EXHIBIT 10.15
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
NON-CONFIDENTIAL EXHIBIT A
PRODUCT COLLABORATION AND
DEVELOPMENT SERVICES AGREEMENT
This Product Collaboration and Development Services Agreement dated as
of November 18, 1999 (the "Agreement"), is entered into by and among IVAX
CORPORATION, a Florida corporation having an office at 0000 Xxxxxxxx Xxxxxxxxx,
Xxxxx, Xxxxxxx 00000, NORTON HEALTHCARE LTD. ("NHL"), an English limited company
having an address at Xxxxxx Basin, 0 Xxxxx Xxxxx, Xxxxxx X00 0XX, XXXXX NORTON
INTERNATIONAL GmbH ("BNI"), a Swiss limited company, having an address in care
of Invico Capital Corporation AG, Xxxxxxxxxx 00, X.X. Xxx 0000, 0000 Xxxxxx,
Xxxxxxxxxxx, and XXXXXXX-XXXXX SQUIBB COMPANY, a Delaware corporation having an
address at X.X. Xxx 0000, Xxx 000 and Province Line Road, Princeton, New Jersey
08543-4000("BMS").
RECITALS
1. The parties have been in discussion as to areas of possible
collaboration in the fields of inhalation technology and of oncology as
well as other areas of mutual interest, and BMS recognises that IVAX
Corporation, NHL and BNI have relevant skills, competence and expertise
related to the formulation and development of products for delivery by
inhalation and devices related thereto. BMS is interested in engaging
IVAX Corporation and its Affiliates to perform development work with
regard to certain proprietary compounds of BMS (the "Services"), and
IVAX Corporation and its Affiliates are willing to perform such
Services and to collaborate with BMS with respect to the development of
certain pharmaceutical formulations or delivery systems having
potentially beneficial therapeutic use in the treatment of disease.
2. IVAX Corporation and/or its indirect wholly owned subsidiary BNI has
proprietary technology pertaining to a system for oral administration
of paclitaxel (the "Oral Delivery System") for which it has filed
patent applications and obtained patents throughout the world, which it
is willing to make available to BMS to assess its practical use and
application and to grant BMS an option to take a licence for its
commercial exploitation.
3. BMS is the holder of marketing authorisations for the anti-cancer agent
TAXOL paclitaxel ("TAXOL"), inter alia, in all countries of the
European Union ("EU") based upon an application under E.C. Directive
87/22 pursuant to which procedure the first authorisation for TAXOL
within the EU was granted in The Netherlands on September 20th 1993,
indicated for the treatment of first and second line ovarian cancer,
treatment of second line breast cancer and treatment of
1
non small cell lung cancer. By virtue of EC Directive 65/65, as
amended, the data submitted by BMS in support of such marketing
authorisations is subject to protection for a period of ten years from
the date of first authorisation in the EU.
4. IVAX Corporation through NHL has applied for a marketing authorisation
in the EU for its injectable formulation of paclitaxel marketed under
the trademark PAXENE, which application was approved by the European
Medicines Evaluation Agency pursuant to the procedure under Regulation
(EC) No. 2309/93 on July 19th, 1999 for the limited indication of
AIDS-related kaposi's sarcoma after failure of prior liposomal
anthracycline therapy (the "PAXENE Authorisation"). The data submitted
in support of the PAXENE Authorisation is likewise subject to
protection for a period of ten years from the date of authorisation.
5. Recognising that the market for PAXENE in respect of its limited
indication is small whilst that for treatment of those conditions for
which TAXOL is indicated is substantial, and that there exists a
potential for the use of PAXENE outside its indicated use, the parties
are in dispute as to the acceptable manner in which IVAX Corporation,
its Affiliates or other appointed representatives may promote PAXENE
and as to the likelihood that the promotion of PAXENE could be
perceived as implying that it has been approved for uses for which
TAXOL is indicated but for which PAXENE is not so indicated, in
evidence whereof BMS has filed suit and obtained an injunction against
the prospective IVAX appointed representative in Germany.
6. In conjunction with the parties' desire to collaborate in the
development of new products, pharmaceutical formulations or delivery
systems, and having regard to their respective interests in the field
of oncology and specifically in relation to the active ingredient
paclitaxel, the parties are desirous (a) of seeking to avoid issues as
to the medical appropriateness of PAXENE being prescribed for uses
outside its approved indication in HIV patients in accordance with the
limited indications approved by the EMEA, and (b) of avoiding any
adverse consequences of any confusion amongst patients and physicians
as to the proper use of the respective products that might arise from
PAXENE being made available to patients not suffering from the
condition for which its use is indicated; and (c) of clarifying their
respective rights and interests in relation respectively to TAXOL and
PAXENE so as to avoid any inadvertent encroachment or infringement by
either in respect of the proprietary rights of the other whilst
exercising fully their respective rights where to do so would not
impinge upon the legitimate rights and interests of the other; and (d)
of avoiding the requirement for BMS to continually monitor the
activities of IVAX or its Affiliates or other appointed representatives
in the promotion and sale of PAXENE and its use outside the approved
indication; and (e) of eliminating the costs and expenses in both time
and money likely to be incurred by both parties if they or their
Affiliates or other appointed
2
representatives are engaged in frequent or repetitive litigation
concerning the promotion and use of PAXENE, all to the ultimate
detriment of patients.
AGREEMENT
In consideration of the Recitals and the mutual promises contained in
this Agreement, IVAX and BMS agree as set forth below.
ARTICLE I
DEFINITIONS
In addition to terms defined elsewhere in this Agreement, certain terms
are defined in Attachment 2. Whenever a capitalised term is used, it is intended
to have the meaning stated in Attachment 2.
ARTICLE II
PRODUCT DEVELOPMENT
2.1 DEVELOPMENT PLAN. Forthwith on receipt from BMS of the initial sum due
pursuant to Article VIII hereof, the parties will meet to agree upon a
Development Plan and Budget and will thereafter use all reasonable
efforts and due diligence to finalise the Development Plan and Budget.
The Development Plan will include an initial feasibility study for a
product containing one of the Active Ingredients, as determined by BMS,
(the "First Product") with defined endpoints and performance criteria,
and a target product profile for the First Product. Upon successful
completion of the feasibility study, the parties will again meet to
complete the details of the Development Plan, including a time and
responsibility schedule for the remainder of the development work and
Budget therefor. Under the Development Plan IVAX will have primary
responsibility for formulation and preclinical testing of the First
Product, and BMS will have primary responsibility for conducting
clinical trials. During this process, BMS will supply to IVAX such of
BMS's Technical Information concerning the Active Ingredient of the
First Product that will be needed by IVAX to conduct the development
work hereunder, and IVAX will supply to BMS such of IVAX's Technical
Information that will be needed by BMS for assisting in the development
work and for conducting clinical trials of the First Product t.
2.2 SUBSEQUENT DEVELOPMENT PROJECT. Upon successful completion or
termination of the initial development project under Section 2.1, if
BMS desires to proceed to develop the second Active Ingredient, the
parties will again meet to agree upon the criteria for a feasibility
study and will agree upon a Development Plan and Budget and a target
product profile for a product containing the second Active
3
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
Ingredient (the "Second Product"). For purposes of this Agreement, the
term "Development Plan" refers to the development plans for both the
First Product and the Second Product, and the term "Product" refers to
either or both of the First Product and the Second Product, as the
context may indicate.
2.3 CONDUCT OF DEVELOPMENT.
(a) IVAX will provide all personnel, facilities and resources
necessary to perform the feasibility, formulation and
preclinical testing phases of the development work and will
conduct these activities in accordance with current good
laboratory practices and current good manufacturing practices
and in compliance with all applicable laws and regulations.
(b) BMS will provide all personnel, facilities and resources
necessary to conduct clinical trials of the Product and will
conduct these activities in accordance with good laboratory
practices and in compliance with all applicable laws and
regulations.
(c) During the course of the development work, each party will
keep the other informed of its progress in the conduct of the
development, and will make appropriate personnel available to
discuss the development work at mutually agreeable times upon
either party's reasonable request.
(d) During the course of the development work, BMS will provide *
such quantities of the Active Ingredient as IVAX may
reasonably request for use in developing the Product, and all
costs of manufacturing clinical trial supplies of Product and
placebo will be borne by BMS.
