EXHIBIT 10.12(a)
----------------
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR
CONFIDENTIAL TREATMENT.
LICENCE 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
( "LICENSEES " defined below)
WHEREAS TEVA together with its Affiliates is developing and/or has
developed and is engaged, inter alia, in the manufacture,
distribution, marketing and sale of certain finished
pharmaceutical products ( "Products" as defined hereunder), from
which specifically are excluded TEVA's oncology products other
than the solid dose formulations thereof; and
WHEREAS it is the intention of TEVA together with its Affiliates to
commence with the registration, marketing, distribution and sale
of the Products in the Territory (as defined hereinafter) as soon
as possible, and that for such purposes, TEVA together with its
Affiliates wishes to appoint LICENSEES as non-exclusive Marketing
Authorisation Holder of certain Products and to license on a
non-exclusive basis the registration dossiers of such Products
that TEVA together with its Affiliates owns or has in its
possession to LICENSEES with the purpose of submitting the
registration dossiers with the relevant regulatory authorities in
the Territory in order to obtain marketing authorisations for the
Products in the Territory and to supply LICENSEES with the
Products in the Territory;
WHEREAS LICENSEES have the capability and the facilities to register,
import, promote, package, sell, market and distribute
pharmaceutical products in the Territory; and
WHEREAS LICENSEES wish to accept their appointment as non-exclusive
holders of Marketing Authorisation and to acquire the
non-exclusive licence right of the registration dossiers of
certain Products and be supplied with their requirements of such
Products for marketing, distribution and sale in the Territory,
subject to the terms and conditions of this Agreement.
WHEREAS TEVA and LICENSEES wish to confirm in writing the undertakings
described above as well as other mutual undertakings with respect
to other Products described 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.
"Control" shall mean 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 "A Products" shall mean Products being the primary objects
of this Agreement and the Supply Agreement between TEVA
together with its Affiliates and LICENSEES set forth in
Appendix A of this Agreement of which the Dossier is either
complete for submission to the Regulatory Authorities or in
development. Such list shall be amended from time to time to
include additional future Products to be mutually agreed
upon between the Parties and/or delete any Products of which
development has been abandoned for whatever reason.
2
1.1.3 "B Products" shall mean Products as listed in Appendix B,
which are excluded from A Products solely on the grounds
that such Products are already being Commercialised by
LICENSEES under LICENSEES' existing contractual commitments.
LICENSEES agree to undertake the regulatory endeavours for
TEVA's B Product Dossiers under Article 4 of this Agreement
on behalf of TEVA. Such list may be amended from time to
time by agreement of TEVA and LICENSEES to include
additional future Products.
1.1.4 "Commercialise" / "Commercialisation" shall mean the
activities carried out in the Territory pertaining to the
importation into, packaging, distribution, marketing and
sale of Products.
1.1.5 "C Products" shall mean a list of Products to be attached as
Appendix C to this Agreement for which Products Licensees
have limited resources available for Commercialisation.
LICENSEES agree to undertake the regulatory endeavours under
Article 4 of this Agreement on behalf of TEVA. Such list may
be amended from time to time by agreement of TEVA and
LICENSEES to include additional future Products.
1.1.6 "Dossier" shall mean the A Product and/or B Product and/or C
Product registration file, as the case may be, which shall
contain all necessary information and data, including
without limitation pharmacokinetic and stability studies,
expert reports, the open part of the Drug Master File, to be
submitted to the Regulatory Authorities in order to obtain
the Marketing Authorisation for such Product in the
Territory.
1.1.7 "LICENSEES" 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 are held by
directors of each company.
1.1.8 "Marketing Authorisation" shall mean any approvals, licences
and permits, including any price and reimbursement
approvals, required by the Regulatory Authorities in the
Territory for the
3
importation, distribution, marketing and sale of A Products
and/or B Products and/or C Products in the Territory.
1.1.9 "Products" shall mean finished pharmaceutical products ready
for use in humans, from which definition oncology products
other than the solid dose formulations thereof are excluded,
now or hereafter developed by TEVA or its Affiliates, or,
now or hereafter in development by TEVA or its Affiliates,
for which TEVA or both Parties have expressed the interest
and commitment to Commercialise in the Territory. The
definition may be extended to include Dossiers that have not
been developed by TEVA and/or its Affiliates, to which title
belongs to TEVA and/or its Affiliates now or hereafter.
