Exhibit 10.2
Execution Version
SUPPLY AGREEMENT
This SUPPLY AGREEMENT (the
“Agreement” ) is made and entered into as of the
day of May, 2008 (the
“Effective Date” ) by and between AMAG
PHARMACEUTICALS, INC. , a Delaware corporation with its
principal place of business at 125 CambridgePark Drive, Cambridge,
MA 02140, U.S.A. ( “AMAG” ), and 3SBIO
INC. , a company incorporated under the laws of the Cayman
Islands, with a place of business at No. 3 A1 Road 10,
Shenyang Economy & Technology Development Zone,
Shenyang, 110027, China ( “3SBio” ).
AMAG and 3SBio are sometimes referred to herein individually as a
“Party” and collectively as the
“Parties.”
RECITALS
WHEREAS , the Parties have entered into that certain
Collaboration and Exclusive License Agreement dated as of the
Effective Date (the “License Agreement” ),
pursuant to which AMAG is granting 3SBio certain rights to Develop
and Commercialize the Product in the Licensed Territory;
WHEREAS , pursuant to Article 7 of the License
Agreement, 3SBio wishes to purchase from AMAG the Product in
finished form in unlabeled vials for clinical and commercial use,
and AMAG is willing to supply 3SBio with such Product for use in
accordance with the terms and conditions of the License
Agreement;
NOW THEREFORE
, in consideration of the mutual
promises and covenants set forth below, 3SBio and AMAG mutually
agree as follows:
1.
DEFINITIONS.
Capitalized terms not otherwise
defined herein shall have the meanings set forth in the License
Agreement. As used in this Agreement, the following
capitalized terms shall have the following meanings:
1.1
“Acceptance
Tests” means those
test methods set forth in Exhibit A to be performed to
determine that the Product supplied to 3SBio conforms to the
Specifications, as such tests may be amended from time to time by
written agreement of the Parties.
1.2
“Capacity
Shortage” shall
have the meaning set forth in Section 5.3.
1.3
“Certificate of
Analysis” shall
have the meaning set forth in Section 2.5.
1.4
“Good Manufacturing
Practice” or
“GMP” means the then-current standards for the
preparation of finished pharmaceuticals, as set forth in the
FD&C Act and applicable regulations promulgated thereunder,
including without limitation 21 CFR §§210-211.
1.5
“ Product ” shall
mean any Product (as defined in the License Agreement) then being
Developed or Commercialized under the License Agreement pursuant to
the terms and conditions of such agreement.
1.6
“Product
Price” shall have
the meaning set forth in Section 4.1.
1.7
“Raw Material
Cost” means the
amounts paid by AMAG to a Third Party for providing raw materials
and packaging materials for producing the Product, to the extent
not reimbursed or refunded or credited to AMAG, and net of any
discounts or other benefits received by AMAG from Third Party
manufacturers, calculated on a per-unit basis and in accordance
with U.S. generally accepted accounting principles consistently
applied.
1.8
“Quality
Agreement” shall
mean the Quality Agreement to be negotiated by the Parties as
described in Section 3.1.
1.9
“Specifications”
shall mean the characteristics and
standards pertaining to the manufacture or supply of the Product,
as set forth in Exhibit A , as the same may be amended
or supplemented from time to time pursuant to
Section 2.5.
2.
PURCHASE AND
SUPPLY.
2.1
Purchase and Supply
Agreement. During
the term of this Agreement, 3SBio agrees to buy, and AMAG agrees to
sell, all of 3SBio’s and its Affiliates’ and permitted
sublicensees’ requirements of Product for Development,
Commercialization and use in accordance with the terms and
conditions of this Agreement and the License Agreement.
2.2
Forecasts.
At least [***] prior to the
first requested delivery date for Product under this Agreement,
3SBio shall deliver to AMAG a detailed forecast of 3SBio’s
requirements for Product for each calendar quarter during the [***]
period beginning with the first requested delivery date for Product
under this Agreement. 3SBio shall thereafter update such
detailed forecast quarterly, no later than the first day of each
calendar quarter, so that each quarter, AMAG shall have been
provided with a rolling detailed forecast for each quarter during
the [***] period commencing [***] after the date on which such
forecast is submitted. The forecast for the first [***]
contained in each such detailed forecast shall be firm and binding
on 3SBio and AMAG. 3SBio may order amounts of Product in
excess of the amounts forecast for such [***] period, and AMAG
shall use commercially reasonable efforts to supply any such
additional amounts ordered; provided, that AMAG shall be
under no obligation to accept purchase orders for amounts exceeding
[***] of the amount forecast for such [***] period. The
quantities indicated for the remaining months of each rolling
forecast will be treated as a forecast only and will not create any
obligations for either Party.
2.3
Ordering. All Product ordered under this Agreement
shall be pursuant to written purchase orders, each of which shall
specify the quantity of Product ordered for Development or
Commercialization and the requested delivery date. The
minimum quantity of Product that may be ordered in a given purchase
order is [***] vials of Product. 3SBio shall submit each such
purchase order to AMAG no later than thirty (30) days prior to the
delivery date indicated in
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
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such purchase order. Any purchase orders
for Product submitted by 3SBio shall reference this Agreement and
shall be governed exclusively by the terms contained herein.
