Exhibit 10.13
YALE EXCLUSIVE LICENSE
AGREEMENT
THIS AGREEMENT by and between YALE
UNIVERSITY, a corporation organized and existing under and by
virtue of a charter granted by the general assembly of the Colony
and State of Connecticut and located in New Haven, Connecticut
(“YALE”), and SCHERING AKTIENGESELLSCHAFT with Offices
in Müllerstrasse 178, D-13353, Berlin, Germany
(“LICENSEE”) shall be effective the date of final
execution below (“Effective Date”). Each of LICENSEE on
one hand and YALE on the other hand, is referred to a
“Party” and collectively as the
“Parties.”
In the course of research conducted
under YALE auspices, Dr. William Sessa, in the Department of
Pharmacology at YALE (the “INVENTOR”), produced an
Invention entitled “eNOS Mutations Useful For Gene Therapy
and Therapeutic Screening” (the “INVENTION”);
and
Pursuant to an assignment by the
INVENTOR to YALE of all his right, title and interest in and to the
INVENTION and any resulting patents, YALE is the owner of the
INVENTION, subject to rights reserved by the U.S. government;
and
LICENSEE wishes to obtain a license
to the INVENTION and any resulting patents, and YALE is willing to
grant such a license to LICENSEE subject to the terms and
conditions of this Agreement;
Therefore, in consideration of these
statements, the parties agree as follows:
ARTICLE 1
DEFINITIONS
The following terms used in this
Agreement shall be defined as set forth below:
1.1
“AFFILIATE” means any
entity or person that directly or indirectly controls, is
controlled by or is under common control with LICENSEE. For
purposes of this definition, “control” means possession
of the power to direct the management of such entity or person,
whether through ownership of more than 50% of voting securities, by
contract or otherwise.
1.2
“CONFIDENTIAL
INFORMATION” means any and all information, KNOW-HOW, and
data, technical or non-technical, which relates to LICENSED
INTELLECTUAL PROPERTY or to the Agreement itself and which is
disclosed to one Party by the other Party during the negotiation of
or under this Agreement.
1.3
“DILIGENCE REPORTS” has
the meaning set forth in Section 6.2.
1.4
“FIELD” means all
cardiovascular-related therapeutic uses of LICENSED INTELLECTUAL
PROPERTY that does not involve small molecule drug
delivery.
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1.5
“FIRST COMMERCIAL SALE”
means the date LICENSEE or an AFFILIATE or sublicensee of LICENSEE
first sells commercially, pursuant to a REGULATORY APPROVAL, a
LICENSED PRODUCT in United States, Japan or any country of the
European Union; provided however, that where such first
commercial sale has occurred in any country for which pricing, or
reimbursement approval is necessary for widespread sale, then such
sale shall not be deemed a FIRST COMMERCIAL SALE until such pricing
or reimbursement approval has been obtained.
1.6
“IND” means an
investigational new drug application required to be filed with the
Federal Food, Drug and Cosmetic Administration pursuant to 21
C.F.R. §312, as such regulations may be amended from time to
time, to test drug products in humans or foreign
equivalent.
1.7
“KNOW-HOW means information
that relates to the LICENSED INTELLECTUAL PROPERTY and is contained
in manuscripts, the Office of Cooperative Research at Yale
invention disclosure form, or other documents or information which
is disclosed by the INVENTORS of the LICENSED INTELLECTUAL PROPERTY
and which is useful, but not patentable.
1.8
“LICENSED INTELLECTUAL
PROPERTY” means the INVENTION as covered by the United States
or foreign patent application(s) and patents(s) arising out of the
provisional patent application attached as Appendix “A”
and owned by YALE during the term of this Agreement and includes
LICENSED INTELLECTUAL PROPERTY referred to in the The Research
Agreement between LICENSEE and YALE as of the Effective Date (see
Appendix B), together with any continuations,
continuations-in-part, and any divisional, or substitute patents,
any reissues or re-examinations of any such applications or
patents, and any extension of the term of any such
patent.
