EXHIBIT 10.5
*** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT (INDICATED BY ASTERISKS) HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER 17 C.F.R. SECTIONS
200.80(B)(4), 200.83 AND 230.406.
OMEPRAZOLE SUPPLY AGREEMENT
This Omeprazole Supply Agreement (the "AGREEMENT") is made as of this 25th day
of September, 2003 (the "EFFECTIVE DATE") by and among SANTARUS, INC.
("SANTARUS"), a corporation of Delaware located at 00000 X. Xxxxx Xxx Xxxxx,
Xxxxx 000, Xxx Xxxxx, XX 00000, INTERCHEM TRADING CORPORATION d/b/a INTERCHEM
CORPORATION ("INTERCHEM"), a corporation of New Jersey located at 000 Xxxxx 00
Xxxxx, Xxxxxxx, Xxx Xxxxxx 00000 and UNION QUIMICO FARMACEUTICA, S.A.
("UQUIFA"), a corporation of Spain located at Xxxxxxxx, 000, 00000, Xxxxxxxxx,
Xxxxx.
WHEREAS, UQUIFA is a manufacturer of Omeprazole (Chemical Abstract No.
73590-58-6) and wishes to manufacture and supply Omeprazole to SANTARUS;
WHEREAS, INTERCHEM imports, warehouses, exports and sells Omeprazole
manufactured by UQUIFA; and
WHEREAS, SANTARUS desires a supply of commercial quantities of Omeprazole.
NOW, THEREFORE, in consideration of the mutual covenants set forth herein,
INTERCHEM, UQUIFA and SANTARUS( each, a "PARTY" and, collectively, the
"PARTIES") agree as follows.
1. SCOPE OF AGREEMENT
1.1. This Agreement shall apply to all purchases of Omeprazole by SANTARUS
from UQUIFA during the term of this Agreement.
1.2. This Agreement does not constitute a purchase order. Purchases under
this Agreement shall be made only with purchase orders issued by
SANTARUS to INTERCHEM (each, a "PURCHASE ORDER"). The Purchase Order
shall set forth the quantities of Omeprazole desired, the desired
delivery date and the desired destination for delivery and shall be in
the form attached hereto as Appendix A. All terms and conditions of the
Purchase Orders shall apply, provided that in the event of a conflict
between the terms of any Purchase Order, order acknowledgement,
packaging slip or other documentation, and the terms of this Agreement,
the terms of this Agreement shall control, unless such documentation
specifically states that it overrides conflicting terms of this
Agreement arid is signed by each of the Parties.
1.3. All Omeprazole sold by INTERCHEM on behalf of UQUIFA to SANTARUS will
be manufactured by UQUIFA in accordance with the terms of this
Agreement.
1
2. MANUFACTURING; OMEPRAZOLE SPECIFICATIONS
2.1. UQUIFA shall manufacture the Omeprazole supplied to SANTARUS in
accordance with (a) the specifications set forth on Schedule A attached
hereto, and (b) the specifications, methods, processes and procedures,
including site of manufacture, set forth in UQUIFA's drug master file
(DMF No. 11551) ("DMF") as filed with the U.S. Food and Drug
Administration ("FDA") (both (a) and (b), including any modifications
approved in accordance with Section 2.2 hereof collectively, the
"SPECIFICATIONS"). If UQUIFA wishes to make any change to the
Specifications (including, but not limited to, any change that could
affect the purity, potency, identity and/or physical properties of the
Omeprazole or the site of its manufacture), it shall notify SANTARUS in
writing in advance thereof and comply with the requirements of Section
2.2 prior to implementing such change. Such notification shall describe
the proposed change in sufficient detail so as to permit SANTARUS to
understand the reasons for the proposed change and evaluate the impact
of such change on its development plans, its plans to seek regulatory
approval and its commercialization plans with respect to finished
dosage form products (the "FINISHED PRODUCTS").
2.2. Without limiting the generality of the foregoing provisions, neither
UQUIFA nor INTERCHEM may change the Specifications unless (a) SANTARUS
has agreed in writing to such change (which agreement SANTARUS may not
unreasonably withhold), or (b) such change is required by (1) any
regulatory agency which has jurisdiction over SANTARUS, UQUIFA and/or
any of the Finished Products, or (2) by the U.S. Pharmacopoeia. If any
change to the Specifications requires the approval of the FDA, other
governmental agency or any foreign regulatory agency equivalent to the
FDA, each having jurisdiction over Omeprazole, the Finished Products or
SANTARUS' marketing of Finished Products (each a "REGULATORY AGENCY"),
such change shall not be implemented until each Regulatory Agency has
approved such change in writing and SANTARUS has had sufficient time to
adopt and implement such change into its operations, including but not
limited to any manufacturing of the Finished Products by SANTARUS'
designated contract manufacturers. For the avoidance of doubt, neither
UQUIFA nor INTERCHEM shall supply to SANTARUS hereunder, and SANTARUS
shall have no obligation to accept any Omeprazole from UQUIFA or
INTERCHEM manufactured in contravention of this Section 2.2.
2.3. INTERCHEM and UQUIFA will take commercially reasonable steps necessary
to enable SANTARUS to secure from the relevant Regulatory Agencies
approval of UQUIFA as a source of supply of Omeprazole for SANTARUS'
Finished Products to be marketed anywhere in the world. Without
limiting the generality of the foregoing, INTERCHEM will supply to
SANTARUS, as soon as possible, sufficient quantities of Omeprazole to
enable SANTARUS to support the filing of one or more New Drug
Application (the "NDA") (or Abbreviated New Drug Application, if
applicable), together with all amendments and supplements thereto,
referencing UQUIFA as its supplier of Omeprazole for its initial
Finished Product candidate. UQUIFA will be responsible for
2
procuring and maintaining all regulatory filings and any other
compliance efforts, including without limitation, the DMF, related to
Omeprazole that are required in order to obtain approval from the FDA
of SANTARUS' NDAs referencing Omeprazole and equivalent approvals from
Regulatory Agencies in other jurisdictions, at no additional cost to
SANTARUS.
