EXHIBIT 10.38
MULTI PRODUCT TECHNOLOGY TRANSFER
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DEVELOPMENT AND LICENSE AGREEMENT
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AGREEMENT, effective as of this 30th August 1994 (hereinafter referred to as the
"Effective Date"), by and between SCHEIN PHARMACEUTICAL, INC, 100 Campus Drive,
Florham Park, NY 07932, U.S.A., (hereinafter referred to as "Schein") and
ETHICAL HOLDINGS PLC, a company registered in the United Kingdom and having its
principal place of business at Corpus Christi House, 9 West Street,
Godmanchester, Cambridgeshire, PE18 8HG, U.K. (hereinafter referred to as
"Ethical").
WITNESSETH THAT:
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WHEREAS, Ethical owns valuable Ethical Know-How (hereinafter defined) and has
sought Patent Rights (hereinafter defined) relating to pharmaceutical
formulations designed to provide controlled release of active constituents from
solid dosage forms; and
WHEREAS, Ethical has a research and development capability in drug delivery
systems and pharmaceuticals in areas, including but not limited to, efficacy,
improved formulations and methods of drug delivery; and
WHEREAS, Schein desires that Ethical develop, as provided for in this Agreement,
****** **** ******** ** ****** **** ******** *** ** ***** *** ***********
******* ** ** *********** *** *** ** **** ****** ***** *** ******* ********* ***
WHEREAS, Schein has expressed an interest in entering into an agreement on terms
similar to those contained herein in respect of the development and marketing in
the United States of the ************* ******* *** ******* ** ******** **
********* ********* ******** ******** ** ************* ***
WHEREAS, Schein desires to effect the final product development and registration
with the regulatory authorities within the United States and outside of the
United States and to make the regulatory filings.
NOW THEREFORE, in consideration of the foregoing and the mutual covenants and
conditions set forth herein, the parties hereto mutually agree as follows:
1. DEFINITIONS
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1.1 In this Agreement, unless the context otherwise requires, the
following terms shall have the meaning set forth in this clause:
1.1.1 "Ethical" means ETHICAL HOLDINGS PLC, Corpus Christi House, 9
West Street, Godmanchester, Cambs., PE18 8HG, UK.
* Page redacted pursuant to confidential treatment request.
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1.1.2 "Schein" means SCHEIN PHARMACEUTICAL, INC, 100 Campus Drive,
Florham Park, NY 07932, U.S.A.
1.1.3 "Effective Date" means 30th August 1994.
1.1.4 "Ethical Know-How" means all proprietary scientific and medical
information, technical data and marketing studies in Ethical's
possession or, from time to time invented or developed or
acquired by or on behalf of Ethical or under the control of
Ethical (other than Schein Know-How) relating specifically to
the registration, marketing, manufacture or use of its **** **
*********** **** ******** ********** as further detailed in
Schedule 1 including, but not limited to, toxicological,
pharmacological, analytical and clinical data, bioavailability
studies, product forms and formulations, control assays and
specifications, methods of preparation and stability data and
specifically including all information contained in all health
registration dossiers to be filed in various countries of the
world, and shall further include all Improvements and
Independent Third Party data which Ethical has access to and is
free to disclose without restriction or compensation to such
Independent Third Party (and relating to the Designated
Products). Notwithstanding the foregoing, the term 'Ethical
Know-How' shall not be deemed to refer to information and data
of the type which would not be required to be maintained as
confidential by either party pursuant to the provision of
Clause 22.
1.1.5 "Schein Know-How" means all proprietary scientific and medical
information and technical data from time to time developed or
acquired by or on behalf of Schein (other than Ethical Know-
How) relating specifically to the manufacture or use of the
technology and all Improvements including, but not limited to,
toxicological, pharmacological, analytical and clinical data,
bioavailability studies, product forms and formulations,
control assays and specifications, methods of preparation and
stability data, and specifically including all information
contained in all health registration dossiers filed by Schein
relating to the Designated Products. Notwithstanding the
foregoing, the term 'Schein Know-How' shall not be deemed to
refer to information and data of the type which would not be
required to be maintained as confidential by either party
pursuant to the provision of Clause 22.
1.1.6 "Patent Rights" means those patents and patent applications
listed in Schedule 2 and any and all patents and patent
applications filed
* redacted pursuant to confidential treatment request
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by or issued to Ethical and licensed or assigned to Ethical
relating to controlled release formulations for oral
administration in man, or the manufacture or use of them,
together with any and all patents that may issue or may have
issued therefrom, including any and all divisions,
continuations, continuations-in-part, extensions, additions or
reissues of or to any of the aforesaid patent applications in
any country in which Ethical has filed, or hereafter files,
patents.
1.1.7 "Prospective Development Products" means those pharmaceutical
compounds discussed by the parties and thereby listed in
Schedule 5 as amended from time to time.
1.1.8 "Designated Products" means the Prospective Development
Products selected by Schein pursuant to Schedule 3 and which
thereby are no longer included in the definition of Prospective
Development Products.
1.1.9 "Designated Product Extensions" means additional dosages,
strengths, indications, changes to specifications,
manufacturing procedures or regulatory compliancies of a
Designated Product in addition to those detailed in the
original Designated Development Programme.
1.1.10 "Territory" means the entire world except in respect of the
************* Product in which case it shall mean solely the
United States, its territories and possessions.
1.1.11 "Net Sales" means the gross sales of a Designated Product
actually invoiced by Schein or Schein's sublicensee hereunder
to an Independent Third Party, less chargebacks and rebates,
the total ordinary and customary trade discounts (but not
including cash discounts for prompt payments), rebate for
inventory price protection to counter competitive pressures,
excise taxes, other consumption taxes, customs duty, credits
and allowances actually granted on account of rejection or
return.
1.1.12 "Independent Third Party" means any party other than Ethical
and Schein and their respective subsidiaries and affiliates.
1.1.13 "Agreement" means this agreement duly signed by the parties.
1.1.14 "Designated Development Programme" means the programme of
development selected by the Notice under Schedule 3 containing
at least the obligations set forth in Schedule 4 prepared by
Ethical and
* redacted pursuant to confidential treatment request
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approved by Schein for the development of a Designated Product
for manufacture, use, promotion, distribution and sale in the
United States. Each Designated Development Programme may be
amended from time to time by the addition of Designated Product
Extensions or exclusion of any Granted Territory or as set out
under Clause 12 and Schedule 3, Clause 2.7, or otherwise as
agreed between the parties.
1.1.15 "Multi Product Development Programme" means the overall
programme of development in respect of all the Designated
Development Programmes.
1.1.16 "FDA" means the United States Food and Drug Administration.
1.1.17 "Marketing Authorisations" means the consent or approval of the
FDA and any applicable comparable state agencies required to
market and distribute a Designated Product in the United
States, its territories and possessions or the consent or
approval of any government or any governmental agency required
to market and distribute a Designated Product outside of the
United States.
1.1.18 "Improvements" means inventions, discoveries, developments,
ideas and indications relating to the Ethical Know-How and
Patent Rights.
1.1.19 "Granted Territory" shall mean those countries within the
Territory in which Ethical, by virtue of Clause 7 or Clause
11.4.8 has the right to use and licence the Patent Rights,
Ethical Know-How and Schein Know-How and to negotiate a licence
or other commercial arrangement with respect to the use, making
and/or manufacture, promotion, marketing and sale of a
Designated Product.