Products that have been initially classified as B Products
or C Products may at any time during the term of this
Agreement be re-classified in A, B, or C Products, if agreed
in writing between the Parties.
1.1.10 "Regulatory Authorities" shall mean any government body or
public organisation responsible for all regulatory matters,
including those incidental thereto, concerning the
Commercialisation of finished pharmaceutical products in the
Territory.
1.1.11 "Supply Agreement" shall mean the supply agreement entered
into between the Parties at the same date of this Agreement.
1.1.12 "Territory" shall mean Spain, including its geographic
territories and possessions and other regions as agreed
between the Parties in writing.
1.1.13 "TEVA Regulatory Contact" shall mean TEVA, consultants or
any party that is so designated by TEVA from time to time,
responsible for the co-ordination and process of certain
regulatory matters on behalf of TEVA under this Agreement.
TEVA shall advise LICENSEES of any changes to the contact
details of Teva Regulatory Contact.
2. APPOINTMENT MARKETING AUTHORISATION HOLDER
2.1 TEVA appoints each of the LICENSEES as non-exclusive Marketing
Authorisation Holder for the A Products in the Territory, which each
of the LICENSEES accepts, and as such, the LICENSEES shall be
permitted to Commercialise the A Products in the Territory.
4
2.2 TEVA grants each of the LICENSEES for the term of this Agreement a
royalty free non-exclusive licence in the Territory of the A Product
Dossiers, which LICENSEES accept, for the sole purpose of LICENSEES
submitting the A Product Dossiers with the relevant Regulatory
Authorities in order to obtain each in their own name one or more
Marketing Authorisations of the respective A Products in the
Territory.
2.3 TEVA grants LICENSEES (each or both as the case may be) for the term
of this Agreement a royalty free non-exclusive limited licence in the
Territory of the B Product and C Product Dossiers from TEVA, which
LICENSEES accept. Such licence is restricted to LICENSEES' sole use of
submitting the B Product Dossier and C Product Dossier from TEVA with
the relevant Regulatory Authorities in order to obtain in their own
name one or more Marketing Authorisations of the respective B Products
and/or C Products from TEVA in the Territory as agreed in writing
between the Parties. For clarity purposes, the licence granted under
this Clause shall be restricted to one or more Marketing
Authorisations per B Product and C Product to be obtained and
maintained by the LICENSEES in the aggregate. LICENSEES shall not be
permitted to Commercialise the B Products and C Products from TEVA in
the Territory without prior written authorisation from TEVA.
2.4 All proprietary rights to the A Product, B Product and C Product
Dossiers from TEVA shall not be assigned to LICENSEES and shall remain
fully vested in TEVA and LICENSEES shall not be allowed to use the A
Product, B Product and C Product Dossier from TEVA for any other
purpose than that described in Clause 2.1 above and in the Supply
Agreement in respect of A Products and Clause 2.3 above in respect of
B Products and C Products from TEVA.
2.5 LICENSEES shall maintain the Marketing Authorisations of A Products, B
Products and C Products from TEVA in their own name and shall refrain
from granting any cross-referral, duplicate access and so-called
piggy-backs to any party without prior written authorisation from
TEVA.
3. MUTUAL CO-OPERATION
3.1 From time to time TEVA shall provide, in its discretion, LICENSEES
with a list of Products with the object of inclusion in this Agreement
and the Supply Agreement. From such list LICENSEES shall identify, in
their discretion, the A Products, which shall be affixed to this
Agreement and the Supply Agreement as addendum. TEVA shall have the
right to remove any A Products from such list at any time prior to the
date of transfer by TEVA of the A Product Dossier to LICENSEES
pursuant to Clause 4.2 below.
5
3.2 Both Parties shall identify from the Products that have not been
identified as A Products pursuant to Clause 3.1 above, the B Products,
which shall be affixed to this Agreement as addendum. Without
derogation to Clause 2.3 above LICENSEES shall use their best efforts
to find suitable partners for TEVA to Commercialise the B Products in
the Territory.
