Document:

exv10w7

 

Exhibit 10.7

Executive Employment Agreement

     This
Executive Employment Agreement (“Agreement”) is entered into as of February 26, 2003 (the
“Effective Date”), by and between Prestwick Pharmaceuticals, Inc., a Delaware corporation (the
“Company”) and Kathleen Clarence-Smith, M.D.,
Ph.D. (the “Executive”).

     Whereas, the Company desires to employ the Executive pursuant this Employment
Agreement as of the Employment Date, defined below, and the Executive desires such employment with
the Company on the terms and conditions set forth below.

     Now Therefore, in consideration of the foregoing recital and the respective covenants
and agreements of the parties contained in this document, the Company and the Executive agree as
follows:

     1. Employment and Duties. During the Employment Period (as defined in paragraph 2 below), the
Executive shall serve as President of the Company until the Company hires a new Chief Executive
Officer or President, which the Executive acknowledges is the intention of the Company, at which
time the Executive shall become the Chief Scientific Officer of the Company (in charge of research
and development). The duties, authority and responsibilities of the Executive shall be commensurate
with the duties, authority and responsibilities customarily accorded an executive officer with such
titles and shall include such duties and responsibilities as may from time to time be reasonably
assigned to the Executive by the Board of Directors (the “Board”) and the Chief Executive Officer
or President of the Company, as applicable. The Executive, to the best of her ability, shall
perform faithfully and competently such services and duties as are customarily incident to such
employment.

     2. Employment Period.

          (a) Basic Rule. The term of this Agreement shall begin on January 1, 2003 (“Employment
Date”), and shall continue thereafter until the date when Executive’s employment terminates
pursuant to Section 2(b) below (the “Employment Period”). Executive’s employment relationship is
at-will; accordingly Executive may terminate her employment with or without Good Reason, and the
Company may terminate her employment with or without Cause (all as provided in Section 2(b) below).

          (b) Termination. Subject to the provisions of Section 10 below:

               (i) Without Cause. The Employment Period shall be terminated immediately if the Company
terminates Executive’s employment without Cause (as defined in Section 2(b)(iii) below) or if
Executive resigns her employment without Good Reason (as defined in Section 2(b)(iv) below).

               (ii) Death or Disability. The Employment Period shall be terminated immediately upon the
Executive’s death or at such time as a physical or mental disability, the existence of which is
confirmed by a licensed health provider, causes Executive to be unable to perform the essential
duties of her position hereunder with or without reasonable accommodation for a period of six (6)
consecutive months.

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               (iii) Cause. The Employment Period shall be terminated immediately (except as otherwise
provided below) if the Company terminates Executive’s employment for Cause and delivers to
Executive a written Notice specifying with particularity the facts and circumstances constituting
Cause for termination of her employment. “Cause” is defined for purposes of this Agreement as any
of the following: (A) a material breach by the Executive of this Agreement or any agreement
entered into between the Executive and the Company that materially impairs the Company’s interests
therein in such a manner as to cause material loss, damage or injury to the Company; (B) gross
negligence, serious misconduct or material failure by Executive in connection with the discharge of
the duties of her position in such a manner as to cause material loss, damage or injury to the
Company; (C) Executive’s engagement in any activity that constitutes a material conflict of
interest with the Company; or (D) Executive’s conviction of, a guilty plea with respect to, or a
plea of nolo contendere to, a charge that Executive has committed a felony under the laws of the
United States or of any state or a crime involving moral turpitude, including, but not limited to,
fraud, theft, embezzlement or any crime that results in or is intended to result in personal
enrichment at the expense of the Company. With regard to for “Cause” termination pursuant to
subsection (C), above, the Employment Period may be terminated by the Company for Cause, no earlier
than thirty (30) days after providing Executive a written Notice specifying with particularity the
facts and circumstances constituting Cause for termination of her employment unless Executive,
during such thirty (30) day period, remedies the breach or violation specified in the notice to the
reasonable, good faith satisfaction of the Board.

               (iv) Good Reason. The Employment Period may be terminated by Executive for Good Reason, no
earlier than thirty (30) days after providing the Company a written Notice specifying with
particularity the facts and circumstances constituting Good Reason for termination of her
employment, unless the Company, during such thirty (30) day period, remedies the breach or
violation specified in the notice to the reasonable, good faith satisfaction of Executive. “Good
Reason” is defined for purposes of this Agreement as any of the following: (A) a material breach
of this Agreement by the Company; (B) a material diminution in the duties or responsibilities of
Executive as contemplated by Section 1 above without her written consent; provided, however, that
no diminution of duties or responsibilities shall be deemed to occur solely because the Company
becomes a subsidiary, division or unit of another corporation or entity as long as Executive’s
position, authorities, duties and/or responsibilities within that subsidiary, division or unit
remain materially unchanged, or because there has been a change in the reporting hierarchy incident
thereto involving Executive; (C) the involuntary relocation of Executive’s place of employment
outside of a 60 mile radius from the Company’s offices in the Washington, D.C. area; or (D) a
reduction in Executive’s base salary without her written consent (other than a reduction in base
salary that also is applicable to other executive’s of the Company).

     3. Base Salary. For services rendered by the Executive pursuant to this Agreement, including
services as a member of the Board, Executive shall be entitled to receive a base salary (“Base
Salary”) at an annual rate of $262,500, as of the Employment Date. Executive’s Base Salary shall
be reviewed no less than annually by the Board and may be increased, but in no event shall decrease
without Executive’s consent, during the Employment Period; provided, however, that Executive’s Base
Salary may be reduced in the event the base salary of the other executive’s of the Company incur a
similar reduction. Executive’s Base Salary, less applicable

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deductions, shall be paid in periodic installments in accordance with the Company’s regular
payroll practices (which as of the date hereof is bi-monthly).

     4. Stock Option. On January 13, 2003, the Company granted Executive under the Prestwick
Pharmaceuticals, Inc. 2003 Equity Incentive Plan (“the Plan”) a non-qualified stock option to
purchase One Million Two Hundred Fifty Thousand (1,250,000) shares of the Company’s common stock at
an exercise price equal to $0.037 per share (the “Option”). The Option is subject to the terms and
conditions of the Plan and Executive’s grant agreement, which will include a three-year vesting
schedule under which, during Executive’s continuous service to the Company (as defined in the
Plan), twenty-five percent (25%) of the Option shares will vest on the one-year anniversary of the
Employment Date and the remaining Option shares will vest in equal monthly installments over the
subsequent two (2) years; provided, however, that the vesting for the Option shall be accelerated
as follows: in the event (a) Executive terminates her employment for Good Reason or the Company
(or a successor following a Change in Control (as defined in the Plan) occurring on or before
January 13, 2005) terminates the Executive without Cause (so long as Executive executes a general
release in favor of the Company on or before the effective date of termination), or (b) there
occurs a Change of Control (as defined in the Plan) after January 13, 2005, then the entire
unvested portion of the Option will immediately accelerate and be fully vested. Executive
acknowledges that except as provided in Sections 4 and 5 of this Agreement, there are no further
commitments on behalf of the Company to grant to Executive any additional option grants. The Board
may consider granting additional stock options to Executive at its sole discretion.

     5. Bonus. In addition to the Base Salary and the Option set forth above, in the event that
Executive meets certain milestones set forth on Exhibit A to this Agreement (as determined by the
Company), Executive shall be granted stock options to purchase up to One Million Two Hundred Fifty
Thousand (1,250,000) shares of Common Stock (as set forth on Exhibit A), which options shall be
fully vested and immediately exercisable on the date of grant and shall have an exercise price
equal to $0.037 per share. In addition, the Board may, in its sole discretion, grant Executive a
cash bonus at any time (“Bonus”).

     6. Indemnification. As an employee, officer and agent of the Company, Executive shall be
indemnified by the Company to the fullest extent permitted by Delaware law. To implement this
provision, the Company shall procure directors and officers liability insurance as soon as
practicable after the Effective Date of this Agreement and shall name Executive as an insured under
its policy.

     7. Expenses. The Executive, in the performance of her duties and responsibilities under this
Agreement, shall be entitled to reimbursement by the Company for all reasonable, ordinary and
necessary travel, entertainment, and other expenses, incurred by the Executive during the
Employment Period in accordance with the policies and procedures established by the Company for its
senior executive officers; provided, however, that Executive shall properly account for such
expenses in accordance with the Company’s policies and procedures, and shall timely submit accurate
and complete reports of such expenses.

     8. Other Benefits. During the Employment Period, the Executive shall be entitled to
participate in and have the benefits of all present and future vacation, holiday, paid leave,

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unpaid leave, life, accident, disability, dental, vision and health plans, pension,
profit-sharing and savings plans and all other plans and benefits which the Company now or in the
future from time to time makes available to employees.

     9. Vacations and Holidays. Executive shall be entitled to accrue such annual vacation time
with full pay as the Company may provide in its standard policies and practices for any other
management executives; provided, however, that in any event Executive shall be entitled to a
minimum of three (3) weeks’ annual paid vacation time.

