Exhibit 10.321
CERTAIN MATERIAL (INDICATED BY AN
ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
EXCLUSIVE PATENT LICENSE
AGREEMENT
This E XCLUSIVE P ATENT L ICENSE A GREEMENT (the “ Agreement” ),
effective as of this 18 th day of June, 2009 (the “
Effective Date” ), is entered into by and between
Glycomed, Inc., a California corporation and a wholly owned
subsidiary of Ligand Pharmaceuticals Incorporated (
“ Glycomed” ), and ParinGenix,
Inc., a Delaware corporation ( “
ParinGenix” ).
W HEREAS ,
Glycomed is the owner of the Patent Rights (as defined below) and
desires that the Patent Rights be used for the clinical development
and subsequent commercialization of Licensed Products (as defined
below) for the treatment and/or prevention of human
disease.
W HEREAS ,
ParinGenix desires to acquire an exclusive license to the Patent
Rights in the Field (as defined below) for such
purposes.
N OW ,
T HEREFORE , in consideration of the foregoing premises and
the mutual covenants contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties agree as follows:
1. Definitions . Terms defined in this
Section 1, and parenthetically defined elsewhere in this
Agreement, will throughout this Agreement have the meaning here or
there provided. Defined terms may be used in the singular or in the
plural, as sense requires.
1.1 “ Affiliate ” means any
corporation or other business entity that controls, is controlled
by or is under common control with ParinGenix.
“Controls,” “control” or
“controlled” as used in this paragraph means direct or
indirect ownership of more than fifty percent (50%) of the
voting stock of such corporation, or more than a fifty percent
(50%) interest, direct or indirect, in the decision-making
authority of such other business entity.
1.2 “ Calendar Quarter ” means
each respective period of three (3) consecutive months ending
on March 31, June 30, September 30 and
December 31.
1.3 “ FDA” means the
United States Food and Drug Administration, or any successor agency
thereto having the administrative authority to regulate the
marketing of human pharmaceutical products or biological
therapeutic products, delivery systems and devices in the
Territory.
1.4 “ Field” means the use of
Licensed Products for the treatment and prevention of human
disease.
1.5 “ First Commercial Sale ”
means the initial sale or transfer by or on behalf of ParinGenix,
its Affiliates, or Sublicensees of a Licensed Product to a third
party.
1.6 “ Fiscal Year ” means the
twelve consecutive months commencing on January 1 and ending
December 31.
1 of 19
1.7 “ Know-How ” means all
inventions, discoveries, trade secrets, information, experience,
data, formulas, procedures and results, including physical,
chemical, biological, toxicological, pharmacological and clinical
data, dosage regimens, control assays and product specifications,
but excluding any Patent Rights, that (a) is possessed as of
the Effective Date by Glycomed, (b) is owned or Controlled by
Glycomed as of the Effective Date, and (c) is necessary or
useful in the use, development, design, registration, or sale of a
Licensed Product.
1.8 “ License ” means the
licenses granted by Glycomed to ParinGenix pursuant to
Section 2.1 below.
1.9 “ Licensed Product ” means
any pharmaceutical product that, but for the License, would
infringe the Patent Rights, including, without limitation, in each
case all formulations and modes of administration thereof. The
Parties agree, for purposes of this Agreement only, that PGX-100
and ODSH are Licensed Products.
1.10 “ NDA” means a New
Drug Application (as more fully defined in 21 C.F.R. 314.5 et
seq. ) and all amendments and supplements thereto filed with
the FDA, or the equivalent application filed with any equivalent
agency or governmental authority outside the United States of
America (including any supra-national agency such as in the
European Union), including all documents, data, and other
information concerning a pharmaceutical product which are necessary
for gaining regulatory approval to market and sell such
pharmaceutical product.