1.9
“LICENSED METHODS” means
any method, procedure, process or other subject matter, the
manufacture, use or sale of which without a license from YALE,
would infringe any ISSUED CLAIM of the LICENSED INTELLECTUAL
PROPERTY.
1.10
“LICENSED PRODUCTS”
means any products, apparatus, kit, or component part thereof in
the FIELD, the manufacture, use or sale of which without a license
from YALE, would infringe any ISSUED CLAIM of the LICENSED
INTELLECTUAL PROPERTY,
1.11
“LICENSED TERRITORY”
shall mean the whole world.
1.12
“ISSUED CLAIM” means a
claim of an issued patent or patent application claiming the
LICENSED INTELLECTUAL PROPERTY that has not been held
unenforceable, unpatentable or invalid by a decision of a court or
government agency of competent jurisdiction, unappealable or
unappealed within the time allowed to appeal, and which has not
been admitted to be invalid or unenforceable through re-issue,
re-examination, disclaimer or otherwise.
1.13
“NDA” means a new drug
application filed with the FDA pursuant to 21 C.F.R. 200, as such
regulations may be amended for approval by such agency for the sale
of LICENSED PRODUCT in the United States. Reference to NDA
includes, to the extent applicable, an biologies license
application.
1.14
“NET SALES: means the amount
invoiced by LICENSEE, an Affiliate or permitted sublicensee for
sales of LICENSED PRODUCTS, as the case may be, to a third party,
less deductions for (i) shipping or freight charges prepaid or
allowed, and other charges such as insurance, relating thereto as
is customary in LICENSEE’S normal business practices; (ii)
sales and excise taxes or customs duties paid by the
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selling party and any other
governmental charge imposed upon the sales of such LICENSED
PRODUCTS, as the case may be; (iii) distributors fees, rebates, or
allowances actually granted, allowed or incurred; (iv) quantity
cash discounts or chargebacks actually granted, allowed or incurred
in the ordinary course of business in connection with the sale of
such LICENSED PRODUCT, as the case may be; (v) allowances or
credits to customers, not in excess of the selling price of such
LICENSED PRODUCTS, as the case may be, on account of governmental
requirements, rejection, outdating recalls or for value of returned
trade goods of such LICENSED PRODUCTS, as the case may be; and (vi)
an estimate for bad debts determined in accordance with such
Party’s normal accounting procedures consistently applied
within and across its pharmaceutical operating units, whether or
not invoiced to the customer. For the purpose of calculating
LICENSEE’S NET SALES, the Parties recognize that (a)
LICENSEE’S customers may include persons in the chain of
commerce who enter into agreements with LICENSEE as to price even
though title to the LICENSED PRODUCT, as the case may be, does not
pass directly from LICENSEE to such customers, and even thought
payment for such LICENSED PRODUCT, as the case may be, is not made
by such customers directly to LICENSEE and (b) in such cases
chargebacks paid by LICENSEE to or thorough a third party (such as
a wholesaler) can be deducted by LICENSEE from gross revenue in
order to calculate a Party’s NET SALES. Any deductions listed
above which involve payment by LICENSEE shall be taken as a
deduction against aggregate sales for the period in which the
payment is made. Sales of LICENSED PRODUCTS, as the case may be,
between a Party and its Affiliates solely for research or clinical
testing purposes shall be excluded from the computation of NET
SALES.
1.15
“PHASE I CLINICAL
TRlAL(S)” means a Phase I clinical trial for a LICENSED
PRODUCT as described in 21 C.F.R. §312 (a).
1.16
“REGULATORY APPROVAL”,
means any approvals, product and/or establishment licenses,
registrations, or authorizations of any federal, state or local
regulatory agency, department, bureau or other governmental entity,
necessary for the manufacture, use, storage, importation, export,
transport or sale of LICENSED PRODUCT in a regulatory
jurisdiction.
ARTICLE 2
LICENSE GRANT AND TERM
2.1
Subject to all the terms and
conditions of this Agreement, YALE hereby grants to LICENSEE an
exclusive, worldwide license, under the LICENSED INTELLECTUAL
PROPERTY within the FIELD, with the right to grant sublicenses, to
make, have made, use, sell, offer to sell, import and export
LICENSED PRODUCTS and to practice any LICENSED METHOD (the
“LICENSE”).
