EXHIBIT 10.12(b)
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CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR
CONFIDENTIAL TREATMENT.
SUPPLY AGREEMENT
is made and entered into as of this 18th day of July 2000
between
TEVA PHARMACEUTICAL INDUSTRIES LTD.
a limited liability company incorporated under the laws of Israel, of 0,
Xxxxx Xxxxxx, 00000 Xxxxxx Xxxxx, Xxxxxx (hereinafter referred to as "TEVA")
and
LABORATORIOS BELMAC,S.A.
a limited liability company incorporated under the laws of Spain, of
Xxxxxxxxxxx, 0 - 0.(x)xxx, 00000 Xxxxxx, Xxxxx
and
LABORATORIOS DAVUR S.L.
a limited liability company incorporated under the laws of Spain, of Xxxxx xx
Xxxxx 000, 00000, Xxxxxx, Xxxxx
("MARKETING AUTHORISATION HOLDERS" defined below)
WHEREAS TEVA and LABORATORIOS BELMAC, S.A. TOGETHER WITH LABORATORIOS DAVUR
S.L. have entered into the Licence Agreement this day for their
appointment as Marketing Authorisation Holder of the Products (as
defined hereunder) and the non-exclusive licence of certain rights and
obligations in the registration files of the Product.
WHEREAS MARKETING AUTHORISATION HOLDERS desire to engage the facilities and
services of TEVA together with its Affiliates to manufacture Product
for MARKETING AUTHORISATION HOLDERS and TEVA has appropriate
facilities to manufacture Product and TEVA together with its
Affiliates is willing to undertake manufacture of Products for
MARKETING AUTHORISATION HOLDERS in accordance with the terms and
conditions set forth herein.
NOW THEREFORE THE PARTIES HERETO AGREE AS FOLLOWS:
1. INTERPRETATION AND DEFINITION
1.1 The preamble to this Agreement forms an integral part hereof. Clause
headings in this Agreement are intended solely for convenience of
reference and shall be given no effect in the interpretation of this
Agreement. All agreed upon and signed annexes to this Agreement,
whether attached at the time of signature hereof or at any time
thereafter, shall be construed as an integral part of this Agreement.
In this Agreement, the following expressions shall bear the meanings
assigned to them below and cognate expressions shall bear
corresponding meanings:
1.1.1 "Affiliates" shall mean with respect to either party, any
person, corporation, company, partnership, joint venture or
other entity controlling, controlled by or under common
control with such party. For such purpose the term "control"
means the holding of 50% or more of the common voting stock
or ordinary shares in, or the right to appoint 50% or more
of the directors of, or the right to share in 50% or more of
the profits of, the said corporation, company, partnership,
joint venture or entity.
1.1.2 "Commercialisation" shall mean the activities carried out in
the Territory pertaining to the importation into,
distribution, marketing and sale of Products.
1.1.3 "Dossier" shall mean the registration file of the Products
(as further defined in the Licence Agreement).
1.1.4 "Launch Date" shall mean the date of Commercialisation of
the Product in the Territory.
1.1.5 "Manufacture" shall mean except as may otherwise be agreed
in writing by the Parties hereto, all technical operations,
including the purchase of raw materials, preparation of the
bulk packages of the Products, final packaging for shipment
and labelling if required, quality control testing,
necessary in order to obtain the Products.
1.1.6 "Manufacturing Cost" shall mean all direct costs of
manufacture, excluding general and administrative costs and
research and development costs.
1.1.7 "Manufacturing Standards" shall mean the specifications of
the Products in compliance with the Dossier, Marketing
Authorisation, cGMP regulations, separate Technical
Agreement and such other specifications as may be agreed to
in writing between the Parties, according to which TEVA or
its Affiliates
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shall manufacture and supply each of the Products under
this Agreement.
1.1.8 "Marketing Authorisation" shall mean any approvals, licences
and permits, required by the Regulatory Authorities in Spain
for the importation, packaging, distribution, marketing and
sale of Products in the Territory.
1.1.9 "MARKETING AUTHORISATION HOLDERS" shall mean Laboratorios
Belmac, S.A. which is owned 100% by Bentley Pharmaceuticals,
Inc. and/or Laboratorios Davur S.L. which is owned 100% by
Laboratorios Belmac, S.A., except in both cases shares held
by directors of each company
1.1.10 "Products" shall mean finished pharmaceutical products ready
for use in humans listed in Appendix A as amended from time
to time hereafter.
1.1.11 "Regulatory Authorities" shall mean any government body or
public organisation responsible for all regulatory matters,
including those incidental thereto, concerning the
importation, distribution, marketing and sale of finished
pharmaceutical products in the Territory.
1.1.12 "Technical Agreement" shall have the meaning set forth in
Clause 3.1 of this Agreement.
