Document:

exv10w10

 

***Text Omitted and Filed Separately

Confidential Treatment Requested Under 17 C.F.R. §§200.80(b)(4) and 230.406

STRINGER SAUL

Exhibit 10.10

(1) CAMBRIDGE LABORATORIES LIMITED

and

(2) PRESTWICK PHARMACEUTICALS, INC.,

_________________________________________

AMENDED AND RESTATED AGREEMENT

_________________________________________

17 Hanover Square London W 1 S 1 HU

Tel: 020 7917 8500 Fax: 020 7917 8555

 

 

THIS AMENDED AND RESTATED AGREEMENT is made 30th day January of 2004

BETWEEN:

	1.  	CAMBRIDGE LABORATORIES LIMITED a company incorporated under the laws of England and having
its principal place of business at Deltic House, Kingfisher Way, Silverlink Business Park,
Wallsend, Tyne and Wear, England (hereinafter “Cambridge”);

AND

	2.  	PRESTWICK PHARMACEUTICALS, INC. a company incorporated under the laws of the State of
Delaware and having its registered office at 1825 K Street Northwest, Suite 1475, Washington
D.C. 20006, USA (hereinafter “Prestwick”).

WHEREAS:

	1.  	Cambridge has the exclusive right to manufacture, develop, market and sell the Product (as
defined herein) throughout the world including a right to grant sub-licences.
	 
	2.  	Cambridge wishes Prestwick to carry out the [...***...] Developments, promote, sell and
distribute the Product in the Territory and to carry out any agreed [...***...] Developments (as
such terms are defined herein) and Prestwick has agreed to do so on the terms set forth herein
	 
	3.  	In September 2002 Cambridge and Prestwick Scientific Capital Inc entered into an agreement
pertaining to the grant by Cambridge to Prestwick Scientific Capital Inc of certain rights in
respect of the Product in the Territory.
	 
	4.  	In December 2002 the parties agreed to the assignment of the benefit and burden of the
obligations of Prestwick Scientific Capital Inc to Prestwick.
	 
	5.  	The parties wish to amend and restate the terms of this Agreement in the manner set forth
below such amendments to apply from the date hereof.

THE PARTIES AGREE as follows:

	1.  	DEFINITIONS and INTERPRETATION

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	1.1  	In this Agreement unless the context requires otherwise the words and phrases set forth in
Schedule I shall have the respective adjacent meanings:
	 
	1.2  	Reference in this Agreement to a person shall be deemed to include any legal entity whether
it be, without limitation, a natural person, partnership, company, corporation, unincorporated
organisation, or any Government or agency thereof.
	 
	1.3  	Where the context admits, reference in this Agreement to the singular shall include the
plural and vice versa and reference to the masculine shall include the feminine and vice
versa.
	 
	1.4  	The headings in this Agreement are for ease of reference and shall not affect its interpretation.
	 
	2.  	GRANT OF RIGHTS
	 
	2.1  	Cambridge hereby:

	 	2.1.1  	appoints Prestwick as its exclusive distributor for the resale of the Product
in the Territory and Prestwick hereby agrees to act in that capacity.
	 
	 	2.1.2  	grants to Prestwick an exclusive, royalty free licence to use Cambridge’s
know-how, Restricted Information and Intellectual Property relating to the Product to
carry out the [...***...] Developments in accordance with the [...***...] Development Plan in
the Territory.
	 
	 	2.1.3  	grants to Prestwick an exclusive, royalty free licence to use Cambridge’s
know-how, Restricted Information and Intellectual Property relating to the Product to
carry out the [...***...] Developments in accordance with any [...***...] Development Plan in
the Territory and to commercialise any such [...***...] Developments in the Territory.
	 
	 	2.1.4  	grants to Prestwick an exclusive, royalty free licence in the Territory to use
Cambridge’s know-how, Restricted Information and Intellectual Property pertaining to
the Product for distributing and selling the Product in the Territory.

	2.2  	It is specifically agreed that Prestwick is not granted any right to manufacture the Product,
the Active Substance or any product resulting from any [...***...] Development or any [...***...]
Development. nor has any right to have such manufactured other than by Cambridge or
Cambridge’s nominated manufacturer. Prestwick shall not manufacture the Product, the Active
Substance or any product resulting from any [...***...] Development or any [...***...] Development or
cause, enable or assist others to do so.

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	2.3  	Cambridge shall ensure that, save as provided for in clause 9.9, no sales of the Product are
made through Cambridge’s web site to any person requiring delivery to an address in the
Territory.
	 
	2.4  	In the event that [...***...], Prestwick grants to Cambridge [...***...] license to use that
technology and the Prestwick Intellectual Property relating to that technology [...***...],
provided that [...***...].
	 
	2.5  	Neither party shall have the right to use the others Intellectual Property or, in the case of
Prestwick, Cambridge’s Restricted Information and the [...***...], other than as expressly
authorised hereunder and subject to the restrictions on such use set forth in the terms of
this Agreement.
	 
	2.6  	Save as expressly provided in any [...***...] Development Plan, Prestwick shall not copy or
reproduce the Active Substance or the Product for any reason or cause, assist or enable others
to do so.
	 
	2.7  	For the duration of this Agreement and for a period of twelve (12) months following the
expiration of any post-termination or post-expiration “sell-off” period (if applicable),
Prestwick shall not be engaged, or cause enable or assist third parties to be engaged, in the
manufacture, marketing, development, distribution or sale of any product, with applications
for treating the symptoms of hyperkinetic movements disorders that respond to the Active
Substance or containing the Active Substance or any similar active substance other than the
Product without the prior written consent of Cambridge. For the sake of clarity “similar
active substance” shall have the same definition as is provided for in EC Commission
Regulation 847/2000 of 27 April 2000. It is agreed by Cambridge that nothing in this Agreement
shall prevent Prestwick from manufacturing, marketing, developing, distributing or selling any
product that is indicated as a cure for (but not for treating the symptoms of) hyperkinetic
movements disorders.
	 
	2.8  	For the duration of this Agreement Cambridge shall not, save as set forth in this clause, be
engaged, or cause enable or assist others to be engaged in the Territory in the manufacture,
marketing, development, distribution or sale of any product, other than the Product or any
product resulting from any [...***...] Development, with applications for treating the symptoms of
hyperkinetic movements disorders that respond to the Active Substance or containing the Active
Substance or any similar active substance without the prior written consent of Prestwick. For
the sake of clarity “similar active substance” shall have the same definition as is provided
for in EC Commission Regulation 847/2000 of 27 April 2000. It is

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agreed by Prestwick that nothing in this Agreement shall prevent Cambridge from
manufacturing, marketing, developing, distributing or selling in the Territory any product
that is indicated as a cure for (but not for treating the symptoms of) hyperkinetic
movements disorders or any product resulting from any [...***...] Development in respect of
which Prestwick has elected not to exercise its rights under clause 6.2

	2.9  	Within [...***...] following the Commencement Date, Cambridge shall provide to Prestwick copies
of those parts of the Restricted Information that Cambridge, in its reasonable opinion,
believes is necessary to enable Prestwick to perform its obligations under this Agreement.
	 
	2.10  	If, at any time up to first commercial sale of the first Product commercialized under this
Agreement following the grant of the NDA , Prestwick is unwilling or unable to obtain
sufficient capital to enable it to perform its obligations pursuant to this Agreement in a
timely manner, Cambridge may terminate this Agreement on [...***...] written notice. If, during
that [...***...] notice period Prestwick acquires capital funding it shall notify Cambridge of
such and if, in Cambridge’s reasonable opinion, such funding is sufficient to allay the short
term fears of Cambridge, the notice shall lapse.
	 
	2.11  	For the purposes of clause 2.10 the phrase “in a timely manner” shall mean that the [...***...]
Development is proceeding in terms of timing substantially in accordance with Schedule 2 with
such changes as the parties may subsequently agree to or which may be required by the study
results or FDA action and Prestwick is performing in all material respects any other of its
obligations hereunder necessary to enable first commercial sale on such Product following
[...***...] in such time frames as are either set forth herein or are otherwise prudent and
conservative in order to meet the anticipated date of [...***...], including but not limited to
those obligations set forth in clauses 3.13, 9.11, 9.12, 9.13, 9.15.1, 9.15.5, 9.15.6, 10.1,
10.9 and 12.5. If Prestwick is unable to fulfil any of the obligations mentioned in or
contemplated by this clause due to a failure of Cambridge to provide Product, information or
materials necessary to enable Prestwick to fulfil them, Cambridge shall not be entitled to
invoke clause 2.10 or to terminate this Agreement.
	 
	2.12  	Prestwick agrees that, subject to the supervision and direction of the Board of Directors of
Prestwick, Kathleen Clarence-Smith is the Prestwick employee with principal responsibility for
implementing Prestwick’s development obligations under the [...***...] Development Plan and will
remain so through the completion of the [...***...] Development Plan unless:

	 	2.1.5  	she resigns or suffers death or disability;

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	 	2.1.6  	she elects to take a different role within Prestwick resulting in her not having
enough time to take primary responsibility for such implementation; or
	 
	 	2.1.7  	her employment is terminated for violation of Prestwick’s policies or any laws or
regulations of the District of Columbia or the United States.

	3  	[...***...] DEVELOPMENT, INDs, NDAs and [...***...] DEVELOPMENTS
	 
	3.1  	As soon as is practicable following the Commencement Date, and in any event no later than
30th September 2002, the parties shall meet and agree the content, and within ten (10) working
days thereafter Prestwick shall prepare, with the co-operation of Cambridge the [...***...]
Development Plan (as described below) and shall arrange to attend the Initial FDA
Consultation.

The [...***...] Development Plan shall contain all relevant information and reports required
from Cambridge and Prestwick, including but not limited to: Prestwick’s estimated financial
requirements to submit and pursue the IND; an estimate of timelines for IND submissions; a
plan of the parties’ strategy for submission of an IND for the first indications (as
referred to in clause 3.4); and relevant GANTT charts wherever needed. The [...***...]
Development Plan, once agreed, shall be appended as Schedule 1A to this Agreement.

	3.2  	Following the Initial FDA Consultation the parties shall agree on the [...***...] Development
Plan.
	 
	3.3  	The obligations of Prestwick regarding [...***...] are based on the assumptions that [...***...]
(hereinafter “the Assumptions”). In the event that the Assumptions are not correct the parties
will review the obligations of Prestwick. Further, the parties acknowledge that the economic
terms of this proposed relationship that are set forth in this agreement are based on the
Assumptions. If, following the Initial FDA Consultation and the IND filing, the Assumptions
prove to be incorrect, [...***...], the parties shall negotiate in good faith to [...***...]. If,
within [...***...] of commencing any such discussions, agreement cannot be reached the matter
shall be referred to the Dispute Escalation procedure set forth in clause 22. Prestwick
reserves the right to terminate this agreement should the Assumptions prove materially
incorrect in the manner and to the extent set forth above but will only exercise that right
following the completion of the steps set forth above.
	 
	3.4  	Following the Initial FDA Consultation and based on the comments of the FDA the parties shall
meet to determine the indications for which NDAs will be sought in furtherance of the

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[...***...] Development Plan and the chronological priority in which the NDA’s will be
accordingly prepared and filed. The parties believe at the date of this Agreement that the
indications from which the first indications will be selected include Huntington’s disease,
tardive dyskinesia or Hyperkinesia [...***...]. The parties acknowledge that the FDA may dictate
the indications in respect of which it will consider the NDAs and/or the chronological order
in which such NDAs will be considered. In addition the parties acknowledge that the FDA
could require actions to be taken in furtherance of the [...***...] Development Plan that could
compromise [...***...].

	3.5  	If the advice received from the FDA either at the Initial FDA Consultation or at any other
time during the course of the prosecution of the NDAs is that the FDA requires the product
that is the subject of the [...***...] Development Plan to be [...***...], the parties shall meet to
discuss in good faith the implications of such a requirement. In the event that the parties
believe it is not possible to convince the FDA to waive this requirement, either party shall
have the right to terminate this Agreement on provision of written notice provided that the
exercise of such right of termination shall not bring to an end Prestwick’s opportunity to
co-invest under clause 6.2 if that opportunity would apply to [...***...]. For the sake of
clarity, in the circumstances contemplated herein that opportunity shall survive termination
and, if Prestwick elects to take up the opportunity to co-invest, the parties shall execute an
agreement pertaining to [...***...] on the terms contemplated by clause 6.2.
	 
	3.6  	Cambridge will complete the [...***...] and other [...***...] currently in progress for the Product
[...***...]. Prestwick will be responsible for any additional costs of completing any additional
[...***...]. Cambridge will provide Prestwick a license to [...***...] the [...***...] from the [...***...]
for [...***...] of and [...***...] within the [...***...]. In addition Cambridge will provide to Prestwick
[...***...] and [...***...] from
such [...***...], as well as all [...***...] and other [...***...] including
without limitation [...***...] during the term of and prior to this Agreement regarding the
[...***...] and [...***...].
	 
	3.7  	Cambridge and Prestwick will collaborate as needed in compiling and filing any submissions to
the FDA , however it will be the obligation of Prestwick to perform the [...***...] Development in
all material respects in accordance with the [...***...] Development Plan with such changes as the
parties may subsequently agree to or which may be required by the study results or FDA action
and submit the application for the NDAs and INDs within the agreed [...***...] Development or
[...***...] Development Plans. Prestwick will further be

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responsible, [...***...], for executing and filing all other regulatory submissions with the
FDA. Cambridge shall provide all such assistance to Prestwick as Prestwick shall reasonably
request in connection with the compiling and filing any such submissions and administering
the FDA’s review of such submissions.

	3.8  	Within [...***...] of the filing of any IND or NDA pertaining to the Product, Prestwick shall
provide to Cambridge a complete copy of such filing and shall thereafter provide Cambridge
with complete copies of any amendments to or updates of the application.
	 
	3.9  	Should the parties decide to seek NDAs for indications for the Product other than
Hyperkinesia, Huntington’s and tardive dyskinesia the parties shall agree upon a plan for a
[...***...] Development regarding such and the costs of undertaking that [...***...] Development shall
be [...***...]. For the sake of clarity the indication of Tourettes will be considered as such an
indication. No [...***...] Development may be undertaken without the prior consent of Cambridge.
	 