     10. Termination Payments. Subject to the provisions of Section 2, above:

          (a) Termination by the Company With Cause or by Executive Without Good Reason. In the event
that the Company terminates Executive’s employment with Cause, or Executive terminates her
employment without Good Reason, the Company shall pay Executive, no later than the effective date
of termination, a lump sum equal to her accrued and unpaid Base Salary through the data of
termination and all accrued but unused vacation pay.

          (b) Termination by the Company Without Cause or by Executive With Good Reason. In the event
that the Company terminates Executive’s employment without Cause, or Executive terminates her
employment with Good Reason, then, subject to Executive’s continued compliance with the terms of
the Company’s Proprietary Information, Inventions, Non-Solicitation and Non-Competition Agreement,
Executive shall receive the following as her sole severance benefits (collectively, the “Severance
Benefits”): (i) Executive will continue to receive payments of her base salary at the same rate in
effect as of the termination effective date, paid on the Company’s standard payroll dates (or in
lump sum, at the Company’s discretion) for the first six months of the Severance Period (as defined
below), subject to standard payroll deductions and withholdings; (ii) Executive will receive a lump
sum payment equal to fifty-percent (50%) of her annual base salary in effect as of the termination
effective date, paid on the last day of the Severance Period, subject to standard payroll
deductions and withholdings; and (iii) if Executive timely elects to continue Executive’s
Company-provided group health insurance coverage pursuant to the federal COBRA law, through the end
of the Severance Period or until such time as Executive qualifies for health insurance benefits
through a new employer, whichever occurs first, the Company will reimburse Executive for the cost
of such COBRA premiums to continue health insurance coverage at the same level of coverage for
Executive and Executive’s dependents (if applicable) in effect as of the termination date. As a
condition of and prior to the receipt of all or any of the Severance Benefits, Executive shall
provide the Company with a general release of known and unknown claims, in a form acceptable to the
Company and the Executive. Executive shall notify the Company in writing immediately upon
qualifying for health insurance benefits through a new employer. For purposes of this Agreement,
the “Severance Period” is defined as twelve (12) months from the effective termination date.

          (c) Termination by Death or Disability.

               (i) Death. In the event of the death of Executive during the Employment Period the Company,
within ten (10) days of receiving notice of such death, shall, in addition to paying Executive’s
estate all Base Salary due or accrued as of the date of her

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death, also shall pay all accrued vacation pay and a pro-rata portion of her cash Bonus, if
applicable.

               (ii) Disability. In the event of Executive’s physical or mental disability (as defined in
Section 2(b)(ii) above) during the Employment Period, the Executive shall receive such benefits
provided under the Company’s disability insurance plan then in effect.

     11. Other Activities. The Executive shall devote substantially all of her working time and
efforts to the business and affairs of the Company, and to the diligent and faithful performance of
the duties and responsibilities duly assigned to her pursuant to this Agreement, except for
vacations, holidays, sickness, and those other activities as described in Section 1 herein.
Executive may engage in civic and not-for-profit activities so long as such activities do not
materially interfere with the performance of her duties hereunder. Executive, at the Employment
Date, serves on the Boards of Directors of Prestwick Companies, Inc., Prestwick Scientific Capital,
Inc. and Prestwick Chemical, Inc., and the Company hereby consents to her continued service in
these capacities, provided that it does not unreasonably interfere with her ability to discharge
her duties to the Company as required hereunder.

     12. Confidential and Proprietary Information. During the Employment Period and thereafter,
the Executive shall not, without the prior written consent of the Board, disclose or use for any
purpose (except in the course of her employment under this Agreement and in furtherance of the
business of the Company) any confidential information, trade secrets or proprietary information or
materials (“Confidential Information”) of the Company. As an express condition of the Executive’s
employment with the Company, the Executive agrees to execute the Company’s Proprietary Information,
Inventions, Non-Solicitation and Non-Competition Agreement attached hereto as Exhibit B.

     13. Absence of Conflict. Executive represents and warrants that her employment by the
Company, and the performance of her obligations as described herein, do not conflict with, and are
not constrained by, any prior agreement or relationship with any party, and that any limitations on
the Executive’s ability to perform as provided hereunder and as contemplated by the parties have
been disclosed in writing to the Company to the extent that they may exist. If, in spite of the
previous sentence, Executive should find that confidential or proprietary information belonging to
any third party might be usable in connection with the Company’s business, she will not disclose it
to the Company or use it on behalf of the Company except as expressly authorized by such third
party; but during her employment by the Company, Executive will use in the performance of her
duties only information which is generally known and used by persons with training and experience
comparable to her own, common knowledge in the industry, otherwise legally in the public domain, or
which is obtained or developed by the Company or by Executive in the course of her work for the
Company.

     14. Assignment. This Agreement, and all rights and obligations under this Agreement, shall be
binding upon and inure to the benefit of and be enforceable by the parties hereto and their
respective heirs, successors, executors, administrators and assigns, provided, however, that
Executive may not delegate any of her duties under this Agreement.

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     15. Arbitration. Dispute Resolution. To ensure rapid and economical resolution of any
disputes which may arise under this Agreement, Executive and the Company agree that any and all
disputes, claims, or controversies of any nature whatsoever arising from or regarding Executive’s
employment or the interpretation, performance, enforcement, or breach of this Agreement shall be
resolved, to the fullest extent allowed by law, by confidential, final, and binding arbitration
conducted by Judicial Arbitration and Mediation Services, Inc. (“JAMS”) in Washington, D.C. under
the then-existing JAMS rules, using a single arbitrator. The parties acknowledge that by agreeing
to this arbitration procedure, they waive the right to resolve any such dispute through a trial by
jury, judge or administrative proceeding. The arbitration shall be completed within six (6) months
from the date the demand for arbitration is filed with JAMS, provided that the arbitrator may
extend such date for good reason as determined in her sole discretion. The arbitrator shall: (a)
have the authority to compel adequate discovery for the resolution of the dispute and to award such
relief as would otherwise be permitted by law; and (b) issue a written arbitration decision
including the arbitrator’s essential findings and conclusions and a statement of the award. The
Company shall pay all JAMS’ arbitration fees. Nothing in this Agreement is intended to prevent
either Executive or the Company from obtaining injunctive relief in court to prevent irreparable
harm pending the conclusion of any such arbitration. The arbitrator, and not a court, shall be
authorized to determine whether the provisions of this paragraph apply to a dispute, controversy,
or claim sought to be resolved in accordance with these arbitration procedures. Notwithstanding
the foregoing, neither party shall be permitted to initiate a demand for arbitration until it has
participated in a non-binding mediation conducted by JAMS, after providing notice to the other
party. Both parties shall participate in such a mediation within forty-five (45) days of delivery
of such notice. If the parties cannot mutually agree upon a mediator within ten (10) days of such
notice, then a mediator shall be designated by JAMS.

     16. Notices. For purposes of this Agreement, notices and other communications provided for in
this Agreement (“Notice”), shall be in writing and shall be delivered personally or sent by United
States certified mail, return receipt requested, postage prepaid, addressed to each party’s last
known address, or to such other address or to the attention of such other persons as the recipient
party has previously indicated to the other party in writing in accordance with this paragraph.
Such Notice shall be effective upon delivery (or refusal of delivery) or three days after it has
been mailed as provided above, whichever occurs first.

     17. Entire Agreement. This Agreement, Exhibits A and B, the Plan and the Option’s grant
agreement represent the entire agreement and understanding between the parties as to the subject
matter hereof, and supersede all prior or contemporaneous agreements, representations,
negotiations, and understandings of the parties, whether written or oral. No waiver, alteration,
or modification of any of the provisions of this Agreement shall be binding unless in writing and
signed by Executive and by the Chairman of the Board.

     18. Waiver. Failure or delay on the part of either party hereto to enforce any right, power
or privilege hereunder shall not be deemed to constitute a waiver thereof. Additionally, a waiver
by either party of a breach of any promise herein by the other party shall not operate as, or be
construed to constitute, a waiver of any subsequent breach by such other party.

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     19. Severability. Whenever possible, each provision of this Agreement shall be interpreted in
such manner as to be effective and valid under applicable law. However, if any provision of this
Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law
or rule in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any
other provision or jurisdiction, and such invalid, illegal, or unenforceable provision will be
reformed, construed and enforced in such jurisdiction so as to render it valid, legal, and
enforceable consistent with the intent of the parties insofar as possible.

     20. Headings. The headings of the paragraphs contained in the Agreement are for reference
purposes only, and shall not in any way affect the meaning or interpretation of any provision of
this Agreement.

     21. Applicable Law. This Agreement shall be governed by and construed in accordance with the
internal substantive laws, and not the choice of law rules, of the District of Columbia.

     22. Counterparts. This Agreement may be executed in one or more counterparts, none of which
need contain the signature of more than one party hereto, and each of which shall be deemed to be
an original, and all of which together shall constitute a single agreement. Facsimile signatures
shall be deemed the equivalent of original signatures.