2.4. UQUIFA shall test, or have tested, each lot of Omeprazole shipped to
SANTARUS using the analytical testing methodologies which are set forth
in the Specifications. With each shipment of Omeprazole, UQUIFA or
INTERCHEM shall deliver to SANTARUS certificates of analysis and
compliance from UQUIFA (a) stating that the Omeprazole being shipped
has been tested and does conform to the Specifications, (b) setting
forth in detail the testing methodology employed by UQUIFA in making
the foregoing determination and the results generated by such tests,
and ( c) confirming compliance with the current good manufacturing
practices ("CGMP") required by the FDA, and other relevant Regulatory
Agencies in those jurisdictions of which SANTARUS has given UQUIFA
notice, with respect to the manufacture and testing of Omeprazole for
use as an active pharmaceutical ingredient in the Finished Products and
subsequent sale in such jurisdictions.
3. FORECASTS
3.1. In order to assist INTERCHEM and UQUIFA in planning the production runs
for Omeprazole, SANTARUS shall use its commercially reasonable efforts
to provide to UQUIFA and INTERCHEM, at least ***
*** of the quantities of Omeprazole required
by SANTARUS, *** period. SANTARUS shall deliver the first such forecast
to INTERCHEM and UQUIFA as soon as reasonably practicable following the
execution of this Agreement, and will update the forecast every ***
thereafter. SANTARUS may, at its discretion, update such forecast more
frequently. It is understood that all such forecasts are intended to be
SANTARUS' estimates of its purchase requirements and they shall not be
binding upon SANTARUS; however, UQUIFA and INTERCHEM shall, at minimum,
supply the amounts specified in Section 3.3.
3.2. After the Finished Products have received approval for marketing from a
Regulatory Agency and have been made generally commercially available
(hereinafter "COMMERCIAL LAUNCH"), UQUIFA and INTERCHEM shall, within
*** days after SANTARUS has provided its *** forecast, notify SANTARUS
in writing of any prospective problems it might have with respect to
supplying SANTARUS' forecasted order quantities. Upon receipt of such
notice, the Parties shall promptly discuss the inability to supply the
amounts forecasted by SANTARUS and work in good faith to agree upon
revised forecast amounts. ***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
3
3.3. Subject to the lead-time requirements specified in Schedule B, UQUIFA
and INTERCHEM shall deliver to SANTARUS' designated facility during any
given month, pursuant to Purchase Orders provided under Section 3.4,
the amount specified in the Purchase Order therefor, which amount may
be ***
***
***
(the "SUPPLY COMMITMENT"). In addition, UQUIFA and INTERCHEM shall use
their best efforts to deliver any and all ordered amounts in excess of
the Supply Commitment.
3.4. SANTARUS shall provide to UQUIFA and INTERCHEM Purchase Orders for
Omeprazole within the lead times set forth in Schedule B. Within ten
(10) business days after the date that a Purchase Order is submitted
(the "ORDER DATE"), INTERCHEM and UQUIFA shall acknowledge receipt of
SANTARUS' Purchase Order and confirm that the amounts of Omeprazole
ordered in the Purchase Order, subject to Section 3.3., will be timely
supplied.
3.5. UQUIFA and INTERCHEM agree to retain a ***
*** . *** of safety stock will be held by INTERCHEM in
the United States and *** of safety stock will be held by UQUIFA in
Spain. UQUIFA AND INTERCHEM will promptly notify SANTARUS if UQUIFA's
manufacturing capacity will be insufficient to fill a Purchase Order
submitted by SANTARUS. Such notice will include the expected duration
of the shortage and its impact on the supply of Omeprazole to SANTARUS.
Such notification shall not operate to relieve UQUIFA or INTERCHEM of
their obligations to deliver the ordered amounts of Omeprazole or
affect SANTARUS' right to pursue any remedies that may be available to
it. UQUIFA and INTERCHEM will use their best efforts to mitigate the
impact on SANTARUS of shortages or other constrained capacity. The
obligations of UQUIFA and INTERCHEM to maintain the safety stock
specified herein shall commence as of the Commercial Launch.
4. ORDER; DELIVERY
4.1. Each Purchase Order for Omeprazole shall specify the quantity of
Omeprazole ordered and the required delivery date and destination,
consistent with the terms of this Agreement. Such delivery dates are
"on dock" at SANTARUS' designated facility for such delivery.
Deliveries must be made on normal business days of the designated
facility unless otherwise coordinated.
4.2. Subject to any agreement between SANTARUS and INTERCHEM and UQUIFA to
the contrary, all orders shall be dispatched by UQUIFA to INTERCHEM,
and INTERCHEM shall make all necessary shipping arrangements to
SANTARUS' designated facility. Freight terms shall be as set forth in
Schedule C.
4.3. INTERCHEM and UQUIFA shall deliver the complete order amounts on the
delivery date specified in the Purchase Order. Following receipt of any
Omeprazole from UQUIFA, INTERCHEM shall be responsible for the
warehousing of the Omeprazole in
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
4
the United States and for coordinating the import/export of the
Omeprazole to the United States and to SANTARUS' designated
manufacturing facilities (which are currently located in the United
States and Canada) in a timely manner and in compliance with the
Specifications and all Applicable Laws (as defined in Section 8.1.1).
INTERCHEM and UQUIFA shall notify SANTARUS of the expected delivery
date of the order to enable receipt to be coordinated.
4.4. Subject to clearance by customs and, if required, the FDA, the
Omeprazole shall be delivered to SANTARUS' designated facility in
UQUIFA's normal packaging and documentation for Omeprazole, including
without limitation cold storage procedures, as reflected in UQUIFA's
DMF, provided that such packaging and documentation shall meet the
customs and regulatory requirements within the United States and/or
Canada, as applicable to the location of SANTARUS' designated facility
for delivery. Each shipment shall include certificates of analysis and
compliance, which include, without limitation, a statement of
compliance with cGMP, and such other documentation and ` information as
may be necessary or desirable for complying with import, export and
customs laws, regulations and requirements as applicable.
5. EXCLUSIVITY; PRICE; PAYMENT
5.1. Subject to Section 5.4, SANTARUS agrees to purchase 100% of its
Omeprazole intended for commercial sale from INTERCHEM and UQUIFA
during the term of this Agreement (the "Exclusivity Obligation").
*** *** ***
5.2. The price for the Omeprazole to be purchased by SANTARUS hereunder is
set forth in Schedule C, as adjusted in accordance with Section 5.3
hereof (the "Price").
5.3. The Price shall be in effect for the *** following the Effective Date
and shall be renegotiated by SANTARUS, on the one hand, and INTERCHEM
and UQUIFA, on the other hand, in good faith on *** reasonably in
advance of the expiration of the applicable *** period and taking into
account then prevailing market conditions.
