Exhibit 10.2
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (this “ Agreement
”) dated as of February 19, 2008, by and between
NOVAVAX, INC., a Delaware corporation (“ Novavax
”), and GRACEWAY PHARMACEUTICALS, LLC, a Delaware limited
liability company (“ Graceway ”). Novavax and
Graceway may be referred to individually as a “Party”
or collectively as the “Parties”.
WHEREAS , Novavax has been engaged in the development,
manufacture, and supply of the Product (as hereinafter
defined);
WHEREAS , on the date hereof, Graceway and Novavax have
entered into an Asset Purchase Agreement (the “ Asset
Purchase Agreement ”) for the acquisition by Graceway
from Novavax of all rights of Novavax associated with the Product
in the Territory; and
WHEREAS , Graceway desires to have Novavax manufacture and
supply, and Novavax desires to manufacture and supply to Graceway,
the Product for sale by Graceway or its designees, subject to the
conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the foregoing and of the
representations, warranties, mutual covenants and agreements
hereinafter set forth and intending to be legally bound hereby, the
Parties hereto agree as follows:
ARTICLE 1
DEFINITIONS AND INTERPRETATIONS
As used
throughout this Agreement, each of the following terms shall have
the respective meanings set forth below:
“
Affiliate ” shall mean, with respect to any Person,
any other Person that, (a) directly or indirectly is in
control of, is controlled by, or is under common control with, the
first Person, (b) is an officer, director, trustee, partner
(general or limited), employee or holder of ten percent (10%) or
more of any class of any voting or non-voting securities or other
equity in the first Person, or (c) is an officer, director,
trustee, partner (general or limited), employee or holder of ten
percent (10%) or more of any class of the voting or non-voting
securities or other equity in any Person which directly or
indirectly is in control of, is controlled by, or is under common
control with, the first Person. For purposes of this definition,
“control” (including with correlative meanings
“controlled by” and “under common control
with”) shall mean possession, directly or indirectly, of
either (i) ten percent (10%) or more of the voting power of
the securities having ordinary voting power for the election of
directors of the first Person, or (ii) the power to direct or
cause the direction of the management or policies of the first
Person (whether through ownership of securities, partnership
interests or any other ownership or debt interests, by contract or
otherwise).
“
Agreement ” shall have the meaning set forth in the
Preamble.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
“
Allergan Agreement ” shall mean the Asset Purchase
Agreement dated as of the date hereof among Graceway, Allergan USA,
Inc. and Allergan, Inc.
“
Asset Purchase Agreement ” shall have the meaning set
forth in the Preamble.
“
Bankruptcy Code ” shall have the meaning set forth in
Section 7.02 .
“
Bankruptcy Laws ” shall have the meaning set forth in
Section 7.02 .
“
cGMP ” shall mean good manufacturing practices
according to 21 C.F.R. Parts 210 and 211.
“
Catalent ” shall mean Catalent Pharma Solutions, Inc.
as the contract manufacturer of the Product pursuant to the
Catalent Agreement.
“
Catalent Agreement ” shall mean the Facility
Reservation Agreement dated February 8, 2002, between Novavax
and Catalent, as renewed and amended by that certain letter
agreement dated February 12, 2008 between Catalent and
Novavax.
“
Catalent Facility ” shall mean Catalent’s
manufacturing facility for the Product located at 3001 Red Lion
Road, Philadelphia, Pennsylvania 10014.
“
Confidential Information ” shall have the meaning set
forth in Section 13.01 .
“
Damages ” shall have the meaning ascribed to such term
in Section 16.01 .
“
Delivery Schedule ” shall have the meaning set forth
in Section 4.01(a) .
“
Expiration Date ” shall have the meaning set forth in
Article 6 .
“
FDA ” means the United States Food and Drug
Administration and successor bodies.
“
Force Majeure Event ” shall have the meaning set forth
in Article 11 .
“
Indemnified Party ” shall have the meaning set forth
in Section 16.03 .
