EXHIBIT 10.56

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

PROMOTIONAL AGREEMENT

THIS PROMOTIONAL AGREEMENT is entered into as of October 9, 2007 (the “Effective
Date”) by and between ANESIVA, INC., a Delaware corporation, having an address
of 650 Gateway Boulevard, South San Francisco, California 94080 (hereinafter
referred to as “Anesiva”), and SAGENT PHARMACEUTICALS, INC., a Wyoming
corporation, having an address of 1901 North Roselle Road, Schaumburg, IL 60195
(hereinafter referred to as “Sagent”). Anesiva and Sagent may each be referred
to herein as a “Party” and may be referred to collectively herein as the
“Parties.”

RECITALS

WHEREAS, Anesiva has received approval from the United States Food and Drug
Administration to market Zingo™ (lidocaine hydrochloride monohydrate) powder
intradermal injection system 0.5mg in the United States; and

WHEREAS, Anesiva desires to appoint Sagent as Anesiva’s sales agent in the
United States and to have Sagent undertake certain other promotional activities
with respect to Zingo™ in the United States; and

WHEREAS, Sagent is willing to accept such appointment and undertake such
activities on the terms set forth herein.

AGREEMENT

NOW, THEREFORE, 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

1.1 “Administrative Fee” shall have the meaning provided in Section 4.2.

1.2 “Adverse Reaction Reports” shall have the meaning provided in Section 6.1
hereof.

1.3 “Affiliate” shall mean, with respect to a first person or entity means any
individual, sole proprietorship, firm, partnership, corporation, trust, joint
venture or other entity, whether de jure or de facto, which, directly or
indirectly, controls, is controlled by or is under common control with such
first person or entity. As used in this definition, “control” means the
possession, directly or indirectly, of the power to direct or cause the
direction of the policies and management of a person or entity, whether by the
ownership of stock, by contract or otherwise.

 

1.

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1.4 “Agreement” shall mean this Promotional Agreement.

1.5 “Anesiva Patents” shall mean any patent or patent application in the
Territory owned or controlled by Anesiva during the Term relating to Product,
method of manufacture or the use thereof.

1.6 “Anesiva Trademarks” shall mean the trademarks set forth in Exhibit A, such
marks being owned and registered by Anesiva or an Anesiva Affiliate.

1.7 “Business Plan” shall have the meaning provided in Section 2.3 hereof.

1.8 “Calendar Quarter” shall mean each of the three (3) month periods commencing
with January 1st, April 1st, July 1st and October 1st and ending, respectively,
on the following March 31st, June 30th, September 30th and December 31st.

1.9 “Commencement Date” shall mean the date of Anesiva’s first Commercial Sale
of the Product.

1.10 “Commercial Sale” shall mean the sale of the Product within the Field and
Territory to a Third Party.

1.11 “Confidential Information” shall mean all information (whether in written,
oral, electronic, visual, tangible, or other form) and materials that are
disclosed by one Party to the other Party prior to the Effective Date or during
the term of this Agreement and are either identified as confidential at the time
of disclosure or should reasonably be believed to be of the type of information
that would be considered confidential under the circumstances.

1.12 “Dispute” shall have the meaning set forth in Section 12.11.

1.13 “Distribution and Administrative Costs” shall mean those out-of-pocket
costs, excluding [*], incurred by a Sagent or for its account that are
specifically due to the [*], or [*], for the distribution of Product in the
Territory and that are consistent with the Business Plan and otherwise with the
terms of this Agreement.

1.14 “Effective Date” shall be the date shown at the top of page 1 of this
Agreement.

1.15 “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetics
Act, as amended from time to time.

1.16 “FDA” shall mean the United States Food and Drug Administration or any
successor entity.

 

2.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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1.17 “Field” shall mean use on intact skin to provide local analgesia prior to
venipuncture or peripheral intravenous cannulation in children 3–18 years of
age, and any future FDA approved indications for the Product.

1.18 “Institution” shall mean any (a) any hospital; (b) any [*] that, in each
case, is associated with a hospital and/or GPO or (c) any [*].

1.19 “Net Sales” shall mean the amount invoiced by Anesiva or its Affiliate (or
by Sagent or its Affiliate on Anesiva’s behalf) for sales of a Product in the
Territory to a Third Party that is an Institution, less:

(a) discounts (including without limitation cash discounts and quantity
discounts), retroactive price reductions, charge-back payments, and customer
rebates;

(b) credits or allowances actually granted upon claims, damaged goods,
rejections, or returns of Product other than any such credits or allowances
arising from manufacturing defects or any defect attributable to Anesiva,
including but not limited to credits, allowances and related costs attributable
to Product recalls;

(c) freight out, postage, shipping, and insurance charges actually paid for
delivery of Product;

(d) [*]; and

(e) taxes (other than income taxes) or duties levied on, absorbed, or otherwise
imposed on sale of Product, including without limitation value-added taxes, or
other governmental charges otherwise imposed upon the billed amount, as adjusted
for rebates and refunds, to the extent not paid by a Third Party.

Sales of Product by and between a Party and its Affiliates are not sales to
Third Parties and shall be excluded from Net Sales calculations for all
purposes. Sales of Product for use in conducting clinical trials, for Product
registration purposes or Regulatory Approvals, of Product shall be excluded from
Net Sales calculations for all purposes. Anesiva shall determine Net Sales in a
manner consistent with all products sold by or on behalf of Anesiva and in
accordance with United States GAAP.

1.20 “Product” shall mean Zingo™ (lidocaine hydrochloride monohydrate) powder
intradermal injection system 0.5mg.

1.21 “Product Labeling” shall mean (a) the FDA full prescribing information for
Product, including any required patient information, and (b) all labels and
other written, printed or graphic matter upon any container, wrapper or any
package insert or outsert utilized with or for Product.

1.22 “Product Rights” shall have the meaning provided in Section 9.3(a) hereof.

 

3.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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1.23 “Promotional Materials” shall mean all written, printed, graphic,
electronic, audio or video matter, including, but not limited to, journal
advertisements, sales visual aids, leave items, formulary binders, reprints,
direct mail, direct-to-consumer advertising, Internet postings, broadcast
advertisements and sales reminder aids (for example, scratch pads, pens and
other such items), in each case created by Anesiva or on its behalf and used or
intended for use by Sagent in connection with any Services hereunder, but
excluding Product Labeling.

1.24 “Regulatory Approvals” shall mean any approvals (including, but not limited
to, NDA approval, labeling, pricing and reimbursement approvals), product,
biologic and/or establishment licenses, registrations or authorizations of any
federal, state or local regulatory agency, department, bureau or other
governmental entity, which are necessary for the commercial manufacture, use,
storage, importation, export, transport or sale of Product in the Territory.

1.25 “Representatives” shall mean the Sagent personnel that carry out the
Services hereunder.

1.26 “SEC” shall have the meaning set forth in Section 11.3.

1.27 “Senior Executive” shall mean, with respect to a particular Party, the
Chief Executive Officer of such Party, or the representative designated by such
individual (provided that such representative is a senior executive officer of
such Party with authority to settle the applicable Dispute submitted for
resolution under Section 12.11).

1.28 “Services Term” shall mean the time period described in Section 2.2.

1.29 “Term” shall have the meaning provided in Section 7.1 hereof.

1.30 “Territory” shall mean the United States and its territories and
possessions.

1.31 “Third Party” shall mean any entity other than Anesiva or Sagent or an
Affiliate of Anesiva or Sagent.

1.32 “Year” shall mean a twelve (12) month period starting on the Commencement
Date or an anniversary thereof, as applicable, during the Term. “Year 1” shall
mean the Year starting on the Commencement Date (and, for clarity, shall also
include any time period between the Effective Date and the Commencement Date),
“Year 2” shall mean the Year starting on the first anniversary of the
Commencement Date, and so on.

 

2. PROMOTION OF PRODUCT

2.1 Services. During the Services Term and subject to the terms and conditions
of this Agreement, Sagent shall provide, or cause to be provided, those
mutually-agreed services in support of the commercialization of the Product in
the Territory that are specified in this Section 2.1 (the “Services”). Beginning
three months prior to the expiration of the Services Term, or

 

4.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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any extension thereof, and for an immediately following time period determined
by Anesiva (not to exceed 6 months), Sagent will continue to provide the
Services and will assist Anesiva during such period in the orderly transition of
responsibility for the Services to Anesiva or its designee, including the
assignment, or commercially reasonable efforts to facilitate such assignment, of
any Sagent contractual commitments necessary for such transition. In negotiating
and entering into any contractual commitments in performing or furtherance of
performing the Services, Sagent shall use commercially reasonable efforts to
include a provision that permits subsequent assignment of such contractual
commitments by Sagent to Anesiva or its designee, but any failure to obtain such
provision shall not be a breach of this Section 2.1, provided that Sagent used
commercially reasonable efforts in attempting to obtain such provision.

(a) Selling Activities:

(i) [*],

(ii) Negotiation of contracts for group purchase accounts,

(iii) Contract directly with individual Institutions when appropriate,

(iv) [*],

(v) Serve as key selling contact for pharmacy departments of Institutions,
utilizing Anesiva representatives when appropriate,

(vi) [*] and

(vii) Along with Anesiva, communicating Product benefits to pharmacy directors
and other key decision makers on [*] of Institutions.

(b) Distribution and Administrative Activities:

(i) Warehousing and distribution of the Product consistent with Anesiva’s
quality standards as set forth in Exhibit B,

(ii) [*].

2.2 Services Term. The Services Term shall commence on the Effective Date and
end on the third anniversary of the Commencement Date. The Services Term may be
extended by [*] by mutual written agreement of the Parties.