2.4 TECHNICAL INFORMATION. IVAX shall supply to BMS such Technical
Information as it may generate or that becomes available to it during
the continuance of this Agreement and that may be necessary in
registering the Product or improvements, modifications or adaptations
thereto. BMS shall supply to IVAX such Technical information as it may
generate or that becomes available to it during the continuance of this
Agreement, and that may be necessary in developing or manufacturing the
Product or improvements, modifications or adaptations thereto. Neither
party shall be obliged to supply to the other party any Technical
Information other than that referred to above. The parties do not
envisage that BMS will need to supply to IVAX any Technical Information
relating to its manufacturing processes for the Active Ingredient
except to the extent necessary in formulating or testing the Product.
IVAX may use Technical Information concerning the Device for any
purposes whatsoever but may use any Technical Information concerning
the Active Ingredient only for the purposes of developing or
manufacturing the Product or improvements, modifications or adaptations
thereto.
4
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
2.5. *
ARTICLE III
ADDITIONAL AGREEMENTS
3.1 SUPPLY AND MANUFACTURING AGREEMENT. During the development process,
provided that BMS shall determine that the results of the feasibility
study are favourable, the parties will negotiate in order to enter into
an agreement or agreements under which BMS will purchase its
requirements of the Devices and, at BMS's option, of the finished
Product, from the appropriate IVAX Affiliate, and IVAX will agree to
supply to BMS the Devices for use in the Product and/or to manufacture
the Product for BMS. Such agreement or agreements (i) shall be on terms
and conditions customary in the pharmaceutical industry for comparable
drug delivery technology and pharmaceutical products, including those
factors referred to in Section 12.2(a), (ii) may, at BMS's option,
include a license to use the "Easi-Breathe" trademark in connection
with the Product(s) and (iii) shall incorporate such provisions of this
Agreement and such other provisions as reasonably and properly required
to permit the registration, distribution, marketing and sale of the
Product in the countries of Territory A under the Patent Rights and/or
IVAX's Technical Information pertaining to the Product for a term
expiring on the date of the last to expire of the Patent Rights.
3.2 DISTRIBUTION RIGHTS. IVAX grants to BMS, in consideration of BMS's
contribution of financial and technical resources to the development of
the Products, the non-exclusive right, and any necessary non-exclusive
license under the Patent Rights and the Technical Information, to
register, distribute, market and sell the Products in Territory A.
3.3 LIMITATIONS ON RIGHTS. BMS shall have no other rights to use or refer
to IVAX's Technical Information and shall have no right whatsoever
under the Patent Rights or under the Technical Information, other than
the right to commercialise the Product as set forth in Section 3.2.
3.4 RIGHTS RETAINED. IVAX shall not be restricted in any way from granting
licenses or distributorships for devices embodying any invention
claimed in the Patent Rights (including devices having the same form as
the Device) for use with products containing active ingredients
(including the Active Ingredients, subject to any BMS patent or other
intellectual property rights relating thereto) for the treatment of any
medical condition, including, but not limited to, respiratory diseases
and other conditions for which the Products are indicated.
3.5 NO LICENSE TO IVAX. Nothing herein shall be construed as giving IVAX
any license under any patent rights owned by BMS relating to the Active
Ingredients,
5
except the right to manufacture Products containing the Active
Ingredients and to supply them on an exclusive basis to BMS.
ARTICLE IV
REGULATORY MATTERS
4.1 BMS UNDERTAKINGS.
(a) Subject to successful completion of the development of a
Product and conduct of clinical trials, BMS shall use
reasonable commercial efforts and the appropriate method to
obtain, as soon as reasonably possible, registrations of the
Product with the health authorities or other competent
authorities in the Principal Territories.
(b) BMS shall furnish IVAX every six months with a report on the
progress of registration of the Product in the Territory A.
(c) Upon obtaining requisite government and health authority
approval, including pricing and reimbursement approval if
necessary, in any country of Territory A upon terms acceptable
to BMS, BMS shall introduce the Product as soon as practicable
in that country, provided that this is commercially viable in
the circumstances of the particular country, and shall
thereafter market, distribute and sell the Product in that
country using efforts and resources equivalent to those
normally used by large pharmaceutical companies selling
products of the same commercial significance in the same
markets.
(d) BMS undertakes not to do anything that would breach the terms
of the health registrations for the Device or the Product in
Territory A, and to ensure that clinical recommendations for
the Device and Product made by it, its distributors and its
and their customers are strictly in accordance with such
health registrations, to the extent that any such breach or
non-compliance would or might reasonably be expected to have
an adverse impact upon or otherwise be to the detriment of the
Device or of IVAX.
(e) Notwithstanding any other provision of this Agreement, BMS
reserves the right in its sole discretion to discontinue the
development or marketing of any Product, to license any
Product to a third party or to third parties, or to copromote
or comarket any Product with a third party or third parties.
4.2 IVAX UNDERTAKINGS. IVAX shall not be obliged to provide any Technical
Information in support of the Product registrations beyond that which
it may have available from time to time and shall not be obliged to
generate information or carry out any work other than that contemplated
under the Development Plan.
6
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
However IVAX will assist BMS by providing advice and consultation in
the event that BMS has problems in registering the Product in the
Principal Territories.
ARTICLE V
PATENTS AND COPYRIGHT
5.1 OWNERSHIP OF INVENTIONS. Rights to all inventions, discoveries,
improvements, modifications or adaptations affecting solely the Device
that are made by either party during the Term shall belong to IVAX, and
BMS shall have the non-exclusive right to use the same in any country
of Territory A * for the duration of this Agreement and any agreement
entered into pursuant to Sections 3.1 or 8.7. Rights to all inventions,
discoveries, improvements, modifications or adaptations affecting
solely the Active Ingredients or the Product that are made by BMS
during the Term shall belong to BMS, provided that in respect of any
such discovery, improvement, modification or adaptation affecting the
Device results in the grant of patent rights in respect thereof to BMS,
IVAX shall be entitled to a non-exclusive * licence thereunder for the
duration of this Agreement and of any agreement entered into between
the parties either pursuant to Article 8.7. or pursuant to the
provisions of Article III, whichever shall be longer. In the event that
such term should expire prior to the expiration of the relevant BMS
patent to which such licence relates, IVAX shall be entitled to call
for an ongoing non-exclusive * licence. Rights to all inventions,
discoveries, improvements, modifications or adaptations affecting the
Product or affecting solely the Active Ingredients that are made by
IVAX during the Term shall belong to IVAX, provided that in respect of
any such discovery, improvement, modification or adaptation affecting
solely the Active Ingredients results in the grant of patent rights in
respect thereof to IVAX, BMS shall be entitled to an exclusive *
licence thereunder for the duration of this Agreement and of any
agreement entered into between the parties either pursuant to Section
8.7. or pursuant to the provisions of Article III, whichever shall be
longer. In the event that such term should expire prior to the
expiration of the relevant IVAX patent to which such licence relates,
BMS shall be entitled to call for an ongoing exclusive licence *. In
relation to any other discovery, improvement, modification or
adaptation affecting either the Product or the Active Ingredients BMS
shall have the exclusive right to market, register and distribute the
Product in any country of Territory A for the duration of this
Agreement, subject to the payment provisions provided in this Agreement
and the supply and manufacturing agreements to be entered into
subsequently.
5.2 PROSECUTION OF PENDING APPLICATIONS. IVAX shall at its own cost
diligently prosecute to grant all subsisting patent applications within
the Patent Rights in the Principal Territories and shall maintain all
patents within the Patent Rights in force for the full terms thereof.
IVAX gives no warranty that the said patent applications will proceed
to grant, and any payments made by BMS hereunder shall not be repayable
in the event that patents are not granted.
7
5.3 FILING OF NEW APPLICATIONS. Where either party develops or acquires an
improvement, modification or adaptation affecting the Product (other
than information relating solely to the Device or the Active
Ingredient), it shall promptly notify the other, and neither party
shall publish the same or do anything that might prejudice the validity
of any patent application that might subsequently be filed with respect
to such improvement, modification or adaptation. In the event that BMS
considers that it is desirable to make further patent applications in
the Principal Territories with respect to improvements, modifications
or adaptations affecting the Product made by either party, it shall
notify IVAX of its decision within sixty (60) days of giving or
receiving the disclosure, and IVAX shall diligently prepare and
prosecute such applications, in detailed consultation with BMS, the
cost thereof to be borne by BMS. In the event that BMS elects not to
make any patent application, or if it has not advised IVAX of its
desire to make a patent application within sixty (60) days of giving or
receiving the disclosure, and if IVAX considers that it is desirable to
make any such patent application, IVAX shall prepare and prosecute such
application and shall bear the cost thereof. In either case, BMS shall
cooperate as needed in the patent prosecution and shall make its
personnel available at no cost to IVAX. Any such further patent
applications shall be included within the term "Patent Rights"
hereunder. If neither party elects to file a patent application within
ninety (90) days after a disclosure is made, or, if either party elects
to file a patent application, after the patent application has been
filed, the disclosing party may proceed to publish information
regarding its improvement, modification or adaptation, provided that
the other party is given a copy of the proposed publication and allowed
to remove therefrom any of its Technical Information.
