Exhibit 10.66
*Portions of this document marked
[*] are requested to be treated confidentially.
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COMMERCIAL MANUFACTURING
AGREEMENT
Salix Pharmaceuticals, Inc.,
Mesalamine Controlled Release Capsules
This Commercial
Manufacturing Agreement (“ Agreement ”) is made
effective as of this 9 th day of September, 2008 (“
Effective Date ”), by and between Salix
Pharmaceuticals, Inc., a California corporation, with a place of
business at 1700 Perimeter Park Drive, Morrisville, NC, 27560
(“ Client ”), and Catalent Pharma Solutions,
LLC, a Delaware limited liability company with a place of business
at 14 Schoolhouse Road, Somerset, New Jersey 08873 (“
Catalent ”).
RECITALS
A. Client is
a pharmaceutical company that develops, markets and sells
pharmaceutical products, including the Product;
B. Catalent
provides contract pharmaceutical development, manufacturing,
packaging and analytical services to the pharmaceutical
industry;
C. Client
desires to engage Catalent to provide certain services to Client in
connection with the processing of Client’s Product, and
Catalent desires to provide such services, all pursuant to the
terms and conditions set forth in this Agreement.
THEREFORE,
in consideration of the mutual
covenants, terms and conditions set forth below, the parties agree
as follows:
ARTICLE 1
DEFINITIONS
The following terms have the
following meanings in this Agreement:
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1.1 “
Acknowledgement ”
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has the meaning
set forth in Section 4.3.
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1.2 “
Affiliate(s) ” means, with respect to Client or any
third party, any corporation, firm, partnership or other entity
that controls, is controlled by or is under common control with
such entity; and with respect to Catalent, Catalent Pharma
Solutions, Inc. (“ CPS, Inc. ”) and any
corporation, firm, partnership or other entity controlled by CPS,
Inc. For the purposes of this definition, “ control
” shall mean the ownership of at least 50% of the voting
share capital of an entity or any other comparable equity or
ownership interest.
1.3 “
Agreement ” has the meaning set forth in the
introductory paragraph, and includes all its Attachments and other
appendices (all of which are incorporated herein by reference) and
any amendments to any of the foregoing made as provided herein or
therein.
1.4 “
API ” means the compound 5-Amino Salicylic Acid, as
further described in the Specifications, as provided in this
Agreement.
1.5 “
API Inventions ” has the meaning set forth in Article
11.
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1.6 “
Applicable Laws ” means all laws, ordinances, rules
and regulations of the United States applicable to the Processing
or any aspect thereof and the obligations of Catalent or Client, as
the context requires, under this Agreement, as amended from time to
time, including (A) all applicable federal, state and local
laws and regulations of the United States, (B) the U.S.
Federal Food, Drug and Cosmetic Act and (C) cGMP.
1.7 “
Batch ” means a defined quantity of Product that has
been or is being Processed in accordance with the
Specifications.
1.8 “
Catalent ” has the meaning set forth in the
introductory paragraph, or any successor or permitted assign.
Catalent shall have the right to cause any of its Affiliates to
perform any of its obligations hereunder, and Client shall accept
such performance as if it were performance by Catalent; provided
that any Affiliate shall, at its cost, comply with all Applicable
Laws, including without limitation, the Regulatory Approval for the
Product, unless Client requests the addition of the Affiliate to
the Regulatory Approval.
1.9 “
Catalent Indemnitees ” has the meaning set forth in
Section 13.2.
1.10 “
Catalent IP ” has the meaning set forth in Article
11.
1.11 “
cGMP ” means current Good Manufacturing Practices
promulgated by the Regulatory Authorities, including within the
meaning of 21 C.F.R. Parts 210 and 211, as amended.
1.12 “
Client ” has the meaning set forth in the introductory
paragraph, or any successor or permitted assign.
1.13 “
Client Indemnitees ” has the meaning set forth in
Section 13.1.
