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Exhibit 10.10
*** Text Omitted and Filed Separately
CONFIDENTIAL TREATMENT REQUESTED
Under 17 C.F.R. §§ 200.80(b)(4)
and 230.406
LICENSE AGREEMENT
by and between
THE SCRIPPS RESEARCH INSTITUTE,
a California nonprofit
public benefit corporation
and
OPTIMER PHARMACEUTICALS, Inc.
a Delaware corporation
TABLE OF CONTENTS
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Page
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1.
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Definitions
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1
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1.1 Affiliate
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1
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1.2 Agricultural Product
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1
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1.3 Confidential Information
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1
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1.4 Field
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2
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1.5 Licensed Product
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2
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1.6 Major Market Country
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2
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1.7 Net Sales
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2
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1.8 Scripps Patent Rights
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1.9 Scripps Technology
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1.10 Valid Claim
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2.
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License Terms and Conditions
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3
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2.1 Grant of License
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3
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2.2 Initial License Fee
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3
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2.3 Three Year Anniversary Fee
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3
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2.4 Royalties
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3
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2.4.1 Percentage
Royalty for Human Licensed Products
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3
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2.4.2 Percentage
Royalty for Veterinarian Licensed Products
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3
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2.4.3 Percentage
Royalty on sales by Sublicensees for Human and Veterinarian
Licensed Products
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2.5 Milestone Payments
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2.6 Quarterly Payments
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2.7 Term of License
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2.8 Sublicense
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2.9 Duration of Royalty
Obligations
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2.10 Reports
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2.11 Records
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2.12 Foreign Sales
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2.13 Foreign Taxes
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3.
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Patent Matters
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6
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3.1 Patent Prosecution and
Maintenance
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6
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3.2 Information to Licensee
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6
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3.3 Patent Costs
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6
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3.4 Ownership
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3.5 Scripps Right to Pursue
Patent
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7
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3.6 Infringement Actions
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3.6.1 Prosecution and
Defense of Infringements
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3.6.2 Allocation of
Recovery
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4.
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Obligations Related to Commercialization
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4.1 Commercial Development
Obligation
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7
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4.2 Governmental Approvals and Marketing of
Licensed Products
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8
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4.3 Indemnity
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4.4 Patent Marking
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4.5 No Use of Name
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4.6 U.S. Manufacture
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4.7 Foreign Registration
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5.
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Limited Warranty
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6.
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Interests in Intellectual Property Rights
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6.1 Preservation of Title
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6.2 Royalty-free License to
Improvements
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6.3 Governmental Interest
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6.4 Reservation of Rights
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9
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7.
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Confidentiality and Publication
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9
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7.1 Treatment of Confidential
Information
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9
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7.2 Publications
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9
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7.3 Publicity
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8.
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Term and Termination
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9
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8.1 Term
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9
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8.2 Termination Upon Default
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8.3 Termination Upon Bankruptcy or
Insolvency
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8.4 Rights Upon Expiration
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8.5 Rights Upon Termination
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8.6 Work-in-Progress
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9.
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Assignment; Successors
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10
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9.1 Assignment
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9.2 Binding Upon Successors and
Assigns
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10.
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General Provisions
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10.1 Independent Contractors
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10.2 Arbitration
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10.2.1 Location
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10.2.2 Selection of
Arbitrators
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10.2.3 Discovery
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10.2.4 Case
Management
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10.2.5 Remedies
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10.2.6 Expenses
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10.2.7 Confidentiality
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10.3 Entire Agreement;
Modification
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10.4 California Law
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10.5 Headings
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10.6 Severability
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10.7 No Waiver
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10.8 Name
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10.9 Attorneys' Fees
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10.10 Notices
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10.11 Compliance with
U.S. Laws
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Exhibit A Disclosure of Scripps Technology
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Exhibit B Sublicense Form
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Exhibit C Milestones
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ii
LICENSE AGREEMENT
This License
Agreement is entered into and made effective as of this 1
st day of June 2004, (the "Effective
Date") by and between THE SCRIPPS RESEARCH INSTITUTE, a California
nonprofit public benefit corporation ("Scripps") located at
10550 North Torrey Pines Road, La Jolla, California 92037, and
OPTIMER PHARMACEUTICALS, INC., a Delaware corporation
("Licensee") located at 10130 Sorrento Valley Road,
Suite D, San Diego, California 92121 with respect to the
facts set forth below.
