Document:

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                                                                   EXHIBIT 10.50

                       FIDELITY NATIONAL TITLE GROUP, INC.

                          EMPLOYEE STOCK PURCHASE PLAN

         Fidelity National Title Group, Inc., a Delaware corporation
(hereinafter referred to as the "Company"), hereby establishes an employee stock
purchase plan to be known as the "Fidelity National Title Group, Inc. Employee
Stock Purchase Plan" (hereinafter referred to as the "Plan"). The Plan shall
become effective on [______________].

                                   ARTICLE I
                               PURPOSE OF THE PLAN

         1.1. PURPOSE. The Company has determined that it is in its best
interests to provide an incentive to attract and retain Employees and to
increase Employee morale by providing a program through which Employees may
acquire a proprietary interest in the Company through the purchase of Company
Stock. The Plan shall permit Employees to subscribe for and purchase shares of
the Company Stock, and to pay the purchase price in installments by payroll
deductions. Participation in the Plan is entirely voluntary and neither the
Company nor any of its Subsidiaries makes any recommendations to their Employees
as to whether they should participate in the Plan. The Plan is not intended to
be an employee benefit plan under the Employee Retirement Income Security Act of
1974, as amended, nor qualify as an "employee stock purchase plan" under Section
423 of the Code.

                                   ARTICLE II
                                   DEFINITIONS

         2.1. BASE EARNINGS. "Base Earnings" means the amount of a Participant's
regular salary before deductions required by law and deductions authorized by
the Participant, including any elective deferrals with respect to a plan of the
Employer qualified under Sections 125 or 401(a) of the Code and any amounts
deferred by the Participant to a nonqualified deferred compensation plan
sponsored by the Employer. In the case of Participants primarily compensated on
a commission basis, "Base Earnings" may include commission earnings not to
exceed $7,500 per month. "Base Earnings" shall not include: wages paid for
overtime, extended workweek schedules or any other form of extra compensation,
payments made by the Employer based upon salary for Social Security, workers'
compensation, unemployment compensation, disability payments or any other
payment mandated by state or federal statute, or salary-related contributions
made by the Employer for insurance, annuity or any other employee benefit plan.

         2.2. BOARD. "Board" means the Board of Directors of the Company.

         2.3. BROKER. "Broker" means the financial institution designated by the
Company to act as Broker for the Plan under Article VIII below.

         2.4. BROKERAGE ACCOUNT. "Brokerage Account" means the bookkeeping entry
maintained by the Company for the purpose of accounting for the benefits accrued
by a Participant under the Plan.
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         2.5. CODE. "Code" means the Internal Revenue Code of 1986, as amended,
and the regulations promulgated thereunder.

         2.6. COMMITTEE. "Committee" means the Committee described in Article
VIII.

         2.7. COMPANY. "Company" means Fidelity National Title Group, Inc., a
Delaware corporation.

         2.8. COMPANY STOCK. "Company Stock" means Class A common stock of the
Company, par value $0.0001 per share.

         2.9. DISTRIBUTION DATE. "Distribution Date" means the date as of which
the distribution of Company Stock to the holders of the outstanding common stock
of Fidelity National Financial, Inc., is effected.

         2.10. EMPLOYEE. "Employee" means each person currently employed by the
Employer who (a) averages at least twenty hours per week, any portion of whose
income is subject to withholding of income tax or for whom Social Security
retirement contributions are made by the Employer, or (b) qualifies as a
common-law employee of the Employer. Persons determined by the Board to be
non-Employees and Employees on a leave of absence are not eligible to become
Participants in the Plan.

         2.11. EMPLOYER. "Employer" means the Company and any Subsidiary that
adopts this Plan with the approval of the Board.

         2.12. PARTICIPANT. "Participant" means an Employee who has satisfied
the eligibility requirements of Section 3.1 and has become a participant in the
Plan in accordance with Section 3.2.

         2.13. PAYROLL PERIOD. "Payroll Period" means the pay periods coinciding
with the Employer's payroll practices, as revised from time to time.

         2.14. PLAN YEAR. "Plan Year" means the twelve consecutive month period
ending each December 31.

         2.15. QUARTER. "Quarter" means the three consecutive calendar month
periods commencing January 1 through March 31, April 1 through June 30, July 1
through September 30 and October 1 through December 31 each Plan Year.

