EXHIBIT 10.13
Dated June 24, 1996
-------------------
ALFA WASSERMANN S.p.A
and
SALIX PHARMACEUTICALS. Inc.
SUPPLY AGREEMENT
Xxxxxxxx Xxxxx + Xxxx
First Floor
Xxxxxx Xxxxx
Xxxx Xxxx
Xxxxxxxxxxxx XX0 0XX
Xxxxxxxx Xxxxx + Xxxx
S O L I C I T O R S
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
ARTICLE 1 - DEFINITIONS................................................. 1
ARTICLE 2 - SUPPLY...................................................... 5
ARTICLE 3 - TERMS AND CONDITIONS OF SUPPLY.............................. 5
ARTICLE 4 - SPECIFICATIONS.............................................. 6
ARTICLE 5 - ORDERS AND QUALITY ASSURANCE................................ 6
ARTICLE 6 - WARRANTIES AID INSPECTION.................................. 7
ARTICLE 7 - INDEMNIFICATION............................................. 8
ARTICLE 8 - CONFIDENTIALITY UNDERTAKING................................. 10
ARTICLE 9 - LICENCE TO MANUFACTURE...................................... 10
ARTICLE 10 - TERMINATION................................................. 11
ARTICLE 11 - NOTICES..................................................... 12
ARTICLE 12 - ENTIRE AGREEMENT AND MODIFICATION........................... 13
ARTICLE 13 - ASSIGNABILITY............................................... 13
ARTICLE 14 - WAIVER OF DEFAULT........................................... 13
ARTICLE 15 - GOVERNING LAW............................................... 13
ARTICLE 16 - FORCE MAJEURE............................................... 13
ARTICLE 17 - LITIGATION.................................................. 14
ARTICLE 18 - HEADINGS.................................................... 14
SUPPLY AGREEMENT
----------------
BETWEEN
ALFA WASSERMANN S.p.A., a corporation organized and existing under the laws
of Italy, with registered of at Contrada S. Emidio 65020 Alanno (Pescara)
Italy, (hereinafter "ALFA"); and SALIX PHARMACEUTICALS, INC., a corporation
organized and existing under the laws of the State of California, United
States of America, with registered office at 0000 X Xxxxxxxx Xxxx, Xxxxx
000, Xxxx Xxxx, Xxxxxxxxxx, XXX 00000 (hereinafter "SALIX").
WHEREAS
(A) ALFA and SALIX have envied into a Licence Agreement (the "Licence
Agreement") of even date herewith with respect to the Products (as defined
below); and
(B) ALFA desires to supply SALIX with Compound (as defined below), subject to
the terms and conditions hereof, and SALIX desires to purchase such
Compound from ALFA.
NOW THEREFORE, for and in consideration of the premises and the understandings
herein contained it is hereby agreed as following;
Article 1 - DEFINITIONS
-----------------------
The following words and expressions used in this Agreement shall have tile
following meanings:
"ACT" means the United States Food, Drug, and Cosmetic
Act and rules and regulations thereunder and the
equivalent legislation, rules and regulations in
any other country in the Territory, as amended
from time to time, as the context requires.
"AFFILIATE(S)" shall mean any corporation, joint-venture other
entity which directly or indirectly controls, is
controlled by or is under common control with a
party to this Agreement. "Control" shall mean the
possession of the power to direct or cause the
direction of the management and policies of a
person or business entity, whether through
ownership of voting securities, by contract or
otherwise;
"APPLICATION(S) means the new drug application ("NDA") for the
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Products to be filed with the U.S. Food and
Drug Administration ("FDA") or any other
applicable
regulatory authority by SALIX.
