|
Exhibit 10.22
EXCLUSIVE LICENSE
AGREEMENT
THIS LICENSE AGREEMENT (the “Agreement”) made this
10th day of September, 2007, (“Effective Date”) between
Maine Medical Center, , a non-profit corporation organized and
existing under the laws of the State of Maine with a principal
place of business at 22 Bramhall Street, Portland, Maine 04102-3175
(hereinafter referred to as “MMC”), and Pipex
Pharmaceuticals, Inc., a Delaware corporation having a place of
business at 3930 Varsity Drive, Ann Arbor, MI 48108 (hereinafter
referred to as “Licensee”).
RECITALS
WHEREAS, MMC, except for certain non-exclusive rights granted
to the United States Government, is the sole and exclusive owner of
the entire right, title and interest in US Patent Application
No.10/786,223, based on PCT/US02/27247, “Copper-Dependent
Non-Traditional Pro-Inflammatory Cytokine Export And Methods,
Compositions And Kits Relating Thereto,” filed August 26,
2002 (see Schedule A); and
WHEREAS, MMC desires to have Licensed Patent Rights (defined
below) developed and commercialized to benefit the public and is
willing to grant such rights upon the terms and conditions set
forth in this Agreement; and
WHEREAS, Licensee has represented to MMC, to induce MMC to
enter into this Agreement, that Licensee shall commit itself to a
diligent program of exploiting the Licensed Patent Rights for the
public interest; and
WHEREAS, Licensee desires to receive a royalty-bearing,
exclusive license under the Licensed Patent Rights;
Now, Therefore, in consideration for the mutual covenants and
promises contained in this Agreement, the parties agree as
follows:
1. DEFINITIONS
1.1 “Corporate
Affiliate” shall mean any entity, corporation or business
organization, which is controlled by or under common control with
Licensee, either directly or indirectly. As used herein, the term
“control” shall mean the direct or indirect ownership
of fifty (50%) or more of the equity having the right to vote for
directors thereof or the ability to otherwise control the
management of the other entity, corporation or business
organization.
1.2 “Earned Royalties”
shall mean royalties payable by Licensee to MMC for the sale of
Royalty-Bearing Products by Licensee or its Corporate Affiliates
pursuant to Section 5.
1.3 “Field of Use”
shall mean all fields of use.
1.4 “Improvements”
shall mean and include any invention, development, technique,
process, procedure or method representing an improvement on the
inventions which are covered by one or more claims of the Licensed
Patent Rights.
1.5 “Licensed Patent
Rights” shall mean United States Patent Number: 10/786,223
(see Schedule A) as well as any continuations, divisionals, and
reissues thereof, any patents issuing from such application or
reexamined certificate thereof, which may issue on any of the
foregoing and any and all corresponding foreign patent applications
and patents.
1.6 “Licensee” shall
mean the licensee that is a party to this Agreement and its
Corporate Affiliate(s).
1
1.7 “Net Proceeds of
Sale” shall mean the gross amount billed by Licensee from the
sale, license, lease or other conveyance of the Royalty-Bearing
Product to third parties, less the following costs actually
incurred by Licensee as an element of such sales: transportation,
special packing and crating charges, insurance, custom duties,
amounts repaid or credited by reason of rejection or return, and
any taxes or other governmental charges levied on the production,
sale, transportation, delivery or use of a Royalty-Bearing Product,
which is paid by or on behalf of Licensee. The transfer by Licensee
of Royalty-Bearing Products to a Corporate Affiliate for such
Affiliate’s own use shall be included within Net Proceeds of
Sale, and such sales shall be reported for royalty purposes using
the average unit price for each such Royalty-Bearing Product
received by Licensee during the reporting period from all third
party end users thereof.