1.1.13 "Teva Supply Contact" shall mean Teva or any party that is
so designated by Teva from time to time, responsible for the
co-ordination of the undertakings of Teva Manufacturing Site
(as defined in Clause 2.3).
1.1.14 "Territory" shall mean Spain, including its territories and
possessions and other regions as agreed to in writing
between the parties.
2. SUPPLY AND PURCHASE OF REQUIREMENTS
2.1 TEVA and its Affiliates undertakes to Manufacture and supply to
MARKETING AUTHORISATION HOLDERS all of their requirements of the
Products for the importation, distribution, marketing and sale in the
Territory in accordance with the terms and conditions of this
Agreement.
2.2 The supply by TEVA and its Affiliates of each Product to MARKETING
AUTHORISATION HOLDERS shall be with due regard to MARKETING
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AUTHORISATION HOLDERS' Preferred Customer Pricing Status. "Preferred
Customer Pricing Status" shall mean the Manufacturing Cost for each
Product at TEVA Manufacturing Site , plus the agreed margin of *.
MARKETING AUTHORISATION HOLDERS' obligation to purchase all of their
requirements of the Products shall be non-exclusive; MARKETING
AUTHORISATION HOLDERS shall be permitted to purchase each Product from
other sources in order to meet their requirements subject to the
conditions precedent that MARKETING AUTHORISATION HOLDERS can
establish by contemporaneous written proof that TEVA's or its
Affiliates' price for such Product exceeds the current price from
other qualified sources and TEVA has not exercised its right to match
such lower price upon written notice within seven (7) days from the
date of MARKETING AUTHORISATION HOLDERS' notification to Teva, which
notice need not be given more frequently than once every two (2)
years.
2.3 Each Product shall be supplied by TEVA or its Affiliates. TEVA Supply
Contact shall provide MARKETING AUTHORISATION HOLDERS of the contact
details of the manufacturing site responsible for the supply of such
Product, which site shall be owned by Teva ("Teva Manufacturing
Site"). TEVA Supply Contact shall advise MARKETING AUTHORISATION
HOLDERS of any changes to the contact details of TEVA Manufacturing
Site and any other information that may be relevant for the
undertakings contemplated hereunder.
3. MANUFACTURE AND SUPPLY OF PRODUCTS
3.1 All Products Manufactured by TEVA Manufacturing Site shall be supplied
in accordance with the Manufacturing Standards. TEVA Manufacturing
Site will supply with each batch a Certificate of Analysis and other
documentation as required by the Spanish Regulatory Authorities. The
QA Departments of both Parties shall enter into a Technical Agreement
covering aspects including without limitation quality control, quality
assurance, documentation and batch release to be attached to this
Agreement as an Appendix. Notwithstanding the foregoing, TEVA shall
conduct pre-licensing stability studies as detailed in the Dossiers
and provide updates to MARKETING AUTHORISATION HOLDERS on their
request. TEVA Manufacturing Site shall also conduct post-licensing
stability studies on the first three batches of each Product;
MARKETING AUTHORISATION HOLDERS shall provide TEVA Manufacturing Site
with free samples of the respective Product, the quantity thereof to
be agreed upon between the Parties. TEVA Manufacturing Site shall
provide the data of such studies to MARKETING AUTHORISATION HOLDERS on
their request.
* Confidential information has been omitted and filed confidentially
with the Securities and Exchange Commission.
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3.2 All Products formulated as tablets or capsules shall be Manufactured
and supplied by TEVA Manufacturing Site in bulk packages, unless
agreed otherwise between the Parties in writing. All other Product
formulations shall be Manufactured and supplied in final finished
dosage form, unless agreed otherwise between the Parties in writing.
Upon TEVA'S request MARKETING AUTHORISATION HOLDERS shall include on
packs, patient information leaflets and package inserts the reference
that the respective Product is licensed from Teva(R).
3.3 MARKETING AUTHORISATION HOLDERS shall be entitled on any business day,
upon reasonable prior written notice to TEVA Manufacturing Site, to
inspect TEVA Manufacturing Site's facilities, in order to verify
compliance by TEVA Manufacturing Site with the applicable
Manufacturing Standards. MARKETING AUTHORISATION HOLDERS shall use
their best efforts to limit audits under this Clause to only one visit
in aggregate per year, unless required by special circumstances by the
requirements of the Spanish Regulatory Authorities.
In the event of dispute between the Parties regarding the conclusions
of such audit, the audit report shall be referred for examination to
an independent expert mutually selected by the Parties in order to
determine its compliance to the applicable Manufacturing Standards.
The findings of such expert shall be final and binding on the Parties.
All costs charged by the expert in connection with its examination
shall be borne by the Party that was found to be incorrect.