“
Indemnifying Party ” shall have the meaning set forth
in Section 16.03 .
“
Lot ” means approximately [* * *] Units of the
Product.
“
Manufacturing Equipment ” shall mean the Manufacturing
Equipment transferred and assigned by Novavax to Graceway pursuant
to the Asset Purchase Agreement.
“
Packaging and Promotional Material ” shall have the
meaning set forth in Article 12.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
“
Person ” or “ person ” means any
individual, corporation, partnership, limited liability company,
joint venture, trust, unincorporated organization, other form of
business or legal entity or governmental authority.
“
Product ” shall mean Estrasorb, as more fully
described on Schedule A to this Agreement, manufactured
and packaged in accordance with the Specifications.
“
Raw Materials ” shall mean the materials, components
and packaging required to manufacture and package the Product in
accordance with the Specifications.
“
Raw Materials Inventory ” shall mean the Raw Materials
acquired by Graceway pursuant to the Allergan Agreement.
“
Raw Materials Specifications ” shall mean the
specifications for the composition, product safety assurance,
manufacture, packaging, and/or quality control of the Raw
Materials, as set forth on Schedule B-1 attached hereto
and made a part hereof, as the same may hereafter be modified by
mutual agreement of the Parties in writing.
“
Specifications ” shall mean the specifications for the
design, composition, product safety assurance, manufacture,
packaging, and/or quality control of the Product, as set forth on
Schedule B-2 attached hereto and made a part hereof, as
the same may hereafter be modified by mutual agreement of the
Parties in writing.
“
Stability Date ” shall have the meaning set forth in
Section 10.06 .
“
Territory ” shall mean the United States, Mexico and
Canada.
“
Third Party Claim ” shall have the meaning set forth
in Section 16.03 .
“
Unit ” means a packaged month of therapy of the
Product for an individual end user, consisting of 56 pouches each
containing 1.74 grams of the Product.
“
United States ” shall mean the fifty states of the
United States of America and its territories and possessions
including Puerto Rico, irrespective of its political structure, and
the District of Columbia.
ARTICLE 2
SUPPLY OF THE PRODUCT
During
the term of this Agreement, Novavax shall manufacture and supply
exclusively to Graceway those quantities of the Product as set
forth in this Agreement. Each Lot manufactured and sold to Graceway
hereunder will conform to all Specifications for the Product, and
shall be manufactured, tested, released and stored in accordance
with cGMPs, applicable FDA and other rules and regulations, and the
terms and conditions of this Agreement. Subject to the terms and
conditions herein, Novavax will provide, at its sole cost and
expense, the facilities, equipment, labor (and supervision thereof)
and know-how necessary for the manufacture, testing
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
(including stability), packaging and supply of the Product to
Graceway in accordance with the terms and conditions of this
Agreement.
ARTICLE 3
TRANSFER PRICE; PAYMENT TERMS
3.01 Transfer Price.
The
transfer price of the Product from Novavax to Graceway pursuant to
this Agreement will be $ [* * *] per Unit. Such transfer price
shall be all inclusive and Graceway shall have no obligation to pay
any other amounts to Novavax related to the manufacture and supply
of the Product to Graceway pursuant to this Agreement, except as
otherwise specifically set forth in this Agreement.
3.02 Payment Terms.
Payment
terms on all deliveries of the Product to Graceway under this
Agreement shall be thirty (30) days from the delivery of an
invoice by Novavax for such Product delivery, which invoice shall
be provided by Novavax to Graceway on or after the delivery of such
Product to Graceway.
ARTICLE 4
LOTS PURCHASED
4.01 Quantity; Schedule of
Delivery.
(a) Graceway
agrees to purchase, and Novavax agrees to manufacture and supply to
Graceway, an aggregate amount of [* * *] Lots in accordance with
the delivery schedule attached hereto at Schedule 4.01
(the “ Delivery Schedule ”).