2.3 Business Plan. The Parties agree to work cooperatively to establish an
initial business plan within [*] of the Effective Date (the “Business Plan”).
The Business Plan will set forth in detail the promotional and other activities
to be performed by Sagent and Anesiva hereunder, including annual production
forecasts, the particular sales accounts to be targeted, annual sales targets,
and the anticipated timing of such activities. In the process of preparing

 

5.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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the Business Plan, Anesiva will make all relevant marketing research, data and
marketing sales plans regarding the Product available to Sagent. All revisions
to the Business Plan shall be in writing and by mutual agreement of Anesiva and
Sagent. The Parties shall continue to work cooperatively to update the Business
Plan as necessary and at least [*]. In the event of any actual conflict between
the terms and conditions of the Business Plan and this Agreement, this Agreement
shall control.

2.4 Performance Standards. Parties, and any Affiliates, shall use their
commercially reasonable efforts to perform their Services and responsibilities
under this Agreement and in accordance with any deadlines, time-related
milestones or timing schedules set forth in the Business Plan with respect to
any of the Services. Parties, and any Affiliates, shall make available qualified
personnel to perform their Services and responsibilities and shall perform in a
professional manner and in accordance with sound and ethical business practices.
Parties, and any Affiliates, shall not permit any of their Representatives to
perform Services or responsibilities related to the Product unless such
Representatives have been fully trained and are knowledgeable about the Product.
Parties shall be responsible for the compliance of their Representatives with
all relevant terms of this Agreement and the Business Plan. Any contracts or
arrangements negotiated by Sagent in connection with the Services are subject to
Anesiva’s final approval; provided, however, that no such approval is required
with respect to any terms of such contracts or arrangements that are specific to
products other than the Product.

2.5 Compliance with Law.

(a) Parties shall in all material respects conform their practices and
procedures relating to the promotion of Product in the Territory to all
applicable laws, regulations and guidelines, including without limitation the
FD&C Act, the Prescription Drug Marketing Act, the Federal Health Care Programs
Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the Pharmaceutical Research and
Manufacturers of America (“PhRMA”) Code of Pharmaceutical Marketing Practices
and the American Medical Association (“AMA”) Guidelines on Gifts to Physicians
from Industry, as the same may be amended from time to time. Sagent shall
promptly notify Anesiva of and provide Anesiva with a copy of any correspondence
or other reports with respect to the marketing, detailing and promotion of
Product submitted to or received from the U.S. Department of Health and Human
Services or its components (including the FDA and the Office of the Inspector
General), PhRMA or the AMA relating to such laws, regulations and guidelines.

(b) Parties shall in all material respects conform their practices and
procedures relating to educating the medical community in the United States with
respect to Product to the Accreditation Council for Continuing Medical Education
(“ACCME”) Standards for Commercial Support of Continuing Medical Education (the
“ACCME Standards”) and any applicable FDA regulations or guidelines, as the same
may be amended from time to time. Sagent shall promptly notify Anesiva of and
provide Anesiva with a copy of any correspondence or other reports submitted to
or received from the ACCME with respect to Product relating to the ACCME
Standards or such FDA regulations.

 

6.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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(c) Without limiting the generality of the foregoing, Sagent shall not promote
the Product outside of the Territory, for any indication outside the Field, or
otherwise contrary to the Product Labeling. In connection with the promotion of
Product hereunder, Sagent shall make no statement, representation or warranty,
oral or written, to Third Parties concerning Product that is inconsistent with,
or contrary to, the Product Labeling or Promotional Materials.

2.6 Promotional Materials.

(a) From time to time during the Services Term, Anesiva shall provide Sagent
with reasonable quantities of all Promotional Materials then being used by
Anesiva, to the extent relevant to the Services and in line with the Business
Plan. Sagent will use such Promotional Materials solely for performance of the
Services, and Sagent will not use, create, or develop any other promotional
materials in connection with the Services without Anesiva’s prior written
consent. Sagent shall distribute Promotional Materials of the type identified in
this Section 2.6 in accordance with the Business Plan and with the terms of this
Agreement.

(b) Anesiva shall use commercially reasonable efforts to modify, as quickly as
reasonably practicable, all trade dress and Promotional Materials to be used by
Sagent to reference Sagent as the sales agent for the Product in the Territory.
For purposes of clarity, the Parties agree that Sagent shall not be referenced
in labels on the Product itself but shall be referenced on cartons containing
the Product and on the package insert describing the full prescribing
information for the Product. Such references shall be maintained thereafter, at
minimum, until the end of the initial three years of the Services Term. In no
event shall Anesiva or its Affiliates be required, in connection with its or
their promotional activities, to distribute any material which contains a
reference to Sagent, but Anesiva may identify Sagent’s involvement in the
promotion of Product therein if Anesiva, in its sole discretion, deems it
appropriate to do so.

(c) Except as specifically permitted by this Section 2.6, neither Party shall
distribute or have distributed any materials bearing the name of the other
without the prior written approval of the other.

(d) Subject to Section 5.1, Anesiva shall own all right, title and interest in
and to the Promotional Materials, including all copyrights appurtenant thereto
but excluding any rights in or to the Sagent trademark or house mark.

2.7 Reports. Within forty-five (45) days after the end of each Calendar Quarter
during the Services Term, Sagent shall furnish to Anesiva a written report
summarizing (a) the Services performed by Sagent during such Calendar Quarter
and (b) any information coming to

 

7.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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Sagent’s attention in the Territory concerning introductions and promotional
activities of products competitive with Product, it being understood that there
is no obligation on Sagent to solicit such information. In the event any serious
complaints or other issues regarding Product are brought to Sagent’s attention,
same will be communicated to Anesiva.

2.8 Anesiva Responsibilities. Other than those activities explicitly allocated
to Sagent pursuant to this Agreement or the Business Plan, Anesiva shall retain
the sole right, and shall bear all costs related thereto, to take such actions
with respect to Product as would normally be done in accordance with accepted
business practices and legal requirements to maintain the authorization and/or
ability to market Product in the Territory. Without limiting the foregoing:

(a) Anesiva will hold title to the Product at all times prior to Commercial Sale
of the Product, stock the Product in the designated Sagent distribution
facilities and bear the risk of any Product loss prior to Commercial Sale.

(b) Anesiva shall remain solely responsible for booking sales of Product
hereunder, holding related credit risk, Product return risk and causing
performance of all related services.

(c) Anesiva will remain solely responsible for all post-market surveillance of
the Product, all safety-related issues involving the Product, and any Product
complaints or medical inquiries.

(d) Anesiva will provide Promotional Materials pursuant to Section 2.6,
Product-specific sales training for Sagent personnel, reasonable quantities of
Zingo trainers (if and to the extent included in the Business Plan) and hospital
in-service training support upon Sagent’s request.

(e) Anesiva will arrange and promote the Product at national and regional trade
shows in a mutually agreed manner complementing Sagent’s Services.

(f) Anesiva will manufacture and shall be responsible for quality and
performance of the Product.

(g) Anesiva will work diligently with Sagent to complete all regulatory filings
and registrations and licenses related to the Product and sale of the Product.

(h) Anesiva will retain responsibility for all activities and costs associated
with any recall of the Product.

(i) Anesiva shall produce sufficient quantities of Product and shall maintain
inventory related to Product at sufficient levels, to meet all Product sales
commitments, forecasts, and reasonable projections, as identified in the
Business Plan, and provide prompt notice of foreseen shortfalls in Product
availability versus the Business Plan. Anesiva shall be solely responsible to
any Institutions in the event of Anesiva’s inability to deliver sufficient
quantities of the Product.

 

8.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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(j) Anesiva shall work in collaboration with Sagent to obtain formulary
registrations for Product in Institutions.

(k) Anesiva shall work in collaboration with Sagent to promote Product benefits
to key [*] decision-makers in Institutions.

(l) Anesiva shall work in collaboration with Sagent to promote Product benefits
to [*] to develop product champions for [*] in Institutions;

(m) Anesiva shall work in collaboration with Sagent to promote Product benefits
to Institution personnel to pull through Product following formulary approvals;
and

(n) Anesiva shall work in collaboration with Sagent to [*] to ensure they are
well-trained on use of Product within Institutions.

Notwithstanding the Business Plan or any other provision herein to the contrary,
Anesiva shall have the sole right and responsibility, with Sagent acting as
Anesiva’s agent in the execution of the Services, for (i) establishing and
modifying the terms and conditions with respect to the sale of Product,
including, without limitation, the price at which Product will be sold, any
applicable discounts, and the approval of customers; (ii) any damage or product
loss in inventory; (iii) establishing and modifying the specifications for the
Product and any label, packaging, or packaging inserts with respect thereto;
(iv) the selection of suppliers; and (v) collection of accounts receivable. In
addition, the Parties acknowledge and agree that Anesiva will be the obligor in
the arrangement to provide wholesalers with the Product and that Anesiva shall
be responsible for any returned Product.

2.9 Diligence.

(a) Sagent shall use commercially reasonable efforts to undertake the Services
and its other responsibilities under this Agreement. Without limiting the
generality of the foregoing and subject to Anesiva providing a commercial supply
of the Product in accordance with the Business Plan, Sagent will achieve, within
[*] following [*] of the [*], [*] for the Product at a [*] of [*] of the [*] (as
set forth the Business Plan) and [*] with [*] of the [*] (as set forth in the
Business Plan), with Anesiva’s approval of such [*] not to be unreasonably
withheld.

(b) Anesiva shall use commercially reasonable efforts to undertake its
responsibilities under this Agreement.