4. FORECASTS, ORDERS AND DELIVERY OF PRODUCTS
4.1 No later than one hundred and eighty (180) days before the Launch Date
of each Product and each month thereafter commencing at the Launch
Date MARKETING AUTHORISATION HOLDERS shall provide TEVA Manufacturing
Site with a twelve (12) months rolling forecast. The forecast for the
first three (3) months shall constitute a Firm Order and shall set
forth (i) the quantities of each Product to be purchased, (ii)
reasonable delivery dates allowing a lead time of ninety (90) days
from the date of Firm Order and (iii) other reasonable instructions
for shipping and packaging. Such Firm Order shall be binding on both
Parties, when confirmed in writing by TEVA Manufacturing Site within
ten (10) working days. The Forecast for the remaining nine (9) months
shall be for production planning purposes only and shall not
constitute a Firm Order.
4.2 Marketing Authorisation Holders shall purchase from Teva Manufacturing
Site not less than the annual minimum quantities of each Product based
on batch size set out in Appendix D. If Marketing Authorisation
Holders fail to meet these minimum quantities in any year, Teva shall
have the
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right to terminate this Agreement on a Product-by-Product basis.
MARKETING AUTHORISATION HOLDERS shall maintain at least three (3)
month inventory of each Product for Commercialisation in the
Territory.
4.3 TEVA Manufacturing Site shall deliver all Products supplied hereunder
Ex Works [place of manufacture site as advised by TEVA Supply contact]
(Incoterms 2000).
4.4 MARKETING AUTHORISATION HOLDERS shall have a maximum of forty-five
(45) days from the date of its receipt of any delivery of Products by
TEVA Manufacturing Site to inspect the quantity and quality delivered
and to accept or reject such delivery, in whole or in part. The
methods of analysis agreed upon by the Parties shall be used to
determine whether or not the Products meet the relevant
specifications. In the event MARKETING AUTHORISATION HOLDERS do not
notify TEVA Manufacturing Site in writing of either acceptance, defect
or a shortage within such forty-five (45) day period, all of such
delivery shall be deemed to be accepted. Notwithstanding the
foregoing, in the event of a latent defect to any batch of the
Products, which could not have been discovered by MARKETING
AUTHORISATION HOLDERS with reasonable diligence within such forty-five
(45) day period, MARKETING AUTHORISATION HOLDERS shall have fifteen
(15) days from the date that such latent defect was in fact discovered
or should have been discovered to notify TEVA Manufacturing Site in
writing, failing which such batch shall be deemed accepted. TEVA
Manufacturing Site shall upon verification of such defect or shortage,
as the case may be, dispatch non-defective quantities of the relevant
Product in a quantity sufficient to cure the shortage or defect free
of charge.
4.5 In the event of dispute between the Parties regarding the quality of
any Products supplied hereunder, the batch in question or
representative samples thereof, shall be referred for examination to
an independent laboratory mutually selected by the Parties and
authorised by the Regulatory Authorities in order to determine its
compliance to the applicable Manufacturing Standards for such Product.
The findings of such laboratory shall be final and binding on the
Parties. All costs charged by the laboratory in connection with its
analysis shall be borne by the Party that was found to be incorrect.
5. PRICE AND TERMS OF PAYMENT
5.1 The price to be paid by MARKETING AUTHORISATION HOLDERS to TEVA
Manufacturing Site for all quantities of the Products supplied by TEVA
Manufacturing Site shall be at Preferred Customer Pricing Status. No
later than one hundred and eighty (180) days before the Launch Date of
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each Product and thereafter once every year before or on the first
business day of the calendar year TEVA Manufacturing Site shall
provide MARKETING AUTHORISATION HOLDERS with the price of each
Product, which shall be applicable on supplies of Products during the
relevant calendar year or portion thereof. Estimates of Manufacture
costs of the Products are set forth in Appendix B of this Agreement
for reference and information purposes only and shall be construed not
to be binding on either Party. The Preferred Customer Status pricing
shall be in effect no less than for a period of three (3) years
following the Launch Date of the particular Product, or, if there is a
Material Event (as defined below), three years after such Material
Event, whichever is later.
5.2 Notwithstanding Clause 5.1 above, Parties acknowledge and agree that
outside factors may affect the price of one or more Products supplied
by TEVA Manufacturing Site, including without limitation changes in
foreign currency exchange rates, inflation, market conditions and
competition, cost of raw materials, labour and public utilities. Upon
the occurrence of such unforeseen events or circumstances Parties
shall meet and negotiate in good faith the prices and terms of this
Agreement in order to re-establish the basic economic balance thereof
with respect to the Product so affected. In the event Parties cannot
reach an agreement, either Party shall have the right to terminate
this Agreement for the relevant Product.
5.3 Payment for all Products shall be effected by MARKETING AUTHORISATION
HOLDERS to TEVA Manufacturing Site within ninety (90) days of the date
of invoice (such date of invoice not to be earlier than the date of
delivery of the relevant Product) Payments due hereunder shall be made
by bank transfer in Euros as directed by TEVA Manufacturing Site.
