Exhibit 10.67
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 406 OF THE S ECURITIES A CT
OF 1933, AS AMENDED .
L ICENSE AND D ISTRIBUTION A GREEMENT
T
HIS
L
ICENSE
AND
D
ISTRIBUTION
A
GREEMENT is made and entered into as of
21 st day of July 2008, by and
between ANESIVA, Inc., a Delaware corporation, having a principal
place of business at 650 Gateway Boulevard, South San Francisco,
California 94080, United States (hereinafter referred to
collectively as, “ANESIVA”) and Lee’s
Pharmaceutical (HK) Limited with its principal place of business at
Unit 110-111, Bio-Informatics Centre, No. 2 Science Park West
Avenue, Hong Kong Science Park, Shatin, New Territories, Hong Kong
(hereinafter referred to as “LPL”), which hereby agree
as follows:
RECITALS
W HEREAS ANESIVA owns or holds exclusive rights to
patents, the Specifications and Test Methods relating to the
manufacture and use of their proprietary Product (as such term is
hereinafter defined), and development, marketing, sales and
distribution rights for the Product; and
W HEREAS ANESIVA owns certain trade names, trademarks,
logos, emblems and indicia of origin which are used in association
with the Product, and
W HEREAS LPL is desirous of obtaining from ANESIVA the
exclusive right and license to market and sell the Product as well
as the methods and Specifications and Test Methods (as such term is
hereinafter defined) in the Territory (as such term is hereinafter
defined) under the Proprietary Marks (as such term is hereinafter
defined), upon the terms and subject to the conditions hereinafter
set forth; and
N OW ,
T HEREFORE
, this Agreement witnesses that in consideration
of the mutual covenants and agreements herein contained and other
good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties hereto hereby covenant
and agree with each other as follows:
Where used in this Agreement the
following terms shall have the following meanings:
1.1. “Affiliate”
means, with respect to any Person, any other Person who directly or
indirectly controls, is controlled by, or is under direct or
indirect common control with, such Person, and includes any Person
in like relation to an Affiliate. A Person is deemed to control
another Person if such Person possesses, directly or indirectly,
the power to direct or cause the direction of the management and
policies of such other Person, whether through the ownership of
voting securities, by contract or otherwise; and the term
“controlled” has a corresponding meaning.
1.2. “Agreement”
means this Agreement as is or it may be amended or supplemented
from time to time, and the expressions “hereof”,
“herein”, “hereto”,
“hereunder”, “hereby” and similar
expressions refer to this Agreement and not to any particular
Section (hereinafter “§”)or other portion of this
Agreement.
CONFIDENTIAL
Page 2 of 21
1.3. “Business
Day” shall mean a day other than Saturday, Sunday or any
day on which banks located in the Territory, are authorized or
obligated to close. Whenever this Agreement refers to a number of
days, such number shall refer to calendar days unless Business Days
are specified.
1.4. “Commercially
Reasonable” shall mean a Party’s reasonable efforts
and diligence in manufacturing and commercializing the Product in
accordance with its business, legal, medical and scientific
judgment, such reasonable efforts and diligence to be in accordance
with the efforts and resources the Party would use for a product
owned by it or to which it has rights, which is of similar market
potential at a similar stage in its product life, taking into
account the competitiveness of the marketplace, the ability of a
contract manufacturer to deliver product, the proprietary position
of the compound, the regulatory structure involved, the
profitability of the applicable Product, and other relevant factors
including, without limitation, technical, legal, scientific,
clinical or medical factors.
1.5. “Documents”
means, collectively, all books, pamphlets, bulletins, memoranda,
letters, notices or other publications or documents prepared by or
on behalf of ANESIVA for use by LPL setting forth information,
standards, requirements, operating procedures, instructions or
policies relating to release testing for the Product.
1.6. “Effective
Date” shall mean the date of last signature of the
Parties hereto.
1.7. “Field of
Use” means use of Product as a topical local
anesthetic.
1.8. “GMP” shall
mean current Good Manufacturing Practices promulgated by U.S. Food
and Drug Administration.