5.4. SANTARUS shall have no further obligation to comply with the
Exclusivity Obligation under the following circumstances:
(a) in the event of breach by INTERCHEM or UQUIFA of any of the
terms set forth herein which breach is not cured within the
period set forth in Section 11.2; or
(b) in the event that the Parties are unable to agree on an annual
adjustment to the Price (as contemplated by 5.3) by at least
*** prior to the expiration of the applicable ***
period.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
5
In the event the Exclusivity Obligation terminates pursuant to Section
5.4(a) or 5.4(b), INTERCHEM and UQUIFA shall be obligated to continue
to perform under the terms hereof at the most recent previous Price
agreed on by the Parties.
5.5. INTERCHEM shall issue its invoice to SANTARUS at the time of shipment.
Each invoice shall set forth, in U.S. Dollars, the applicable Price for
the shipment properly determined in accordance with the provisions of
this Agreement. Payment of the invoice by SANTARUS shall be within ***
days following receipt of such invoice. Payment shall be subject to the
inspection and acceptance procedures set forth in Section 6. SANTARUS
may withhold a portion of any invoice that it disputes in good faith
pending resolution of such dispute. All invoices and payments shall be
in U.S. Dollars.
6. INSPECTION OF SHIPMENTS
6.1. SANTARUS shall visually inspect or have visually inspected the
Omeprazole delivered hereunder for obvious damage and/or shortage
(collectively, "OBVIOUS DAMAGE") immediately upon receipt and shall
provide INTERCHEM and UQUIFA with written notice of any such Obvious
Damage within *** days after receipt. SANTARUS shall be deemed to
have accepted any shipment of Omeprazole but only with respect to
Obvious Damage, unless INTERCHEM or UQUIFA receives the written notice
required within the ** -day time period specified above. At its
discretion, SANTARUS may also test, or have tested, any lot of
Omeprazole supplied to SANTARUS.
6.2. At any time within *** after receipt of any lot of Omeprazole but
promptly after discovery, SANTARUS may provide INTERCHEM with written
notice of any non-obvious damage, including adulteration of the
Omeprazole, failure to meet Specifications, or other latent damage
(collectively, "NON-OBVIOUS DAMAGE"). Obvious Damage and Non-Obvious
Damage shall hereinafter be collectively referred to as "DAMAGE".
6.3. SANTARUS may reject any portion of any shipment of Omeprazole which
contains any Damage by providing written notice to UQUIFA of its
rejection. SANTARUS agrees to provide UQUIFA's Quality Control
Department with documentation of Damage to confirm the existence
thereof in connection with any notice of rejection.
6.4. If UQUIFA and SANTARUS disagree as to the existence of Damage, then
they will
***
***
***
***
6.5. Provided SANTARUS provides notice of the damage claimed within ***
days of receipt of the allegedly Damaged Omeprazole in the case of
Obvious Damage and within *** of receipt of the allegedly Damaged
Omeprazole in the case of Non-Obvious Damage, whether or not UQUIFA
accepts SANTARUS' basis for rejection, promptly on receipt of a notice
of rejection and/or shortage, UQUIFA and INTERCHEM
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
6
shall, at SANTARUS' request, and at no additional cost to SANTARUS,
deliver to SANTARUS quantities of replacement Omeprazole equal to the
rejected or short quantities as soon as reasonably practicable
thereafter, and in no event more than *** days after such notice is
given. UQUIFA and INTERCHEM will use expedited means of transport, if
so requested by SANTARUS ***
***
6.6. Notwithstanding any other provisions of this Agreement, SANTARUS
agrees, if so requested by UQUIFA, to return to UQUIFA, at UQUIFA's
expense, any Omeprazole that is, or is claimed to be, Damaged or
otherwise to dispose of such Omeprazole as UQUIFA may request.
7. CONFIDENTIALITY
7.1. During the term of this Agreement, the Parties may disclose certain
confidential and proprietary information and data to each other
relating to their respective products, including active pharmaceutical
ingredients and Finished Products ("PRODUCTS") and businesses,
including, but not limited to financial and other business information,
Product samples, formulas, manufacturing processes, specifications,
drawings, schematics and other technical, customer and Product
development plans, forecasts, strategies and other data. Except as
otherwise specifically provided herein, all information disclosed by
one Party (in such capacity, the "DISCLOSING PARTY") to the other Party
(in such capacity, the "RECEIVING Party") relating to the Disclosing
Party's Products and/or its business operations and the results,
reports, etc., of testing and evaluation of any such information shall
constitute "PROPRIETARY INFORMATION."
7.2. Proprietary Information disclosed by a Disclosing Party to a Receiving
Party hereunder shall be used by the Receiving Party solely in
connection with exercising its rights or performing its obligations
under this Agreement.
7.3. In consideration of the Disclosing Party's disclosure and supply of
Proprietary Information, each Party, as a potential Receiving Party,
agrees that, for the term of the Agreement and for a period of ***
years thereafter, it shall use the Disclosing Party's Proprietary
Information exclusively to conduct the activities contemplated under
this Agreement. Each Party further agrees, as a potential Receiving
Party, for the term of the Agreement and for a period of *** years
thereafter, it shall not disclose, without the express written consent
of the Disclosing Party, any Proprietary Information, including this
Agreement or the interest of the Disclosing Party in exploring the
possibility of entering into a business relationship with the Receiving
Party, to any person other than to those employees, consultants or
agents of the Receiving Party ("REPRESENTATIVES") who will be directly
involved in fulfilling the Receiving Party's obligations under this
Agreement, provided that such Representatives have assumed like
obligations of confidentiality in writing to the Disclosing Party.
Notwithstanding the foregoing, (a) SANTARUS may disclose the existence
and terms of this Agreement to bona fide potential investors,
acquirers, corporate partners and financial advisors and (b) UQUIFA
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
7
may disclose the existence (but not the terms of) this Agreement to
bona fide potential investors and financial advisors.
7.4. Each Party, as a potential Receiving Party, agrees to advise those of
its Representatives who receive Proprietary Information (and such other
persons who may receive Proprietary Information as permitted by 7.3(a)
or 7.3(b) above) that such information (a) is proprietary and
confidential to the Disclosing Party and (b) shall not be disclosed to
anyone except as authorized herein. Each Party further agrees to take
such reasonable precautions as it normally takes with its own
confidential and proprietary information to prevent unauthorized
disclosure or use of such Proprietary Information.