5.4 Notwithstanding delivery of the Products to MARKETING AUTHORISATION
HOLDERS, or the mode thereof, title in the Products shall pass to
MARKETING AUTHORISATION HOLDERS upon receipt by TEVA Manufacturing
Site of full payment therefor. Risk of loss and damage in and to the
Product shall pass to MARKETING AUTHORISATION HOLDERS upon delivery
thereof at the agreed delivery location.
6. ADVERSE REACTIONS
6.1 Both Parties shall co-operate with one another and share information
concerning the safety and efficacy of the Products and other
information that may affect the use, sale and marketing of the
Products.
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6.2 Both Parties shall promptly notify each other in writing of any
information concerning any serious or unexpected side-effect, injury,
toxicity, or sensitivity reaction, any unexpected incidents or any
adverse drug experience reports and the severity thereof associated
with the Products, the use, sale and marketing thereof. Both Parties
shall notify each other upon request by the other of other information
concerning not serious adverse reactions attributable to the use of
the Products.
6.3 Nothing in this Article shall be construed as overriding the duty and
responsibilities of both Parties to report adverse reactions
concerning the Product to any Regulatory Authorities in the Territory.
6.4 Both Parties shall advise each other of the names and contact details
of persons responsible for pharmacovigilance / reporting of adverse
reactions / medical information matters in its organisation and shall
keep these details up to date.
7. RECALL
7.1 Whenever a recall in the Territory of a Product manufactured by Teva
Manufacturing Site is being contemplated for any reason, both Parties
shall promptly consult with each other with the purpose of deciding
the appropriate action to be taken with respect thereto. For the sake
of clarity, the responsibility of any recall shall rest with MARKETING
AUTHORISATION HOLDERS as the Marketing Authorisation holder, but it is
agreed that MARKETING AUTHORISATION HOLDERS shall fully consult with
TEVA if a recall is contemplated. Nothing in this Article shall be
construed as overriding the Parties' duties and obligations towards
any Regulatory Authorities in the Territory.
7.2 In the event the recall is due to any act or omission of either Party,
the Party to which such recall is attributable shall bear the costs
and expenses related directly to such recall, or in the case of action
from the Regulatory Authorities regarding a recall which is not
attributable to any act or omission of either Party, the direct costs
and expenses shall be shared equally by TEVA (50%) and the MARKETING
AUTHORISATION HOLDERS (50%).
8. REPRESENTATIONS AND WARRANTIES
8.1 TEVA represents and warrants to the best of its knowledge after
reasonable enquiry that the Manufacturing, use and sale of the
Products,
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in accordance with the corresponding Dossiers, shall contravene no
patents or rights owned or held by third parties in the Territory, it
being understood that the sale of certain Products in the Territory;
provided however it being understood that is anticipated to be cleared
from patent protection on the dates mentioned in Appendix C. For the
avoidance of any doubt, the anticipated dates set forth in Appendix C
are based on the information available to TEVA at the date of this
Agreement. TEVA shall inform MARKETING AUTHORISATION HOLDERS in
writing of any information becoming available to TEVA in the future
that would alter such dates.
8.2 TEVA represents and warrants that (i) the Product supplied hereunder
will be of merchantable quality and fit for the purposes set forth in
the Product package insert, (ii) the Product supplied hereunder shall
be manufactured, packaged (when applicable pursuant to Clause 3.2) and
stored in accordance with the Manufacturing Standards (iii) the
Product supplied hereunder shall be free and clear of all security
interests, liens, or other encumbrances of any kind or character. For
the avoidance of any doubt, the warranties set out in this Clause are
the only warranties given by TEVA and are made in lieu of all other
warranties, express or implied. Any implied warranties of fitness for
a particular purpose or merchantibility applicable to the Product are
hereby excluded.
8.3 MARKETING AUTHORISATION HOLDERS represent and warrant that all
Products purchased hereunder shall be properly packaged (when
applicable pursuant to Clause 3.2), transported and stored in
accordance with the relevant Dossier and Marketing Authorisation.
8.4 Each Party represents and warrants to the other that it holds and will
hold all licences and permits required from all relevant authorities
for the implementation of this Agreement and that it will maintain
such licences and permits for the term of this Agreement, and also
after termination of this Agreement (for any reason) during such
continuing period that any Products manufactured and supplied
hereunder by TEVA are held in inventory by MARKETING AUTHORISATION
HOLDERS.
9. MATERIAL EVENT
9.1 The following occurrences shall be considered a Material Event for
purposes of this Agreement and the Licence Agreement:
9.1.1 for each respective Product, where MARKETING AUTHORISATION
HOLDERS fail to place a Firm Order for such Product with
TEVA Manufacturing Site within 24 months of the date of the
respective Marketing Authorisation, or such later date due
to existing patent
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restrictions as referred to in Clause 6.1 of the Licence
Agreement between the Parties of even date; or
9.1.2 for all respective Products, where MARKETING AUTHORISATION
HOLDERS shall come under the direct or indirect or de facto
direction or control of any party, other than the direction
and control which such parties are under on the date of this
Agreement; or
9.1.3 for all Products, upon TEVA's initiation of commercial
operations in Spain concerning all or substantially all of
the Products through TEVA's acquisition of or joint venture
engagement or similar transactions with a party in Spain.