Any term or condition in any order, confirmation or other document
furnished by 3SBio or AMAG that is in any way inconsistent with the
terms and conditions of this Agreement is hereby expressly
rejected. Within fifteen (15) days after receipt of a
purchase order placed pursuant to this Section 2.3, AMAG shall
confirm the date for delivery of the applicable quantity of Product
and any quantities in excess of the permissible variance under
Section 2.2. As used in this Agreement, all references
to days shall be deemed to be references to calendar
days.
2.4
Unordered Product.
For any given quarter, if
3SBio fails to order and complete the purchase of at least the
quantities of such Product set forth in the binding forecast for
that quarter, then 3SBio shall pay to AMAG an amount equal to:
[***]. Following payment of such amount, AMAG shall, at its
sole option, either (a) deliver the Unordered Product Units to
3SBio or (b) credit such amount against future orders of
Product.
2.5
Product Specifications;
Testing. All
Product supplied hereunder will conform to the Specifications at
the time of delivery and shall have a remaining shelf life of not
less than [***] from the date of delivery to 3SBio. AMAG will
test each batch of Product in accordance with the Acceptance Tests
and supply 3SBio with a certificate of analysis (
“Certificate of Analysis” ) confirming that such
batch meets the Specifications. 3SBio may then retest the
batch of Product as more fully set forth in Section 5.5 to
confirm that it meets the Specifications. The Parties
acknowledge that the Specifications and Acceptance Tests may need
to be refined and modified as the Parties gain experience with the
manufacture, testing and use of Product. Accordingly, the
Parties agree to negotiate in good faith to modify the
Specifications and Acceptance Tests from time to time as the
Parties’ experience with the manufacture, testing and use of
the Product warrants. 3SBio acknowledges that AMAG may be
required to modify the Specifications in light of regulatory
requirements imposed by the FDA or other Regulatory Authority, and
that 3SBio may not unreasonably withhold its agreement from any
such modifications. If any regulatory requirement imposed by
the SFDA would require a change to the Specifications or the
Acceptance Tests, the Parties will promptly discuss such change and
negotiate amendments to the Specifications or the Acceptance Tests
in good faith. The Parties agree to allocate on an equitable basis
any costs of developing and implementing revised procedures in
response to SFDA requirements.
3.
MANUFACTURE.
3.1
Quality Agreement.
Promptly after the Effective
Date, the Parties will negotiate the terms of a quality agreement
governing the quality assurance obligations and responsibilities of
the Parties with respect to the manufacture and supply of the
Product (as amended or modified from time to time according to its
terms, the “Quality Agreement” ). In the
event of a discrepancy between the provisions of the Quality
Agreement and the provisions of this
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
3
Agreement, the provisions of the Quality
Agreement shall control with respect to terms governing quality of
the Product and the provisions of this Agreement shall control with
respect to all other terms.
3.2
Regulatory
Inspections. AMAG
specifically agrees to cooperate with any inspection by the SFDA,
including without limitation any inspection required for approval
of 3SBio’s MAA in the Licensed Territory. The Parties
understand that such assistance and cooperation will not require
substantial expenditures by AMAG, and the Parties shall discuss in
good faith the equitable allocation of any unexpected expenses
resulting from such inspection. Notwithstanding the
foregoing, 3SBio shall be solely responsible for any Out-of-Pocket
Costs incurred in connection with the conduct of any inspection by
the SFDA, including without limitation travel costs of any SFDA
personnel. AMAG shall promptly inform 3SBio of the findings
of any such inspection and notify 3SBio of any corrective action
that AMAG may be required to undertake as a result of any such
inspection.
3.3
Quality Control
Audits. Upon
written request to AMAG, 3SBio shall have the right, no more than
once per calendar year, to have representatives visit the
manufacturing facilities of AMAG during normal business hours to
review manufacturing operations, to assess its compliance with GMP
and quality control procedures, and to discuss any related issues
with AMAG’s manufacturing and management personnel.
Upon written request to 3SBio, AMAG shall have the right, no more
than once per calendar year, to have representatives visit the
packaging facilities of 3SBio during normal business hours to
review packaging operations, to assess its compliance with GMP and
quality control procedures, and to discuss any related issues with
3SBio’s packaging and management personnel.
3.4
Change in Manufacturing
Process. AMAG
shall notify 3SBio in writing before it implements any change in
the materials, equipment, process or procedures used to manufacture
Product that (a) would constitute a major change under GMP or
(b) AMAG would be required to report to the FDA under
applications laws and regulations.
3.5
Compliance with Laws.
AMAG shall comply with all
applicable present and future orders, regulations, requirements and
laws of any and all United States federal, state, provincial and
local authorities and agencies, including without limitation all
laws and regulations of such territories applicable to the
transportation, storage, use, handling and disposal of hazardous
materials. AMAG will maintain during the term of this
Agreement all government permits, including without limitation
health, safety and environmental permits, necessary for the conduct
of the actions and procedures that it undertakes pursuant to this
Agreement. 3SBio shall provide AMAG with written notice of
any additional regulatory requirements of the Licensed Territory
that relate to the manufacture of Product for the Licensed
Territory. AMAG shall use commercially reasonable efforts to
comply with such additional requirements, and shall provide 3SBio
with prompt written notice of any Out-of-Pocket Costs associated
with such compliance, which, to the extent not included in the
Product Price, shall be borne by 3SBio.