1.14 “
Client IP ” has the meaning set forth in Article
11.
1.15 “
Client-supplied Materials ” means any materials to be
supplied by or on behalf of Client to Catalent for Processing, as
provided in Attachment B , including API.
1.16 “
Commencement Date ” means the first date upon which a
Regulatory Authority approves Catalent as a manufacturer of any
Product.
1.17 “
Confidential Information ” has the meaning set forth
in Section 10.2.
1.18 “
Contract Year ” means, with respect to Contract Year
1, the period beginning on the Effective Date and ending on
December 31st of the first anniversary of the calendar year
following the Commencement Date, and with respect to each Contract
Year thereafter, each consecutive calendar year period beginning on
January 1st and ending on December 31st.
1.19 “
Defective Product ” has the meaning set forth in
Section 5.1.
1.20 “
Effective Date ” has the meaning set forth in the
introductory paragraph.
1.21 “
Exception Notice ” has the meaning set forth in
Section 5.1.
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1.22 “
Facility ” means Catalent’s facility located in
Winchester, Kentucky, USA or such other facility as agreed in
writing by the parties.
1.23 “
Firm Commitment ” has the meaning set forth in
Section 4.2.
1.24 “
Invention ” has the meaning set forth in Article
11.
1.25 “
Losses ” has the meaning set forth in
Section 13.1.
1.26
[*] .
1.27 “
Process ” or “ Processing ” means
the compounding, filling or pressing, producing and bulk packaging
(but not secondary or retail packaging) of the API and Raw
Materials into Product, in accordance with the Specifications and
under the terms of this Agreement.
1.28 “
Processing Date ” means the day on which Product is
scheduled to be compounded by Catalent, as identified in an
Acknowledgement in accordance with Section 4.3.
1.29 “
Process Inventions ” has the meaning set forth in
Article 11.
1.30 “
Product ” means the fully compounded bulk
pharmaceutical product containing the API that has been Processed
in accordance with the Specifications.
1.31 “
Product Maintenance Services ” has the meaning set
forth in Section 2.3.
1.32 “
Purchase Order ” has the meaning set forth in Section
4.3.
1.33 “
Quality Agreement ” has the meaning set forth in
Section 9.7.
1.34 “
Raw Materials ” means all raw materials, supplies,
components and packaging necessary to manufacture and ship Product
in accordance with the Specifications, as provided in Attachment
B , but not including Client-supplied Materials.
1.35 “
Recall ” has the meaning set forth in
Section 9.6.
1.36 “
Regulatory Approval ” means any approvals, permits,
product and/or establishment licenses, registrations or
authorizations, including approvals pursuant to U.S.
Investigational New Drug applications, New Drug Applications and
Abbreviated New Drug Applications, as applicable, of any Regulatory
Authorities that are necessary or advisable in connection with the
development, manufacture, testing, use, storage, exportation,
importation, transport, promotion, marketing, distribution or sale
of Product in the Territory.
1.37 “
Regulatory Authority ” means the international,
federal, state or local governmental or regulatory bodies,
agencies, departments, bureaus, courts or other entities in the
United States (including the United States Food and Drug
Administration) responsible for (A) the regulation
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(including pricing) of any aspect of
pharmaceutical or medicinal products intended for human use or
(B) health, safety or environmental matters
generally.
1.38 “
Review Period ” has the meaning set forth in
Section 5.1.
1.39 “
Rolling Forecast ” has the meaning set forth in
Section 4.2.
1.40 “
Specifications ” means the procedures, requirements,
standards, quality control testing and other data and the scope of
services as set forth in Attachment B , along with any valid
amendments or modifications thereto, in accordance with Article
8.
1.41 “
Supplier ” has the meaning set forth in
Section 3.2(B).
1.42 “
Term ” has the meaning set forth in
Section 16.1.