	3.10  	Prestwick will provide [...***...] updates on progress of the [...***...] Development Plan and any
[...***...] Development plan and shall make available to Cambridge via an [...***...] license access
to all information, materials, assays, data and reports including the final study reports
(hereinafter “Data”), to the extent owned or controlled by Prestwick and transferable, arising
from the [...***...] Development or any [...***...] Development that may be used by Cambridge to
obtain any regulatory approvals in all markets outside the Territory. In addition Prestwick
will provide to Cambridge all relevant listings of studies conducted as part of any [...***...]
Development Plan or [...***...] Plan. Following termination (unless terminated due to Cambridge’s
breach) or expiration of this Agreement, Cambridge shall have the exclusive worldwide right to
use such of the Data arising from the [...***...] Development it wishes to use following payment
to Prestwick of a sum equal to [...***...]. Notwithstanding the foregoing sentences and the use of
the terms [...***...], the parties agree that Prestwick’s obligations shall (i) not extend to Data
consisting of [...***...] or records [...***...] or [...***...] as per [...***...]; and (ii) be subject to
[...***...] by those [...***...] including, without limitation, (a) those [...***...], (b) those [...***...]
reference or use of the [...***...]; and (c) [...***...] of [...***...]. Prestwick shall use reasonable
endeavours to secure transferable rights to Data within the foregoing context.
	 
	3.11  	Save as set forth above, each party will be responsible for the expenses it incurs in
fulfilling its obligations under the [...***...] Development Plan.

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	3.12  	All INDs and NDAs shall be in the name of Prestwick and shall be held and maintained at all
times by Prestwick at its cost, subject to any right of Cambridge to require surrender or
transfer of such in accordance with this Agreement or any requirement of the FDA. Prestwick
acknowledges that, to the extent permissible under United States law, including, without
limitation, the U.S. Food and Drug Act, as amended, and the regulations promulgated thereunder
(and in any event as between the parties), the beneficial interest in any INDs and, NDAs is
and shall be with Cambridge. Upon termination or expiration of this Agreement, Prestwick
shall, [...***...], do all things necessary to transfer the all INDs and NDAs to Cambridge or
Cambridge’s nominee, and Prestwick hereby irrevocably appoints Cambridge as its attorney to
sign all such documents and do all such things as are necessary to effect such transfer,
should Prestwick fail to do so within the said [...***...] period. The obligations set forth in
this clause shall survive termination or expiration of this Agreement.
	 
	3.13  	Prestwick shall, as soon as reasonably practicable following the Commencement Date apply for
and thereafter maintain during the term of this Agreement, all other approvals, licences and
permits, aside from those set forth above, necessary to import and supply the Product, in
order to be able to lawfully purchase the Product from Cambridge and distribute the Product in
accordance with this Agreement.
	 
	4  	[...***...] DEVELOPMENT
	 
	4.1  	Prestwick shall not engage in any [...***...] Developments until [...***...] and shall not undertake,
directly or indirectly any [...***...] Developments without the prior written agreement of
Cambridge.
	 
	4.2  	With regard to [...***...] Developments the parties shall, through the forum of quarterly
development meetings which shall alternate between the Prestwick and Cambridge offices, set
forth their ideas for any [...***...] Developments and keep each other fully appraised of the
progress of any [...***...] Developments they are undertaking. Upon notification of any proposed
[...***...] Development by either party to the other party, the party receiving notice shall have
[...***...] and confirm whether [...***...] , such [...***...] period commencing at the later of the date
of [...***...].
	 
	4.3  	The party responsible for implementing the endorsed [...***...] Developments shall provide
complete and comprehensive progress and financial reports on the endorsed [...***...] Development
at the quarterly development meetings.

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	4.4  	The parties will agree the financial costs associated with any endorsed [...***...] Development
Plan at the quarterly meetings. Where the parties have agreed [...***...] of a [...***...] Development
Plan the party undertaking such Plan shall [...***...]. A [...***...] shall be agreed at the
aforementioned quarterly development meetings.
	 
	4.5  	If both parties agree to a [...***...] Development Plan proposed by one party, they shall [...***...]
of that [...***...] Development Plan. In such cases where the costs have been[...***...], the
ownership of the Data specifically associated with that [...***...] Development and any
Intellectual Property arising therefrom shall be owned [...***...] and the parties will continue
to [...***...] the Net Sales Revenue from sales of any Product resulting therefrom.
	 
	4.6  	Should Prestwick, having initially endorsed a [...***...] Development Plan elect not to pursue
its obligations with respect to such Plan all rights pertaining to the specific [...***...]
Development shall revert to Cambridge. Cambridge may thereafter exploit the specific [...***...]
Development within the Territory as Cambridge sees fit and the specific [...***...] Development
and the Product resulting therefrom shall no longer be subject to the exclusive license set
forth in clause 2 hereof.
	 
	4.7  	Should Cambridge, having initially endorsed a [...***...] Development Plan elect not to pursue
its obligations with respect to such Plan, all work on such Plan shall cease and Cambridge
shall [...***...]. For the sake of clarity all Intellectual Property and Data shall revert to the
party that brought the technology subject to that Intellectual Property and Data to the
[...***...] Development Plan and any new Intellectual Property and Data generated by the [...***...]
Development Plan shall be owned by Cambridge. In such circumstances Cambridge shall not be
entitled to commercialise that new Intellectual Property and Data generated by the [...***...]
Development Plan in the Territory for the duration of this Agreement.
	 
	4.8  	If one party initially wishes to pursue a [...***...] Development Plan and the other party does
not wish to [...***...] of that [...***...] Development Plan , whether this is the result [...***...] or
otherwise, the party wishing to pursue the [...***...] Development Plan may do so but shall, save
as set forth below, [...***...]. If the party that did not originally wish to [...***...] of such
Development Plan later decides that it would like to, it shall [...***...] in pursuing that
[...***...] Development Plan and shall thereafter [...***...] of completing that [...***...] Development.

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	4.9  	If Prestwick [...***...] then [...***...] shall be [...***...] and the provisions of clauses 11.1 and
11.2 shall apply mutatis mutandis. If Prestwick [...***...] then any Data generated by Prestwick
and any Intellectual Property pertaining thereto shall be owned by Prestwick in so far as it
relates to the specific [...***...] Development Plan. Similarly if Cambridge [...***...] then [...***...]
and, the provisions of clauses 11.1 and 11.2 shall apply mutatis mutandis and any Data
generated by Cambridge in such a circumstance and any Intellectual Property pertaining thereto
shall in so far as it relates to the specific [...***...] Development will be owned by Cambridge.
For the sake of clarity any Data and Intellectual Property arising from [...***...] shall be owned
by Cambridge[...***...].
	 
	4.10  	Prestwick shall have an exclusive royalty free license to use Cambridge’s Intellectual
Property and Data arising from any [...***...] Development Plan, but specifically excluding any
Intellectual Property arising from [...***...], in the Territory on the terms and subject to the
restrictions as set forth in clause 2 above.
	 
	4.11  	Cambridge shall have an exclusive, royalty free license to use any Intellectual Property and
Data arising from any [...***...] Development that, in accordance with the preceding provisions,
shall be owned by Prestwick, anywhere outside the Territory.
	 
	5  	[...***...] DEVELOPMENTS GENERALLY
	 
	5.1  	Prestwick shall obtain the prior written approval of Cambridge (which approval shall not be
unreasonably withheld or delayed) to any experiment or protocol for any clinical or
pre-clinical trial it is to undertake as part of any [...***...] Development and any submissions
to the FDA or an Ethics Committee regarding such studies and any correspondence it intends to
send to the FDA or an Ethics Committee regarding any such studies. Prestwick shall provide
Cambridge with as much notice as possible of any meetings it may have with the FDA or an
Ethics Committee in respect of any studies undertaken as part of any [...***...] Development Plans
together with information on what it intends to say at those meetings. Cambridge shall have
the option, at its own cost, to attend any such meetings.
	 
	5.2  	Prestwick shall obtain the prior written approval of Cambridge before appointing any third
party to assist it with any study undertaken as part of any [...***...] Development Plan including
but not limited to any CRO, investigator, IVRS service provider, laboratory, statistical
analyst, data management provider or medical writer. Prestwick shall provide Cambridge with
such details as Cambridge may reasonably require regarding any such third party and a copy of
the written agreement Prestwick intends to enter into with that third party. The consent of

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Cambridge to the appointment of any third party to assist it with any study shall not be
unreasonably withheld or delayed. Prestwick shall remain wholly and principally liable to
Cambridge for any breach of the terms of this Agreement by any third party appointed by
Prestwick hereunder.

	5.3  	Any party undertaking a [...***...] Development shall comply with the protocol, GCP and all
requirements of the FDA in undertaking any study as part of the ...***...] Development.
	 
	5.4  	Cambridge shall provide to Prestwick, [...***...], such quantities of the Product needed for any
[...***...] Development Plan, the Active Substance, any analytical reference standard materials
and placebo as Prestwick reasonably requires in order to undertake and complete any study
being undertaken as part of a [...***...] Development. For the sake of clarity Cambridge is not
required to provide to Prestwick clinical trials packs and Prestwick shall be responsible,
[...***...], for putting together such packs.
	 
	5.5  	Prestwick shall keep an accurate inventory of all Product, Active Substance, analytical
reference standard materials and placebo supplied to it to be used for the purpose of studies
to be carried out pursuant to the [...***...] Development Plans and shall, on completion of all
such studies:

	 	5.5.1  	either [...***...] for all such unused Product, Active Substance or reference
standard materials and placebo under [...***...]; or
	 
	 	5.5.2  	[...***...] any portions thereof.

	5.6  	Cambridge may, on reasonable notice and during normal working hours and not more than[...***...],
inspect all records of Prestwick pertaining to any study being undertaken by Prestwick under
any [...***...] Development Plans.
	 
	5.7  	Prestwick shall provide Cambridge with as much notice as is practical in the circumstances of
any inspection by the FDA of Prestwick, or any third party appointed to assist Prestwick, in
relation to a study under any [...***...] Development Plans and shall permit Cambridge to attend
such inspection should Cambridge so desire.
	 
	5.8  	In the event that any of the work undertaken under any of the [...***...] Development Plans
results in any Product having a different Specification for manufacture and sale inside the
Territory from that which applies for outside the Territory, the parties will, in good faith,
review the terms pertaining to the commercial supply of the Product resulting from the [...***...]
Development plan in question and Prestwick shall provide to Cambridge,

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[...***...], all reasonable assistance with technology transfer and the cost and expense of
which such technology transfer shall be borne [...***...].

	5.9  	Where any Intellectual Property and/or Data is acquired by Prestwick as a result of any
[...***...] Development[...***...], the following conditions shall apply:

	 	5.9.1  	Where Cambridge has contributed no expertise or financial input to the
generation of such Intellectual Property and/or Data, Prestwick:

	 	5.9.1.1  	shall use the Intellectual Property and/or Data, to the extent it has any
application to the Product, for the purpose of commercial exploitation of the
Product in the Territory;
	 
	 	5.9.1.2  	shall not use such Intellectual Property and/or Data, and shall not assign,
license or sell any rights under such Intellectual Property to any third party
for use, with any products which might reasonably be seen as competitive with
the Product;
	 
	 	5.9.1.3  	subject to clauses 5.9.1.1 and 5.9.1.2, shall otherwise be free to exploit
such Intellectual Property and/or Data.

	 	5.9.2  	Where Cambridge has contributed expertise or financial input to the generation
of such Intellectual Property and/or Data, Prestwick:

	 	5.9.2.1  	shall use the Intellectual Property and/or Data, to the extent it has any
application to the Product, for the purpose of commercial exploitation of the
Product in the Territory;
	 
	 	5.9.2.2  	shall not use such Intellectual Property and/or Data, and shall not assign,
license or sell any rights under such Intellectual Property and/or Data to any
third party for use, with any products which might reasonably be seen as
competitive with the Product;
	 
	 	5.9.2.3  	subject to clauses 5.9.2.1 and 5.9.2.2, may otherwise exploit such
Intellectual Property and/or Data but only upon prior agreement with Cambridge
as to reasonable commercial terms therefor.

	5.10  	On termination or expiration of this agreement Prestwick shall sell and assign to Cambridge
all of its Intellectual Property (other than any such Intellectual Property which has no
possible application to the Product) and Data arising from any [...***...] Development and
Cambridge

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may at its sole discretion purchase such from Prestwick at a sum equal to [...***...]. For the
sake of clarity this requirement does not extend to Prestwick Intellectual Property.

	5.11  	Save as provided herein, the parties agree to share equally the burden of any third party
claims, actions, damages, liabilities or losses arising from any clinical trial undertaken
pursuant to any [...***...] Development Plans or [...***...] Development Plans and to which Cambridge
provided authority.
	 
	5.12  	Prestwick indemnifies and shall keep Cambridge indemnified against legal liability to third
parties in respect of any claims, actions, damages, liabilities or losses arising from any
clinical trial undertaken pursuant to any [...***...] Development to the extent that such arise
from the negligence or wilful malfeasance of Prestwick or the failure of Prestwick or any
third party appointed to assist Prestwick with any study, to comply with the protocol for the
study, or any requirement of GCP or the FDA in relation to such study.
	 
	5.13  	Cambridge indemnifies and shall keep Prestwick indemnified against legal liability to third
parties in respect of any claims, actions, damages, liabilities or losses arising from any
clinical trial undertaken pursuant to any [...***...] Development Plans to the extent that such
arise from the negligence or wilful malfeasance of Cambridge resulting in any Product or
Active Substance supplied for any clinical trial not complying with the specifications for
such.
	 
	5.14  	Prestwick indemnifies and shall keep Cambridge indemnified against legal liability to third
parties in respect of any claims, actions, damages, liabilities or losses arising from any
clinical trial undertaken in relation to the Product that has not been approved by Cambridge
or is not in accordance with any [...***...] Development Plans.
	 
	6  	[...***...] DEVELOPMENTS
	 
	6.1  	Cambridge [...***...] an [...***...] for [...***...] and shall undertake, [...***...], that [...***...] as it
sees fit. Cambridge will keep Prestwick appraised of its activities with the [...***...] at the
scheduled quarterly development meetings. Prestwick shall not [...***...].
	 
	6.2  	For the sake of clarity as related to [...***...], Prestwick shall [...***...]. In the event that
Prestwick [...***...] on essentially similar terms as agreed for the Product. Should Prestwick
[...***...] then Cambridge shall have the right [...***...]. For the sake of clarity any [...***...]
resulting from [...***...] is not a Product or a [...***...] Development the rights to which are
subject to the license set forth in clause 2 hereof. The right of Prestwick to [...***...].

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	7  	ORPHAN DRUG DESIGNATIONS AND APPLICATIONS
	 
	7.1  	Cambridge shall supply to Prestwick such information pertaining to the Product as is required
by Prestwick to maintain or obtain orphan drug designations relating to the Product.
	 
	7.2  	Cambridge shall, at Prestwick’s cost, transfer to Prestwick ownership of the Existing Orphan
Drug Designations. Prestwick shall be responsible for maintaining and enforcing the Existing
Orphan Drug Designations at its own cost.
	 