5.4 DEFENCE OF PATENT RIGHTS. In the event of opposition or challenge by
any third party to any of the Patent Rights, IVAX shall take reasonable
steps to defend the Patent Rights and shall keep BMS fully informed of
the action taken by it, provided that IVAX shall not be obliged to
undertake any action which, in its opinion, is not commercially
justified. IVAX shall notify BMS if, in its opinion, it is not
commercially justified to defend the Patent Rights, and in such event,
BMS shall have the right to defend the Patent Rights itself in
consultation with and on terms agreed by IVAX and shall keep IVAX fully
informed of the actions taken by it. Notwithstanding any action by BMS
hereunder, IVAX shall have the right to take subsequent action itself
to defend the Patent Rights. The proceeds of any action against any
third party pursuant to this Section 5.4 shall belong to the party
taking action against such third party.
5.5 CLAIMS OF INFRINGEMENT. To the best of IVAX's knowledge and belief the
exercise of the rights granted or to be granted to BMS hereunder will
not result in the infringement of valid patents of third parties.
Subject thereto, IVAX gives no warranty in this respect and does not
give BMS any indemnity against costs, damages, expenses or royalties
arising out of proceedings brought against BMS or
8
any distributor or customer of BMS by any third party. Should BMS be
sued for infringement of any patent or patents of the third party by
reason of its use or sale of the Device or Product, IVAX shall on
request assist BMS in its defence to such action to the extent that in
all the circumstances it is reasonable to do so but shall otherwise be
under no obligations in respect thereof. All costs of any such action
shall be borne by BMS, to whom shall belong all sums that may be
recovered from the third party. BMS shall not oppose, and shall take
steps to permit, intervention by IVAX in any such proceedings at IVAX's
cost if IVAX believes that its intervention is necessary to protect the
Patent Rights or any other rights of IVAX.
5.6 TERMINATION. On termination or expiration of this Agreement, BMS shall
have no further right to use or refer to the Technical Information or
the Patent Rights, and BMS shall transfer to IVAX all documentation
embodying or referring to the Technical Information; provided, however,
that this provision will not prevent any continued rights therein that
may be granted to BMS under an agreement entered into pursuant to
Section 3.1 or 8.7.
5.7 COPYRIGHT. IVAX owns all copyrights pertaining to the Device, and BMS
acquires no right or interest in or to such copyrights under this
Agreement.
ARTICLE VI
OPTION FOR LICENCE TO ORAL DELIVERY SYSTEM
6.1. OPTION FOR LICENSE TO ORAL DELIVERY SYSTEM. IVAX will cause BNI to
grant to BMS an option giving BMS the exclusive right to negotiate for
a license to the Oral Delivery System in accordance with the terms of
the Licence Option Agreement attached hereto as in Attachment 5 (the
"Option Agreement").
ARTICLE VII
UNDERTAKINGS REGARDING PACLITAXEL
7.1 PROPER PROMOTION OF PAXENE. In recognising the rights of BMS as more
particularly detailed in Recital 4 to this Agreement, IVAX maintains
its right and entitlement (which BMS acknowledges) to use all
commercially reasonable efforts to market, distribute and sell PAXENE
for the Indicated Use in the European Union under the PAXENE
Authorisation and under any additional marketing authorisations that it
may receive in Territory B to market, distribute and sell PAXENE for
the Indicated Use, whilst avoiding the marketing and/or sale of PAXENE
by IVAX, its Affiliates or other appointed representatives for any use
or indication for which it is not appropriately authorised and in
respect of which TAXOL is approved in these countries and which would,
directly or indirectly, impinge upon the BMS data protection rights.
9
7.2 PROPER PROMOTION OF TAXOL. In recognising the rights of IVAX as more
particularly detailed in Recital 4 to this Agreement, BMS likewise
acknowledges the need to avoid the marketing and/or sale of TAXOL by
BMS, its Affiliates or other appointed representatives for any use or
indication for which it is not appropriately authorised and in respect
of which PAXENE is approved in Territory B and which would, directly or
indirectly impinge upon the IVAX data protection rights.
7.3 AVAILABILITY OF PAXENE. Without prejudice to the foregoing, IVAX agrees
to use its best efforts to ensure the availability of PAXENE to all
patients suffering from advanced AIDS-related kaposi's sarcoma who have
failed prior liposomal anthracycline therapy and to patients suffering
from any other disease or condition for which it may subsequently be
approved.
7.4 AVAILABILITY OF TAXOL. Without prejudice to the foregoing, BMS agrees
to use its best efforts to ensure the availability of TAXOL to all
patients suffering from conditions or diseases for which it is
indicated and to patients suffering from any other disease or condition
for which it may subsequently be approved.
7.5 ADDITIONAL INDICATIONS. Without prejudice to the foregoing, it is
expressly agreed by and between the parties that this Agreement shall
not preclude either party from seeking to expand the indications of
their respective paclitaxel products in respect of any overlapping or
other indications. Each of the parties confirm their commitment to
ongoing research and the conduct of clinical trials to make available
all necessary information and data to support applications to the
responsible Authorities to secure the approval for the marketing and
sale of their respective products for such additional indications
including by IVAX in respect of breast, ovarian and non-small cell lung
cancer and, for the avoidance of any doubt which might otherwise arise,
the provisions of Sections 7.1 and 7.2 above shall not preclude either
party from conducting clinical trials in relation to those areas of
treatment for which the product of the other is indicated for use.
7.6 ADDITIONAL INDICATIONS. In the event that during the term of this
Agreement relevant to this Article VII, the PAXENE Authorisation shall
be amended to include any additional indication other than one for
which TAXOL is indicated, the definition of Indicated Use shall be
amended accordingly, and the terms of this Article and of the Agreement
shall apply to the sale and supply of PAXENE for such revised Indicated
Use, and the parties shall negotiate in good faith as to the terms
applicable thereto pursuant to Section 8.6 (b) and as to the
appropriate market therefor.
10
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
ARTICLE VIII
TERM, TERMINATION AND PAYMENTS
8.1 DURATION. This Agreement shall become effective on the date hereof and
shall continue in effect for a period expiring on November 15, 2002
provided that (a) the duration of the Option for Licence of the Oral
Delivery System shall be for a term of 6 months only expiring May 15,
2000 and (b) the duration of the obligations accepted by the parties
under Article VII shall be for a term expiring on November 15, 2001.
Notwithstanding the foregoing, BMS may, at its option, extend the
obligations of the parties under Article VII for the third year of the
Agreement. If BMS shall wish to exercise such right, BMS shall so
advise IVAX by written notice to IVAX given not later than May 15,
2001. BMS shall notify IVAX in any event prior to the said May 15, 2001
whether it does or does not intend to exercise such option.
8.2. In consideration for the rights granted to BMS for the first and second
years of the Agreement under Articles III and VI, and the obligations
accepted by IVAX under Articles II and VII, BMS shall pay IVAX the
following amounts, without deduction or credit for the amount paid
under the letter agreement dated August 24, 1999, which letter
agreement is hereby amended accordingly:
*
8.3. (a) In consideration of the rights granted to BMS for the third
year of the Agreement under Article III and the obligations
accepted by IVAX under the provisions of Article II, if BMS
does not extend the Agreement in accordance with Section 8.1,
BMS shall pay to IVAX on May 15, 2001, the sum of *
(b) In the event, however, that BMS elects to extend the Agreement
in accordance with Section 8.1, BMS shall pay to IVAX on the
fifteenth day of November 2001 the sum of *
8.4. CURRENCY AND BUSINESS DAYS. All payments under Sections 8.2 and 8.3
will be made in US dollars. Any payment falling due on a day which is a
weekend or holiday shall be paid on the next succeeding business day
thereafter.