[Signature Page Follows]

 7.

 

     In Witness Whereof, each of the parties has executed this Agreement, in the case of
the Company by its duly authorized officer, as of the day and year set forth below.

	 	 	 	 	 
	Dated: 2/26, 2003
	 	 	 	 
	 
	 	 	 	 
	 	 	 
	 	 	Kathleen Clarence-Smith, M.D., Ph.D.

Executive
	 
	 	 	 	 
	Dated: 2/26, 2003	 	Prestwick Pharmaceuticals, Inc.
	 
	 	 	 	 
	

	 	By:	 	 
	

	 	 	 	 
	

	 	 	 	   Edgar G. Engleman,
   Chairman
of the Board of Directors

 8.

 

Exhibit A

Bonus Options

1) Upon the achievement of the License Milestone (as defined in that Series A Preferred Stock and
Warrant Purchase Agreement dated as of February 26, 2003), Executive shall be granted a stock
option to purchase 750,000 shares of the Company’s Common Stock.

2) If the Company makes its final submission for its NDA filing for PL-047 (acceptable to the FDA)
prior to September 30, 2003, Executive shall be granted a stock option to purchase 500,000 shares
of the Company’s Common Stock;

or

     If the Company makes its final submission for its NDA filing for PL-047 (acceptable to the
FDA) between September 30, 2003 and December 31, 2003, Executive shall be granted a stock option to
purchase 250,000 shares of the Company’s Common Stock.

 9.

 

Prestwick Pharmaceuticals, Inc.

1825 K Street, N. W., Suite 1475

Washington, D.C. 20005

August 31, 2004

Dr. Kathleen Clarence Smith

Prestwick Pharmaceuticals, Inc.

1825 K Street, N. W., Suite 1475

Washington, D.C. 20005

Dear Kitty:

This is a follow up letter to memorialize the understanding and consensus that was reached at the
Board of Directors meeting of Prestwick Pharmaceuticals, Inc. on July 29, 2004. My own sense is
that this was a productive discussion and that we have settled on a framework for managing the
affairs of the business over the near term. Please let me know if you have any comments on the
following elements of that framework.

1. Executive Committee. The Board of Directors has formed an Executive Committee comprised of five
members: you, Bob Flanagan, Ed Engleman, Jim Healy and me. In addition, as you know, I have
agreed to serve as the Executive Chairman of the Company. Acting principally through me in my role
as Executive Chairman, the Executive Committee will interact with and oversee management on a
weekly basis and in between regularly scheduled meetings of the Board of Directors. I am expecting
to set up a weekly meeting or conference call with you, David Cory, Chris O’Brien and John Nester
to discuss operational, finance, personnel and other matters. The Executive Committee will also
meet with this group from time to time as may be recommended by me as Executive Chairman. In
addition, we will also discuss the status of the proposed Series B financing and interaction with
prospective investors.

2. Acting Chief Executive Officer. You have been appointed to serve as acting Chief Executive
Officer of the Company and Bob Flanagan has stepped down from this role. You will report to me as
the Executive Chairman. Subject to meeting agreed upon performance criteria and objectives, the
plan will be for you to serve in this role for the next six (6) month period effective as of August
1, 2004. The initial performance criteria and objectives that we have mutually agreed to with you
are set forth on Exhibit A to this letter. At the end of this six (6) month period, the Board of
Directors will re-assess this arrangement with you. As you know, your Executive Employment
Agreement, dated February 26, 2003, permits certain changes in duties and positions with the
Company. This letter is designed to provide a general understanding as to your role in the Company
over this period of time and nothing in this letter is intended to amend or modify your

 

 

Executive Employment Agreement, or to confer any right to fill a specific executive position or
perform certain duties for the Company.

3. Appointment of President. David Cory has been appointed to serve as President of the Company,
in addition to serving in his role as Chief Commercial Officer. He will report to both you, as
Acting Chief Executive Officer, and to the newly-formed Executive Committee and me as the
newly-designated Executive Chairman.

Kitty, if this is consistent with your understanding of the consensus that was reached among the
Board of Directors and you at our July 29, 2004 meeting, please acknowledge this by executing this
letter below.

	 	 	 	 	 
	 	 	Sincerely,
	 
	 	 	 	 
	 	 	Prestwick Pharmaceuticals, Inc.
	 
	 	 	 	 
	

	 	By:	 	 
	

	 	 	 	 
	

	 	 	 	   Melvin D. Booth
   Executive
Chairman
	 
	 	 	 	 
	Acknowledged and Agreed:
	 	 	 	 
	 
	 	 	 	 
	Dr. Kathleen Clarence-Smith
	 	 	 	 

 

 

Exhibit A

Dr. Kathleen Clarence-Smith, Acting Chief Executive Officer

Performance Criteria and Milestones

August 1, 2004 – January 31, 2005

1. Relationship and Interaction with the Food and Drug Administration. One of your primary duties
will be to interact with the Food and Drug Administration, particularly as it relates to
tetrabenazine approval and the filing of the NDA.

2. Other Tetrabenazine-related matters. Another primary duty of yours will be to assist in filling
out the sales and marketing team and preparing for the launch of tetrabenazine and to help with the
ramp up of sales of tetrabenazine in Canada.

3. Raising Additional Capital. One of your other primary duties will be to assist the Company
raising the proposed Series B financing and to support this effort through your interaction with
prospective investors. Unless the Board of Directors elects to change course and not raise outside
capital, the Company needs to raise significant private equity to meet its business objectives with
respect to tetrabenazine specifically and with respect to other drugs in the pipeline generally.
Accordingly, you will be expected to diligently and earnestly support the capital raising efforts
of the Company and to work closely with the Executive Committee, the Board of Directors and other
members of the management team to fulfill this objective.

4. Interacting with the Executive Committee and Management Team. As indicated above, you will be
expected to work closely with the Chairman, the Executive Committee and other members of the
management team to meet the Company’s near-term and long term objectives. Your performance will be
judged in part on your ability to interact and work productively and cooperatively with the
Chairman and the members of the Executive Committee and management team.

5. Javitt License. You will be expected to assist with the negotiation of the Javitt patent
license.

6. Lisuride. You will be expected to move forward the clinical and regulatory development of the
lisuride subcutaneous pump and the lisuride patch, and to assist with negotiations to obtain
additional Schering intellectual property associated with lisuride.

7. Slow-Release L-Dopa. You will be expected to assist with the decision as to whether the Company
will move forward with the slow-release L-Dopa and, if the decision is to move forward, to advance
its clinical development.exv10w9

 

Exhibit 10.9

***Text Omitted and Filed Separately

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

(1) CAMBRIDGE LABORATORIES LIMITED

and

(2) PRESTWICK PHARMACEUTICALS, INC.,

____________________________________________

AGREEMENT FOR CANADIAN RIGHTS

TO NITOMAN

____________________________________________

17 Hanover Square London W1S 1HU

Tel: 020 7917 8500 Fax: 020 7917 8555

 

 

THIS AGREEMENT is made the 26th day of April 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:

	3.  	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.
	 
	4.  	Cambridge wishes to appoint Prestwick to promote, sell and distribute the Product in the
Territory and Prestwick has agreed to accept such appointment on the terms set forth herein.

THE PARTIES AGREE as follows:

	1.  	DEFINITIONS and INTERPRETATION
	 
	1.1  	In this Agreement unless the context requires otherwise the words and phrases set forth in
Schedule 1 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.

 

	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 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
or the Active Substance nor has any right to have such manufactured other than by Cambridge or
Cambridge’s nominated manufacturer. Prestwick shall not manufacture the Product or the Active
Substance or cause, enable or assist others to do so.

	2.3  	The previous agreement between Cambridge and [...***...] for distribution of the Product in the
Territory has been terminated and [...***...] has informed Cambridge that [...***...]. This
notwithstanding [...***...] has advised Prestwick that there are [...***...] in the Territory that
[...***...] can be reasonably projected [...***...]. Following the Commencement Date the parties shall
[...***...] in order to endeavour to determine [...***...]. Following such review the parties shall
determine whether a review of the [...***...] of this Agreement is in order. Any disagreement
between the parties on this issue shall be referred through the Dispute Escalation Procedure
set forth in clause 19. Furthermore in the event of any claim made by a third party in respect
of Product distributed by [...***...], Cambridge shall address such claim pursuant to its
agreement with [...***...] and will keep Prestwick indemnified against any actions, proceedings,
costs, claims, damages, demands, expenses, losses and liabilities, including attorney’s fees,
incurred by Prestwick as a result of any such claim.

	2.4  	Prestwick shall not appoint any sub-distributor or otherwise sub-license any rights granted
hereunder without the prior written approval of Cambridge to both the identity of the
sub-distributor or sub-licensee and the terms of the agreement such terms to be no less
onerous than those set forth herein. Cambridge approval 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 arising from any act or omission of any sub-distributor or
sub-licensee.