"COMPOUND" shall mean the raw material known as "rifaximin",
which is 2,7-(Epoxypentadeca [1,11,13]trienimino)
benzofuro [4,5-e-]-pyrido[1,2-a]benzimidazole-
1,15(2H)-doine, 25-(acetyloxy)-5,6,21,23-
tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-
octamethyl-, [2S-(2R*, 00 X, 00X, 00X*,00X*,00X*
,00X*, 00X*,00X*,00X*,00X*,00X)]-(Xxxxxxxx
Abstract No. 80-621-814) together with all
products analogs and isomers thereof and any
improvements or developments to any of the
foregoing owned or controlled by or licenced to
ALFA in inspect thereof during the term of this
Agreement;
"FACILITY means the plant where the Compound will be
manufactured for the purposes of supplying SALIX
hereunder. Such plant unless notified to SALIX
under Article 2.3 shall be the plant of Alfa
Chemicals Italiana S.r.l. located at Xxxxxx
Xxxxxxxx Xx 00, xx.00, 00000 Xxxxxxxx (Como).
"FDA" shall mean the United States Food and Drug
Administration or any successor agency performing
a similar function or an equivalent foreign
regulatory agency (including without limitation,
the Health Protection Branch in Canada);
"GOVERNMENT" means the FDA other regulatory authority, or
successor agencies thereto.
"LICENCE" shall mean an agreement between the parties of
even date herewith granting a licence in respect
of the Patents and the Technology Rights for the
exploitation of the Product by SALIX within the
Territory;
"MANUFACTURER" shall mean the manufacturer appointed by ALFA to
manufacture the Compound on behalf of ALFA which
manufacturer is at the date hereof Alfa Chemicals
Italiana S.r.l. and which Manufacturer shall be
changed only as provided in Article 2.3
2
"MANUFACTURING LICENCE" shall mean the license granted by ALFA to SALIX to
manufacture the Compound in accordance with the
terms of Article 9.
"NDA" shall mean applications filed with the FDA
requesting approval to market a new drug,
including but not limited to New Drug Applications
and Product License Approvals (PLA), as
applicable.
"NDA APPROVAL" means the date upon which the FDA approves SALIX'S
NDA for the applicable Product.
"NET SALES" shall mean the gross invoiced amount received by
SALIX (or any of its sub-licensees or distributor)
for commercial sales to third parties (who shall
not be Affiliates, sublicensees or distributors of
SALIX or its Affiliates) of the Products in the
Territory, net of all normal trade and cash
discounts and net of all rebates, returns,
transportation and insurance charges, sales, value
added or other direct taxes charged on any
invoice, customs duties and surcharges allowed to
the purchasers as deductions from the purchase
price of the Products or otherwise as specified on
the invoice;
"PATENTS" shall mean the patents and/or patent applications
listed in Part 1 of the Schedule and any other
patent rights in the Territory now existing or
hereafter acquired by or licenced to ALFA
pertaining to the subject matter of such patents
and patent applications or otherwise to the
Compound and/or the Product and any divisions,
continuations and continuations-in-part of any
such patents or patent rights and any patent
granted in respect thereof for the full terms
thereof including any reexaminations, renewals,
extensions and reissues thereof and including any
supplementary protection certificates;
"PRODUCTS" shall mean those pharmaceutical products for human
use in the treatment and/or prevention of
gastrointestinal and respiratory tract diseases
and conditions containing the Compound as an
active ingredient;
"PUTTING INTO COMMERCE" shall mean the date of the first commercial sale
of Products to third parties (who shall not be
Affiliates or sublicensees or distributors of
SALIX or its
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Affiliates) by or on behalf of SALIX or any
sublicensees or distributors of SALIX or its
Affiliates under the terms of this Agreement made
in any part of the Territory after all relevant
marketing and pricing approvals shall have been
granted by the relevant regulatory authorities in
respect of the Product in such part of the
Territory;
"SCHEDULE" shall mean the Schedule hereto comprising Parts 1
to 3 thereof;
"SPECIFICATIONS" means the requirements, standards and other items
for Compound attached as Part 2 of the Schedule,
as amended from time to time in accordance with
the provisions hereof to comply with the
Applications.