         2.16. QUARTER END. "Quarter End" means the last day of each Quarter
(March 31, June 30, September 30 or December 31).

         2.17. SUBSIDIARY. "Subsidiary" means any corporation in which the
Company owns, directly or indirectly, at least fifty percent (50%) of the total
combined voting power of all classes of stock, or any other entity (including,
but not limited to, partnerships and joint ventures) in which the Company owns,
directly or indirectly, at least fifty percent (50%) of the combined equity
thereof.

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                                  ARTICLE III
                          ELIGIBILITY AND PARTICIPATION

         3.1. ELIGIBILITY. Eligibility under the Plan shall be determined as
follows:

                  (a) Each Employee of the Employer who participated in or was
eligible to participate in the Fidelity National Financial, Inc. Employee Stock
Purchase Plan (the "FNF ESPP") prior to the Distribution Date shall be eligible
to become a Participant in the Plan following the Distribution Date.

                  (b) All other Employees of the Employer shall be eligible to
become Participants in the Plan on the first day of the next Payroll Period (to
the extent practical under the Employer's payroll practices) following the
delivery of an enrollment form provided by the Employer (the "Enrollment Form")
coincident with or next following the completion of ninety days of employment
with the Employer.

         3.2. PARTICIPATION. As soon as administratively practicable following
the Distribution Date, as determined by the Committee in its sole discretion, an
Employee who has satisfied the eligibility requirements of Section 3.1 may
become a participant in the Plan upon his or her completion and delivery to the
Human Resources Department of the Company an Enrollment Form authorizing payroll
deductions. Payroll deductions for a Participant shall commence on the first day
of the next Payroll Period coincident with or next following the filing of the
Participant's Enrollment Form and shall remain in effect until revoked by the
Participant by the filing of a notice of withdrawal from the Plan under Article
VII or by the filing of a new Enrollment Form providing for a change in the
Participant's payroll deduction rate in accordance with Section 4.2 below.

         3.3. SPECIAL RULES. In the event that a person is excluded from
participation in the Plan under Section 2.10 above and a court of competent
jurisdiction determines that the person is eligible to participate in the Plan,
the person shall be treated as an Employee only from the date of the court's
determination and shall not be entitled to retroactive participation in the
Plan.

                                   ARTICLE IV
                               PAYROLL DEDUCTIONS

         4.1. PARTICIPANT ELECTION. Upon the Enrollment Form, each Participant
shall designate the amount of payroll deductions ("Participant Contributions")
to be made from his paycheck to purchase Company Stock under the Plan. The
amount of Participant Contributions shall be designated in whole percentages of
Base Earnings, of at least 3% not to exceed 15% of Base Earnings for any Plan
Year. The amount so designated upon the Enrollment Form shall be effective as of
the next Payroll Period and shall continue until terminated or altered in
accordance with Section 4.2 below.

         4.2. CHANGES IN ELECTION. A Participant may terminate participation in
the Plan at any time prior to the close of a Payroll Period as provided in
Article VII. A Participant may decrease or increase the rate of Participant
Contributions once each Quarter by completing and delivering to the Human
Resources Department of the Company a new Enrollment Form

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setting forth the desired change. Any change under this Section 4.2 shall become
effective on the first day of the next Payroll Period (to the extent practical
under the Employer's payroll practices) following the delivery of the new
Enrollment Form.

         4.3. PARTICIPANT ACCOUNTS. The Company shall establish and maintain a
separate Brokerage Account for each Participant. The amount of each
Participant's Participant Contributions shall be credited to his or her
Brokerage Account. No interest will be paid or allowed on amounts credited to a
Participant's Brokerage Account. All Participant Contributions withheld by the
Company under the Plan are general corporate assets of the Company and may be
used by the Company for any corporate purpose. The Company is not obligated to
segregate such Participant Contributions.