*CONFIDENTIAL TREATMENT REQUESTED

3.

 

	2.5  	Cambridge shall ensure that no sales of the Product are made through Cambridge’s web site to
any person requiring delivery to an address in the Territory.

	2.6  	Neither party shall have the right to use the others Intellectual Property or, in the case of
Prestwick, Cambridge’s Restricted Information, other than as expressly authorised hereunder
and subject to the restrictions on such use set forth in the terms of this Agreement.

	2.7  	Prestwick shall not copy or reproduce the Active Substance or the Product for any reason or
cause, assist or enable others to do so.

	2.8  	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.
	 
	2.9  	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, 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 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 take up the opportunity afforded to it under clause 4.2.

*CONFIDENTIAL TREATMENT REQUESTED

4.

 

	2.10  	Within [...***...] days 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.
	 
	2.11  	If, at any time up to first commercial sale of the first Product commercialized under the US
Agreement following the grant of the Marketing Authorisation for the Product in the United
States, 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.
	 
	2.12  	For the purposes of clause 2.12 the phrase “in a timely manner” shall mean that Prestwick is
performing in all material respects any of its obligations hereunder necessary for commercial
distribution of the Product following [...***...]. 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 2.11 or to terminate this Agreement.
	 
	3.  	MARKETING AUTHORISATION
	 
	3.1  	A Marketing Authorisation for the Territory already exists and is owned by [...***...]. If The
Regulatory Authority requires the Marketing Authorisation to be in the name of Prestwick
Cambridge shall procure that [...***...] assigns the Marketing Authorisation to Prestwick. If
Prestwick presents evidence that it would be more advantageous to both parties if the
Marketing Authorisation were held by Prestwick, Cambridge shall present such evidence to
[...***...] and use all reasonable endeavours to procure that [...***...] assigns the Marketing
Authorisation to Prestwick. Until the date of transfer of the Marketing Authorisation from
[...***...] Limited to Prestwick Cambridge shall procure that the Marketing Authorisation is
renewed and maintained [...***...] save that Cambridge shall procure that any changes to the
Marketing Authorisation required by the Regulatory Authority during this time to permit
Prestwick to sell the Product in the Territory are [...***...].

*CONFIDENTIAL TREATMENT REQUESTED

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	3.2  	Following the date of transfer of the Marketing Authorisation from [...***...] Limited to
Prestwick it shall be held, renewed and maintained at all times by Prestwick [...***...], subject
to any right of Cambridge to require surrender or transfer of such in accordance with this
Agreement or any requirement of the Regulatory Authority. Prestwick acknowledges that the
beneficial interest in all Marketing Authorisations is and shall be with Cambridge. Upon
termination or expiration of this Agreement, Prestwick shall, [...***...], do all things necessary
to transfer all Marketing Authorisations 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 [...***...].
The obligations set forth in this clause shall survive termination or expiration of this
Agreement.
	 
	3.3  	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  	In the event that Cambridge wishes to commercialize in the Territory any [...***...] Development
it shall offer to Prestwick the rights to have such [...***...] Development included in the scope
of this Agreement.
	 
	4.2  	In the event that Cambridge wishes to commercialise in the Territory any [...***...] Development
it shall offer Prestwick the opportunity to acquire rights to sell and distribute such a
product on the same terms as set forth in clause 6.2 of the US Agreement.
	 
	4.3  	Save as expressly agreed to the contrary in writing under this Agreement or the US Agreement,
Prestwick shall not undertake, directly or indirectly any [...***...] Developments or [...***...]
Developments in the Territory. Nothing herein shall prejudice the obligations and rights of
the parties regarding [...***...] Developments or [...***...] Developments set forth in the US
Agreement. In the event that it is agreed in writing that Prestwick shall undertake [...***...]
Developments in the Territory the provisions of the US Agreement concerning [...***...]
Developments shall apply mutatis mutandis.

*CONFIDENTIAL TREATMENT REQUESTED

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	5.  	THE PRODUCT
	 
	5.1  	Save as provided in clause 7.1 all Product supplied by Cambridge to Prestwick shall comply
with the relevant Specification set forth in the Marketing Authorisation.
	 
	5.2  	All Product supplied by Cambridge to Prestwick shall have been manufactured in accordance
with GMP and other relevant manufacturing standards in the Territory and the provisions of the
Marketing Authorisation. Save as provided in clause 7.1, unless otherwise required by the
Regulatory Authority the packaging for the Product shall consist of [...***...] and shall
otherwise comply with the Marketing Authorisation.
	 
	5.3  	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 Marketing Authorisation.
	 
	5.4  	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 [...***...] Limited and is thus ultimately
beyond the control of Cambridge.
	 
	5.5  	The parties shall discuss periodically during the term of this Agreement, but not less that
once in each calendar quarter, supply issues including, specifically (i) [...***...] 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 [...***...], and (v) [...***...] strategies and planning.

*CONFIDENTIAL TREATMENT REQUESTED

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	6.  	COMMERCIALIZATION OF THE PRODUCT
	 
	6.1  	Prestwick will sell the Product in the Territory upon the terms set out below.
	 
	6.2  	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.
	 
	6.3  	Save as is permitted under the US Agreement, 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.
	 
	6.4  	It is expressly agreed and understood that any enquiries Prestwick receives in relation to
the Product from the United States must be dealt with under the terms of the US Agreement and
Prestwick is not to sell Canadian Product in the United States. Save as set forth above
Prestwick shall not supply the Product to any customer in any country that is:

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

	6.5  	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.
	 
	6.6  	Prestwick shall forward to Cambridge, within [...***...], all enquiries received by Prestwick
regarding the Product from persons outside the Territory unless that enquiry falls within the
territory of the US Agreement in which case Prestwick may deal with it under the terms of the
US Agreement. Similarly Cambridge shall forward to Prestwick, [...***...], all enquiries received
by Cambridge regarding the Product from persons in the Territory.
	 
	6.7  	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.
	 
	6.8  	Prestwick shall comply with all laws and regulations in the Territory, all requirements of
the Regulatory Authority in the Territory and, when distributing the Product, all restrictions
set forth

*CONFIDENTIAL TREATMENT REQUESTED

8.

 

	   	in any Marketing Authorisation. Without in any way limiting the generality of the foregoing,
under no circumstance shall Prestwick, [...***...].
	 
	6.9  	The Marketing Plan, the Minimum Sales Quantities for [...***...], Minimum Order Quantities for
[...***...] and the Minimum Marketing Activities for the Territory are appended to this Agreement
as Schedules 2, 3, 4 and 5. 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. No later than [...***...] the parties
shall meet and agree upon the Minimum Order Quantities and/or Minimum Sales Quantities for the
[...***...] of this Agreement. In the event that the parties have not agreed upon the Minimum
Order Quantities and/or Minimum Sales Quantities for the [...***...] of this Agreement [...***...] the
matter shall be referred to the Dispute Escalation procedure set forth in clause 19. Either
party may, if it so desires, [...***...] request a review of the Marketing Plan, the Minimum
Marketing Activities, the Minimum Order Quantities and the Minimum Sales Quantities save that
no review of the Minimum Order Quantities or Minimum Sales Quantities may request a variation
[...***...]. Any dispute between the parties regarding any changes to the Marketing Plan, the
Minimum Marketing Activities, the Minimum Order Quantities or the Minimum Sales Quantities
shall be referred to Dispute Escalation procedure set forth in clause 19.

	6.10  	On the Commencement Date 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 the Marketing Plans and the Minimum Marketing Activities.

	6.11  	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.

	6.12  	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. Prestwick shall also, at its cost, perform post-market stability analysis in respect
of the Product.

*CONFIDENTIAL TREATMENT REQUESTED

9.

 

	6.13  	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.
	 
	6.14  	In connection with the promotion and marketing of the Product Prestwick shall:

	 	6.14.1  	store the Product in accordance with the provisions pertaining to storage in the
Marketing Authorisation;
	 
	 	6.14.2  	not misuse, tamper with or in any way alter or modify the Product,
	 
	 	6.14.3  	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 [...***...];.
	 
	 	6.14.4  	not use, in relation to the marketing, distribution and sale of the Product, [...***...];
	 
	 	6.14.5  	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 Regulatory Authority 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
[...***...] in such form as agreed by the parties;
	 
	 	6.14.6  	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 to use any such
[...***...];
	 
	 	6.14.7  	observe and comply with the Adverse Events Reporting procedure to be agreed between
the parties and the requirements of any Regulatory Authority regarding Adverse Events
Reporting;

*CONFIDENTIAL TREATMENT REQUESTED

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	 	6.14.8  	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 6 (subject to
appropriate consultation with Cambridge) and the requirements of the Regulatory
Authority regarding recall of products.

	6.15  	Prestwick shall not:

	 	6.15.1  	pledge the credit of Cambridge in any way;
	 
	 	6.15.2  	[...***...].