"TECHNOLOGY RIGHTS" shall mean all intellectual property and other
proprietary rights and all confidential
information and knowhow pertaining to the Compound
and/or the Product or otherwise to the Patents in
any respect (including without limitation all
improvements, inventions, derivatives, formulation
data, specifications, manufacturing procedures and
technology, technical information, know-how, trade
secrets, pharmacology, toxicology and other pre-
clinical data, clinical data, regulatory
information and marketing data) within the
possession or control of ALFA (whether developed
by or licensed to ALFA) (and all such rights and
information within the possession or control of
any other licensee of ALFA having right in respect
of the Compound or the Product) in existence as at
the date hereof or arising during the term of this
Agreement which are available to ALFA for the
Territory.
"TERRITORY" shall mean the United States (its territorial
possessions, territories and the Commonwealth of
Puerto Rico) and Canada;
"VALID CLAIM" shall mean a claim of an issued and unexpired
patent included within the Patents, which has not
been held permanently revoked, unenforceable or
invalid by a decision of a court or other
governmental agency of competent jurisdiction
unappealable or unappealed within the time allowed
for appeal and which has not been admitted to be
invalid or unenforceable through reissue or
4
disclaimer or otherwise;
ARTICLE 2 - SUPPLY
------------------
2.1 Subject to the terms hereof, ALFA agrees to sell to SALIX, and SALIX agrees
(subject only to the provisions of Article 9) to purchase from ALFA, all
such quantities of Compound required by SALIX for use in the manufacture of
Product for sale in the Territory in exercise of the rights granted to
SALIX by ALFA under the Licence.
2.2 ALFA, at its sole expense, will provide all labour, utilities, equipment,
raw materials and components necessary for manufacturing, shipping and
storage of the Compound in compliance with the Specifications and the
warranties contained in Article 6.1.
2.3 Subject to the prior written approval of SALIX (which approval shall not be
unreasonably withheld or delayed but may be conditional upon receipt of
necessary Government approvals), ALFA may change the Manufacturer and/or
the Facility. In such event, the obligations of ALFA under this Agreement
shall continue and ALFA shall remain solely responsible for the performance
of its obligations under this Agreement notwithstanding the appointment of
a Manufacturer. ALFA shall use its best endeavours to procure that the
Manufacturer shall comply in full with all obligations of ALFA hereunder.
ARTICLE 3 - TERMS AND CONDITIONS OF SUPPLY
------------------------------------------
3.1 The price to be paid by SALIX to ALFA for Compound shall be as set forth in
Part 3 of the Schedule and shall be inclusive of the cost of carriage
insurance and freight of the Compound to SALIX as specified in Article 3.2.
3.2 The Compound will be delivered by ALFA to a plant in close proximity to a
major airport, as designated by SALIX from time to time by notice to ALFA.
Title and risk shall be deemed to have passed to SALIX when the Compound is
delivered by the carrier to the plant designated by SALIX.
3.3 SALIX will pay for each shipment within forty-five (45) days after
whichever shall be the later of the date the relevant invoice is received
by SALIX or the date of receipt of the Compound, by SWIFT (international
communications) wire transfer in US dollars to such bank and account in
Italy as is designated by ALFA in writing for such purpose. ALFA shall be
responsible for securing any governmental permits or making any filings
with the Italian government required in connection with such payment.
3.4 For a period of [*] following the Putting into Commerce of Product for each
indication, ALFA shall provide [*] to SALIX quantities of Compound not
exceeding [*] of Compound required in connection with the actual total
sales of Product by SALIX during such period, [*] in
5
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
connection with the launch and promotion and marketing of the Products.
ARTICLE 4 - SPECIFICATIONS
--------------------------
4.1 Specifications
--------------
The Compound shall be manufactured, packaged, stored and shipped by ALFA
fully in accordance with the Specifications as described in Part 2 of the
Schedule. The Specifications may be changed by mutual agreement which will
be reached in good faith by the parties.