8.5. TERMINATION BY EITHER PARTY. This Agreement may be terminated by either
party upon written notice to the other party before its set term:
(a) immediately in the case of bankruptcy, insolvency, application
for suspension of payments, dissolution or liquidation of the
other party;
11
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission; approximately
3 pages omitted.
(b) in the event the other party fails to comply with any provision
of this Agreement in any material way and does not remedy the
breach within ninety days after having been notified by the
other party; and
8.6. TERMINATION BY BMS.
*
8.7. CONTINUATION OF PRODUCT DEVELOPMENT. If upon expiration of the Term of
this Agreement the development of the Product under the provisions of
Articles II and III hereof shall be incomplete and BMS shall notify
IVAX that it desires the development arrangements to continue, the
parties shall enter into such new or further Agreement to provide
therefor upon the same or essentially similar terms as the relevant
terms hereof (including specifically but not limited to the provisions
of Articles II, III, IV and V of this Agreement) but upon the basis
that the rights granted to BMS under Article III and obligations
accepted by IVAX under the provision of Articles II and III are fully
paid up by virtue of the payments made by BMS hereunder, but in all
respects subject to ongoing payment by BMS of the agreed developments
costs and to the financial terms of the manufacturing and supply
agreements entered or to be entered into between the parties pursuant
to the provisions of Article III.
8.8. SURVIVAL. Termination of this Agreement for any reason, or the
invalidity or partial invalidity hereof, shall not bring to an end the
obligations under Articles 8.7, 8.9, X and XI, and in view of the
survival of these obligations, the parties will work together to agree
upon an alternative means to accomplish their commercial objectives as
nearly as possible, notwithstanding the invalidity, partial invalidity
or termination of this Agreement.
8.9. RETURN OF DATA. Subject to the provisions of Section 8.7. above, on
termination of this Agreement for any reason, (a) IVAX will promptly
return to BMS all documents and data of any kind relating to the Active
Ingredient within the custody or control of IVAX, (b) BMS will promptly
return to IVAX all documents and data of any kind relating to the
Device within the custody or control of BMS, and c) BMS will pay to
IVAX all payments accrued hereunder prior to the effective date of
termination and permit IVAX to keep all payments previously received
(except as provided in Section 8.6 (e)).
ARTICLE IX
REPRESENTATIONS AND WARRANTIES
9.1 IVAX REPRESENTATIONS AND WARRANTIES. IVAX represents and warrants to
BMS that
12
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission; approximately
3 pages omitted.
(a) This Agreement has been approved by all requisite corporate
action and that it constitutes the valid and binding agreement
of IVAX and of each of its Affiliates that is a party hereto;
and
(b) It will obtain and maintain all necessary permits,
registrations and licenses required to develop the Product
under this Agreement.
9.2 BMS REPRESENTATIONS AND WARRANTIES. BMS represents and warrants to IVAX
that
(a) This Agreement has been approved by all requisite corporate
action and that it constitutes the valid and binding agreement
of BMS; and
(b) It will obtain and maintain all necessary permits,
registrations and licenses required to supply the Active
Ingredient and conduct clinical trials of the Product under
this Agreement.
9.3 COMPLIANCE WITH LAWS. IVAX and BMS will each obtain and maintain all
necessary permits, registrations and licenses required to perform their
respective obligations under this Agreement. BMS will comply with all
laws, rules and regulations in effect from time to time applicable to
the registration, marketing, distribution and sale of the Product or
any other activities to be performed by BMS hereunder.
9.4 *
ARTICLE X
CONFIDENTIALITY
10.1 OBLIGATION OF CONFIDENTIALITY. Each party agrees to maintain secret and
confidential all Technical Information obtained from the other both
pursuant to this Agreement and prior to and in contemplation of it and
all other information that it may acquire from the other in the course
of this Agreement, to respect the other's proprietary rights therein,
to use the same exclusively for the purposes of this Agreement, and to
disclose the same only to those of its employees, contractors and
distributors pursuant to this Agreement (if any) to whom and to the
extent that such disclosure is reasonably necessary for the purpose of
this Agreement and to the health authorities in Territory A insofar as
this is necessary or desirable in order to obtain registration of the
Product with such health authorities.
13
10.2 EXCLUSIONS. The foregoing obligations of Section 10.1 above shall not
apply to Technical Information or other information that:
(a) prior to receipt thereof from one party was in the possession
of the other and at its free disposal;
(b) is subsequently disclosed to the recipient party without any
obligations of confidence by a third party who has not derived
it directly or indirectly from the other under a
confidentiality obligation;
(c) is or becomes generally available to the public in printed
publications in general circulation in Territory A through no
act or default of the recipient party or its agents or
employees; or
(d) is legally required to be disclosed, provided that the
recipient party notifies the disclosing party prior to making
such disclosure and cooperates with the disclosing party to
seek any legal protections that may be available with respect
to such disclosure.
10.3 EMPLOYEES AND CONTRACTORS. Each party shall procure that all its
employees, contractors, distributors and (in the case of IVAX)
licensees (if any) who have access pursuant to this Agreement to any
information of the other to which the obligations of Section 10.1 apply
are subject to these obligations and shall further procure that so far
as is reasonably practicable all of such contractors, distributors and
licensees enter into written undertakings to this end.
10.4 PUBLIC ANNOUNCEMENTS. Neither party will make any public announcement
or other public disclosure of the existence of this Agreement or its
terms without the prior written consent of the other party, provided
that, if either party is required to disclose the existence of this
Agreement or its terms under applicable securities or other laws, the
parties will co-operate with respect to the required disclosure to
achieve a mutually acceptable statement or statements and to prepare
appropriately redacted copies of documents for filing, if required. Any
press release or other announcement issued by IVAX shall conform to the
statement set out in Attachment 4.
10.5 LITIGATION. The parties agree not to introduce as evidence, or refer in
any way to this Agreement, the Exhibits hereto, or any information
concerning any of them, in any litigation involving the parties or
their Affiliates, whether currently pending or hereafter instituted,
except in any litigation claiming a breach of this Agreement. For
purposes of any such litigation the parties hereby stipulate, for
themselves and their Affiliates, that the existence of this Agreement
and any related agreements or arrangements, and any terms or conditions
thereof, is irrelevant and inadmissible for any purpose whatsoever.
Each party consents to
14
the other's use of a copy of this Section 10.5 for the sole purpose of
preventing or opposing any act prohibited hereby.
10.6. TAX WITHHOLDING. All sums due under this Agreement:
(a) are exclusive of any value added tax, which shall be payable
in addition on the rendering by IVAX of any appropriate value
added tax invoice;
(b) shall be made by telegraphic transfer to the credit of IVAX's
bank account to be designated in writing by IVAX; and
(c) shall be made in full without deduction of taxes charges and
other duties that may be imposed. The parties shall cooperate
in all respects necessary to take advantage of such double
taxation agreements as may be available. If any government
entity asserts that withholding taxes should have been paid on
payments made hereunder, or should be paid on payments to be
made hereunder, IVAX shall be fully responsible for payment of
such withholding taxes; BMS will not pay any such tax or
assessment but will refer the claim directly to IVAX.
ARTICLE XI
INDEMNITY
11.1 INDEMNITY BY IVAX. IVAX will defend, indemnify and hold BMS and its
Affiliates and their respective officers, directors and employees
harmless from and against any and all liability, damage, loss, cost or
expense (including reasonable attorney's fees and expenses) arising out
of or resulting from any claim by a third party that the grant by IVAX
of the rights granted to BMS under Articles III or IV or the
obligations accepted by IVAX under Articles II and VII are in breach of
any contract, understanding, or commitment between IVAX or its
Affiliates and such third party. This provision and the provisions of
Section 11.2 below shall not apply to any claim subject to the
provisions of Article V (Patents and Copyright).
11.2 INDEMNITY PROCEDURE. In the case of any indemnity under Section 11.1.
above, BMS will promptly notify IVAX of any such claim or proceeding
and will permit IVAX, at its expense, to appoint counsel and control
the defence of such claim or proceeding; provided, however, that BMS
may in its discretion participate at its own expense in such defence;
and provided further, that the IVAX will not settle any such claim or
proceeding without the prior written consent of BMS, which consent will
not be unreasonably withheld.