1.11 “ Net Sales ” means the
aggregate gross sales of Licensed Products to unaffiliated third
parties in the Territory by ParinGenix and its Affiliates, less
amounts attributable to the Licensed Products, ParinGenix or its
Affiliates determined to deduct and recognized in their respective
financial statements in accordance with GAAP (or comparable
financial standards) and with ParinGenix’ and its
Affiliates’ standard accounting principles consistent with
GAAP (or comparable financial standards), including, but not
limited to the following: (i) trade discounts, credits or
allowances, including slotting allowances and retroactive price
adjustment (i.e. shelf-stock adjustments); (ii) credits or
allowances additionally granted upon returns, rejections or
recalls; (iii) freight, shipping and insurance charges;
(iv) taxes, duties or other governmental tariffs (other than
income taxes); and (v) trade rebates, chargebacks, managed
care rebates and government mandated rebates. In the case of a sale
or a transfer to an Affiliate or Sublicensee, the Net Sales amount
of such sale or transfer shall not be deemed a “sale of
Licensed Product in the Territory” subject to the Net Sales
computation unless such Affiliate or Sublicensee is the end user
consumer of the Licensed Product in which case such sale would be
deemed a “sale of Licensed Product in the Territory”
subject to the Net Sales computation.
1.12 “ Patent Rights ” means the
United States letters patent as indicated in Attachment A ,
including without limitation, any divisions, continuations,
continuations-in-part, reissues, re-examinations, renewals,
substitutions, extensions, provisionals, inventor’s
certificates or supplementary protection certificates of such
patent or patent applications and all foreign patents which are
directed to the subject matter specifically described in the United
States patents listed in Attachment A .
1.13 “ Royalty Term” means,
on a Licensed Product-by-Licensed Product and country-by-country
located within the Territory basis, the period of time commencing
on the First
2 of 19
Commercial Sale in such country and ending upon
the later of (a) five (5) years after the date of First
Commercial Sale of such Licensed Product in such country, or
(b) five (5) years after the expiration of the last to
expire of an issued patent under the Patent Rights claiming the
manufacture, use or sale of such Licensed Product in such
country.
1.14 “ Sublicense ” means the
present, future or contingent transfer of any license, right,
option, first right to negotiate or other right granted for PGX-100
or ODSH; or otherwise granted under the Patent Rights or Know-How,
in whole or in part; provided, however , that Sublicensing
shall not include any transfer or sale of all or substantially all
of the assets of ParinGenix where as part of such transaction
ParinGenix transfers the License to a third party and the third
party agrees to assume and be bound by all of ParinGenix’
obligations under this Agreement.
1.15 “ Sublicensee ” means a party
that is granted a Sublicense.
1.16 “ Sublicensing Revenue ”
means the revenue ParinGenix or its Affiliates receives from
Sublicensees as a royalty payment from the “net sales”
(as defined in the Sublicense agreement) of a Licensed Product made
in the Territory during the Royalty Term for such Licensed
Product.
1.17 “ Territory ” means the
United States of America and each other country in which
(a) Glycomed notifies ParinGenix in writing that Patent Rights
have issued, and (b) ParinGenix, within thirty (30) days
after its receipt of such notice, accepts in writing as an
additional country in the “Territory.”
2. License Grant; Know-How .
2.1 License . Subject to ParinGenix’
compliance with Articles 6 (License Issue Fee and Royalties) and 7
(Payments; Records; Audits), and subject to the other terms and
conditions of this Agreement, Glycomed hereby grants to ParinGenix,
and ParinGenix accepts, (a) an exclusive, royalty-bearing
license, with the right to Sublicense, under the Patent Rights to
import, make, have made, use, promote the use, and sell Licensed
Products in the Field in the Territory, and (b) a
non-exclusive, royalty-bearing license, with the right to
Sublicense, under the Know-How to import, make, have made, use,
promote the use, and sell Licensed Products in the Field and in the
Territory. In the event Glycomed is the owner of other patents
involving desulfated heparin that are not included in the Patent
Rights, Glycomed hereby covenants to never sue ParinGenix for
patent infringement or any related claim or cause of action arising
out of or relating to such patents.