	7.  	FORECASTS AND ORDERS
	 
	7.1  	On the Commencement Date Prestwick shall place with Cambridge a written irrevocable order for
[...***...]. The parties agree that, because Prestwick, at the time of placing that order, will
not have [...***...] and will not have [...***...] from the [...***...] for the [...***...] of the [...***...] in
accordance with the [...***...] save in respect of [...***...]. The [...***...] will be transported, in
export pack, to the contract manufacture where they will be held pending the grant of a Drug
Establishment License to Prestwick and approval from the Regulatory Authority to the
packaging. Once the Regulatory Authority has granted approval to the packaging Cambridge shall
procure that the [...***...] is packaged in accordance with approved packaging, [...***...], and shall
thereafter deliver the Product [...***...]. Title to those Units shall pass at the time of payment
of the invoice in respect of these Units pursuant to clause 8.7. Risk in respect of those
Units shall remain with Cambridge until delivery to Prestwick.
	 
	7.2  	To enable Cambridge to plan the manufacture of the Product and the Active Substance Prestwick
shall, no later than [...***...] after the Commencement Date, 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 the
[...***...]. The [...***...] of each updated twelve (12) month forecast shall constitute an order,
binding on Prestwick, for the quantity of the Product for each of those [...***...]. The quantity
set forth in the binding part of the forecast may be altered [...***...] during the [...***...] in
which it is binding by Prestwick within a range of [...***...] and may not otherwise be altered.
	 
	7.3  	Prestwick shall ensure that, at the time of submitting the updated forecasts pursuant to
clause 7.2, it has submitted to Cambridge written irrevocable 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

*CONFIDENTIAL TREATMENT REQUESTED

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	   	quantity in the binding part of any forecast in accordance with clause 7.2 it must submit an
amended order to reflect that. Save for the initial order placed pursuant to clause 7.1,
each 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.
	 
	7.4  	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 7.1, 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.
	 
	7.5  	Cambridge’s obligation to supply Product in accordance with clause 9.1 shall apply in respect
of orders placed in accordance with the clauses 7.2 to 7.3. 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 [...***...].
	 
	7.6  	If Cambridge has any reasonable concerns with the quantities forecast it may refer the matter
through the Dispute Escalation Procedure set forth in clause 19.
	 
	7.7  	Prestwick shall not, in each year of this Agreement, order less than the Minimum Order
Quantity for that year nor sell less than the Minimum Sales Quantity for that year. 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 5 and 15 hereof equal to the Minimum Order Quantity for that
year.
	 
	7.8  	Cambridge shall be entitled to terminate this Agreement in accordance with the provisions of
clause 20 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 Quantities or sell the Minimum Sales Quantities is because of a failure of
Cambridge to manufacture or supply quantities of the Product complying with the warranties set
forth in clauses 5 and 15 hereof equal to the Minimum Order Quantities.

*CONFIDENTIAL TREATMENT REQUESTED

12.

 

	7.9  	Prestwick shall ensure that it holds [...***...] stocks of the Product (calculated as [...***...] of
its then current annual forecast).
	 
	8.  	PRICE AND PAYMENT
	 
	8.1  	In the first year of this Agreement the price for the Product shall be:

	 	8.1.1  	For the first [...***...] Units ordered in that year, [...***...] per Unit; and
	 
	 	8.1.2  	For all Units ordered in that year over and above [...***...] the greater of
[...***...] per Unit or fifty percent (50%) of the Net Sales Revenue.

	8.2  	In the second year and all subsequent years of this Agreement the price for the Product shall
be: -

	 	8.2.1  	For the first [...***...] Units ordered in that year, [...***...] per Unit; and
	 
	 	8.2.2  	For all Units ordered in that year over and above [...***...] the greater of
[...***...] per Unit or fifty percent (50%) of the Net Sales Revenue.

	8.3  	Prestwick shall use commercially reasonable endeavours to seek [...***...] for the Product in
sales of the Product.
	 
	8.4  	In respect of Product for which the price to be paid by Prestwick is the greater of [...***...]
per Unit or fifty percent (50%) of the Net Sales Revenue Prestwick shall purchase Product at a
transfer price of [...***...] per Unit and, within [...***...] of the end of each month, 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 8.5. The parties shall, within [...***...] of receipt by Cambridge of Prestwick’s account,
in good faith, agree upon the Net Sales Revenue for that month. Based on that agreed Net Sales
Revenue the parties shall agree upon the amount to be paid to ensure that Cambridge is paid
the greater of [...***...] per Unit and fifty percent (50%) of the Net Sales Revenue and that sum
shall be paid within [...***...] days of such agreement being reached.
	 
	8.5  	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

*CONFIDENTIAL TREATMENT REQUESTED

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	   	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 twelve
(12) month period.
	 
	8.6  	If there is an increase [...***...] 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
[...***...].
	 
	8.7  	Save in respect of [...***...] to be manufactured and delivered in accordance with clause 7.1,
Cambridge shall invoice Prestwick following delivery of the Product in accordance with clause
9. Cambridge shall issue an invoice for [...***...] Units to be manufactured in accordance with
clause 7.1 upon delivery of [...***...].
	 
	8.8  	Unless expressly stated to the contrary elsewhere herein, payment in full of any amounts due
to Cambridge by Prestwick shall be made in Canadian 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:
	 
	   	[...***...]
	 
	8.9  	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.
	 
	9.  	SUPPLY AND DELIVERY
	 
	9.1  	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 7 above.
	 
	9.2  	In the event that Prestwick does not take delivery of any order of the Product [...***...] then
Prestwick [...***...].

*CONFIDENTIAL TREATMENT REQUESTED

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	9.3  	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.
	 
	9.4  	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.
	 
	9.5  	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.
	 
	9.6  	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.
	 
	10.  	RETENTION OF TITLE AND PASSING OF RISK
	 
	10.1  	Save as provided in clause 7.1, risk in each order of Product shall pass to Prestwick upon
supply in accordance with clause 9.1. 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.
	 
	11.  	INTELLECTUAL PROPERTY
	 
	11.1  	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
provided herein, or is necessary for the proper performance of this Agreement by Cambridge, no
licence,

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	   	express or implied, is granted by this Agreement by Prestwick under any of the Prestwick
Intellectual Property.

	11.2  	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.
	 
	11.3  	Prestwick shall not:

	 	11.3.1  	use the Trade Mark in any way which might prejudice its distinctiveness or validity
or the goodwill of Cambridge therein;
	 
	 	11.3.2  	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.

	11.4  	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.

	11.5  	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

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	   	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.
	 
	11.6  	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. 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.
	 
	11.7  	Except for such uses permitted hereunder, 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.
	 
	11.8  	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.
	 
	12.  	RESTRICTED INFORMATION
	 
	12.1  	Except as provided in clause 12.3 and 12.4 any party receiving and Restricted Information
from the other shall at all times during the continuance of this Agreement and after its
termination;

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

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

17.

 

	 	12.2.1  	the Regulatory Authority or other governmental authority in the Territory;
and
	 
	 	12.2.2  	any third party appointed pursuant to clause 2.4 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.

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

	 	12.3.1  	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
	 
	 	12.3.2  	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 save
that any Restricted Information disclosed or acquired pursuant to the US Agreement
shall remain confidential and not be covered by this exemption; or
	 
	 	12.3.3  	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
	 
	 	12.3.4  	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.

	12.4  	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 12.1 to 12.3. 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.

*CONFIDENTIAL TREATMENT REQUESTED

18.

 

	13.  	FORCE MAJEURE
	 
	13.1  	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.
	 
	13.2  	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.
	 
	13.3  	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.
	 
	13.4  	Save as provided in clauses 13.2 and 13.3, 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
Force Majeure shall be entitled to terminate this Agreement forthwith by giving written notice
to the other.
	 
	14.  	PERIOD OF AGREEMENT
	 
	14.1  	This Agreement shall take effect on the Commencement Date and (subject to termination in
accordance with all other relevant provisions hereof) shall continue in force for an initial
period ten (10) years from the date of the grant of the last Marketing Authorisation obtained
by Prestwick pertaining to the Product. If Prestwick wishes to continue with the Agreement
after the initial ten (10) year 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.
	 
	14.2  	If this Agreement continues in force after the initial period of ten (10) 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.

*CONFIDENTIAL TREATMENT REQUESTED

19.

 

	15.  	WARRANTY, INDEMNITY AND INSURANCE BY CAMBRIDGE
	 
	15.1  	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.
	 
	15.2  	Except for the warranties set forth in clauses 5 and 15, 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:

	 	15.2.1  	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

	 	15.2.2  	any liability of Cambridge with respect to any Product which:

	 	15.2.2.1  	has been tampered with or in any way altered or modified other than by
Cambridge; or,
	 
	 	15.2.2.2  	has been subject to misuse, negligence or accident other than by Cambridge;
or
	 
	 	15.2.2.3  	has been stored, handled, maintained or used in a manner contrary to
regulatory requirements or Cambridge’s instructions; or
	 
	 	15.2.2.4  	has exceeded its stated expiry date.