2.10 No Competitive Products. Sagent shall not [*] any [*] during the Term.

 

9.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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2.11 Costs. Each Party shall be solely responsible for its own costs and
expenses in performing its responsibilities under this Agreement, except as set
forth in Section 4.2 or as otherwise mutually agreed by the Parties in writing.
Sagent agrees that the only compensation owed to Sagent for Services provided by
Sagent under this Agreement shall be the payments set forth in this Article 4.

2.12 Proprietary Rights in Product. Anesiva retains and shall at all times
retain all proprietary rights and proprietary interests in Product and shall
retain title to all Product until the point of sale to wholesalers and/or
end-users. Sagent shall neither have nor represent that it has any control or
proprietary or property interests in Product.

2.13 Other Products. Upon Anesiva request, Sagent shall work with Anesiva in the
identification of [*] which may be suitable for development in [*] and shall
work jointly with Anesiva to forward development of such candidates as may be
subsequently mutually agreed.

2.14 Other Services. Sagent may from time-to-time provide additional
consultative or logistics support outside the scope of this Agreement upon
mutual agreement at an incremental cost to be negotiated by the Parties in good
faith.

 

3. MANAGEMENT

3.1 Project Lead. The Parties shall each appoint an authorized representative
(“Project Lead”) with whom communications between the Parties relating to
Services will be directed. Each Party will notify the other as to the name of
the individual so appointed. Each Party may replace its Project Lead at any
time, upon written notice to the other Party.

3.2 Exchange of Information. Sagent shall provide Anesiva with copies of any
written communications disseminated by Sagent generally to its representatives
performing the Services relating to promotional strategy for the Product. During
the Services Term and subject to any other provision of this Agreement, each
Party will provide the other with all material information reasonably relevant
to the overall commercialization of the Product in the Field within the
Territory within a reasonable time after such information becomes known to the
Party, provided such information is not received from an independent Third Party
under a secrecy obligation.

 

4. PAYMENT TERMS.

4.1 Set-Up Fee. Within [*] after the Effective Date, Anesiva shall pay to Sagent
a non-refundable set-up fee of [*]. Such fee shall be fully creditable against
royalty payments due to Sagent hereunder as follows: (a) [*] will be creditable
against royalties due for the [*] in which gross sales of Product in the U.S.
exceed [*]; and (b) [*] will be creditable against royalties due for the [*] in
which gross sales of Product in the U.S. exceed [*].

 

10.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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4.2 Cost Reimbursement. Anesiva will reimburse Sagent for any Distribution and
Administrative Costs that are reasonably incurred by Sagent in performing the
Services during the Services Term, which reimbursement shall consist of [*] of
such Distribution and Administrative Costs, plus an administrative fee
(“Administrative Fee”) equal to [*] of such Distribution and Administrative
Costs for [*], [*] of such Distribution and Administrative Costs for [*], [*] of
such Distribution and Administrative Costs for [*], and [*] of such Distribution
and Administrative Costs for [*] (if applicable). Following the expiration of
the Services Term, Sagent shall receive no other payments under this
Section 4.2. Notwithstanding anything to the contrary herein, Anesiva shall have
no obligation to make any payments with respect to Distribution and
Administrative Costs that were not incurred in relation to Sagent’s provision of
the Services and approved by Anesiva (such approval not to be unreasonably
withheld) or anticipated in the Business Plan.

4.3 Royalties During Services Term. Solely during the Services Term, Anesiva
shall pay to Sagent royalties on Net Sales at the following royalty rates:

 

Year

  

Royalty Rate

[*]

   [*]

If the Services Term is extended by [*] by mutual agreement pursuant to
Section 2.2, the royalty rate for [*] will be [*].

4.4 Sunset Royalties. During the [*] following the end of the Services Term,
Anesiva shall pay Sagent royalties on Net Sales at the following royalty rates:

 

Year

  

Royalty Rate

[*]

   [*]

4.5 Royalty Reports and Payments. Within [*] after the end of any Calendar
Quarter in which royalties are owed under Section 4.4, Anesiva shall deliver to
Sagent a true and accurate report of Net Sales during such Calendar Quarter,
accompanied by any royalties due under Section 4.4 with respect to such Net
Sales. Royalties due under Section 4.3 shall be invoiced and paid pursuant to
Section 4.6. To accommodate financial reporting requirements, Anesiva shall
provide Sagent a good faith estimate of such Royalties earned within [*] of the
end of each Calendar Quarter.

4.6 Method of Payment. Any payments due to a Party under this Agreement shall be
made in U.S. dollars by wire transfer to a bank and account designated in
writing by such Party. For payments due under Section 4.2 or 4.3, Sagent will
submit written invoices within [*] following the end of each Calendar Quarter to
Anesiva specifying the payment due under

 

11.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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Section 4.2 or 4.3, including a description of any Distribution and
Administrative Costs or Net Sales, as the case may be. 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:

Anesiva, Inc.

650 Gateway Boulevard

South San Francisco, CA 94080

Attention: Accounts Payable

4.7 Books and Records. Anesiva shall keep full, clear, and accurate records for
a period of at least [*] after the relevant payment is owed pursuant to this
Agreement, setting forth the sales and other disposition of Products sold or
otherwise disposed of in sufficient detail to enable royalties payable to Sagent
hereunder to be determined. Sagent shall keep full, clear, and accurate records
for a period of at least [*] after the relevant payment is owed pursuant to this
Agreement, setting forth any Distribution and Administrative Expense that is
reimbursable pursuant to Section 4.2. Each Party shall have the right to
nominate an independent firm of certified public or chartered accountants who
shall have access to the books and records of the other Party during reasonable
business hours for the purpose of verifying any amounts payable under this
Agreement or information provided in connection therewith. The fees and expenses
of the accountants performing such verification shall be borne by the Party
requesting the audit, unless such audit reveals an underpayment by the audited
Party, or an overpayment by the auditing Party, of [*] or more and exceeding [*]
over the period being audited, in which case the audited Party shall bear the
costs and expenses of such verification.

4.8 Taxes. If provision is made in law or regulation for withholding of taxes of
any type, levies or other charges with respect to the any amounts payable
hereunder to Sagent, Anesiva shall promptly pay such tax, levy or charge for and
on behalf of Sagent to the proper governmental authority, and shall promptly
furnish Sagent with receipt of such payment. Anesiva shall have the right to
deduct any such tax, levy or charge actually paid from payment due Sagent or to
be promptly reimbursed by Sagent if no further payments are due Sagent. Anesiva
agrees to assist the Sagent in claiming exemption from such deductions or
withholdings under double taxation or similar agreement or treaty from time to
time in force and in minimizing the amount required to be so withheld or
deducted.

4.9 Sales Tracking. It is understood and agreed that, in the event that there
are more than [*] sales of Product to [*], the Parties will need to establish a
[*] mechanism for tracking sales of Product to [*], for the purpose of
calculating Net Sales and royalty payments hereunder. At the written request of
either Party during the Services Term, the Parties shall use good faith efforts
to agree on such a mechanism (solely for use in calculating Net Sales and
royalties for the then-current and future Calendar Quarters), taking into
account the then-available sources for determining such sales and the respective
costs of such determinations.

 

12.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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5. LICENSE; TRADEMARKS

5.1 License. Solely during the Services Term and subject to the terms and
conditions of this Agreement, Anesiva hereby grants to Sagent the right (with
the right to grant sublicenses solely to Sagent Affiliates) to engage in the
Services with respect to the Product in the Field in the Territory and to use
the Anesiva Trademarks and Promotional Materials in connection with such
Services, all in accordance with the Business Plan. Such right shall be
exclusive; provided, however, nothing herein is intended to restrict Anesiva’s
retained rights described in Section 5.2.

5.2 Anesiva Retained Rights. Anesiva shall retain at all time the right (a) to
commercialize the Product itself or directly through an Affiliate, to customers
other than Institutions, and (b) to engage one or more Third Parties to provide
services in support of the commercialization of the Product in the Territory
with respect to end-users that are not Institutions, including without
limitation office-based physicians. In the event that Anesiva so engages a third
party to provide such services during the Services Term, Anesiva and Sagent
shall discuss in good faith possible ways to minimize any interference between
the Services and such engagement.

5.3 No Other Licenses. Nothing in this Agreement shall be interpreted to grant
either Party any rights under any patents, trademark, or other intellectual
property of the other Party that are not expressly granted herein, whether by
implication, estoppel or otherwise.

5.4 Anesiva Trademarks. The ownership and use of the Anesiva Trademarks shall be
governed by the following provisions:

(a) Anesiva or an Affiliate of Anesiva shall retain the ownership of the entire
right, title and interest in and to the Anesiva Trademarks.

(b) Anesiva shall, at its cost and expense, file (to the extent necessary) in
the Territory and endeavor in good faith to obtain the registration of the
Anesiva Trademarks in the Territory, and, when registered, thereafter maintain
the Anesiva Trademarks in the Territory. Sagent agrees that in using Anesiva
Trademarks in its activities under this Agreement it will not represent in any
way that it has any right or title to the ownership of the Anesiva Trademarks or
the registration thereof, and the registration will remain in the ownership of
Anesiva. Such Anesiva Trademarks will be used by Sagent on behalf of, and in the
interest of, Anesiva, and Sagent will first obtain the written approval of
Anesiva of the form and manner in which the Anesiva Trademarks will be used
upon, in connection with, or in relation to materials other than Promotion
Materials as may be permitted by this Agreement.