RECITALS
A. Scripps
is engaged in fundamental scientific biomedical and biochemical
research including research relating to treatments for Feline
Immunodefficiency Virus ("FIV") and Human Immunodefficiency
Virus ("HIV").
B. Licensee
is engaged in research and development of treatments for FIV and
HIV for human and veterinarian therapeutics.
C. Scripps
has disclosed to Licensee certain technology described in certain
technology disclosures, patents and patent applications listed on
Exhibit A attached hereto and incorporated herein
by reference.
D. Scripps
has the exclusive right to grant a license to the technology listed
on Exhibit A, subject to certain rights of the
U.S. Government to use such technology for its own purposes,
resulting from the receipt by Scripps of certain funding from the
U.S. Government.
E. Scripps
desires to grant to Licensee, and Licensee wishes to acquire, an
exclusive worldwide right and license to the technology listed on
Exhibit A and to certain patent rights and know-how of
Scripps with respect thereto, subject to the terms and conditions
set forth herein, with a view to developing and marketing
diagnostic and therapeutic products within the Field
(as defined below).
AGREEMENT
NOW, THEREFORE,
in consideration of the mutual covenants and conditions set forth
herein, Scripps and Licensee hereby agree as follows:
1.
Definitions . Capitalized terms shall
have the meaning set forth below.
1.1
Affiliate . The term "Affiliate"
shall mean any entity which directly or indirectly controls, is
controlled by or is under common control with Licensee. The term
"control" as used herein means the possession of the power to
direct or cause the direction of the management and the policies of
an entity, whether through the ownership of a majority of the
outstanding voting securities or by contract or otherwise.
1.2
Agricultural Products . The term
"Agricultural Product", individually, or "Agricultural Products",
collectively, shall mean any one or more product, device, method,
procedure, software, computer program, material, or element
utilized by the agricultural and farming industry for the purpose
of improving, restricting or otherwise modifying growth or
productivity of plants; or preventing or treating disease or insect
or fungal infestation in plants; or controlling or modifying
certain traits of plants or producing improved or modified seeds
and plants; or techniques and methods for evaluating efficacy or
determining the safety of an Agricultural Product such as
utilization in determining toxicity to living things or otherwise
involved in the general field of agriculture.
1.3
Confidential Information . The term
"Confidential Information" shall mean any and all proprietary or
confidential information of Scripps or Licensee which may be
exchanged between the
1
parties at any time and from time to time during
the term of this Agreement. Information shall not be considered
confidential to the extent that it:
-
-
a. Is
publicly disclosed through no fault of any party hereto, either
before or after it becomes known to the receiving
party; or
b. Was
known to the receiving party prior to the date of this Agreement,
which knowledge was acquired independently and not from another
party hereto (or such party's employees); or
c. Is
subsequently disclosed to the receiving party in good faith by a
third party who has a right to make such disclosure; or
d. Has
been published by a third party as a matter of right.
1.4
Field . The term "Field" shall mean
all human and veterinarian applications and shall exclude
Agricultural Products.
1.5
Licensed Product . The term "Licensed
Product" shall mean any product which cannot be developed,
manufactured, offered for sale, imported, used or sold without
(i) infringing one or more claims under Scripps Patent Rights;
or (ii) utilizing any part of Scripps Technology not otherwise
included within Scripps Patent Rights.
1.6
Major Market Country . The term
"Major Market Country" shall mean any of the following countries
and their respective territories and possessions: Canada, France,
Germany, Italy, Japan, Thailand, the United Kingdom and the
United States.
1.7
Net Sales . The term "Net Sales"
shall mean the gross amount invoiced by Licensee, or its Affiliates
and sublicensees, or any of them, on all sales of Licensed
Products, less (i) discounts actually allowed,
(ii) credits for claims, allowances, retroactive price
reductions or returned goods, (iii) prepaid freight and
(iv) sales taxes or other governmental charges actually paid
in connection with sales of Licensed Products. For purposes of
determining Net Sales, a sale shall be deemed to have occurred when
an invoice therefor shall be generated or the Licensed Product is
shipped for delivery. Sales of Licensed Products by Licensee, or an
Affiliate or sublicensee of Licensee to any Affiliate or
sublicensee which is a reseller thereof shall be excluded, and only
the subsequent sale of such Licensed Products by Affiliates or
sublicensees of Licensee to unrelated parties shall be deemed Net
Sales hereunder.