1.43 “
Territory ” means the United States of America, and
any other country that the parties agree in writing to add to this
definition of Territory in an amendment to this
Agreement.
1.44 “
Unit Pricing ” has the meaning set forth in
Section 7.1(B).
1.45 “
Validation Services ” has the meaning set forth in
Section 2.1.
ARTICLE 2
VALIDATION, PROCESSING &
RELATED SERVICES
2.1
Validation Services . Catalent shall perform the
qualification, validation and stability services described in
Attachment A (the “ Validation Services
”). Notwithstanding anything to the contrary in this
Agreement, the Validation Services shall apply to Client’s
[*] for Contract Year 1.
2.2
Supply and Purchase of Product . Catalent shall Process
Product in accordance with the Specifications, the Applicable Laws
and the terms and conditions of this Agreement.
2.3
Product Maintenance Services . Client will receive product
maintenance services (the “ Product Maintenance
Services ”), [*] , as applicable. In the event
Client does not [*] pursuant to Section 4.1 herein.
Catalent shall keep accurate records of any Product Maintenance
Services utilized by Client during a given Contract Year. Beginning
at the end of Contract Year 2, either, party may request an annual
review of the actual usage of Product Maintenance Services and
Client shall be entitled to audit Catalent’s records
regarding Product Maintenance Services rendered to Client.
Thereafter, the parties shall [*] .
2.4 Other
Related Services . Catalent, shall provide such Product-related
services, other than Validation Services, Processing or Product
Maintenance Services, as agreed to in writing by the parties from
time to time. Such writing shall include the scope and fees for any
such services and
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be appended to this Agreement. The
terms and conditions of this Agreement shall govern and apply to
such services.
ARTICLE 3
MATERIALS
3.1
API .
A. Client
shall supply to Catalent for Processing, at Client’s sole
cost and risk, API, and any other Client-supplied Materials, in
quantities sufficient to meet Client’s requirements for
Product, as set forth in Article 4. Client shall deliver such
items, together with associated certificates of analysis, to the
Facility no later than [*] days before, but not earlier than
[*] months prior to, the Processing Date upon which such
items will be used by Catalent. Client shall be responsible at its
expense for securing any necessary export or import clearances or
permits required in respect of supply to Catalent of such items.
Catalent shall use such items solely and exclusively for Processing
of the Product. Prior to delivery of any such items, Client shall
provide to Catalent a copy of all associated material safety data
sheets, and shall promptly provide any updates or revisions
thereto.
B. Within 30
days of receipt of API or any other Client-supplied Materials by
Catalent, Catalent shall inspect such items to verify their
identity and test such items to confirm that they meet the
associated specifications or certificate of analysis. In the event
that Catalent detects a nonconformity with Specifications, Catalent
shall give Client prompt oral and written notice of such
nonconformity. Catalent shall not be liable for any defects in API
or any other Client-supplied Materials, or in Product as a result
of defective API or any other Client-supplied Materials, unless
Catalent failed to properly perform the foregoing obligations.
Catalent shall follow Client’s reasonable written
instructions in respect of return or disposal of defective API or
any other Client-supplied Materials, at Client’s sole cost
and risk.
C. Client
shall retain title to API and any other Client-supplied Materials
at all times and shall [*] .
3.2 Raw
Materials .
A. Catalent
shall be responsible for sourcing and qualifying third-party
suppliers of Raw Materials. Catalent shall also be responsible for
procuring, inspecting and releasing adequate Raw Materials as
necessary to, meet the Firm Commitment, unless otherwise agreed to
by the parties in writing. Unless a particular Raw Material can be
replaced with the same raw material from another supplier, Catalent
shall not be liable for any delay in delivery of Product if
(i) Catalent, exercising commercially reasonable efforts, is
unable to obtain, in a timely manner, a particular Raw Material
necessary for Processing and (ii) Catalent placed orders for
such Raw Materials promptly following receipt of Client’s
Firm Commitment. In the event that any Raw Material becomes subject
to purchase lead time beyond the Firm Commitment time frame,
the
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parties will negotiate in good faith
an appropriate amendment to this Agreement, including Sections 3.4
and 4.2.