1.9. “Government Regulatory
Authority” shall mean any court, tribunal, arbitrator,
authority, agency, commission, official or other instrumentality of
the United States of America, SFDA in the Territory and/or other
political subdivision in the Territory or other governmental
instrumentality of a United Nations recognized sovereign state
having subject matter jurisdiction over the Product(s) as the case
may be.
1.10. “Generally Accepted
Accounting Principles” shall mean accounting rules used
to prepare, present, and report financial statements for a wide
variety of entities, including publicly-traded and privately-held
companies, non-profit organizations, and governments. Generally
GAAP includes local applicable Accounting Framework, related
accounting law, rules and Accounting Standard.
1.11. “Gross
Margin” means the difference between the Gross Sales and
Manufacturing Cost.
1.12. “Gross
Sales” shall mean, in accordance with the Generally
Accepted Accounting Principles published by the Financial
Accounting Standards Board of the United States, the amount
invoiced by LPL or its Affiliates for sales of the Product in the
Territory to a third party, other than to Affiliates, less the
value-added tax and other similar sales taxes related to the sale
of the Licensed Product to the extent included in the gross
invoice.
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 406 OF THE S ECURITIES A CT
OF 1933, AS AMENDED .
CONFIDENTIAL
Page 3 of 21
1.13.
“Improvements” means any future innovations,
inventions, designs, plans, drawings, specifications, techniques,
data and technical information relevant to the use (indications) or
sale of the Product including, but not limited to, modified
packaging.
1.14. “Law” or
“Laws” , as the case may be, shall mean all
laws, statutes, rules, regulations, ordinances, guidelines and
other pronouncements having the effect of law in any country with
jurisdiction over either of the Parties and/or Product(s) or any
domestic or foreign state, province, county, city or other
political subdivision or of any Health Registration Authority or
Regulatory Authority in the Territory.
1.15. “License”
shall mean the right granted by ANESIVA to LPL for the distribution
of the Product in the Territory either on its own or through
LPL’s third party distributors.
1.16. “Exchange
Rate” shall mean the spot Exchange Rate published in
The Wall Street Journal as quoted by Reuters at 4:00 PM on
the prior Business Day.
1.17. “Manufacturing
Cost” shall mean, with respect to Product, the sum of the
following, all of which shall be calculated in accordance with U.S.
Generally Accepted Accounting Principles:
(a) The amounts paid by ANESIVA to
any third party for (i) providing raw materials and packaging
materials for producing the Product, (ii) manufacturing,
filling and/or finishing Product or any component thereof,
(iii) storing, insuring and packaging Product, and
(iv) release and stability testing Product, including with
respect to the foregoing, all taxes (other than income taxes) and
customs duty charges imposed by governmental authorities with
respect thereto, to the extent paid by ANESIVA and not reimbursed
or refunded by a third party;
(b) The direct costs and charges
incurred by ANESIVA in connection with the manufacture, filling,
finishing, testing (including direct quality control and quality
assurance activities), storing, insuring and packaging Product not
otherwise accounted for pursuant to subsection (a) above;
and
(c) A reasonable allocation of
indirect labor, administration costs and facilities costs
(including electricity, water, sewer, waste disposal, property
taxes and depreciation over the expected life of buildings and
equipment) attributable to the manufacture, filling, finishing,
testing, storing, insuring and packaging of Product; provided that
such indirect labor, administration costs and facilities costs
shall only include an allocation, to the units or sections directly
engaged in the activities listed in the subsection (b) above,
of such indirect labor, administration costs and/or facilities
costs incurred by ANESIVA.
Without limiting the generality of
the foregoing provisions of this §1.17, Manufacturing Costs
shall exclude, all costs and charges related to or occasioned by
unused manufacturing capacity; the manufacture of other products at
ANESIVA’s or a third party contractor’s facility;
depreciation of property, plant or equipment not specifically
related to manufacturing Product; allocation of administrative
costs and general corporate overhead of ANESIVA or its third party
contractors; ANESIVA’s cost of capital, whether or not such
capital is attributable to the manufacturing of any Product; and
any employee costs associated with equity incentive
plans.