	7.3  	If any of the developments of the Product appear that they may qualify for Orphan Drug status
the parties shall discuss and agree whether such a status should be sought. The costs of
obtaining such status shall, unless otherwise agreed, [...***...].
	 
	7.4  	Prestwick acknowledges that the beneficial interest in any Orphan Drug Designation for the
Product shall be and remain the property of Cambridge’s licensor, [...***...]. Upon termination or
expiration of this Agreement, Prestwick shall, [...***...], do all things necessary to either:

	 	7.4.1  	transfer any Orphan Drug Designations for the Product in the Territory to
Cambridge or Cambridge’s nominee, and Prestwick hereby irrevocably appoints Cambridge
as its attorney to sign all such documents and do all such things as are necessary to
effect such transfer, should Prestwick fail to do so within the said [...***...]; or
	 
	 	7.4.2  	should such transfer not be permissible by applicable law or regulation, allow
Cambridge or Cambridge’s nominee unfettered reference to and use of the Orphan Drug
Designations. In such circumstances, Prestwick shall, at Cambridge’s cost, keep such
Orphan Drug Designations current and shall not allow the Orphan Drug Designations to
lapse nor act in any way which would render the Orphan Drug Designations liable to be
revoked.

The obligations set forth in this clause 7.4 shall survive termination or expiration of this
Agreement.

	8  	THE PRODUCT
	 
	8.1  	All Product supplied by Cambridge to Prestwick shall comply with the relevant Specification
set forth in the NDA. In the event of any [...***...] Development giving rise to any new Product,
this clause shall be read mutatis mutandis.

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	8.2  	All Product supplied by Cambridge to Prestwick shall have been manufactured in accordance
with GMP and other relevant manufacturing standards in the Territory, the provisions of the
NDA and at an FDA approved site.
	 
	8.3  	Prestwick shall be entitled, if its evidenced requirements for the supply of the Product for
the Territory dictate, to request that Cambridge secure a second site of manufacturing to meet
the supply requirements of the Territory. The selection of manufacturer will be the sole
responsibility of Cambridge provided however that Prestwick shall participate in the decision
and be entitled to comment on the suitability of the manufacturer. Cambridge will ensure that
the selected manufacturer appointed is able to provide sufficient quantities of the Product to
meet the requirements of Prestwick and that all Product supplied to Prestwick is manufactured
in accordance with GMP and other relevant manufacturing standards in the Territory the
provisions of NDA and at an FDA approved site.
	 
	8.4  	If, in the reasonable opinion of Cambridge, it at any time ceases to be commercially
practicable to continue to manufacture and supply the Product, Cambridge shall have the right
to discontinue the manufacture of the Product and cease supply of the Product to Prestwick
provided that it shall give Prestwick as much notice as is, in the circumstances, reasonable
and, unless withdrawal is required on safety grounds, not less that six (6) months notice. In
such circumstances Cambridge will use reasonable endeavours to assign to Prestwick, should
Prestwick so desire, its rights to the Product for the Territory though Prestwick acknowledges
that such assignment shall be subject to the consent of [...***...] and is thus ultimately beyond
the control of Cambridge.
	 
	8.5  	The parties shall discuss periodically during the term of this Agreement, but not less that
once in each calendar quarter, supply issues including, specifically [...***...] and [...***...] for
Product and Active Substance, (ii) [...***...] of both parties of both Product and Active
Substance, (iii) [...***...] concerning the Product, Active Substance or any component of
either,(iv) [...***...]or[...***...], and (v) [...***...] strategies and planning.
	 
	9  	COMMERCIALIZATION OF THE PRODUCT
	 
	9.1  	Prestwick will sell the Product in the Territory upon the terms set out below.
	 
	9.2  	Prestwick shall obtain all Product, Active Substance and analytical reference standard
materials directly and solely from Cambridge and Cambridge shall supply such Product in the
Territory exclusively to Prestwick.

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	9.3  	Prestwick shall not seek customers or establish or maintain any branch or distribution depot
for the Product outside the Territory provided however that Prestwick may establish and
maintain an intermediate storage depot outside the Territory provided such is used solely for
the purpose of holding stocks of the Product pending shipment to purchasers in the Territory.
	 
	9.4  	Prestwick shall not supply the Product to any customer in any country that is:

	 	9.4.1  	outside the Territory;
	 
	 	9.4.2  	in the Territory if to the reasonable or actual knowledge of Prestwick that
customer intends to supply the Product outside the Territory.

	9.5  	Prestwick shall specify upon any supply that Cambridge’s rights in the Trade Mark and other
Intellectual Property are not exhausted with regard to any re-supply of the Product.
	 
	9.6  	Prestwick shall forward to Cambridge, within [...***...], all enquiries received by Prestwick
regarding the Product from persons outside the Territory. Similarly Cambridge shall forward to
Prestwick, within two [...***...], all enquiries received by Cambridge regarding the Product from
persons in the Territory.
	 
	9.7  	Prestwick shall not hold itself out as Cambridge’s agent for sales of the Product or
otherwise as being entitled to bind Cambridge in any way.
	 
	9.8  	Prestwick shall comply with all laws and regulations in the Territory, all requirements of
the FDA in the Territory and, when distributing the Product, all restrictions set forth in any
NDA. Without in any way limiting the generality of the foregoing, under no circumstance shall
Prestwick, [...***...].
	 
	9.9  	The parties shall, as soon as is practical after the date of this Agreement determine whether
[...***...] Prestwick to [...***...] or the parties agree that Prestwick [...***...], Prestwick and
Cambridge shall undertake such actions as are necessary and advisable to [...***...] to Prestwick
and Prestwick shall do so and shall comply with all laws and regulations in the Territory and
all requirements of the FDA pertaining to [...***...]. In such circumstances Cambridge shall be
[...***...]. If the parties decide that Cambridge shall [...***...] then Cambridge shall comply with
all laws and regulations in the Territory and all requirements of the FDA pertaining to
[...***...] and shall be entitled [...***...].
	 
	9.10  	The initial schedule, of Minimum Sales Quantities will be set forth in schedule 7 to this
Agreement following determination of such pursuant to clause 9.11. The parties anticipate that
the Minimum Sales Quantities will be revised on an annual basis and subject to the mutual

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	   	agreement of the parties. In the event that the parties are unable to agree upon any
revision of the Minimum Sales Quantities the parties shall follow the procedure set forth in
clause 22.
	 
	9.11  	[...***...] the parties shall agree upon the Marketing Plan, the Minimum Sales Quantities and the
Minimum Marketing Activities for the Territory. The Marketing Plan, the Minimum Marketing
Activities, the Minimum Order Quantities and the Minimum Sales Quantities shall cover
activities to be undertaken by Prestwick in the marketing of the Product in the Territory
after the grant of the initial NDA. The parties acknowledge that, with the developments of the
Product contemplated by this Agreement, there will be a number of Marketing Plans. At the same
time the parties shall appoint two members each to the Joint Marketing Committee. The Joint
Marketing Committee shall be responsible for day to day consultation regarding the Marketing
Plan, any reporting that has to be undertaken regarding any Marketing Plan, the review and
evaluation of all Marketing Plans, forecasts, Minimum Order Quantities, Minimum Sales
Quantities and the Minimum Marketing Activities. The Joint Marketing Committee shall review
all Marketing Plans, forecasts and Minimum Order Quantities quarterly and make such changes as
are agreed necessary.
	 
	9.12  	Prestwick shall at all times that it is not required to the contrary by any law, regulation,
court or governmental agency, market the Product in accordance with the Marketing Plan in all
material respects and undertake no less than the Minimum Marketing Activities.
	 
	9.13  	Prestwick shall be responsible for releasing the Product into the market and shall conduct
any assays or tests on the Product at its own cost. Cambridge shall provide to Prestwick, at
no cost to Prestwick, details of any assays or tests that may be helpful to Prestwick in this
regard.
	 
	9.14  	Prestwick shall use all reasonable endeavours to promote sales of the Product throughout the
Territory and, provided Cambridge complies with its obligations to supply Product under this
Agreement, to satisfy market demand therefore and avoid out-of-stock situations.
	 
	9.15  	In connection with the promotion and marketing of the Product Prestwick shall:

	 	9.15.1  	store the Product in accordance with the provisions pertaining to storage in the NDA;
	 
	 	9.15.2  	not misuse, tamper with or in any way alter or modify the Product;
	 
	 	9.15.3  	provide Cambridge, each quarter, with reports in such form as Cambridge may
reasonably require of the activities undertaken by Prestwick in the Territory in the
marketing and promotion of the Product [...***...];
	 
	 	9.15.4  	not use, in relation to the marketing, distribution and sale of the Product, [...***...];

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	 	9.15.5  	use in relation to the marketing distribution and sale of the Product only
promotional materials [...***...] and which comply with the relevant laws and regulations
and requirements of the FDA in the Territory and which have been approved in writing by
Cambridge prior to use. Cambridge shall, on the Commencement Date, provide to Prestwick
a computer disk containing samples of promotional materials Cambridge currently uses in
relation to the Product. Prestwick shall submit to Cambridge for approval any
promotional materials Prestwick proposes using and Cambridge shall provide approval or
details of required alterations within [...***...] of receipt. Promotional materials used
by Prestwick shall contain an acknowledgement of Cambridge’s ownership of the Trade
Mark in such form as agreed by the parties;
	 
	 	9.15.6  	be responsible for producing [...***...] supplies of all materials necessary for the
marketing of the Product in the Territory and at the request of Cambridge provide to
Cambridge copies of such sales aids, including catalogues, sales brochures and sales
manuals as they relate to the Product. Cambridge shall be entitled [...***...];
	 
	 	9.15.7  	observe and comply with the Adverse Events Reporting procedure to be agreed between
the parties and appended as Schedule 8 prior to the first commercial sale of the first
Product to be commercialised under this Agreement following grant of the first NDA and
the requirements of any FDA regarding Adverse Events Reporting;
	 
	 	9.15.8  	in the case of product recall from the market execute such recall in accordance with
the Recall Procedure agreed between the parties and specified in Schedule 9 (subject to
appropriate consultation with Cambridge) and the requirements of the FDA regarding
recall of products.

	9.16  	Prestwick shall not:

	 	9.16.1  	pledge the credit of Cambridge in any way;
	 
	 	9.16.2  	[...***...].

	10  	FORECASTS AND ORDERS
	 
	10.1  	No later than March 31 2004 Prestwick shall supply to Cambridge a written non-binding
forecast of its requirements of the Product for the next twelve (12) months. That twelve (12)
month forecast shall be updated [...***...] no later than the seventh [...***...] of each [...***...]. The
parties shall meet [...***...] to agree upon the quantity of Prestwick’s initial order of the
Product , such quantity to be consistent with the forecasts that have been provided

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	   	to that date and shall take into account not only anticipated sales but also Prestwick’s
required stock holding as set forth in clause 10.9. That order shall be placed by Prestwick
within [...***...] of that meeting and shall become binding on such date and Cambridge shall
deliver that quantity of the finished, packaged and labelled Product in its final container
so ordered [...***...]. From [...***...], the [...***...] of each [...***...] updated twelve (12) month
forecast shall constitute an order, binding on Prestwick, for the quantity of the Product
for each of [...***...]. The quantity set forth in the binding part of the forecast may be
altered [...***...] by Prestwick within a range of [...***...] and may not otherwise be altered in
subsequent updated forecasts.
	 
	10.2  	From [...***...] Prestwick shall ensure that, at the time of submitting the updated forecasts
pursuant to clause 10.1, it has submitted to Cambridge written orders for the quantity of the
Product set out for each of the [...***...] of that forecast. If it wishes to alter any order
because it has altered any quantity in the binding part of any forecast in accordance with
clause 10.1 it must submit an amended order to reflect that. Any order shall be for [...***...] of
the Product. Failure to submit any written order shall not relieve Prestwick of its obligation
to purchase the quantities set forth in the binding part of the forecast.
	 
	10.3  	All orders for the Product shall be in writing and shall specify clearly the quantity of the
Product required and, save for the initial order placed under clause 10.1, shall specify a
delivery date not less than [...***...]. Unless an order is not consistent with the then current
forecast or otherwise not in compliance with this agreement, all such orders shall be binding
on Cambridge. Cambridge shall notify Prestwick of its receipt of any order in writing within
[...***...] of receipt.
	 
	10.4  	Cambridge’s obligation to supply Product in accordance with clause 12.1 shall apply in
respect of orders placed in accordance with the clauses 10.1 to 10.3. If Prestwick requires
and orders additional quantities of the Product over and above those set forth in the binding
part of the forecast, Cambridge shall use reasonable endeavours to fulfil that order provided
always that the date for delivery of any such additional order shall be no less than [...***...].
	 
	10.5  	The Minimum Order Quantity for any [...***...] shall be [...***...].
	 
	10.6  	If Cambridge has any reasonable concerns with the quantities forecast and the resulting
Minimum Order Quantities it may refer the matter through the Dispute Escalation Procedure set
forth in clause 22.

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	10.7  	Prestwick shall not, in each year of this Agreement, order less than the Minimum Order
Quantity nor sell less than the Minimum Sales Quantity. If Prestwick fails to sell the Minimum
Sales Quantity in any one year, [...***...]. Prestwick shall not be held to be in breach of its
obligations hereunder if the reason for Prestwick’s failure to either order the Minimum Order
Quantity or sell the Minimum Sales Quantity is because of a failure of Cambridge to
manufacture or supply quantities of the Product complying with the warranties set forth in
clause 8 and 18 hereof equal to the Minimum Order Quantities.
	 
	10.8  	Cambridge shall be entitled to terminate this Agreement in accordance with the provisions of
clause 23 in the event that Prestwick fails, in any two consecutive years during the term of
this Agreement, to order the cumulative Minimum Order Quantities for those two years or sell
the cumulative Minimum Sales Quantities for those two years save that such right of
termination shall not arise when the reason for Prestwick’s failure to either order the
Minimum Order Quantity or sell the Minimum Sales Quantity is because of a failure of Cambridge
to manufacture or supply quantities of the Product complying with the warranties set forth in
clauses 8 and 18 hereof equal to the Minimum Order Quantities.
	 
	10.9  	Prestwick shall ensure that it holds [...***...] stocks of the Product [...***...].
	 
	11  	PRICE AND PAYMENT
	 
	11.1  	It is the intention of the parties that Prestwick shall, save in the circumstances set forth
in clause 4, pay to Cambridge fifty percent (50%) of the Net Sales Revenue for sales of the
Product. To achieve this Prestwick shall pay for each order at the rate of [...***...] for each
Unit of the Product and, at the end of each [...***...], there shall be a calculation and
reconciliation as provided for in clause 11.3. In the event that any Product resulting from
any [...***...] Development does not come [...***...], then the parties shall agree upon what
constitutes a Unit with regard to such a Product.
	 