(c) Sagent recognizes Anesiva’s title in and to the Anesiva Trademarks and to
the registration thereof, and will not, at any time, do or authorize any act or
thing that will in any way impair the rights of Anesiva in and to the Anesiva
Trademarks and the registration thereof. Wherever Anesiva’s trademarks or

 

13.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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tradenames are used (e.g., on any package, label or advertisement), the first or
most prominent use shall always be accompanied by a legend acceptable to Anesiva
indicating that Product is a registered trademark of Anesiva and the Anesiva
trademarks and tradenames are licensed to Sagent by Anesiva. In the event that
Sagent, either directly or indirectly, challenges the title of Anesiva to any
Anesiva Trademark or the validity of such registration obtained by Anesiva for
the same, and Sagent fails to withdraw such challenge within [*] of receipt of
Anesiva’s written request therefor, Anesiva shall have the right to terminate
this Agreement.

(d) Sagent shall, upon Anesiva’s request, and at Anesiva’s expense, reasonably
assist Anesiva in any action reasonably necessary or desirable to protect the
Anesiva Trademarks used or proposed to be used hereunder. Sagent shall as soon
as practicable notify Anesiva of any apparent infringement by a Third Party of
any of the Anesiva Trademarks.

(e) After discussion and upon notice and demand from Anesiva, Sagent shall
immediately discontinue the use of any of the Anesiva Trademarks upon notice
from a Third Party that such use is or is alleged to be an infringement of such
Third Party’s trademark rights, unless Sagent determines that it does not wish
to discontinue use of any of the Anesiva Trademarks, in which case all liability
of Anesiva, Sagent and their respective Affiliates arising out of Sagent’s use
of any such Anesiva Trademark after such notice shall be borne by Sagent. In the
event of any such Third Party notice, request by Anesiva to discontinue the use
of an Anesiva Trademark and subsequent discontinuance by Sagent, Anesiva shall
select a new Anesiva Trademark to be used with Product and shall promptly notify
Sagent in writing of such selection.

 

6. REGULATORY MATTERS

6.1 Adverse Reaction Reports. Sagent shall report to Anesiva all information
necessary to permit Anesiva to make timely reports as required by any
governmental regulatory agency in the Territory regarding Product and shall
report at least quarterly concerning any findings associated with the use of
Product that may suggest significant hazards, contraindications, side effects or
precautions pertinent to the safety of Product (“Adverse Reaction Reports”).
Anesiva shall promptly, and in all cases within [*] of confirmation of such
Adverse Reaction Report, notify Sagent of any Adverse Reaction Report requiring
the alteration of the manner in which Sagent performs the Services, which
communication shall be held in confidence by Sagent pursuant and subject to the
terms of Article 11. Should either Party learn of any hazard that is severe,
serious or unexpected, concerning the Product, such hazard data shall be
communicated to the other Party immediately in writing or confirmed in writing
if such immediate communication is non-written. Anesiva shall be responsible for
complying with all applicable laws regarding the reporting of such hazards to
governmental authorities. The aforementioned information shall be addressed as
follows:

 

in the case of Sagent to:    Sagent Pharmaceuticals, Inc.    1901 North Roselle
Road    Schaumburg, Illinois 60195    Attention: [*]    Phone: [*]

 

14.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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in the case of Anesiva to:    Anesiva, Inc.    650 Gateway Boulevard    South
San Francisco, California 94080    Attention: [*]    Phone: [*]

or to such other address as may thereafter be provided by either Party.

6.2 Voluntary Product Recalls. If either Party believes that a voluntary recall
or market withdrawal of Product is necessary, such Party shall notify the other
Party within [*] of its determination and both Parties shall cooperate to allow
such recall or market withdrawal to occur under the direction of Anesiva (as set
forth in Section 2.8(h)). In the event of a dispute about whether to recall
Product, Anesiva shall have the final authority with respect to such matters,
which authority shall be exercised in good faith.

6.3 Regulatory Obligations. Anesiva shall be solely responsible for all
activities in connection with the Regulatory Approvals for Product in the
Territory, including without limitation communicating and preparing and filing
all reports (including without limitation adverse drug experience reports) with
the FDA. Sagent agrees to cooperate with Anesiva as requested, at Anesiva’s
expense, in preparing and filing all such reports. Anesiva shall pay all fees
associated with obtaining and maintaining the Regulatory Approvals.

 

7. TERM OF AGREEMENT AND TERMINATION

7.1 Term. The term of this Agreement (the “Term”) shall commence on the
Effective Date and continue until the earlier of (a) [*] after the end of the
Services Term or (b) termination of this Agreement in accordance with this
Article 7.

7.2 Termination for Breach. Either Party shall have the right to terminate this
Agreement by written notice to the other in the event that the other shall
commit any material breach of its obligations hereunder and shall fail to remedy
same within [*] after being called upon in writing to do so. For purposes of
this Agreement, the term “material breach” shall include, but not be limited to,
Sagent’s failure to comply with the provisions of Section 2.1, Section 2.5,
Section 2.9(a), or Section 2.10.

7.3 Termination for Bankruptcy. Either Party shall have the right to terminate
this Agreement effective upon written notice to the other Party in the event the
non-notifying Party becomes insolvent or makes an assignment for the benefit of
creditors, or in the event bankruptcy or insolvency proceedings are instituted
against the non-notifying Party or on the non-notifying Party’s behalf.

 

15.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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7.4 Effect of Termination. Upon any termination or expiration of this Agreement
pursuant to this Article 7, for whatever reason, then, in any such case, all of
Sagent’s rights hereunder regarding Product and the use of the Anesiva
Trademarks and the Promotional Materials shall automatically terminate and
automatically revert to Anesiva, effective as of such time, and Sagent shall
have no further rights thereto. Upon termination or expiration hereof, Sagent
shall immediately cease performing the Services and promptly return to Anesiva
all Promotional Materials and samples of Product then in the possession of
Sagent, its Affiliates and any of their respective sales representatives. Upon
any termination of this Agreement prior to the end of the Services Term (other
than termination by Sagent pursuant to Section 7.2), Sagent shall continue to
provide the Services for a time period determined by Anesiva (not to exceed 6
months) and shall assist Anesiva during such period in the orderly transition of
responsibility for the Services to Anesiva or its designee, including the
assignment of any contracts necessary for such transition.

7.5 Survival. The rights and obligations of the Parties under the following
provisions of this Agreement shall survive expiration or any termination of this
Agreement: Sections 2.6(d), 2.12, 4.7, 7.4, 7.5, and Articles 1 (to the extent
relevant), 9, 10, 11, and 12. In any event, expiration or termination of this
Agreement shall not relieve the Parties of any liability which accrued hereunder
prior to the effective date of such expiration or termination nor preclude
either Party from pursuing all rights and remedies it may have hereunder or at
law or in equity with respect to any breach of this Agreement, nor prejudice
either Party’s right to obtain performance of any obligation. Notwithstanding
the foregoing, the use by either Party hereto of a termination right provided
for under this Agreement shall not give rise to the payment of damages or any
other form of compensation or relief to the other Party with respect thereto.

 

8. REPRESENTATIONS AND WARRANTIES.

8.1 Mutual Representations and Warranties. Each of the Parties hereby represents
and warrants to the other Party as follows:

(a) such Party (i) is a corporation duly organized, validly existing and in good
standing under the laws of the state or territory in which it is incorporated,
(ii) has the corporate power and authority to enter into this Agreement and
perform its obligation hereunder, and (iii) is in compliance with all
requirements of applicable law, except to the extent that any noncompliance
would not have a material adverse effect on the properties, business, financial
or other condition of such Party and would not materially adversely affect such
Party’s ability to perform its obligations under this Agreement;

(b) this Agreement is a legal and valid obligation binding upon such Party and
enforceable in accordance with its terms, and the execution, delivery and

 

16.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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performance of the Agreement by such Party does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a Party or by which
it is bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having jurisdiction over it; and

(c) it has taken all necessary corporate action on its part to authorize the
execution and delivery of this Agreement.

8.2 Disclaimer. EXCEPT AS PROVIDED IN SECTION 8.1, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, VALIDITY AND/OR ENFORCEABILITY OF THEIR RESPECTIVE
INTELLECTUAL PROPERTY RIGHTS, AND NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES, ARISING FROM A COURSE OR DEALING, USAGE OR TRADE
PRACTICES, IN ALL CASES WITH RESPECT THERETO.

 

9. OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS.

9.1 Intellectual Property. Anesiva shall solely own all right, title and
interest in Product, Anesiva Patents, Anesiva Trademarks and Product Labeling.
Sagent shall solely own all right, title and interest in the Sagent trademark.

9.2 Patent Prosecution. Anesiva shall have the sole right, but not the
obligation, to file applications for, prosecute and maintain the Anesiva
Patents. Anesiva shall not be obligated to disclose to Sagent any prosecution
information relating to the Anesiva Patents.

9.3 Enforcement Rights.

(a) Notification of Infringement. If Sagent learns of any misappropriation of
any Product, Anesiva Patents, Anesiva Trademarks or Information of Anesiva (the
“Product Rights”), or any infringement or threatened infringement by a Third
Party of the Anesiva Patents in the Territory, Sagent shall promptly notify
Anesiva and shall provide such other Party with all available evidence of such
misappropriation or infringement.

(b) Enforcement of Patents and Product Rights in the Territory. Anesiva shall
have the sole right, but not the obligation, to institute, prosecute and control
at its own expense any action or proceeding with respect to infringement of any
Anesiva Patents or any misappropriation of the Product Rights in the Territory,
by counsel of its own choice. Sagent shall cooperate with Anesiva, at Anesiva’s
expense, in any such action or proceeding brought by Anesiva against a Third
Party. Any amounts recovered by Anesiva pursuant to this subsection (b) shall
belong exclusively to Anesiva. Anesiva shall have the sole right to control
settlement of such action.