4.2 Filings.
--------
At SALIX's request following the execution of this Agreement; ALFA shall
promptly (but not later than sixty (60) days after receipt of such request
provide all technical data knowhow and other information relating to the
Patents or the Technology Rights required and necessary to enable SALIX to
file the Applications with respect to the Products in compliance with all
relevant Government regulations.
ARTICLE 5 - ORDERS AND QUALITY ASSURANCE
----------------------------------------
5.1 Delivery Date.
-------------
SALIX shall place firm orders for Compound in economical batches with a
delivery date of not less than ninety (90) days after ALFA's receipt
thereof. SALIX shall submit its initial purchase order not later than 30
days following NDA Approval. Compound shall be shipped to SALIX within the
time frame requested in the applicable purchase order, provided that ALFA
has at least a ninety day lead time.
5.2 Forecasts.
---------
Commencing from the date of filing of the Applications SALIX shall provide
to ALFA a 12 month forecast of its requirements for Products and Compound
which forecast will be updated quarterly until the first Putting into
Commerce. Thereafter, SALIX shall provide a rolling 12 month forecast,
updated monthly.
5.3 SALIX agrees to purchase [*] of SALIX;s
last forecasts for any forecast period, and ALFA agrees to fulfill SALIX's
purchase orders to the extent such orders exceed its revised forecasts for
any forecast period by [*]
ALFA shall use its best efforts to fulfill SALIX purchase orders to the
extent such orders exceed its revised forecasts for any forecast period by
more than [*]
5.4 Quality Assurance.
-----------------
6
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
ALFA, at its sole expense, will perform all testing for the release of raw
materials and components listed in the Specifications. ALFA will supply a
chemical Certificate of Analysis with each batch of Compound and any other
documentation required by law. Complete copies of all test results and/or
assays will be submitted to SALIX promptly following any request therefor
during the term hereof.
ARTICLE 6 - WARRANTIES AND INSPECTION
-------------------------------------
6.1 ALFA Warranties.
---------------
ALFA warrants and undertakes that in respect of all Compound delivered:-
6.1.1 as at the date of delivery to SALIX, such Compound will comply fully
with the Specifications;
6.1.2 as at the date of delivery to SALIX such Compound shall have been
manufactured, packaged, labelled, stored and shipped fully in
accordance with all relevant GMP's, all applicable laws and
regulations and requirements and all commitments and undertakings
made in any applicable regulatory filings;
6.1.3 it will prepare and maintain all such batch records and samples as
may be required for the manufacture of chemical compounds for
pharmaceutical use of this type by any relevant regulatory
authority, for the full period required under any applicable
regulations.
6.2 ALFA confirms that it shall grant to SALIX and its authorised
representatives full access to all such records, documentation and data of
ALFA or its manufacturer(s), as may reasonably be required by SALIX for the
purpose of inspecting the compliance by ALFA with the warranties set out
above Provided Always that such inspection will take place not more than
twice in each calendar year and shall take place upon reasonable notice
upon normal working hours. ALFA will procure access for SALIX to any
Facility at which the Compound is manufactured whether such Facility is
within the control of ALFA or any third party Manufacturer.
6.3 Reporting.
---------
Both parties shall promptly
6.3.1 notify the other party of any governmental inspection of the
Facility by the FDA or any other governmental agency department
which relates to or could adversely affect the manufacture and/or
supply of Compound hereunder; and
6.3.2 supply the other parry with all written communications to or from
Government relating to the above.
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6.4 Quality Control Evaluation.
--------------------------
Within forty-five (45) days of receipt of each shipment of Compound, SALIX
may make a visual or other quality control evaluation of such shipment. If
any shipment fails to conform to the Specifications or shall have been
manufactured, packaged or shipped under conditions which do not comply with
this Agreement, SALIX may reject the same by giving prompt written notice
to ALFA within such forty-five (45) day period, specifying the manner in
which it fails to meet the requirements hereof. If SALIX fails to give
such notice within such period, SALIX shall be deemed to have waived its
right to reject such shipment due to failure to meet Specifications
Provided Always that such waiver shall without prejudice to the rights of
SALIX against ALFA in connection with any latent defect contained in the
Compound or otherwise any breach by ALFA of the warranties contained in
Article 6.1.