4. MUTUAL REGULATORY ENDEAVOURS
4.1 TEVA shall provide LICENSEES with the Dossiers of the A Products and
any other necessary information in the English language to submit the
Dossiers to the relevant Regulatory Authorities to obtain the
Marketing Authorisation in the Territory in their own name. TEVA
undertakes to sign all necessary waivers or letters of approval with
the sole purpose of enabling the granting of the Marketing
Authorisation to LICENSEES.
Parties acknowledge and agree that the anticipated data package
availability set forth in Appendix D are subject to change. TEVA
shall inform LICENSEES of any changes to such dates.
4.2 TEVA shall transfer by mutual consent the A Product Dossier to each of
the LICENSEES from the anticipated date of data package availability.
The transfer by TEVA of the A Product Dossier shall be subject to the
condition precedent of TEVA's prior receipt from each of the LICENSEES
of a letter of access concerning the relevant Dossier and Marketing
Authorisation, or similar document, together with the power of
attorney from each of the LICENSEES to TEVA to sign on behalf of
Licensees such notice, or similar document solely in the Permitted
Event (as defined hereunder) under this Agreement in form and
substance satisfactory to TEVA,
LICENSEES shall submit the Dossiers of the A Products with the
Regulatory Authorities within six (6) months of the date of their
receipt from TEVA . LICENSEES shall provide TEVA with copies of the
Acknowledgement of Receipt from the Regulatory Authorities of each
submitted Dossier. LICENSEES shall be responsible for an accurate
translation of the Dossiers of the A Products and any other necessary
information in Spanish. LICENSEES shall provide TEVA upon its request
with copies of such translations free of charge.
Licensees shall submit the Dossiers of the A Products to the
Regulatory Authorities in the Territory in accordance with all
applicable laws and regulations, including without limitation data
exclusivity rules, applicable now or hereafter in the Territory.
6
4.3 TEVA shall provide LICENSEES with any additional information and
assistance required answering any questions raised by the Regulatory
Authorities in respect of the submissions pursuant to Clause 4.2
above. The information and assistance to be provided by TEVA shall be
based on data and information available with TEVA at the time of the
request from the Regulatory Authorities for additional information.
LICENSEES shall refrain from answering any questions concerning Part
II of the Dossier without prior written authorisation from TEVA.
In the event any request from the Regulatory Authorities requires
additional studies, data or other information involving substantial
work and/or costs, Parties will engage in good faith discussions to
decide whether the Marketing Authorisation procedure of the
respective A Product is to be progressed. If it is decided to
continue such procedure Parties shall agree on each Parties' share in
the costs involved.
4.4 LICENSEES shall be responsible for obtaining Marketing Authorisations
of the A Products and the maintenance thereof, including without
limitation any renewals and/or variations. LICENSEES shall bear all
fees, costs and expenses incurred in connection hereof.
4.5 TEVA shall use its best reasonable efforts to assist LICENSEES with
the validating and updating of the Dossier and corresponding Marketing
Authorisation as required by local regulations during the term of this
Agreement.
4.6 LICENSEES shall provide TEVA with photocopies of the Marketing
Authorisations granted to LICENSEES, including without limitation any
renewal certificates.
4.7 The regulatory endeavours of TEVA under this Article shall be
undertaken by TEVA Regulatory Contact.
4.8 The provisions of and mutual undertakings under this Article shall
also apply to B Products and C Products from TEVA to be agreed upon by
the Parties, except that all cost related to the C Products as
referred to in Clause 4.4 above shall be paid by TEVA. If, however, by
written consent of the Parties a C Product becomes an A Product,
Licensees will refund such costs to TEVA. LICENSEES shall provide TEVA
with the specification of all cost involved subject to TEVA's approval
prior to Licensees' undertakings under this Article.
5. REPRESENTATIONS AND WARRANTIES
7
5.1 TEVA represents and warrants to the best of its knowledge after
reasonable enquiry that the development of the A Product, B Product
and C Product Dossiers from TEVA and the manufacture, use and sale of
the A Product has not infringed any third party intellectual property
rights, it being understood that the sale of certain A Products in the
Territory is anticipated to be cleared from patent protection on the
dates mentioned in Appendix E. For the avoidance of any doubt, the
anticipated dates set forth in Appendix E are based on the information
available to TEVA at the date of this Agreement. TEVA shall inform
LICENSEES in writing of any information becoming available to TEVA in
the future that would alter such dates.