2.2 Know-How And Other Documentation . Upon
the written request of ParinGenix, Glycomed shall use commercially
reasonable efforts to assemble and transfer to ParinGenix such of
the readily available Know-How as it is able without incurring
undue expense or without undue effort. Glycomed shall also use
commercially reasonable efforts to assemble and transfer to
ParinGenix any lab notebooks and other documentation relating to
the Patent Rights (collectively, “
Documentation” ) in its possession as it is able
without incurring undue expense or without undue effort.
3. Sublicensing .
3 of 19
3.1 Right to Grant Sublicenses . During the
term of this Agreement, ParinGenix will have the right to grant
Sublicenses to Patent Rights and the Know-How in the Field and for
the Territory.
3.2 ParinGenix Remains Responsible .
ParinGenix is responsible for the actions or omissions of its
Sublicensees and must not grant any rights that are inconsistent
with the rights granted to and obligations of ParinGenix hereunder.
Any act or omission of a Sublicensee that would be a breach of this
Agreement if performed by ParinGenix will be deemed to be a breach
by ParinGenix of this Agreement.
3.3 Required Sections . Each Sublicense
granted by ParinGenix must provide that the obligations to Glycomed
of Paragraphs 7.3 (Audits), and 18.5 (Insurance), and Articles 4
(Confidentiality Obligations), 11 (Patent Marking), 12 (Patent
Matters), 14 (Indemnification), and 17 (Publicity) of this
Agreement be binding upon the Sublicensee as if it were a party to
this Agreement. ParinGenix will attach copies of these Paragraphs
and Articles to all Sublicenses.
3.4 Sublicensing Revenue . ParinGenix shall
ensure that all Sublicensing Revenue received by ParinGenix or its
Affiliates shall only be in cash. ParinGenix shall provide Glycomed
with a copy of each executed Sublicense within thirty
(30) days of the date of execution of such
Sublicense.
4. Confidentiality .
4.1 Confidentiality Obligations .
(a) Each party shall, at all times during the term
of this Agreement and for a ten (10) year period following
termination or expiration hereof, keep, and shall ensure that its
officers, directors, employees, and agents keep, completely
confidential and shall not publish or otherwise disclose and shall
not use, directly or indirectly, for any purpose, any Confidential
Information furnished to it by the other party, except to the
extent such disclosure or use is expressly permitted by the terms
of this Agreement or is reasonably necessary for the performance of
this Agreement.
(b) Glycomed recognizes that by reason of
ParinGenix’ status as an exclusive licensee of the Patent
Rights in the Field, ParinGenix has an interest in Glycomed’s
maintaining in confidence any information of Glycomed relating to
the terms of this Agreement or the Licensed Product, except to the
extent that disclosure or use is expressly permitted by the terms
of this Agreement or is reasonably necessary for the performance of
this Agreement.
4.2 Permitted Disclosures . Each party may
disclose Confidential Information to the extent that such
disclosure is:
(a) Made in response to a valid order of a court of
competent jurisdiction or other governmental body of a country or
any political subdivision thereof of competent jurisdiction;
provided, however, that the receiving party, if not legally
prohibited, shall first have given notice to the disclosing party
and given the disclosing party a reasonable opportunity to quash
such order and to obtain a protective order requiring that the
Confidential Information and/or documents that are the subject of
such order be held in confidence by such court or
4 of 19
agency or, if disclosed, be used only for the
purposes for which the order was issued; and provided further that
if a disclosure order is not quashed or a protective order is not
obtained, the Confidential Information disclosed in response to
such court or governmental order shall be limited to that
information which is legally required to be disclosed in such
response to such court or governmental order;
(b) Otherwise required by law, in the opinion of
legal counsel to the receiving party;
(c) Made by the receiving party to (i) the
regulatory authorities as required in connection with applications
for regulatory approvals for the Licensed Product; provided,
however, that reasonable measures shall be taken to assure
confidential treatment of such information or (ii) the United
States Patent and Trademark Office or any equivalent agency or
governmental authority outside the United States of America in
connection with any filing, prosecution, divisions, continuations,
continuations-in-part, reissues, re-examinations, renewals,
substitutions, extensions or provisionals involving any patent
application or issued patent;
(d) Made by the receiving party to third parties as
may be necessary in connection with the development and
commercialization of the Licensed Product as contemplated by this
Agreement, including, without limitation, Sublicensing; provided,
however, that the receiving party in question shall in each case
obtain from the proposed third party recipient a written
confidentiality undertaking containing confidentiality obligations
no less onerous than those set forth in this Article 4;
or
(e) Made by the receiving party to third parties
regarding disclosure of the existence and terms of this Agreement
under obligations of confidentiality (i) to agents, advisors,
lenders and investors, and (ii) to potential agents, advisors,
lenders, purchasers (in mergers and acquisitions and/or licensing
transactions), investors and other business partners, in connection
with such Party’s activities hereunder, in connection with
such Party’s financing activities or if in the process of a
mergers and acquisitions and/or licensing transaction, but only to
the extent required for such activities.