1.1.20 "Quarter" shall mean any of the four quarters commencing 31st
August, 30th November, 28th February and 31st May of any year.
1.2 In this Agreement
1.2.1 the singular includes the plural and vice versa, the masculine
includes the feminine and vice versa and references to natural
persons include corporate bodies, partnerships and vice versa.
1.2.2 any references to Clause or Schedule shall, unless otherwise
specifically provided, be to a Clause or Schedule of this
Agreement. All the Schedules of this Agreement shall have the
same force and
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effect as if they were set out in the main body of the
Agreement.
2. WARRANTY
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2.1 Ethical warrants that it is exclusive owner of all rights, title and
interest in and to the Patent Rights and Ethical Know-How and that it
is free to enter into this Agreement and to carry out all of the
provisions hereof including its agreement to grant to Schein an
exclusive licence with the right to grant certain sub-licences with
respect to the Designated Products in the Territory without any
consents from any third parties.
2.2 Ethical represents and warrants that the Designated Development
Programmes shall be in accordance with current Good Laboratory
Practices and current Good Manufacturing Practices, as per statute and
regulations of the FDA and with the laws and regulations of any other
governmental authority applicable thereto and that all laboratory,
scientific, technical and/or other data submitted by or on behalf of
Ethical relating to a Designated Product shall be true and correct and
shall not contain any deliberate or negligent falsification,
misrepresentation or omission.
2.3 Each of Ethical and Schein represents and warrants to the other that
it is not currently debarred, suspended or otherwise excluded by any
United States governmental agency from receiving Federal contracts.
3. LICENCE GRANT
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3.1 Subject to Clause 3.5 below, Ethical hereby grants to Schein, for the
Term (as hereinafter defined) of this Agreement the exclusive right
under the Patent Rights and Ethical Know-How with the right to
sublicence to make and/or manufacture, use, promote, market,
distribute and sell the Designated Products in the Territory.
3.2 All proprietary rights and rights of ownership with respect to the
Patent Rights, and Ethical Know-How shall, at all times, remain solely
with Ethical and Schein shall have no proprietary rights in or to the
Patent Rights and Ethical Know-How other than those specifically
granted herein. All proprietary rights to Schein Know-How belong to
and shall, at all times, remain solely with Schein, other than as
specifically provided herein.
3.3 For the term of this Agreement, Ethical agrees that it will not,
directly or indirectly, market, sell or distribute in the Territory,
or develop or assist in the development for use, manufacture,
marketing, promotion, sale or distribution in the Territory, any
Designated Product except as provided in
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this Agreement
3.4 For the avoidance of doubt Ethical shall have a continuing right to
make, have made and use for its own investigational and developmental
purposes (but not sell, directly or indirectly in, or to the
Territory) any Designated Product in the Territory. If Ethical
acquires or develops Improvements for the Designated Products it shall
make these available to Schein as part of the licence granted
hereunder.
3.5 For the avoidance of doubt the rights granted to Schein shall not
affect or prejudice Ethical's ability, at the request of Independent
Third Parties, to use the Ethical Know-How and Patent Rights to
formulate new chemical entities and/or new active compounds (other
than the Designated Products) for marketing and sale in the Territory.
4. SELECTION OF DESIGNATED PRODUCTS
--------------------------------
4.1 Schein agrees to select, in accordance with Schedule 3, ** ********
********** ******** **** *** *********** *********** *********
4.2 On the date on which each Prospective Development Product is selected
by Schein in accordance with Schedule 3 and thereby becomes a
Designated Product, the following provisions will apply from that date
to each such Designated Product.
4.2.1 Schein and Ethical shall immediately start work under the
Designated Development Programme for the Designated Product.
4.2.2 In the event that Designated Product Extensions are requested
by Schein and mutually agreed then the Designated Development
Programme shall be amended by Ethical and Schein to reflect
such agreed amendments.
4.2.3 For the period starting with the Effective Date and ending with
the first commercial sale of the Designated Product in the
Territory to an Independent Third Party, Ethical shall report
to Schein on a monthly basis the progress of the Designated
Development Programme of the Designated Product. Ethical will
use all reasonable efforts to carry out the Designated
Development Programme in accordance with the timetable set
forth therein subject to Clause 12. Ethical will carry out the
Designated Development Programme in accordance with all
applicable laws and regulations including, without limitation,
applicable United States laws and FDA regulations.
* redacted pursuant to confidential treatment request.
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4.2.4 Ethical will, on a continuous basis, provide to Schein any
Ethical Know-How developed, information acquired or development
planned in relation to the Designated Product and all
Improvements and modifications to the Designated Product.
4.2.5 Ethical shall make available to Schein, on a reasonable
consultation basis without charge to Schein, such advice of its
technical personnel as may reasonably be requested by Schein in
connection with the Designated Development Programme.
4.2.6 Schein shall disclose to Ethical and Ethical shall disclose to
Schein all reports or other knowledge they may possess with
respect to "adverse drug experiences" (as defined in
regulations promulgated by the FDA), mis-labelling, stability
failures or microbiological contamination with respect to the
Designated Product within 10 (ten) days of becoming aware of
same. With respect to "serious adverse drug experiences" (as
defined in 21 CFR #312.32 and #314.80 promulgated by the FDA),
Schein shall disclose to Ethical and Ethical shall disclose to
Schein all reports and other knowledge they may possess as soon
as possible, and in no event later than 2 (two) business days
of the receipt of such report or notification of the serious
adverse drug experience. The timing and content of such
disclosure shall comply with all FDA regulations applicable to
notification to the FDA with respect to such matters and shall
comply with the laws and regulations of any relevant country in
the Territory in which the Designated Product is promoted,
marketed, distributed and sold.
4.2.7 Throughout the term of each Designated Development Programme,
and in any event no less than 4 (four) times a year, Schein
shall furnish to Ethical any Schein Know-How and any other
information and data developed or acquired by or under the
control of Schein with respect to the Designated Product for
Ethical's use in any Granted Territory, and subject to
corresponding obligations of confidentiality as set forth
herein, all such Schein Know-How and information and data
without restriction and without additional compensation to
Schein, other than provided for in this Agreement, subject to
the following sentence. Schein shall be under no obligation to
provide any Schein Know-How, information or data to Ethical
hereunder if the disclosure of such would be in violation of
any bona fide agreement with any Independent Third Party and
such violation can be proved by Schein.
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5. PAYMENT
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5.1 In consideration of the granting of the exclusive licence under Clause
3 to use the Ethical Know-How and Patent Rights, Schein agrees to pay
Ethical U.S.$ 5,000,000 (five million U.S. dollars) upon the signing
of this Agreement.
5.2 The parties further agree that, subject to Clause 12 and Schedule 3,
Clauses 2.7 and 2.8, Schein will pay Ethical the sum of $27,000,000
(twenty seven million U.S. dollars), divided equally among the twelve
(12) Designated Development Programmes (the "Notional Sums") such
Notional Sums to be payable in accordance with Schedule 4, Clauses 2
and 3.