15
ARTICLE XII
MISCELLANEOUS
12.1 NOTICE.
(a) All notices, requests, consents and other communications
required or permitted under this Agreement will be in writing
and will be (as elected by the person giving such notice) sent
by facsimile (with confirmation received of the recipient's
number) to the numbers set forth below or will be hand
delivered by messenger or courier service, or mailed by
registered or certified mail (postage prepaid), return receipt
requested, or delivered by overnight delivery service,
addressed to:
If to IVAX: IVAX Corporation
0000 Xxxxxxxx Xxxx.
Xxxxx, Xxxxxxx 00000
Attention: President
Facsimile: (000) 000-0000
with a copy to: IVAX Corporation
0000 Xxxxxxxx Xxxx.
Xxxxx, Xxxxxxx 00000
Attention: General Counsel
Facsimile: (000) 000-0000
If to BMS: Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Xxxxx 000 and Province Line Road
Princeton, New Jersey 08543-4000
Attention: Senior Vice President, Worldwide Medicines
Group and Associate General Counsel
Facsimile: 000-000-0000
(b) Each such notice will be deemed delivered (1) on the date
delivered if by personal or overnight delivery, (2) on the
date sent by telecopy if so sent, and (3) on the date upon
which the return receipt is signed or delivery is refused or
the notice is designated by the postal authorities as not
deliverable, as the case may be, if mailed.
(c) By giving to the other parties at least fifteen (15) days
written notice thereof, the parties and their respective
successors and permitted assigns will have the right from time
to time and at any time during the term of this Agreement to
change their respective addresses.
16
12.2 FURTHER ASSURANCES. Each party agrees to execute and deliver any and
all such other and additional instruments and documents and do any and
all such other acts and things as may be necessary or expedient to
effectuate more fully this Agreement and to carry out the business
contemplated by this Agreement.
12.3 FORCE MAJEURE. The inability of any party to commence or complete its
obligations hereunder by the dates herein required resulting from
delays caused by strikes, insurrection, acts of God, war, acts of
judicial bodies or other government entities, emergencies, shortages or
unavailability of materials, or other similar causes beyond the party's
reasonable control which will have been timely communicated to the
other party, will extend the period for the performance of the
obligations for the period equal to the period(s) of any such
delays(s); provided that such party will continue to perform to the
extent feasible in view of such force majeure; and provided further,
that if such force majeure will continue for a period of six (6)
months, either party will have the right to terminate this Agreement
upon written notice to the other.
12.4 ASSIGNMENT; BINDING EFFECT. Either party may assign this Agreement
without the other's consent to any of its Affiliates or delegate all or
part of its obligations to an Affiliate; provided, however, that the
assignee or delegate shall assume and be bound by the provisions of
this Agreement, and its performance hereunder shall be guaranteed by
the original party to this Agreement. Except as specifically permitted
herein, neither party may assign its rights and/or obligations
hereunder or any interest therein to any other party without the prior
written consent of the other party; provided however that, for the
avoidance of doubt, a change of control of either party will not be
deemed an assignment and thus will not require the other party's
consent save in respect of any change of control of IVAX where any
acquiring party shall be a corporation having an interest in the field
of oncology and being authorised to market and sell any pharmaceutical
product containing a taxane as an active ingredient. Subject to the
foregoing, this Agreement will be binding upon and inure to the benefit
of the parties hereto and their respective successors and permitted
assigns.
12.5 WAIVER AND AMENDMENT. Any representation, warranty, covenant, term or
condition of this Agreement which may legally be waived, may be waived,
or the time of performance thereof extended, at any time by the party
hereto entitled to the benefit thereof, and any term, condition or
covenant (including, without limitation, the period during which any
condition is to be satisfied or any obligation performed) may be
amended by the parties hereto at any time. Any such waiver, extension
or amendment will be evidenced by an instrument in writing executed by
an officer authorised to execute waivers, extensions or amendments. No
waiver by any party, whether express or implied, of its rights under
any provision of this Agreement will constitute a waiver of such
party's rights under such provisions at any other time or a waiver of
such party's rights under any other provision of this Agreement. No
failure by any party to take any
17
action against any breach of this Agreement or default by another party
will constitute a waiver of the former party's right to enforce any
provision of this Agreement or to take action against such breach or
default or any subsequent breach or default by such other party.
12.6 SEVERABILITY. In the event that any one or more of the provisions
contained in this Agreement will be declared invalid, void or
unenforceable, the remainder of the provisions of this Agreement will
remain in full force and effect, and such invalid, void or
unenforceable provision will be interpreted in a manner which
accomplishes, to the extent possible, the original purpose of such
provision. The foregoing is not intended to supersede any specific
provision of this Agreement. is specifically agreed that BMS's decision
to discontinue the development work shall not, in and of itself, affect
the payments provided under Sections 8.2 and 8.3.which will continue
until they have all been made, except as stated in Section 8.6(e).
12.7 SECTION HEADINGS. The section headings in this Agreement are for
convenience of reference only and will not be deemed to affect the
interpretation of any provision of this Agreement.
12.8 NO THIRD PARTY RIGHTS. The provisions of this Agreement are for the
exclusive benefit of the parties to this Agreement, and no other Person
(including without limitation any creditor of any party to this
Agreement) will have any right or claim against any party to this
Agreement by reason of those provisions or be entitled to enforce any
of those provisions against any party to this Agreement.
12.9 RELATIONSHIP OF PARTIES. This Agreement will not constitute or be
construed as creating a marketing partnership or distribution
arrangement with respect to paclitaxel injection or any other form of
partnership or joint venture between or among the parties, and no party
will be liable for any debts or obligations of the other parties. No
party will in any way be considered as being an agent or representative
of the other parties in any dealings with any third party, and no party
may act for, or bind, the other parties in any such dealings.
12.10 GOVERNING LAW. This Agreement has been entered into and will be
construed and enforced in accordance with the laws of England without
reference to the choice of law principles thereof.
12.11 JURISDICTION; VENUE. Any suit, action or proceeding against any party
with respect to this Agreement or any judgement entered by any court in
respect of this Agreement will be brought in the High Court of Justice
in London, England, and the parties hereto accept the exclusive
jurisdiction of those courts for the purpose of any such suit, action
or proceeding. In addition, the parties irrevocably waive, to the
fullest extent permitted by law, any objection which they may now or
hereafter have to the laying of venue of any suit, action or proceeding
arising out
18
of or relating to this Agreement, or any judgement entered by any court
in respect hereof brought in London, England, and further irrevocably
waive any claim that any suit, action or proceeding brought in London,
England was brought in an inconvenient forum. The parties will jointly
petition the court to maintain all records of any such proceeding under
seal, including all pleadings, briefs, evidence, transcripts, and other
documents pertaining to the proceeding, and not to make the same
publicly available except as may be necessary to enter and enforce any
judgement rendered in any such proceeding or to take an appeal
therefrom, provided, however, that any appellate proceeding will also
be kept under seal.
12.12 Arbitration.
(a) In the event that either party gives written notice of its
desire to arbitrate a dispute regarding a revised payment
schedule under Section 8.6 (g), such dispute shall be settled
by arbitration in London, England, in accordance with the
then-existing international arbitration rules (the "Rules") of
the American Arbitration Association ("AAA"), and judgement
upon the award rendered by the arbitrators may be entered in
any court having jurisdiction thereof; provided, however, that
the law applicable to any controversy shall be the law of
England. In any arbitration pursuant to this provision, the
award or decision shall be rendered by a majority of the
members of a Board of Arbitration consisting of three (3)
members, one of whom shall be appointed by each party and the
third of whom shall be the chairman of the panel and be
appointed by mutual agreement of said two party-appointed
arbitrators. The persons appointed as arbitrators will have at
least five (5) years' experience in the field of
pharmaceutical licensing and distribution, including senior
negotiating responsibilities with major pharmaceutical
companies, and will not have had any prior affiliation with
either party, whether as employees, consultants, directors,
legal counsel, or any similar relationship. In the event of
failure of the two party-appointed arbitrators to agree within
sixty (60) days after the commencement of the arbitration
proceeding upon the appointment of the third arbitrator, the
third arbitrator shall be appointed by the AAA in accordance
with the Rules. In the event that either party shall fail to
appoint an arbitrator within thirty (30) days after the
commencement of the arbitration proceeding, such arbitrator
and the third arbitrator shall be appointed by the AAA in
accordance with the Rules. In determining the schedule of
payments to be made for the remaining Services and rights
granted under the Agreement, the arbitrators will be directed
to consider all of the following:
(i) Contractual arrangements regarding similar
pharmaceutical products entered into by others in
similar circumstances and by the parties themselves;
but as to existing agreements, taking account of
19
improvements made and achievements recognised since
their most recent product development agreements;
(ii) The uniqueness of the IVAX technology, including its
patented inventions and its know-how, and the
experience of its Affiliates in developing and
manufacturing pulmonary drugs, including their
knowledge of propellants, product formulations,
regulatory requirements, and manufacturing methods;
(iii) The advantages of the IVAX inhalation device over
conventional devices, such as its ease of use,
convenience, dosing accuracy, reliability in
delivering product directly to the lungs, and success
in obtaining regulatory approvals;
(iv) The cost that BMS would incur to develop or contract
for the development of its own inhalation device for
use with the Active Ingredients, such as design,
engineering, testing, procurement of manufacturing
equipment, and hiring of personnel, as well as the
loss of potential product sales during the time that
would be required to develop the necessary
capabilities and facilities; and
(v) the fact that one of the devices that may be used in
the Products has received numerous awards for design
and engineering excellence.