 

17.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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10. INDEMNIFICATION

10.1 Indemnification by Anesiva. Subject to Section 10.3, Anesiva shall
indemnify, defend and hold Sagent and its Affiliates and their respective
directors, officers, employees and agents (collectively, the “Sagent
Indemnitees”) harmless from and against any liabilities, damages, costs or
expenses, including reasonable attorneys’ fees (collectively, “Liabilities”) in
connection with any claim, lawsuit or other action by a Third Party, to the
extent arising out of, relating to, or resulting from (a) the breach by Anesiva
of any of its covenants, representations, or warranties contained within this
Agreement; (b) the gross negligence or willful misconduct of Anesiva, its
Affiliates, or their respective directors, officers, employees and, agents; or
(c) the manufacture, use or sale of Product, in each case except to the extent
such claim, lawsuit or other action results from the gross negligence or willful
misconduct of a Sagent Indemnitee or from Sagent’s breach of this Agreement.

10.2 Indemnification by Sagent. Subject to Section 10.3, Sagent shall indemnify,
defend and hold Anesiva, its Affiliates, and their respective directors,
officers, employees, and agents (collectively, “Anesiva Indemnitees”) harmless
from and against any Liabilities in connection with any claim, lawsuit or other
action by a Third Party, to the extent arising out of, relating to, or resulting
from (a) the breach by Sagent of any of its covenants, representations, or
warranties contained within this Agreement; or (b) the gross negligence or
willful misconduct of Sagent, its Affiliates, or their respective directors,
officers, employees and, agents; in each case except to the extent such claim,
lawsuit or other action results from the gross negligence or willful misconduct
of an Anesiva Indemnitee or from Anesiva’s breach of this Agreement.

10.3 Procedure. In the event of a claim by a Third Party against a Party
entitled to indemnification under this Agreement (“Indemnified Party”), the
Indemnified Party shall promptly notify the other Party (“Indemnifying Party”)
in writing of the claim and the Indemnifying Party shall undertake and solely
manage and control, at its sole expense, the defense of the claim and its
settlement. The Indemnified Party shall cooperate with the Indemnifying Party,
including, as requested by the Indemnifying Party entering into a joint defense
agreement. The Indemnified Party may, at its option and expense, be represented
in any such action or proceeding by counsel of its choice. The Indemnifying
Party shall not be liable for any litigation costs or expenses incurred by the
Indemnified Party without the Indemnifying Party’s written consent. The
Indemnifying Party shall not settle any such claim unless such settlement fully
and unconditionally releases the Indemnified Party from all liability relating
thereto, unless the Indemnified Party otherwise agrees in writing.

10.4 Insurance. Effective as of the Commencement Date, each Party, at its own
expense, shall maintain comprehensive general/product liability insurance with a
minimum limit of liability of [*] per occurrence and in the aggregate and shall,
at the other Party’s request, provide the such other Party with a certificate of
such insurance naming the other Party as an additional insured. Each Party shall
provide at least [*] notice to the other Party prior to cancellation or material
change in such Party’s policy. Such notices of cancellation or material change
shall be given in accordance with Section 12.8 hereof.

 

18.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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11. CONFIDENTIALITY

11.1 Generally. During the term of this Agreement and for a period of [*]
following expiration or termination of this Agreement, each Party (a) shall
maintain in confidence all Confidential Information of the other Party;
(b) shall not use such Confidential Information for any purpose except as
permitted by this Agreement; and (c) shall not disclose such Confidential
Information to anyone other than those of its Affiliates, sublicensees,
prospective sublicensees, employees, consultants, advisors, agents or
subcontractors who are bound by written obligations of nondisclosure and non-use
no less stringent than those set forth in this Article 11 and to whom such
disclosure is necessary in connection with such Party’s activities as
contemplated in this Agreement. Each Party shall ensure that such Party’s
Affiliates, sublicensees, prospective sublicensees, employees, consultants,
agents and subcontractors comply with these obligations. Each Party shall notify
the other promptly on discovery of any unauthorized use or disclosure of the
other’s Confidential Information, including without limitation, the other’s
trade secrets or proprietary information.

11.2 Exceptions. The obligations of confidentiality, non-disclosure, and non-use
set forth in Section 11.1 shall not apply to the extent the receiving Party (the
“Recipient”) can demonstrate that the disclosed information (a) was in the
public domain at the time of disclosure to the Recipient by the other Party, or
thereafter entered the public domain, in each case other than as a result of
actions of the Recipient, its Affiliates, employees, licensees, agents or
subcontractors, in breach of this Agreement; (b) was rightfully known by the
Recipient or its Affiliates (as shown by its written records) prior to the date
of disclosure to the Recipient by the other Party; or (c) was received by the
Recipient or its Affiliates on an unrestricted basis from a Third Party
rightfully in possession of such information and not under a duty of
confidentiality to the other Party. Notwithstanding any other provision of this
Agreement, Recipient’s disclosure of Confidential Information shall not be
prohibited if such disclosure: (i) is in response to a valid order of a court or
other governmental body of the U.S., provided that Recipient provides the other
Party with prior written notice of such disclosure in order to permit the other
Party to seek a protective order or other confidential treatment of such
Confidential Information; or (ii) is otherwise required by applicable law or
regulation or by the rules of a nationally recognized securities exchange.

11.3 Publicity. The Parties agree that the public announcement of the execution
of this Agreement shall be substantially in the form of the press release
attached as Exhibit C. Any other publication, news release or other public
announcement relating to the existence, or the terms and conditions, of this
Agreement or to the performance hereunder, shall first be reviewed and approved
by both Parties unless such publication, news release or other public
announcement contains information previously approved by the other Party for
release hereunder (provided such information remains true, complete, and
accurate); provided, however, that any disclosure which is required by law or
regulation or by the rules of a nationally recognized securities exchange as
advised by the disclosing Party’s counsel may be made without the prior consent
of the other Party, although the other Party shall be given prompt notice of any
such legally required disclosure and to the extent practicable shall provide the
other Party an opportunity to comment on the proposed disclosure. Parties hereby
agree and

 

19.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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consent to: (a) the inclusion of the text set forth in Exhibit D in their
filings with the U.S. Securities and Exchange Commission (the “SEC”) (including
without limitation any filings on Form 8-K) and (b) the filing of a copy of this
Agreement with the SEC as required by applicable law or regulation, provided
that Parties endeavor to obtain confidential treatment of financial and trade
secret information contained herein.

 

12. GENERAL PROVISIONS

12.1 Performance by Affiliates. The Parties recognize that each Party may
perform some or all of its obligations under this Agreement through Affiliates;
provided, however, that each Party shall remain responsible for the performance
by its Affiliates and shall cause its Affiliates to comply with the provisions
of this Agreement in connection with such performance. Each Party hereby
expressly waives any requirement that the other Party exhaust any right, power
or remedy, or proceed against an Affiliate, for any obligation or performance
hereunder prior to proceeding directly against such Party.

12.2 Entire Agreement; Amendment. This Agreement by and between the Parties
hereto, is both a final expression of the Parties’ agreement and a complete and
exclusive statement with respect to all of its terms. The Exhibits referred to
in this Agreement are incorporated herein and made a part of this Agreement by
this reference. This Agreement supersedes all prior and contemporaneous
agreements and communications, whether oral, written or otherwise, concerning
any and all matters contained herein. No trade customs, courses of dealing or
courses of performance by the Parties shall be relevant to modify, supplement or
explain any term(s) used in this Agreement. This Agreement may only be amended,
modified or supplemented in a writing expressly stated for such purpose and
signed by the Parties to this Agreement.

12.3 Relationship Between the Parties. The relationship between the Parties, as
established by this Agreement, is solely that of independent contractors. This
Agreement does not create any partnership, joint venture or similar business
relationship between the Parties. Neither Party is a legal representative of the
other Party, and neither Party can assume or create any obligation,
representation, warranty or guarantee, express or implied, on behalf of the
other Party for any purpose whatsoever.

12.4 Non-Waiver. The failure of a Party to insist upon strict performance of any
provision of this Agreement or to exercise any right arising out of this
Agreement shall neither impair that provision or right nor constitute a waiver
of that provision or right, in whole or in part, in that instance or in any
other instance.

12.5 Assignment. No Party may assign or delegate any or all of its rights or
obligations under this Agreement without the prior written consent of every
other Party to this Agreement except to an Affiliate. If a Party assigns this
Agreement to an Affiliate, such Party will also promptly inform the other Party
and guarantee the performance by its Affiliate of all of such Party’s
obligations under the Agreement. Notwithstanding the foregoing, Anesiva may,
with notice, but without Sagent’s consent and at Anesiva’s sole discretion,
assign any or all of

 

20.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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its rights and obligations under this Agreement to a Third Party in connection
with the sale, transfer or other disposition of the part of Anesiva’s business
to which this Agreement relates. Any assignment or delegation of rights or
obligations under this Agreement that is not in compliance with this
Section 12.5 shall be void and without effect. This Agreement is binding upon
and inures to the benefit of the Parties to it, and to their permitted
successors and assigns.

12.6 No Third Party Beneficiaries. This Agreement is neither expressly nor
impliedly made for the benefit of any party other than those executing it.

12.7 Severability. If, for any reason, any part of this Agreement is adjudicated
invalid, unenforceable or illegal by a court of competent jurisdiction, such
adjudication shall not affect or impair, in whole or in part, the validity,
enforceability or legality of any remaining portions of this Agreement. All
remaining portions shall remain in full force and effect as if the original
Agreement had been executed without the invalidated, unenforceable or illegal
part.