5.3 Each Quarter, Ethical shall prepare and send to Schein invoices in
respect of the percentage amounts of the Notional Sums due (if any) in
that Quarter under each Designated Development Programme. It is hereby
agreed the total amount so invoiced shall, with the exception of any
invoices in respect of payments due under Clause 3.8 of Schedule 4 and
unless otherwise agreed in writing by the parties, be subject to a
maximum of U.S.$********* **** ******* **** ******** per Quarter. Any
such amounts shall be payable 30 (thirty) days after the date of
Schein's receipt of the invoice.
5.4 In the event that scientific results do not indicate that one or more
of the Designated Product objectives can be obtained, or if any
Designated Development Programme contemplated hereby is terminated or
abandoned for any reason whatsoever, Schein may nominate or elect to
apply the balance of the Notional Sums in respect of the Common
Landmarks not therefore achieved under that Designated Development
Programme at the date of nomination to
5.4.1 an alternative Designated Development Programme;
5.4.2 the development programme relating to nifedipine for **** ***
***** daily administration as contemplated by the Licence &
Development Agreement dated 15th January 1993 between Schein
and Ethical;
5.4.3 the development programme relating to ********* *** **** *****
************** as contemplated by the Licence & Development
Agreement dated 30th November 1993; or
5.4.4 any Designated Product Extension.
* redacted pursuant to confidential treatment request
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5.5 For the first two nominations under Clause 5.4.1 above the amount of
the Notional Sums paid up to the date of nomination (the "Paid Up
Sum") in respect of the Designated Development Programme terminated or
abandoned shall be credited against the alternative Designated
Development Programme chosen. For the third and fourth nomination
under Clause 5.4.1 an amount equal to the Paid Up Sum shall be
deferred and payable by Schein on successful completion of the
alternative Designated Development Programme.
6. THIRD PARTY NEGOTIATIONS
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6.1 Ethical hereby undertakes that for, either a period of 18 (eighteen)
months beginning with the Effective Date for those Prospective
Development Products for which there are reference products as
identified in Schedule 5 attached hereto, or for a period of 6 (six)
months after the introduction of a reference product for those
Designated Products for which at the Effective Date there are no
reference products as identified in Schedule 5 (and in no event less
than 18 [eighteen] months beginning with the Effective Date), or for
such longer period as may be mutually agreed in writing between the
parties, not to enter into any negotiations or discussions with any
Independent Third Party in respect of any Prospective Development
Product.
6.2 In the event that, subsequent to the period set out in Clause 6.1,
Ethical enters into substantive negotiations or discussions with an
Independent Third Party in respect of any Prospective Development
Product it shall so notify Schein (the "Notice"). On receipt of the
Notice by Schein, its General Counsel shall, subject to reasonable
confidentiality undertakings, have the right to reasonable satisfy
himself that such substantive negotiations or discussions are bona
fide. Ethical may disclose to such Independent Third Party the
existence of this Agreement but not the terms hereof, may not disclose
Schein as a party to this Agreement and may not disclose the indentity
of any Prospective Development Product except for the specific
Prospective Development Product which is the subject of the
negotiations.
6.3 Upon receipt of the Notice, Schein shall have 8 weeks within which to
inform Ethical in writing as to whether or not it wishes Ethical to
prepare a development programme, as set out under Schedule 3, Clause
2.3, in respect of the Prospective Development Product detailed in the
Notice. If no such response is received by Ethical within such a
period, Ethical shall not be under any obligation to consider any
response received subsequently.
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6.4 Upon receipt of the development programme Schein shall have 8 weeks to
notify Ethical in writing as to whether or not it wishes to select the
development programme as the Designated Development Programme. If no
such response is received by Ethical within such a period, Ethical
shall not be under any obligation to consider any response received
subsequently.
6.5 For the avoidance of doubt, it is hereby agreed that Ethical may,
whilst it is complying with its obligations as detailed in Clauses
6.2, 6.3 and 6.4 continue its negotiations or discussions but not
enter into any definitive agreement with any Independent Third Party
in respect of any Prospective Development Product PROVIDED ALWAYS
THAT, should Schein give notice as set out under Clause 6.3 and 6.4,
Ethical shall promptly cease all such negotiations or discussions.
6.6 In the event that Ethical subsequent to the Effective Date enters in
to substantive negotiations with an Independent Third Party with
respect to any product not included in Schedule 5 it shall have no
obligation to so notify Schein.
6.7 In the event that Ethical, subsequent to the period detailed in Clause
6.1 and subsequent to Schein having selected all twelve Designated
Products, enters into substantive negotiations with an Independent
Third Party with respect to any Prospective Development Product
Ethical shall give notice of the fact to Schein. Schein shall for a
period of 4 (four) weeks from the date of such notice have the right,
subject to additional payments being agreed between the parties, to
select in accordance with Schedule 3 that Prospective Development
Product as a Designated Product in addition to the twelve otherwise
contemplated herein. In the event that Schein does not so select that
Prospective Development Product or in the event that the additional
payments cannot be agreed within the four week period Schein's rights
as set out in this Clause shall irrevocably lapse.
7. FIRST RIGHT OF REFUSAL
----------------------
7.1 Within 24 (twenty four) months of the selection by Schein of a
Designated Product, Ethical shall notify Schein in writing of its
interest in entering into a licence agreement or other commercial
arrangement with an Independent Third Party for the use, manufacture,
marketing, distribution, promotion and sale of that Designated Product
in any country within the Territory (the "Request").
7.2 If Schein agrees to grant the Request (such agreement to be sent to
Ethical in a written notice within 4 [four] weeks of receipt by Schein
of the
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Request) then Ethical shall have the unrestricted right to use and
sub-licence the Patent Rights and Ethical Know-How and Schein Know-How
to make and/or manufacture, use, promote, market, distribute and sell
that Designated Product in the relevant country (subject to reasonable
and appropriate compensation being paid to Schein, such compensation
to be based on the amount of work and money expended by Schein in
respect of the Designated Product and the country detailed in the
Request).
7.3 Any licence fee received by Ethical pursuant to Clause 7.2 shall
belong exclusively to Ethical. Ethical agrees that Schein shall
receive a minimum royalty of **** **** *** * **** ******** of net
sales of each such Designated Product (but in no event less than the
running royalty as provided in Clause 13.1) and the royalties shall be
subject to Clauses 13, 14 and 15.
7.4 The minimum royalty set out in Clause 7.3 may be subject to review and
renegotiation in the event of intensive competative pressures, local
pricing policies in any particular country in the Territory or any
other factors which in either party's reasonable commercial opinion
justify a review and the parties undertake to conduct such review and
renegotiation in good faith.
8. RUNNING ROYALTIES
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8.1 Schein shall pay to Ethical running royalties as follows:
8.1.1 ** ****** ******** of the Net Sales of each Designated Product.
8.1.2 Schein shall promptly give notice to Ethical of the date of
first commercial sale of each of the Designated Products in
each of the counties in the Territory.
8.1.3 In the event the royalty rates set forth immediately above
exceed those allowable by applicable law or governmental rule
or regulation, they shall be so modified as to conform to the
maximum royalty rate allowable.
8.1.4 The obligation to pay running royalties hereunder shall
terminate with respect to sales of the Designated Product which
follow the termination of this Agreement.