1.8 “Royalty-Bearing
Product” shall mean any products, process or services which
would, except for the rights granted to Licensee hereunder,
infringe one or more valid claims in the Licensed Patent Rights. In
the event a Royalty-Bearing Product is sold in combination with
another apparatus or product, as part of a kit, or in any other
combination, and the Royalty-Bearing Product is not separately
valued on the invoice or other document evidencing such sale, the
Net Proceeds of Sale of Royalty-Bearing Product when sold
separately or, in the absence of such list price, shall be
determined by multiplying the aggregate selling price of the
combination by a fraction: the numerator of which shall be
Licensee’s standard costs for the Royalty-Bearing Product and
the denominator of which shall be Licensee’s standard cost
for the total combination at the time of the sale. In the event
that both the Royalty-Bearing Product and other product have
separate list prices, but are being sold at a combination price
which is less than the total of the separate list prices, then the
Net Proceeds of Sale of the Royalty-Bearing Product shall be
determined by multiplying the invoice price charged for the
combination by the ratio of the list price of the Royalty-Bearing
Product to the sum of the list prices of the Royalty-Bearing
Product and such other products.
1.9 “Reporting Period”
shall begin on the first day of Licensee’s fiscal year and
end on the last day of Licensee’s fiscal year.
1.10 “Sublicense
Royalty” shall mean any payments that Licensee or a Corporate
Affiliate receives from a Sublicensee in consideration of the
sublicense of the Licensed Patent Rights granted Licensee under
Section 2.1, including without limitation license fees, milestone
payments, license maintenance fees, and other payments, but
specifically excluding royalties on Net Proceeds of
Sales.
1.11 “Sublicensee”
shall mean any non-Corporate Affiliate sublicensee of the Licensed
Patent Rights granted to Licensee under Section 2.1.
1.12 “Term” shall mean
the term of this Agreement, which shall commence on the Effective
Date and shall remain in effect until the expiration or abandonment
of all issued patents and filed patent applications within the
Licensed Patent Rights, unless earlier terminated in accordance
with the provisions of this Agreement.
1.13 “Territory” shall
mean worldwide.
2. LICENSE GRANT
2.1 Subject to the terms of this
Agreement, MMC hereby grants to Licensee, except for a
non-exclusive license granted to the U.S. Government, a
royalty-bearing, exclusive license, including the right to
sublicense to others in accordance with Section 3 hereof, under the
Licensed Patent Rights to develop, make, have made, use, sell,
lease, license, import and offer to sell Royalty-Bearing Products
and practice the inventions claimed in the Licensed Patent Rights
in the Field in the Territory.
2.2 Licensee agrees that any
Royalty-Bearing Product used or sold in the United States will be
manufactured substantially in the United States.
2
2.3 MMC retains the right to
practice under the Licensed Patent Rights for research, teaching,
and educational purposes.
2.4 Licensee acknowledges that the
U.S. federal government retains a royalty-free, non-exclusive,
non-transferable license to practice any government-funded
invention claimed in any Licensed Patent Rights as set forth in 35
U.S.C. §§ 200 et seq., and the regulations promulgated
thereunder, as amended, or any successor statutes or
regulations.
2.5 Nothing in this Agreement shall
be construed to confer any rights upon Licensee by implication,
estoppel, or otherwise as to any technology or patent rights of MMC
or any other entity other than the Licensed Patent Rights,
regardless of whether such technology or patent rights shall be
dominant or subordinate to any Licensed Patent Rights.
3. SUBLICENSES
3.1 Licensee may grant sublicenses
hereunder to persons, firms or corporations under terms and
conditions, which are not inconsistent with the provisions of this
Agreement, and subject to the foregoing provisions:
(a) Licensee shall provide MMC with a copy of each sublicense
agreement entered into hereunder within thirty (30) days of
execution of each such sublicense agreement. No sublicense
agreement entered into by Licensee hereunder shall impose any
direct obligation of MMC to the sublicensee, or obligation of the
sublicensee to MMC, except as set forth in subsection (b)
below.
(b) Upon termination of this Agreement, MMC shall be
substituted for Licensee in all sublicense agreements executed
prior to termination of this Agreement. Licensee, upon
acknowledgement of such substitution by each sublicensee, shall be
discharged of all obligations occurring thereafter.
4. DUE DILIGENCE
4.1 Licensee agrees to use
reasonable best efforts to effect introduction of the use of
Licensed Patent Rights into the commercial market as soon as
practical, consistent with sound and reasonable business practices
and judgments.