7.5. In the event that the Receiving Party is required by any government
regulation, law, court order or rule or otherwise becomes legally
compelled to disclose any Proprietary Information, it will provide the
Disclosing Party with prompt advance notice in writing so that the
Disclosing Party may, at its discretion, reasonably intervene prior to
disclosure. The Receiving Party will exercise its commercially
reasonable efforts to obtain reliable assurance that confidential
treatment will be accorded to such Proprietary Information.
7.6. Notwithstanding any of the foregoing, the term "Proprietary
Information" and the obligation of confidentiality associated therewith
shall not apply to the following information: (a) information which, at
the time of the Disclosing Party's disclosure to the Receiving Party,
is publicly known; (b) information which, after the Disclosing Party's
disclosure to the Receiving Party, becomes publicly known, except where
such knowledge is the result of the Receiving Party's breach of this
Agreement or otherwise is the result of any unauthorized disclosure by
any of its employees or Representatives; (c) information which, prior
to the Disclosing Party's disclosure to the Receiving Party, was
already in the Receiving Party's possession, as evidenced by its prior
written records; or (d) information which, subsequent to the Disclosing
Party's disclosure to the Receiving Party, is obtained by the Receiving
Party from a third Party which is lawfully in possession of such
information and not subject to a contractual or fiduciary relationship
to the Disclosing Party with respect thereto.
7.7. Upon the termination of this Agreement, the Receiving Party shall, if
so requested by the Disclosing Party, promptly return to the Disclosing
Party the originals and all copies of any Proprietary Information then
in the Receiving Party's possession. Notwithstanding the foregoing,
Receiving Party may retain one copy of such Proprietary Information for
archival purposes.
8. QUALITY OF OMEPRAZOLE; REGULATORY MATTERS; REPRESENTATIONS AND
WARRANTIES
8.1. UQUIFA hereby represents, warrants and covenants as follows:
8.1.1. At all times during the term of this Agreement, UQUIFA's
facilities shall remain in compliance with, and the Omeprazole
shall be manufactured and delivered in compliance with, all
applicable laws, regulations and standards, including but not
limited to, the provisions of the Federal Food, Drug and
Cosmetic Act, as
8
amended from time to time (the "Act"); the FDA's cGMP
including the FDA's Guidance for Industry, Manufacturing,
Processing or Holding Active Pharmaceutical Ingredients, March
1998, and any updates thereto; FDA's regulations for drug
establishment registration; the Specifications; the other
rules and regulations promulgated under the Act relating to
the manufacture of pharmaceutical products; and equivalent
laws, regulations and standards promulgated by Regulatory
Agencies in all jurisdictions for which SANTARUS has given
notice to UQUIFA (collectively, the "Applicable Laws").
8.1.2. No Omeprazole constituting or being a part of any shipment to
SANTARUS shall at the time of any such shipment be adulterated
within the meaning of the Act, or the rules and regulations
promulgated thereunder, as such law, rule or regulation is
constituted and in effect at the time of any such shipment.
8.1.3. All Omeprazole supplied to SANTARUS hereunder (i) shall comply
with the Specifications; (ii) shall have been manufactured,
stored and shipped in accordance with the Specifications,
applicable approvals from Regulatory Agencies and all
Applicable Laws, (iii) may be introduced into public commerce
consistent with the intended use for Omeprazole pursuant to
Applicable Laws, and (iv) will have expiration dating of not
less than *** .
8.1.4. All necessary licenses, permits or approvals required by
Applicable Laws in connection with the manufacture, storage,
and shipment of Omeprazole, including without limitation
permits related to manufacturing facilities shall be obtained
and maintained.
8.1.5. UQUIFA will (i) respond fully and accurately to all inquiries
directed to it by the FDA or any other Regulatory Agency that
may impact the quality or timely delivery of Omeprazole and
promptly notify SANTARUS of same, (ii) assist SANTARUS in
responding to inquiries directed to SANTARUS by the FDA or
other Regulatory Agencies, and (iii) provide the FDA or other
Regulatory Agencies with such information and data as is
requested by the FDA or other Regulatory Agencies with respect
to the manufacture, use, route of synthesis and testing of the
Omeprazole.
8.1.6. UQUIFA's DMF is current and acceptable to the FDA and UQUIFA's
manufacturing facilities are in compliance with the FDA's
cGMP.
8.1.7. UQUIFA has disclosed to SANTARUS all warning letters or
similar notices relating to its manufacturing facilities or
import alerts (including FDA Form 483's), if any, for products
manufactured in its facilities issued *** and
UQUIFA will during the term disclose in timely fashion all
such letters, alerts and notices.
8.1.8. UQUIFA has, and shall maintain, sufficient facilities,
personnel and resources to meet its obligations to supply
Omeprazole under this Agreement.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
9
8.1.9. UQUIFA is not aware of any claim by a third party that the
Omeprazole supplied hereunder or its process for manufacturing
the Omeprazole supplied hereunder would, if carried out in the
United States, Canada or Spain or in any other country where
generic Omeprazole is manufactured or sold, infringe,
misappropriate or violate any patent, trade secret or other
intellectual property right in effect in such countries.
8.1.10. To UQUIFA's knowledge (after reasonable inquiry and
investigation), the Omeprazole supplied to SANTARUS under this
Agreement and UQUIFA's process for manufacturing the
Omeprazole supplied hereunder will not infringe,
misappropriate or violate any patent, trade secret or other
intellectual property right in effect during the term of this
Agreement in the United States, Canada or Spain.
8.1.11. There are no pending or threatened claims against UQUIFA
asserting that any of the activities of UQUIFA relating to the
manufacture, import, use and sale of Omeprazole in the United
States, Canada or Spain or the conduct of the activities
contemplated herein by SANTARUS, infringe, misappropriate or
violate the rights of any third party.
8.2. INTERCHEM hereby represents, warrants and covenants as follows:
8.2.1. At all times during the term of this Agreement, INTERCHEM's
facilities shall remain in compliance with, and following
delivery by UQUIFA, the Omeprazole shall be shipped and stored
in compliance with, the Specifications and all Applicable
Laws.
8.2.2. INTERCHEM shall not cause any Omeprazole shipped to SANTARUS
to, at the time of any such shipment, be adulterated within
the meaning of the Act, or the rules and regulations
promulgated thereunder, as such law, rule or regulation is
constituted and in effect at the time of any such shipment.
8.2.3. All necessary licenses, permits or approvals required by
Applicable Laws in connection with the storage and shipment of
Omeprazole by INTERCHEM shall be obtained and maintained.