6.5 Disposal.
--------
SALIX shall not dispose of any non-conforming shipment without written
authorization and instructions from ALFA. ALFA shall promptly notify SALIX
as to the disposal thereof (at ALFA's sole cost and expense) at the
conclusion of any investigation by ALFA. In no event shall this
investigation exceed sixty (60) days from receipt by ALFA of SALIX's
written notice provided for in Section 6.4.
6.6 Disputes.
--------
Any dispute as to whether any shipment of Compound fails in whole or part
to meet the requirements hereof shall be resolved by an independent testing
organization of recognized repute within the U.S. pharmaceutical industry
agreed upon by the parties, the appointment of which shall not be
unreasonably withheld or delayed by either party. The cost of such
independent testing organization shall be paid by the party in error with
respect to such shipment.
6.7 Product
-------
ALFA shall have the right to inspect or cause to be inspected (at its sole
cost) at any time samples of the Products in order to ascertain whether
they are manufactured using the Compound, and in compliance with the
manufacturing and quality standards established by FDA and for such purpose
shall have the right to visit such facilities at which the Product is
manufactured and to inspect records and samples held at such Facilities
Provided Always that such inspection shall not take place more than once in
each year and shall be upon reasonable notice during normal business hours.
ARTICLE 7 - INDEMNIFICATION AND DAMAGES
---------------------------------------
7.1 In Favour of SALIX.
------------------
ALFA shall defend, indemnify and hold SALIX and its Affiliates and the
respective
8
officers, directors and employees of each harmless from and against any and
all claims, demands, losses, damages, liabilities (including without
limitation Product liability), settlement amounts, cost or expenses
whatsoever (including reasonable legal fees and costs and court costs)
arising from or relating to any claim, action or proceeding made or brought
against such person by a third party as a result of ALFA's negligence,
willful misconduct or breach of this Agreement (including, without
limitation, ALFA's failure to comply with the Specifications, any breach by
ALFA of the warranties contained in Article 6.1 or otherwise any breach of
the provisions of this Agreement by ALFA).
7.2 In Favour of ALFA.
-----------------
Except as otherwise provided in Section 7. 1, SALIX shall defend, indemnify
and hold ALFA and its Affiliates and the respective officers, directors and
employees of each harmless from and against any and all claims, demands,
losses, damages, liabilities (including without limitation Product
liability), settlement amounts, cost or expenses whatsoever (including
reasonable legal fees and costs and court costs) arising from or relating
to any claim, action or proceeding made or brought against such person by a
third party as a result of SALIX's manufacture, use, sale and/or
distribution of the Products.
7.3 Notice: Defence
---------------
In the event of any claim, action or proceeding for which a person is
entitled to indemnity hereunder, the person seeking indemnity ("Claimant")
shall promptly notify the relevant party ("Indemnitor") of such matter in
writing. Indemnitor shall then promptly assume responsibility for and
shall have full control of such matter, including settlement negotiations
and any legal proceedings, and Claimant shall fully cooperate in
Indemnitor's handling and defence thereof Provided Always that Indemnitor
shall keep Claimant fully informed of the progress and conduct of any such
negotiations or legal proceedings and shall not in any settlement or
defence of the same make any admission or otherwise act in such manner as
may prejudice the continuing business or reputation of Claimant without the
prior consent in writing of Claimant (such consent not to be unreasonably
withheld or delayed).
7.4 Consequential Damages.
---------------------
Notwithstanding any provision of this Agreement which might otherwise be to
the contrary, neither party shall under any circumstances be liable to the
other for any indirect loss, lost profits, economic loss or other
consequential damages and in the event of any breach by either party of the
terms of this Agreement or otherwise in the event of the negligence of
either party the damages recoverable shall be limited to such damages as
may be suffered as a direct consequence of any such breach or negligence,
Provided Always that such limitation shall not apply to the indemnity
provisions contained in Articles 7.1 and 7.2 and any such indemnity shall
extend to the full amount of any sums paid by the Claimant to any third
party in connection with such matters (whether or not such sums paid to the
third party include
9
consequential or indirect loss).