(b) Novavax
acknowledges and agrees that all of the Raw Materials Inventory is
being held by Novavax at the Catalent Facility. Novavax is
permitted to use such Raw Materials Inventory solely in connection
with the manufacture of the Product for Graceway pursuant to this
Agreement. In the event that the Raw Materials Inventory has
expired or lacks sufficient expiration dating (two (2) years), or
additional Raw Materials are required for Novavax to manufacture
the required Lots for Graceway pursuant to this Agreement, then
Novavax will acquire sufficient additional Raw Materials to produce
the required Lots without additional expense to Graceway.
4.02 Conflicts.
To the
extent of any conflict or inconsistency between this Agreement and
any order, acknowledgement, confirmation, acceptance or any similar
document, the terms of this Agreement shall govern.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
ARTICLE 5
ADDITIONAL AGREEMENTS
5.01 Other Affiliates.
If any
other Affiliate of Graceway desires to purchase the Product from
Novavax pursuant to the terms of this Agreement, then, upon the
execution of a copy of this Agreement by such Affiliate, Novavax
shall accord such Affiliate all of the benefits hereof and treat
such Affiliate the same as Graceway for the purposes of this
Agreement; provided , that this Section 5.01
will not be construed to relieve Graceway of any of its obligations
hereunder.
5.02 Exclusive Rights.
During
the term of this Agreement, Novavax shall supply Graceway, on an
exclusive basis, with the Product for sale in the Territory and
neither Novavax nor any of its Affiliates shall sell or distribute
the Product within the Territory.
5.03 Insurance.
Each of
Novavax and Graceway agrees to procure and maintain in full force
and effect during the term of this Agreement valid and collectible
insurance policies of a type and coverage amount consistent with
Novavax’s and Graceway’s past practices. Upon
Graceway’s request, Novavax shall provide to Graceway a
certificate of coverage or other written evidence reasonably
satisfactory to Graceway of such insurance coverage. Upon
Novavax’s request, Graceway shall provide to Novavax a
certificate of coverage or other written evidence reasonably
satisfactory to Novavax of such insurance coverage.
5.04 Personnel.
During
the term of this Agreement, Novavax (itself or through one or more
third party contract manufacturers) shall maintain a workforce of
appropriate size, training and experience sufficient for the
manufacturing, packaging, testing (including stability) and supply
of the Product to Graceway pursuant to the terms and conditions of
this Agreement, and for the satisfaction of Novavax’s
obligations under this Agreement.
5.05 Manufacturing
Equipment.
Novavax
shall use the Manufacturing Equipment solely for purposes of
manufacturing and supplying the Product to Graceway pursuant to the
terms and conditions of this Agreement. Novavax shall, during the
term of this Agreement, clean and maintain the Manufacturing
Equipment in good operating condition and repair (ordinary wear and
tear excepted) and in accordance with good industry and
manufacturing practices and applicable laws, rules and regulations.
Novavax shall, at its sole cost and expense, be responsible for
maintaining all warranty, service and maintenance agreements
related to the Manufacturing Equipment in full force and effect,
including all preventative maintenance and calibration
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
programs
and agreements during the term of this Agreement. Graceway, as the
owner of the Manufacturing Equipment, shall bear the risk of loss
of the Manufacturing Equipment, but subject to Novavax’s
compliance with its obligations under this Agreement.
ARTICLE 6
TERM
Subject
to the survival provisions of Section 17.12 , the term
of this Agreement shall commence on the date hereof and, unless
terminated earlier pursuant to Article 7 , shall remain
in effect until the later of the following dates (the “
Expiration Date ”): (a) July 31, 2008, or
(b) such time that Novavax has delivered, and Graceway has
accepted in accordance with the terms of this Agreement, the
aggregate number of Lots set forth in Section 4.01
.