5.2 TEVA represents and warrants that each of the A Product, B Product and
C Product Dossier from TEVA is valid and comply, to the best of its
knowledge, with the standards and specifications in force on the date
on which it was transferred to LICENSEES. TEVA represents that it or
its Affiliates has the full right, title and interest in the A
Products and C Products and the right to grant the interests thereto
provided in this Agreement.
5.3 TEVA and LICENSEES each represent and warrant it has all required
permits, approvals, regulatory licences and resources to carry on its
business and to undertake the activities contemplated in this
Agreement.
5.4 TEVA and LICENSEES each represent and warrant to the best of their
knowledge after reasonable enquiry that their trademarks or marks to
be used in the Commercialisation of the A Products have not infringed
any third party trademark rights.
5.5 Licensees represent and warrant to the best of their knowledge after
reasonable enquiry that their undertakings under this Agreement,
including without limitation their regulatory endeavours under Article
4 and Commercialisation under Article 6 have not infringed any third
party intellectual property rights.
5.6 TEVA and LICENSEES agree to notify each other promptly if the
representations under this Article are no longer true.
6. LAUNCH OF A PRODUCT ON MARKET
6.1 LICENSEES shall Commercialise each A Product in the Territory within
24 months following the date of grant of the respective Marketing
Authorisation. If on the date of such Commercialisation patent rights
to a certain A Product owned by a third party have not expired,
LICENSEES
8
shall then Commercialise such A Product within two (2) months
following such expiry date.
Parties entered into the Supply Agreement on the same date of this
Agreement.
6.2 During the term of LICENSEES' appointment as Marketing Authorisation
Holder under this Agreement, neither LICENSEES, nor its Affiliates,
shall directly or indirectly without prior authorisation of TEVA (i)
solicit customers for the A Products outside the Territory, (ii)
establish a branch or distribution depot for the A Products outside
the Territory and (iii) sell the A Products outside the Territory in
whatever form or fashion.
6.3 LICENSEES shall Commercialise each A Product in the Territory under
their own trademarks or marks. Such trademarks or marks used by
LICENSEES shall remain the exclusive property of LICENSEES.
7. MATERIAL EVENT
7.1 The following occurrences shall be considered a Material Event for A
Products for purposes of this Agreement and the Supply Agreement:
7.1.1 for each respective A Product, where LICENSEES fail to place
a purchase order for such A Product with TEVA within 24
months of the date of the respective Marketing
Authorisation, or such later date pursuant to Article 6 of
this Agreement; or
7.1.2 for all A Products, where LICENSEES shall come under the
direct or indirect or de facto direction or control of any
party other than the direction or control which such parties
are under on the date of this Agreement; or
7.1.3 for all A 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 transaction with a party in Spain.
7.2 For the avoidance of any doubt, the occurrence of any Material Event
shall not itself terminate this Agreement, save the provisions
pursuant to Article 10 below.
8. CONSEQUENCES MATERIAL EVENT
9
Upon the occurrence of any Material Event pursuant to Article 7
above, LICENSEES shall be obligated to transfer or arrange the
transfer to TEVA or Affiliate designated by TEVA within one (1) month
as from the date of such Material Event the letter of access, or
similar document in form and substance satisfactory to TEVA
concerning each relevant Marketing Authorisation, including any
Marketing Authorisations granted after the date of Material Event
which were applied for from the Regulatory Authorities, together with
a photocopy of the corresponding complete and current Dossier of
LICENSEES for each A Product the Material Event has occurred free of
charge. LICENSEES shall undertake to sign all papers, documents and
instruments, and do all that may be necessary to obtain such
Marketing Authorisation and Dossier in Teva's name.
In the event TEVA or designated Affiliate has not obtained such
relevant letter of access or similar document within such one (1)
month period, this event shall be a "Permitted Event" under this
Agreement. Licensees shall permit Teva to exercise the power of
attorney pursuant to Clause 4.2 above to obtain such Marketing
Authorisation to Teva or designated Affiliate.
9. CONFIDENTIALITY
9.1 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.
9.2 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
10
whatsoever except in the performance of their duties in furtherance of
this Agreement.
9.3 Confidential Information shall not include information that can
clearly be demonstrated to have been:
9.3.1 Generally known to the public through no fault of the Party
to whom the Confidential Information was disclosed;
9.3.2 Known to and in the lawful possession of a Party prior to
disclosure thereto by the other Party, as evidenced by
written evidence; or
9.3.3 Obtained from a third party lawfully in possession and with
no limitation regarding disclosure thereof, and having the
right to disclose the same; or
9.3.4 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.