1.8
Scripps Patent Rights . The term
"Scripps Patent Rights" shall mean rights arising out of or
resulting from (i) any and all U.S. and foreign patent
applications and patents covering Scripps Technology, (ii) the
patents proceeding from such applications, (iii) all claims of
continuations-in-part directed solely to subject matter
specifically described in Scripps Technology, and
(iv) divisional, continuations, reissues, reexaminations, and
extensions of any patent or application set forth in (i)-(iii)
above, so long as said patents have not been held invalid and/or
unenforceable by a court of competent jurisdiction from which there
is no appeal or, if appealable, from which no appeal has
been taken.
1.9
Scripps Technology . The term
"Scripps Technology" shall mean so much of the technology as is
proprietary to Scripps and disclosed in the patents, patent
applications and disclosures listed on Exhibit A which is
attached hereto and incorporated herein by reference, together with
materials, information and know-how that are specifically related
to the subject matter of the patents, patent applications, and
disclosures listed on Exhibit A and are proprietary to
Scripps, whether or not the same is eligible for protection under
the patent laws of the United States or elsewhere, and whether
or not the same would be enforceable as a trade secret or the
copying of which would be enjoined or restrained by a court as
constituting unfair competition.
1.10
Valid Claim . The term "Valid Claim"
shall mean a claim of any issued and unexpired patent within the
Scripps Patent Rights which has not been held unenforceable,
unpatentable or invalid by a decision of a court or governmental
body of competent jurisdiction in a ruling that is unappealable
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or unappealed within the time allowed for appeal,
which has not been rendered unenforceable through disclaimer or
otherwise, and which has not been lost through an interference
proceeding; provided that if a claim of a pending patent
application has not issued as a claim of an issued patent within
the Scripps Patent Rights within ten (10) years after the
filing date from which such claim takes priority, such pending
claim shall not be a Valid Claim for the purposes of
this Agreement.
2.
License Terms and Conditions .
2.1
Grant of License . Scripps hereby
grants to Licensee an exclusive, worldwide license, including the
right to sublicense, to Scripps Technology and under Scripps Patent
Rights, to make, to have made, to import, to use, to offer for
sell, and to sell Licensed Products in the Field, subject to the
terms of this Agreement.
2.2
Initial License Fee . In partial
consideration for the exclusive license granted pursuant to
Section 2.1 hereof, Licensee shall pay to Scripps a
nonrefundable license fee upon execution of this Agreement in the
amount of fifty thousand (50,000) shares of Optimer
Pharmaceutical Inc.'s common stock. The license fee described
in this Section is consideration for the grant and continuation of
the license hereunder, and Scripps shall have no obligation to
return any portion of such license fee, notwithstanding any failure
by Licensee to develop any Licensed Product or market any Licensed
Product commercially, and notwithstanding the volume of sales of
any such Licensed Product.
2.3
Three Year Anniversary Fee . Upon the
third anniversary of the Effective Date of this License Agreement,
Licensee shall pay to Scripps a nonrefundable anniversary fee of
[***] [***] ($[***]) dollars.
2.4
Royalties .
2.4.1
Percentage Royalty for Human Licensed Products
. As additional consideration for the
exclusive license granted pursuant to Section 2.1 hereof,
Licensee shall pay to Scripps a continuing royalty for human
Licensed Products on a country-by-country basis in the amount of
(i) [***] percent ([***]%) of Net Sales by Licensee of
Licensed Products which cannot be made, imported, used or sold in
such country without utilizing one or more Valid Claims with
offsets allowed for royalties paid to third parties for required
licenses for the commercialization of a Licensed Product, however,
the percentage royalty paid to Scripps may not be reduced below
[***] percent ([***]%), (ii) of [***] percent ([***]%) of Net
Sales of Licensed Products, in all countries where the manufacture,
use or sale of such Licensed Product is not covered by a Valid
Claim in such country but is covered by Scripps Technology with
offsets allowed for royalties paid to third parties for required
licenses for the commercialization of a Licensed Product, however,
the percentage royalty paid to Scripps may not be reduced below
[***] [***] percent ([***]%).