B. In certain
instances, Client may require a specific supplier, manufacturer or
vendor (“ Supplier ”) to be used for Raw
Material. In such an event, (i) such Supplier will be
identified in the Specifications, (ii) Client shall be
responsible for the timeliness, quantity, and quality of supply of
Raw Materials from such Supplier, (iii) Catalent shall not be
liable for any defects in Raw Materials from such Supplier, or in
Product as a result of such defective Raw Materials, unless
Catalent failed to properly perform any testing required by the
Specifications, and (iv) the Raw Materials from such Supplier
shall be deemed, for purposes of liability hereunder,
Client-supplied Materials. If the cost of the Raw Material from any
such Supplier is greater than Catalent’s costs for the same
raw material of equal quality from other suppliers, Catalent shall
notify Client in writing and provide Client with documentary
evidence of the same. If Client does not, within 20 business days
of its receipt of such notice, designate a lower cost supplier
identified in such notice, then Catalent shall [*] . If the
documented cost of the Raw Material from any supplier mandated by
Client is less than Catalent’s documented cost for the same
raw material of equal quality from other suppliers, then Catalent
shall [*] . [*] will be responsible for all costs
associated with qualification of any such Supplier who has not been
previously [*] . Catalent shall maintain an inventory of Raw
Materials in sufficient quantities to be able to supply up to
[*] per dose strength that is included in the Firm
Commitment portion of the most recent Client forecast.
Notwithstanding anything to the contrary in this
Section 3.2(B), a sole supplier of any Raw Material shall not
be deemed a Supplier required by Client, nor shall the Raw Material
supplied by such supplier be deemed Client-supplied
Materials.
3.3
Artwork and Packaging . Client shall provide or approve,
prior to the procurement of applicable components, all artwork,
advertising and packaging information necessary for Processing, if
any. Such artwork, advertising and packaging information is and
shall remain the exclusive property of Client, and Client shall be
solely responsible for the content thereof. Such artwork,
advertising and packaging information or any reproduction thereof
may not be used by Catalent in any manner other than performing its
obligations hereunder.
3.4
Reimbursement for Materials . In the event of (A) a
Specification change for any reason, (B) obsolescence of any
Raw Material or (C) further to Section 16.3(C),
termination or expiration of this Agreement, [*] shall bear
the cost of any unused Raw Materials (including packaging), so long
as [*] .
ARTICLE 4
[*], PURCHASE ORDERS &
FORECASTS
4.1
[*] .
4.2
Forecast . On or before the 15 th day of each calendar month,
beginning at least 90 days prior to the anticipated Commencement
Date, Client shall furnish to Catalent a written [*]
rolling
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forecast of the quantities of
Product that Client intends to order from Catalent during such
period (“ Rolling Forecast ”). The first
[*] months of such Rolling Forecast shall constitute a
binding order for the quantities of Product specified therein
(“ Firm Commitment ”) and the following
[*] ; of the Rolling Forecast shall be non-binding, good
faith estimates; provided however that Client shall
be obligated to provide purchase orders for the Firm commitment. If
Client fails to timely provide a Rolling Forecast, the most
recently provided Rolling Forecast shall be deemed resubmitted for
the then-current [*] .
4.3
Purchase Orders .