	11.2  	Prestwick shall use commercially reasonable endeavours to seek [...***...] for the Product in
sales of the Product.
	 
	11.3  	Within [...***...] of the end of each [...***...] Prestwick shall provide to Cambridge an account
setting forth the quantity of the Product purchased by Prestwick from Cambridge, the quantity
of the Product sold by Prestwick in the Territory and a calculation, including all information
relevant to that calculation, of the Net Sales Revenue for sales of the Product. Cambridge
shall be entitled to audit the records of Prestwick pursuant to clause 11.4. The parties
shall, within [...***...] of receipt by Cambridge of Prestwick’s account, in good faith,

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	   	agree upon the Net Sales Revenue for that [...***...]. Based on that agreed Net Sales Revenue
the parties shall agree upon the amount to be paid by either party to the other to ensure
that Cambridge is paid fifty percent (50%) of the Net Sales Revenue and that sum shall be
paid within [...***...] of such agreement being reached.
	 
	11.4  	Cambridge shall have the right to appoint an independent auditor to whom Prestwick has no
reasonable objections to review the books of accounts (including computer records) and records
of Prestwick relating to sales of the Product to confirm the accuracy of the reports provided
pursuant to this Agreement and Prestwick shall allow said independent auditor to enter the
premises and have access to the relevant records of Prestwick for the purpose of carrying out
the audit contemplated herein which right shall be exercisable once during any [...***...] period.
	 
	11.5  	If there is [...***...] and Cambridge has used reasonable endeavours to [...***...], the parties
shall meet and discuss in good faith other ways in which [...***...] of the Product can be
[...***...].
	 
	11.6  	Cambridge shall invoice Prestwick following delivery of the Product in accordance with clause
10.
	 
	11.7  	Unless expressly stated to the contrary elsewhere herein, payment in full of any amounts due
to Cambridge by Prestwick shall be made in US Dollars within [...***...] of the date of
Cambridge’s invoice in respect of such amounts by telegraphic transfer to Cambridge’s bank
account the details of which will be provided to Prestwick from time to time by Cambridge in
writing and which are, at the date of signature of this Agreement:
	 
	   	[...***...]
	 
	11.8  	Should any amount not be paid by Prestwick on or before the due date for payment Prestwick
shall pay to Cambridge, in addition to the amount not paid, interest on any amount so unpaid
at the rate of [...***...] from the date payment of such amount was due until the date payment in
full is received by Cambridge and Cambridge shall also be entitled to withhold further
deliveries of the Product, until such payment is made in full.
	 
	12  	SUPPLY AND DELIVERY
	 
	12.1  	Cambridge will supply the Product to Prestwick [...***...]. Cambridge shall use all commercially
reasonable endeavours to supply the Product on the date set forth in the orders provided in
accordance with clause 10 above.

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	12.2  	In the event that Prestwick does not take delivery of any order of the Product [...***...] then
Prestwick [...***...].
	 
	12.3  	In the event that Cambridge fails to deliver any order of the Product within [...***...] of the
delivery date and, as a result, Prestwick necessarily and unavoidably incurs penalty charges
from its shippers, handlers or storers, then Prestwick shall be entitled, on providing full
documentary evidence of incurring and paying such penalty charges, to have such reimbursed by
Cambridge.
	 
	12.4  	Within [...***...] of any consignment of the Product Prestwick shall inspect such and shall be
entitled to return to Cambridge any quantity of the Product which does not comply with the
relevant Specification or which is in excess of the quantity of the Product ordered. Prestwick
shall be deemed to have accepted any quantity of the Product not returned to Cambridge
within[...***...]. For the avoidance of doubt, Prestwick’s inspection shall have no affect on and
will not diminish Cambridge’s obligation to provide Product meeting the requirements of this
Agreement.
	 
	12.5  	Prestwick shall purchase from Cambridge and provide to the relevant regulatory body in the
Territory, at its cost, any analytical reference standard materials and samples required for
importation testing.
	 
	12.6  	If there is any dispute between the parties as to whether any quantity of the Product
complies with the relevant Specification the matter shall be referred to an independent
laboratory to be mutually agreed between the parties for its opinion. The opinion of the
independent laboratory shall be binding on the parties and the fees of the laboratory shall be
borne by the party whose position is not sustained by the laboratory
	 
	13  	RETENTION OF TITLE AND PASSING OF RISK
	 
	13.1  	Risk in each order of Product shall pass to Prestwick upon supply in accordance with clause
12.1. Notwithstanding delivery, possession of the Product by Prestwick or the passing of risk,
legal title to and ownership of each order of Product shall not pass to Prestwick unless and
until Cambridge has received payment in cleared funds of the whole of its invoice in relation
thereto.
	 
	14  	INTELLECTUAL PROPERTY
	 
	14.1  	Other than is expressly provided herein, or is necessary for the proper performance of this
Agreement by Prestwick, no licence, express or implied, is granted by this Agreement by
Cambridge under any of the Intellectual Property of Cambridge. Other than is expressly

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	   	provided herein, or is necessary for the proper performance of this Agreement by Cambridge,
no licence, express or implied, is granted by this Agreement by Prestwick under any of the
Prestwick Intellectual Property.
	 
	14.2  	Prestwick shall ensure that each reference to and use of the Trade Mark is in a manner from
time to time approved by Cambridge and where appropriate is accompanied by an acknowledgement,
in a form approved by Cambridge, that the same is a trade mark of Cambridge.
	 
	14.3  	Prestwick shall not:

	 	14.3.1  	use the Trade Mark in any way which might prejudice its distinctiveness or validity
or the goodwill of Cambridge therein;
	 
	 	14.3.2  	use or make any application for registration in the Territory of any trade marks or
trade names so resembling the Trade Mark or any trade mark or trade name of Cambridge
as to be likely to cause confusion or deception.

	14.4  	Cambridge warrants that it has not, [...***...], received any notice or claim that the
manufacture, use, sale or export of the Product infringes the intellectual property rights of
any third party and that, to the best of its knowledge and belief but without having
undertaken any patent or intellectual property rights searches, the import and sale of the
Product in the Territory will not infringe the intellectual property rights of any third
party.
	 
	14.5  	Prestwick shall promptly and fully notify Cambridge of any actual, threatened or suspected
infringement, whether in the Territory or otherwise, of any of the Intellectual Property of
either party pertaining to the Product that comes to Prestwick’s notice. In the event that the
infringement concerns the Intellectual Property of Cambridge in the Product Cambridge shall,
after consultation with Prestwick, at its own cost, take whatever action it deems reasonably
necessary in relation to the infringement and Prestwick shall, at the request and expense of
Cambridge, do all such things as may be reasonably required to assist Cambridge in taking any
such action. In the event that the infringement concerns any Intellectual Property of
Prestwick in the Product or any Prestwick Intellectual Property Prestwick shall, after
consultation with Cambridge, at its own cost, take whatever action it deems reasonably
necessary in relation to the infringement and Cambridge shall, at the request and expense of
Prestwick, do all such things as may be reasonably required to assist Prestwick in taking any
such action. In the event that the infringement concerns the jointly owned Intellectual
Property the parties shall agree, through the Joint Marketing Committee, upon the manner in
which the infringement of those

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	   	jointly owned Intellectual Property rights shall be dealt with. The costs of taking any
action agreed upon in relation to infringement of those jointly owned Intellectual Property
rights and the benefit of any award of damages or any settlement in favour of Prestwick and
Cambridge or the burden of any award of damages or settlement against Prestwick and
Cambridge [...***...].
	 
	14.6  	Save as provided below, Cambridge indemnifies and shall keep Prestwick indemnified against
any costs, damages and liabilities to any third party arising from any claim by that third
party that the manufacture, importation, use or sale of the Product infringes any intellectual
property rights of that third party. Each party indemnifies the other and shall keep the other
indemnified against any costs, damages and liabilities to any third party arising from any
claim by that third party that the manufacture, importation, use or sale of any Product
arising from any [...***...] Development Plan that the other did not contribute to infringes any
intellectual property rights of that third party. The parties shall [...***...] the costs of
defending any action or proceeding, the benefit of any award of damages or any settlement in
favour of Prestwick and Cambridge or the burden of any award of damages or settlement against
Prestwick and Cambridge in relation to any claim by a third party that the manufacture,
importation, use or sale of any Product arising from any [...***...] Development Plan to which the
parties contributed equally infringes any intellectual property rights of that third party.
Prestwick indemnifies and shall keep Cambridge indemnified against any costs, damages and
liabilities to any third party arising from any claim by that third party that the use by
Cambridge of any Prestwick Intellectual Property in relation to the Product infringes any
intellectual property rights of that third party.
	 
	14.7  	Prestwick hereby acknowledges that it shall not acquire any rights in respect of any trade
names or trade marks of Cambridge (including but not limited to the Trade Mark) or of the
goodwill associated therewith and that all such rights and goodwill are, and shall remain,
vested in Cambridge.
	 
	14.8  	Prestwick shall at the expense of Cambridge take such steps as Cambridge may reasonably
require to assist Cambridge in maintaining the validity and enforceability of the Intellectual
Property pertaining to the Product and Prestwick will not do or allow or authorise anyone to
do any act which would or might invalidate or be inconsistent with the Intellectual Property
pertaining to the Product and shall not omit or allow or authorise anyone to omit to do any
act which, by its omission, would have that effect or character.

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	14.9  	Cambridge shall at the expense of Prestwick take such steps as Prestwick may reasonably
require to assist Prestwick in maintaining the validity and enforceability of the Prestwick
Intellectual Property and Cambridge will not do or allow or authorise anyone to do any act
which would or might invalidate or be inconsistent with the Prestwick Intellectual Property
and shall not omit or allow or authorise anyone to omit to do any act which, by its omission,
would have that effect or character.
	 
	15  	RESTRICTED INFORMATION
	 
	15.1  	Except as provided in clause 15.3 and 15.4 any party receiving and Restricted Information
from the other shall at all times during the continuance of this Agreement and after its
termination;

	 	15.1.1  	keep all Restricted Information confidential; and
	 
	 	15.1.2  	not use any Restricted Information for any purpose other than the performance of its
obligations under this Agreement.

	15.2  	Restricted Information may be disclosed by Prestwick if required by law and to the extent
necessary for the purposes contemplated by this Agreement to:

	 	15.2.1  	the FDA or other governmental authority in the Territory; and
	 
	 	15.2.2  	any third party appointed pursuant to clause 5.2 each such case only to the extent
necessary for the purposes contemplated by this Agreement and subject in every case to
Prestwick using its commercially reasonable endeavours to ensure that the person in
question signs a confidentiality agreement with Prestwick pertaining to the Restricted
Information which contains obligations with regard to confidentiality no less onerous
than those set forth in this Agreement.

	15.3  	Restricted Information may be used by Prestwick for any purpose or disclosed by Prestwick to
the extent only that:

	 	15.3.1  	it is at the date hereof or hereafter becomes public knowledge through no act or
omission of Prestwick its agents or employees (provided that in doing so Prestwick
shall not disclose any Restricted Information which is not public knowledge); or
	 
	 	15.3.2  	it can be shown by Prestwick, to the reasonable satisfaction of Cambridge, to have
been known to Prestwick prior to its being disclosed by Cambridge to Prestwick; or
	 
	 	15.3.3  	hereafter is rightfully received, unsolicited, from a third party not in violation of
any non-disclosure obligation owed to or in favour of Cambridge; or

 

 

	 	15.3.4  	Prestwick can verify by documentary evidence such information was hereafter developed
by members of Prestwick’s staff not having any dealings with the Product, independently
of any disclosure by Cambridge

	15.4  	In the event that Prestwick wishes to disclose any Restricted Information related to [...***...]
Developments in connection with the evaluation, negotiation or consummation of an investment
in Prestwick or any Affiliate of Prestwick by any third party or a collaboration between
Prestwick or any Affiliate of Prestwick and a third party, Prestwick may make such disclosure,
subject to such disclosure being made under obligations of confidentiality no less stringent
than those imposed on the receiving party in clauses 15.1 to 15.3. Prestwick agrees that under
no circumstances shall it disclose details of any [...***...] Developments to any potential
investor or collaborator. Prestwick shall inform Cambridge of any disclosure of any Restricted
Information, and to whom disclosed, promptly following such disclosure.
	 
	16  	FORCE MAJEURE
	 
	16.1  	Neither party shall be under any liability to the other for failure or delay in the
performance of any obligation hereunder or part thereof (other than obligations to pay money)
to the extent and for the period that such performance is prevented by reason of Force Majeure
provided that the party claiming the benefit of this clause gives written notice of the Force
Majeure to the other.
	 
	16.2  	In the event that Cambridge is prevented from supplying the Product to Prestwick by reason of
an event of Force Majeure at the manufacturer of the Product or the Active Substance and such
event has or is reasonably likely to continue for a period of [...***...], Cambridge shall use all
reasonable endeavours, subject to limitations set forth in its existing contractual
arrangements, to appoint another manufacturer of the Product or the Active Substance.
	 
	16.3  	In the event that the event of Force Majeure is [...***...] and such [...***...] endures for more
than [...***...] then either party may terminate this Agreement on the provision of written notice
to the other. In the event that the event of Force Majeure is [...***...] and such [...***...]
endures for more than [...***...] the parties shall negotiate in good faith toward a resolution of
the situation.
	 
	16.4  	Save as provided in clauses 16.2 and 16.3, if the performance of this Agreement shall be
hindered or prevented for a period exceeding [...***...] due to an event of Force Majeure
affecting either party which cannot be removed or abated the party not claiming the benefit of

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	   	Force Majeure shall be entitled to terminate
this Agreement forthwith by giving written
notice to the other.
	 
	17  	PERIOD OF AGREEMENT
	 
	17.1  	This Agreement shall take effect on the Commencement Date and (subject to clause 17.2 below,
or to termination in accordance with all other relevant provisions hereof) shall continue in
force for an initial period fifteen (15) years from the date of the grant of the last NDA
obtained by Prestwick pertaining to the Product. If Prestwick wishes to continue with the
Agreement after the Initial Period it shall, no later than six (6) months prior to the
expiration of the initial term, provide to Cambridge a written request for an extension of the
term of the Agreement and if Prestwick is then in material compliance with its obligations
hereunder, such extension shall be automatically granted.

	 	17.1.1  	If this Agreement continues in force after the initial period of fifteen (15) years,
the parties shall agree the Minimum Marketing Activities, the Marketing Plan, the
Minimum Order Quantity and the Minimum Sales Quantity for each year of the extended
term.

	18  	WARRANTY, INDEMNITY AND INSURANCE BY CAMBRIDGE
	 
	18.1  	Cambridge warrants that there is no statutory, regulatory, judicial, contractual or
organizational impediment to it granting to Prestwick the rights granted hereunder. For the
purposes of clarity, the term “organizational” in the immediately preceding sentence refers to
the charter and by-laws of Cambridge.
	 