8.1.5 Royalty term may be subject to review and renegotiation in the
event of intensive competitive pressures, local pricing
policies in any particular country in the Territory or any
other factors which in
* redacted pursuant to confidential treatment request
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either party's reasonable commercial opinion justify a review
and the parties undertake to conduct such review and
renegotiation in good faith.
9. PAYMENT OF RUNNING ROYALTIES BY SCHEIN
--------------------------------------
9.1 Running royalties due to Ethical under Clause 8 of this Agreement
shall accrue when a Designated Product is invoiced by Schein.
9.2 Running royalties accruing hereunder shall be due and payable on the
45th (forty-fifth) day following the close of each fiscal quarterly
period of Schein.
9.3 Running royalties accruing hereunder shall be paid in U.S. dollars to
Ethical or Ethical's designee, acceptable to Schein in its reasonable
business judgement, duly named by Ethical in written notice to Schein.
9.4 Running royalties accruing hereunder shall be paid in U.S. dollars.
9.5 If, at any time, legal restrictions in the Territory prevent the
prompt payment of running royalties or any portion thereof accruing
hereunder, the parties shall meet to discuss suitable and reasonable
alternative methods of reimbursing Ethical the amount of such running
royalties.
10. ROYALTY REPORTS BY SCHEIN
-------------------------
10.1 Each payment of running royalties made to Ethical hereunder shall be
accompanied by a written report, prepared and signed by a financial
officer of Schein, showing the Net Sales for the months of the
quarterly period for which payment is being made. In the event that no
running royalty is due to Ethical hereunder for any such quarterly
period, Schein shall so report.
10.2 Schein shall maintain and keep, for a period of at least 3 (three)
years or, if shorter, for such period as required by applicable U.S.
federal or state law, complete and accurate records in sufficient
details to enable any running royalties which shall have accrued
hereunder to be determined.
10.3 Subject to Clause 10.2 above, and upon the request of Ethical, but not
exceeding once in any one yearly period, Schein shall permit an
independent public accountant, selected by Ethical and acceptable to
Schein, which acceptance shall not be unreasonably withheld, to have
access (subject to reasonable confidentiality undertakings) to such of
the records of Schein as may be necessary to verify the accuracy of
the royalty reports and payments submitted to Ethical hereunder. Any
such inspection
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of Schein's records shall be at Ethical's expense except that, if
any such inspection reveals an underpayment in an amount of running
royalty actually paid to Ethical hereunder in any quarterly period
of 5% (five percent) or more of the amount of such running royalty
actually due to Ethical hereunder, then the expense of such
inspection shall be borne by Schein instead of by Ethical. Any
amount of discrepancy shall be paid promptly to Ethical.
11. PROJECT MANAGERS & REPORTING
----------------------------
11.1 In order to establish and maintain clear and effective
communication, each party shall appoint one of their senior managers
(a "Programme Director") to supervise and co-ordinate its
obligations hereunder and act as the principal interface with the
other party and deal with all matters relating to corporate
liaisons. Each party will promptly, after execution of this
Agreement, notify the other of its senior manager chosen to
discharge such responsibility. Either party may change the Programme
Director chosen provided that notice of the change is promptly given
to the other party.
11.2 Each Programme Director shall be responsible for:
11.2.1 the appointment of employees to be directly responsible for
each of the Designated Development Programmes (the "Project
Managers")
11.2.2 co-ordination and dissemination of all information within
their own organisation; and
11.2.3 dealing with all matters relating to the Designated
Development Programmes and obtaining resolution of any
disputes relating thereto.
11.3 Status meetings between the Programme Directors and/or Project
Managers and/or other employees will be held on a quarterly basis at
mutually agreed locations to review the status of the work being
performed under the Designated Development Programmes. The status
meetings will be chaired by Ethical.
11.4 Status meetings between the chairmen of Ethical and Schein and/or
other management and/or employees will be held on a half yearly
basis at mutually agreed locations. The meetings will be chaired
alternately by Ethical's and Schein's Chairmen respectively. The
agenda for such meetings shall include a review of the Multi Product
Development Programme and a progress report and an assessment of
each Designated Development
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Product. The Programme Directors will deliver reports at such
meetings, such reports to include at least the following
information:
11.4.1 the current status of each party's activities on each
Designated Development Programme;
11.4.2 each party's planned activities for the next reporting period
in respect of each Designated Development Programme;
11.4.3 an expression of whether each party's activities are then on
schedule with each Designated Development Programme and, if
not, a description of why not and what actions are necessary
to return to the Designated Development Programme timetable;
11.4.4 identification of actual and anticipated problems areas which
may affect each Designated Product being developed and
marketed by the estimated dates set out in each Designated
Development Programme;
11.4.5 additions to or deletions from Schedule 5;
11.4.6 a review of the costings included in each Designated
Development Programme;
11.4.7 a review, exchange and update of any additional Ethical Know-
How or Schein Know-How; and
11.4.8 a review of the effort being made by Schein to develop,
obtain Marketing Authorisation and commercialise each
Designated Product and a report by Schein on whether or not
it has made, or may forseeably make, the determination that
it does not intend to develop, obtaining Marketing
Authorisation or commercialise any one of the Designated
Products in any country in the Territory. In the event that
it is agreed Schein is no longer making or no longer intends
to make or is no longer able to make such effort then
Schein's right to commercialise that Designated Product in
that particular country of the Territory shall terminate and
Ethical shall have the rights as further detailed in Clause
7.2 in respect thereof and Schein shall be compensated as
contemplated by Clauses 7.2 and 7.3. Furthermore Schein shall
promptly execute and sign all such applications, instruments
and documents and do all such acts and things as may
reasonably be required by Ethical to transfer any Marketing
Authorisation obtained in respect of the Designated Product
in any applicable country in the Territory to Ethical or its
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nominee and to enable Ethical or its nominee to be named any
enjoy the benefit of any such Marketing Authorisation to the
exclusion of Schein.
12. ADDITIONAL WORK
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12.1 It is hereby agreed by the parties that the Notional Sums set out in
Clause 5.2 are in consideration of Ethical carrying out its
obligations as detailed in Schedule 4 under each Designated
Development Programme in compliance with all applicable laws and
regulations in order to achieve Marketing Authorisation in the
United States and carry out its other obligations as provided in
this Agreement.
12.2 In the event that additional development activities are required to
be undertaken by Ethical, other than as set out under Schedule 4, in
order to achieve Marketing Authorisation in the United States any
additional costs (the "Special Costs") connected with such work
shall be included in the relevant Designated Development Programme.
The additional work and Special Costs will be discussed and agreed
with Schein in advance and the relevant Designated Development
Programme will be amended accordingly.
12.3 In the event that additional development activities are required in
order to comply with applicable laws and regulations outside the
United States (except in the Granted Territories) Ethical shall be
entitled to undertake that work and make additional charges to
Schein in respect of that work (the "Additional Charges"). The
additional work and Additional Charges will be discussed and agreed
with Schein in advance and the relevant Designated Development
Programme will be amended accordingly.
13. MONIES DUE FROM ETHICAL
-----------------------
13.1 ******* ***** *** ** ****** *** ******* ******** ** *** *******
******* ******** ******** ** ******* **** ** *********** ***** *****
***** * ******** ****** ** ************ ********* ** *****
********** *********** ******** ** *** **** ** * ********** *******
** *** ******* **********
14. PAYMENT OF MONIES DUE FROM ETHICAL
----------------------------------
14.1 The percentage of running royalties due to Schein under clause 13 of
this Agreement shall accrue as and when running royalties are
actually received by Ethical in respect of Designated Product sales
in any Granted Territory in accordance with the provisions below.