ARTICLE 7
TERMINATION
7.01 Breach.
This
Agreement may be terminated, prior to the Expiration Date, by
either Party by giving written notice of its intent to terminate
and stating the grounds therefor if the other Party shall
materially breach or materially fail in the observance or
performance of any representation, warranty, guarantee, covenant or
obligation under this Agreement. The Party receiving such notice
shall have sixty (60) days from the date of receipt thereof to
cure the breach or failure; provided , that the cure period
for a failure to make timely payment hereunder shall be only thirty
(30) days. If the Party receiving such notice does not cure
such breach or failure within such cure period, then this Agreement
shall automatically terminate effective as of the end of such
period.
7.02 Insolvency, Etc.
This
Agreement may be terminated, prior to the Expiration Date, upon
thirty (30) days advance written notice by either Party:
(a) in the event that the other Party hereto shall
(i) apply for or consent to the appointment of, or the taking
of possession by, a receiver, custodian, trustee or liquidator of
itself or of all or a substantial part of its property,
(ii) make a general assignment for the benefit of its
creditors, (iii) commence a voluntary case under the United
States Bankruptcy Code, as now or hereafter in effect (the “
Bankruptcy Code ”), (iv) file a petition seeking
to take advantage of any law (the “ Bankruptcy Laws
”) relating to bankruptcy, insolvency, reorganization,
winding-up, or composition or readjustment of debts, or (v) take
any corporate action for the purpose of effecting any of the
foregoing; or (b) if a proceeding or case shall be commenced
against the other Party hereto in any court of competent
jurisdiction, seeking (i) its liquidation, reorganization,
dissolution or winding-up, or the composition or readjustment of
its debts, (ii) the appointment of a trustee, receiver,
custodian, liquidator or the like of the Party or of all or any
substantial part of its assets, or (iii) similar relief under
any Bankruptcy Laws, or an order, judgment or decree approving any
of the foregoing shall be
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
entered
and continue unstayed for a period of sixty (60) days; or
(c) an order for relief against the other Party hereto shall
be entered in an involuntary case under the Bankruptcy Code.
7.03 Effect of
Termination.
(a) Notwithstanding
the termination of this Agreement for any reason, each Party hereto
shall be entitled to recover any and all Damages which such Party
shall have sustained by reason of the breach by the other Party
hereto of any of the terms of this Agreement. Termination of this
Agreement for any reason shall not release either Party hereto from
any liability which at such time has already accrued or which
thereafter accrues from a breach or default prior to such
termination, nor affect in any way the survival of any other right,
duty or obligation of either Party hereto which is expressly stated
elsewhere in this Agreement to survive such termination. In the
case of a termination under Section 7.01 above, the
non-defaulting Party may pursue any remedy available in law or in
equity with respect to such breach, subject to the terms of
Section 17.01 .
(b) In
the event that this Agreement expires or is terminated for any
reason, Novavax shall return to Graceway (at no cost to Graceway)
any Raw Materials Inventory that has not been utilized prior to the
expiration or earlier termination of this Agreement. Novavax shall
deliver, and Graceway shall accept delivery of, any such Raw
Materials Inventory within five (5) days after such expiration
or termination of this Agreement to a location designated by
Graceway. Such delivery shall be F.O.B. Catalent Facility.
7.04 Cleaning and Restoration of
Manufacturing Equipment.
(a) Prior
to or promptly after the expiration or termination of this
Agreement, Novavax shall (i) clean the Manufacturing Equipment
in accordance with good industry and manufacturing practices and
applicable laws, rules and regulations; (ii) restore the
Manufacturing Equipment to the condition that existed as of the
date of this Agreement (ordinary wear and tear excepted); (iii)
disconnect, disassemble and make the Manufacturing Equipment
available for removal from the Catalent Facility; and
(iv) make its personnel reasonably available to assist
Graceway in said removal. Graceway shall remove the Manufacturing
Equipment from the Catalent Facility within forty-five
(45) days after receiving written notice from Novavax that the
Manufacturing Equipment is ready for transport. Novavax shall be
solely responsible for all costs and expenses incurred by it
(including, without limitation, rent and other non-routine costs
incurred to clean, handle or decommission the Manufacturing
Equipment irrespective of when incurred) in complying with its
obligations under this Section 7.04(a) ;
provided , that Graceway agrees to reimburse Novavax for up
to Two Hundred Fifty Thousand Dollars ($250,000) of such costs and
expenses to the extent supported by reasonably detailed
documentation (excluding any rent expenses with respect to the
period prior to June 30, 2008).