	15.3  	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 5 as qualified by
clause 15.2 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 15.4
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.

20.

 

	15.4  	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:

	 	15.4.1  	the negligence or wilful malfeasance of Cambridge; or
	 
	 	15.4.2  	any breach of the terms of this agreement by Cambridge.

	15.5  	In the event of Prestwick receiving a claim from a third party pertaining to the matters set
forth in clause 15.4 above Prestwick shall:

	 	15.5.1  	promptly notify Cambridge of any claim made against it in relation to such matters;
	 
	 	15.5.2  	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;
	 
	 	15.5.3  	co-operate fully with and give every reasonable assistance to Cambridge or its
insurers in the investigation and handling of any claim.

	15.6  	Notwithstanding anything to the contrary in this Agreement Cambridge shall not be liable in
any manner whatsoever including under clause 15.3 and 15.4 for any loss of profits, savings,
contracts or business or any indirect or consequential losses of whatsoever nature.
	 
	15.7  	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.
	 
	15.8  	Cambridge will provide to Prestwick at Prestwick’s request, a broker’s or insurer’s
certificate confirming such insurance cover is in place.
	 
	16.  	WARRANTY, INDEMNITY AND INSURANCE BY PRESTWICK
	 
	16.1  	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

21.

 

	   	“organizational” in the immediately preceding sentence refers to the charter and by-laws of
Prestwick.
	 
	16.2  	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:

	  	16.2.1  	the negligence or wilful malfeasance of Prestwick; or
	 
	  	16.2.2  	any breach of the terms of this agreement by Prestwick.

	16.3  	In the event of Cambridge receiving a claim from a third party pertaining to the matters set
forth in clause 16.2 above Cambridge shall:

	 	16.3.1  	promptly notify Prestwick of any claim made against it in relation to such matters;
	 
	 	16.3.2  	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;
	 
	 	16.3.3  	co-operate fully with and give every reasonable assistance to Prestwick or its
insurers in the investigation and handling of any claim; and

	16.4  	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.
	 
	16.5  	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.
	 
	16.6  	Prestwick will provide to Cambridge at Cambridge’s request, a broker’s or insurer’s
certificate confirming such insurance cover is in place.

22.

 

	17.  	NOTICES
	 
	17.1  	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

	18.  	ASSIGNMENT
	 
	18.1  	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.
	 
	19.  	DISPUTE ESCALATION
	 
	19.1  	In the event that the parties are unable to reach agreement on any review of the Minimum
Marketing Activities, the content of any Marketing Plan, the Minimum Sales Quantities or the
Minimum Order Quantities the matter shall, in the first instance, be addressed as soon as
possible and, at the latest, at the immediately succeeding quarterly meeting of the Joint
Marketing Committee as is appropriate given the nature of the matter. For the sake of clarity
a failure of Prestwick to use Minimum Marketing Activities in accordance with clause 6.11, to
materially comply with the Marketing Plan in accordance with clause 6.11, to provide a
forecast or any updated forecast in accordance with clause 7.2, to order the Minimum Order
Quantities or sell the Minimum Sales Quantities in accordance with clause 7.7 are material
breaches to be dealt with pursuant to either clause 20.1.1 or, in the case of failure to order
the Minimum Order Quantities

23.

 

	 	or sell the Minimum Sales Quantities, clauses 7.7 and 7.8 and such matters shall not be
dealt with through the escalation procedure set forth in this clause.
	 
	19.2  	If, following either good faith discussions between 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
[...***...].
	 
	19.3  	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 19.4.
	 
	19.4  	In the event that the parties, having gone through the steps set forth in clauses 19.1 to
19.3, 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 20.3 the parties shall send written requests to
the arbitrators of their 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.
	 
	19.5  	If the issue concerns any proposed alteration to the Minimum Sales Quantities, the Minimum
Order Quantities or any updated forecast then, until agreement is reached the Minimum Sales
Quantities or the Minimum Order Quantities for the relevant year set forth in either Schedule
3 or

*CONFIDENTIAL TREATMENT REQUESTED

24.

 

	   	Schedule 4 as is appropriate and/or the immediately preceding forecast, as is applicable,
shall continue to apply until the issue is resolved and, if no arbitration decision is
reached within [...***...] of the matter being first referred to arbitration, then the Minimum
Sales Quantities or Minimum Order Quantities or forecast shall be set at:

	 	19.5.1  	A fifteen percent (15%) increase where such failure to agree falls within the first
three years following the Commencement Date; and,
	 
	 	19.5.2  	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.
	 
	20.  	TERMINATION
	 
	20.1  	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:

	 	20.1.1  	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 [...***...], 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 [...***...] shall be
extended for so long as such party continues to use good faith 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;
	 
	 	20.1.2  	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;
	 
	 	20.1.3  	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;

*CONFIDENTIAL TREATMENT REQUESTED

25.

 

	 	20.1.4  	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.

	20.2  	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 eighteen (18) 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 the [...***...] period following the change of
control to maintain at least the same level of promotional spend and detail sales force
efforts for the Product as had been expended and exerted (calculated on an annualised basis)
for the [...***...] in which the change of control occurred, such expenditures and exertion shall
be deemed to constitute “sufficient priority” for the purposes of this clause.
	 
	20.3  	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.
	 
	20.4  	The termination of this Agreement shall be without prejudice to any right or remedy available
to either party at such termination.
	 
	21.  	CONSEQUENCES OF TERMINATION
	 
	21.1  	Upon the termination or expiration of this Agreement for any reason:

	 	21.1.1  	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;

*CONFIDENTIAL TREATMENT REQUESTED

26.

 

	 	21.1.2  	Unless expressly provided to the contrary herein, all licences granted hereunder,
shall come to an end immediately and Prestwick shall, subject to clause 21.1.3
immediately cease all activities carried out pursuant to those licences;
	 
	 	21.1.3  	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 up to [...***...] following the date of termination provided
that if Cambridge does not make such request, then Cambridge shall purchase from
Prestwick [...***...];
	 
	 	21.1.4  	Prestwick shall [...***...] of termination or, if Cambridge has requested Prestwick
continue to supply pursuant to clause 21.1.3, 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;
	 
	 	21.1.5  	Prestwick shall within [...***...] of termination or, if Cambridge has requested
Prestwick continue to supply pursuant to clause 21.1.3, 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.
	 
	 	21.1.6  	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 21.1.3, 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 Regulatory Authority) 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.
	 
	 	21.1.7  	Prestwick shall promptly following termination or, if Cambridge has requested
Prestwick continue to supply pursuant to clause 21.1.3, expiry of the [...***...] period
set out in that clause, cease to promote, market, advertise or solicit customers for or
sell the Product;

*CONFIDENTIAL TREATMENT REQUESTED

27.

 

	 	21.1.8  	Neither party shall have any claim against the other for compensation for
loss of distribution rights, loss of goodwill or any similar loss; and,
	 
	 	21.1.9  	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 2.8, 3.2, 8.1, 8.2, 8.4, 8.5, 8.8, 11.6, 12, 15.2, 15.3, 15.4, 15.5, 15.6,
15.7, 15.8, 16.2, 16.3, 16.4, 16.5, 16.6, 18, 21, 23 and 24) shall continue in full
force in accordance with their terms; and

	21.2  	Termination shall be without prejudice to the accrued rights and obligations of the parties
available at the time of termination.
	 
	22.  	ENTIRE AGREEMENT
	 
	22.1  	This Agreement and the provisions of any schedules hereto and those provisions of the US
agreement that are specifically cross referenced herein constitute the entire agreement
between the parties and supersedes all previous communications or representations, agreements
or understandings whether oral or written between the parties with respect to the subject
matter hereof, which are hereby excluded.
	 
	22.2  	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.
	 
	22.3  	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.
	 
	23.  	AGENCY
	 
	23.1  	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

28.

 

	   	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.
	 
	24.  	GOVERNING LAW AND JURISDICTION
	 
	24.1  	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.
	 
	24.2  	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.
	 
	25.  	CONSENT OR AGREEMENT
	 
	25.1  	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 Price Evans	 	 	 
	For and on behalf of

	 	)	 
	CAMBRIDGE
LABORATORIES LIMITED

	 	)	 
	 
	 	 	 
	Signed by:
	 	 	 
	 
	 	 	 
	

	 	)	 
	/s/
Kathleen Clarence-Smith	 	 	 
	For and on behalf of

	 	)	 
	PRESTWICK PHARMACEUTICALS INC.

	 	)	 

29.

 

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;
	 
	 	 
	“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;
	 
	 	 
	“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 and
those set forth in The Food and Drugs Act and the
Food and Drugs Regulations of Canada;
	 
	 	 
	“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;

 30.