14.2 The percentage of running royalties accruing hereunder shall be due
and
* redacted pursuant to confidential treatment request
Page 15
payable on the 45th (forty fifth) day following the close of each
fiscal quarterly period of Ethical.
14.3 The percentage of running royalties accruing hereunder shall be paid
in U.S. dollars to Schein or Schein's designee, duly named by Schein
in written notice to Ethical.
14.4 If, at any time, legal restrictions prevent the prompt payment of
monies or any portion thereof accruing hereunder, the parties shall
meet to discuss suitable and reasonable alternative methods of
reimbursing Schein the amount of such percentage of running
royalties.
15. ROYALTY REPORTS BY ETHICAL
--------------------------
15.1 Ethical shall maintain and keep, for a period of at least 3 (three)
years or, if shorter, for such period as required by applicable law
complete and accurate records in sufficient details to enable any
running royalties which shall have accrued hereunder to be
determined.
15.2 Subject to Clause 15.1 above, and upon the request of Schein, but
not exceeding once in any one yearly period, Ethical shall permit an
independent public accountant, selected by Schein and acceptable to
Ethical, which acceptance shall not be unreasonably withheld, to
have access (subject to reasonable confidentiality undertakings) to
such of the records of Ethical as may be necessary to verify the
accuracy of the royalty reports and payments submitted to Schein
hereunder. Any such inspection of Ethical's records shall be at
Schein's expense except that, if any such inspection reveals an
underpayment in an amount of running royalty actually paid to Schein
hereunder in any quarterly period of 5% (five percent) or more of
the amount of such running royalty actually due to Schein hereunder,
then the expense of such inspection shall be borne by Ethical
instead of by Schein. Any amount of discrepancy shall be paid
promptly to Schein.
16. REGISTRATION AND APPROVAL OF THE DESIGNATED PRODUCTS
----------------------------------------------------
16.1 Ethical and Schein agree that Designated Product development should
progress as specified in Schedule 4, attached hereto and that they
shall commit to their respective obligations the necessary resources
to comply with the timetables of any Designated Development
Programme.
16.2 Subject to any agreement to the contrary as contemplated by Clause
11.4.8, Schein undertakes to use all reasonable endeavours to obtain
Marketing Authorisations for each and every Designated Product in
the Territory
Page 16
(except for Marketing Authorisations in any Granted Territory) and
to promptly submit all necessary applications for Marketing
Authorisations in the Territory (except for Marketing Authorisations
in any Granted Territory).
16.3 Schein shall bear the cost of all application fees to government
authorities for Marketing Authorisations including, without
limitation, new drug applications ("NDA") filed with the FDA or any
other fees concerning approvals from government authorities
necessary to commercialise the Designated Products in the Territory,
other than Marketing Authorisations required in any Granted
Territory. The Marketing Authorisations (except for any Marketing
Authorisations in any Granted Territory) and all NDAs in the
Territory shall be the sole and exclusive property of Schein.
17. DESIGNATED PRODUCT MANUFACTURE
------------------------------
17.1 Schein undertakes to manufacture or have manufactured each
Designated Product in the Territory and shall ensure such
manufacturing shall comply with prevailing Good Manufacturing
Practice for sale of the relevant Designated Product in the relevant
country of the Territory (except in any Granted Territory). Schein
may request Ethical to supply the Multipor coating materials
required in connection with the manufacture of the Designated
Products.
17.2 In the event that Ethical or upon mutual agreement a third party
manufacturer is to supply a Designated Product to Schein, the supply
price will be fully absorbed manufacturing costs plus *** ********
********, such costs to be defined and set out in a separate supply
agreement to be mutually agreed upon between the parties.
17.3 Once in any yearly period, at the request of Schein, Ethical shall
permit an independent public accountant selected by Schein and
acceptable to Ethical, such acceptance not to be unreasonably
withheld, to have access (subject to reasonable confidentiality
undertakings) to such of the records and documentation of Ethical as
may be necessary to verify that the supply price being charged to
Schein is equal to the fully absorded manufacturing costs plus ***
******** ******** as set out in Clause 17.2.
18. TERM
----
18.1 The term ("Term") of this Agreement shall come into force as of the
Effective Date and, subject to clause 19, shall remain in force in
respect of a Designated Product in each country in the Territory for
a period of 16 (sixteen) years from the date of the first commercial
sale to an Independent
* redacted pursuant to confidential treatment request
Page 17
Third Party of such Designated Product in such country of the
Territory (except the Granted Territories) or the life of any
patents issued in the applicable country in the Territory relating
to such Designated Product and included in the Patent Rights,
whichever is the longer.
18.2 This Agreement shall automatically be extended thereafter for
successive 1 (one) year periods unless;
18.2.1 either party notifies the other of its decision not to renew
this Agreement at least 12 (twelve) months prior to the
commencement of any such renewal term; provided, however,
that the failure to extend this Agreement with respect to one
Designated Product in any country in the Territory shall in
no way affect the extension of this Agreement with respect to
such Designated Product in any other countries in the
Territory or other Designated Products for which no such
notice has been given; or
18.2.2 it is mutually agreed in writing by both parties, and subject
to reasonable additional compensation being payable to
Ethical, to extend the Agreement in respect of a Designated
Product in any country in the Territory by a period of time
greater than 1 (one) year; provided, however, that an
agreement to extend this Agreement with respect to one
Designated Product in any country in the Territory shall in
no way affect the extension of this Agreement with respect to
such Designated Product in any other countries in the
Territory or other Designated Products for which no such
agreement has been reached.
19. TERMINATION
-----------
19.1 If any party shall go into liquidation either voluntary or
compulsory (except for the purpose of amalgamation, reconstruction
or restructuring previously approved of in writing by the parties
hereto) or sell or dispose of its undertaking or the major part
thereof or in any manner assign except as contemplated herein this
Agreement or make any assignment for the benefit of creditors or
cease or threaten to cease to carry on business or is unable to pay
its debts as they fall due; or
19.2 if a receiver or receiver and manager or judicial manager or
administrator is appointed for any party over the whole or any part
of its assets and is not withdrawn within 30 (thirty) days of
appointment; or
19.3 if any party shall commit any material breach (whether remediable or
not) of its obligations under this Agreement and (if remediable)
shall fail to
Page 18
remedy the breach within 90 (ninety) days of written notice,
calculated from the date of receipt of such notice, given by the
other party to the party required to do so
then, upon the happening of any one or more of such events, the other party
shall have the right forthwith by notice in writing to terminate this
Agreement.
19.4 Termination of this Agreement, due to the fault of either party,
shall be without prejudice to any other rights or remedies then or
thereafter available to either party under this Agreement or
otherwise.
19.5 The rights of either party to terminate this Agreement prior to
the expiration of its Term shall not be affected in any way by that
party's waiver of or failure to take action with respect to any
previous breach hereunder.