	18.2  	Except for the warranties set forth in clauses 8 and 18, Cambridge makes no representations
or warranties of any kind, express, implied or otherwise. Cambridge specifically disclaims and
Prestwick hereby expressly waives any claim in respect of:

	 	18.2.1  	any express or implied warranty of merchantability, satisfactory quality or fitness
for a particular purpose with respect to the Product whether used alone or in
connection with other substances or materials; or
	 
	 	18.2.2  	any liability of Cambridge with respect to any Product which:

	 	18.2.2.1  	has been tampered with or in any way altered or modified other than by
Cambridge; or,
	 
	 	18.2.2.2  	has been subject to misuse, negligence or accident other than by Cambridge; or

 

 

	 	18.2.2.3  	has been stored, handled, maintained or used in a manner contrary to
regulatory requirements or Cambridge’s instructions; or
	 
	 	18.2.2.4  	has exceeded its stated expiry date.

	18.3  	If any quantity of Product supplied by Cambridge is released for distribution and is
subsequently found not to comply with the warranties set forth in clause 8 as qualified by
clause 18.2 above then Cambridge shall replace the defective quantity of Product at
Cambridge’s expense. If a recall of any batch of the Product is necessitated in the
consequences contemplated by this clause then Cambridge shall pay any documented out of pocket
expenses incurred by Prestwick in undertaking such recall. Save as provided in clause 18.4 the
above mentioned replacement of defective Product shall be Prestwick’s sole and exclusive
remedy for any claim, loss or damage suffered or incurred by Prestwick caused thereby or
resulting from any breach of warranty.
	 
	18.4  	Cambridge shall indemnify Prestwick against legal liability to third parties in respect of
all actions, proceedings, costs, claims, damages, demands, expenses, losses and liabilities in
relation to death of or personal injury to human beings to the extent that the same arise
from:

	 	18.4.1  	the negligence or wilful malfeasance of Cambridge; or
	 
	 	18.4.2  	any breach of the terms of this agreement by Cambridge.

	18.5  	In the event of Prestwick receiving a claim from a third party pertaining to the matters set
forth in clause 18.4 above Prestwick shall:

	 	18.5.1  	promptly notify Cambridge of any claim made against it in relation to such matters;
	 
	 	18.5.2  	not accept any compromise or settlement or take any other material steps in relation
to the subject of such claim without the prior approval of Cambridge and its insurers
in writing;
	 
	 	18.5.3  	co-operate fully with and give every reasonable assistance to Cambridge or its
insurers in the investigation and handling of any claim.

	18.6  	Notwithstanding anything to the contrary in this Agreement Cambridge shall not be liable in
any manner whatsoever including under clause 18.3 and 18.4 for any loss of profits, savings,
contracts or business or any indirect or consequential losses of whatsoever nature.
	 
	18.7  	Cambridge will at its own cost maintain throughout the period of this Agreement and for a
period expiring on the date of expiration of the shelf life of the last batch of the Product
sold

 

 

	   	to Prestwick, insurance cover indemnifying itself against such of its liabilities arising
under the foregoing indemnities as are insurable. Cambridge shall also affect at its own
cost such insurance as may be required by governmental or statutory bodies in the Territory.
	 
	18.8  	Cambridge will provide to Prestwick at Prestwick’s request, a broker’s or insurer’s
certificate confirming such insurance cover is in place.
	 
	19  	WARRANTY, INDEMNITY AND INSURANCE BY PRESTWICK
	 
	19.1  	Prestwick warrants that there is no statutory, regulatory, judicial contractual or
organizational impediment to it entering into this agreement. For the purposes of clarity, the
term “organizational” in the immediately preceding sentence refers to the charter and by-laws
of Prestwick.
	 
	19.2  	Prestwick hereby indemnifies and shall keep Cambridge indemnified from and against legal
liability to third parties in respect of all actions, proceedings, costs, claims, damages,
demands, expenses, losses and liabilities to the extent that the same arise from:

	 	19.2.1  	the negligence or wilful malfeasance of Prestwick; or
	 
	 	19.2.2  	any breach of the terms of this agreement by Prestwick.

	19.3  	In the event of Cambridge receiving a claim from a third party pertaining to the matters set
forth in clause 19.2 above Cambridge shall:

	 	19.3.1  	promptly notify Prestwick of any claim made against it in relation to such matters;
	 
	 	19.3.2  	not accept any compromise or settlement or take any other material steps in relation
to the subject of such claim without the prior approval of Prestwick and its insurers
in writing;
	 
	 	19.3.3  	co-operate fully with and give every reasonable assistance to Prestwick or its
insurers in the investigation and handling of any claim; and

	19.4  	Notwithstanding anything to the contrary in this Agreement Prestwick shall not, except in
respect of death or personal injury arising from the negligence of Prestwick, be liable for
any loss of profits, savings, contracts or business or any indirect or consequential losses of
whatsoever nature.
	 
	19.5  	Prestwick will at its own cost maintain throughout the period of this Agreement and for a
period expiring on the date of expiration of the shelf life of the last batch of the Product
sold to Prestwick, insurance cover indemnifying Prestwick against such of its liabilities
arising under

 

 

	   	the foregoing indemnities as are insurable. Prestwick shall also affect at its own cost such
insurance as may be required by governmental or statutory authorities in the Territory.
	 
	19.6  	Prestwick will provide to Cambridge at Cambridge’s request, a broker’s or insurer’s
certificate confirming such insurance cover is in place.
	 
	20  	NOTICES
	 
	20.1  	Any notice given under or in connection with this Agreement shall be in writing and left at
or sent by first class post, registered post or facsimile transmission to the address of the
other party specified at the head of this Agreement or such other address as that party may
from time to time specify in accordance with this clause. If sent by first class post a notice
shall be deemed to have been delivered when in the normal course of the post it would have
been delivered and if sent by facsimile a notice shall be deemed to have been received within
twelve hours of transmission as evidenced by the message confirmation generated by the
facsimile machine.

	 	 	 
	Cambridge	 	Prestwick
	Facsimile: 00 44 191 296 9379

	 	Facsimile: 001 202 296 7450

	21  	ASSIGNMENT
	 
	21.1  	Neither party shall be entitled to assign any of its rights or duties under this Agreement
without the prior written consent of the other which consent shall not be unreasonably
withheld, except that Cambridge may assign this Agreement to any Affiliate of Cambridge or in
connection with the sale of the business or substantially all of the assets to which this
Agreement relates and Prestwick may assign any of its rights or duties hereunder to any
Affiliate of Prestwick. Prestwick or Cambridge, as applicable, shall remain wholly and
principally liable for any breach of any terms of this Agreement by their respective Affiliate
in the case of an assignment as provided above.
	 
	22  	DISPUTE ESCALATION
	 
	22.1  	In the event that the parties are unable to reach agreement on any matter concerning the
content of any [...***...] Development Plan, the content of any [...***...] Development Plan, the
Minimum Marketing Activities, the content of any Marketing Plan, the Minimum Sales Quantities
or the initial order to be placed by Prestwick or Cambridge has referred a concern about any
forecast or Minimum Order Quantities to Dispute Escalation the matter shall, in the first
instance, be addressed as soon as possible and, at the latest, at the immediately succeeding
quarterly meeting of either the Development Steering Committee or the Joint

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	   	Marketing Committee as is appropriate given the nature of the matter. For the sake of
clarity a failure on the part of Prestwick or Cambridge to perform any [...***...] Development
materially in accordance the provisions of clause 4 and 5 or the failure of Prestwick to use
Minimum Marketing Activities in accordance with clause 9.12, to materially comply with the
Marketing Plan in accordance with clause 9.12, to provide a forecast or any updated forecast
in accordance with clause 10.1, to order the Minimum Order Quantities or sell the Minimum
Sales Quantities in accordance with clause 10.7 are material breaches to be dealt with
pursuant to either clause 23.1.1 or, in the case of failure to order the Minimum Order
Quantities or sell the Minimum Sales Quantities, clauses 10.7 and 10.8 and such matters
shall not be dealt with through the escalation procedure set forth in this clause.
Furthermore a failure on the part of Prestwick to perform the [...***...] Development in all
material respects in accordance with the [...***...] Development Plan as provided in clause 3.7
may be treated by Cambridge, at its sole discretion, as either a material breach under
clause 23.1.1 or an action under which it may invoke clause 2.10 but shall not be dealt with
through the escalation procedure set forth in this clause.
	 
	22.2  	If, following either good faith discussions between the Development Steering Committee or the
Joint Marketing Committee as the case may be or expiration of [...***...] of the matter being
referred, whichever is the earlier, agreement has not be reached as to resolution of the
dispute, the matter shall be referred to [...***...].
	 
	22.3  	If, following either good faith negotiations between [...***...] or [...***...] of the matter being
referred to those persons, whichever is the earlier, agreement has not been reached as to
resolution of the dispute, either party may refer the matter to [...***...]. If, following either
good faith negotiations among the [...***...] or [...***...] of the matter being referred to the
[...***...], whichever is the earlier, agreement has not been reached as to the resolution of the
dispute then it shall be referred to binding arbitration in accordance with and subject to the
terms of clause 22.4.
	 
	22.4  	In the event that the parties, having gone through the steps set forth in clauses 22.1 to
22.3, are unable to reach agreement on any on any matter it shall be referred to a binding
arbitration to take place in London before three independent arbitrators with appropriate
knowledge and experience to address the issues to be placed before them: one selected by
Cambridge, one by Prestwick and the third appointed by the first two. Within [...***...] of the
expiry of the time limit set forth in clause 22.3 the parties shall send written requests to
the arbitrators of their

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	   	choice for their assistance with resolution of the matter. The parties shall, as soon as is
practicable inform each other of the identity of their arbitrator so that the two selected
arbitrators may appoint the third. The arbitration shall be based solely on the written
submissions of the parties in support of their final positions concerning the matter. Within
[...***...] of determination of the three arbitrators and notification of such to the parties,
the parties shall submit their written submissions to the arbitrators and provide copies of
such to the other party. The arbitrators shall be limited to making a ruling in favour of
the position of one of the parties on the issue and will be directed by the parties to
render their decision no later than [...***...] following the submissions by the parties. The
vote of the majority of the arbitrators shall be final and binding.
	 
	22.5  	If the issue concerns any updated Minimum Sales Quantities, Minimum Order Quantities or any
updated forecast then, until agreement is reached the previous year’s Minimum Sales Quantities
or the previous Minimum Order Quantities and forecast, as is applicable, shall continue to
apply until the issue is resolved and, if no arbitration decision is reached within six (6)
months of the matter being first referred to arbitration, then the Minimum Sales Quantities or
Minimum Order Quantities or forecast shall be set at

	 	22.5.1  	A twenty five percent (25%) increase where such failure to agree falls within the
first three years following the Commencement Date; and,
	 
	 	22.5.2  	A [...***...] increase where such failure to agree falls in the fourth or any
subsequent year following the Commencement Date, and then readjusted retroactively to
reflect the decision.

	23  	TERMINATION
	 
	23.1  	In addition to all other rights of termination specified herein either party shall be
entitled to terminate this Agreement by notice to the other party having immediate effect if:

	 	23.1.1  	that other party commits any material breach of any of the provisions of this
Agreement and in the case of a breach capable of remedy that other party fails to
remedy the breach within [...***...] of receipt of a notice specifying the breach and
requiring it to be remedied provided however that in the event that prior to the
expiration of any such [...***...] period, the breaching party has, in good faith, taken
substantive steps to rectify the breach but, due to reasons beyond the control of such
party, it requires more than [...***...] to complete the remedy, then the [...***...] period
shall be extended for so long as such party continues to use good faith

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	 	   	substantive efforts to rectify the breach but in no event shall such extension of
time under this proviso extend for more than [...***...] following the receipt of such
notice;
	 
	 	23.1.2  	an encumbrancer takes possession of or a receiver is appointed over any property or
assets of that other party which would have an adverse affect on that party’s ability
to meet its obligations under this Agreement;
	 
	 	23.1.3  	that other party makes any voluntary arrangement with its creditors or becomes
subject to an administrative order or a similar event in any jurisdiction occurs;
	 
	 	23.1.4  	that other party goes into liquidation or receivership other than for the purpose of
amalgamation or reconstruction or otherwise ceases or threatens to cease to carry on
business.

	23.2  	Cambridge shall be entitled to terminate this Agreement in the event that there is a change
in ownership and control of Prestwick and, following such due diligence exercise as is
permitted in the circumstances, Cambridge, in its reasonable opinion believes the Product will
not be given sufficient priority. Cambridge shall retain the right to terminate this Agreement
on the provision of written notice for a period of [...***...] months following the change of
ownership or control of Prestwick and Cambridge may, at any time during that period terminate
this Agreement on the provision of written notice if, in its reasonable opinion it believes
the Product is not receiving sufficient priority. For the avoidance of doubt, if Prestwick
commits (on an annualised basis) for [...***...] following the change of control to maintain at
least the same level of [...***...] Development spend, [...***...], any promotional spend and detail
sales force efforts for the Product as had been expended and exerted (calculated on an
annualised basis) for [...***...] in which the change of control occurred, such expenditures and
exertion shall be deemed to constitute “sufficient priority” for the purposes of this clause.
	 
	23.3  	Any right to terminate this Agreement given by this clause shall be without prejudice to any
other right or remedy of either party in respect of the breach concerned.
	 
	23.4  	The termination of this Agreement shall be without prejudice to any right or remedy available
to either party at such termination.
	 