A. From time
to time as provided in this Section 4.3(A), Client shall
submit to Catalent a [*] purchase order for Product
specifying the number of Batches to be Processed, the Batch size
(to the extent the Specifications permit Batches of different
sizes) and the requested delivery date for each Batch (“
Purchase Order ”); provided , that no Purchase
Order may be for less than [*] . Concurrently with the
submission of each Rolling Forecast, Client shall submit a Purchase
Order for the Firm Commitment. Purchase Orders for quantities of
Product in excess of the Firm Commitment shall be submitted by
Client at least [*] days in advance of the delivery date
requested in the Purchase Order (“Lead Time
Requirement”). Catalent shall be obligated to accept any
Purchase Order that meets the Lead Time Requirement and that is for
a quantity of Product that does not exceed [*] of the
quantity of Product set forth and agreed upon in the Firm
Commitment. Catalent may reject Purchase Orders in excess of
[*] more than the Firm Commitment. Failure to provide a
Purchase Order does not absolve Client of its obligation regarding
the Firm Commitment.
B. Catalent
shall confirm in writing that a Purchase Order has been accepted
within [*] business days of receipt thereof by written
acknowledgement (“ Acknowledgement ”) that it
accepts or rejects such Purchase Order. Each Acknowledgement shall
include the Processing Date and shall either confirm the delivery
date set forth in the Purchase Order or set forth a reasonable
alternative delivery date; provided that any alternative delivery
date proposed by Catalent is within [*] business days of the
delivery date set forth in the Purchase Order. Catalent’s
failure to timely provide an Acknowledgement shall be deemed an
acceptance of Client’s Purchase Order.
C. Notwithstanding
Section 4.3(A), Catalent shall use commercially reasonable
efforts to supply Client with quantities of Product which are up to
[*] % in excess of the quantities specified in the Firm
Commitment, subject to Catalent’s other supply commitments
and manufacturing, packaging and equipment capacity;
provided , that Catalent’s failure to supply Client
with quantities in excess of the quantities specified in the Firm
Commitment shall not constitute a breach of this Agreement by
Catalent.
D. In the
event of a conflict between the terms of any Purchase Order or
Acknowledgement and this Agreement, the terms of this Agreement
shall control.
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4.4
Postponement of Processing Date . Notwithstanding
Section 4.5, Catalent reserves the right to postpone the
Processing Date of all, or any part of, a Purchase Order upon
written notice to Client, if Client refuses or fails to timely
supply conforming API or any other Client-supplied Materials in
accordance with Section 3.1. In such event, Catalent shall
exercise commercially reasonable efforts to reschedule the
Processing Date within a reasonable time and the parties shall
negotiate in good faith a reasonable alternative delivery date for
the Product subject to the affected Purchase Order.
4.5
Modification of Purchase Orders . An accepted Purchase Order
may be modified only, by a written change order signed by both
parties. Unless otherwise specifically agreed by the parties
pursuant to a written change order, both Client shall remain
responsible for the Firm Commitment and Catalent shall Process the
Product in accordance with the Firm Commitment.
4.6
Delivery . Catalent shall use commercially reasonable
efforts to deliver in the quantity and on the shipment date
specified for it on the Purchase Order, via the mode(s) of
transportation and to the party and destination specified on such
Purchase Order. Catalent shall provide Client with as much advance
notice as possible (and will use its best efforts to provide at
least [*] days advance notice where possible) if Catalent
determines that any Processing will be delayed or eliminated for
any reason.
4.7
Observation of Processing . In addition to Client’s
audit right pursuant to Section 9.5, Client may send up to
[*] representatives to the Facility to observe Processing
for a maximum of [*] days per Contract Year (unless
otherwise agreed by Catalent in writing), so long as Client
provides Catalent at least [*] days’ advance written
notice of the attendance of such Client representatives, including
the name and title of each such representative. [*] shall be
given access to Catalent’s Facility only upon
Catalent’s consent, which consent shall not be unreasonably
withheld. Such representatives shall abide by all Catalent safety
rules and other applicable employee policies and procedures, and
Client shall be responsible for such compliance. [*]
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4.8
Inability to Supply . If Catalent determines that it will
not be able to supply Products to Client in material satisfaction
of the most recent Firm Commitment, Catalent shall promptly notify
Client in writing of such determination, which notice shall provide
Client with the details on the extent of the expected shortfall of
supply, the causes of such inability to supply, and
Catalent’s proposed solution to the problem. Upon such notice
of a supply problem, or in any event upon Catalent’s failure
to timely deliver Product in accordance with Client’s
Purchase Order, (i) Client and Catalent will immediately meet
and work together, in good faith, to identify an appropriate
resolution to the supply problem, provided that Section 4.9
shall become applicable in the absence of any such resolution, and
(ii) Catalent shall, during any such shortfall of supply, use
commercially reasonable efforts to continue to supply Products to
Client.