(b) Novavax
shall be responsible for complying with the terms of the Catalent
Agreement that are applicable to Novavax’s obligations
hereunder, including terms related to (i) the use,
maintenance, occupancy or possession of the Catalent Facility,
(ii) the cleaning and removal of the Manufacturing Equipment
from the Catalent Facility, and (iii) the restoration of
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
the
Catalent Facility as required by Catalent, whether under the
Catalent Agreement or otherwise.
7.05 Transfer
Assistance.
(a) During
the term of this Agreement and for ninety (90) days after the
acceptance by Graceway of the last Lot (per the Delivery Schedule),
Novavax shall, at Graceway’s request, assist Graceway with
(i) the relocation of the Manufacturing Equipment to a new
location and the installation of the Manufacturing Equipment at
such new location such that the Manufacturing Equipment is fully
operational at such new location for the manufacturing of the
Product in accordance with the Specifications and
(ii) designating alternative supplier(s) of the Product and
qualifying and enabling Graceway, any alternative supplier(s) and
supplier’s manufacturing sites to manufacture and supply the
Product in accordance with all applicable laws, Product approvals
and Specifications, including (A) the transfer and disclosure
of, and enablement of such parties and sites with respect to
technology and (B) the provision of relevant technical
documentation, technical expertise, and development reports and/or
historical documentation reasonably necessary for the transfer and
qualification of both analytical methodologies and manufacturing
processes with respect to such parties and sites. All such
assistance shall be provided during Novavax’s normal business
hours at times and locations to be mutually agreed upon by the
Parties.
(b) Novavax shall make any
technically qualified individuals with knowledge of the manufacture
of the Product available, at a rate of [* * *] per hour, to provide the
assistance described in Section 7.05(a) above. Such
individuals shall remain as employees of Novavax, and nothing
herein shall be construed to impose upon Graceway any obligations
as an employer of any such individual.
7.06 Transfer of
Records.
Upon
the expiration or termination of this Agreement, Novavax shall
promptly deliver to Graceway all documentation, records and files
in Novavax’s possession related to the manufacturing, testing
and/or release of the Product, whether generated before or during
the term of this Agreement, including all regulatory reports,
validation documents, batch record history and stability and
Product complaint databases.
ARTICLE 8
SHIPMENT AND DELIVERY; INVENTORY AND RAW MATERIALS
8.01 Shipment and
Delivery.
(a) All
shipments of the Product pursuant to this Agreement shall be F.O.B.
Catalent Facility (i.e., Graceway will pay for shipment). All
shipments must be accompanied by a packing slip which describes the
articles and shows the shipment’s destination. Novavax agrees
to promptly forward the original bill of lading or other shipping
receipt for each shipment in accordance with Graceway’s
instructions. Novavax further agrees to promptly render,
after
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
delivery
of goods or performance of services, correct and complete invoices
to Graceway, and to accept payment by check or, at Graceway’s
discretion, other cash equivalent (including electronic transfer of
funds).
(b) The
risk of loss with respect to the Product shall remain with Novavax
until the point at which such Product is delivered to the loading
dock at the Catalent Facility. Novavax will pack all the Product
ordered hereunder in a manner suitable for shipment and sufficient
to enable the Product to withstand the effects of shipping,
including handling during loading and unloading.
(c) Novavax
shall provide to Graceway upon each shipment of each Lot the
following: (i) Novavax’s standard certificate of analysis for
each Lot certifying that the delivered batch contained in the Lot
is in conformance with all the
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