                                   ARTICLE V
                              COMPANY CONTRIBUTIONS

         5.1. OFFICERS AND DIRECTORS. For each Officer or director of the
Employer who is a Participant in the Plan and remains an Employee on each day
from each Quarter End until the anniversary of that Quarter End (the "Matching
Date"), the Employer shall make a Matching Contribution to the Brokerage Account
of that Participant. The Matching Contribution shall be in an amount equal to
one-half of the amount of Participant Contributions set aside into the
Participant's Brokerage Account for the Quarter ending on the applicable Quarter
End. The Matching Contribution shall be made as soon as is practical to the
Broker following the Matching Date. Withholding taxes, if any, shall be made
upon such Matching Contribution based upon the Participant's existing
withholding percentages or as otherwise required by law from the Participant's
Base Earnings. For purposes of the Plan, "Officer" means president, secretary,
vice president, treasurer or assistant vice president and shall be determined by
the Committee as of any Quarter End.

         5.2. OTHER PARTICIPANTS. For each Participant who the Committee
determines is not an Officer or director of the Employer under Section 5.1 above
and who remains an Employee on each day from each Quarter End until the Matching
Date, the Company shall make a Matching Contribution to the Brokerage Account of
that Participant. Except as otherwise provided in Section 5.3 below, the
Matching Contribution shall be in an amount equal to one-third of the amount of
Participant Contributions set aside into the Participant's Brokerage Account for
the Quarter ending on the applicable Quarter End. The Matching Contribution
shall be made as soon as is practical to the Broker following the Matching Date.
Withholding taxes, if any, shall be made upon such Matching Contribution based
upon the Participant's existing withholding percentages or as otherwise required
by law from the Participant's Base Earnings.

         5.3. TEN-YEAR EMPLOYEES. Notwithstanding the provisions of Section 5.2
above, with respect to each Participant who has completed at least ten
consecutive years of employment with the Employer at the time any Matching
Contribution will be made ("Ten-Year Employee"), the Matching Contribution for
such Participant under Section 5.2 above shall be one-half of the amount of the
Participant's Contributions instead of one-third. For purposes of this Section
5.3, a Participant's years of employment with Fidelity National Financial Inc.
("FNF") prior to the Distribution Date, including all direct and indirect
subsidiaries of FNF, shall be included in determining whether the Participant is
a Ten-Year Employee.

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         5.4. CHANGES IN STATUS. In the event that a Participant becomes an
Officer or director of the Employer, as described in Section 5.1 herein, or a
Ten-Year Employee, as described in Section 5.3 herein, during a Quarter, for
purposes of determining such Participant's Matching Contribution, all
Participant Contributions made during the Quarter in which the change in status
occurred shall be considered to have been made as an Officer, director or
Ten-Year Employee for that Quarter.

                                   ARTICLE VI
                                PURCHASE OF STOCK

         6.1. PURCHASE OF COMPANY STOCK. Absent an election by the Participant
to terminate his or her payroll deductions and have his or her Brokerage Account
returned, as soon as is practical following the transfer of funds from the
Employer to the Broker following the close of each Payroll Period or, with
respect to Matching Contributions, Quarter End, the Plan shall cause the Broker
to purchase on behalf of each Participant the maximum number of shares and
partial shares of Company Stock at the purchase price determined under Section
6.4 as can be purchased with the amounts held in each Participant's Brokerage
Account. If there are amounts held in a Participant's Brokerage Account that are
not used to purchase Company Stock, all such amounts shall be held in the
Participant's Brokerage Account and carried forward to the next Payroll Period.

         6.2. DELIVERY OF COMPANY STOCK.

                  (a) Company Stock acquired under the Plan may either be issued
directly to Participants or may be issued to the Broker engaged by the Company
to administer the Plan under Article VIII. If the Company Stock is issued in the
name of the Broker, all Company Stock so issued ("Plan Held Stock") shall be
held in the name of the Broker for the benefit of the Plan. The Broker shall
maintain Brokerage Accounts for the benefit of the Participants that shall
reflect each Participant's interest in the Plan Held Stock. Such accounts shall
reflect the number of whole and partial shares of Company Stock that are being
held by the Broker for the benefit of each Participant.

                  (b) Any Participant may elect to have the Company Stock
purchased under the Plan from his or her Brokerage Account be issued directly to
the Participant. Any election under this paragraph shall be on the forms
provided by the Company and shall be issued in accordance with paragraph (c)
below.