4.9
Back-Up Trigger . In. the event that Catalent is unable for
any reason to timely supply Client with Purchase Orders made in
accordance with Article 4 other than for reasons attributable to
Client’s negligence, intentional wrongful actions, failure to
supply API, or default
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hereunder and such inability to
supply lasts longer than [*] consecutive days, then in
addition to, and without limitation of, any legal or equitable
remedies available to Client as a result of any breach of this
Supply Agreement by Catalent, Client shall be free to engage a
third party manufacturer for the Product or manufacture it directly
upon written notice to Catalent, and Catalent shall reasonably
cooperate with Client and such third party to effectuate the
limited transfer of Product from Catalent to Client or such third
parry, as appropriate, to enable Client or the third party to
manufacture Product; provided, however, that, during the Initial
Term, upon receiving notice from Catalent that Catalent is in a
position to [*] .
ARTICLE 5
TESTING; SAMPLES;
RELEASE
5.1
Testing; Releasing; Rejection . Within [*] days after
Catalent completes Processing of a Batch, Catalent shall provide
Client or its designee with a certificate of analysis for such
Batch. Client shall be responsible for final release of Product
(including testing), at its cost. Following Client’s receipt
of a shipment of a Batch, Client or Client’s designee may
test samples of such Batch to confirm that the Specifications have
been met. Unless within [*] days after Client’s
receipt of a Batch (“ Review Period ”), Client
or its designee notifies Catalent in writing (an “
Exception Notice ”) that such Batch does not meet the
warranty set forth in Section 12.1 (“ Defective
Product ”), the Batch shall be deemed accepted by Client
and Client shall have no right to reject such Batch. However,
Client’s acceptance of a Batch shall not preclude a
subsequent rejection of such Batch or any portion thereof following
discovery of latent defects in such Batch, including discovery of
any substance that would cause Product to be adulterated within the
meaning of the United States Food, Drug, and Cosmetic Act. Client
must notify Catalent in writing within [*] days of discovery
of a latent defect, and such discovery shall not exceed [*]
after Processing. Upon timely receipt of an Exception Notice from
Client, Catalent shall conduct an appropriate investigation in its
discretion to determine whether or not it agrees with Client that
Product is Defective Product and to determine the cause of any
nonconformity.
If a shipment or partial shipment is
rejected by Client pursuant to the provisions of this
Section 5.1, Client shall return to Catalent at
Catalent’s request and expense (or, at the election of
Client, destroy and provide evidence of such destruction to
Catalent) any such rejected portion of the Batch. Catalent shall
(i) credit the original invoice and credit the amount, if any,
paid by Client in respect of the rejected portion of the Batch
(provided that if there are no additional Purchase Orders under
this Agreement, the amount of the credit shall be converted into a
refund and Catalent shall refund such amount to Client) if Catalent
agrees that the applicable portion of the Batch is non-conforming,
and (ii) adjust the invoice to Client for any portion of the
Batch that was not rejected, payment of which is due in accordance
with the terms of the original invoice. However, the provisions of
this Section 5.1 are subject to Limitations of Liability
contained in Article 14.
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During the pendency of any rejection
discussions Catalent shall, at Client’s request, use
commercially reasonable efforts to promptly supply Client with
additional Product, which Client shall purchase on the same terms
as Product that is the subject of the rejection
discussions.
