LICENSE AND SUPPLY
AGREEMENT
THIS AGREEMENT
is made and entered into as of this 12th day of October, 2006 by
and between:
Meiji Seika
Kaisha, Ltd., a company organized and existing under the laws of
Japan and having its principal place of business at 4-16, Kyobashi
2-chome, Chuo-ku, Tokyo 104-8002 Japan (hereinafter referred to as
“Licensor”), and
Cornerstone
BioPharma Inc., a company organized and existing under the law of
Nevada and having its principal place of business at 2000 Regency
Parkway, Suite 255 Cary, North Carolina, 27518 USA
(hereinafter referred to as “Licensee”).
WHEREAS,
Licensor has developed a cephalosporin antibiotic known as
Cefditoren Pivoxil; and
WHEREAS,
Licensor and Purdue Pharmaceutical Products L.P.
(“Purdue”) entered into the License Agreement dated
March 20, 2003 (“Purdue License Agreement”)
wherein Licensor granted to Purdue a license to manufacture and
commercialize the product containing Cefditoren Pivoxil in the
United States, Puerto Rico and Canada; and
WHEREAS, under
the Purdue License Agreement, Purdue has acquired and owns certain
registrations for the product containing Cefditoren Pivoxil in the
United States and has conducted marketing activities for such
product in the United States; and
WHEREAS,
Licensor and Purdue entered into the Settlement Agreement dated
March 31, 2006, pursuant to which, the Purdue License
Agreement will terminate effective upon the earlier to occur of the
date on which Licensor and a new partner introduced by Purdue enter
into a license agreement with respect to the product containing
Cefditoren Pivoxil in the United States or October 31, 2006;
and
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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WHEREAS,
Licensee is a new partner introduced by Purdue; and
WHEREAS,
Licensor and Licensee entered into the Confidentiality Disclosure
Agreement dated September 1, 2006 (the “Confidentiality
Disclosure Agreement”) to enable Licensee to evaluate its
interest in obtaining a license from Licensor for commercializing
the product containing Cefditoren Pivoxil in the United States;
and
WHEREAS, as a
result of the said evaluation, Licensee has indicated its desire to
obtain an exclusive license to commercialize the product containing
Cefditoren Pivoxil in the United States with benefits of the
transfer of the registrations for such product from Purdue, and
Licensor is willing to grant such license to Licensee;
and
WHEREAS,
Licensor and Licensee entered into the Letter of Intent dated
September 13, 2006 (“Letter of Intent”) to confirm
their intent to enter into a license and supply agreement for the
product containing Cefditoren Pivoxil in the United States and to
set forth basic terms and conditions for such agreement;
and
WHEREAS, after
further discussion and negotiation, Licensor and Licensee have
reached agreement on detailed terms and conditions for such license
and supply agreement.
NOW, THEREFORE,
it is hereby agreed by the parties hereto as follows:
For the purpose
of this Agreement, the following terms shall have the following
meanings:
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(a)
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The
term “API” shall mean Compound in amorphous powder form
ready to be formulated.
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(b)
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The
term “API Specifications” shall mean the specifications
and analytical method relating to the API attached hereto as Annex
A.
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(c)
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The
term “Compound” shall mean a cephalosporin antibiotic
known as Cefditoren Pivoxil (INNM) developed and invented by
Licensor.
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(d)
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The
term “Launching Date” shall have the meaning as set
forth in Paragraph 2 of Article 4.
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(e)
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The
term “Net Sales” shall mean the amount invoiced by
Licensee for the sale of the Product to customers in the Territory
less: (i) cash, trade and quantity discounts allowed; (ii)
credits and allowances for returns, rejections and chargebacks;
(iii) costs incurred for freight, insurance and
transportation; (iv) sales and use taxes, duties or other
government tariffs and other similar taxes incurred and government
mandated rebates; and (v) estimated contract rebates and bid
rebates (which shall be adjusted to reflect actual rebates on a
periodic basis); all of which shall be determined in accordance
with U.S. generally accepted accounting practices.
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(f)
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The
term “Patents” shall mean (i) all U.S. patents
listed in Annex B attached hereto and (ii) all other patents
relating to the Compound and/or the Product which Licensor may
obtain in the Territory during the term of this
Agreement.
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(g)
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The
term “Product” shall mean the pharmaceutical product
containing the Compound as an active ingredient in the finished
form suitable for use by ultimate customers, as identified by the
Product Registrations.
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(h)
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The
term “Product Registrations” shall mean the
registrations of the Product granted by the United States Food and
Drug Administration, as listed in Annex C attached
hereto.