9.2 For the avoidance of any doubt, the occurrence of any Material Event
shall not itself terminate this Agreement, save the provisions
pursuant to Article 12 below.
10. CONSEQUENCES MATERIAL EVENT
Upon the occurrence of any Material Event pursuant to Article 9 above,
TEVA shall be obligated to supply MARKETING AUTHORISATION HOLDERS with
the Products with due regard to MARKETING AUTHORISATION HOLDERS'
Preferred Customer Status, as set forth in Section 5,1 above.
Following the end of all periods during which the Marketing
Authorisation Holders have Preferred Customer Pricing Status, the
parties shall renegotiate in good faith the price of each relevant
Product commensurate with the prevailing market conditions in the
Territory representing an equitable reward to TEVA for the supply of
Products to MARKETING AUTHORISATION HOLDERS as Marketing Authorisation
holder. In the event Parties cannot reach an agreement, either Party
shall have the right to terminate this Agreement for the relevant
Product.
11. CONFIDENTIALITY
11.1 The term "Confidential Information" shall hereafter be defined as any
secret and/or proprietary information, including without limitation
chemical processes, pharmaceutical formulations, business information
and data, business strategies, product development information,
financial information and data, market studies, and possible or
intended submissions to the relevant Regulatory Authorities,
regardless whether such information is verbal, written, graphic,
photographic, recorded, prototype, sample or in any other form.
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11.2 Each Party shall treat and maintain in strict confidence and secrecy
and shall not use, for a period of ten (10) years from the date of
termination of this Agreement, the Confidential Information disclosed
by the other Party (including all information disclosed prior to the
date hereof). Neither Party shall use any portion of the Confidential
Information disclosed to it by the other Party or disclose such
information to any person or entity whatsoever, except as specifically
provided herein. The Parties may disclose the Confidential Information
of the other Party to their respective consultants, Affiliates,
directors, officers and employees, but only to the extent for which
such disclosure is necessary in furtherance of this Agreement,
provided such Party shall procure from such persons commitments to
treat and maintain the Confidential Information in strict confidence
and secrecy and to not use the information for any purpose whatsoever
except in the performance of their duties in furtherance of this
Agreement.
11.3 Confidential Information shall not include information that can
clearly be demonstrated to have been:
11.3.1 Generally known to the public through no fault of the Party
to whom the Confidential Information was disclosed;
11.3.2 Known to and in the lawful possession of a Party prior to
disclosure thereto by the other Party, as evidenced by
written evidence; or
11.3.3 Obtained from a third party lawfully in possession and with
no limitation regarding disclosure thereof, and having the
right to disclose the same; or
11.3.4 Required to be disclosed by operation of law, provided that
prior to any such disclosure the Party required to make such
disclosure shall notify the other Party in order to enable
the other Party to seek an appropriate protective order and
provided that any such disclosure shall only be to the
extent required to comply with the applicable law.
11.4 In the event that either Party at any time requests return of the
Confidential Information that it provided to the other Party, the
other Party shall promptly surrender to the requesting Party all
documents, records, notes, copies, computer files and other material
containing the applicable Confidential Information and shall not
retain any copies thereof.
12. TERM AND TERMINATION
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12.1 This Agreement and the Licence Agreement that is entered into on the
same date shall become effective as from the date of signature and
shall for each Product be concluded an initial term of 5 years
starting from its Launch Date and shall thereafter be renewed
automatically on an annual and Product-by-Product basis unless either
party provides the other with not less than 6 months' prior written
notice of its intention not to renew.
12.2 Notwithstanding Clause 12.1 above, this Agreement may be terminated
earlier in the way and manner described below:
12.2.1 In the event that a Party to this Agreement should be
dissolved, becomes insolvent, makes a voluntary or
involuntary assignment of assets for the benefit of
creditors, be assigned in bankruptcy court, or otherwise be
faced with circumstances reasonably warranting the
conclusion that, that Party will not be able within the
foreseeable future, to adequately comply with its
obligations under this Agreement, then the other Party to
this Agreement may terminate the Agreement immediately, by
giving notice of its intention to terminate in writing, and
without the Party thereby being terminated having any
entitlement to compensation under whatever title;
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12.2.2 Either Party shall have the right to terminate this
Agreement upon three (3) months written notice to the other
Party in the event of any (direct or indirect) voluntary,
involuntary or compulsory change in the ownership of the
other Party, without any entitlement to compensation under
whatever title. This right of termination is in addition to
and shall not limit TEVA's right to terminate under Article
10.