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 406 OF THE S ECURITIES A CT
OF 1933, AS AMENDED .
CONFIDENTIAL
Page 4 of 21
1.18. “Marketing
Authorization” shall mean the final approval of
registrations and permits required by applicable Government
Regulatory Authority in the Territory. In the People’s
Republic of China, the Imported Drug License shall serve as the
Marketing Authorization. In Hong Kong and Macau, the Certificate of
Drug/Product Registration shall serve as the Marketing
Authorization.
1.19. “Party”
means a Party to this Agreement and any reference to a Party
includes its successors and permitted assigns;
“Parties” means every Party together.
1.20. “Person”
shall mean any legal person including, for example, an individual,
corporation, partnership, Limited Liability Company, trust,
business trust, association, Joint Stock Company, joint venture,
pool, syndicate, sole proprietorship, unincorporated organization,
governmental authority or any other form of entity.
1.21. “Product”
means ANESIVA’s powder intradermal injection system,
comprising lidocaine hydrochloride monohydrate, 0.5 mg, indicated
for use on intact skin to provide topical local analgesia prior to
venipuncture or peripheral intravenous cannulation and marketed in
the United States under the brand name Zingo™.
1.22. “Proprietary
Marks” means the marks, trademarks, trade names and other
commercial symbols and related logos relating to the Product for
use in the Territory, together with such other trade names,
trademarks, symbols, logos, distinctive names, service marks,
marks, logo designs, insignia or otherwise which may be designated
by ANESIVA. The trademark for the Product is
“Zingo”.
1.23. “Quality Assurance
Department” or “QA” shall mean the group or
department that performs the quality review functions. QA reviews
and approves quality-related documents and procedures.
1.24. “Specifications and
Test Methods” means the Specifications, the documents,
and all information and data relating to techniques for, methods of
or practices of release testing for the Product.
1.25.
“Specifications” means all specifications,
methods, applications, criteria, qualities, requirements and all
other information in connection with the use, handling,
distribution, marketing and/or sale of the Product published,
promulgated or conveyed by or on behalf of ANESIVA to LPL in any
manner whatsoever, including any manual, specification booklet,
letter, notice, memorandum or other written from, from time to
time.
1.26. “Serious Adverse
Events” shall mean any adverse experience that result in
any of the following outcomes: death, a life-threatening
experience, inpatient hospitalization or prolongation of existing
hospitalization, a persistent or significant disability/incapacity,
or a congenital anomaly/birth defect. Important medical events that
may not result in death, be life-threatening or require
hospitalization may be considered a Serious Adverse Event when,
based upon appropriate medical judgment, they may jeopardize the
patient or subject and may require medical or surgical intervention
to prevent one of the outcomes listed in this
definition.
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 406 OF THE S ECURITIES A CT
OF 1933, AS AMENDED .
CONFIDENTIAL
Page 5 of 21
1.27. “SFDA”
means the Chinese State Food and Drug Administration.
1.28. Trademark License .
ANESIVA shall grant to LPL an exclusive license to use and display
one or more of ANESIVA’s trademarks in the Territory as set
forth in §2.4, consistent with ANESIVA’s trademark usage
guidelines ( “ Guidelines”). All Products shall
be branded and marked as specified by the Guidelines.
1.29. “Term” of
the Agreement shall have the meaning set forth in
§2.1.
1.30. “Territory”
shall mean People’s Republic of China, Hong Kong and
Macau.
1.31. “Transfer
Price” shall have the meaning set forth in
§4.5.
1.32. “ [*]
” shall mean a [*] used for [*] of a [*] device. The
[*] is not intended to work as a [*] and does not provide any
[*].
2. Terms, Grant of Licences,
Regulatory Submissions and Drug Release Testing, and
Governance
2.1. The sole and exclusive license
granted in this §2 shall have a Term composed of the [*] and
any [*] or [*].