5.2
Discrepant Results . In the event of a disagreement between
the parties regarding whether Product is Defective Product, which
disagreement cannot be resolved by the parties within [*]
days of the date of the Exception Notice, the parties shall cause a
mutually agreeable independent third party to review records, test
data and to perform comparative tests and/or analyses on samples of
the alleged Defective Product and its components, including API and
other Client-supplied Materials. The independent party’s
results as to whether or not Product is Defective Product and the
cause of any nonconformity shall be final and binding. Unless
otherwise agreed to by the parties in writing, the costs associated
with such testing and review shall be borne by [*] . In the
event the cause of nonconformity cannot be determined or assigned,
the costs associated with the Defective Product and the replacement
of the same shall be shared equally between the parties.
5.3
Defective Processing . Catalent will, at Client’s
option, either replace any Batch of Defective Product, or credit
any payments made by Client for such rejected Batch. THE OBLIGATION
OF CATALENT TO REPLACE DEFECTIVE PRODUCT OR CREDIT PAYMENTS MADE BY
CLIENT FOR DEFECTIVE PRODUCT SHALL BE [*] .
5.4
Supply of Material for Defective Product . In the event
Catalent replaces Defective Product pursuant to Section 5.3,
Client shall supply, at Catalent’s cost, subject to
Section 14.1 herein, Catalent with sufficient quantities of
API, and other Client-supplied Materials in order for Catalent to
complete such replacement Batch.
ARTICLE 6
DELIVERY
6.1
Delivery . Catalent shall segregate and store all Product
until acceptance as set forth in Section 5.1. Catalent shall
tender Product for delivery [*] the Facility promptly
following Catalent’s release of Product. [*] shall be
responsible for all costs and risk of loss associated with shipment
of the Product. Client shall designate a qualified carrier to
Catalent.
6.2
Failure to Take Delivery . If Client fails to take delivery
of any Product on any scheduled delivery date, Catalent shall store
such Product as Client’s agent, and [*] . For each
such Batch of stored Product, Client agrees that: (A)
[*] , (B) [*] , (C) [*] ,
(D) [*] , and (E) [*] . Within 5 days
following a written request from Catalent, Client shall provide
Catalent with a letter confirming items (A) through
(E) of this Section for each Batch of stored
Product.
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ARTICLE 7
PAYMENTS
7.1
Fees . In consideration for Catalent performing services
hereunder:
(A) Client
shall pay to Catalent any unpaid fees for Validation Services set
forth on Attachment A . Such fees shall be paid within
[*] days following invoice, which invoice shall be submitted
to Client by Catalent upon the completion of the relevant phase of
the Validation Services.
(B) Client
shall pay Catalent the unit pricing for Product set forth on
Attachment C (“ Unit Pricing ”). Such
fees shall be paid within [*] days following invoice, which
invoice shall be submitted to Client by Catalent upon tender of
delivery of Product as provided in Section 6.l.
(C) Subject
to Section 2.3, Client shall [*] set forth on
Attachment C . Such [*] shall be submitted to Client
by Catalent upon the anniversary of each Contract Year during the
Term. However, [*] will be [*] .
(C) Other
Fees . Client shall pay Catalent for all other fees and
expenses of Catalent owing in accordance with the terms of this
Agreement, including pursuant to Sections 2.4, [*] ,
[*] and 16.3. Such fees and expenses shall be paid within
[*] days [*] , which invoice shall be submitted to
Client by Catalent as and when appropriate.
7.2 Unit
Pricing Adjustments . Beginning on January 1, [*] ,
the Unit Pricing shall be subject to an [*] price
adjustment, effective on each anniversary date of the first
[*] following the Effective Date. For any increases in Unit
Pricing, the increase shall not exceed [*] . Catalent will
provide Client with reasonable supporting documentation for such
increase at least ninety (90) days prior to a proposed price
increase. Alternatively, for any decreas
