Exhibit 10.28
[ ]
= Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.
CONFIDENTIAL PROVISIONS
MARKED
EXHIBIT 10.28
(CONFIDENTIAL)
PATENT LICENSE
AGREEMENT
between
PROTEIN DESIGN LABS,
INC.
and
MEDIMMUNE, INC.
This Agreement
(“Agreement”), effective as of July 17, 1997
(“Effective Date”), is made by and between PROTEIN
DESIGN LABS, INC., a Delaware corporation having offices at 2375
Garcia Avenue, Mountain View, CA 94043, USA (hereinafter
“PDL”) and MEDIMMUNE, INC., a Delaware corporation,
having offices at 35 West Watkins Mill Road, Gaithersburg, MD 20878
(hereinafter “MEDIMMUNE”).
RECITALS
A. MEDIMMUNE
desires to license certain patents owned or controlled by PDL
related to a humanized antibody directed against RSV (as defined
below), which antibody has involved significant development efforts
undertaken by MEDIMMUNE (including without limitation the antibody
known as “MEDI-493”); and
B. PDL is
willing to license to MEDIMMUNE such rights under the terms and
conditions of this Agreement.
AGREEMENT
NOW THEREFORE, in consideration of
the mutual covenants herein contained and intending to be legally
bound, the parties agree as follows:
All references to Exhibits, Articles
and Sections shall be references to Exhibits, Articles and Sections
of this Agreement. In addition, except as otherwise expressly
provided herein, the following terms in this Agreement shall have
the following meanings:
1.01 “Affiliate”
means, with respect to a party
hereto, any corporate or other entity which, directly or
indirectly, controls, is controlled by, or is under common control
with such party where “control” means the ownership of
not less than 50% of the voting shares of a corporation, or
decision-making authority as to an unincorporated
entity.
1
1.02 “Combination
Product(s)” shall
mean any product containing both a pharmaceutically active agent or
ingredient which constitutes a Licensed Product and one or more
other pharmaceutically active agents or ingredients which do not
constitute Licensed Products.
1.03 “Field”
means the field of human prophylaxis
and therapy.
1.04 “Licensed
Product(s)” shall
mean an Antibody for which MEDIMMUNE has undertaken significant
development efforts (e.g., conducted or sponsored a human clinical
trial), which product is an Antibody that binds to RSV (including
without limitation, the MEDI-493 product of MEDIMMUNE or
MEDIMMUNE’s sublicensees and any modifications or
improvements) whose development, importation, manufacture, use or
sale would, but for a license under this Agreement, infringe a
Valid Claim. “Antibody” as used in the preceding
sentence shall include, without limitation, monospecific and
bispecific antibodies; less than full-length antibody forms such as
Fv, Fab, and F(ab’)(2); single-chain antibodies; and antibody
conjugates bound to a toxin, label or other moiety.
1.05 “Net
Sales” shall mean
the aggregate gross revenues, whether in cash or in kind, derived
by or payable from or on account of the sale of Licensed Products,
less an allowance of Five Percent (5%) to cover factors such
as (a) credits or allowances, if any, actually granted on
account of price adjustments, recalls, rejection or return of items
previously sold, (b) excise and sales taxes, duties or other
taxes imposed on and paid with respect to such sales (excluding
income or franchise taxes of any kind) and (c) outer packing,
freight and freight insurance costs. If MEDIMMUNE or any of its
Affiliates or sublicensees receive non-cash consideration for any
Licensed Product sold or otherwise transferred to an independent
third party not an Affiliate of the seller or transferor, the fair
market value of such non-cash consideration on the date of such
transfer as known to MEDIMMUNE, or as reasonably estimated by
MEDIMMUNE if unknown, shall be included in the definition of Net
Sales.
1.06 “PDL Patent
Rights” means the
patents (as well as any foreign counterparts or patent applications
thereto) identified on Exhibit A , including any
addition, continuation, continuation-in-part or division thereof or
any substitute application therefor; any patent issued with respect
to such patent application, any reissue, extension or patent term
extension of any such patent, and any confirmation patent or
registration patent or patent of addition based on any such
patent.