2.2
The LICENSE is expressly made
subject to Yale’s reservation of the right to make, use and
practice the LICENSED INTELLECTUAL PROPERTY for its own
non-commercial purposes. Nothing in this Agreement shall be
construed to grant by implication, estoppel or otherwise any
licenses under patents of YALE other than the LICENSED INTELLECTUAL
PROPERTY.
2.3
Unless terminated earlier as
provided in Article 12, the LICENSE shall commence on the date of
full execution of this Agreement and the LICENSE, shall
automatically end on the date of the last to expire of the patents
described in the LICENSED INTELLECTUAL PROPERTY.
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2.4
If LICENSED INTELLECTUAL PROPERTY
exists in countries outside the U.S., the LICENSE granted in
Article 2.1 shall automatically convert to a paid-up, non-exclusive
license, on a country-by-country basis when the last to expire of
the patents as described in the LICENSED INTELLECTUAL PROPERTY in
that country expires,
2.5
Appendix B is incorporated and a
part of this Agreement.
ARTICLE 3
SUBLICENSES
3.1
YALE hereby grants to LICENSEE the
right to sublicense the right to make, use, sell, offer to sell,
import or export any LICENSED PRODUCT and to practice any LICENSED
METHOD, provided this Agreement is in effect and LICENSEE is not in
breach.
3.2
Any sublicense granted by LICENSEE
shall include substantially the same Definitions, and provisions on
Due Diligence, Confidentiality and Publicity, Reporting
Requirements, Indemnification, Insurance and Warranties, Patent
Notices and Use of Yale’s Name: provided further ,
such sublicenses do not relieve LICENSEE from the royalty rate
obligations of Article 5 of this Agreement.
3.3
If, prior to LICENSEE reaching the
“B3” decision, that is, to file an IND and initiate
Phase I CLINICAL TRIALS in the United States with respect to a
LICENSED PRODUCT, LICENSEE enters into a sublicense with a third
party with respect to such LICENSED PRODUCT for such third party to
Solely develop and commercialize such LICENSED PRODUCT, then
LICENSEE shall pay to YALE Thirty (30%) Percent of any lump sum
fee, milestone payment, or advance payment received by LICENSEE
from any sublicensee. “Solely” means that Schering does
not retain any rights to develop and commercialize such LICENSED
PRODUCT, that is, for the avoidance of doubt, Schering acts in the
nature of a broker and grant all its rights and responsibilities to
a third party.
3.4
LICENSEE shall promptly:
a) provide YALE with a copy of each sublicense
granted by LICENSEE under this Agreement and any amendments to such
sublicense or termination of it;
b) guarantee to pay all payments due YALE from
sublicenses; and
c) summarize and deliver copies of all reports due
to LICENSEE from sublicensees.
ARTICLE 4
LICENSE ISSUE FEE
4.1
LICENSEE shall pay to YALE, upon
execution of this Agreement, a non-refundable license issue fee of
Fifty Thousand ($50,000.00) Dollars. Said fee is not an advance
upon Earned Royalties.
4.2
LICENSEE shall pay the following
milestone payments. Milestone payments are paid once only on the
first LICENSED PRODUCT that meets such milestone regardless of the
number of LICENSED PRODUCTS, the number of times a milestone is
reached or number of indications for such LICENSED PRODUCT
(S).
4.2.1 One Hundred-Fifty Thousand ($150,000.00)
Dollars:
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upon entering LICENSEE’S
“B2” phase of drug development (preclinical development
dossier and regulatory toxicity).
4.2.2 Eight Hundred-Twenty-Five Thousand
($825,000.00) Dollars:
upon filing the first 1ND for the
first LICENSED PRODUCT in any one of the United States, or Japan or
a country in the European Union.
4.2.3 Nine Hundred Thousand ($900,000.00)
Dollars:
upon filing first BLA or NDA in the
United States.
4.2.4 One Million Five Hundred Thousand
($1,500,000.00) Dollars:
upon the FIRST COMMERCIAL SALE of
the first LICENSED PRODUCT.