8.2.4. INTERCHEM will (i) respond fully and accurately to all
inquiries directed to it by the FDA or any other Regulatory
Agency that may impact the quality or timely delivery of
Omeprazole and promptly notify SANTARUS of same, (ii) assist
SANTARUS in responding to inquiries directed to SANTARUS by
the FDA or other Regulatory Agencies, and (iii) provide the
FDA or other Regulatory Agencies with such information and
data as is requested by the FDA or other Regulatory Agencies
with respect to the manufacture, use, route of synthesis and
testing of the Omeprazole.
10
8.2.5. INTERCHEM has disclosed to SANTARUS any and all warning
letters or similar notices relating to its shipping and/or
storage facilities or import alerts (including FDA Form
483's), if any, issued *** and INTERCHEM will
during the term continue to disclose in timely fashion all
such notices.
8.2.6. INTERCHEM has, and shall maintain, sufficient facilities,
personnel and resources to meet its obligations under this
Agreement.
8.2.7. INTERCHEM is not aware of any claim by a third party that
UQUIFA's process for manufacturing the Omeprazole supplied
hereunder would, if carried out in the United States, Canada
or Spain or in any other country where generic Omeprazole is
manufactured or sold, infringe, misappropriate or violate any
patent, trade secret or other intellectual property right in
effect in such countries.
8.2.8. To INTERCHEM's knowledge (after reasonable inquiry and
investigation), UQUIFA's current process for manufacturing the
Omeprazole supplied hereunder and the Omeprazole supplied
utilizing such process does not infringe, misappropriate or
violate any patent, trade secret or other intellectual
property right in effect during the term of this Agreement in
the United States.
8.2.9. There are no pending or threatened claims against INTERCHEM
asserting that any of the activities of INTERCHEM relating to
the manufacture, import, use and sale of Omeprazole in the
United States, Canada or Spain or the conduct of the
activities contemplated herein by SANTARUS, infringe,
misappropriate or violate the rights of any third party.
8.3. SANTARUS hereby represents, warrants and covenants to SANTARUS'
knowledge (after reasonable inquiry and investigation), the Finished
Product will not infringe, misappropriate or violate any third party
patent, trade secret or other intellectual property right in effect
during the term of this Agreement in the United States or Canada
(provided, that SANTARUS' representation does not extend to any
infringement, misappropriation or violation that arises out of or
relates to the Omeprazole or the process for manufacturing the
Omeprazole).
8.4. Each Party represents and warrants that all corporate action on its
part and on the part of each of its officers and directors necessary
for the authorization, execution and delivery of this Agreement has
been taken, it has the full right and authority to enter into this
Agreement and perform its obligations hereunder and that it is not
aware of any obligations owed to third parties that would conflict with
its ability to perform its obligations hereunder.
8.5. If requested in writing by SANTARUS (which request shall be delivered
to both UQUIFA and INTERCHEM), INTERCHEM and UQUIFA shall permit
SANTARUS or its authorized representatives to inspect INTERCHEM's
and/or UQUIFA's facilities and records and be given access to
INTERCHEM's and/or UQUIFA's personnel (at reasonable times, upon
reasonable advance notice and in the company of an
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
11
INTERCHEM or UQUIFA representative, as the case may be, during normal
business hours), to the extent SANTARUS deems reasonably necessary to
enable SANTARUS to verify compliance by INTERCHEM and/or UQUIFA with
its obligations under this Agreement and to verify compliance with any
Applicable Laws.
8.6. UQUIFA and INTERCHEM shall provide to SANTARUS yearly confirmation that
it has timely filed with the FDA and all other relevant Regulatory
Agencies, the required Annual Progress Report to UQUIFA's DMF for the
year then ended.
8.7. SANTARUS shall provide INTERCHEM and UQUIFA copies of product
complaints, or notices or inquiries from the FDA or other Regulatory
Agencies, which raise issues with respect to the manufacture or product
quality of the Omeprazole provided by UQUIFA to SANTARUS. UQUIFA shall
fully and appropriately investigate such matters and provide SANTARUS
with a report of its investigation. In the event that INTERCHEM or
UQUIFA receives any complaint, claims or adverse reaction reports
regarding Omeprazole, including notices from the FDA regarding any
alleged regulatory non-compliance of Omeprazole, such Party shall
promptly and not more than *** after receipt, provide to
SANTARUS all information contained in the complaint, report or notice
and such additional information regarding Omeprazole as SANTARUS may
reasonably request. INTERCHEM and UQUIFA shall comply, at a minimum,
with FDA requirements for complaint handling with respect to such
complaints, claims or adverse reaction reports.
8.8. SANTARUS, INTERCHEM and UQUIFA each further represents and warrants,
for itself, that it shall comply with all Applicable Laws in the
performance of its obligations hereunder.
8.9. UQUIFA and INTERCHEM shall promptly notify SANTARUS of any problems or
unusual production situations which have, or are reasonably likely to
have, an adverse effect on UQUIFA's or INTERCHEM's ability to perform
its obligations hereunder or to deliver the Omeprazole to SANTARUS in a
timely manner. In addition, UQUIFA and INTERCHEM shall notify and, if
applicable, provide copies of any notices or communications to,
SANTARUS of any FDA or other governmental agency inspection,
investigation or other inquiry or communication relating to the
manufacture of the Omeprazole or to any facility at which the
Omeprazole is manufactured, including, but not limited to, any FDA FORM
483 or warning letter, promptly and not more than *** after UQUIFA or
INTERCHEM becomes aware of such inspection, investigation or other
inquiry or communication and shall promptly thereafter provide to
SANTARUS a written summary of all findings and corrective actions taken
or planned by UQUIFA or INTERCHEM, including any written responses from
UQUIFA or INTERCHEM to the FDA or other governmental agency. Such
notices shall not operate to relieve UQUIFA or INTERCHEM of their
obligations to deliver the ordered amounts of Omeprazole or affect
SANTARUS' right to pursue any remedies that might be available to it.
8.10. INTERCHEM and UQUIFA each covenants that it will not in the performance
of its obligations under this Agreement use the services of any person
debarred or suspended
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
12
under 21 U.S.C. Section 35(a) or (b). INTERCHEM and UQUIFA each
represents that it does not currently have, and covenants that it will
not hire, as an officer or an employee, any person who has been
convicted of a felony under the laws of the United States for conduct
relating to the regulation of any drug product under the Act.