12.3 Notwithstanding Clause 12.1 above, this Agreement may be terminated
earlier and in part on a Product-by-Product basis in the way and
manner described below:
12.3.1 If one of the Parties to this Agreement commits a breach of
any provision of this Agreement pertaining to a certain
Product and fails to remedy such breach within forty-five
(45) days after written notification of the breach by the
Party not in default, then, the Party not in default shall
have the right to terminate this Agreement in regard of that
relevant Product. If it is apparent that such breach is not
capable of remedy, the Party not in default shall have the
right to terminate this Agreement in regard of that relevant
Product immediately on the date of its written notification
of the breach;
12.3.2 In the event of termination of this Agreement upon three (3)
months written notification by either Party pursuant to
Clause 5.2 and Article 10 and upon three (3) months written
notification by TEVA pursuant to Clause 4.2 of this
Agreement.
13. RIGHTS AND OBLIGATIONS UPON TERMINATION
13.1 Termination of this Agreement for whatever reason (by expiration of
term or otherwise) shall not affect the liabilities of the Parties
hereunder in respect of matters outstanding at the time of such
termination.
13.2 In the event of termination of this Agreement or on a
Product-by-Product basis in accordance with Sections 12.2 or 12.3
above:
13.2.1 TEVA shall have the option, exercisable by written notice
within thirty (30) days of termination, of repurchasing all
stocks of the Products, held by MARKETING AUTHORISATION
HOLDERS, in good and marketable condition at the price paid
to TEVA Manufacturing Site to MARKETING AUTHORISATION
HOLDERS. If the said option is not exercised, MARKETING
AUTHORISATION HOLDERS shall be entitled to continue to
market the Products in the Territory;
13.2.2 Neither Party shall be entitled to any compensation for loss
of profit or loss of goodwill directly or indirectly
attributable to such termination or for any other reason;
13.2.3 Each Party shall return to the other all Confidential
Information supplied by one Party to the other in accordance
with Clause 11.4 above.
13.3 The provisions of Articles 1, 7, 8, 11, 13, 14 and 21 shall survive
termination of this Agreement.
14. CROSS-INDEMINIFACTION
14.1 TEVA agrees to defend, indemnify and hold harmless MARKETING
AUTHORISATION HOLDERS and its Affiliates, its respective officers,
agents, and employees from and against any and all claims, losses,
suits, liabilities, damages and expenses (including, but not limited
to, reasonable attorney's fees) arising out of injuries to persons
and/or damage to property due to (i) a breach by TEVA of any of its
representations and warranties under Article 8 of this Agreement
and/or (ii) a material breach by TEVA of any of its obligations under
this
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Agreement and/or (iii) any damages resulting from the use of the
Products Manufactured by Teva Manufacturing Site which damages are
attributable to acts or omissions of Teva Manufacturing Site in the
Manufacture of such Products and/or (iv) the willful misconduct or
negligence of TEVA in its performance in accordance with this
Agreement.
14.2 MARKETING AUTHORISATION HOLDERS agree to defend, indemnify and hold
harmless TEVA and its Affiliates, its respective officers, agents, and
employees from and against any and all claims, losses, suits,
liabilities, damages and expenses (including, but not limited to,
reasonable attorney's fees) arising out of injuries to persons and/or
damage to property due to (i) a breach by MARKETING AUTHORISATION
HOLDERS of any of its representations and warranties under Article 8
of this Agreement and/or (ii) a material breach by MARKETING
AUTHORISATION HOLDERS of any of its obligations under this Agreement
and/ or (iii) any damages attributable to any acts or omissions in the
Commercialisation of the Products and/or (iv) the willful misconduct
or negligence of MARKETING AUTHORISATION HOLDERS in its performance in
accordance with this Agreement.
14.3 Indemnification pursuant to Clauses 14.1 and 14.2 as the case may be
shall be subject to the condition that either Party shall notify the
other if it becomes aware of any claims, actions, suits, losses,
liability, costs or expenses in respect of which indemnification by
the other Party is called for by this Article. Both Parties shall
consult and co-operate to the extent possible in the defense of any
such claims or suits or negotiations pertaining hereto.
Notwithstanding each Party's responsibility in respect of court
proceedings, neither Party shall take any action with respect to such
claims or suits to prejudice the interests of the other Party.
14.4 Each Party shall effect and maintain product liability insurance
reasonably sufficient to cover damages relating to the Product under
this Agreement. The Parties shall provide each other with proof of
such insurance upon request.
14.5 In the event any third party makes a claim or files a suit alleging
that Teva or the Marketing Authorisation Holders have infringed an
intellectual property right, including a patent or trademark, of such
third party, relating to a Product (an "Infringement Claim"), the
parties agree to inform each other of such infringement or alleged
infringement and to assist each other in taking the necessary steps to
defend these rights.