 

	 	 	 
	“[...***...] Developments”

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

	 	means the representatives of each party
appointed pursuant to clause 7.10 who are
responsible for overseeing the
performance and evaluation of the
Marketing Plan;
	 
	 	 
	“Marketing Authorisation”

	 	means the authorisation from the
Regulatory Authority permitting the sale,
marketing and promotion of the Product in
the Territory on a licensed basis;
	 
	 	 
	“Marketing Plan”

	 	means the plan for the marketing of the
Product in the Territory set forth in
Schedule 2 to be appended to this
Agreement at the time provided in clause
6.10 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 3 to be appended
to this Agreement at the time provided in
clause 6.10 of this Agreement;
	 
	 	 
	“Minimum Order Quantities”

	 	means the minimum quantities of the
Product to be ordered by Prestwick for
the Territory in any twelve month period
set forth in Schedule 4;
	 
	 	 
	“Minimum Sales Quantities”

	 	means the quantities of the Product to be
sold by Prestwick in the Territory set
forth in Schedule 5 to this Agreement;
	 
	 	 
	“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 the
prior written approval of Cambridge which
approval shall not be unreasonably
withheld.

*CONFIDENTIAL TREATMENT REQUESTED

 31.

 

	 	 	 
	‘Product”

	 	means Cambridge’s pharmaceutical product
in the form of tablets containing 25 mgs
of the Active;
	 
	 	 
	“[...***...] Developments”

	 	means [...***...] other than any
[...***...] and shall include such
things as [...***...] ;
	 
	 	 
	“Regulatory Authority”

	 	means the regulatory body in the
Territory responsible for the granting of
marketing authorisations;
	 
	 	 
	“Restricted Information”

	 	means any information oral, visual,
electronic or 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 Marketing Authorisation;
	 
	 	 
	“Territory”

	 	means Canada;
	 
	 	 
	“Trade Mark”

	 	means the trade mark NITOMAN;
	 
	 	 
	“Unit”

	 	means [...***...] of [...***...] ;
	 
	 	 
	“US Agreement”

	 	Means the amended and restated agreement
between the parties pertaining to the
rights to the Product for the United
States;
	 
	 	 
	“Working Days”

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

*CONFIDENTIAL TREATMENT REQUESTED

 32.

 

SCHEDULE 2

MARKETING PLAN

As per attached

 

 

NitomanTM

(tetrabenazine)

25 mg Tablets

Canada Business Plan

Draft

April 6, 2004

 

 

	 	 	 	 	 	 	 	 	 	 	 
	1.	 	Situation Analysis	 	 	3	 
	

	 	 	1.1	 	 	Background
	 	 	3	 
	

	 	 	 	 	 	[...***...]	 	 	 	 
	

	 	 	 	 	 	[...***...]	 	 	 	 
	

	 	 	 	 	 	[...***...]	 	 	 	 
	

	 	 	1.2	 	 	Key Market Statistics
	 	 	6	 
	

	 	 	1.3	 	 	Market Trends
	 	 	7	 
	

	 	 	1.4	 	 	Competition
	 	 	7	 
	

	 	 	 	 	 	[...***...]	 	 	 	 
	

	 	 	 	 	 	[...***...]	 	 	 	 
	

	 	 	 	 	 	[...***...]	 	 	 	 
	

	 	 	1.5	 	 	Promotional Strategies
	 	 	 9	 
	2. Key Issues	 	 	10	 
	3.	 	Product Strategy	 	 	 10	 
	

	 	 	3.1	 	 	Commercial
	 	 	 10	 
	

	 	 	 	 	 	3.1.1 Distribution/Reimbursement
	 	 	10	 
	

	 	 	 	 	 	3.1.2 Pricing
	 	 	10	 
	

	 	 	3.2	 	 	Regulatory
	 	 	 10	 
	4.	 	Promotional Tactics	 	 	 10	 
	

	 	 	4.1	 	 	Positioning
	 	 	 11	 
	

	 	 	4.2	 	 	Sales Force
	 	 	 11	 
	

	 	 	4.3	 	 	Sales Training
	 	 	 13	 
	

	 	 	4.4	 	 	Sales Promotion Materials
	 	 	 13	 
	

	 	 	4.5	 	 	Advertising
	 	 	 13	 
	

	 	 	4.6	 	 	Public Relations
	 	 	 13	 
	5.	 	Medical Education	 	 	 13	 
	

	 	 	5.1	 	 	Medical Conventions
	 	 	 14	 
	

	 	 	5.2	 	 	Promotional Budget
	 	 	 15	 

*CONFIDENTIAL TREATMENT REQUESTED

2.

 

	 	 	 	 	 	 	 	 	 
	1.	 	Situation Analysis	 	 
	 
	 	 	 	 	 	 	 	 
	

	 	1.1 Background	 	 	 	 	 	 	 
	 	 	[...***...]	 	 
	 
	 	 	 	 	 	 	 	 
	1.1.1	 	Huntington’s disease	 	 
	 	 	[...***...]	 	 
	 
	 	 	 	 	 	 	 	 
	1.1.2	 	Tardive Dyskinesia	 	 
	 	 	[...***...]	 	 
	 
	 	 	 	 	 	 	 	 
	1.1.3	 	Other Forms of Chorea	 	 
	 	 	[...***...]	 	 

Table 1: Most Common Causes of Chorea

	 	 	 	 	 	 	 
	 	 	 
	 	Hereditary

	 	 	 	 	 
	 	     [...***...]
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 	 
	 	Secondary
	 	 	 	 	 
	 	     [...***...]
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 	 
	 	Unknown Etiology
	 	 	 	 	 
	 	     [...***...]
	 	 	 	 	 
	 	 
	 	 	 	 	 
	 	 

	 	 	 	 	 
	 
	 	1.2	 	Key Market Statistics
	 
	 	 	 	 
	 	 	[...***...]

*CONFIDENTIAL TREATMENT REQUESTED

 3.

 

	 	 	 	 	 
	 
	 	1.3	 	Market Trends
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	1.4	 	Competition
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	1.4.1	 	[...***...]
	 
	 	 	 	 
	1.4.2	 	[...***...]
	 
	 	 	 	 
	 
	 	1.5	 	Promotional Strategies
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	2.	 	Key Issues
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	3.	 	Product Strategy
	 
	 	 	 	 
	 
	 	3.1	 	Commercial
	 
	 	 	 	 
	3.1.1	 	Distribution/Reimbursement
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	3.1.2	 	Pricing
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	3.2	 	Regulatory
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	4.	 	Promotional Tactics
	 
	 	 	 	 
	 	 	[...***...]

*CONFIDENTIAL TREATMENT REQUESTED

 4.

 

	 	 	 	 	 
	 
	 	4.1	 	Positioning
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	4.2	 	Sales Force
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	4.3	 	Sales Training
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	4.4	 	Sales Promotion Materials
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	4.5	 	Advertising
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	4.6	 	Public Relations
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	5.	 	Medical Education
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	5.1	 	Medical Conventions
	 
	 	 	 	 
	 	 	[...***...]
	 
	 	 	 	 
	 
	 	5.2	 	Promotional Budget
	 
	 	 	 	 
	 	 	[...***...]

*CONFIDENTIAL TREATMENT REQUESTED

 5.

 

SCHEDULE 3

MINIMUM MARKETING ACTIVITIES

The commercial personnel will
be comprised of three full time equivalent (FTE)
[...***...] and a [...***...]
— dedicated to the product in Canada.

[...***...]

Anticipated
marketing spending to support the Canadian activity will be in the
region of $300,000 per annum (excluding personnel costs) for the
first 5 years, to include, but not limited to, [...***...]

*CONFIDENTIAL TREATMENT REQUESTED

 

 

SCHEDULE 4

MIMIMUM ORDER QUANTITIES

	 	 	 
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]

For the sake of clarity Year 1 of this Agreement shall be the period of 12 months commencing on the

Commencement Date, Year 2 the twelve months thereafter etc etc

*CONFIDENTIAL TREATMENT REQUESTED

 

 

SCHEDULE 5

MINIMUM SALES OUANTITIES

	 	 	 
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]
	[...***...]
	 	[...***...]

For the sake of clarity Year 1 of this Agreement shall be the period of 12 months commencing on the

Commencement Date, Year 2 the twelve months thereafter etc etc

*CONFIDENTIAL TREATMENT REQUESTED

 

 

SCHEDULE 6

PRODUCT RECALL PROCEDURE

Prestwick shall ensure that its stock management system and records enable full traceability of all
orders and batches of Product supplied to customers so that recall on a batch by batch basis is
able to be undertaken expeditiously if required.

Prestwick shall in accordance with its product recall procedure carry out a recall of the Product
whenever so directed or requested by the Regulatory Authority or other governmental authority in
the Territory. In the absence of any such direction or request Prestwick shall only carry out a
recall of the Product when so requested by Cambridge.