	23.5  	Notwithstanding any provision of this Agreement which might otherwise be to the contrary,
Cambridge agrees that it shall have no right to terminate this Agreement except (i) in the
event of a material breach by Prestwick which has not been cured under clause 23.1.1 or (ii)
pursuant

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	   	to clauses 2.10 (but subject to the qualification thereon in clause 2.11), 3.5, 10.8, 16.3,
16.4, 23.1.2, 23.1.3, 23.1.4, or 23.2,
	 
	24  	CONSEQUENCES OF TERMINATION
	 
	24.1  	Upon the termination or expiration of this Agreement for any reason:

	 	24.1.1  	Prestwick shall disclose to Cambridge, within [...***...] of termination, details of all
orders for the Product obtained by Prestwick up to the date of termination whether
fulfilled or not and Prestwick’s complete customer list for the Product including
prescribing physicians, wholesalers and hospitals and details of all pricing
arrangements with wholesalers, hospitals, buying groups, Health Maintenance
Organisations and Managed Care Organisations;
	 
	 	24.1.2  	Unless expressly provided to the contrary herein, all licences granted hereunder,
shall come to an end immediately and Prestwick shall, subject to clause 24.1.3
immediately cease all activities carried out pursuant to those licences;
	 
	 	24.1.3  	Prestwick shall, but only upon request by Cambridge, continue to supply on a non
exclusive basis the Product in the Territory in respect of which the Agreement has been
terminated, for a period of [...***...] following the date of termination provided that if
Cambridge does not make such request, then Cambridge shall purchase from Prestwick at
the sum paid by Prestwick any Product in Prestwick’s inventory that is still in
saleable condition and has more two years until expiry;
	 
	 	24.1.4  	Prestwick shall within [...***...] of termination or, if Cambridge has requested
Prestwick continue to supply pursuant to clause 24.1.3, the expiry of the [...***...]
period set out in that clause, send to Cambridge or otherwise dispose of in accordance
with the directions of Cambridge all unsold Product, all samples of the Product and all
advertising, promotional or sales material relating to the Product in the possession or
control of Prestwick;
	 
	 	24.1.5  	Prestwick shall within [...***...] of termination or, if Cambridge has requested
Prestwick continue to supply pursuant to clause 24.1.3, the expiry of the [...***...]
period set out in that clause, return to Cambridge all documents, electronic files and
copies it has of any of the Restricted Information provided that Prestwick may keep one
copy, subject to all confidentiality obligations set forth herein and may use and
disclose such copy solely for archival and compliance with regulatory requirements.

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	 	24.1.6  	To the extent not already provided, Prestwick shall give to Cambridge within [...***...]
of termination or, if Cambridge has requested Prestwick continue to supply pursuant to
clause 22.1.3, expiry of the [...***...] period set out in that clause, all copies of all
information and Data produced or received (including but not limited to any
correspondence from the FDA) as part of any [...***...] Development Plan ; provided that
Prestwick may keep one copy, subject to all confidentiality obligations set forth
herein and may use and disclose such copy solely for archival and compliance with
regulatory requirements.
	 
	 	24.1.7  	Prestwick shall promptly following termination or, if Cambridge has requested
Prestwick continue to supply pursuant to clause 24.1.3, expiry of the [...***...] period
set out in that clause, cease to promote, market, advertise or solicit customers for or
sell the Product;
	 
	 	24.1.8  	Neither party shall have any claim against the other for compensation for loss of
distribution rights, loss of goodwill or any similar loss; and,
	 
	 	24.1.9  	the provisions of those clauses of this Agreement which by their nature are required
to survive termination in order to have full effect (including but not limited to
clauses 2.7, 3.5 (and, as a result, the opportunity set forth in 6.2 if that
opportunity exists in the circumstances contemplated by clause 3.5), 3.10, 3.12, 4.5,
4.9, 5.5, 5.10, 5.11, 5.12, 5.13, 5.14, 7.4, 13.1, 14, 15, 16 18, 19 and this clause
24) shall continue in full force in accordance with their terms; and
	 
	 	24.1.10  	Prestwick shall, at Cambridge’s request, grant to Cambridge a world wide license at
a royalty to be agreed or, if not agreed referred through the arbitration procedure set
forth in clause 22.4, to use such of Prestwick’s Intellectual Property and/or Data that
Cambridge has not otherwise purchased and had assigned to it in accordance herewith,
and/or any Prestwick Intellectual Property, required by Cambridge to continue to
commercialise any Product.

	24.2  	Termination shall be without prejudice to the accrued rights and obligations of the parties
available at the time of termination.
	 
	25  	ENTIRE AGREEMENT
	 
	25.1  	This Agreement and the provisions of any schedules hereto and the side letter of even date
constitute the entire agreement between the parties and supersedes all previous

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	   	communications or representations, agreements or understandings whether oral or written
between the parties with respect to the subject matter hereof, which are hereby excluded.
	 
	25.2  	Amendment or waiver of any provision of this Agreement must be made in writing and agreed to
in writing by a duly authorised representative of each party.
	 
	25.3  	If any provision of this Agreement is agreed by the parties to be illegal void or
unenforceable under any law that is applicable hereto or if any court or other authority of
competent jurisdiction in a final decision so determines this Agreement shall continue in
force save that such provision shall be deemed to be excised herefrom with effect from the
date of such agreement or decision or such earlier date as the parties may agree and the
parties shall, as soon as is practicable after such ruling, renegotiate the terms of this
Agreement solely to take account of any deletion having to be made pursuant to this clause and
with the aim of retaining, in so far as is legally permissible, the spirit and intendment of
this Agreement.
	 
	26  	AGENCY
	 
	26.1  	Nothing contained in this Agreement shall or be deemed to constitute a partnership nor a
relationship of principal and agent or a joint venture between the parties and neither party
shall bind nor conduct itself in a manner to suggest it has authority to bind the other in any
way except as expressly permitted in this Agreement.
	 
	27  	GOVERNING LAW AND JURISDICTION
	 
	27.1  	This Agreement is governed by and should be construed in accordance with the laws of England
and, save where this Agreement provides for resolution of any issue through reference to
arbitration or an independent laboratory, the parties hereby submit to the exclusive
jurisdiction of the English Courts.
	 
	27.2  	The failure on the part of either party to exercise or enforce any right conferred upon it
hereunder shall not be deemed to be a waiver of any such right or operate to bar the exercise
of enforcement thereof at any time or times thereafter.
	 
	28  	CONSENT OR AGREEMENT
	 
	28.1  	Whenever in this Agreement there is a requirement of securing the consent or agreement of a
party to this Agreement, the parties agree that such consent or agreement will not be
unreasonably withheld or delayed.

 

 

IN WITNESS whereof this Agreement has been executed by the duly authorised representatives of the
parties the day and year first above written hereinafter.

 

 

	 	 	 	 	 
	Signed by:

	 	 	)	 
	 
	 	 	 	 
	/s/
Mark
P. Evans                                        

	 	 	)	 
	 
	 	 	 	 
	For and on behalf of

	 	 	)	 
	 
	 	 	 	 
	CAMBRIDGE LABORATORIES

LIMITED
	 	 	 	 
	 
	 	 	 	 
	Signed by:

	 	 	)	 
	 
	 	 	 	 
	/s/
Robert
Whitehead                       

	 	 	)	 
	 
	 	 	 	 
	For and on behalf of

	 	 	)	 
	 
	 	 	 	 
	PRESTWICK PHARMACEUTICALS,
INC.

	 	 	)	 

 

 

SCHEDULE 1

DEFINITIONS

	 	 	 
	“Active Substance”

	 	means tetrabenazine
	 
	 	 
	“Affiliate”

	 	means, a person or body corporate that directly or
indirectly controls or is controlled by or is under
common control with the person or body corporate
specified. For the purposes of this definition “control”
shall mean the possession, direct or indirect, of the
power to direct or cause the direction of the management
and policies of a body corporate though the ownership of
shares or otherwise;
	 
	 	 
	“Commencement Date”

	 	means the date of signature of this Agreement by the
last of the parties to sign;
	 
	 	 
	“Dossier”

	 	means the dossier of information to be formulated by the
parties (in accordance with their respective
responsibilities as contained herein) and intended to
form the basis of the IND and NDA, which dossier is
based upon the dossier for the Product that exists at
the Commencement Date;
	 
	 	 
	[...***...] Development”

	 	means [...***...], to enable the first NDA to be granted for
the Product,
	 
	 	 
	“[...***...] Development Plan”

	 	means any plans for the [...***...] Development, including
forecast expenditure, agreed between the parties
following the Initial FDA Consultation and thereafter
appended as Schedule 2 to this Agreement;
	 
	 	 
	“Ethics Committee”

	 	means the body defined in GCP with responsibility for
observance and maintenance of ethical standards in the
Territory, or the equivalent body in the Territory and
whether locally referred to as an Ethics Committee, an
Institutional Review Board or otherwise;

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	“Existing Orphan Drug Designations”

	 	means the existing Orphan Drug designations for the
Product in the Territory;
	 
	 	 
	“FDA”

	 	means the U.S. Food and Drug Administration;
	 
	 	 
	“Force Majeure”

	 	means any cause preventing or hindering the performance
of this Agreement arising from or attributable to acts,
events or circumstances beyond the reasonable control of
the party affected including but not limited to
epidemic, disease, Act of God, shortage of materials,
war, labour disputes, accidents, fire, breakdown of
machinery, acts of government or other legal authority,
riot or civil commotion and whether ejusdem generis to
the above causes or not;
	 
	 	 
	“[...***...] Developments”

	 	means developments of the Product or the Active
Substance [...***...] and shall include such things as
[...***...];
	 
	 	 
	“GCP”

	 	means Good Clinical Practice as defined in the GCP
guidelines published by the International Committee on
the Harmonization of Good Clinical Practice and as
adopted by the FDA;
	 
	 	 
	“GMP”

	 	means, as relevant to the Product, the principles and
guidelines of good manufacturing practice as contained
in Directive 91/356/EEC, as such principles and
guidelines are interpreted and expanded in “The Rules
Governing Medicinal Products in the European Community,
Volume IV. Good Manufacturing Practice for Medicinal
Products and as described in the United States Code of
Federal Regulations (Title 21, Parts 210-211, 600 and
610);
	 
	 	 
	“IND”

	 	means any Investigational New Drug application and/or
authorisation filed with the FDA pertaining to the
Product;
	 
	 	 
	“Initial FDA Consultation”

	 	means the consultation between the parties and the FDA
to take place as soon as is practicable following the
Commencement Date;

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	“Intellectual Property”

	 	means patents, trade marks (including the Trade Mark),
service marks, registered designs, rights in designs,
applications for any of the foregoing trade or business
names, copyrights, rights under licences and consents
for any such thing and all rights or forms of protection
of a similar nature or having equivalent or similar
effect subsisting anywhere in the world;
	 
	 	 
	“[...***...] Developments”

	 	means any development of [...***...] the Active Substance or
the Product [...***...];
	 
	 	 
	“Joint Marketing Committee”

	 	means the representatives of each party appointed
pursuant to clause 9.11 who are responsible for
overseeing the performance and evaluation of the
Marketing Plan;
	 
	 	 
	“Marketing Plan”

	 	means the plan for the marketing of the Product in the
Territory set forth in Schedule 4 to be appended to this
Agreement at the time provided in clause 9.11 of this
Agreement as such plan may be updated following review
pursuant to this Agreement;
	 
	 	 
	“Minimum Marketing Activity”

	 	means the minimum marketing activities to be undertaken
by Prestwick in the marketing of the Product in the
Territory as set forth in Schedule 5 to be appended to
this Agreement at the time provided in clause 9.11 of
this Agreement;
	 
	 	 
	“Minimum Order Quantity”

	 	means the minimum quantities of the Product to be
ordered by Prestwick for the Territory in any twelve
month calendar year period . ;
	 
	 	 
	“Minimum Sales Quantity”

	 	means the quantities of the Product to be sold by
Prestwick in the Territory set forth in Schedule 7 to
this Agreement;
	 
	 	 
	“NDA”

	 	means any New Drug Application pertaining to the Product;
	 
	 	 
	“Net Sales Revenue”

	 	means invoiced gross sales less ordinary and customary
charges and deductions. The parties agree that no
deduction for bad debts is permissible. Deductions,
discounts and charges from gross sales shall not exceed
20% except with

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	 	the prior written approval of Cambridge
which approval shall not be unreasonably withheld.
	 
	 	 
	“Prestwick Intellectual Property”

	 	means intellectual property owned by or under the
control of Prestwick and relating to (i) fast-dissolving
formulations of pharmaceutical compounds and (ii)
sustained delivery formulations of pharmaceutical
compounds.
	 
	 	 
	“Product”

	 	means Cambridge’s pharmaceutical product in the form of
tablets containing either 25 mgs or 12.5 mgs of the
Active Substance and shall include any Product arising
from any [...***...] Development save as expressly provided
to the contrary;
	 
	 	 
	“[...***...] Developments”

	 	means [...***...] or [...***...] and, for the sake of clarity,
excludes any [...***...]. The parties acknowledge that any
[...***...];
	 
	 	 
	“[...***...] Development Plan(s)”

	 	means the plan or plans for the [...***...] Developments
including a budget for each sub-plan mutually agreed
between the parties. The [...***...] Development Plans, once
agreed, shall be appended as Schedule 3 to this
Agreement;
	 
	 	 
	“[...***...] Development”

	 	means a development of [...***...],
	 
	 	 
	“Restricted Information”

	 	means any information oral, visual, electronic of
written, which (a) is disclosed by one party to the
other pursuant to, in contemplation of or otherwise in
connection with this Agreement; or (b) comes to the
attention of either and relates to the Active Substance
or Product or the business of the other or any Affiliate
of the other (whether or not such information is
expressly stated to be confidential or marked as such);
	 
	 	 
	“Specification”

	 	means, save as provided herein, the specification of the
Product as described in any NDA;

* Confidential Treatment
Requested

 

 

	 	 	 
	“Territory”

	 	means the United States of America;
	 
	 	 
	“Trade Mark”

	 	means the trade mark XENAZINE;
	 
	 	 
	“Unit”

	 	means [...***...] of [...***...];
	 
	 	 
	“Working Days”

	 	means Monday to Friday and excludes any UK or Territory
public or bank holidays.

* Confidential Treatment
Requested

 

 

SCHEDULE IA

[...***...] DEVELOPMENT PLAN

The [...***...] Development Plan shall contain all relevant information and reports required from
Cambridge and Prestwick, including but not limited to: [...***...]. The [...***...] Development Plan, once
agreed, shall be appended as Schedule IA to this Agreement.

* Confidential Treatment
Requested

 

 

SCHEDULE 2

[...***...] DEVELOPMENT PLAN

* Confidential Treatment
Requested

 

 

SCHEDULE 3

[...***...] DEVELOPMENT PLAN

Means the plan or plans for the [...***...] Developments including a budget for each sub-plan mutually
agreed between the parties. The [...***...] Development Plans, once agreed, shall be appended as
Schedule 3 to this Agreement

* Confidential Treatment
Requested

 

 

SCHEDULE 4

MARKETING PLAN

	1.  	[...***...]
	 
	2.  	[...***...]
	 
	3.  	[...***...]
	 
	4.  	[...***...]
	 
	5.  	[...***...]
	 
	6.  	[...***...]

