for each country shall be consolidated for each
calendar quarter and the applicable royalty payable determined
therefrom. WARF is exempt from paying income taxes under U.S. law.
Therefore, all payments due under this Agreement shall be made
without deduction for income taxes, assessments, or other charges
of any kind which may be imposed on WARF by any government outside
of the United States or any political subdivision of such
government with respect to any amounts payable to WARF pursuant to
this Agreement, where WARF has registered as a tax exempt entity
and any such jurisdiction has approved such claim; otherwise,
Licensee shall be entitled to deduct from any payments due to WARF
all applicable taxes.
(iii) A full accounting showing how
any amounts owing to WARF under Sections 2B and 4C have been
calculated shall be submitted to WARF on the date of each such
payment. Such accounting shall be on a per-country and product
line, model or trade name basis and shall be summarized on a form
similar to that shown in Appendix C of this Agreement. In the event
no payment is owed to WARF, a statement setting forth that fact
shall be supplied.
Section 5. Certain Warranties
.
A. WARF represents and warrants
that, except as otherwise provided under Section 14 of this
Agreement with respect to U.S. Government interests:
(i) WARF and Yeda are the sole
owners of the Licensed Patents or otherwise have the sole and
exclusive right to grant the licenses granted to Licensee in this
Agreement, and to the best of the WARF’s knowledge, free and
clear of any liens, claims, and encumbrances of any
non-governmental third party;
(ii) WARF and Yeda have entered into
a definitive agreement granting to WARF the exclusive right to
grant, negotiate, execute, administer and enforce exclusive
licenses under the Licensed Patents with Licensee and such
definitive agreement does not conflict with any provision or right
or obligation granted or received hereunder;
(iii) subject to Section 2C above
and to any research rights previously granted by Licensors to the
inventors of the Licensed Patents or research rights reserved by
the inventors of the Licensed Patents, WARF and Yeda have not
granted to any third party any rights to or under the Licensed
Patents that currently conflict or in the future will conflict
with, contradict, or overlap with those granted hereunder;
and
(iv) WARF and Yeda have not received
any notification that the Licensed Patents are invalid or that the
exercise of any rights granted hereunder will infringe on any
patent or other proprietary right of any third party.
Nothing in this Agreement shall be construed
as:
(i) a warranty or representation by
the Licensors as to the validity or scope of any of the Licensed
Patents;
(ii) a warranty or representation
that anything made, used, sold or otherwise disposed of under the
license granted in this Agreement will or will not infringe patents
of third parties; or
(iii) an obligation to furnish any
intellectual property not provided in the Licensed Patents or any
services other than those specified in this Agreement.
Page 6 of 19
B. THE LICENSORS MAKE NO
REPRESENTATIONS, EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, AND ASSUME NO RESPONSIBILITIES WHATSOEVER WITH RESPECT
TO THE USE, SALE, OR OTHER DISPOSITION BY LICENSEE, ITS
SUBLICENSEE(S), OR THEIR VENDEES OR OTHER TRANSFEREES, OF PRODUCTS
INCORPORATING OR MADE BY USE OF INVENTIONS LICENSED UNDER THIS
AGREEMENT.
C. Licensee represents and warrants
that Products produced under the license granted herein for sale in
the United States shall be manufactured substantially in the United
States as required by 35 U.S.C § 204 and applicable
regulations of Chapter 37 of the Code of Federal
Regulations.
Section 6. Recordkeeping
.
A. Licensee shall keep books and
records sufficient to verify the accuracy and completeness of
Licensee’s accounting referred to above, including, without
limitation, inventory, purchase and invoice records relating to all
Products and their manufacture. In addition, Licensee shall
maintain documentation evidencing that Licensee is in fact pursuing
the development of Products as required herein. Such documentation
may include, but is not limited to, invoices for studies advancing
development of Products, laboratory notebooks, internal job cost
records, and filings made to the Internal Revenue Department to
obtain tax credit, if applicable, for research and development
activities. Such books and records shall be preserved for a period
of not less than four (4) years after they are created during the
term of this Agreement. Licensee shall use commercially reasonable
efforts to include similar recordkeeping provisions in any
sublicense granted under this Agreement.
B. Licensee shall take all steps
necessary so that WARF may, within thirty (30) days of its request
and at WARF’s cost and expense (except as provided under
Section 6D below), but not more than once in any consecutive four
(4) calendar quarters, review all the relevant books and records
relating to Licensee’s activities under this Agreement to
allow WARF to verify the accuracy of Licensee’s royalty
reports