ARTICLE 8 - CONFIDENTIALITY UNDERTAKING
---------------------------------------
8.1 During the term of this Agreement and for a period of ten (10) years
thereafter, SALIX shall keep secret and confidential and shall use all
reasonable endeavours to procure that the same is kept confidential all
technical and scientific data, information and know-how and documentation
disclosed to it by ALFA under the terms of this Agreement and shall not
disclose the same to any third party save only as may be required in
connection with the performance of its obligations hereunder or in
connection with any sublicence granted or any potential Investor in SALIX.
8.2 During the term of this Agreement and for a period of ten (10) years
thereafter, ALFA shall keep secret and confidential and shall use all
reasonable endeavours to procure that the same is kept confidential all
technical and scientific data, information and know-how and documentation
disclosed by it to SALIX under the terms of this Agreement together with
all information developed by it from any such information or documentation
and all information data and documentation supplied to it by SALIX in
connection with this Agreement and shall not disclose the same to any third
party save only as may be required in connection with the performance of
its obligations or otherwise to any potential investor in ALFA or any other
licensee of the Patent and/or Technology Rights in respect of any territory
outside the Territory Provided such licensees or potential investor agree
to be bound by the same conditions of confidentiality agreed to by ALFA
herein.
8.3 The obligations contained in Articles 8.1 and 8.2 shall not apply to any
part of such data information or documentation which
8.3.1 shall otherwise than by reason of the default of the recipient after
the date hereof enter the public domain;
8.3.2 the recipient can show was in its possession free of any obligation
of confidentiality prior to the date of receipt in connection with
this Agreement
8.3.3 the recipient is obliged by law or statutory or regulatory authority
to disclose
ARTICLE 9 - LICENCE TO MANUFACTURE
----------------------------------
9.1 In the event that for any reason whatsoever ALFA shall fail to supply SALIX
in accordance with written orders placed by SALIX on ALFA for the Compound
under the terms of this Agreement for a period of ninety (90) days SALIX
shall be granted a license (under all relevant Patents and Technology
Rights) to manufacture the Compound within the Territory or elsewhere. Such
license shall be upon terms whereby:-
9.1.1 such licence shall be continuing, sublicensable and irrevocable in
the event that any such failure to supply continues for a further
period of ninety (90)
10
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
days;
9.1.2 SALIX shall be permitted to manufacture the Compound for the purpose
only of the use of the Compound for use and sale of Products within
the Territory;
9.1.3 [*] shall be due in connection with such manufacturing licence
Provided That, for the avoidance of doubt, SALIX shall continue to
pay all sums due under the provisions of the Licence;
For the purpose of establishing any such manufacturing facility, ALFA will
deliver to SALIX at the request of SALIX after the date hereof all such
information, data and technology relating to the Patents and the Technology
Rights or otherwise relating to processes for the manufacture of the
Compound as SALIX( may reasonably require to enable it to establish a
manufacturing facility and to permit such manufacturing facility to produce
three test batches of the Compound and to enable such manufacturing
facility to qualify as a supplier under the Applications and all regulatory
provisions. In this respect, SALIX shall be entitled to procure that the
NDA shall permit the substitution of SALIX and/or its subcontractor
manufacturer at any time in the event that the Manufacturing License
becomes operative, at the request of SALIX.
9.2 In consideration of the loss of ALFA's appointment to supply all quantities
of Compound required by SALIX (as contemplated under Article 2.1) SALIX
agrees to pay ALFA [*] in respect of the manufacture by SALIX of the
Compound under this Article 9 which is dependent upon the delivery of the
items referred to in Article 9.1. The [*] for such manufacture under the
respective Patents while such Patents are in force or which utilises to a
significant extent confidential know-how of ALFA for such time as it
remains confidential Provided however that no royalties will be due to ALFA
if SALIX does not use such Patents or confidential know-how or if the items
delivered pursuant to Article 9.1 are not sufficient to enable such
manufacture by SALIX.