* Confidential Treatment
Requested

 

 

SCHEDULE 5

MINIMUM MARKETING ACTIVITIES

Prestwick will be responsible for marketing and sales of the Product in the U.S. In view of
tetrabenazine’s importance to Prestwick’s strategy, Prestwick is committed to providing sales and
marketing resources that Prestwick believes will enable it to penetrate the market and meet or
exceed its goals. The following describes the resources that Prestwick anticipates it will allocate
using [...***...]:

* Confidential Treatment
Requested

 

 

SCHEDULE 6

MINIMUM ORDER QUANTITIES

	 	 	 
	Year
	 	Units

* Confidential Treatment
Requested

 

 

SCHEDULE 7

MINIMUM SALES QUANTITIES

	 	 	 
	Year
	 	Units

* Confidential Treatment
Requested

 

 

SCHEDULE 8

 

 

SCHEDULE 9

PRODUCT RECALL PROCEDURE

 

 

THIS AMENDMENT NO. 1 is made as of the 1st day of December, 2004, to that certain AMENDED AND
RESTATED AGREEMENT, dated January 30, 2004, amending and restating that certain Agreement, dated
September 26, 2002, (as so amended by this said Amendment No. 1, the “Agreement”), BETWEEN:

	1.  	CAMBRIDGE LABORATORIES LIMITED [...***...] having its principal place of business at [...***...] and
being a [...***...] having its registered office at 17 Hanover Square, London W1S 1HU, England
(hereinafter “Cambridge-England”);

AND

	2.  	PRESTWICK PHARMACEUTICALS, INC. a company incorporated under the laws of the State of
Delaware and having its registered office at 1825 K Street Northwest, Suite 1475, Washington
D.C. 20006, USA (hereinafter “Prestwick”)

Capitalized terms used in this Amendment No. 1 but not otherwise defined herein shall have the
meanings given to such terms in the Agreement.

WHEREAS:

	1.  	The Agreement relates to Prestwick’s undertaking of the
[...***...] Developments, the
promotion, sale and distribution of the Product in the Territory, and, if mutually agreed by
the Parties, [...***...] Developments.

	2.  	Prestwick desires, pursuant to a Sponsored Research Agreement, substantially in the form
attached hereto as Exhibit I (hereinafter the “Sponsored Research Agreement”), with the
Massachusetts General Hospital (hereinafter “MGH”), to fund a study on certain effects of the
active ingredient in the Product (hereinafter the “Study”).

	3.  	The Study may result in inventions (hereinafter “Study Inventions”) that constitute [...***...]
Developments under the Agreement and to which MGH has granted to Prestwick and Cambridge, as
Prestwick’s sublicense or assignee, an option to obtain a license (hereinafter the “Option”).

	4.  	[...***...] has established [...***...] as a [...***...] in [...***...] that [...***...] contemplates will, as
soon as possible, be [...***...] under the laws of [...***...] and will become [...***...] under the same
[...***...]; and pursuant to that certain notice, dated September 14, 2004 [...***...] to Prestwick,
and acknowledged by Prestwick,

[...***...] will [...***...] to [...***...] all of [...***...] upon the [...***...] of [...***...].

* Confidential Treatment
Requested

 

 

THE PARTIES AGREE as follows:

1. The Parties agree that as between the two of them the provisions of the Agreement relating to
[...***...] Developments shall apply to Study Inventions that constitute [...***...] Developments under the
Agreement (“Study-Invented [...***...] Developments”).

2. In order to give effect to Section 1 of this Amendment No. 1, Prestwick, as permitted under the
Sponsored Research Agreement, agrees that (i) following the completion of the Study, Cambridge and
Prestwick will determine whether they mutually desire to develop any of the Study-Invented [...***...]
Developments, (ii) if Cambridge and Prestwick so determine to develop any of the Study-Invented
[...***...] Developments, then Prestwick shall assign to Cambridge Prestwick’s rights to so obtain such
license rights to such Study-Invented [...***...] Developments under the Option and Cambridge shall
exercise the Option to so obtain such license rights and such license rights shall be included in
the intellectual property rights licensed to Prestwick by Cambridge under the provisions of the
Agreement as they apply to [...***...] Developments.

3. Prestwick and Cambridge hereby agree that upon the [...***...] of [...***...] and the effectiveness of
the [...***...] as a [...***...] and shall, in accordance with the [...***...], thereupon and thereafter be
[...***...] all of [...***...] under the Agreement.

4. The terms and conditions of the Agreement shall, except as otherwise provided in this Amendment
No. 1, apply to this Amendment No. 1.

[Signature Page Follows]

* Confidential Treatment
Requested

					
	 
	 	2
	 	 

 

 

IN WITNESS whereof this Agreement has been executed by the duly authorised representatives of the
parties the day and year first above written hereinafter.

	 	 	 	 	 	 	 
	Signed by:
	 	 	)	 	 	 
	 
	 	 	 	 	 	 
	Mark Evans /s/
	 	 	)	 	 	 
	 
	 	 	 	 	 	 
	For and on behalf of
	 	 	)	 	 	 
	 
	 	 	 	 	 	 
	CAMBRIDGE LABORATORIES LIMITED [...***...]
	 	 	 	 	 
	 
	 	 	 	 	 	 
	Signed by:
	 	 	)	 	 	 
	 
	 	 	 	 	 	 
	Kathleen Clarence-Smith /s/
	 	 	)	 	 	THE LAW GROUP

	 
	 	 	 	 	 	 
	

	 	 	)	 	 	Approved as to form
	 
	 	 	 	 	 	 
	For and on behalf of

	 	 	)	 	 	               Initial ___
	 
	 	 	 	 	 	 
	PRESTWICK PHARMACEUTICALS, INC.

	 	)	 	 	 

* Confidential Treatment
Requested

					
	 
	 	3exv10w11

 

Exhibit 10.11

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4) and 230.406

Agreement

among

SCHERING Aktiengesellschaft

Müllerstrabe 178

13342 Berlin

(hereinafter called “SCHERING”)

and

NeuroBiotec GmbH

Tegeler Straibe 6

13353 Berlin

(hereinafter called “NEUROBIOTEC”)

and

 

Prestwick Pharmaceuticals, Inc.

1825 K Street

Washington, D.C. 2006

(hereinafter called “PRESTWICK”)

 

 

  2

RECITALS

Whereas SCHERING and NEUROBIOTEC have entered into a Technology Transfer Agreement as amended as of
May 30, 2002 (the “Technology Transfer Agreement”) concerning the sale and transfer of patents and
know-how relating to the development, production and marketing of (1) a ready to use pharmaceutical
speciality for trans-dermal use (the “Patch Product”) and (2) all other non per-oral ready to use
pharmaceutical specialties for sustained release (collectively the “Other Sustained Release
Products”) in humans containing Lisuride and/or Lisuride hydrogen maleate and/or all other
pharmaceutically active salts and esters of Lisuride (the “Product(s)”) from SCHERING to
NEUROBIOTEC;

Whereas NEUROBIOTEC has identified PRESTWICK as partner for the development and marketing in the
United States of America (the “U.S.”) and Canada of the Patch Product (the “U.S./Canada Patch
Product”) and the Other Sustained Release Products (the “U.S./Canada Other Sustained Release
Products” — collectively with the U.S./Canada Patch Product, the “U.S./Canada Products”) and has
negotiated with PRESTWICK an exclusive, sublicensable license-, development, commercialisation- and
drug supply agreement relating to the development and sale of the U.S./Canada Products (the
“Prestwick Cooperation”);

Whereas SCHERING under the Technology Transfer Agreement has an option to obtain exclusive,
sub-licensable development, production and marketing rights for the “U.S./Canada Patch Product”
(the “U.S./Canada Option”), and a right of first refusal to take an exclusive, sub-licensable
license to develop, produce and market the “U.S./Canada Other Sustained Release Products” (the
“U.S./Canada Right of First Refusal”);

Whereas PRESTWICK wishes to take over the development and marketing of the U.S./Canada Patch
Product without being restricted by SCHERING’s U.S./Canada Option, and the development and
marketing of the U.S./Canada Other Sustained Release Products without being restricted by
SCHERING’s U.S./Canada Right of First Refusal;

Whereas SCHERING is prepared to waive its U.S./Canada Option and its U.S./Canada Right of First
Refusal under the conditions set forth in this Agreement in order to allow NEUROBIOTEC to grant all
rights to the U.S./Canada Products to PRESTWICK;

 

 

  3

Whereas the parties agree that this Agreement shall be conditional on the execution of the
Prestwick Cooperation;

Whereas the parties have already entered into an agreement concerning the development and marketing
of the Products by Prestwick for the U.S. in August/September, 2003 (the “U.S. Agreement”);

Whereas the parties agree that this Agreement shall replace the U.S. Agreement;

Whereas the parties agree that the Prestwick Cooperation is likely to improve considerably the
prospects for a timely introduction of the U.S./Canada Products and that the simultaneous and
coordinated development activities in Europe and the U.S. and Canada are intended to result in
development cost reductions and to generate other synergies for the parties hereof.

The parties, therefore, hereby agree to and amend the Technology Transfer Agreement as follows:

	1.  	Definitions
	 
	   	“Affiliate” has the meaning set forth in Article 1 of the Technology Transfer Agreement.
	 
	   	“Agreement” means this three-party-agreement by and among SCHERING, NEUROBIOTEC and
PRESTWICK.
	 
	   	“Business Day” means a day which is not a Saturday, a Sunday or other day on which banks are
required or authorized by law to be closed in Washington D.C., U.S., or Berlin, Germany.
	 
	   	“Confidential Information” has the meaning set forth in Section 8.1.
	 
	   	“Development Cost” has the meaning set forth in Article 1 of the Technology Transfer
Agreement.
	 
	   	“Existing Schering Data” has the meaning set forth for the term “Data” in Article 1 of the
Technology Transfer Agreement.

 

 

  4

	   	“First Commercial Sale” means the date on which the first Product is sold commercially by
PRESTWICK or on PRESTWICK’s behalf by any sublicensee of PRESTWICK in the U.S. or Canada.
	 
	   	“Know-how” means: techniques, data and information relating to the Products, including, but
not limited to, inventions, practices, methods, manufacturing processes, knowledge,
know-how, skill, trade secrets, experience, test data (including pharmacological,
toxicological, pre-clinical and clinical test data); data, records and information derived
from pre-clinical development, clinical development or CMC/process development, regulatory
submissions, adverse reactions, analytical and quality control data, marketing, pricing,
distribution, cost, sales and manufacturing data or descriptions.
	 
	   	“Net Sales” means the amount invoiced by PRESTWICK or any sublicensee of PRESTWICK (each a
“Seller”) for sales of a Product to unaffiliated third parties less the following deductions
applicable to the Products for:

	 	(i)  	transportation charges and insurance charges paid by the Seller;
	 
	 	(ii)  	sales and excise taxes or customs duties paid by the Seller or any other
governmental charges imposed upon the sale of the Products and paid by the Seller;
	 
	 	(iii)  	rebates and premiums granted or allowed in connection with the sale of a
Product;
	 
	 	(iv)  	allowances or credits to customers on account of governmental requirements,
price differences, rejection, outdating, returns or recalls of the Products;
	 
	 	(v)  	quantity discounts, cash discounts or chargebacks granted in connection with
the sale of the Products,
	 
	 	(vi)  	provisions for price reductions.

	   	In the event a Product is sold in the form of a combination product containing one or more
active ingredients in addition to a Product, Net Sales for such combination product will be
adjusted by multiplying actual Net Sales of such combination product by the fraction A /
(A+B) where A is the invoice price of the Product, if sold separately, and B is the invoice
price of any other active

 

 

  5

	   	ingredient or ingredients in the combination, if sold separately. If the other active
ingredient or ingredients in the combination are not sold separately, Net Sales shall be
calculated by multiplying actual Net Sales of such combination product by the fraction A / C
where A is the invoice price of the Product if sold separately, and C is the invoice price
of the combination product. If neither the Product nor the other active component or
components of the combination product is sold separately, Net Sales shall be determined
between SCHERING and PRESTWICK in good faith.
	 
	   	“Other Sustained Release Products” has the meaning set forth in the first paragraph of the
Recitals above.
	 
	   	“Patch Product” has the meaning set forth in the first paragraph of the Recitals above.
	 
	   	“Prestwick Cooperation” has the meaning set forth in the second paragraph of the Recitals
above.
	 
	   	“Product(s)” has the meaning set forth in the first paragraph of the Recitals above.
	 
	   	“Step I Milestone” means the fee to be paid by SCHERING to NEUROBIOTEC pursuant to Section
7.1 (ii) of the Technology Transfer Agreement in order to retain its option right pursuant
to Section 7.2 of the Technology Transfer Agreement.
	 
	   	“Technology Transfer Agreement” has the meaning set forth in the first paragraph of the
Recitals above.
	 
	   	“U.S.” has the meaning set forth in the second paragraph of the Recitals above.
	 
	   	“U.S. Agreement” has the meaning as set forth in the seventh paragraph of the Recitals
above;
	 
	   	“U.S./Canada Option” has the meaning as set forth in the third paragraph of the Recitals
above.
	 
	   	“U.S./Canada Other Sustained Release Product” has the meaning set forth in the second
paragraph of the Recitals above.

 

 

  6

	   	“U.S./Canada Patch Product” has the meaning set forth in the second paragraph of the
Recitals above.
	 
	   	“U.S./Canada Products” has the meaning set forth in the second paragraph of the Recitals)
above.
	 
	   	“U.S./Canada Right of First Refusal” has the meaning set forth in the third paragraph of the
Recitals above.

	2.  	Waiver of Rights
	 
	   	In consideration of the payment of royalties to SCHERING by PRESTWICK pursuant to Section 3
below and the reduction of the Step I Milestone pursuant to Section 4 below, SCHERING hereby
waives its U.S./Canada Option and its U.S./Canada Right of First Refusal vis-à-vis
NEUROBIOTEC in favour of PRESTWICK in order to allow NEUROBIOTEC to grant all rights to the
U.S./Canada Products to PRESTWICK under the Prestwick Cooperation, and Schering hereby
agrees that the execution of the Prestwick Cooperation will not contravene, and shall be
permitted under, the Technology Transfer Agreement. Accordingly, Articles 6, 7 and 10 of the
Technology Transfer Agreement shall not apply to the U.S./Canada Products. The scope of
application of Articles 6, 7 and 10 of the Technology Transfer Agreement is thus reduced to
the development, production and marketing of Products outside the U.S. and Canada and/or any
Product other than the U.S./Canada Products in the U.S. or Canada.
	 
	3.  	Royalties
	 
	3.1  	In consideration of the waiver by SCHERING of its U.S./Canada Option and its U.S./Canada
Right of First Refusal in PRESTWICK’s favour pursuant to Section 2 above, PRESTWICK shall pay
to SCHERING royalties based on Net Sales of Products in the amount of

	 	 	 	 	 
	 

	 	-
	 	[...***...]% for the Patch Product; and
	

	 	-
	 	[...***...]% for Other Sustained Release Products.

	* Confidential Treatment Requested

 

 

  7

	   	The Parties will meet and discuss in good faith if the marketing of the Products by
PRESTWICK becomes economically unviable because of significant generic competition to the
U.S./Canada Patch Product marketed by PRESTWICK.
	 