14.6 Upon receipt of notice to the parties of an Infringement Claim, (i) if
the parties jointly determine to continue to sell the Products in the
Territory, they shall then jointly agree in writing upon how any
eventual liabilities
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will be shared if the third party prevails in the Infringement Claim;
(ii) if Teva decides that the sales of the Products in the Territory
shall continue and the Marketing Authorisation Holders have not
agreed, the Marketing Authorisation Holders shall continue the sales
of the Products in the Territory only upon receipt from Teva of a
written indemnity for all costs and liabilities relating to the
Infringement Claim; and (iii) if the Marketing Authorisation Holders
decides that the sales of the Products in the Territory shall continue
and Teva has not agreed, the Teva shall continue supply the Products
to the Marketing Authorisation Holders only upon receipt from the
Marketing Authorisation Holders of a written indemnity for all costs
and liabilities relating to the Infringement Claim. If no agreement is
reached as set forth in the prior sentence, Teva shall repurchase any
inventory of the affected Products held by the Marketing Authorisation
Holders at the paid to the Teva Manufacturing Site and pay for any
costs and fees for returning such inventory.
15. SEVERABILITY
If any term or provision of this Agreement shall be held invalid or
unenforceable, the remaining terms hereof shall not be affected but
shall be valid and enforced to the fullest extent permitted by law.
The Parties hereto shall use best efforts to substitute a valid, legal
and enforceable provision, which, in so far as practical, implements
the purpose hereof.
16. WAIVER
Failure by either Party at anytime to terminate this Agreement (either
in whole or in part) as a result of a material or persistent breach of
the terms hereof by the other Party or to enforce any of the terms or
conditions of this Agreement, shall not prejudice the right of that
Party subsequently to terminate this Agreement (either in whole or in
part) or enforce its rights hereunder for a subsequent breach of its
obligation hereunder by the other Party.
17. ASSIGNMENT AND DELEGATION
This Agreement, or any part thereof, and the rights and/or obligations
of TEVA hereunder, shall be assignable and/or delegable to its
Affiliates without the prior written consent of the other Party
provided that any such assignment or delegation shall not relieve such
assigning party of its obligations hereunder, and such party shall
remain liable for the proper performance hereunder.
15
18. ENTIRE AGREEMENT
This Agreement, including the preamble and Appendices, constitutes,
with the Licence Agreement and the Rights Agreement, signed on the
same date, the entirety of the agreements binding the Parties on the
subject matter hereof and cancels and replaces all previous
agreements, negotiations, commitments and documents pertaining to the
object of this Agreement. Any amendment thereto, discharge or release
therefrom or other modification thereto, shall be expressed in writing
and signed by the Parties' duly authorised representatives.
For purposes of clarity, no Firm Order, or similar documents delivered
subsequent to the date of this Agreement containing terms and
conditions inconsistent herewith or in addition to this Agreement
shall be effective to amend or modify this Agreement.
19. INDEPENDENT PARTY
This Agreement does not constitute either Party as the agent, legal
representative, or partner of the other for any purpose whatsoever.
Neither Party is granted any right or authority to assume or to create
any obligation or responsibility, express or implied, on behalf of or
in the name of the other, with regard to any manner or thing
whatsoever, unless otherwise specifically agreed upon in writing.
20. NOTICES
Any notice or other written communication required or permitted to be
made or given hereunder may be made or given by either party by
facsimile; by first-class mail, postage prepaid; or by air courier to
the mailing address or facsimile numbers set as below:
If to TEVA:
Teva Pharmaceutical Industries Ltd.
0, Xxxxx Xxxxxx, 00000 Xxxxxx Xxxxx, Xxxxxx
Attention: VP Export & Coordination (N. America/Europe)
Telephone: x000 0 0000 000 Facsimile: x000 0 0000 000
With a copy to:
Teva Pharmaceuticals Europe B.V.
16
Industrieweg 23; 0000 XX Xxxxxxxxx, Xxx Xxxxxxxxxxx
Attention: President
Telephone: x00 (0)000 000 000 Facsimile: x00 (0)000 000 000
If to MARKETING AUTHORISATION HOLDERS:
X/x Xxxxxxxxxxxx Xxxxxx, X.X.
Xxxxxxxxxxx, 0 - 0.(x)xxx, 00000 Xxxxxx, Xxxxx
Attention: Managing Director
Telephone: Facsimile:
With a copy to:
Bentley Pharmaceuticals, Inc.
00 Xxxxxxxxx Xxxx, 0xx Xxxxx
Xxxxx Xxxxxxx, XX 00000, XXX
Attention: President
Telephone: x0 000 000 0000 Facsimile: x0 000 000 0000
or to such other addresses or facsimile numbers as either party shall
designate by notice, similarly given, to the other party. Notices or
written communications shall be deemed to have been sufficiently made
or given: (i) if mailed, fourteen days after being dispatched by mail,
postage prepaid; (ii) if by air courier, seven days after delivery to
the air courier company; or (iii) if by facsimile with confirmed
transmission, within five days of transmission.