9.3 To ensure the provision by ALFA of continuity of supply of the Compound
ALFA will procure that at all times after Putting into Commerce of the
Compound it will have at least two facilities fully qualified by FDA and
capable of manufacturing such Compound in compliance with Article 6 for and
on behalf of SALIX.
ARTICLE 10 - TERMINATION
------------------------
10.1 Termination.
-----------
This agreement shall come into force and effect as at the last date of
execution of these presents and shall continue thereafter until whichever
shall be the earlier of:
10.1.1 the expiry of a period of ten years from the date of Putting into
Commerce of the first Product for a non-orphan indication;
11
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
10.1.2 the date of the first commercial sale of a generic of any Product
by a third party in any part of the Territory
and shall continue thereafter torn year to year unless and until either
party shall give not less than six months notice in writing to the other
party of termination.
10.2 In addition to any other rights or remedies a party may have, either party
may terminate this Agreement upon the occurrence of any of the following
events of default which is not cured within thirty (30) days after written
notice thereof is received by the other party:
10.2.1 breach by the other party of any of its material obligations
hereunder; or
10.2.2 should the other party become subject of proceedings involving
bankruptcy, receivership, administration, insolvency, moratorium
of payment reorganization or liquidation, or make any assignation
for the benefit of the creditors or any equivalent measures in
any relevant jurisdiction.
10.3 In the event of termination of the Agreement under the provisions of
Article 10.1 or in the event of termination of this Agreement by SALIX
under Article 10.2, the Manufacturing Licence shall immediately become
effective and thereafter SALIX shall be permitted to manufacture the
Compound under the terms of the Manufacturing Licence.
10.4 The obligations under Articles 6, 7, 8 and 9 shall survive any expiration
or other termination of this Agreement in accordance with their terms.
ARTICLE 11 - NOTICES
--------------------
Except as otherwise herein provided, all notices to be served or notified to the
parties hereunder shall be mailed by registered airmail return receipt requested
to their respective addresses listed below or to any other address subsequently
communicated in writing, and shall be deemed to have been given seven working
days after the date of mailing.
Party By Mail
----- -------
to SALIX: SALIX HOLDINGS Ltd
0000 X. Xxxxxxxx Xxxx,
Xxxxx 000, Xxxx Xxxx,
Xxxxxxxxxx 00000
to ALFA: ALFA XXXXXXXXX S.p.A
Attn. Xx. Xxxxxx Xxxxxxxxx
--------------------------
Xxx Xxxxxxx xxx '00 xx 0
00000 Xxxxxxx, Xxxxx
12
ARTICLE 12 - ENTIRE AGREEMENT AND MODIFICATION
-----------------------------------------------
This Agreement (including the Schedule and the Licence) constitutes the entire
agreement between the parties relating to the subject matter hereof. Save as
expressly provided in the licence all prior agreements or arrangements, written
or oral, between the parties relating to the subject matter hereof are hereby
cancelled and superseded. This Agreement may not be modified except in writing
signed by both parties.
ARTICLE 13 - ASSIGNATION
------------------------
13.1 ALFA shall have the right to assign this Agreement, in whole but not in
part, to any Affiliate of its choice to whom the Patents and Technology
Rights may have been transferred and SALIX hereby acknowledges and accepts
any such assignation but shall not otherwise assign or purport to assign
this Agreement (in whole or in part) without the prior consent in writing
of SALIX.
13.2 SALIX shall have the right to assign this Agreement, in whole but not in
part, to any Affiliate of its choice and ALFA hereby acknowledges and
accepts any such assignation but shall not otherwise assign or purport to
assign this Agreement (in whole or in part) without the prior consent in
writing of ALFA.
13.3 This Agreement shall be binding upon the successors and assignees (and any
subsequent assignee) of each of the parties.