1.07 “Territory”
means the world.
1.08 “Valid
Claim” means any
claim in any issued patent included in the PDL Patent Rights which
has not been disclaimed or held unenforceable or invalid by a
governmental agency or court of competent jurisdiction by a
decision beyond right of review.
1.09 “Europe”
means one or more the following
countries: U.K., France, Germany, Italy and Spain.
2
2.01 License
Grant. Subject to the terms and conditions
of this Agreement, PDL hereby grants and MEDIMMUNE hereby accepts a
nonexclusive license under the PDL Patent Rights limited to the
Field and Territory, including the right to grant sublicenses
(subject to Section 2.02), to make, import, have made, use or
sell Licensed Products.
2.02 Limitation on
Sublicenses; Notification of Grant of Sublicense.
MEDIMMUNE shall have the
right to grant sublicenses of its rights under Section 2.01
only in connection with the assignment or license by it of a
Licensed Product to a third party and only with respect to that
Licensed Product. The right to grant sublicenses under
Section 2.01 shall be on terms and conditions which are
subject to and subordinate to the terms of this Agreement. Promptly
following execution of any sublicense hereunder, but in any event
not less than ten (10) days thereafter, MEDIMMUNE shall notify
PDL of the identity of the sublicensee and the scope of the
sublicense.
2.03 Notification of
Other Potential Licensee. PDL shall use commercially reasonable efforts to
notify MEDIMMUNE in the event that a third party proposes to obtain
a license under the PDL Patent Rights in the Field. MEDIMMUNE shall
have a period of ten (10) business days from notification to
propose terms for an amendment to this Agreement for an exclusive
license in the Field and Territory. PDL agrees to reasonably
consider any proposal to enter into an amendment to this Agreement
for an exclusive license proposed by MEDIMMUNE, but neither party
shall have any obligation to enter into such amendment.
2.04 [ ]
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3.
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MILESTONE
PAYMENTS; ROYALTIES, REPORTS
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3.01 Payments.
In consideration for the
license granted by PDL under Article 2 of this Agreement MEDIMMUNE
shall pay the amounts set forth in this
Section 3.01.
(a) Initial
Payment. Unless this Agreement is terminated
as provided in Section 7.02(a), not later than
September 1, 1997 MEDIMMUNE shall pay to PDL a nonrefundable
signing and licensing fee in the sum of
[ ].
(b) Milestone
Payments.
i. Filing
of Biologics License Application(s). Within thirty (30) days
following the submission of a biologics license application (or
foreign counterpart thereto) to regulatory authorities with respect
to a Licensed Product in any country in the Territory, MEDIMMUNE
shall pay to PDL a one time nonrefundable sum of
[ ].
ii. Approval to Market in
the U.S. Within thirty (30) days
following the initial approval to market a Licensed Product in the
U.S., MEDIMMUNE shall pay to PDL the nonrefundable sum of
[ ].
iii. Approval to Market
in Europe. Within thirty (30) days
following the initial approval to market a Licensed Product in any
country in Europe, MEDIMMUNE shall pay to PDL the nonrefundable sum
of
[ ].
3
iv. First
Sale in the U.S. Within thirty (30) days
following the initial sale of a Licensed Product that, but for the
licenses granted to MEDIMMUNE under this Agreement would infringe a
Valid Claim in the U.S., MEDIMMUNE shall pay to PDL the
nonrefundable sum of
[ ].
v. First
Sale in Europe. Within thirty (30) days
following the initial sale of a Licensed Product that, but for the
licenses granted to MEDIMMUNE under this Agreement would infringe a
Valid Claim in any country in Europe, MEDIMMUNE shall pay to PDL
the nonrefundable sum of
[ ].
Each milestone set forth in this
Section 3.01 shall be deemed achieved and the corresponding
milestone payment due upon the achievement of the milestone,
whether by MEDIMMUNE, its Affiliates or sublicensees. Any payment
made by MEDIMMUNE for the achievement of any milestone herein shall
be paid by MEDIMMUNE only once.