It is expressly understood that, should the recall have been caused by Cambridge’s failure to
supply Product complying with the provisions of this Agreement, Cambridge shall reimburse Prestwick
for all reasonable out-of-pocket expenses borne by Prestwick in connection with the Product recall,
as well as replace the quantities of the Product recalled at its cost. If the recall is the result
of Prestwick failing to comply with its obligations under this Agreement then Prestwick shall bear
all expenses in connection with the recall and shall replace, at its cost, the quantity of the
Product recalled under the terms of this Agreement

Then as per attached together with the then current product recall procedures of Health Canada.

 

 

PRESTWICK PHARMACEUTICALS

STANDARD OPERATING PROCEDURE – PRODUCT RECALLS IN CANADA

1 PURPOSE

[...***...]

2 SCOPE

[...***...]

3 RESPONSIBILITIES

   [...***...]

4 ASSOCIATED DOCUMENTS

[...***...]

5 PROCEDURE

[...***...]

*CONFIDENTIAL TREATMENT REQUESTED

 

 

Attachment 1

PRODUCT RECALL PROCEDURES

TABLE OF CONTENTS

	 	 	 	 	 
	1. Recall – Background and Objectives 
	 	 	2	 
	2. Definitions 
	 	 	2	 
	3. Recall Notification 
	 	 	4	 
	4. Health Hazard Evaluation and Recall Classification 
	 	 	4	 
	5. Recall Strategy 
	 	 	5	 
	6. Recall Communications 
	 	 	7	 
	7. Termination of a Product Recall 
	 	 	9	 
	8. General Industry Guidance 
	 	 	9	 
	9. Recall Responsibilities – Health Protection Branch 
	 	 	9	 

[...***...]

PRODUCT RECALL PROCEDURES

1. Recall – Background and Objectives

[...***...]

2. Definitions

[...***...]

3. Recall Notification

[...***...]

4. Health Hazard Evaluation and Recall Classification

[...***...]

5. Recall Strategy

[...***...]

6. Recall Communications

[...***...]

7. Termination of a Product Recall

[...***...]

8. General Industry Guidance

[...***...]

9. Recall Responsibilities – Health Protection Branch

[...***...]

*CONFIDENTIAL TREATMENT REQUESTED

 

 

REGIONAL RECALL COORDINATORS –

FIELD OPERATIONS DIRECTORATE

[...***...]

NATIONAL RECALL COORDINATOR –

FIELD OPERATIONS DIRECTORATE

[...***...]

BUREAU RECALL COORDINATOR – FOOD, DRUG,

AND ENVIRONMENTAL

[...***...]

MEDIA OFFICER

[...***...]

DIRECTORS-GENERAL: FOOD, DRUG, AND ENVIRONMENTAL

HEALTH DIRECTORATES

[...***...]

DIRECTOR-GENERAL: FIELD OPERATIONS DIRECTORATE

[...***...]

ASSISTANT DEPUTY MINISTER

[...***...]

*CONFIDENTIAL TREATMENT REQUESTED

 

 

SCHEDULE 5 ATTACHMENT 2

CUSTOMER CONTACT RECORD           MEDICAL INFORMATION o            PRODUCT COMPLAINT o            ADVERSE EVENT o

	 	 	 	 	 	 	 	 	 
	CONTACT #

	 	DATE   (ddmmmyyyy)
	 	Tel o  Mail o
	 	PRODUCT
	 	Lot #
	 
	 	 	 	 	 	 	 	 
	NAME

	 	 	 	 	 	E-MAIL	 	 
	 
	 	 	 	 	 	 	 	 
	TELEPHONE

	 	 	 	 	 	FAX	 	 
	 
	 	 	 	 	 	 	 	 
	ADDRESS

	 	 	 	 	 	CITY	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	PROVINCE	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	POSTAL CODE	 	 
	 
	 	 	 	 	 	 	 	 
	 
	CUSTOMER:     o Pharmacist,    o Physician,   o Dentist,    o Nurse,    o Sales Rep,    o Consumer,    o Other (Explain)
	 
	 	 	 	 	 	 	 	 
	 
	DETAILS OF CONTACT
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	urgency of response: answer while on phone  o      asap  o           no rush (action date?) o
	 
	MEDICAL INFORMATION QUESTION
	 
	INDICATION o      DOSAGE o       PHARMACOKINETICS o       ADVERSE EVENT o           COMPARISON o
	OTHER (details)
	 
	PRODUCT COMPLAINT
	 
	PACKAGING o       POTENCY o   BROKEN TABLET/CAPSULES o    FOREIGN MATERIAL o   POTENTIAL RECALL o
	OTHER (details)
	 
	PRODUCT TO BE RETURNED    Y o N o  if yes, product received(ddmmmyyyy)
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	ADVERSE EVENTS
	 
	SERIOUS o            NON-SERIOUS o            LACK OF EFFECT o
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	EVENT(S)

	 	 	 	 	 	 	 	 	 	 	 	OUTCOME	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	PATIENT
INITIALS	 	DATE OF BIRTH (ddmmmyyyy)	 	AGE	 	SEX
M o F o	 	WEIGHT	 	REACTION ONSET (ddmmmyyy	 	 
	 
	SUSPECT DRUG(S)
	 
	DRUG(S)	 	 	 	DAILY DOSE/ROUTE	 	 	 	THERAPY DATES (ddmmmyyy) /DURATION	 	 	 	 
	

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	did reaction abate after stopping drug Y o  N o NA o
	 
	CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (EXCLUDE THOSE USED TO TREAT REACTION)
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 
	 
	OTHER RELEVANT HISTORY (E.G., DIAGNOSES, ALLERGIES, PREGNANCY WITH LAST MONTH OF PERIOD, ETC.)
	 
	 
	 	 
	 
	RESPONSE TO CUSTOMER
	 
	 	 

	 	 	 	 	 	 	 	 	 
	 
	RESPONSE to CUSTOMER (ddmmmyyy)

	 	 	 	verbal o
	 	written o
	 	sales rep visit o
	FORM SENT TO PRESTWICK ON (ddmmmyyy)	 	RESPONSE RECEIVED FROM PRESTWICK (ddmmmyyy)
	 

 

Attachment 3

	 	 	 	 	 	 	 
	Product Recall Response Form

	 
	 	 	 	 	 	 
	  [Prestwick Logo]
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  1. To:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  (see list attached, if more than one)
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  2. Product Recall Class of Defect:

	 	 	 	III
	 	 3. Counterfeit/Fraud (specify)*
	  (circle one)
	 	 	 	 	 	 
	 
	  4. Product:

	 	 	 	 	 	5. Marketing Authorisation Number:*
	   
	 	 	 	 	 	 
	

	 	 	 	 	 	For use in humans/animals (delete as required)
	 
	 	 	 	 	 	 
	  6. Brand/Trade Name:

	 	 	 	 	 	7. INN or Generic Name:
	 
	 	 	 	 	 	 
	  8. Dosage Form:

	 	 	 	 	 	9. Strength:
	 
	 	 	 	 	 	 
	  10. Batch/Lot Number:

	 	 	 	 	 	11. Expiry Date:
	 
	 	 	 	 	 	 
	  12. Pack size and Presentation:

	 	 	 	 	 	13. Date Manufactured:*
	 
	 	 	 	 	 	 
	  14. marketing Authorisation Holder:*
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  15. Manufacturer+:

	 	 	 	 	 	16. Recalling Firm (if different):
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  Contact Person:

	 	 	 	 	 	Contact Person:
	 
	 	 	 	 	 	 
	  Telephone:

	 	 	 	 	 	Telephone:
	 
	 	 	 	 	 	 
	  17. Recall Number Assigned (if available)
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  18. Details of Defect/Reason for Recall:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  19. Information on distribution including exports (type of customer, e.g., hospitals):*
	 
	 	 	 	 	 	 
	  20. Action taken by Issuing Authority:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  21. Proposed Action:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	  22. From (Issuing Authority):

	 	 	 	 	 	23. Contact Person:
	 
	 	 	 	 	 	 
	

	 	 	 	 	 	Telephone:
	 
	 	 	 	 	 	 
	  24. Signed:	 	 25. Date:               26. Time:*
	 

 

THIS AMENDMENT NO. 1 is made as of the 1st day of December, 2004, to that certain AGREEMENT
FOR CANADIAN RIGHTS TO NITOMAN, dated April 26, 2004 (as so amended by this said Amendment No. 1,
the “Agreement”), BETWEEN:

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

AND

	27.  	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:

	28.  	The Agreement relates to Prestwick’s undertaking of the promotion, sale and distribution of
the Product in the Territory, and, if mutually agreed by the Parties, [...***...] Developments.
	 
	29.  	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”).
	 
	30.  	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”).
	 
	31.  	[...***...] 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, [...***...]to [...***...] all of [...***...] upon the [...***...]of [...***...].

THE PARTIES AGREE as follows:

*CONFIDENTIAL TREATMENT REQUESTED

1

 

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/ 

	

	 	 	)	 	 	 
	For and on behalf of

	 	 	)	 	 	 
	PRESTWICK PHARMACEUTICALS, INC.

	 	 	)	 	 	 

*CONFIDENTIAL TREATMENT REQUESTED

3

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