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(i)
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The
term “Technical Information” shall mean pre-clinical
and clinical data and other technical and scientific data, know-how
and information pertaining to the Compound and the Product which
are available to Licensor as of the date of this Agreement or will
subsequently be available to Licensor during the term of this
Agreement and which are
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useful or
necessary for due performance of this Agreement, including all
data, know-how and information heretofore furnished to Licensee by
Licensor under the Confidentiality Disclosure Agreement. Technical
Information shall not include any technical information and
know-how pertaining to the manufacturing process or method of the
Compound.
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(j)
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The
term “Territory” shall mean the United States, its
territories and possessions, including Puerto Rico.
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(k)
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The
term “Trademark” shall mean “SPECTRACEF
®
” owned by
Licensor in the Territory.
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Article 2 . Grant of License
1. Subject to
the terms and conditions set forth below, Licensor hereby grants
Licensee, and Licensee hereby accepts from Licensor, an exclusive
license to manufacture or have manufactured the Product from the
API supplied by Licensor and to offer to sell, sell, and have sold
such Product in the Territory under the Patents, the Technical
Information and the Product Registrations.
2. Licensee
shall have the right to co-promote the Product in the Territory
with a third party approved by Licensor in writing and in advance.
In the event that Licensee desires to enter into co-promotion
arrangements with any third party, Licensee shall notify Licensor
of details of such third party including information showing such
third party’s ability to co-promote the Product and shall
seek Licensor’s written approval, such approval not to be
unreasonably withheld or delayed.
Article 3 . Supply of Technical
Information
1. Within
thirty (30) days after the execution of this Agreement,
Licensor shall furnish Licensee with the Technical Information
which Licensor deems useful or necessary for due
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performance of
this Agreement. The information will be updated from time to time
during the term of this Agreement.
2. Further,
from time to time during the term of this Agreement, Licensor shall
furnish Licensee with additional Technical Information then
available to Licensor to the extent that such Technical Information
is deemed by Licensor as useful or necessary for due performance of
this Agreement.
3. Should,
during the term of this Agreement, it become evident that any data
or information not then available to Licensor is necessary for due
performance of this Agreement, then the parties hereto shall, in
good faith, consult with each other with respect
thereto.
4. During the
term of this Agreement, Licensee shall furnish Licensor without
charge, for unrestricted use by Licensor and/or its licensees, with
all data and information obtained or acquired by Licensee relating
to or necessary for use of the Compound and the Product as a
pharmaceutical product.
Article 4 . Transfer of Product Registrations —
Launch
1. Promptly
upon execution of this Agreement, Licensor shall instruct Purdue to
transfer the holder status of the Product Registrations to Licensee
free of charge. If the holder status of the Product Registrations
has already been transferred from Purdue to Licensee prior to
execution of this Agreement as permitted by the Letter of Intent,
Licensor shall admit that the holder status of the Product
Registrations has been transferred from Purdue to
Licensee.
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(a)
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Within sixty (60) days after
completion of transfer of the holder status of the Product
Registrations from Purdue to Licensee or, if the holder status of
the Product Registrations has already been transferred from Purdue
to Licensee prior to execution of this Agreement, then within sixty
(60) days after execution of this Agreement, Licensee shall
commence promotion of the Product in the Territory.
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(b)
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If
Licensee has purchased or subsequently purchases the Product from
Purdue, Licensee may immediately initiate sale of such Product in
the Territory. Licensee shall have no liability for and no
obligation to accept any return of Product sold by Purdue or any
other party prior to the effective date of this
Agreement.
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(c)
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The
“Launching Date” means the earlier of
(i) January 1, 2007 or (ii) the date that Licensee
receives samples of the Product in form and quantity suitable for
detailing physicians. The Launching Date shall be confirmed in
writing between Licensor and Licensee promptly upon occurrence
thereof.
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Article 5 . License Fee and Royalty
Payment
1. In
consideration for the licenses granted to Licensee under
Article 2, Licensee shall pay to Licensor a non-refundable
license fee (hereinafter referred to as the “License
Fee”) in the total amount of US$6,000,000 payable in the
following installments:
1
st payment: US$250,000 within thirty (30) days
after execution of this Agreement, 2 nd payment: US$1,000,000 on the first anniversary
date of this Agreement, 3 rd payment: US$1,000,000 on the second anniversary
date of this Agreement, 4 th payment: US$1,000,000 on the third anniversary
date of this Agreement, 5 th payment: US$1,250,000 on the fourth anniversary
date of this Agreement, 6 th payment: US$1,500,000 on the fifth anniversary
date of this Agreement.