2.2. The Initial Term shall begin as
of the Effective Date of this Agreement between the Parties and
shall continue in effect until [*] from the date of the first
launch of the Product in the Territory [*].
2.3. [*] shall be the [*] of this
Agreement for [*] of [*] from [*] or [*], unless [*] notifies the
[*] that it does not intend to [*] no less than [*] prior to the
[*] of the [*] or any [*].
2.4. Subject to the provisions of
this Agreement, and solely during the Term, ANESIVA
hereby:
(a) covenants and agrees to license
exclusive right to the Product [*] to LPL in the Territory to
enable LPL to promote, market and sell the Product in the
Territory;
(b) grants to LPL the exclusive
right and license to use the Proprietary Marks and trademarks in
connection with the marketing, distribution and sale of the Product
within the Territory; and
(c) grants LPL a royalty-bearing
license to all intellectual property related to the Product
including, but not limited to, the Proprietary Marks for
LPL’s use in the Territory as may be necessary and required
under the Laws and regulations and a fully paid license to all
governmental authorizations, product documentation, marketing
materials and the like. All costs associated with registering or
maintaining the Proprietary Marks or other intellectual property
will be [*].
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 406 OF THE S ECURITIES A CT
OF 1933, AS AMENDED .
CONFIDENTIAL
Page 6 of 21
2.5. During the Term of the
Agreement, LPL shall be responsible for the application,
prosecution and maintenance of Marketing Authorizations in the
Territory for the Product, with the Imported Drug License being
held in ANESIVA’s name in the People’s Republic of
China and the Certificate of Drug/Product Registration being held
in LPL’s name in Hong Kong and Macau under the following
conditions:
(a) LPL agrees to [*] the Marketing
Authorization application and maintenance [*] which are [*] to
SFDA, including [*] related to any required amendments to the
initial application. LPL shall be responsible for filing an
application for a Marketing Authorization in the Territory for the
Product as soon as LPL prepares an approvable dossier, but in no
event [*] as well as the sNDA for the adult indication now under US
FDA review from ANESIVA and after ANESIVA’s initial
discussions with the Chinese SFDA for its Product manufacturing
Joint Venture. LPL will keep ANESIVA updated regarding the status
of the Approvals and will provide ANESIVA with copies of all
Approvals upon issuance. Upon termination of the Agreement, LPL
will assign or cause to be assigned to ANESIVA (or another entity
designated by ANESIVA) all Approvals, to the extent such assignment
is legally permissible.
(b) ANESIVA agrees to provide LPL
with a current and complete copy of the U.S. approved regulatory
dossier for the Product and to supplement this regulatory dossier
as new data or information becomes available. LPL agrees to modify
this dossier in accordance with the requirements of the Territory
for submission in the Territory. In order to facilitate
ANESIVA’s support, LPL shall provide copies of the SFDA
correspondence documents and any submissions to SFDA translated
into English with appropriate certification.
(c) ANESIVA agrees to support LPL in
addressing any SFDA questions subsequent to submission and
approval.
(d) LPL and ANESIVA will [*] of any
SFDA manufacturing site inspection that requires longer than [*] on
site at ANESIVA or ANESIVA’s contract manufacturer. In the
case where SFDA requires a manufacturing change that is not
required by either U.S. or EU regulatory authorities, then this
change will be paid for by [*].
(e) The Parties shall [*] determine
the specific drug release testing requirements for the Territory
pursuant to Territory Law and shall negotiate in good faith the [*]
and costs for such release testing for shipment of Product for
human use in the Territory.
2.6. Both Parties shall appoint a
project leader within [*] of signing this Agreement, through which
all communications regarding this Agreement will be initially
directed. The project leaders will facilitate direct communication
between functional experts, decision making individuals and other
personnel as needed to manage activities under this
Agreement.
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 406 OF THE S ECURITIES A CT
OF 1933, AS AMENDED .
CONFIDENTIAL
Page 7 of 21
3.1. ANESIVA shall register the
Proprietary Marks and such other intellectual property rights as
required for the Territory within a Commercially Reasonable time
after its execution of this Agreement if such Proprietary Marks and
other intellectual property rights have not already been
registered. All registrations shall be at [*].