ARTICLE 14 - WAIVER OF DEFAULT
------------------------------
No waiver of any default by either party shall be deemed to constitute a waiver
of any subsequent default with respect to the same or any other provision
hereof. No waiver shall be effective unless made in writing with specific
reference to the relevant provision(s) of this Agreement and signed by a duly
authorized representative of the party granting the waiver.
ARTICLE 15 - GOVERNING LAW
--------------------------
This Agreement is written and executed in two originals in the English language.
All notices, communications and proceedings to be in English. It shall be
governed by and construed in accordance with the laws of Scotland, without
giving any effect to any conflict of laws principles or rules.
ARTICLE 16 - FORCE MAJEURE
--------------------------
Save as expressly provided in Clause 7 neither party shall be liable in any
manner in respect of any breach by such party of its obligations hereunder
(other than any breach of any obligation to make payment on the due date) where
such breach arises from any circumstance outside such party's reasonable
control. Amongst said circumstances are included, by way of example only and
not implying any limitation, fires, floods, earthquakes, accidents, explosions,
quarantine restrictions, strikes labour shortages shortages of raw materials for
the manufacturing of the Products, or acts of any public authority, including
13
foreign ones.
ARTICLE 17 - LITIGATION
-----------------------
The parties hereby agree that any legal action or proceeding arising out of or
in connection with this Agreement shall be brought in the Scottish Courts and
the parties hereby prorogate the non-exclusive jurisdiction of the Court of
Session, Edinburgh.
ARTICLE 18 - HEADINGS
---------------------
Headings are inserted for convenience and shall not affect the meaning or
interpretation of this Agreement IN WITNESS WHEREOF, these present consisting of
this and the twelve preceding pages together with the Schedule hereto are
executed as follows:-
For and on behalf of
SALIX PHARMACEUTICALS, INC
at
on the 24 day of June 1996
By[SIGNATURE ILLEGIBLE] Director
in the presence of
/s/ Xxxxxxx Xxxxxxx
XXXXXXX XXXXXXX
................................Name of Witness
c/o ALFA WASSERMANN
................................Address of Witness
MILANO
................................
For and on behalf of
ALFA WASSERMANN S.p.A.
at
on the 24 day of June 1996
By /s/ Xxxxx Xxxxxxxx Director
in the presence of
/s/ Xxxxxxxxx XxXxxxx
Xxxxxxxxx X. XxXxxxx
................................Name of Witness
c/o SALIX PHARMACEUTICALS
................................Address of Witness
PALO ALTO, CA
................................
14
This is the Schedule referred to in the foregoing Supply Agreement between Alfa
Wassermann S.p.A and Salix Pharmaceuticals, Inc., dated June 24, 1996.
SCHEDULE
PART 1
THE PATENTS
PATENTS
--------------------------------------------------------------------------------
CASE FILING DATE FILING NO. G R A N T I N G NO. OF THE EXPIRY DATE
DATE GRANTED PATENT
S 34 05/11/1981 262,123 07/27/1982 4,341,785 05/11/2001
S 50 04/26/1985 727,521 12/10/1985 4,557,866 04/26/2005
S 73 06/28/1993 083,453 10/04/1994 5,352,679 06/28/2013
Case S 34 (product patent): IMIDAZO-RIFAMYCIN DERIVATIVES WITH ANTIBACTERIAL
UTILITY
Case S 50 (processing patent) : PROCESS FOR THE SYNTHESIS OF PYRIDO-IMIDAZO
RIFAMYCINS
Case S 73 (patent for therapeutical use) : USE OF RIFAXIMIN AND PHARMACEUTICAL
FORMULATIONS CONTAINING IT IN THE TREATMENT OF GASTRIC DYSPEPSIA CAUSED BY
HELICOBACTER PYLORI.
ALL AS FILED FOR THE TERRITORY.
-------------------------------
15
PART 2
COMPOUND SPECIFICATION
---------------------------------------------------------------
[*]
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
PART 3
PRICES
[*]
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