(b) The arbitrators will be further instructed to select a value
and to establish a payment schedule consisting of at least
four (4) substantial milestone payments, reimbursement of
costs and expenses, and ongoing royalties in an amount
reflecting royalties paid by others in the industry for the
use of proprietary technology, as well as amounts received by
IVAX for similar arrangements, taking account of improvements
made and achievements recognised since finalisation of its
most recent product development agreements.
(c) Any dispute arising under this Agreement except those covered
by sub-paragraph 12.12 (a) will be resolved in a private
judicial proceeding pursuant to Section 12.11.
12.13 EQUITABLE REMEDIES. Each of the parties acknowledges and agrees that,
in the event of a breach or threatened breach of this Agreement by any
party or the failure of a party to perform in accordance with the
specific terms hereof, the other party hereto will be irreparably
damaged and that monetary damages would not provide an adequate remedy.
Accordingly, it is agreed that, in addition to any and all other rights
which may be available, at law or in equity, the non-breaching
20
party will be entitled to injunctive relief and/or specifically to
enforce the terms and provisions hereof in any court of competent
jurisdiction.
12.14 REMEDIES CUMULATIVE. The rights and remedies given in this Agreement to
a non-defaulting party will be deemed cumulative, and the exercise of
one of such remedies will not operate to bar the exercise of any other
rights and remedies reserved to a non-defaulting party under the
provisions of this Agreement or given to a non-defaulting party at law
or in equity.
12.15 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which will be deemed an original but all of which
together will constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Agreement by their
authorised representatives effective as of the date first above written.
IVAX CORPORATION XXXXXXX-XXXXX SQUIBB COMPANY
By: By:
------------------------------- -------------------------------
Name: Name:
----------------------------- -----------------------------
Title: Title:
---------------------------- ----------------------------
XXXXX NORTON NORTON HEALTHCARE LTD.
INTERNATIONAL, GmbH.
By: By:
------------------------------- -------------------------------
Name: Name:
----------------------------- -----------------------------
Title: Title:
---------------------------- ----------------------------
21
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
ATTACHMENT 1
ACTIVE INGREDIENTS
*
Second compound to be determined by BMS during the first eighteen (18) months of
the Agreement.
----------------------
* Subject to verification at the time of negotiation of the initial Development
Plan.
22
ATTACHMENT 2
DEFINITIONS
"Active Ingredient" means either of the compounds identified on
Attachment 1.
"Affiliate" means any Person that controls, is controlled by or is
under common control with BMS or IVAX, as the case may be. The term "control"
means the ownership, directly or indirectly, or the power to direct the voting
or disposition, of fifty percent (50%) or more of the voting stock or income
interests of the subject Person, or such other arrangement as in fact
constitutes actual control. For purposes solely of Section 8.6(a), an Affiliate
shall also be deemed to include any third party acting by right of reference to
or making use authorised by IVAX of any preclinical or clinical data of IVAX or
any other IVAX Affiliate in obtaining a marketing authorisation referred to
implicitly or explicitly therein.
"Budget" means the costs agreed by the parties, which are reasonably
anticipated to be incurred by IVAX on a quarterly basis for the development of
the Product.
"Development Plan" means a plan mutually devised and agreed by IVAX and
BMS relating to the development of any Product, defining the responsibilities of
each party for development and registration work and the time schedules for such
work.
"Device" means an inhalation device developed, modified or adapted for
use in connection with an Active Ingredient under this Agreement, which may be
covered under one or more of the Patent Rights.
"Indicated Use" means (in relation to PAXENE) the treatment of patients
with advanced AIDS related kaposi's sarcoma who have failed prior liposomal
anthracycline therapy.
"IVAX" means IVAX Corporation, a Florida corporation, or its Affiliate
owning the rights or performing the services in question, which is NHL or BNI,
as the case may be.
"Know-How" means all confidential information of any type concerning
the Device that is known to IVAX, or that may become known to IVAX during the
term of this Agreement. Such information shall include, without limitation,
information concerning manufacturing methods and skills, and physical data.
"Patent Rights" means:
(a) the patents and applications as briefly described in
Attachment 3 hereto;
23
(b) all patent applications that may hereafter be filed in
Territory A by or on behalf of IVAX which either are based on
or claim priority from any of the foregoing patents and
applications or which are in respect of any improvements to
the device claimed in the patents and patent applications set
out in Attachment 3 hereto;
(c) all patents which may be granted pursuant to any of the
foregoing patent applications; and
(d) all supplementary patent certificates granted in relation to
the patents and patent applications referred to in sub-clauses
(a) through (c) above;
"PAXENE" means any injectable paclitaxel product marketed under or by
reference to the PAXENE Authorisation.
"Person" means any natural person, corporation, unincorporated
organisation, partnership, association, joint stock company, joint venture,
limited liability company, trust or government, or any agency or political
subdivision of any government, or any other entity.
"Principal Territories" means the countries currently comprising the
European Union (Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, the Netherlands, Spain, Sweden, Portugal, and the
United Kingdom),the People's Republic of China, Canada, Mexico, South Africa,
the United States, and any other significant pharmaceutical markets in Territory
A. A "Principal Territory" shall mean one of these Principal Territories.
"Product" means a pharmaceutical product in finished dosage form
including an Active Ingredient that is developed by means of the Services to be
provided pursuant to this Agreement.
"Regulatory Application" means a formal application submitted to the
appropriate Regulatory Authority under applicable law seeking approval to market
a Product within Territory A.
"Regulatory Approval" means a communication in writing from the
appropriate Regulatory Authority permitting the marketing of a Product within
Territory A.
"Regulatory Authority" means a governmental regulatory authority which
has authority over the clinical testing, manufacturing, marketing, or sale of
pharmaceutical products in any jurisdiction covered by this Agreement.
"Technical Information" means Know-How, processes, formulations,
concepts, ideas, preclinical, clinical, pharmacological or other data and
testing results, experimental methods or results, and other information relating
to the development, formulation, registration or manufacture of the Product or
relating to the Active Ingredient.
24
"Term" means the period during which this Agreement is in effect.
"Territory A" means the world.
"Territory B" means all countries of the European Union, together with
Iceland, Liechtenstein, Monaco, and Switzerland.
25
ATTACHMENT 3
PATENT RIGHTS
See attached.
26
BAI PATENT LIST
[MEDICAMENT DISPENSING DEVICE]
STATUS AS OF JULY 12, 1999
AP AFRICAN REGIONAL PROPERTY ORGANIZATION
APPLICATION NO.: AP/P/92/00390
FILED: 15 MAY 1992
PATENT NO.: AP320
STATUS: GRANTED
AR ARGENTINA
APPLICATION NO.: 322442
FILED 1 JUNE 1992
PATENT NO.: 246183
STATUS: GRANTED
AU AUSTRALIA
APPLICATION NO.: 90340/91
FILED 29 NOVEMBER 1991
PATENT NO.: 644925
STATUS: GRANTED
BG BULGARIA
APPLICATION NO.: 96390
FILED 28 MAY 1992
PATENT NO.: 61027
STATUS: GRANTED
BR BRAZIL
APPLICATION NO.: PI 9202048
FILED: 29 MAY 1992
PATENT NO.:
STATUS: GRANTED-AWAITING LETTERS PATENT AND PATENT NUMBER
CA CANADA
APPLICATION NO.: 2091367
FILED: 29 NOVEMBER 1991
PATENT NO.: 2091367
STATUS: GRANTED
1
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
*
*
*
*
*
*
*
*
*
EP EUROPE
APPLICATION NO.: 929003212.8
FILED: 29 NOVEMBER 1991
PATENT NO.: 559736
STATUS: GRANTED.