                  (c) In the event that Company Stock under the Plan is issued
directly to a Participant, the Company will deliver to each Participant a stock
certificate or certificates issued in his or her name for the number of shares
of Company Stock purchased as soon as practicable after the Company Stock is
purchased. Where Company Stock is issued under this paragraph, only full shares
of stock will be issued to a Participant. The time of issuance and delivery of
shares may be postponed for such period as may be necessary to comply with the
registration requirements under the Securities Act of 1933, as amended, the
listing requirements of any securities exchange on which the Company Stock may
then be listed, or the requirements under other laws or regulations applicable
to the issuance or sale of such shares.

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         6.3. PURCHASE PRICE. The purchase price for any Offering Period shall
be the Fair Market Value of Company Stock on the date shares are purchased.

         6.4. FAIR MARKET VALUE. For purposes of the Plan, the term "Fair Market
Value" on any given date means the value of one share of Company Stock,
determined as follows:

                  (a) If the Company Stock is then listed or admitted to trading
on the New York Stock Exchange ("NYSE"), NASDAQ National Market System
("NASDAQ") or a stock exchange that reports closing sale prices, the Fair Market
Value shall be the opening sale price on the date of valuation, or, if no
opening sale price is quoted or no sale takes place on such day, then the Fair
Market Value shall be the opening sale price of the Company Stock on the next
preceding day on which a sale occurred.

                  (b) If the Company Stock is not then listed or admitted to
trading on the NYSE, NASDAQ, or a stock exchange that reports closing sale
prices, the Fair Market Value shall be the average of the opening bid and asked
prices of the Company Stock in the over-the-counter market on the date of
valuation.

                  (c) If neither (a) nor (b) is applicable as of the date of
valuation, then the Fair Market Value shall be determined by the Committee in
good faith using any reasonable method of valuation, which determination shall
be conclusive and binding on all interested parties.

         6.5. FEES AND COMMISSIONS. The Company shall pay the Broker's
administrative charges for opening and maintaining the Brokerage Accounts for
the Participants and the brokerage commissions on purchases made for such
Brokerage Accounts that are attributable to the purchase of Company Stock with
Participant Contributions and Matching Contributions under the Plan. Such
Brokerage Accounts may be utilized for other transactions as described in
Section 6.6 below, but any fees, commissions or other charges by the Broker in
connection with such transactions shall, in certain circumstances described in
Section 6.6, be payable directly to the Broker by the Participant.

         6.6. PARTICIPANT ACCOUNTS WITH BROKER. Each Participant's Brokerage
Account shall be credited with all cash dividends paid with respect to full
shares and fractional shares of Company Stock purchased with Participant
Contributions and Matching Contributions, unless the Company Stock is registered
in the Participant's name under Section 6.2 above. Unless directed otherwise,
all cash dividends on Company Stock held in a Participant's Brokerage Account
shall automatically be reinvested in Company Stock as soon as is practical
following receipt of the dividends by the Broker. Applicable fees and brokerage
commissions on the reinvestment of such dividends will be payable by the
Participant. Any stock dividends or stock splits that are made with respect to
Company Stock purchased with Participant Contributions and Matching
Contributions shall be credited to the Participant's Brokerage Account without
charge to the Participant. Any Participant may request that a certificate for
any or all of the full shares of Company Stock credited to his or her Brokerage
Account be delivered to him or her at any time, provided that the Participant
shall be charged by the Broker for any fees applicable to such request. A
Participant may request the Broker to sell any or all of the full or fractional
shares of Company Stock allocated to his or her Brokerage Account. Unless

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directed otherwise by the Participant, the Broker shall mail to the Participant
a check for the proceeds, less any applicable fees and brokerage commissions and
any transfer taxes, registration fees or other normal charges associated with
such a sale, which shall be paid by the Participant. Except as provided in
Section 7.1 below, any sale of Company Stock held in a Participant's Brokerage
Account shall not affect his or her status as a Participant. A Participant may
purchase or sell additional shares of Company Stock through his or her Brokerage
Account at any time through separate purchases arranged through the Broker. The
Participant shall pay any and all costs, commissions or fees associated with any
such transactions to the Broker, including, but not limited to, purchases,
sales, reinvestment of dividends, requests for certificates and crediting of
stock dividends or stock splits.