4.2 In addition, Licensee shall
adhere to the following milestones:
a. Licensee shall deliver to MMC on or before the first
anniversary of this Agreement, a business plan describing
Licensee’s commercialization plans for the Licensed Patent
Rights.
b. There may be New Patentable Indications that MMC presents
to the Licensee during the term of this agreement. MMC shall
promptly disclose these New Patentable Indications in writing to
Licensee. Licensee will evaluate the New Patentable Indications and
Licensee shall have one hundred eighty (180) days to evaluate the
merits of these New Patentable Indications. Licensee shall provide
written notice of interest in pursuing these New Patentable
Indications within this period and seek of License for these New
Patentable Indications. If they do not decide to fund and pursue
these New Indications, MMC shall have the right to pursue licensing
of these New Indications to a Third Party and royalties payable
under Section 5.1 hereof shall not be due for said additional
indication.
4.3 In the event that the
milestones in this Section 4.1 are not achieved and/or Royalties
are not paid in accordance with Section 5, MMC shall have the
option to convert the license granted to it under Section 2.1
hereof to a non-exclusive license or to terminate the Agreement.
Such option shall be exercised by written notice to Licensee in
accordance with Section 16, and shall become effective on the
30 th day
following the date of the notice. Upon the effective date of
conversion to a non-exclusive license or termination of the
Agreement under this Section 4.3, MMC shall have the right to
license others under the Licensed Patent Rights.
3
5. ROYALTIES AND PAYMENT
TERMS
5.1 In consideration for the
Licensed Patent Rights set forth in Section 2 of this
Agreement,
a. Licensee shall pay to MMC on the Effective Date, a license
issue fee of ten thousand dollars ($10,000), and ten thousand
dollars ($10,000) three months after the Effective Date. These
payments are nonrefundable and are payable in common stock of the
Licensee calculated based upon the closing bid price on the
Effective Date of this Agreement.
b. Licensee shall pay MMC the following non-refundable license
maintenance fees at the times set forth below:
(1) One Hundred Thousand dollars
($100,000) within thirty (30) days after submission to the FDA the
first filing of a New Drug Application (NDA) based upon an
indication covered by a validly issued claim of the Licensed Patent
Rights; and
(2) Two Hundred Fifty Thousand
dollars ($250,000) within thirty (30) days after the approval by
the FDA of the first NDA based upon an indication covered by a
validly issued claim of the Licensed Patent Rights;
(3) Milestone payment described
above can be paid in cash, or common stock of the Licensee or an
Affiliate thereof.
5.2 Licensee shall pay MMC an
Earned Royalty composed of three percent (3%) of the Net Proceeds
of Sale of a Royalty-Bearing Product based upon an FDA-approved or
comparable foreign agency-approved indication in such territory
that is covered by a validly issued claim of the Licensed Patent
Rights, and such additional royalty as may be due under Section 5.4
below.
5.3. In the event that in any
royalty period, Licensee, in order to exploit the license granted
under this Agreement in any country makes royalty payments to one
or more Third Parties (“Third Party Payments”) as
consideration for a license to an issued patent or patents, in the
absence of which the Licensed Product could not legally be used or
sold in such country, then Licensee shall have the right to reduce
the royalties otherwise due to MMC pursuant to Section 5.2 above
for such Licensed Product by fifty percent (50%) of such Third
Party Payments. Notwithstanding the foregoing, such reductions
shall in no event reduce such royalty for such Licensed Product in
any such country to less than fifty percent (50%) of the rates and
amounts otherwise specified above.
5.4 To the extent Licensee does not
develop, make, have made, use, sell, lease, license, import, or
offer to sell Royalty-Bearing Products, but sublicenses its rights
under this Agreement to another who does so, Licensee shall pay to
MMC fifteen percent (15%) of any upfront payments received by
Licensee in consideration of such sublicenses of the Licensed
Patent Rights, excluding amounts received by Licensee from third
parties in connection with the issuance of debt or equity
securities in Licensee or to fund or reimburse research and
development of Licensed Product. This fifteen percent (15%) payment
shall be Licensee’s sole compensation to MMC for monies it
receives as a result of such sublicenses in lieu of royalty
payments under Sections 5.1 to 5.3 above. Any payments due to MMC
under this Section 5.5 shall be included
| 