21. GOVERNING LAW AND DISPUTE SETTLEMENT
This Agreement, shall be exclusively governed and construed in
accordance with the laws of The Netherlands. The Parties shall
undertake all reasonable efforts in order to solve in an amicable
manner any controversy arising in connection with this Agreement. Any
controversy or dispute or claim arising between the Parties which
cannot be settled amicably in connection with this Agreement or any
agreement in furtherance thereof including disputes with respect to
the validity of those Agreements, shall be finally and exclusively
settled by the competent court in Utrecht, The Netherlands.
22. COUNTERPARTS
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original and all of which together shall be
considered one and the same agreement.
17
23. FORCE MAJEURE
23.1 Neither Party shall be liable for non-performance or delay in the
fulfilment of its obligations when any such non-performance or delay
shall be occasioned by and unforeseeable cause beyond the reasonable
control of Teva or Marketing Authorisation Holder, as the case may be,
including without limitation, acts of God, fire, flood, earthquakes,
explosions, sabotage, strikes, or labour disturbances (regardless of
the reasonableness of the demands of the labour force), or any acts,
restraints, requisitions, regulations, or directives issued by a
competent government authority ("Force Majeure Events").
18
23.2 In the event that either Party is prevented from discharging its
obligations under this Agreement on account of a Force Majeure Event,
such Party shall notify the other forthwith, and shall nevertheless
make every endeavour, in the utmost good faith, to discharge its said
obligations, even if in a partial or compromised manner. In the event
a Force Majeure Event subsists for a period of ninety (90) consecutive
days, the Party not claiming the Force Majeure Event shall be entitled
to terminate this Agreement forthwith, on written notice to the Party
claiming the Force Majeure Event.
IN WITNESS WHEREOF, each of the Parties has executed this Agreement and the
Appendices hereto as of the date below.
TEVA PHARMACEUTICAL INDUSTRIES LTD. LABORATORIOS BELMAC, S.A.
Signature: /s/ X.XX. XXXXXX Signature: /s/ XXXXX X. XXXXXX
------------------------------ -------------------
Name: X.XX. Xxxxxx Name: Xxxxx X. Xxxxxx
Designation: V.P. Europe Designation: President
Signature: /s/ S.W. HU Signature:
------------------------------ -------------------
Name: S.W. Hu name:
---------------------------
Designation: Legal Counsel Europe designation:
--------------------
Date: July 18, 2000 date: July 18, 2000
LABORATORIOS DAVUR S.L.
Signature: /s/ XXXXX X. XXXXXX
--------------------------
Name: Xxxxx X. Xxxxxx
Designation: President
Signature:
--------------------------
Name:
--------------------------
Designation:
--------------------------
Date: July 18, 2000
19
APPENDIX A
LIST OF PRODUCTS Page 1 OF 2
Product Nr. Active Ingredient Formulation
----------- ----------------- -----------
* * *
* Confidential information has been omitted and filed confidentially
with the Securities and Exchange Commission.
20
APPENDIX A
List of Products Page 2 of 2
Product Nr. Active Ingredient Formulation
----------- ----------------- -----------
* * *
* Confidential information has been omitted and filed confidentially
with the Securities and Exchange Commission.
00
XXXXXXXX X
NON-BINDING COST ESTIMATES OF MANUFACTURE BY TEVA MANUFACTURING SITE
PURSUANT TO CLAUSE 5.1
Page 1 of 2
Product Nr. Active Ingredient Cost per 1,000 tabl/caps unless
otherwise indicated (in U.S. $)
----------- ----------------- ------------------------------------
* * *
* Confidential information has been omitted and filed confidentially
with the Securities and Exchange Commission.
00
XXXXXXXX X
NON-BINDING COST ESTIMATES OF MANUFACTURE BY TEVA MANUFACTURING SITE
PURSUANT TO CLAUSE 5.1
Page 2 of 2
Product Nr. Active Ingredient Cost per 1,000 tabl/caps unless
otherwise indicated (in U.S. $)
----------- ----------------- ------------------------------------
* * *
* Confidential information has been omitted and filed confidentially
with the Securities and Exchange Commission.
23
APPENDIX C
NON-BINDING ANTICIPATED PATENT EXPIRY DATES SUBJECT TO CHANGE
PURSUANT TO CLAUSE 8.1
PRODUCT NR. ACTIVE INGREDIENT DATE PATENT NR.
----------- ----------------- ---- ----------
* * * *
* Confidential information has been omitted and filed confidentially
with the Securities and Exchange Commission.
24
APPENDIX D
ANNUAL MINIMUM QUANTITIES PURSUANT TO CLAUSE 4.2
Batch size not available yet on the date of this Agreement.