3.02 Annual Maintenance
Fee. In
further consideration of the license granted under Article 2, not
later than June 30, 2000 and not later than May 31 each
year thereafter, MEDIMMUNE shall pay PDL a nonrefundable annual
maintenance fee in the amount of
[ ].
3.03 Royalties to PDL;
Credits Against Royalties.
(a) In further consideration
of the rights and licenses granted under Article 2, MEDIMMUNE shall
pay to PDL a royalty of
[ ]
of the Net Sales of all Licensed Products sold by MEDIMMUNE or its
Affiliates or sublicensees to non-Affiliated third parties in each
country in the Territory until the last date on which there is a
Valid Claim that, but for the licenses granted to MEDIMMUNE under
this Agreement, would be infringed by the making, importing, using,
having made or sale of that Licensed Product in such country in the
Territory or by the manufacture of Licensed Product in the country
of manufacture.
(b) [ ]
3.04 Sales
Among Affiliates . Sales between and among
MEDIMMUNE, its sublicensees and its Affiliates of Licensed Products
which are subsequently resold or to be resold by such sublicensees
or Affiliates shall not be subject to royalty, but in such cases
royalties shall accrue and be calculated on any subsequent sale of
such Licensed Products to a non-affiliated third party.
3.05 Combination
Products . Net Sales in a
particular country in the Territory, in the case of Combination
Products for which the pharmaceutically active agent or ingredient
constituting a Licensed Product and each of the other
pharmaceutically active agents or ingredients not constituting
Licensed Products have established market prices in that country in
the Territory when sold separately, shall be determined by
multiplying the Net Sales for each such Combination Product by a
fraction, the numerator of which shall be the established market
price for the Licensed Product(s) contained in the Combination
Product and the denominator of which shall be the sum of the
established market prices for the Licensed Product(s) plus the
established market prices for the other pharmaceutically active
agents or ingredients contained in the Combination Product. When
such separate market prices are not established in that
country
4
in the Territory, then the parties shall
negotiate in good faith to determine a fair and equitable method of
calculating Net Sales in that country for the Combination Product
in question.
3.06 Withholding.
(a) Payments.
MEDIMMUNE shall pay all
amounts payable to PDL under Section 3.01 and
Section 3.02 from a U.S. bank account. Any deductions for any
taxes or other withholding that may be applicable to the payments
to PDL under Sections 3.01 and 3.02 shall be promptly paid by
MEDIMMUNE to the appropriate governmental authority and MEDIMMUNE
shall provide proof of payment to PDL.
(b) Royalty
Payments. MEDIMMUNE may withhold from
royalties due to PDL amounts for payment of any withholding tax
that MEDIMMUNE has paid to any taxing authority with respect to
royalties due on account of the sale or manufacture of Licensed
Products in the Territory. MEDIMMUNE agrees to reasonably cooperate
with PDL in obtaining a foreign tax credit in the U.S. with respect
to royalties due to PDL on the sale or manufacture of Licensed
Products.
3.07 Currency
Conversion. All amounts payable to PDL under
this Agreement shall be payable in U.S. Dollars by wire transfer
to-a bank account designated by PDL. In the case of royalties on
Net Sales, all amounts payable shall first be calculated in the
currency of sale and then converted into U.S. Dollars using the
average of the daily exchange rates for such currency quoted by
Citibank, N.A. for each of the last fifteen (15) banking days
of each calendar quarter.
3.08 Royalty
Reports.
(a) Current
Reports. MEDIMMUNE agrees to make written
reports and royalty payments to PDL within forty-five
(45) days after the close of each calendar quarter during the
term of this Agreement, beginning with the calendar quarter in
which the date of first commercial sale occurs. These reports shall
show for the calendar quarter in question Net Sales by MEDIMMUNE,
its Affiliates and sublicensees of the Licensed Products in the
Territory on a country-by-country basis, details of the quantities
of Licensed Products sold in each country and the country of
manufacture if different, and the royalty due to PDL thereon
pursuant to Article 2. Concurrently with the making of each such
report, MEDIMMUNE shall make any payment due to PDL of royalties
for the period covered by such report.
(b) Termination
Report. For
each Licensed Product, MEDIMMUNE also agrees to make a written
report to PDL within ninety (90)&n