                                  ARTICLE VII
                                   WITHDRAWAL

         7.1. IN SERVICE WITHDRAWALS. At any time prior to the close of a
Payroll Period, any Participant may withdraw the amounts held in his or her
Brokerage Account by executing and delivering to the Human Resources Department
for the Company written notice of withdrawal on the form provided by the
Company. In such a case, the entire balance of the Participant's Brokerage
Account shall be paid to the Participant, without interest, as soon as is
practicable. Upon such notification, that Participant shall cease to participate
in the Plan for the remainder of the Payroll Period in which the notice is
given. Any Employee who has withdrawn under this Section shall be excluded from
participation in the Plan for the remainder of the Payroll Period, but may then
be reinstated as a Participant for a subsequent Payroll Period by executing and
delivering a new Enrollment Form to the Committee.

         7.2. TERMINATION OF EMPLOYMENT.

                  (a) In the event that a Participant's employment with the
Employer terminates for any reason, the Participant shall cease to participate
in the Plan on the date of termination. As soon as is practical following the
date of termination, the entire balance of the Participant's Brokerage Account
shall be paid to the Participant or his or her beneficiary, without interest.

                  (b) A Participant may file a written designation of a
beneficiary who is to receive any shares of Company Stock purchased under the
Plan or any cash from the Participant's Brokerage Account in the event of his or
her death. Beneficiary designations may be changed by the Participant at any
time by written notice. If a Participant dies, the Committee may rely upon the
most recent beneficiary designation it has on file as being the appropriate
beneficiary. If a Participant dies and no valid beneficiary designation exists,
or the beneficiary has predeceased the Participant, the Committee shall deliver
any cash or shares of Company Stock to the executor or administrator of the
estate of the Participant, or if no such executor or administrator has been
appointed to the knowledge of the Committee, the Committee, in its sole
discretion, may deliver such shares of Company Stock or cash to the spouse or
any one or more dependents or relatives of the Participant, or if no spouse,
dependent or relative is known to the Committee, then to such other person as
the Committee may designate.

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                                  ARTICLE VIII
                               PLAN ADMINISTRATION

         8.1. PLAN ADMINISTRATION.

                  (a) Authority to control and manage the operation and
administration of the Plan shall be vested in the Board, or a committee
("Committee") appointed by the Board. Until such time as the Board appoints a
Committee to administer the Plan, the Board shall serve as the Committee for
purposes of the Plan. The Board or Committee shall have all powers necessary to
supervise the administration of the Plan and control its operations.

                  (b) In addition to any powers and authority conferred on the
Board or Committee elsewhere in the Plan or by law, the Board or Committee shall
have the following powers and authority:

                           (i) To designate agents to carry out responsibilities
         relating to the Plan;

                           (ii) To administer, interpret, construe and apply
         this Plan and to answer all questions that may arise or that may be
         raised under this Plan by a Participant, his or her beneficiary or any
         other person whatsoever;

                           (iii) To establish rules and procedures from time to
         time for the conduct of its business and for the administration and
         effectuation of its responsibilities under the Plan; and

                           (iv) To perform or cause to be performed such further
         acts as it may deem to be necessary, appropriate, or convenient for the
         operation of the Plan.

                  (c) Any action taken in good faith by the Board or Committee
in the exercise of authority conferred upon it by this Plan shall be conclusive
and binding upon a Participant and his or her beneficiaries. All discretionary
powers conferred upon the Board shall be absolute.

         8.2. LIMITATION ON LIABILITY. No Employee of the Employer nor any
member of the Board or Committee shall be subject to any liability with respect
to his or her duties under the Plan unless the person acts fraudulently or in
bad faith. To the extent permitted by law, the Company shall indemnify each
member of the Board or Committee, and any other Employee of the Employer with
duties under the Plan who was or is a party, or is threatened to be made a
party, to any threatened, pending or completed proceeding, whether civil,
criminal, administrative, or investigative, by reason of the person's conduct in
the performance of his or her duties under the Plan.