20. CONSEQUENCES OF TERMINATION
---------------------------
20.1 If this Agreement is terminated prior to the date of expiration
above by fault of Schein;
20.1.1 Schein and Ethical shall promptly make an accounting to one
another of the inventory of all Designated Products which it
has in the Territory and the Granted Territory, respectively,
if any, as of the date of such termination and said parties
shall thereafter have the right for a period of 6 (six)
months after said termination to sell such inventory of
Designated Product provided that the Net Sales thereof shall
be subject to the royalty provisions of Clauses 9 and 13
****** ***** ** *************** ******* ** **** **** ***
********* ***** ****** ***** and so payable to Ethical and/or
Schein as the case may be. Thereafter, any remaining
inventory of Designated Product shall be disposed of by
mutual agreement in accordance with regulatory requirements.
Clauses 8, 9, 10, 13 (as amended by this Clause 20.1.1), 14
and 15 shall survive such termination until all remaining
inventory of Designated Product has been sold.
20.1.2 Ethical shall have the unrestricted right to use and
sublicence Schein Know-How and to make, manufacture, use,
promote, distribute and sell the Designated Products in the
Territory for the Term subject to reasonable and appropriate
compensation being payable to Schein by Ethical including
without limitation the royalties ************ ** ****** **
******* ************** ** **** **** *** ********* *****
****** *****
* redacted pursuant to confidential treatment request
Page 19
20.2 If this Agreement is terminated prior to the date of expiration
above due to the fault of Ethical, Schein shall have the
unrestricted right to continue to use and sublicence the Patent
Rights and Ethical Know-How and to make, manufacture, use, promote,
distribute and sell the Designated Products in the Territory for the
unexpired balance of the Term, in which case Clause 8.1.1 shall read
as if it contained the figure **** **** ***** **** ********. Clauses
8 (as amended by this Clause 20.2), 9, 10, 13, 14, and 15 shall
survive such termination.
20.3 If any of the patents included in the Patent Rights is found by a
court of applicable jurisdiction to be invalid or unenforceable in
that jurisdiction in the Territory and as a result thereof an
Independent Third Party would be entitled to manufacture or
distribute and thereafter commercialises any of the Designated
Products in that jurisdiction in the Territory utilising a part of
the technology covered by the Patent Rights which would have a
material impact on the Net Sales of that Designated Product and such
impact can be shown, then Schein in its discretion may terminate
this Agreement with respect to such Designated Product in that
jurisdiction in the Territory or, at Schein's election, continue
this Agreement in full force and effect with respect to such
Designated Product in which case Clause 8.1.1 shall read as if it
contained the figure of **** **** ***** **** ********* Clauses 8 (as
amended by this Clause 20.3), 9, 10, 13, 14 and 15 shall survive
such termination.
21 SCHEIN BREAK POINT
------------------
21.1 Schein may terminate this Agreement by written notice to Ethical
(the "Break Notice") in the event that it makes the determination
for any reason that it is no longer able, or no longer wishes to
fund the Designated Development Programmes according to the terms
set out in this Agreement such termination to be effective 6 (six)
months after receipt by Ethical of the Break Notice (the "Break
Date"), Clauses 21.2, 21.3 and 21.4 shall survive such termination.
21.2 Schein hereby undertakes that in the event it gives the Break Notice
neither Schein, its affiliates nor in the event of any amalgamation,
reconstruction or restructuring the company succeeding Schein or its
affiliates upon such amalgamation, reconstruction or restructuring
shall for a period of time calculated from the Break Date an in
accordance with the table in Clause 21.3 enter into any commercial
arrangement in the Territory relating to the development, use,
manufacture, promotion, marketing, distribution or sale (the "Non
Compete Activity") of any of the Designated Products other than as
set out in Clauses 21.4.1, 21.4.2, 21.4.3 and 21.4.4.
* redacted pursuant to confidential treatment request
Page 20
21.3 Break Date Period of Non Compete Activity
within one year of the two years
Effective Date
between one and three three years
years after the Effective
Date
more than three years after five years
the Effective Date
21.4 In the event that this Agreement is terminated by a Break Notice
Ethical, subject to Clause 21.5, shall have the unrestricted right
to continue to use and sublicence the Patent Rights, Ethical Know-
How and Schein Know-How and to develop, use, manufacture, promote,
market, distribute and sell the Designated Products in the Territory
except those Designated Products which at the date of Break Notice
21.4.1 are already commercialised; or
21.4.2 regulatory filings have been made in respect thereof; or
21.4.3 such regulatory filings are to be made within the next 12
(twelve) months.
21.4.4 for which pivotal bioavailability studies have already
commenced.
21.5 For the Designated Products described in Clauses 21.4.1, 21.4.2,
21.4.3 and 21.4.4 above Schein shall, subject to the payment of
royalties to Ethical in accordance with Clause 8 (which shall
survive termination as contemplated in this Clause), have the
unrestricted right to develop, use, manufacture, promote, market,
distribute and sell such Designated Products in the Territory.
21.6 Ethical shall pay Schein reasonable compensation, agreed to by
Schein, on a Designated Product by Designated Product basis in
respect of those Designated Products not included in Clause 21.4.1,
21.4.2, 21.4.3 and 21.4.4 in the event that it enters into
satisfactory arrangement with an Independent Third Party in respect
of such Designated Products.
Page 21
22. INFORMATION TRANSFER; CONFIDENTIALITY AND CO-OPERATION
------------------------------------------------------
22.1 Within 30 (thirty) days following the signing of this Agreement,
Ethical shall provide to Schein copies of relevant Ethical Know-How.
22.2 Each party shall hold in strict confidence any tangible information
relating to the Prospective Development Products marked confidential
received from the other party (or oral information which is reduced
to tangible form within 30 [thirty] days of disclosure and noted to
be confidential), unless such information:
22.2.1 Is already in its possession;
22.2.2 Is already in the public domain or knowledge at the time of
disclosure or later comes into the public domain or knowledge
without fault on the part of the recipient;
22.2.3 Is subsequently disclosed to the recipient by a third party
who did not acquire it in confidence from the other party;
22.2.4 Is required to be disclosed in connection with any legal
proceedings or in order to obtain permission to manufacture
of market at Designated Product in the Territory; or
22.2.5 Is disclosed with the prior written consent of the other
party, such consent not to be unreasonably withheld.
This provision shall remain valid for a period of 5 (five) years
after termination of this Agreement.
22.3 During the Term of this Agreement, at least semi-annually, Ethical
shall furnish to Schein any Ethical Know-How and any other
information and data developed or acquired by or under the control
of Ethical with respect to the Designated Products. Ethical hereby
acknowledges and agrees that Schein may use, within the Territory,
all such Ethical Know-How and information and data without
restriction and without additional compensation to Ethical, other
than as provided in this Agreement, to make, have made, use and sell
the Designated Products in the Territory as envisaged hereunder.
22.4 During the Term of this Agreement, at least semi-annually, Schein
shall furnish to Ethical any Schein Know-How and any other
information and data developed or acquired by or under the control
or Schein with respect to the Designated Products, and Ethical may
use in any Granted Territory
Page 22
all such Schein Know-How and information and data without
restriction and without additional compensation to Schein, other
than provided for in this Agreement, subject to the following
sentence. Schein shall be under no obligation to provide any Schein
Know-How, information or data to Ethical hereunder if the disclosure
of such would be in violation of any bona fide agreement with any
Independent Third Party and such violation can be proved by Schein.