12.8 Notices. Any notice to be given under this Agreement must be in writing and
delivered either in person, by any method of mail (postage prepaid) requiring
return receipt, or by overnight courier or facsimile confirmed thereafter by any
of the foregoing, to the Party to be notified at its address(es) given below, or
at any address such Party has previously designated by prior written notice to
the other. Notice shall be deemed sufficiently given for all purposes upon the
earlier of: (a) the date of actual receipt; (b) if mailed, three calendar days
after the date of postmark; or (c) if delivered by overnight courier, the next
business day the overnight courier regularly makes deliveries.

If to Sagent, notices must be addressed to:

Sagent Pharmaceuticals, Inc.

1901 North Roselle Road

Schaumburg, Illinois 60195

Attention: [*]

Telephone: [*]

Facsimile: [*]

If to Anesiva, notices must be addressed to:

Anesiva, Inc.

650 Gateway Boulevard

South San Francisco, CA 94080

Attention: General Counsel

Telephone: [*]

Facsimile: [*]

12.9 Force Majeure. Except for the obligation to make payment when due, each
Party shall be excused from liability for the failure or delay in performance of
any obligation under this Agreement by reason of any event beyond such Party’s
reasonable control including but not limited to Acts of God, fire, flood,
explosion, earthquake, or other natural forces, war,

 

21.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

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civil unrest, accident, destruction or other casualty, any lack or failure of
transportation facilities, any lack or failure of supply of raw materials, any
strike or labor disturbance, or any other event similar to those enumerated
above. Such excuse from liability shall be effective only to the extent and
duration of the event(s) causing the failure or delay in performance and
provided that the Party has not caused such event(s) to occur. Notice of a
Party’s failure or delay in performance due to force majeure must be given to
the other Party within [*] after its occurrence. Notwithstanding the foregoing,
should the event(s) of force majeure suffered by a Party extend beyond a [*],
the other Party may then terminate this Agreement by written notice to the
non-performing Party, with the consequences of such termination as set forth in
Sections 7.4 and 7.5.

12.10 LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR
ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING
FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF
THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS
PARAGRAPH IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF ANY PARTY UNDER SECTION 10.1 or 10.2, OR DAMAGES AVAILABLE FOR
BREACHES OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 11.

12.11 Dispute Resolution; Arbitration. The Parties initially shall attempt to
settle any controversy or claim (whether such claim sounds in contract, tort, or
otherwise) arising out of or relating to this Agreement, or the breach thereof
(a “Dispute”) through good faith negotiations between the Project Leads in the
spirit of mutual cooperation. If the Project Leads are unable to resolve such
Dispute within [*], the Parties shall submit such Dispute to the Parties’
respective Senior Executives for good faith discussion and attempted resolution.
If the Senior Executives are unable to resolve such Dispute within [*], such
Dispute shall be settled by final and binding arbitration in San Francisco,
California pursuant to then current rules for arbitration of commercial disputes
promulgated by the American Arbitration Association. Judgment upon the award
rendered by the arbitrator may be entered in any court having jurisdiction
thereof. In no event shall the arbitrator have any right or power to award
punitive or exemplary damages. All negotiations and discussions pursuant to this
Section 12.11 shall be confidential, and the Parties agree that all information
concerning or disclosed as part of such negotiations and discussions are and
such shall be treated as compromise and settlement negotiations for purposes of
applicable rules of evidence.

12.12 Governing Law. Notwithstanding its place of execution or performance, this
Agreement shall be governed by and construed in accordance with the laws of the
State of California, irrespective of its laws regarding choice or conflict of
laws.

12.13 Interpretation

(a) Captions & Headings. The captions and headings of clauses contained in this
Agreement preceding the text of the articles, sections, subsections and

 

22.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
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paragraphs hereof are inserted solely for convenience and ease of reference only
and shall not constitute any part of this Agreement, or have any effect on its
interpretation or construction.

(b) Singular & Plural. All references in this Agreement to the singular shall
include the plural where applicable, and all references to gender shall include
both genders and the neuter.

(c) Articles, Sections & Subsections. Unless otherwise specified, references in
this Agreement to any article shall include all sections, subsections, and
paragraphs in such article; references in this Agreement to any section shall
include all subsections and paragraphs in such sections; and references in this
Agreement to any subsection shall include all paragraphs in such subsection.

(d) Days. All references to days in this Agreement shall mean calendar days,
unless otherwise specified.

(e) Ambiguities. Ambiguities and uncertainties in this Agreement, if any, shall
not be interpreted against either Party, irrespective of which Party may be
deemed to have caused the ambiguity or uncertainty to exist.

12.14 Counterparts. This Agreement may be executed in one or more counterparts
(which may be delivered via facsimile), each of which shall be deemed an
original document, and all of which, together with this writing, shall be deemed
one instrument.

12.15 Further Assurances. Each Party to this Agreement shall, at its own
expense, furnish, execute, and deliver all documents and take all actions as may
reasonably be required to effect the terms and purposes of this Agreement.

IN WITNESS WHEREOF, the Parties, intending to be bound hereby, have executed
this Agreement as of the date first written above.

 

ANESIVA, INC.       SAGENT PHARMACEUTICALS, INC. By:  

/s/    John P. McLaughlin        

    By:  

/s/    Jeffrey Yordon        

Name:  

John P. McLaughlin

    Name:  

Jeffrey Yordon

Title:  

CEO

    Title:  

CEO

 

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EXHIBIT A

ANESIVA TRADEMARKS

[SEE FOLLOWING PAGES]

 

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MARK

   APPLICATION/
REGISTRATION
NO.  

GOODS/SERVICES

   CURRENT
STATUS [*]    [*]   [*]    [*]

 

 

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EXHIBIT B

ANESIVA QUALITY STANDARDS

[SEE FOLLOWING PAGES]

 

 

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QUALITY AGREEMENT

INTRODUCTION

This Quality Agreement between Anesiva, Inc. (“Anesiva”) (located at 650 Gateway
Boulevard, South San Francisco, CA 94080) and Sagent Pharmaceuticals, Inc.
(“Sagent”) (located at 1901 N. Roselle Road, Suite 700, Schaumburg, IL 60195)
defines Quality responsibilities as they are related to the storage, handling
and distribution of Anesiva finished pharmaceutical product “Zingo” (lidocaine
hydrochloride monohydrate), “Product”. This Agreement shall be effective
October 9, 2007 (“Effective Date”) by and between both parties.

Changes to this Agreement may be made solely by an amendment in writing signed
by both parties. A history of revisions will be maintained in Exhibit A.

DEFINITIONS

 

A. Batch or Production Lot: shall mean a specific quantity of Product identified
by a distinctive lot number.

 

B. Change: A planned, temporary or permanent alteration or replacement of an
approved or validated process, , equipment, service, or facility used in the
storage, handling or distribution of Product.

 

C. Major Change: A Change that affects items specified in the regulatory
submission or changes that could affect the safety, identity, strength, quality,
purity of the Product, e.g. changes to validated facilities, utilities,
equipment, computer systems, storage, and shipping process.

 

D. Deviation: A departure from an established quality standard, such as:
Corporate Policy, Standard Operating Procedure, packaging order, environmental
monitoring procedure, equipment maintenance procedure, or any unusual occurrence
that could affect the Product. Deviations may be either planned or unplanned
departures from established quality standards and may have the potential to
affect the safety, identity, strength, function/performance, quality or purity
of a Product.

 

E. Regulations: Any appropriate regulation or directive as dictated by the US
Food and Drug Administration (FDA), or other pertinent regulatory authority.

 

F. Validation: Establishing documented evidence which provides a high degree of
assurance that a specific process, procedure, operation, piece of equipment,
facility, software, etc. will perform consistently meeting its predetermined
specifications and attributes.

 

G. Recall: Removal or correction of a product that a regulatory agency or
parties considers to be in violation of the laws it administers and against
which the agency would initiate legal action, e.g., seizure.

 

 

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PROVISIONS

Regulatory Standards and Audits: Sagent will operate in accordance with all
standards of current Good Manufacturing Practice (“cGMP”) per 21CFR parts 210,
211, and 820 and any other pertinent regulations, including all applicable
international, federal, state and local regulations relating to the storage,
handling or distribution of the Product.

Anesiva shall have the right to perform [*] audits of Sagent and its
subcontractors as related to the Products to assess compliance with cGMP and
applicable product and establishment standards. For [*] audits, audits shall be
coordinated and scheduled through Sagent (including audits of Sagent’s
subcontractors) at mutually agreeable times upon at least [*] advance written
notice to Sagent.

Anesiva may perform “for-cause” audits of Sagent or its subcontractors in the
event of failure or recall of a Product lot or other major cGMP/regulatory
compliance violation related to the storage, handling or distribution of the
Product. In these instances, the [*] advance written notification is waived and
the audit to be coordinated and scheduled through Sagent (including audits of
Sagent’s subcontractors) as soon as mutually agreed.

At the conclusion of each audit, Anesiva will hold a wrap-up meeting with Sagent
and/or its subcontractors to review all significant audit observations. Within
[*] of receipt of Anesiva’s audit report, Sagent will provide a written response
to Anesiva including a response to all Anesiva’s observations and details
regarding corrective or preventive actions.

Sagent will have an audit system as part of its qualification of subcontractors.
Anesiva may review all audit reports as such reports related to Anesiva Product
upon reasonable request, and request Sagent to perform for-cause audits of its
subcontractors as such audits relate to Anesiva Product and do not violate the
terms of Sagent’s agreements with its subcontracts. Subject to the provisions
above, Anesiva will have access to audit the contractors responsible for
storage, handling, distribution and destruction of the Product.

 

1) Quality Responsibilities: Anesiva and Sagent agree on the allocation of
quality responsibilities between the Parties as set forth in Exhibit B of this
Agreement. Where Sagent has subcontracted operations which would be subject to
this Agreement, Sagent shall ensure its subcontractor complies with the
applicable terms of this Agreement.