                                   ARTICLE IX
                                  COMPANY STOCK

         9.1. LIMITATIONS ON PURCHASE OF SHARES. The maximum number of shares of
Company Stock that shall be made available for sale under the Plan shall be
[________] shares, subject to adjustment under Section 9.4 below. The Company
will issue the shares of

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Company Stock to be sold to Participants under the Plan. If the total number of
shares of Company Stock that would otherwise be issuable pursuant to rights
granted pursuant to Article VI of the Plan at the purchase date exceeds the
number of shares then available under the Plan, the Company shall make a pro
rata allocation of the shares remaining available in as uniform and equitable a
manner as is practicable. In such event, the Company shall give written notice
of such reduction of the number of shares to each Participant affected thereby
and any unused Participant Contributions shall be returned to such Participant
if necessary.

         9.2. VOTING COMPANY STOCK. The Participant will have no interest or
voting right in shares to be purchased under Article VI of the Plan until such
shares have been purchased.

         9.3. REGISTRATION OF COMPANY STOCK. Shares to be delivered to a
Participant under the Plan will be registered in the name of the Plan unless
designated otherwise by the Participant.

         9.4. CHANGES IN CAPITALIZATION OF THE COMPANY. Subject to any required
action by the stockholders of the Company, the number of shares of Company Stock
covered by each right under the Plan that has not yet been exercised and the
number of shares of Company Stock that have been authorized for issuance under
the Plan but have not yet been placed under rights or that have been returned to
the Plan upon the cancellation of a right, as well as the purchase price per
share of Company Stock covered by each right under the Plan that has not yet
been exercised, shall be proportionately adjusted in the event of a stock split,
stock dividend, spin-off, reorganization, recapitalization, merger,
consolidation, exchange of shares or similar transaction affecting the shares of
Company Stock. Such adjustment shall be made by the Board, whose determination
in that respect shall be final, binding and conclusive. Except as expressly
provided herein, no issue by the Company of shares of stock of any class, or
securities convertible into shares of stock of any class, shall affect, and no
adjustment by reason thereof shall be made with respect to, the number or price
of shares of Company Stock subject to any right granted hereunder.

         9.5. MERGER OF COMPANY. In the event that the Company at any time
proposes to merge into, consolidate with or to enter into any other
reorganization pursuant to which the Company is not the surviving entity
(including the sale of all or substantially all of its assets or a "reverse"
merger in which the Company is the surviving entity), the Plan shall terminate,
unless provision is made in writing in connection with such transaction for the
continuance of the Plan and for the assumption of rights theretofore granted, or
the substitution for such rights of new rights covering the shares of a
successor corporation, with appropriate adjustments as to number and kind of
shares and prices, in which event the Plan and the rights theretofore granted or
the new rights substituted therefore, shall continue in the manner and under the
terms so provided. If such provision is not made in such transaction for the
continuance of the Plan and the assumption of rights theretofore granted or the
substitution for such rights of new rights covering the shares of a successor
corporation, then the Board or Committee shall cause written notice of the
proposed transaction to be given to the persons holding rights not less than 10
days prior to the anticipated effective date of the proposed transaction, and,
concurrent with the effective date of the proposed transaction, such rights
shall be exercised automatically in accordance with Article

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VI as if such effective date were the end of a Payroll Period unless a
Participant withdraws from the Plan as provided in Article VII.

                                   ARTICLE X
                              MISCELLANEOUS MATTERS

         10.1. AMENDMENT AND TERMINATION. Since future conditions affecting the
Company cannot be anticipated or foreseen, the Board reserves the right to
amend, modify, or terminate the Plan at any time. Upon termination of the Plan,
all benefits shall become payable immediately. Notwithstanding the foregoing, no
such amendment or termination shall affect rights previously granted, nor may an
amendment make any change in any right previously granted which adversely
affects the rights of any Participant. In addition, no amendment may be made
without prior approval of the stockholders of the Company if such amendment
would:

                  (a) Increase the number of shares of Company Stock that may be
issued under the Plan;

                  (b) Materially modify the requirements as to eligibility for
participation in the Plan; or

                  (c) Materially increase the benefits that accrue to
Participants under the Plan.