8.11. Each party shall maintain insurance as follows:
8.11.1. UQUIFA shall maintain commercial general liability insurance
and product liability insurance with a minimum limit per
occurrence or accident of $ *** and an annual aggregate limit
of $ *** for the term of this Agreement and for *** years
thereafter. Upon request, UQUIFA will provide to SANTARUS
copies of insurance certificates reflecting the above.
8.11.2. INTERCHEM shall maintain commercial general liability
insurance and product liability insurance with a minimum limit
per occurrence or accident of $ *** and an annual aggregate
limit of $ *** for the term of this Agreement and for ***
years thereafter. Upon request, INTERCHEM will provide to
SANTARUS copies of insurance certificates reflecting the
above.
8.11.3. SANTARUS shall maintain commercial general liability insurance
with a minimum limit per occurrence or accident of $ *** and
an annual aggregate limit of $ *** and product liability
insurance with a minimum limit per occurrence or accident of $
*** and an annual aggregate limit of $ *** for the term of
this Agreement and for *** years thereafter. Notwithstanding
the foregoing, SANTARUS shall increase its insurance coverage
as reasonably prudent in connection with the Commercial
Launch. Upon request, SANTARUS will provide to UQUIFA or
INTERCHEM copies of insurance certificates reflecting the
above.
8.12. INTERCHEM and UQUIFA shall immediately notify SANTARUS of any
information of the following kind about Omeprazole provided to
SANTARUS:
8.12.1. information indicating that shipped product has not been
manufactured or supplied in accordance with the
Specifications, cGMP, this Agreement or in compliance with
Applicable Laws; and
8.12.2. information concerning any bacteriological contamination, or
any significant chemical, physical or other changes or
deterioration in the shipped Omeprazole, or the failure of one
or more shipped lots of Omeprazole to meet Specifications,
including stability parameters.
8.13. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NO PARTY MAKES ANY
WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, AND EACH PARTY
SPECIFICALLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
13
9. INDEMNIFICATION
9.1. SANTARUS hereby agrees to and shall defend, indemnify, and hold
harmless INTERCHEM, UQUIFA, their affiliates and each of their
respective employees, officers, directors and agents (the "SUPPLIER
INDEMNITEES"), from, against, and in respect of, any and all losses,
judgments, damages, liabilities, suits, actions, expenses (including
reasonable attorney's fees), and proceedings arising from any claims of
any third party to the extent resulting from:
9.1.1. any misrepresentation, breach of warranty, or the
non-fulfillment of any obligation, covenant, or duty on the
part of SANTARUS under this Agreement;
9.1.2. any claim, complaint, suit, proceeding or cause of action
against any of the Supplier Indemnitees alleging physical
injury or death, brought by or on behalf of an injured party,
or loss of service or consortium or a similar such claim,
complaint, suit, proceeding or cause of action brought by a
spouse, relative or companion of an injured party due to such
physical injury or death, and in each case arising out of the
Finished Products, except to the extent resulting from (i) any
misrepresentation, breach of warranty, or the non-fulfillment
of any obligation, covenant, or duty on the part of INTERCHEM
or UQUIFA under this Agreement, (ii) any negligence or willful
misconduct of the Supplier Indemnitees in performing this
Agreement, or (iii) any claim subject to INTERCHEM's and
UQUIFA's indemnification obligations under Section 9.2;
9.1.3. any negligence or willful misconduct of SANTARUS, its
employees, officers and directors in performing this
Agreement; and
9.1.4. any claim of patent infringement relating to a Finished
Product or the process for manufacturing a Finished Product
(excluding any claim of patent infringement arising out of or
relating to the Omeprazole or the process for manufacturing
the Omeprazole), which claim, if true, would be in
contravention of the representations, warranties and covenants
of SANTARUS hereunder.
9.2. UQUIFA hereby agrees to and shall defend, indemnify, and hold harmless
SANTARUS, its affiliates and each of their respective employees,
officers, directors and agents (the "SANTARUS INDEMNITEES"), from,
against, and in respect of, any and all losses, judgments, damages,
liabilities, suits, actions, expenses (including reasonable attorney's
fees), and proceedings arising from any claims of any third party to
the extent resulting from:
9.2.1. any misrepresentation, breach of warranty, or the
nonfulfillment of any obligation, covenant, or duty on the
part of UQUIFA under this Agreement;
9.2.2. any claim, complaint, suit proceeding or cause of action
against any of the Santarus Indemnitees alleging physical
injury or death, brought by or on behalf of an injured party,
or loss of service or consortium or a similar such claim,
complaint, suit, proceeding or cause of action brought by a
spouse, relative or
14
companion of an injured party due to such physical injury or
death, and in each case arising out of the Omeprazole supplied
by INTERCHEM and UQUIFA to SANTARUS, except to the extent
resulting from (i) any misrepresentation, breach of warranty,
or the non-fulfillment of any obligation, covenant, or duty on
the part of SANTARUS under this Agreement, (ii) any negligence
or willful misconduct of the Santarus Indemnitees in
performing this Agreement, or (iii) any claim subject to
SANTARUS' indemnification obligations under Section 9.1;
9.2.3. any negligence or willful misconduct of UQUIFA or their
respective employees, officers or directors in performing this
Agreement; and.
9.2.4. any claim of patent infringement relating to the Omeprazole
supplied to SANTARUS or the process for manufacturing the
Omeprazole supplied to SANTARUS which claim, if true, would be
in contravention of the representations, warranties and
covenants of UQUIFA hereunder.
9.3. INTERCHEM hereby agrees to and shall defend, indemnify, and hold
harmless the Santarus Indemnitees from, against, and in respect of, any
and all losses, judgments, damages, liabilities, suits, actions,
expenses (including reasonable attorney's fees), and proceedings
arising from any claims of any third party to the extent resulting
from:
9.3.1. any misrepresentation, breach of warranty, or the
nonfulfillment of any obligation, covenant, or duty on the
part of INTERCHEM under this Agreement;
9.3.2. any negligence or willful misconduct of INTERCHEM or their
respective employees, officers or directors in performing this
Agreement.
9.4. The foregoing indemnification obligations are subject to the following:
***
***
***
***
***
9.5. The indemnification rights provided for herein are in addition to, and
not in substitution for, any and all remedies available to a Party
under this Agreement or otherwise at law or in equity. Notwithstanding
anything to the contrary in this Section 9, each Party may, and
expressly reserves the right to, seek judicial relief from any court of
competent jurisdiction in order to obtain an injunction or other
equitable relief.