4.2.5 Three Million ($3,000,000.00)
Dollars:
upon first Ten Million
($10,000,000.00) Dollars in NET SALES.
4.3
Neither the license issue fee of
Article 4.1 nor the milestone payments of Article 4.2 shall be
credited against royalties payable under Article 5. If there
is no ISSUED CLAIM in the LICENSED INTELLECTUAL PROPERTY claiming
the LICENSED PRODUCT in whole or in part, then LICENSEE shall not
pay the Milestones stated in Sections 4.2.4 and 4.2.5.
ARTICLE 5
ROYALTIES
5.1
Provided there is a ISSUED CLAIM in
such country, as consideration for the license granted under this
Agreement LICENSEE on a country-by-country basis shall pay to YALE
an earned royalty of NET SALES in each calendar year as
follows:
4% on NET SALES up to $250
million
5% on NET SALES greater than $250
million and less than $500 million
6% on NET SALES greater than $500
million
5.2
LICENSEE shall pay all royalties
accruing to YALE within thirty (30) days after the end of each
calendar quarter (March 31, June 30, September 30 and December 31)
in which NET SALES occur.
5.3
During the term of this Agreement,
LICENSEE agrees to pay an annual License Maintenance Fee
(“LMF”) commencing on the January 1 after the date of
final execution and every January 1 thereafter until the January 1
that LICENSEE starts to pay Minimum Royalty Payments under Article
5.4. The LMF shall be Fifteen Thousand ($15,000.00)
Dollars.
5.3.1 The LMF shall not be owed YALE
in those years in which LICENSEE is funding Professor Sessa’s
laboratory with a minimum of Seventy Five Thousand ($75,000.00)
Dollars in direct costs.
5.4
Provided royalties are due pursuant
to Section 5.1 of this Agreement, during the term of this
Agreement, LICENSEE agrees to pay YALE annual Minimum Royalty
Payments (“MRP”), commencing on the first January 1 to
occur Six (6) months after the date of the FIRST COMMERCIAL SALE in
the United States. The MRP shall be in the
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amount of Fifty Thousand Dollars
($50,000.00). LICENSEE shall continue to pay the MRP until the end
of the term of the last to expire ISSUED CLAIM in the LICENSED
INTELLECTUAL PROPERTY that claims the LICENSED PRODUCT. YALE shall
fully credit each MRP made against any Earned Royalties payable by
LICENSEE in the same year.
5.5
If it is established that any ISSUED
CLAIM is dominated by another patent and LICENSEE is required to
obtain a license from a third party in order to practice the
LICENSED INTELLECTUAL PROPERTY, then royalty payment due YALE may
be reduced by the royalty and payments made to such third party,
but in no event may LICENSEE reduce the earned royalty on NET SALES
by more than Forty Percent (40%). LICENSEE shall justify any such
deduction to YALE.
YALE shall pay any and all taxes
levied on account of royalties or other payments that it receives
from LICENSEE under this Agreement. If laws or regulations require
that taxes be withheld, LICENSEE will (i) deduct those taxes from
the remittable royalty, (ii) timely pay the taxes to the proper
taxing authority, and (iii) send proof of payment to YALE within
thirty (30) days of receipt of confirmation of payment from the
relevant taxing authority. LICENSEE agrees to make all lawful and
reasonable efforts to minimize such taxes to YALE.
5.6
Payments by LICENSEE under this
Agreement shall be paid to YALE in U.S. dollars by wire transfer of
immediately available funds to an account at a commercial bank
designated by YALE. Where payments are based on NET SALES in
countries other than the United States, the amount of such NET
SALES expressed in the currency of each country shall be converted
first into Deutsche Marks, or if the Deutsche Mark shall have been
replaced by the Euro, into Euros, and then into U.S. dollars at the
average exchange rate (calculated at the average of the
“bid” and “asked” exchange rate) for the
applicable quarter, provided, however, that the conversion of the
currency in question into Deutsche Marks or Euros prior to
conversion into U.S. dollars shall be for calculation purposes
only, and no additional fee or commission will be incurred as a
consequence of the multiple currency conversions. In determining
the average exchange rate for an