9.4 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.
10. TERM AND TERMINATION
10.1 This Agreement and the Supply Agreement that is entered into on the
same date shall become effective as from the date of signature and
shall for each A Product be concluded an initial term of 5 years
starting from the date of its Commercialisation 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.
10.2 This Agreement that is entered into in respect of B Products and C
Products from TEVA shall become effective as from the date of
signature and shall thereafter be renewed automatically on an annual
basis and Product-by-Product basis unless either Party provides the
other with not less than thirty (30) days prior written notice of its
intention not to renew.
11
10.3 Notwithstanding Clause 10.1 and 10.2 above, this Agreement may be
terminated earlier in the way and manner described below:
10.3.1 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;
10.3.2 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 control or effective
control of the other Party, without any entitlement to
compensation under whatever title as a result of such
termination.
10.4 Notwithstanding Clause 10.1 and 10.2 above, this Agreement may be
terminated earlier and in part on a Product-by-Product basis if one of
the Parties to this Agreement commits a material breach of any
provision of this Agreement pertaining to a certain A Product, B
Product and/or C Product from TEVA 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 immediately on the date of its written notification of the
breach.
10.5 Notwithstanding Clause 10.1 above, this Agreement may be terminated
earlier and in part on a Product-by-Product basis in the way and
manner described in Clause 12.3 of the Supply Agreement.
11. RIGHTS AND OBLIGATIONS UPON TERMINATION
11.1 Upon termination of this Agreement pursuant to Clause 10.1 above, TEVA
shall assign its rights in the relevant A Product Dossier and
corresponding Marketing Authorisations to LICENSEES subject to the
conditions precedent that LICENSEES have provided TEVA within one (1)
month from the date of such termination with the letter of access or
12
similar document in form and substance satisfactory to TEVA concerning
each respective Marketing Authorisation, together with a photocopy of
the complete and current Dossier of LICENSEES and in the way and
manner described in Article 8 of this Agreement. For the avoidance of
any doubt, the assignment of rights shall be non-exclusive and for the
Territory only.
11.2 Upon termination of this Agreement pursuant to Clause 10.2 above for
each respective B Product and/or C Product from Teva, LICENSEES shall
provide TEVA or Affiliate designated by TEVA within one (1) month from
the date of such termination with the letter of access or similar
document in form and substance satisfactory concerning each respective
Marketing Authorisation, including any applications for Marketing
Authorisations, together with the original complete and current
Dossier of the relevant B Product and/or C Product from TEVA.
11.3 Upon termination of this Agreement of each respective A Product for
reason or cause of TEVA's material breach of any of its obligations
under this Agreement and/or the Supply Agreement, the provisions of
Clause 11.1 of this Agreement shall survive such termination.
11.4 Upon termination of this Agreement of each respective A Product for
reason or cause of (i) each of LICENSEES' material breach of any of
its obligations under this Agreement and/or the Supply Agreement (ii)
the direct or indirect change in control of each of LICENSEES pursuant
to Clause 10.3.2 above and (iii) LICENSEES' failure to satisfy the
annual minimum quantities on a Product-by-Product basis pursuant to
Clause 12.3.2 of the Supply Agreement and (iv) Clause 10.3.1 of this
Agreement, LICENSEES shall within one (1) month from the date of such
termination provide TEVA or Affiliate designated by TEVA with the
letter of access or similar document in form and substance
satisfactory to TEVA concerning each respective Marketing
Authorisation, including any applications for Marketing
Authorisations, together with the original of the complete and current
relevant Dossier of LICENSEES and in the way and manner described in
Article 8 of this Agreement. LICENSEES shall sign all necessary
waivers or letters of approval with the sole purpose of transferring
the concerned Product Dossiers and/or Marketing Authorisations back to
TEVA.
11.5 In the event TEVA or designated Affiliate has not obtained the letter
of access or similar document in form and substance satisfactory to
TEVA within such one (1) month period under this Article, this event
shall be construed as Permitted Event under this Agreement. Licensees
shall permit TEVA to exercise the power of attorney pursuant to Clause
4.2
13
above to transfer such Marketing Authorisation to TEVA or designated
Affiliate.