9.6. IN NO EVENT SHALL ANY OF THE PARTIES HERETO BE RESPONSIBLE OR LIABLE TO
THE OTHER UNDER ANY PROVISION OF THIS AGREEMENT OR UNDER ANY THEORY OF
NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR
ANY CONSEQUENTIAL, INDIRECT, SPECIAL, OR EXEMPLARY DAMAGES OR LOST
PROFITS. FOR THE PURPOSE OF CLARITY, NOTHING IN THIS SECTION IS
INTENDED TO LIMIT THE INDEMNIFICATION OBLIGATIONS OF ANY PARTY WITH
RESPECT TO THE
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
15
CHARACTERIZATION OF ANY CLAIM BY A THIRD PARTY AS CONSEQUENTIAL,
INDIRECT, SPECIAL, OR EXEMPLARY DAMAGES OR LOST PROFITS.
10. COSTS AND EXPENSES OF RECALL
10.1. SANTARUS shall have sole control and responsibility for conducting all
voluntary and involuntary recalls or other related action
(collectively, "RECALLS") of units of any Finished Product; provided,
however, that UQUIFA agrees to reimburse SANTARUS for all of its
reasonable costs and expenses incurred with respect to any Recalls
arising out of any of the causes set forth in Sections 9.2.1 through
9.2.4. This Section 10 is intended to augment and not limit the
indemnification provisions of Section 9 herein.
11. TERM AND TERMINATION.
11.1. This Agreement shall be effective for a period of four (4) years from
the Effective Date hereof (the "INITIAL TERM") and shall be
automatically renewed for additional two (2) year terms unless written
notice of intent to terminate is provided by SANTARUS at least twelve
(12) months prior to the expiration of the Initial Term or any
extension term.
11.2. This Agreement may be terminated by (i) SANTARUS upon ninety (90) days
written notice to INTERCHEM or UQUIFA, as the case may be, of a failure
by INTERCHEM or UQUIFA to perform or observe any material covenant,
condition or agreement to be performed or observed by it under this
Agreement, unless such breach has been cured within the 90-day notice
period and (ii) UQUIFA upon ninety (90) days written notice to SANTARUS
of a failure by SANTARUS to perform or observe any material covenant,
condition or agreement to be performed or observed by it under this
Agreement, unless such breach has been cured within the 90-day notice
period; provided, however, that with respect to a failure to timely
supply ordered quantities of Omeprazole under this Agreement, UQUIFA
and INTERCHEM combined shall have the right to cure such breach no more
than once during the term of this Agreement unless otherwise agreed by
SANTARUS in writing; and provided, further, that if the breach by
SANTARUS is a failure to pay an invoice when due (except as provided in
Section 5.5), then the notice and cure period shall be fifteen (15)
days.
11.3. SANTARUS may terminate this Agreement effective immediately upon
written notice to UQUIFA and INTERCHEM in the event that (a) UQUIFA or
INTERCHEM dissolves, is declared insolvent or bankrupt by a court of
competent jurisdiction; (b) a voluntary or involuntary petition of
bankruptcy is filed in any court of competent jurisdiction by UQUIFA or
INTERCHEM; or (c) this Agreement is assigned by UQUIFA or INTERCHEM for
the benefit of creditors. UQUIFA or INTERCHEM may terminate this
Agreement effective immediately upon written notice to SANTARUS in the
event that (a) SANTARUS dissolves, is declared insolvent or bankrupt by
a court of competent jurisdiction; (b) a voluntary or involuntary
petition of bankruptcy is filed in any court of competent jurisdiction
by SANTARUS; or (c) this Agreement is assigned by SANTARUS for the
benefit of creditors.
16
11.4. SANTARUS may terminate this Agreement upon thirty (30) days' prior
written notice to INTERCHEM and UQUIFA (or a shorter period required by
the agency with jurisdiction) in the event that any governmental agency
takes any action, or raises any objection, that prevents SANTARUS from
importing, exporting, purchasing or selling either the Omeprazole or
the Finished Product for a period reasonably anticipated to endure for
more than 120 days.
11.5. In the event of termination of this Agreement by SANTARUS due to an
uncured breach of this Agreement by INTERCHEM or for INTERCHEM's
dissolution, insolvency or bankruptcy pursuant to Section 11.3, UQUIFA
will supply Omeprazole directly to SANTARUS, at SANTARUS' election,
under terms of an agreement no less favorable to SANTARUS than the
terms herein.
11.6. SANTARUS may terminate this Agreement effective immediately upon
written notice to INTERCHEM and UQUIFA should any legal proceeding be
instituted against INTERCHEM or UQUIFA, which is reasonably likely to
materially adversely impact INTERCHEM's and/or UQUIFA's ability to
properly perform under this Agreement or subject SANTARUS to any
material risk of liability or loss.
11.7. In the event of termination of this Agreement by SANTARUS pursuant to
Section 11.4, SANTARUS ***
***
***
***
***
11.8. The provisions of this Section 11 as to termination shall not limit or
restrict the rights of any Party to seek remedies or take measures that
may be otherwise available to it at law or equity in connection with
the enforcement and performance of obligations under this Agreement.
12. NOTICES
Any and all notices required to be given under this Agreement will be in writing
and effective upon receipt, sent by facsimile transmission, mailed postage
prepaid by first-class certified or registered mail, or sent by express courier
service, at the respective addresses, as follows:
IF TO SANTARUS, TO:
Santarus, Inc.
00000 X. Xxxxx Xxx Xxxxx
Xxxxx 000
Xxx Xxxxx, XX 00000
Attention: Vice President, Manufacturing
and Product Development
Telephone Number: (000) 000-0000
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
17
Facsimile Number: (000) 000-0000
With a copy to:
Santarus, Inc.