 

2) Notification to Anesiva Quality Assurance department: Sagent will notify
Anesiva of any issues, which Sagent reasonably believes may relate to the
quality of the service being provided to Anesiva. For the Product subject to
this agreement, notification and/or approval by Anesiva Quality Assurance is
required as specified for the following issues:

 

  •  

Facility Changes. Prior notification of significant changes to validated
facilities, utilities, and equipment.

 

  •  

Process Changes. Prior notification and Anesiva approval of major changes to the
storage, handling and distribution process.

 

 

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  •  

Deviation. Review and approval of significant deviations from the agreed and
ultimately validated processing, storage or distribution instructions specific
to Anesiva product.

 

  •  

Investigations. Notification as soon as reasonably possible of investigations
related to the Product and approval of investigation action plans.

 

  •  

Controlled Temperature Failure: In the event of a failure of a controlled
temperature unit (exceeding defined storage conditions) that houses any Product,
or samples, Sagent shall notify Anesiva as soon as possible.

 

3) Notification of and Investigation of Safety and Product Complaints: Anesiva
shall be responsible for evaluating all complaints and for notifying the
appropriate federal, state and local authorities of any customer complaints or
other occurrences regarding the Products which are required to be so reported.
Anesiva shall maintain a complaint file and shall notify Sagent of any
complaints relating to the Product, which may be the result of, or have an
effect on, the storage, handling, distribution, and shipping operations
performed by Sagent. Sagent shall assist Anesiva as is reasonably necessary in
investigating complaints and shall maintain a complaint file and shall forward
complaint reports relating to the Product to Anesiva within [*] after completion
of complaint investigation. As needed, Sagent shall provide interim status
reports to Anesiva of complaint investigations. As part of such investigation,
Sagent may inspect and analyze Products only under a joint mutually agreed
investigation action plan to thoroughly investigate the product complaint. If
such investigation concludes that the complaint is [*].

Sagent shall notify Anesiva of any complaints and/or Adverse Reaction Reports it
receives within [*] as required per 21 CFR 314.80(c)(iii). It is Anesiva’s
responsibility to fully investigate each occurrence and comply with all
applicable laws regarding reporting to government agencies. Anesiva shall notify
Sagent within [*] of confirmation of such Adverse Reaction Reports requiring the
alteration of the manner in which Sagent performs its services.

 

4) Material Review Board: A joint Material Review Board (MRB) as per Anesiva
standard operating procedure shall be formed with Quality and other appropriate
personnel from both Sagent and Anesiva. The MRB may be convened, at the request
of either Sagent or Anesiva Quality Assurance units to resolve any applicable
issues related to the Product.

 

5) Regulatory Submissions: Anesiva will be solely responsible for the submission
and maintenance of documentation to regulatory authorities and all associated
fees in support of the Products including but not limited to drug applications,
labeling and promotional materials, drug listing forms, and annual or other
reports as required by applicable regulations. Anesiva shall drug list the
Product using Anesiva’s labeler code and NDC number. Upon Anesiva’s request,
Sagent will provide Anesiva with the information necessary to complete
regulatory submissions under Anesiva direction in a timely and effective manner.
Sagent will obtain prior approval from Anesiva of changes to the content of the
documents that directly affect Anesiva regulatory submissions. Anesiva will
provide Sagent written notification of the destination of a submission.

 

6) Regulatory Approval: Anesiva or its licensees shall be responsible for
obtaining all necessary regulatory approvals for the Product from the United
States Food and Drug Administration (the “FDA”) and any foreign regulatory
authorities.

 

 

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7) Inspections by Regulatory Agencies/Access: Each Party will provide the other
Party with reasonably screened copies of international and US regulatory agency
inspection reports or regulatory actions (e.g., warning letters) which may have
an impact on the storage, handling and distribution of the Product. Both Parties
will inform each other in a timely fashion when regulatory agencies are seeking
to schedule inspections concerning the Products at Sagent Facilities. Anesiva
representatives will be allowed to be present as an observer only during the
inspection with the inspectors at Sagent facilities (including the distribution
center) during the course of Regulatory Inspections related to Anesiva Products.
Anesiva shall not directly or actively participate or interfere in such
inspection or interface with the regulatory authority during such inspection
unless at Sagent’s request or unless inspectors specifically inquire as to
Anesiva Products. Anesiva will be informed of all such communication and
commitments which could impact Anesiva’s Regulatory submissions. Anesiva
representative(s) will be allowed review and approval of responses to any
observations for Anesiva Product purged only of Confidential Information that is
unrelated to the Products. Anesiva commits to ensuring that its review and
approval of responses does not infringe on Sagent’s ability to respond to
Regulatory Agency observations in the time specified by those Regulators.

 

8) Access to Sagent and Distribution Facility: In accordance with the provisions
for Regulatory Standards and Audits as per this Agreement, Anesiva and
designates shall have access to observe and inspect Sagent’s facilities and
procedures, including all validation/verification activities, and documentation
related to the Product(s) upon reasonable notice to Sagent. Employees of Anesiva
on Sagent facilities, or its subcontractor’s facilities, shall at all times
comply with all Sagent rules and regulations.

 

9) Product Status and Release: Anesiva shall be solely response for quality
assurance approval and release of Product to commerce. Once approved for release
by Anesiva, Sagent’s further distribution of the Product shall be conducted in
accordance with applicable cGMPs and the terms of this Agreement. Each lot of
Product will be shipped to Sagent under Quarantine status. Sagent or Sagent’s
designee shall store product in a designated Quarantine status, unavailable to
shipment for distribution, until Anesiva Quality Assurance provides formal
disposition in writing with approval of the release of the lot for commercial
distribution. Anesiva shall notify Sagent in writing when Product is ready for
shipment and shall provide to Sagent the release documentation as specified per
Exhibit C.

 

10) Lot Number & Traceability: Sagent will maintain a system for identifying and
tracking product by its unique Anesiva lot number.

 

11) Inventory Management: Sagent will maintain Product inventory with Product
status, lot number and expiration date. Product will be picked and shipping
according to FIFO (First In, First Out) practices, unless otherwise directed in
writing by Anesiva.

 

 

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12) Changes to Facility or Process: In the event that Anesiva desires any change
to the storage, handling and distribution process, Anesiva shall deliver written
notice to Sagent specifying such change desired by Anesiva, and Sagent shall
respond to any such notice within [*] after Sagent receipt. In the event that
Sagent desires any change to the storage, handling and distribution process,
Sagent shall deliver written notice to Anesiva specifying such change desired by
Sagent and Anesiva shall respond to any such notice within [*] after Anesiva
receipt. Anesiva shall [*] Sagent for the [*] by Sagent as a result of [*].

 

13) Validation: As required by applicable regulations related to distribution of
the Product, Sagent or Sagent’s subcontractors as the case may be will maintain
its equipment, facility, and utilities in an acceptable validated state as is
appropriate for Sagent or its subcontractors operations. Records of
(re)validation as they reasonably relate to Anesiva Product will be maintained
and available for inspection. Upon request, Sagent will provide Anesiva with
copies of all validation protocols, reports, and supporting documentation used
to support the storage, handling and distribution process related to Anesiva
Product purged only of Confidential Information that is unrelated to the
Products.

 

14) Environmental Monitoring: Sagent agrees to store Anesiva Product (s) under
appropriate label storage conditions and in a secure area, monitored to ensure
that they comply with all the quality specifications and attributes (e.g.
temperature and humidity).

 

15) Annual Update Requirements: As specified in Section 5 above, Anesiva shall
be responsible for the filing and maintenance of any drug application for the
Product as well as any and all supplement or annual reports to its drug
application for the Product. Company shall be responsible for completing such
submissions and for payment of associated fees. Upon request from Sagent. Sagent
will provide Anesiva, with Product related documentation as such documentation
pertains to Sagent’s or Sagent’s subcontractors operations in connection with
storage, handling, or distribution the Product for the purpose of updating
regulatory information upon request.

 

16) Communication: All communications to each Party’s respective quality and
regulatory affairs department as required under this Agreement will be directed
to the appropriate personnel identified in Exhibit D-Quality and Regulatory
Contacts. Subject to Applicable Law, each Party will give the other Party prior,
reasonable written notice in the event of significant changes in senior
corporate or plant management and/or ownership and of any changes in the Contact
Personnel identified in Exhibit D.

 

17) Recall: In the event either Party believes it may be necessary to conduct a
recall, field correction, market withdrawal, stock recovery, or other similar
action (individually or collectively, a “Recall”) or in the event of any action
by any Regulatory Authority to detain or destroy Product or prevent release of
Product (“Seizure”) with respect to any Product, Anesiva and Sagent shall
consult with each other as to how best to proceed, it being understood and
agreed that the final decision as to any Recall of any Product shall be made by
Anesiva; provided, however, that Sagent shall not be prohibited hereunder from
taking any action that it is required to take by applicable law. Each Party
shall inform the other as to the status of all Product in each Party’s
possession, which was Seized or quarantined as a result of the need to initiate
a Recall.

 

18)

Drug Pedigrees: Sagent shall be responsible for assuring compliance with all
applicable United States Federal and State drug pedigree requirements. For the
sole purpose of complying with such

 

 

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drug pedigree requirements, Anesiva authorizes Sagent to designate on behalf of
Anesiva Sagent’s distributors as Authorized Distributors of Record. Anesiva
shall assist Sagent in complying with drug pedigree requirements including but
not limited to maintaining a publicly available list of Sagent’s Authorized
Distributors of Record.