11.6 Upon termination of this Agreement for whatever reason or cause,
neither Party shall be entitled to any compensation for loss of profit
or loss of goodwill directly or indirectly attributable to (i) such
termination or (ii) for any other reason.
11.7 Upon termination for whatever reason or cause, LICENSEES and TEVA
shall return to each other all Confidential Information supplied by
one Party to the other in accordance with Clause 9.4 above.
11.8 The provisions of Articles 1, 5, 9, 11, 12 and 19 shall survive
termination of this Agreement.
12. CROSS-INDEMINIFICATION
12.1 TEVA agrees to defend, indemnify and hold harmless LICENSEES and their
Affiliates, their 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 5 of this Agreement and/or (ii) a material breach by
TEVA of any of its obligations under this Agreement and/or (iii) the
wilful misconduct or negligence of TEVA in its performance in
accordance with this Agreement.
12.2 LICENSEES agrees 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 LICENSEES of any of their representations and
warranties under Article 5 of this Agreement and/or (ii) a material
breach by LICENSEES of any of their 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 wilful misconduct or
negligence of LICENSEES in their performance in accordance with this
Agreement.
12.3 Indemnification pursuant to Clauses 12.1 and 12.2 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
14
possible in the defence 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.
12.4 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.
12.5 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 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 and pay for such
inventory returned at the price paid to Teva.
13. SEVERABILITY
If any term or provision of this Licence 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.
14. WAIVER
Failure by either Party at anytime to terminate this Agreement 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
15
prejudice the right of that Party subsequently to terminate this
Agreement or enforce its rights hereunder for a subsequent breach of
its obligation hereunder by the other Party.
15. 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.
16. ENTIRE AGREEMENT
This Agreement, including the preamble and Appendices, constitutes,
with the Supply 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.
17. 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.
18. 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:
16
If to TEVA:
Teva Pharmaceutical Industries Ltd.
0, Xxxxx Xxxxxx, 00000 Xxxxxx Xxxxx, Xxxxxx
Attention: VP Global Product Development (Generics)
Telephone: x000 0 0000 000 Facsimile: x000 0 0000 000
With a copy to:
Teva Pharmaceuticals Europe B.V.
Industrieweg 23; 0000 XX Xxxxxxxxx, Xxx Xxxxxxxxxxx
Attention: President
Telephone: x00 (0)000 000 000 Facsimile: x00 (0)000 000 000
If to LICENSEES:
X/x Xxxxxxxxxxxx Xxxxxx, X.X.
Xxxxxxxxxxx, 0 - 0.(x)xxx, 00000 Xxxxxx, Xxxxx
Attention: Managing Director
Telephone: x00 00 000 0000 Facsimile: + 34 91 388 7647
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.
19. 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
17
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.
20. 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.
18
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 A 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 A 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
List of B Products Page 1 of 1
Product Nr. Active Ingredient Formulation
----------- ----------------- -----------
* * *
* Confidential information has been omitted and filed confidentially with
the Securities and Exchange Commission.
22
APPENDIX C
List of C Products Page 1 of 1
No list available yet on the date of this Agreement
23
APPENDIX D
NON- BINDING ANTICIPATED DATES OF DATA PACKAGE AVAILABILITY REFERRED TO IN
CLAUSE 4.1
Page 1 of 2
Product Nr. Active Ingredient Anticipated Date
----------- ----------------- ----------------
* * *
* Confidential information has been omitted and filed confidentially with
the Securities and Exchange Commission.
24
APPENDIX D
NON- BINDING ANTICIPATED DATES OF DATA PACKAGE AVAILABILITY REFERRED TO IN
CLAUSE 4.1
Page 2 of 2
Product Nr. Active Ingredient Anticipated Date
* * *
* Confidential information has been omitted and filed confidentially with
the Securities and Exchange Commission.
25
APPENDIX E
NON-BINDING ANTICIPATED PATENT EXPIRY DATES SUBJECT TO CHANGE PURSUANT TO
CLAUSE 5.1
Page 1 of 1
Product Nr. Active Ingredient Date Patent Nr.
----------- ----------------- ---- ----------
* * * *
* Confidential information has been omitted and filed confidentially with
the Securities and Exchange Commission.
26