2.4.2
Percentage Royalty for Veterinarian Licensed Products
. As additional consideration for the
exclusive license granted pursuant to Section 2.1 hereof,
Licensee shall pay to Scripps a continuing royalty for veterinarian
Licensed Products on a country-by-country basis in the amount of
(i) [***] percent ([***]%) of Net Sales by Licensee of
Licensed Products which cannot be made, imported, used or sold in
such country without utilizing one or more Valid Claims with
offsets allowed for royalties paid to third parties for required
licenses for the commercialization of a Licensed Product, however,
the percentage royalty paid to Scripps may not be reduced below
[***] percent ([***]%); (ii) of [***] percent ([***]%) of Net
Sales of Licensed Products, in all countries where the manufacture,
use or sale of such Licensed Product is not covered by a Valid
Claim in such country but is covered by Scripps Technology with
offsets allowed for royalties paid to third parties for required
licenses for the commercialization of a Licensed Product, however,
the percentage royalty paid to Scripps may not be reduced below
[***] [***] percent ([***]%).
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2.4.3
Percentage Royalty on sales by Sublicensees for Human and
Veterinarian Licensed Products
.
For the royalty on Net Sales by sublicensees the following
formula will be used to determine the percentage royalty that
Licensee shall pay to Scripps:
R=[***][***]
(T-P),
where, R= the percentage of royalty to be paid to Scripps;
where, T= the percentage royalty paid to Licensee on Net Sales
of Licensed Product covered by Scripps Patent Rights by a
sublicensee; and
where, P= the percentage royalty paid to third parties by
Licensee
Provided that R shall not be less than [***]% for patented human
products covered by an issued claim; and [***]% for human
unpatented products; and [***]% for patented veterinarian products
covered by an issued claim; and [***]% for unpatented veterinarian
products.
2.5
Milestone Payments . In consideration
for the license granted to Licensee, Licensee shall pay to Scripps
within thirty (30) days upon the first occurrence, in a Major
Market Country, of each milestone specified below for the first
Licensed Product to meet such milestone. Payment of the milestones
shall be in cash or common stock or a combination thereof at
Licensee's option. If registered common stock comprises part of the
payment, the registered common stock shall be priced at the
arithmetic average of the closing trading prices for the twenty
(20) trading days just prior to the date of
the milestone.
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Initiation of First Multi-Center trial
(equivalent to Phase III in the U.S.)
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$
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[***]
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Filing of First Market Application to a
regulatory agency (ex. PLA)
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$
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[***]
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Market Approval or its equivalent in another
country
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$
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[***]
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2.6
Quarterly Payments .
2.6.1
Sales by Licensee . With regard to
Net Sales made by Licensee or its Affiliates, royalties shall be
payable by Licensee quarterly, within sixty (60) days after
the end of each calendar quarter, based upon the Net Sales of
Licensed Products during such preceding calendar quarter,
commencing with the calendar quarter in which the first commercial
sale of any Licensed Product is made.
2.6.2
Sales by Sublicensees . With regard
to Net Sales made by sublicensees of Licensee or its Affiliates,
royalties shall be payable by Licensee quarterly, within ninety
(90) days after the end of each calendar quarter, based upon
the Net Sales of Licensed Products by such sublicensee during such
preceding calendar quarter, commencing with the calendar quarter in
which the first commercial sale of any Licensed Product is made by
such sublicensee.
2.7
Term of License . Unless terminated
sooner in accordance with the provisions of this Agreement, the
term of this license shall expire when the last of the royalty
obligations set forth in Section 2.10 below have expired.
Notwithstanding the foregoing, if applicable government regulations
require a shorter term and/or a shorter term of exclusivity than
provided for herein, then the term of this License Agreement shall
be so shortened or this License Agreement shall be amended to
provide for a non-exclusive license, and, in such event, the
parties shall negotiate in good faith to reduce appropriately the
royalties payable as set forth under the section heading
"Royalties" hereof.