3.6
Documentation and
Samples. AMAG
shall maintain complete, accurate and authentic accounts, notes,
data and records pertaining to the methods and facilities used for
the manufacture, processing, testing, packing, labeling, holding
and distribution of the Product in accordance with the applicable
laws and regulations in the United States. AMAG shall
retain
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samples of Product from each batch of Product
supplied under this Agreement after 3SBio’s acceptance of
such batch under Section 5.5. AMAG shall retain such
records and samples for a period of three (3) years following
the date of manufacture, or longer if required by United States
law, and upon 3SBio’s written request shall make available to
3SBio copies of such records and portions of such
samples.
3.7
Rework. AMAG shall not rework any batch of
Product without 3SBio’s prior written consent, not to be
unreasonably withheld.
4.
PRICES AND
PAYMENT.
4.1
Product Price.
a.
For all Product delivered to 3SBio
pursuant to this Agreement, 3SBio shall pay to AMAG a price (the
“Product Price” ) equal to [***], subject to the
adjustments described in below in Section 4.1(b) and
(c).
b.
The Product Price will be subject to
adjustment by AMAG under this Section 4.1(b) during the
term of this Agreement, based [***]. AMAG shall inform 3SBio
of any such adjustment to the Product Price prior to implementing
such adjustment, which shall apply to all orders from and after the
adjustment date. In the event that [***], then upon
adjustment to the Product Price under this Section 4.1(b), the
Parties shall use reasonable and good faith efforts to agree,
within forty-five (45) days after the adjustment date, to an
amendment to this Agreement that provides for a revised Product
Price. If the Parties do not agree on a revised Product Price
within such forty-five (45) day period, then the Parties shall
refer the matter to the Chief Executive Officers of the Parties, or
their designees, for continued good faith negotiations for an
additional forty-five (45) day period. If the Chief Executive
Officers of the Parties, or their designees, do not agree on a
revised Product Price during such additional forty-five (45) day
period, then 3SBio shall have the right, but not the obligation, to
terminate this Agreement and the License Agreement, pursuant to
Section 13.4 thereof, at will upon thirty (30) days written
notice to AMAG. During such forty-five (45) day negotiation
periods and thirty (30) day period prior to such termination of
this Agreement and the License Agreement, the adjusted Product
Price [***] shall apply to all orders from and after the adjustment
date.
c.
The Product Price will be subject to
adjustment under this Section 4.1(c) in the event that
[***].
4.2
Method of Payment.
At the time of each shipment
of Product hereunder, AMAG shall provide to 3SBio a written invoice
for Product supplied in such delivery. All payments due
hereunder to AMAG shall be paid to AMAG in United States dollars
not later than thirty (30) days following the receipt of the
applicable invoice. Payment shall be made by wire
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
5
transfer of immediately available funds into a
deposit account of AMAG designated by AMAG from time to time.
Payment of any such amounts shall be considered effected as of the
date on which AMAG’s account is credited with the applicable
amount. In addition to any other remedies AMAG may have,
3SBio shall be solely responsible for any additional costs, or any
reduction in value of local currency in relation to Dollars,
resulting from untimely payments during any period after amounts
payable to AMAG hereunder are due. Any invoiced amount that
is not paid when due shall be assessed a late payment fee at the
rate of two percent (2%) per month or the maximum rate permitted by
applicable law with respect to such obligations, whichever is
less.
4.3
Taxes. 3SBio will make all payments to AMAG
hereunder free and clear of any taxes imposed by or under the
authority of any government or public authority (including, without
limitation, any sums due to be paid to AMAG hereunder that are
subject to any withholding or similar tax), but excluding any
corporate income tax, partnership tax or other business tax to
which AMAG may be subject. 3SBio will pay such additional
amount as may be required to ensure that the net amount received by
AMAG hereunder will equal the full amount that would have been
received by AMAG had not such tax (excluding any corporate income
tax, partnership tax or other business tax to which AMAG may be
subject) been imposed or withheld, including that 3SBio will be
responsible for the payment of all sales taxes due and payable on
the purchase of the Product. AMAG and 3SBio, without
prejudice to the foregoing, will use their best endeavors to do all
such lawful acts and things and to sign all such lawful deeds and
documents as will enable 3SBio to take advantage of any applicable
legal provision or any double taxation treaties with the object of
paying the sums due to AMAG without imposing or withholding any
tax.
4.4
Blocked Currency.
In the event that 3SBio is
prohibited or restricted from making payment of any monies at a
time when such monies are due and payable to AMAG hereunder by any
reason of a legal requirement within the Licensed Territory, 3SBio
shall promptly so advise AMAG in writing. 3SBio shall, upon
AMAG’s request, deposit any blocked funds to the credit of
AMAG in a separate interest-bearing account in a bank or other
depository in the