If, at any time
until the fifth anniversary date of this Agreement, a generic
Cefditoren is launched in the Territory, then Licensee shall be
released from the obligation to pay the portion of the
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License Fee
that comes due after such generic launch and the minimum purchase
requirements under Article 8 shall no longer apply.
2. In
consideration for the licenses granted to Licensee under
Article 2, Licensee shall pay to Licensor a running royalty of
[***] percent ([***] %) of the Net Sales of the Product for a
period often (10) years from the Launching Date. If Licensee
sells the Product before the Launching Date, Licensee shall pay to
Licensor a running royalty of [***] percent ([***] %) of the Net
Sales of the Product generated from such sales as well.
3. Licensee
shall pay the running royalty to Licensor in the currency of United
States Dollar within sixty (60) days after the end of each
calendar quarter. Each payment of the running royalty shall be
accompanied by a statement which sets forth the gross sales, the
Net Sales, the quantity of the Product sold and the running royalty
payable for the applicable calendar quarter.
4. Licensee
shall keep and maintain books and records relating to sales of the
Product made under this Agreement so that the running royalty
payable and the royalty statement may be verified. Upon thirty
(30) days’ prior written notice to Licensee, on a day
and at a time reasonably acceptable to Licensee during normal
business hours, Licensor may audit such books and records through
an independent certified public accountant selected by Licensor and
accepted by Licensee, which approval shall not be unreasonably
withheld. Such certified public accountant shall execute a written
non-disclosure agreement reasonably acceptable to Licensee. Such
audit shall occur no more often than once any calendar year and
shall be limited to such of Licensee’s records as may be
necessary to determine, in respect of any calendar quarter ending
not more than three years prior to the date of such request, the
correctness of any report and/or payment made under this Agreement.
Expenses for such certified public accountant shall be borne by
Licensor, provided that if such audit reveals more than five
percent (5%) underpayment of the running royalty payable, expenses
for said accountant shall be borne by Licensee.
5. The License
Fee and the running royalty due Licensor hereunder shall be paid by
remitting to the bank account designated by Licensor.
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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Article 6 . Notice of Adverse Reactions
With respect to
details of the mechanism and procedures for notice of adverse
reactions regarding the Product, Licensor and Licensee shall enter
into a separate agreement in writing.
Article 7 . Supply of API
1. Subject to
the terms and conditions of this Agreement, Licensor shall sell the
API to Licensee, and Licensee shall purchase the API exclusively
from Licensor during the term of this Agreement.
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2.
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Supply Price of API
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(a)
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For
the first year from the Launching Date, the supply price of API
shall be [***]/kg (potency) C.I.P. San Juan, or such other
destination as may be agreed by Licensor and Licensee (which
agreement shall not be unreasonably withheld), by air and shall be
subject to the adjustment based on the foreign exchange fluctuation
set forth in (c) below.
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(b)
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On
or before the first date of each and every six (6) month
period after the first year from the Launch Date, Licensee shall
provide Licensor with an updated Licensee’s ex-factory price
of the Product. Effective on the first date of each and every such
six (6) month period, the supply price of subsequent purchases
of API shall be revised to be the greater of (i) [***]/kg
(potency) or (ii) the supply price of API calculated in
accordance with the following formula, subject to the adjustment
based on the foreign exchange fluctuation set forth in
(c) below:
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Future Supply
Price of API = {{[0.5] x [(the updated Cornerstone’s
ex-factory price of the Product divided by the previous
Cornerstone’s ex-factory price of the Product) – (1)]}
+ 1} x {current supply price of API}
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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(c)
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In
the event that the exchange rate of the US$ to the Japanese Yen as
of the date on which any firm written order for the API is placed
by Licensee (the “Exchange Rate”) fluctuates more than
[***] above or below the exchange rate of US$l=Japanese
Yen
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[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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[***], then the
supply price of API in respect of such order shall be adjusted in
accordance with the following formula:
Supply Price of
API Adjusted by Exchange Rate={[(current supply price of API x
Japanese Yen [***]/US$) + (current supply price of API x the
Exchange Rate)] divided by 2} divided by the Exchange
Rate
(d) In the
event that the transactions of API are not feasible for Licensor
and/or Licensee from an economical reason(s) with the supply price
of API which is generated from the calculation method described in
above (b) and/or (c) and it is deemed that Licensor
and/or Licensee is unable to continue the transactions of API from
the said reason(s), Licensor and Licensee shall discuss in good
faith measures to be taken to cope with such situation, such
measures may include sourcing API from third-party
manufacturers.