4.3 Definition; Exclusions; Return of
Confidential Information .
(a) “Confidential Information” means
(i) where Glycomed is the receiving party, any information
relating to the terms of this Agreement or the Licensed Product,
and the business affairs and other activities of ParinGenix or its
Affiliates, and (ii) where ParinGenix is the receiving party,
any information relating to the terms of this Agreement or the
Licensed Product, and the business affairs and other activities of
Glycomed or its Affiliates.
(b) Notwithstanding the foregoing, Confidential
Information shall not include any information that:
(i) at the time of disclosure is or later comes into
public domain through no fault of receiving party;
5 of 19
(ii ) can be demonstrated by documentation or other
competent proof to have been in the receiving party’s
possession prior to disclosure by the disclosing party;
(iii) is subsequently received by the receiving party
from a third party who is not bound by any obligation of
confidentiality with respect to said information; or
(iv) that is independently developed by or for the
receiving party without reference to the disclosing party’s
Confidential Information.
(c) Upon termination of this Agreement, the parties,
their Affiliates and Sublicensees shall return all Confidential
Information transferred under this Agreement; provided, however,
that each party shall be permitted to retain one complete set of
the Confidential Information for archival purposes to monitor
compliance with this Section.
5. Diligence .
5.1 Commercially Reasonable Efforts .
ParinGenix, during the term of this Agreement, will utilize its
Commercially Reasonable Efforts, in proceeding with the
development, manufacture and sale of Licensed Products in the
Territory. “Commercially Reasonable Efforts” for the
purposes of this Article, means the efforts and resources which
would be used (including without limitation the promptness in which
such efforts and resources would be applied) by a party consistent
with its normal business practices, which in no event shall be less
than the level of efforts and resources standard in the
pharmaceutical industry for a company similar in size and scope to
such party, with respect to a product or potential product at a
similar stage in its development or product life taking into
account efficacy, safety, pre-clinical and clinical results or the
lack thereof, commercial value, regulatory issues factors, standard
product planning, the competitiveness of alternative products of
third parties that are in the marketplace, and the patent and other
proprietary position of such product, and other market factors. The
efforts of a Sublicensee will be considered the efforts of
ParinGenix for purposes of determining whether Commercially
Reasonable Efforts have been met. In determining Commercially
Reasonable Efforts with respect to a particular Licensed Product,
ParinGenix or its sublicensees may in all circumstances exercise
reasonable and prudent business judgment and sound fiscal
management in meeting their diligence and other obligations
hereunder.
5.2 Additional Diligence Obligations . In
addition to the obligations set forth in Section 5.1 above,
ParinGenix, or a Sublicensee, shall have a First Commercial Sale of
a Licensed Product in the Territory no later than the earlier of:
(a) June 30, 2015, or (b) two years after
notification of approval from the FDA with respect to the first
Licensed Product to be so approved.
5.3 Termination for Failure to Comply with
Diligence . If ParinGenix fails to adhere to the diligence
obligations set forth in this Article 5 (Diligence) Glycomed may
terminate the Agreement; provided however, that ParinGenix may
extend the date required for a First Commercial Sale for one year,
and thereafter on a year-by-year basis, with the payment of fifty
thousand dollars ($50,000) for each annual extension period prior
to the expiration of the then current diligence period.
6 of 19
6. License Issue Fee and Royalties
.