EPC NATIONAL FILINGS IN:
AT AUSTRIA
BG BELGIUM
CH SWITZERLAND
DE GERMANY
DK DENMARK
ES SPAIN
FR FRANCE
GB GREAT BRITAIN
GR GREECE
IT ITALY
LI LIECHTENSTEIN
LU LUXEMBOURG
NL THE NETHERLANDS
SE SWEDEN
2
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
REGISTERED IN:
BERMUDA
(REGISTERED AS NO. 135)
BAHRAIN
(REGISTERED AS NO. 1100)
BOTSWANA
(REGISTERED AS NO. EP 559736)
CYPRUS
(REGISTERED AS NO. 1904)
HONG KONG
(REGISTERED AS 1140/96)
JERSEY
(REGISTERED AS NO. 577)
*
*
*
*
*
HU HUNGARY
APPLICATION NO.: 9201803
FILED: 29 MAY 1992
PATENT NO.: 213685
STATUS: GRANTED
ID INDONESIA
APPLICATION NO.: P-001042
FILED: 30 NOVEMBER 1991
PATENT NO.: ID 300297
STATUS: GRANTED
IE IRELAND
APPLICATION NO.: 4063/91
FILED: 22 NOVEMBER 1991
PATENT NO.: 73212
STATUS: GRANTED
3
IL ISRAEL
APPLICATION NO.: 100342
FILED: 11 DECEMBER 1991
PATENT NO.: 100342
STATUS: GRANTED
IN INDIA
APPLICATION NO.: 325/CAL/92
FILED: 13 MAY 1992
PATENT NO.: 177774
STATUS: GRANTED
JP JAPAN
APPLICATION NO.: 4/501197
FILED: 29 NOVEMBER 1991
PATENT NO.: 2535297
STATUS: GRANTED
KR SOUTH KOREA
APPLICATION NO.: 92-9443
FILED: 92-9443
PATENT NO.: 130915
STATUS: GRANTED
LK SRI LANKA
APPLICATION NO.: 10385
FILED: 29 MAY 1992
PATENT NO.: 10385
STATUS: GRANTED
MX MEXICO
APPLICATION NO.: 92/02525
FILED: 28 MAY 1992
PATENT NO.: 178369
STATUS: GRANTED
4
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
MY MALAYSIA
APPLICATION NO.: PI 9200827
FILED: 15 MAY 1992
PATENT NO.: 110200-A
STATUS: GRANTED
NG NIGERIA
APPLICATION NO.: 115/92
FILED: 21 MAY 1992
PATENT NO.: 12159
STATUS: GRANTED
NO NORWAY
APPLICATION NO.: 930484
FILED: 29 NOVEMBER 1991
PATENT NO.: 304461
STATUS: GRANTED
NZ NEW ZEALAND
APPLICATION NO.: 240742
FILED: 26 NOVEMBER 1991
PATENT NO.: 240742
STATUS: GRANTED
OA AFRICAN INTELLECTUAL PROPERTY ORGANIZATION
APPLICATION NO.: 60219
FILED: 27 MAY 1992
PATENT NO.: 10046
STATUS: GRANTED
*
*
*
*
*
5
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
PK NORTH KOREA
APPLICATION NO.: 250/92
FILED: 24 MAY 1992
PATENT NO.: 133218
STATUS: GRANTED
PL POLAND
APPLICATION NO.: P294799
FILED: 4 JUNE 1992
PATENT NO.: 169729
STATUS: GRANTED
PT PORTUGAL
APPLICATION NO.: 99710
FILED: 6 DECEMBER 1991
PATENT NO.:
STATUS: GRANTED/AWAITING LETTERS PATENT AND PATENT NUMBER
RO ROMANIA
APPLICATION NO.: 92 200744
FILED: 29 MAY 1992
PATENT NO.: 108415
STATUS: GRANTED
RU RUSSIA
APPLICATION NO.: 5052149.14
FILED: 29 MAY 1992
PATENT NO.: 2088264
STATUS: GRANTED
*
*
*
*
*
6
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
*
*
*
*
*
*
*
*
*
*
TR TURKEY
APPLICATION NO.: 431/92
FILED: 29 MAY 1992
PATENT NO.: 26977
TW TAIWAN
APPLICATION NO.: 80109372
FILED: 30 MAY 1991
PATENT NO.: 62015
STATUS: GRANTED
VE VENEZUELA
APPLICATION NO.: 92/00752
FILED: 26 MAY 1992
Patent No.: I-752-92
STATUS: GRANTED/AWAITING LETTERS PATENT
*
*
*
*
*
7
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
US UNITED STATES
APPLICATION NO.: 039,302
FILED: 29 NOVEMBER 1991
PATENT NO.: 5,447,150
STATUS: ISSUED
*
*
*
*
*
ZA SOUTH AFRICA
APPLICATION NO.: 919521
FILED: 3 DECEMBER 1991
PATENT NO.: 919521
STATUS: GRANTED
8
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
STATUS AT 4/10/99
NORTON HEALTHCARE LIMITED
PATENTS/APPLICATIONS - INHALERS
MULTIDOSE DRY POWDER INHALER
P69654 Page 9
------
COUNTRY APPLN DATE APPLN NO. PATENT NO PROGRESS STATUS
------- ---------- --------- --------- ---------------
*
AD 2 JUNE 92 AP/P/92/00394 AP 272 GRANTED
AR 9 JUNE 92 322489 246873 GRANTED
AU 29 NOV 93 99326/91 647851 GRANTED
BG 12 JUN 92 96457 61218 GRANTED
BR 15 JUN 92 PI 9202223 GRANTED
CA 29 NOV 91 2091366 2091366 GRANTED
*
CO 12 JUNE 92 361.045 24.961 GRANTED
CZ 3 JUNE 92 PV 1678-92(CS) 281662 GRANTED
EP# 29 NOV 91 91920759.7 0561830 GRANTED
*
HU 11 JUNE 92 9201956 216770 GRANTED - Await Letters Patent
ID 14 DEC 91 P-001152 ID 000312 GRANTED
IE 6 DEC 91 4240/91 76470 GRANTED
IL 11 DEC 91 100341 100341 GRANTED
IN 21 MAY 92 346/CAL/92 190711 GRANTED
*
JP 29 NOV 91 4/500057 2535296 GRANTED
KR 15 JUNE 92 92-10412 128232 GRANTED
LK 15 JUNE 92 10393 10393 GRANTED
*
*
NG 8 JUNE 92 134/92 11327 GRANTED
NO 29 NOV 91 P930382 305785 GRANTED
NZ 2 DEC 91 240833 240833 GRANTED
OA 3 JUNE 92 60224 10031 GRANTED
9
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
STATUS AT 4/10/99
NORTON HEALTHCARE LIMITED
PATENTS/APPLICATIONS - INHALERS
MULTIDOSE DRY POWDER INHALER
P69654 Page 10
------
COUNTRY APPLN DATE APPLN NO. PATENT NO PROGRESS STATUS
------- ---------- --------- --------- ---------------
*
PK 3 JUNE 92 264/92 133022 GRANTED
PL 12 JUNE 92 P294877 169814 GRANTED
FT 13 DEC 91 99805 99805 GRANTED - Await Letters Patent
RO 12 JUNE 92 92-200787 111825 GRANTED
RU 11 JUNE 92 5052303.14 2077893 GRANTED
*
*
SK 3 JUNE 92 PV 1678-92(SK) 000000 XXXXXXX
XX 15 JUNE 92 523/92 25963 GRANTED
TW 9 DEC 91 80109644 62016 GRANTED
US 29 NOV 91 039301 5503144 GRANTED
VE 12 JUNE 92 815/92 I-815-92 GRANTED - Await Letters Patent
*
*
ZA 27 NOV 91 919363 919363 GRANTED
The European Patent has been registered in:
Hong Kong (Registered as No. 483/97)
Jersey (Registered as No. 589)
Cyprus (Registered as No. 1999)
# Designated AT/BE/CH/LI/DE/DK/ES/FR/GB/GR/IT/LU/NL/SE
10
ATTACHMENT 4
IVAX SIGNS PRODUCT COLLABORATION AND DEVELOPMENT SERVICES
AGREEMENT WITH XXXXXXX-XXXXX SQUIBB
MIAMI - November 19, 1999 -- IVAX Corporation (AMEX:IVX) today
announced it has entered into a product collaboration and development services
agreement with Xxxxxxx-Xxxxx Squibb Company (BMS) in the areas of inhalation
technology and oncology.