         10.2. BENEFITS NOT ALIENABLE. Benefits under the Plan may not be
assigned or alienated, whether voluntarily or involuntarily. Any attempt at
assignment, transfer, pledge or other disposition shall be without effect,
except that the Company may treat such act as an election to withdraw funds in
accordance with Article VII.

         10.3. NO ENLARGEMENT OF EMPLOYEE RIGHTS. This Plan is strictly a
voluntary undertaking on the part of the Employer and shall not be deemed to
constitute a contract between the Employer and any Employee or to be
consideration for, or an inducement to, or a condition of, the employment of any
Employee. Nothing contained in the Plan shall be deemed to give the right to any
Employee to be retained in the employ of the Employer or to interfere with the
right of the Employer to discharge any Employee at any time.

         10.4. GOVERNING LAW. To the extent not preempted by Federal law, the
Plan shall be construed in accordance with and governed by the laws of the State
of Florida, excluding any conflicts or choice of law rule or principle that
might otherwise refer construction or interpretation of this Plan to the
substantive law of another jurisdiction.

         10.5. NON-BUSINESS DAYS. When any act under the Plan is required to be
performed on a day that falls on a Saturday, Sunday or legal holiday, that act
shall be performed on the next succeeding day which is not a Saturday, Sunday or
legal holiday. Notwithstanding the above, Fair Market Value shall be determined
in accordance with Section 6.5.

         10.6. COMPLIANCE WITH SECURITIES LAWS. Notwithstanding any provision of
the Plan, the Committee shall administer the Plan in such a way to insure that
the Plan at all times complies with any requirements of Federal securities laws.
For example, affiliates may be

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required to make irrevocable elections in accordance with the rules set forth
under Section 16b-3 of the Securities Exchange Act of 1934, as amended.

         IN WITNESS WHEREOF, FIDELITY NATIONAL TITLE GROUP, INC. has caused this
instrument to become effective as of [_____________].

                                    FIDELITY NATIONAL TITLE GROUP, INC.

                                    By:
                                        --------------------------------
                                    Its:
                                        --------------------------------

                                       11exv10w9

 

Exhibit 10.9

DISTRIBUTORSHIP AGREEMENT

THIS AGREEMENT effective this 29th day of August 2005, by and between:

Cytokine PharmaSciences, Inc. (hereinafter “CPSI”), a Delaware corporation with principal offices
at Walnut Hill Plaza, 150 South Warner Road, Suite 420, King of Prussia, Pennsylvania 19406 USA and
Controlled Therapeutics (Scotland) Limited, a Scottish limited liability company, having its
principal offices at One Redwood Place, Peel Park Campus, East Kilbride, Scotland G74 5PB
(hereinafter referred to as “CTS”); and

Beijing Med-Pharm Corporation, a Delaware corporation having offices at 600 West Germantown Pike,
Suite 400, Plymouth Meeting, Pennsylvania 19462, USA (hereinafter referred to as “Distributor”).

RECITALS

A. By license agreement dated October 1, 1992, as amended from time to time through the date hereof
(the “BTG License Agreement”), the British Technology Group Limited (“BTG”) has granted certain
rights to CTS relating to the manufacture and composition of the Product (as hereafter defined).

B. CTS desires to appoint Distributor as its exclusive distributor to market, promote and sell the
Product in the Territory (as hereinafter defined) and Distributor desires to accept such
appointment by purchasing from CTS all of Distributor’s requirements of the Product for sale and
distribution in the Territory, all in accordance with the terms and conditions hereinafter set
forth.

C. CTS is a wholly owned subsidiary of CPSI and the parties deem it necessary for CPSI to join as a
party hereto to guarantee CTS’ performance hereunder.

     NOW, THEREFORE, in consideration of the mutual promises set forth herein, the parties hereto,
intending to be legally bound, hereby agree as follows:

	1.	 	Definitions.

     As used herein, the following terms shall have the respective meanings set forth below:

     1.1 “Affiliate” shall mean, as to a party hereto, any corporation or other legal entity
controlling, controlled by or under common control with such party. For purposes hereof, “control”
shall mean direct or indirect ownership or control, now or hereafter, of more than 50% of the
outstanding shares, stock, equity or other interest entitled to vote for the election of directors
or other managing authority (other than any shares of stock whose voting rights are subject to
restriction) of the subject corporation or other legal entity, provided that such
corporation or other legal entity shall be deemed to be an Affiliate for the purposes of this
Agreement only for so long as such ownership or control by reason of the foregoing exists.