00000 X. Xxxxx Xxx Xxxxx
Xxxxx 000
Xxx Xxxxx, XX 00000
Attention: Sr. Dir., Legal Affairs
Telephone Number: (000) 000-0000
Facsimile Number: (000) 000-0000
IF TO INTERCHEM, TO:
Interchem Trading Corporation
000 Xxxxx 00 Xxxxx
X.X. Xxx 0000
Xxxxxxx, XX 00000
Attention: Xxxxxx X. Pizza
Telephone Number: 000-000-0000
Facsimile Number: 000-000-0000
IF TO UQUIFA, TO:
Union Quimico Farmaceutica, SA
Xxxxxxxx, 000
00000 Xxxxxxxxx, Xxxxx
Attention: Xxxx X. Xxxxxxx, Chief Executive
Telephone Number: 000-00-00-000-00-00
Facsimile Number: 011-34-93-488-04-91
With a copy to:
Union Quimico Farmaceutica, SA
Xxxxxxxx, 000
00000 Xxxxxxxxx, Xxxxx
Attention: Legal Affairs
Telephone Number: 000-00-00-000-00-00
Facsimile Number: 011-34-93-488-04-91
13. MISCELLANEOUS
13.1. Force Majeure. In the event that any Party hereto is prevented from
complying, either in whole or in part, with any of the terms or
provisions of this Agreement by reason of fire, flood, storm, strike or
lockout, riot, war, rebellion, lack or failure of transportation
18
facilities, court order, accident, or Acts of God, and to the extent
that the foregoing are beyond a Party's reasonable control, then,
unless conclusive evidence to the contrary is provided, upon written
notice by the Party whose performance is so affected to the other, the
requirements of this Agreement so affected (to the extent affected)
shall be suspended during the period of, and only to the extent of,
such disability. Said Party shall be excused by reason of said force
majeure only so long as it is exercising its best efforts to overcome
said reason.
13.2. Assurances. Each Party to this Agreement shall execute, acknowledge and
deliver such further instruments and documents, and do all such other
acts and things as may be required by law or as may be necessary or
advisable to carry out the intents and purposes of this Agreement. The
Parties will cooperate with each other and offer reasonable assistance
in carrying out their respective responsibilities under this Agreement.
13.3. Compliance with Laws. Each Party will comply with all applicable laws,
rules and regulations in the conduct of its responsibilities and
activities under this Agreement.
13.4. Governing Law. This Agreement shall be construed in accordance with the
internal laws of the State of *** without reference to the conflict of
laws provisions thereof. Each of the Parties hereto consents and agrees
to the exclusive jurisdiction and venue of the state and federal courts
sitting within the State of *** in connection with any legal
proceedings brought by any other part relating to the subject matter of
this Agreement and further agrees and consents that any resulting
judgment rendered by any such court against a Party shall be valid and
binding on such Party and may be entered in any jurisdiction in which
such Party is located.
13.5. Severability. If any provision of this Agreement shall be held to be
invalid, illegal, or unenforceable, the validity, legality, or
enforceability of the remaining provisions hereof shall not in any way
be affected or impaired thereby unless the purposes of the Agreement
cannot be achieved. In the event any provision shall be held invalid,
illegal, or unenforceable the Parties shall use best efforts to
substitute a valid, legal, and enforceable provision which insofar as
practical implements the purposes hereof.
13.6. No Assignment. No Party shall assign its rights and/or obligations
under this Agreement without the prior written consent of the other
Parties hereto, except that (a) SANTARUS may assign this Agreement in
connection with the transfer or sale of all or substantially all of its
assets or business to which the subject matter of this Agreement
relates or in connection with any merger, consolidation or
reorganization, without UQUIFA's or INTERCHEM's prior written consent;
and (b) UQUIFA and/or INTERCHEM may assign this Agreement in connection
with the transfer or sale of all or substantially all of its assets or
business to which the subject matter of this Agreement relates or in
connection with any merger, consolidation or reorganization with
SANTARUS's prior written consent, which consent may not be unreasonably
withheld.
13.7. Waiver. No delay, waiver, omission or forbearance on the part of any
Party to exercise any right, option, duty or power arising out of any
breach or default by any other Party of any of the terms, provisions or
covenants hereof, will constitute a waiver by such Party of
19
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
its rights to enforce any such right, option, duties or power as
against the other Party hereto, or its rights as to any subsequent
breach or default by the other Party.
13.8. Survival. Upon termination or expiration of this Agreement, the
obligations of the Parties which by their nature should survive and the
obligations under Sections 7-13 of this Agreement and under any
existing confidentiality agreements between the Parties shall survive.
13.9. Entire Agreement. This Agreement and the Schedules attached hereto and
the confidentiality agreements referenced in Section 13.8 constitute
the full understanding and entire agreement between the Parties and
supersede any and all prior oral or written understandings and
agreements with respect to the subject matter hereof. No terms,
conditions, understandings, or agreements purporting to modify, amend,
waive or terminate this Agreement, or any provision hereof, shall be
binding except by the execution of a writing specified to be an
explicit amendment to this Agreement duly executed by the authorized
signatories of the Parties hereto. No modification, waiver,
termination, rescission, discharge or cancellation of any right or
claim under this Agreement shall affect the right of any Party to
enforce any other claim or right hereunder.
13.10. Binding Agreement. Subject to Section 13.6, this Agreement shall be
binding upon the Parties and their respective successors and permitted
assigns and shall insure to the benefit of the Parties and their
respective successors and permitted assigns.
13.11. Headings. The headings used in this Agreement are for convenience of
reference only and are not a part of the text hereof.
13.12. Counterparts. This Agreement may be executed in counterparts, each of
which shall constitute an original and all of which shall together
constitute a single agreement.
[Remainder of This Page Intentionally Left Blank]
20
IN WITNESS WHEREOF, the Parties hereby agree to the terms and conditions of this
Agreement.
SANTARUS, INC. INTERCHEM TRADING
CORPORATION d/b/a INTERCHEM
CORPORATION
By: /s/ Xxxxxx X. Xxxxxx By: /s/ Xxxxxx X. Pizza
--------------------------------------- --------------------------------
Name: Xxxxxx X. Xxxxxx Name: Xxxxxx X. Pizza
Title: President & CEO Title: President
Date: 10/13/03 Date: 9/29/2003
UNION QUIMICO FARMACEUTICA,
S.A.
By: /s/ Xxxx Xxx Xxxxxxx
---------------------------------
Name: Xxxx Xxx Xxxxxxx
Title: Chief Executive
Date: 6.10.2002
[SIGNATURE PAGE TO OMEPRAZOLE SUPPLY AGREEMENT]
SCHEDULE A
SPECIFICATIONS
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
SCHEDULE B
LEAD TIME
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
SCHEDULE C
PRICING AND SHIPPING TERMS
FREIGHT TERMS: INTERCHEM and UQUIFA shall make all necessary shipping
arrangements to SANTARUS' designated facility, *** SANTARUS'
designated facility, freight prepaid.
SHIPPING METHOD: Air Freight
PRICE:
***
***
***
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
APPENDIX A
FORM OF PURCHASE ORDER
*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