 

19) Labeling: Labeling operations and labeling supply shall be the
responsibility of Anesiva. Anesiva shall assure vendor(s) used for label supply
are qualified. To the extent the Product labeling and or label bears Sagent’s
trademark, Anesiva shall make no changes to Sagent’s trademark without prior
written consent of Sagent. The labeling and or label shall also specify Anesiva
as the party to be contacted for further information about the Product. To the
extent Sagent’s name and or trademark appears on the Product label, the label
shall specify “Manufactured by Anesiva” and “Distributed by Sagent” as required
and allowed for under 21 CFR 201.1(h)(5).

The shipping label shall be in Healthcare Distribution Management Association
(HDMA) format and shall include the following information:

 

  •  

Name and address of Company

 

  •  

NDC number

 

  •  

Lot Number

 

  •  

Lot Expiration Date

 

  •  

Quantity

 

  •  

Storage and special transport conditions

 

  •  

Any special requirements (if applicable

 

20) Promotion: Upon Sagent’s reasonable request, Anesiva shall promptly provide
such promotional materials and objective evidence as is reasonably required to
substantiate promotional and advertising material related to the Product for
Sagent’s review and comment.

 

21) Packaging: Package Performance Testing. Anesiva shall be responsible for all
packaging validations (i.e. simulated shipping studies conducted against ASTM
standards or equivalent) and shipping studies (i.e. temperature monitoring
studies) to ensure the Product is shipped in a manner that is verified as not
adversely affecting the safety, identity, strength, quality, purity, or efficacy
of the Product. Results of such studies and other package integrity tests shall
be made available to Sagent upon request.

 

 

 

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THE PARTIES HAVE CAUSED THIS QUALITY AGREEMENT TO BE EXECUTED BY THEIR
AUTHORIZED REPRESENTATIVES AS OF THE EFFECTIVE DATE:

 

Contract Acceptor

/s/ David G. Perkins                                10 Oct 07

Signature/Date Sagent, QUALITY ASSURANCE HEAD ANESIVA, INC.

/s/ Melissa Morandi                                09 Oct 07

Signature/Date Anesiva, VICE PRESIDENT, QUALITY ASSURANCE

 

 

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Exhibit A

Document Revision History

[*]

 

 

CONFIDENTIAL — THIS DOCUMENT IS PROPERTY OF ANESIVA INC.

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Exhibit B

Quality Responsibilities

[*]

 

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Exhibit C

Batch Release Documentation

[*]

 

 

CONFIDENTIAL — THIS DOCUMENT IS PROPERTY OF ANESIVA INC.

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Quality & Regulatory Contacts

[*]

 

 

CONFIDENTIAL — THIS DOCUMENT IS PROPERTY OF ANESIVA INC.

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EXHIBIT C

PRESS RELEASE

 

LOGO [g86308logo-exhcpg4.jpg]    LOGO [g86308logo2-exhcpg4.jpg] Anesiva
Contacts:    Sagent Investor Contact: Paul Goodson    Ron Pauli, Chief Financial
Officer Sr. Dir., Investor Relations    847-908-1604 650-246-6898   
investors@anesiva.com    Sagent Media Contact:    Geoff Curtis, WeissComm
Partners    312-550-8138

ANESIVA SIGNS CO-PROMOTION AND DISTRIBUTION AGREEMENT WITH SAGENT
PHARMACEUTICALS

FOR ZINGO™ IN U.S. HOSPITALS

Sagent to Accelerate Anesiva’s Penetration of the Hospital Market with Zingo

SOUTH SAN FRANCISCO, CA, and SCHAUMBURG, IL, October 12, 2007 — Anesiva, Inc.
(Nasdaq: ANSV) and Sagent Pharmaceuticals, Inc., today announced an agreement in
which Sagent will co-promote for three years Anesiva’s Zingo™ (lidocaine
hydrochloride monohydrate) powder intradermal injection product and will manage
U.S. distribution. Zingo, a needle-free product that provides fast-acting
topical, local analgesia, has been recently approved by the U.S. Food and Drug
Administration (FDA) to reduce the pain associated with venous access
procedures, such as IV insertions or blood draws, in children three to 18 years
of age.

Under the agreement, Sagent will join with Anesiva to co-promote Zingo within
hospitals as well as facilitating contract negotiations with hospitals and group
purchasing organizations. Sagent’s team will focus their selling efforts toward
hospital pharmacists, with Anesiva promoting primarily to physicians and nurses.
In addition, Sagent will manage Zingo warehousing and distribution services. The
terms of the agreement provide for Sagent to earn a royalty based on Anesiva’s
net sales of Zingo and for Anesiva to reimburse Sagent for certain direct
expenses. Anesiva may designate additional marketing partners to address
non-hospital affiliated markets.

 

 

CONFIDENTIAL — THIS DOCUMENT IS PROPERTY OF ANESIVA INC.

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“We are very excited to work with their extremely seasoned sales and national
accounts team to support Zingo’s penetration of the hospital market,” said John
P. McLaughlin, chief executive officer of Anesiva. “Together with Anesiva’s
experienced marketing organization and planned sales force of 15
representatives, we will have complementary roles and provide synergistic
selling efforts to launch Zingo successfully in U.S. hospitals. Anesiva will
also leverage Sagent’s established infrastructure for warehousing and
distribution services.”

“We are excited about the opportunity to collaborate with an organization of
Anesiva’s quality in introducing Zingo to hospital markets and will fully align
our extensive hospital-focused sales and distribution resources to support
Zingo,” stated Jeffrey Yordon, chairman, founder and chief executive officer of
Sagent Pharmaceuticals. “The Anesiva co-promote marks an important advance in
Sagent’s rapid evolution and Zingo fits nicely with Sagent’s mission of
delivering customer-focused products to patients.”

About Zingo

Zingo is a ready-to-use, single-use, needle-free system that delivers 0.5 mg
sterile lidocaine powder into the skin and provides topical, local analgesia in
one to three minutes after administration. This rapid onset, which may be
especially useful in pediatric populations and busy emergency room settings,
means the product can be incorporated into a medical procedure allowing
uninterrupted care, an important advantage over current options. Venous access
procedures, like IV insertions and blood draws, are among the most common
interventions performed at a hospital, with more than 18 million pediatric
venous access procedures and 400 million total procedures per year in U.S
hospitals. In addition to the hospital setting, Zingo may be used in physicians’
offices and clinical laboratories. In clinical trials, Zingo was well tolerated.
Common side effects were redness, red dots and swelling of the skin at the site
of administration.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the
leader in the development and commercialization of novel therapeutic treatments
for pain. The company has one FDA-approved product, Zingo™, for the reduction of
pain associated with peripheral venous access procedures in children three to 18
years of age. The second product in Anesiva’s pipeline, Adlea™ (formerly 4975),
has been shown to reduce pain after only a single administration for weeks to
months in multiple settings in numerous mid-stage clinical trials for
site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco,
CA. For more information about Anesiva’s leadership in the development of
products for pain management, and an overview of the clinical challenges being
addressed by its product candidates, go to http://www.anesiva.com.

 

 

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About Sagent Pharmaceuticals, Inc.

Sagent Pharmaceuticals is a privately held specialty pharmaceutical company
focused on developing, manufacturing, sourcing and marketing pharmaceutical
products, with a specific focus on injectable products. Sagent has created a
unique, global network of resources, comprised of rapid development
capabilities, sophisticated manufacturing and innovative drug-delivery
technologies, quickly yielding an extensive portfolio of pharmaceutical products
that fulfills the evolving needs of patients. Sagent currently has more than 200
products in development. For more information about Sagent, please visit
www.SagentPharma.

Anesiva Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of
the safe harbor provisions of the United States Private Securities Litigation
Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,”
“forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,”
“believes,” “predicts,” “potential,” “continue,” and similar expressions are
intended to identify such forward-looking statements. Forward-looking statements
in this press release include matters that involve known and unknown risks,
uncertainties and other factors that may cause actual results, levels of
activity, performance or achievements to differ materially from results
expressed or implied by this press release. Such risk factors include, among
others: the timing and results of Anesiva’s clinical trials, whether Anesiva is
able to manufacture its products on commercially reasonable terms, whether
Anesiva can secure the adoption of Zingo on hospital formularies and otherwise
penetrate the hospital market, and the degree to which Zingo gains market
acceptance. Actual results may differ materially from those contained in the
forward-looking statements in this press release. Additional information
concerning these and other risk factors is contained in Anesiva’s quarterly
report on Form 10-Q for the quarter ended June 30, 2007.

Anesiva undertakes no obligation and does not intend to update these
forward-looking statements to reflect events or circumstances occurring after
this press release. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this press
release. All forward-looking statements are qualified in their entirety by this
cautionary statement.

 

 

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EXHIBIT D

LANGUAGE FOR SEC FILINGS

On October [    ], 2007, Anesiva, Inc. (“Anesiva”) entered into a Promotional
Agreement (the “Agreement”) with Sagent Pharmaceuticals, Inc. (“Sagent”)
relating to Anesiva’s Zingo™ (lidocaine hydrochloride monohydrate) powder
intradermal injection product. Under the Agreement, Sagent will undertake
certain promotional activities with respect to Zingo in the United States for a
period of three (3) years. These activities will include the co-promotion of
Zingo to hospitals, facilitation of Zingo-related contract negotiations with
hospitals and group purchasing organizations, and the management of the
warehousing and distribution of Zingo. Anesiva will pay Sagent an upfront fee as
well as royalties on sales of Zingo to hospitals and related markets during an
agreed-upon time period. In addition, Anesiva will reimburse Sagent for certain
direct expenses. Under the Agreement, Anesiva may designate additional marketing
partners to address non-hospital markets.

 

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.