	3.2  	All royalties shall be calculated on a Product by Product basis and shall be payable on a
country-by-country basis from the date of the First Commercial Sale of a Product in the U.S.
until ten (10) years from the First Commercial Sale of such Product in the U.S., and from the
date of the First Commercial Sale of a Product in Canada until ten (10) years from the First
Commercial Sale in Canada.
	 
	3.3  	PRESTWICK shall make payments to SCHERING quarterly within sixty (60) days after the end of
each calendar quarter in which Net Sales occurred. A report summarizing the Net Sales of each
Product during the relevant quarter shall be delivered to SCHERING within thirty (30) days
following the end of each calendar quarter for which payments are due; in the event such date
is not a Business Day, then payment shall be made the next succeeding Business Day.
	 
	3.4  	Royalty payments by PRESTWICK to SCHERING under this Agreement shall be paid in U.S. Dollars
by wire transfer of immediately available funds to an account at a commercial bank such bank
account being designated by SCHERING at least ten (10) Business Days before payment is due.
Any failure by PRESTWICK to make a payment within five (5) Business Days after the date when
due, shall obligate PRESTWICK to pay to SCHERING computed interest, the interest period
commencing on the due date and ending on the payment day, at a rate per annum equal to the
Prime Rate as publicly announced by Bank of America on REUTERS_screen <USPRIME1>
[...***...], or the highest rate allowed by law, whichever is lower. The interest calculation
shall be based on the act/act computation method. The interest rate shall be adjusted whenever
there is a change in the Prime Rate quotation on REUTERS screen <USPRIME1> mentioned
above. Interest shall be compounded annually in arrears. Such interest shall be due and
payable on the tender of the underlying principal payment.
	 
	3.5  	Where Net Sales are generated in Canadian Dollars, the amount of such Net Sales expressed in
Canadian Dollars shall be converted into U.S. Dollars

	* Confidential Treatment Requested

 

 

  8

	   	based on the 10am Midpoint Rate published by the Federal Reserve Bank of New York on REUTERS
screen <FEDSPOT> on the last Business Day of the applicable calendar quarter.
	 
	3.6  	SCHERING shall pay any and all taxes levied on account of all payments it receives by
PRESTWICK under this Agreement. If laws or regulations require that taxes be withheld,
PRESTWICK will (i) deduct those taxes from all remittable payments, (ii) timely pay the taxes
to the proper taxing authority, and (iii) send proof of payment to SCHERING within thirty (30)
days of receipt of confirmation of payment from the relevant taxing authority. PRESTWICK
agrees to make all lawful and reasonable efforts to minimize such taxes to SCHERING and
SCHERING shall execute any and all instruments and take any and all such actions as are
reasonably requested by PRESTWICK in furtherance of such efforts.
	 
	3.7.1.  	PRESTWICK will maintain complete and accurate records relevant to the calculation of
revenues under this Agreement. Not more often than once each year, PRESTWICK shall make the
said records available for inspection for the period required by applicable laws, but not less
than two (2) years from creation of individual records by a certified public accountant or
chartered accountant selected by SCHERING (subject to the consent of PRESTWICK not to be
unreasonably withheld or delayed) or SCHERING’s internal accountants, for the sole purpose of
verifying for SCHERING the correctness of calculations and classifications of such revenues
under this Agreement. SCHERING shall bear its own costs related to such audit; provided that,
for any underpayments greater than five (5) percent by PRESTWICK, PRESTWICK shall pay SCHERING
the amount of underpayment, interest as provided for in Section 3.4 from the time the amount
was due and SCHERING’s out-of-pocket expenses. For any underpayments of less than five (5)
percent by PRESTWICK, PRESTWICK shall pay SCHERING the amount of underpayment. Any
overpayments by PRESTWICK will be refunded to PRESTWICK or credited to future royalties, at
PRESTWICK’s discretion. Any records or accounting information received from PRESTWICK shall be
Confidential Information for the purposes of Section 8 below. Results of any such audit shall
be provided to SCHERING and PRESTWICK and shall also constitute Confidential Information of
PRESTWICK for the purposes of Section 8 below.

 

 

  9

	3.7.2.  	If there is a dispute between the SCHERING and PRESTWICK following any audit performed
pursuant to Section 3.7.1, either Party may refer the issue (an “Audit Disagreement”) to an
independent certified public accountant or chartered accountant for resolution. In the event
an Audit Disagreement is submitted for resolution by either SCHERING or PRESTWICK, they shall
comply with the following procedures: (i) the Party submitting the Audit Disagreement for
resolution shall provide written notice to the other Party that it is invoking the procedures
of this Section 3.7.2; (ii) within thirty (30) Business Days of the giving of such notice,
SCHERING and PRESTWICK shall jointly select a recognized international accounting firm to act
as an independent expert to resolve such Audit Disagreement. (iii) The Audit Disagreement
submitted for resolution shall be described by SCHERING and PRESTWICK to the independent
expert, which description may be in written or oral form, within ten (10) Business Days of the
selection of such independent expert. (iv) The independent expert shall render a decision on
the matter as soon as practicable. (v) The decision of the independent expert shall be final
and binding unless such Audit Disagreement involves alleged fraud, breach of this Agreement or
construction or interpretation of any of the terms and conditions thereof. (vi) All fees and
expenses of the independent expert, including any third party support staff or other costs
incurred with respect to carrying out the procedures specified at the direction of the
independent expert in connection with such Audit Disagreement, shall be borne by SCHERING and
PRESTWICK in [...***...] to the [...***...] to the [...***...] by the [...***...] (e.g. SCHERING [...***...], the
independent expert [...***...], then SCHERING [...***...] and PRESTWICK pays [...***...] of the
independent expert’s costs).
	 
	4.  	Reduction of Step I Milestone
	 
	   	In consideration of the waiver by SCHERING of its U.S./Canada Option and its U.S./Canada
Right of First Refusal pursuant to Section 2 above, SCHERING and NEUROBIOTEC agree that the
Step I Milestone to be paid by SCHERING pursuant to Section 7.1 (ii) of the Technology
Transfer Agreement to retain the Option outside the U.S. and Canada shall be reduced by
[...***...] to [...***...]. In consideration thereof, the refundable part of the Step I Milestone
pursuant to Section 7.3 hyphen 1 of the Technology Transfer Agreement shall be reduced by
[...***...] to [...***...].

	* Confidential Treatment Requested

 

 

  10

	5.  	Exchange of Know-how
	 
	   	NEUROBIOTEC has made and continues to make available to PRESTWICK upon effectiveness of the
Prestwick Cooperation all of its Know-how required to accelerate the development and
approval of the U.S./Canada Products. Furthermore, NEUROBIOTEC and PRESTWICK will
continuously exchange among each other all of their Know-how concerning the Products which
they gain in connection with the development of the Products immediately upon receipt, and
NEUROBIOTEC and PRESTWICK will ensure that SCHERING has access to their Know-how to the
extent set forth in Sections 7.1 and 7.2 of the Technology Transfer Agreement. For the
avoidance of doubt, it is set forth herein that the information rights of the parties under
Section 9 below shall remain unaffected.
	 
	6.  	Access to Existing Schering Data
	 
	   	Within the framework of a due diligence to be pursued by PRESTWICK, SCHERING shall grant
PRESTWICK access to Existing Schering Data which are required or advisable for PRESTWICK to
evaluate its interest in the U.S./Canada Products. For such access by PRESTWICK, NEUROBIOTEC
shall use its allocated free access or reimburse SCHERING as set out in Article 3 of the
Technology Transfer Agreement.
	 
	7.  	Separation of Development Costs
	 
	   	NEUROBIOTEC and PRESTWICK will maintain complete and accurate records which are relevant to
the calculation of the development costs. Development costs which occur for the Patch
Product and the Other Sustained Release Products in and outside the U.S. and Canada shall be
collected and recorded in a way which allows for a clear separation of these categories of
costs. Development costs which cover development work for the Patch Product and the Other
Sustained Release Products in and outside the U.S. and Canada shall be shown separately.
This separation shall ensure, in particular, that the Development Cost which are to be
reimbursed in part by SCHERING to NEUROBIOTEC pursuant to Section 7.3 of the Technology
Transfer Agreement in connection with Section 4 hereof in the event that SCHERING exercises
its option pursuant to Section 7.2 of the Technology Transfer Agreement outside the U.S. and
Canada can be identified.

 

 

  11

	8.  	Confidentiality
	 
	8.1  	Except to the extent expressly authorized by this Agreement or otherwise agreed in writing,
the Parties agree that the receiving Party shall keep confidential and shall not publish or
otherwise disclose or use for any purpose other than as provided for in this Agreement any
Know-how and other information and materials furnished to it by another Party pursuant to this
Agreement or any Know-how developed during the course of the collaboration hereunder, except
to the extent that it can be established by the receiving Party that such Confidential
Information:

	 	(a)  	was already known to the receiving Party, other than under an obligation of
confidentiality, at the time of disclosure by the other Party; or
	 
	 	(b)  	was generally available to the public or otherwise part of the public domain at
the time of its disclosure to the receiving Party; or
	 
	 	(c)  	became generally available to the public or otherwise part of the public domain
after its disclosure and other than through any act or omission of the receiving Party
in breach of this Agreement; or
	 
	 	(d)  	was disclosed to the receiving Party, other than under an obligation of
confidentiality, by a third party who had no obligation to the disclosing Party not to
disclose such information to others; or
	 
	 	(e)  	was independently discovered or developed by the receiving Party as documented
in its corporate records.

	8.2  	Each Party may disclose Confidential Information hereunder to the extent such disclosure is
reasonably necessary in filing or prosecuting patent applications, prosecuting or defending
litigation, filing or updating any drug approval application, complying with applicable
governmental laws, rules and regulations or financing or conducting development of the
U.S./Canada Products, provided that, if a Party is required by law or regulation to make any
such disclosures of another Party’s Confidential Information it will, except where
impracticable for necessary disclosures, for example in the event of medical emergency, give
reasonable advance notice to the disclosing Party of such disclosure requirement and, except
to the extent inappropriate in the case of patent applications, will use its reasonable
efforts to secure confidential treatment of such Confidential Information required to be
disclosed.

 

 

  12

	8.3  	NEUROBIOTEC and PRESTWICK herewith consent to the disclosure of their Confidential
Information by SCHERING to any Affiliate of SCHERING provided that such Affiliate accepts the
Confidential Information on the terms of this Agreement.
	 
	8.4  	This Section 8 shall survive the termination or expiration of this Agreement.
	 
	9.  	Adverse Drug Reactions
	 
	9.1  	Each party agrees to provide to the other two parties (a) without undue delay all information
that relates to the safety of the Products to the extent that such information relates to any
serious adverse reaction thereto, including, without limitation, information relating to
serious adverse reactions that must be reported immediately to any regulatory authority, and
(b) all other information that relates to the safety of the Products.
	 
	9.2  	Within a period of two (2) months from the execution of this Agreement, and before enrolment
of the first patient in a Product-related study that is conducted sponsored or cosponsored by
PRESTWICK and before the first IND, IND equivalent, NDA or NDA equivalent for the Products is
transferred or granted to PRESTWICK, SCHERING, NEUROBIOTEC and PRESTWICK will adopt a standard
operating procedure to govern the investigation of and action to be taken with regard to
product-related adverse drug experience reports (from both clinical studies and marketing
experience), such that each of NEUROBIOTEC, PRESTWICK and SCHERING can comply with their legal
obligations worldwide. The standard operating procedure will: (i) define responsibilities for
adverse experience handling for initial, follow-up and/or periodic submission to government
agencies of significant information on the Products from pre-clinical laboratory, animal
toxicology and pharmacology studies, pre-clinical and clinical development of the Products and
(ii) include arrangements for the exchange of serious and non-serious cases including formats
and timelines, information from Periodic Safety Update Reports, Periodic Reports and answers
to safety-related queries by regulatory authorities; and (iii) be promptly amended as changes
in legal obligations require or as otherwise agreed to by SCHERING, NEUROBIOTEC and PRESTWICK.

 

 

  13

	10.  	Continuation of Technology Transfer Agreement
	 
	   	Except as amended hereby, the remaining terms and conditions of the Technology Transfer
Agreement shall remain in full force and effect as a two party agreement between NEUROBIOTEC
and SCHERING. PRESTWICK confirms that it has received a copy of the Technology Transfer
Agreement and is fully aware of its contents. NEUROBIOTEC and PRESTWICK will ensure that the
Prestwick Cooperation will not conflict in any way with the Technology Transfer Agreement
except as expressly provided for in this Agreement.
	 
	11.  	Term and Termination of the Agreement
	 
	11.1  	This Agreement shall become effective at the same time as the Prestwick Cooperation becomes
effective, and fully replace the U.S. Agreement; provided, however, that Sections 6, 8 and 11
shall be effective from the execution of the U.S. Agreement.
	 
	11.2  	Should the Prestwick Cooperation be terminated for any reason, this Agreement shall, subject
to Section 11.1 above, remain null and void or be terminated with the consequence that all
rights and obligations of the parties concerning the development and commercialization of the
U.S./Canada Products shall again fully be subject to the Technology Transfer Agreement; in
particular, Articles 6, 7 and 10 of the Technology Transfer Agreement shall again apply to the
U.S./Canada Products. Sections 8 and 11 shall, however, survive the termination of this
Agreement at all times.
	 
	12.  	Miscellaneous
	 
	12.1  	This Agreement, its rights and obligations, shall not be assignable or transferable by either
party to any third party without the prior written consent of the other parties, provided that
such consent shall not be required in any case where any party hereto assigns its rights under
this Agreement to any of its Affiliates.
	 
	12.2  	No amendment, modification or addition hereto shall be effective or binding on any party
unless set forth in writing and executed by duly authorized representatives of all parties.
This includes amendments, modifications and additions to this clause.
	 

 

 

14

	12.3  	This Agreement shall be governed by, subject to and construed in accordance with the laws
of Germany. Place of proceedings shall be Berlin.

SCHERING AKTIENGESELLSCHAFT

	 	 	 
	[ILLEGIBLE] /s/
	 	[ILLEGIBLE] /s/
	 
	 	 
	Date: 13 Jan 04

	 	Date: 13.1.04
	 
	 	 
	NEUROBIOTEC GMBH
	 	 
	 
	 	 
	[ILLEGIBLE] /s/
	 	[ILLEGIBLE] /s/
	 

	 	 
	Date: 2 Feb 04

	 	Date: 2 Feb 04
	 
	 	 
	PRESTWICK PHARMACEUTICALS INC.
	 	 
	 
	 	 
	Kathleen
Clarence-Smith /s/
	 	 
	 

	 	 
	Date: Feb 3, 2004

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