23. INFRINGEMENT
------------
23.1 Ethical and Schein each agree to notify the other in writing of any
alleged infringement or potential infringement of any Patent Rights
or any information or allegations impacting on the validity of any
such Patent Rights, in the Territory promptly after becoming aware
of the same.
23.2 Upon the giving of such notice, Ethical and Schein shall immediately
consult together to decide what steps shall be taken to prevent or
terminate such infringement, and the parties shall take such steps
as they shall so agree, including the institution of legal
proceedings where necessary in the name of one of the parties of the
joint names of Ethical and Schein as appropriate, in which event
costs and expenses incurred and damages recovered shall be share in
such proportions as the parties may agree.
23.3 If, within 30 (thirty) days after such consultation that parties
have failed to agree on the steps to be taken or the proportions in
which costs and damages should be shared, Ethical may take such
steps as it may decided and all damages recovered in any proceedings
shall belong to Ethical.
23.4 If, within 60 (sixty) days after such consultation Ethical does not
take action against an alleged infringer or potential infringer or
has failed to notify Schein of its intent to commence an action to
terminate the alleged infringement or potential infringement, then
Schein shall have the right to commence such action on its own
behalf at its own cost and expense and to use Ethical's name in
connection therewith, in which case any recoveries shall inure to
the benefit of Schein.
23.5 Schein and Ethical shall each provide all such assistance and co-
operate, including the furnishing of documents and information as
may be required to give effect to such joint or independent action
as may be taken under Clauses 23.2, 23.3 and 23.4 above.
23.6 Ethical hereby represents that, to the best of its knowledge, none
of the Patent Rights or Ethical Know-How infringe on the patent or
other legally protected proprietary rights of any Independent Third
Party, and it has not
Page 23
received any notice or claim of any such infringement worldwide.
Ethical agrees to hold Schein harmless from any judgements, losses
or costs (including reasonable attorney's fees) incured in the event
a claim or legal action is asserted against Schein to the effect
that the manufacture, use or sale of the Product infringes the
patent rights or other legally protected proprietary rights of any
Independent Third Party PROVIDED ALWAYS THAT Schein fulfils its
obligations under Clauses 23.1 and 23.5 above and that Schein has
made no admission of liability either in whole or in part without
Ethical's consent (such consent not to be unreasonably withheld).
23.7 Ethical and Schein shall each give to the other prompt written
notice of any claim or action made against either of them alleging
that any of the Patent Rights infringe the rights of an Independent
Third Party and arising from the manufacture, use or sale of any
Designated Product in the Territory. Ethical and Schein agree to co-
operate and collaborate with each other in undertaking a full
investigation of the situation and in taking such action as they
shall agree is appropriate in the circumstances.
23.8 Subject to Clauses 23.2 and 23.4 above, Ethical shall be solely
responsible for, and bear the cost of, the prosecution and
maintenance of the Patent Rights.
23.9 The provisions of this Clause 23 shall survive termination of this
Agreement.
24. SURVIVAL OF REPRESENTATIONS, WARRANTIES AND AGREEMENTS
------------------------------------------------------
24.1 Except as otherwise specifically provided in this Agreement, all
representations, warranties and agreements contained in this
Agreement shall survive the execution and delivery of this Agreement
and remain in full force and effect regardless of any investigation
made by or on behalf of either Ethical or Schein.
25. ARBITRATION
-----------
25.1 All disputes arising in connection with the Agreement shall be
settled under the Rules of Conciliation and Arbitration of the
International Chamber of Commerce by one or more arbitrator in
accordance with the said Rules, as follows:
25.2 Each of the parties shall designate its arbitrator within 15
(fifteen) days from notification by registered letter. The two
arbitrators thus designated
Page 24
shall designate a third arbitrator within 30 days from designation
of the second arbitrator, the said third arbitrator shall preside
over the arbitration court. Arbitration should be held in London if
Ethical initiates the request and if Schein initiates the request
arbitration should be held in New York.
26. DISCLAIMER OF AGENCY
--------------------
26.1 The parties acknowledge that each of Schein and Ethical are
independent contractors and nothing herein contained shall be deemed
to create any relationship in the nature of agency, joint venture,
partnership or similar relations between Schein and Ethical.
27. SEVERABILITY
------------
27.1 Whenever possible each provision of this Agreement shall be
interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement should be
prohibited or invalid under applicable law, such provision shall be
ineffective to the extent of such invalidity without invalidating
the remainder of such provision or the remaining provisions of this
Agreement to the extent such modification does not impair or change
the intent of the parties hereto.
28. PARAGRAPH HEADINGS
------------------
28.1 The subject headings of the Articles in this Agreement are included
for the purposes of convenience only, and shall not affect the
construction or interpretation of any of its provisions.
29. TRANSFER OF RIGHTS AND OBLIGATIONS
----------------------------------
29.1 This Agreement, in whole or in part, shall not be assignable by
either party hereto to any Independent Third Party without the prior
written consent of the other party hereto except that either party
may assign this Agreement to an affiliated company or the successor
or assignee of substantially all of its business. It is expressly
understood and agreed by the parties hereto that the assignor of any
rights hereunder shall remain bound by its duties and obligations
hereunder.
30. NOTICES
-------
30.1 Any notice required or report required or permitted to be given or
made under this Agreement by either party to the other shall be in
writing, sent by hand or by registered or express mail or courier,
postage prepaid, telex or telefax, addressed to such other party at
its address indicated at the
Page 25
beginning of this Agreement or to such other address as the
addressee shall have last furnished in writing to the addressor, and
shall be effective upon receipt by the addressee.
31. DISCLOSURE
----------
31.1 Ethical and Schein shall have the right, subject to the written
approval of the other, to disclose to any Independent Third Party in
connection with any announcement, news release, or for any other
reason the existence of this Agreement but not the terms hereof.
Notwithstanding the foregoing, each party shall have the right to
make such disclosures relating to this Agreement as may be required
by applicable laws and regulations.
32. FORCE MAJEURE
-------------
32.1 Ethical and Schein shall not be liable for delays if such delays are
due to force majeure case, such as strikes, disputes with workmen,
failure of supplies from ordinary sources, fire, floods, earthquake,
governmental regulation against the aims of this Agreement, war,
legislation or any other cause, either similar or dissimilar to the
foregoing, beyond the reasonable control of the parties which cannot
be overcome by due diligence.
33. FURTHER ASSURANCES
------------------
33.1 From and after the Effective Date, without further consideration,
Ethical and Schein shall, from time to time during the term of this
Agreement, upon the request by the other, perform all actions and
execute, acknowledge and deliver all such further documents or
instruments as may be reasonably required to give effect to the
purpose and intent of this Agreement.
33. ENTIRE AGREEMENT: AMENDMENT
---------------------------
33.1 This Agreement contains the entire understanding of the parties with
respect to the matters contained herein and supersedes any previous
agreements and may be altered or amended only by a written
instrument duty executed by both parties hereto.
Page 26
IN WITNESS WHEREOF, the parties hereto have executed this Agreement in
duplicate originals.
ETHICAL HOLDINGS PLC SCHEIN PHARMACEUTICAL INC.