3.2. LPL confirms that all rights,
title and interest in the Proprietary Marks or related to the
Proprietary Marks are the sole property of ANESIVA, and this
Agreement shall not operate to convey any interest or rights in the
Proprietary Marks to LPL.
3.3. ANESIVA shall include the
applicable Proprietary Marks on all packages of the Product
delivered to LPL (or as directed by LPL to its customs brokers).
LPL shall make use of the Proprietary Marks in all materials and
activities related to the marketing, sale and distribution of the
Product. The Proprietary Marks used by LPL shall comply with the
form of the Proprietary Marks as registered in the
Territory.
3.4. At all times, LPL shall use the
ANESIVA registered trademarks in reference to the applicable
Product in the Territory unless prohibited by Law of the Territory.
In any such event, ANESIVA and LPL shall meet to resolve any such
legal prohibition in accordance with the Laws and regulations of
the Territory.
4.1. LPL shall pay ANESIVA a [*] of
[*] will be paid within [*] of signing of this
Agreement.
4.2. LPL shall pay ANESIVA a [*] of
[*] upon the [*] for the Product in the Territory [*]. The [*] will
be paid within [*] from issuance of the Imported Drug
License.
4.3. LPL shall purchase the Product
from ANESIVA at ANESIVA’s Manufacturing Cost. Such payments
shall be made [*] after the Product is received by LPL and subject
to inspection by LPL.
4.4. Royalty on Sales: LPL shall pay
a [*] royalty rate of [*] of Gross Margin as royalty payment to
ANESIVA, to be paid in US Dollars at the end of every calendar
quarter.
4.5. Transfer Price: ANESIVA shall
supply the Product at Manufacturing Cost. Transfer Price for the
Product shall in no instance be [*] per unit during the term of the
Agreement. At the end of any [*] but not later than [*] after the
end of the year, ANESIVA shall deliver to LPL a true and accurate
report of actual Manufacturing Costs for such calendar year
together with a detailed description of Manufacturing Costs for
such year.
4.6. At the end of any [*] and
within [*] after the publication of LPL quarterly report but not
later than [*] after the end of the [*], LPL shall deliver to
ANESIVA a true and accurate report of royalties payable for such
[*], including the calculation of Gross Margins. Any payments due
under this Agreement shall be made in United States Dollars,
calculated based on Exchange Rate at the date of the report of
Manufacturing Costs for such quarter submitted by ANESIVA under
§4.5 and shall be
C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R
ULE 406 OF THE S ECURITIES A CT
OF 1933, AS AMENDED .
CONFIDENTIAL
Page 8 of 21
paid by wire transfer to a bank and account
designated in writing by ANESIVA. For payments, ANESIVA will submit
written invoices. Payment of each such invoice not subject to a
good faith dispute will be due in full within [*] following receipt
of invoice. Invoices shall be sent to the following
address:
Lee’s Pharmaceutical (HK)
Limited
Unit 110-111, Bio-Informatics Centre,
No. 2 Science Park West Avenue,
Hong Kong Science Park,
Shatin, New Territories, Hong Kong
Wire instructions to ANESIVA are as
follows or as amended on sent invoices:
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Bank
Name:
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Routing/ABA
Number:
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4.7 ANESIVA shall have the right to
audit Gross Sales by giving a [*] notice to LPL. LPL shall allow
access to all sales and accounting records related to the Product
to ANESIVA’s appointed audit firm. Such audit is limited to
[*] time per calendar year and could cover a period of [*]. In the
event that actual Gross Sales are more than [*] less than LPL
reported for any calendar quarter audited, then LPL shall bear the
cost of the audit.
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5.
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Product
Supply, Shipping, Ordering
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5.1. Product sold to LPL for use in
the Territory shall be in [*] for commercial sale and are FCA
(INCOTERMS 2000) ANESIVA’s manufacturing plant (or any plant
of a designated contrac