6.1 License Issue Fee . As partial
consideration for the rights conveyed by Glycomed under this
Agreement, ParinGenix shall pay to Glycomed a one-time,
non-refundable, non-creditable license issue fee of Three Hundred
Fifty Thousand Dollars ($350,000), due and payable in full on the
Effective Date.
6.2 Royalties . ParinGenix and its Affiliates
shall pay Glycomed royalties on Net Sales of Licensed Products on a
Licensed Product by Licensed Product and country by country located
in the Territory basis at the rate of three percent (3.0%). The
payments specified in this Section 6.2 (collectively, “
Royalty Payments ”) shall be payable only for the
period equal to the Royalty Term for such Licensed
Product.
6.3 Sublicensing Revenue . ParinGenix and its
Affiliates shall pay Glycomed one hundred percent (100%) of
the Sublicensing Revenue received by ParinGenix and its Affiliates
from a Sublicensee if the royalty received by ParinGenix or its
Affiliates on “net sales” of any Licensed Product made
by such Sublicensee is three percent (3%) or less. In the
event the royalty received by ParinGenix or its Affiliates from a
Sublicensee on “net sales” of any Licensed Product made
by such Sublicensee is greater than three percent (3%), ParinGenix
and its Affiliates shall pay Glycomed the amount of the
Sublicensing Revenue representing three percent (3%) of
“net sales” and ParinGenix or its affiliates shall
retain the difference.
6.4 Taxes . The parties agree to cooperate
with one another and use reasonable efforts to avoid or reduce
obligations for any and all income or other taxes required by
Applicable Law to be withheld or deducted from any of the royalty
and other payments made by or on behalf of a party hereunder
(“ Withholding Taxes ”). The applicable paying
party under this Agreement (the “ Paying Party
”) shall, if required by applicable law, deduct from any
amounts that it is required to pay to the recipient party hereunder
(the “ Recipient Party ”) an amount equal to
such Withholding Taxes, provided that the Paying Party shall give
the Recipient Party reasonable notice prior to paying any such
Withholding Taxes. Such Withholding Taxes shall be paid to the
proper taxing authority for the Recipient Party’s account and
evidence of such payment shall be secured and sent to recipient
within one (1) month of such payment. The Paying Party shall,
at the Recipient Party’s cost and expense, do all such lawful
acts and things and sign all such lawful deeds and documents as the
Recipient Party may reasonably request to enable the Paying Party
to take advantage of any applicable legal provision or any double
taxation treaties with the goal of paying the sums due to the
Recipient Party hereunder without withholding or deducting any
Withholding Taxes. For the sake of clarity, in no event shall the
Paying Party be required to pay any additional amounts, whether in
the nature of a “gross up” payment or otherwise, to the
Recipient Party on account of such Withholding Taxes.
6.5 No Multiple Royalties . No multiple
royalties will be payable to Glycomed because any Licensed Product
or its manufacture, use, or sale are or will be covered by more
than one patent application or issued patent included as part of
Patent Rights.
6.6 Patent Rights Invalidity .
Notwithstanding anything to the contrary contained herein, if any
patent or any claim thereof included within the Patent Rights shall
be found invalid by a court of competent jurisdiction,
ParinGenix’ obligation to pay Glycomed royalties based
on
7 of 19
such patent or claim or any claim patentably
indistinct therefrom shall cease as of the date of such decision.
ParinGenix shall not, however, be relieved from paying Glycomed any
royalties, fees, expenses, or other liabilities that accrued prior
to the date of such decision or that are based on any of
Glycomed’s Patent Rights not the subject of such decision. In
the event that the patent office in the country or region where a
specific patent application has been filed issues a final
rejection, of any patent or patent application or claim thereof
included within the Patent Rights, ParinGenix’ obligation to
pay Glycomed royalties based on such patent or claim or any claim
patentably indistinct there from shall cease as of the date of such
decision, unless and until after such rejection is rescinded or
reversed and such patent or claims are allowed. ParinGenix shall
not, however, be relieved from paying Glycomed any royalties, fees,
expenses, or other liabilities th