-------------------- -------------------------
Sign [SIGNATURE ILLEGIBLE] Sign [SIGNATURE ILLEGIBLE]
--------------------------- ----------------------------
Print /s/ Dr. G. W. Guy Print /s/ MARTIN SPERBER
--------------------------- ----------------------------
Date 30th August 1994 Date 30th August 1994
--------------------------- ----------------------------
Page 27
SCHEDULE 1
** ********* ************ ******* ** *** **********
*** ******* ************* ********* ** ******** ** ******* ***
*************
*** ******** ************* ********* ** ******** ** ******* ***
*************
*** ********** ******** ** * ******* * *********** ********* ***** ****
******* **** ******* ****** *** ********
*** *********** ********** ** ******* ** *** ************* ********
** ************ *** ** ***** **** **** ** **** ** ********* ****
***********
* page redacted pursuant to confidential treatment request
Page 1 of 1
SCHEDULE 2
----------
******* *** ****** ************ ******** ** *** ************ ********** *******
*********** ***** ****** ** *** ********* ******
* redacted pursuant to confidential treatment request
Page 1 of 10
[ * ]
* page redacted pursuant to confidential treatment request
Page 2 of 10
[ * ]
* page redacted pursuant to confidential treatment request
Page 3 of 10
[ * ]
* page redacted pursuant to confidential treatment request
Page 4 of 10
[ * ]
* page redacted pursuant to confidential treatment request
Page 5 of 10
[ * ]
* page redacted pursuant to confidential treatment request
Page 6 of 10
[ * ]
* Page redacted pursuant to confidential treatment request.
Page 7 of 10
[ * ]
* Page redacted pursuant to confidential treatment request.
Page 8 of 10
[ * ]
* Page redacted pursuant to confidential treatment request.
Page 9 of 10
[ * ]
* page redacted pursuant to confidential treatment request
Page 10 of 10
SCHEDULE 3
1. Selection of Designated Products
--------------------------------
1.1 Subject to Clause 1.2 of Schedule 3 Schein shall, for a period of no
longer than 24 (twenty four) months from the Effective Date, select at
least (one) Designated Product each and every 2 (two) months in
accordance with Clause 2 hereunder subject to a maximum of 12 (twelve)
such Designated Products.
1.2 In the event that Schein wishes to select the Buprenorphone Product
(as defined in Schedule 5) it must do so in accordance with Clause 2
hereunder and prior to the 31st January 1995. Any attempt to select
the ************* Product by Schein at any time subsequent to 31st
January 1995 shall, unless Ethical agrees otherwise in writing, be
invalid and of no effect.
2. Selection Procedure
-------------------
2.1 On a continuous basis Ethical and Schein will discuss the commercial
possibilities of the Prospective Development Products listed in
Schedule 5, as amended from time to time. Such discussions to include,
but not be limited to, the appropriate technologies, commercial
opportunities, project plans and development work.
2.2 In the event that Schein decides it wishes to proceed with further
investigations of a Prospective Development Product, it shall request
in writing that Ethical prepares a development programme.
2.3 Ethical shall have one month to prepare the development programme in
accordance with Schedule 4 and send the same to Schein.
2.4 Schein shall then decide, after further discussions between the
parties if necessary, whether or not it wishes to select that Possible
Development Product as a Designated Product and that it wishes to
select the development programme as the Designated Development
Programme. In the event that it does, it shall notify Ethical of the
fact in writing (the "Notice").
2.5 On receipt of the Notice, Ethical shall immediately commence the
Designated Development Programme for the Designated Product. A copy of
the Designated Development Programme shall be attached to this
Schedule 3.
* redacted pursuant to confidential treatment request
Page 1 of 2
2.6 In the event that Ethical exercise its rights under Clause 6 this
shall be reflected in amendments to the Designated Development
Programme.
2.7 Any amendments to the Designated Development Programme agreed by the
parties subsequent to Ethical's receipt of the Notice including, but
not limited to, any Additional Charges, Designated Product Extensions,
Special Charges or additional landmarks, shall be clearly evidenced in
that Designated Development Programme. Additional monies due as a
result of such amendments shall also be clearly evidenced in that
Designated Development Programme.
2.8 In the event that Schein selects the ************* Product as a
Designated Product Ethical shall be entitled, in addition to any other
monies due hereunder, to a further payment of US$********* ****
********* **** ******* ******** ** dollars) on the date of Schein
obtaining the United States Marketing Authorities approval of either
the ********* ** ****** ********* ********** whichever is the earlier.
2.9 Any licence granted to Schein by Ethical for the ************* Product
shall be only in respect of the United States and shall be exclusive
in respect of the ********* ********** and non exclusive in respect
of the ****** ********* ********** to the extent of the rights of the
innovator of such product existing at the Effective Date.
* redacted pursuant to confidential treatment request
Page 2 of 2
SCHEDULE 4
----------
Designated Development Programmes.
---------------------------------
1. Each Designated Product shall have a Designated Development Programme
prepared by Ethical and reviewed and approved by Schein which describes
the ******* *********** *********** ******* ************ *** **********
******** ** ** ******** ** ****** ********** ******** ** ******* *******
*** ********** *** ********** ******* ** *** ********** ** ***********
*** ********** *********** ********* **** ******* *** *********** **
******* **** ******* ** ************** ************ ********* ********
*********** ******** ***** *************** ******* *** *******
********** ******** *** *** *********** ** ****** **** ******* ** ***
******* ******* ******* ********** ******* *** **********
************ ********* ********** **** ***** ************* *********
************ ********** ** **** ******* ** *** ********* ******* ***
******* ************* *** ********** *********** ********* *** **
******* **** **** ** **** ** *** ****** ******* ** *** ******* ** *****
** ******** ******** ******* *** ********** ************* ******* *****
***** ** ******** ** ******* *********** **** **** ******* ** ***
********** ******* ****** ** *** ***** ** *** ********** ***********
********* ** **** **** ** **** ** ** ******
2. Each Designated Development Programme will identify ** ***** ***
********** *** *** ** ****** * ***** **** ******* ************ ***
********** ** ********** ** ***** **** ********
2.1 * ********** ******* ** *** ******** *** ** ********** ** ****
****** ********* ***
2.2 * ******* ** ********** ******* *** ******* ******** ** *******
******** ** *** ********** *** ********** ** **** ****** *********
3. ******* ** ******** * ****** *** *** ****** *** *** ****** ********* ***
********** ******** ** *** ******** *** ****
********** ******* **
****** ******** ******** *** ***
*************** ****************
3.1 ********* ** * ********** *******
** *** *** ** ******** ** ***
* redacted pursuant to confidential treatment request
Page l of 2
SCHEDULE 4
----------
*** ********** ** ********** *** *************
******* ** ************ **
*** ************ ** *** ***** ***************
** ******** ****** ***
*** ********** ** *** **** *** *** ** *** ** ***
************ ** *** ******** *************
**** ** ********** ********** ***
*** ********** ** ***** ****** *********** *********
******* ** *** **** ********* *********** ** ***
********** ******** **
*** ********** ** *** *** ***** *************** **
******** ******** ***
*** ********** ** ************ *************
********** *********** ** ******* ***
*** ********** ** *** ******* *************** ******** ***
* redacted pursuant to confidential treatment request
Page 2 of 2
SCHEDULE 5
----------
[ * ]
* Page redacted pursuant to confidential treatment request
Page 1 of 1