IVAX subsidiaries and BMS will collaborate to develop one or more of
Xxxxxxx-Xxxxx Squibb's proprietary molecules for use with IVAX's patented
inhalation devices, primarily for the treatment of asthma. Xxxxxxx-Xxxxx Squibb
will retain worldwide rights to market respiratory products containing its
compounds. BMS will purchase the devices that IVAX will manufacture from IVAX on
terms to be agreed upon.
In the field of oncology, Xxxxxxx-Xxxxx Squibb, which markets
paclitaxel for injection under the brand name Taxol(R) for the treatment of
various forms of cancer, has been granted an option to license IVAX's patented
system for the oral administration of paclitaxel on terms to be agreed upon.
Additionally, each party has agreed to respect the other's lawful data
protection rights in its marketing of paclitaxel in the European Union, where
IVAX recently received approval of its proprietary Paxene(R) (paclitaxel
injection) product to treat AIDS-related Kaposi's sarcoma.
The initial term of the agreement is three years. The agreement may be
terminated under certain specified circumstances. Subject to the possible events
of termination, the payments to be received during the term of the agreement
could be significant to IVAX.
Dr. Xxxxxxx Xxxxx, chairman and chief executive officer of IVAX
Corporation, commented, "This collaboration agreement with Xxxxxxx-Xxxxx Squibb
utilizes the combination of our innovative, award-winning, patented inhalation
devices and Xxxxxxx-Xxxxx Squibb's next-
1
generation asthma molecules to create respiratory products of major commercial
significance. Further, the possibility of a collaboration with Xxxxxxx-Xxxxx
Squibb in developing and commercializing our oral system for administering
paclitaxel, the most important oncology drug in the world, is another
significant step in the advancement of IVAX's oncology program."
IVAX Corporation, headquartered in Miami, Florida, is a holding company
with subsidiaries engaged in the research, development, manufacture, and
marketing of branded and generic pharmaceuticals and veterinary and diagnostic
products in the U.S. and international markets.
Except for the historical matters contained herein, statements in this
press release, including those relating to the development and commercialization
of pharmaceutical products and the receipt by IVAX of future payments from
Xxxxxxx-Xxxxx Squibb, are forward-looking and are made pursuant to the safe
harbor provisions of the Securities Litigation Reform Act of 1995. Investors are
cautioned that forward-looking statements involve risks and uncertainties which
may affect IVAX's business and prospects, including the risk that the
collaborative agreement with Xxxxxxx-Xxxxx Squibb may not result in successful
development or commercialization of respiratory, oncology, or other products,
the risk that the agreement may terminate before IVAX has received any
significant amount of payments, and certain other risks and uncertainties based
on economic, competitive, governmental, technological and other factors
discussed in the Company's filings with the Securities and Exchange Commission.
CONTACT:
Xxxx X. Xxxxxxx
Director, Investor Relations and Corporate Communications
IVAX Corporation
000-000-0000
xxxx_xxxxxxx@xxxx.xxx
xxx.xxxx.xxx
2
ATTACHMENT 5
LICENSE OPTION AGREEMENT
This Agreement is entered into effective November 18, 1999, 1999 (the
"Effective Date") by and between Xxxxx Xxxxxx International GmbH, a Swiss
corporation having an office at Zurich Switzerland ("BNI"), and Xxxxxxx-Xxxxx
Squibb Company, a Delaware corporation having an office at Rte. 206 and Province
Line Road, Princeton, NJ 08543-4000 ("BMS").
RECITALS
WHEREAS, BNI owns proprietary technology (the "BNI Technology")
pertaining to an system of making paclitaxel available by oral administration
(the "Oral Product"), for which it has filed patent applications and obtained
patents throughout the world; and
WHEREAS, BNI is an indirect wholly-owned subsidiary of IVAX
Corporation, which has provided to BMS certain confidential and proprietary data
of BNI regarding the Oral Product; and
WHEREAS, BMS desires to further review BNI's confidential material and
to negotiate with BNI on an exclusive basis for a license under the BNI
Technology to manufacture and market the Oral Product, it being understood that
obtaining rights to the Oral Product would be a beneficial line extension for
BMS and that BMS would obtain an advantage over other prospective licensees by
the exclusive negotiation period granted hereunder;
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing and for other good
and valuable consideration, the parties hereto agree as follows:
1. GRANT OF OPTION. BNI hereby grants to BMS the exclusive right to
negotiate for a license under the BNI Technology in the European Union (the
"Territory").
2. TERM. The exclusive negotiation period granted to BMS hereunder
shall begin on the Effective Date and shall expire six (6) months thereafter, on
March 31, 2000 (the "Term"). During the Term, BNI will not negotiate with any
person other than BMS regarding the licensing of rights to the Oral Product in
the Territory.
3. CONFIDENTIALITY. All documentation provided by either party to the
other hereunder will be subject to the confidential disclosure agreement entered
into between BMS and IVAX Corporation on January 23, 1997, as amended on August
24, 1999.
4. NO GRANT OF LICENSE. No license or warranty is granted, conveyed or
implied with respect to the BNI Technology, and neither BNI nor any of its
Affiliates shall have any liability to BMS or any of its Affiliates resulting
from the licensing negotiations or the use of BNI's confidential information by
BMS or its Affiliates. Nothing in this Agreement shall be construed to create,
constitute, give effect to or otherwise imply a joint venture, partnership,
agency or employment relationship of any kind between the Parties.
5. TERMINATION. This Agreement may not be amended or terminated except
by the parties' mutual written consent.
6. EFFECT OF TERMINATION. Upon the termination or expiration hereof, if
no license agreement is entered into, BMS will return to BNI all documents,
samples and other materials that it has received from BNI and
1
its Affiliates pertaining to the Oral Product, or developed by use of materials
received from BNI, retaining no copies thereof.
7. GOVERNING LAW. This Agreement and the performance of the parties'
obligations hereunder, shall be governed by the law of the State of New York
applicable to commercial transactions, notwithstanding the choice of law
principles of New York or any other jurisdiction.
8. JURISDICTION. The exclusive jurisdiction for the adjudication of any
legal claim that may arise under, out of, in connection with, or relating to
this Agreement or any breach hereof, shall be the proper Florida state court
based on the amount in controversy, and venue shall be in Dade County. BMS
hereby submits to the jurisdiction of such courts and agrees to accept service
of process by mail to its address set forth in Section 10.1 or by any other
manner of service legally permitted by such court for actions arising out of
contracts entered into in the State of Florida. BMS hereby waives any objection
that it might otherwise have to jurisdiction in such forum, including, but not
limited to, objections based on lack of jurisdiction, inconvenient forum, and
the like.
IN WITNESS WHEREOF, the parties have executed this Agreement effective
as of the date stated in the opening paragraph hereof.
XXXXX XXXXXX INTERNATIONAL GMBH XXXXXXX-XXXXX SQUIBB COMPANY
By: By:
------------------------------- -------------------------------
Name: Name:
----------------------------- -----------------------------
Title: Title:
---------------------------- ----------------------------
2
* Portions of this document have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
* Portions of the Attachments to this document have been omitted pursuant to a
request for Confidential Treatment and filed separately with the Commission.
PRODUCT COLLABORATION AND
DEVELOPMENT SERVICES AGREEMENT
INDEX
-----
ARTICLE PAGE
------- ----
I. Definitions 3
II. Product Development 3
III. Additional Agreements 5
IV. Regulatory Matters 6
V. Patents and Copyright 7
VI. Option for Licence to Oral Delivery System 9
VII. Undertakings Regarding Paclitaxel 10
VIII. Term, Termination and Payments 11
IX. Representations and Warranties 16
X. Confidentiality 17
XI. Indemnity 18
XII. Miscellaneous 19
ATTACHMENTS
-----------
1. Active Ingredients
2. Definitions
3. Patent Rights
4. Press Statement
5. Licence Option Agreement