2.8
Sublicense . Licensee shall have the
sole and exclusive right to grant sublicenses to any party with
respect to the rights conferred upon Licensee under this Agreement,
provided, however, that (i) any such sublicense shall be
subject in all respects to the restrictions, exceptions, royalty
obligations, reports, termination provisions, and other provisions
contained in this Agreement (but not including the payment of
a license fee pursuant to Section 2.2 hereof) and
(ii) each such sublicensee, and the form and substance of each
such sublicense, shall be subject to the prior written approval of
Scripps, which
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approval shall not be unreasonably withheld,
provided, however, that any sublicense granted to an Affiliate of
Licensee shall not be subject to Scripps's prior written approval.
No approval shall be required as to any sublicense which utilizes
the form of sublicense attached hereto as Exhibit B. Licensee
shall pay Scripps, or cause its Affiliate or sublicensee to pay
Scripps, the same royalties on all Net Sales made by Licensee, its
Affiliate or sublicensee. Each Affiliate and sublicensee shall
report its Net Sales to Scripps through Licensee, which Net Sales
shall be aggregated with any Net Sales of Licensee for purposes of
determining the Net Sales upon which royalties are to be paid
to Scripps.
Except as set
forth below, any sublicense revenues, other than royalties, due
Licensee pursuant to the grant of a sublicense to a party not an
Affiliate but excluding any payments for research, development, or
equity ("Sublicense Revenue"), so long as said equity payment
reflects the current fair market value of the stock, as determined
by such sublicensees' board of directors, which determination will
be acceptable as long as it is reasonable and reflects industry
standards in comparable arrangements, shall be reported to Scripps
by Licensee. For the first three years of this Agreement, the
calculation of Scripps' percentage of Sublicense Revenue shall be
based on a pro-rata contribution of Scripps Technology if it is
sublicensed in combination with non-Scripps technology. For the
fourth year and after Scripps shall receive [***]% of the
Sublicense Revenue with no reductions if sublicensed in combination
with non-Scripps technology. Licensee shall pay Scripps a portion
of Sublicense Revenue according to the following schedule:
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First six (6) months after execution of this
agreement
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[***]% of the Sublicense Revenue
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Second six (6) months after execution of
this agreement
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[***]% of the Sublicense Revenue
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Third six (6) months after execution of this
agreement
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[***]% of the Sublicense Revenue
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Fourth six (6) months after execution of
this agreement
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[***]% of the Sublicense Revenue
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Third year after execution of this
agreement
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[***]% of the Sublicense Revenue
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2.9
Duration of Royalty Obligations . The
royalty obligations of Licensee as to each Licensed Product shall
terminate: (i) on a country-by-country basis concurrently with
the expiration of the last to expire of Scripps Patent Rights
utilized by or in such Licensed Product in each such country; or
(ii) with respect to Licensed Products utilizing only Scripps
Technology but not Scripps Patent Rights, fifteen (15) years
after the date of first commercial sale of such Licensed Product in
such country.
2.10
Reports . Licensee shall furnish to
Scripps at the same time as each royalty payment is made by
Licensee, a detailed written report of Net Sales of the Licensed
Products and the royalty due and payable thereon, including a
description of any offsets or credits deducted therefrom, on a
product-by-product and country-by-country basis, for the calendar
quarter upon which the royalty payment is based.
2.11
Records . Licensee shall keep, and
cause its Affiliates and sublicensees to keep, full, complete and
proper records and accounts of all sales of Licensed Products in
sufficient detail to enable the royalties payable on Net Sales of
each Licensed Product to be determined. Scripps shall have the
right to appoint an independent certified public accounting firm
approved by Licensee, which approval shall not be unreasonably
withheld, to audit the records of Licensee, its Affiliates and
sublicensees as necessary to verify the royalties payable pursuant
to this Agreement provided such auditor executes a confidentiality
agreement standard for the industry. Licensee, its Affiliates and
sublicensees shall pay to Scripps an amount equal to any additional
royalties to which Scripps is entitled as disclosed by the audit,
plus interest thereon at the rate of one and one-half percent
(1.5%) per month. Such audit shall be at Scripps's expense;
provided, however, that if the audit discloses that Scripps was
underpaid royalties wi
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