(e) The
payment terms for the API for one-year period from the Launching
Date shall be advance payment by T.T. remittance to the bank
designated by Licensor. Thereafter, the payment terms for the API
shall be by Letter of Credit confirmed by a first-class bank within
thirty (30) days after B/L date.
3. Licensee
shall place a firm order for the API at least three (3) months
prior to a desired shipping date for the API. Licensor shall use
commercially reasonable efforts to ship API within five
(5) days of the desired shipping date and in amounts not less
than ninety five percent (95%) of the amount ordered. By the first
day of each month, Licensee shall submit to Licensor a non-binding
six (6) months rolling purchasing forecast of the API which
shall be the best estimates of Licensee but which shall not be
binding upon Licensee.
4. One quantity
unit for an order for the API shall be 320kg (potency).
Article 8 . Minimum Purchase of AP
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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For each year
during the five (5) year period from the Launching Date,
Licensee shall agree to purchase the API from Licensor sufficient
to support the targeted gross sales of the Product listed
below.
Year 1 -
$8,000,000
Year 2 -
$11,000,000
Year 3 - [***]
Year 4 - [***] Year 5
- [***]
The minimum
purchase quantity in each year shall be set at 80% of the quantity
of API required to produce the Product in the quantity equivalent
to the respective targeted sales above. However, with respect to
Year 1, if Licensee purchases the Product of 60ct 200mg
tablets/bottle from Purdue, the quantity of API equivalent to such
Product purchased from Purdue shall be deducted from the minimum
purchase quantity in Year 1. If Licensee’s purchases of API
are less than the annual minimum purchase quantity defined above,
Licensee shall pay to Licensor an amount calculated in accordance
with the following formula:
(Minimum
Purchase Quantity — Actual Purchase Quantity) x Then Current
API price x 50%
In addition to
the above mentioned payment, in case it is deemed that Licensee is
not able to achieve the above targeted gross sales in any year of
the above five (5) year period, Licensor and Licensee shall
discuss in good faith measures to be taken to cope with such
situation, which may include Licensee changing an existing
co-promotion agreement or entering into a new co-promotion
arrangement to co-promote the Product with Licensee.
Article 9 . Sales Promotion
1. Licensee
agrees to do all reasonable efforts to obtain the largest possible
sales turnover of the Product in the Territory.
[***]
Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission.
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2. Licensee
shall promote at its own expense the sale of the Product
efficiently and continuously by, for example, distributing
scientific literature and samples, by advertising in professional
publications, by detailing doctors and hospitals, and by any other
suitable means.
Article 10 . Sales Report
Licensee shall,
within thirty (30) days after the end of each quarter, submit
to Licensor a quarterly sales report showing quantity of the
Product sold during the preceding quarter and quantity of stock of
the Product.
1. Subject to
the terms and conditions set forth below, Licensor hereby grants
Licensee an exclusive and non-transferable (except as permitted
pursuant to Paragraph 2(a) of Article 15) license to use the
Trademark for or in connection with sale and promotion of the
Product in the Territory, and Licensee agrees to use the Trademark
for such purpose. Notwithstanding the foregoing, Licensee shall be
permitted to grant co-promotion partners (approved by Licensor
under Paragraph 2 of Article 2) the right to use the
Trademark in connection with the sale and promotion of the Product.
Licensor represents that as of the date of this Agreement, Licensor
has no actual knowledge that use of the Trademark in connection
with the sale and promotion of the Product by Licensee in the
Territory will infringe any third party rights. In addition,
Licensee shall be permitted to use any Uniform Resource Identifier
(“URI”) or domain names that correspond to the Product
in the Territory, and to control the content of any resources
intended for viewing in the Territory accessed under such URI or
domain names on the World Wide Web, provided that in respect of the
use of each URI or domain name, Licensee shall obtain prior written
approval from Licensor.
2. Licensee
acknowledges that the Trademark shall always remain the property of
Licensor. Licensor shall be exclusively responsible for the payment
of the maintenance costs of the Trademark. Licensee shall not do
anything which is likely to diminish or impair the image
and
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value of the
Trademark. With respect to use of the Trademark, Licensee shall
comply with all instructions given by Licensor.
3. Licensee
shall furnish Licensor with copies of its representative
promotional materials, packages and package insertions to be used
for the Product for Licensor’s inspection and approval in
advance of the distribution by Licensee in the Territory. If within
five (5) business days after receipt of such materials by
Licensor or its designee, Licensor does not inform Licensee in
writing of its decision, such material shall be considered as
approved by Licensor.
The inspection
and approval referred to in the previous paragraph shall be limited
to verifying the correct use of the Trademark in the promotional
materials and shall not be unreasonably withheld.
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