     1.2 “Commencement Date” shall have the meaning set forth in Section 2.2.

 

 

     1.3 “Confidential Information” means any information (whether or not reduced to writing) that
either party hereto from time to time shall possess in relation to the development, formulation,
manufacture, testing, marketing or distribution of the Product and that is not generally known to
the public or the pharmaceutical industry, unless such general knowledge results from disclosure by
either party hereto or any recipient of such information as permitted by Section 7.1 from and after
the date hereof.

     1.4 “Contract Year” means, for the first Contract Year, the period beginning on the date of
first sale of the Product by Distributor in the Territory and ending December 31 of the following
year (such that the first Contract Year shall consist of more than 12 but fewer than 24 months)
and, for each subsequent Contract Year, the successive calendar year or portion thereof during the
term of this Agreement.

     1.5 “Product” shall mean a vaginal insert infused with dinoprostone as described generally in
the Product Registration (as hereinafter defined) in the Territory.

     1.6 “Product Registration” shall mean all applicable approval granted by the governmental and
regulatory authorities in the Territory permitting Distributor to import, market, promote,
distribute and sell the Product in the Territory, as the same shall be amended from time to time.

     1.7 “Quarter” shall refer to the quarterly periods ending March 31, June 30, September 30 and
December 31.

     1.8 “Specifications” shall mean the specifications for the Product set forth in the Product
Registration or other approval to market the Product in the Territory, as the same may be amended
from time to time and the specifications listed on Exhibit 1.8.

     1.9 “Territory” shall mean the People’s Republic of China.[Note: Hong Kong and Macau will be
addressed later in an amendment to this Agreement]

	2.	 	Regulatory Filings and Cooperation.

     2.1 Termination of Prior Distributor. As of the date of this Agreement, the distribution
rights for the Product in the Territory are currently in the hands of a third party. CTS, with the
assistance of Distributor, shall use its best efforts to terminate such distribution rights within
[30 days] of the date hereof.

     2.2 Certificate of Termination. As soon as possible following such termination, CTS will
provide an authorized officer’s certification certifying that (a) such termination is effective and
(b) to CTS’s best knowledge, there are no claims or cause of actions threatened or filed in
connection with such terminated relationship. The date Distributor receives such certification
shall be the “Commencement Date.”

     2.3 Commencement Date. This Agreement shall become effective on the Commencement Date.

     2.4 Product Registration. Within the ten (10) days of the Commencement Date, CTS shall, at
CTS’s expense, provide an authorized officer’s certification certifying that the Product
Registration is held solely by CTS.

     2.5 Exclusive Distributorship. Within twenty (20) days of the Commencement Date, CTS shall
(a) notify the relevant governmental authorities of the Territory of the existence

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and terms of this Agreement (as required by the laws or regulations of the Territory) and name
Distributor as its exclusive distributor for the Product in the Territory and (b) provide
Distributor a certified copy of such notification to the relevant governmental authorities

     2.6 Up-Front Payment. In consideration for the grant of exclusive rights under this
Agreement, Distributor shall pay CPSI the amount of Five Hundred Thousand Dollars ($500,000) by
wire transfer to a bank account designated by CPSI within ten (10) days of receipt of the certified
copy of the notification referred to in Section 2.5(b).

     2.7 Maintenance. Distributor shall maintain the Product Registration in the Territory at
Distributor’s expense.

     2.8 Cooperation. CTS shall provide (a) cooperation and support to Distributor in connection
with maintenance of the Product Registration and (b) all required information (including
Confidential Information) that is necessary or useful for the development and/or marketing the
Product. Subject to Section 7.1, Distributor may freely use such information, whether Confidential
Information or not, for the purpose of developing and marketing the Product. In such case,
Distributor shall provide promptly to CTS a summary in English, at Distributor’s expense, of all
material governmental and regulatory submissions prior to the time they are filed.

     2.9 Reporting. Distributor shall keep CTS fully informed of developments that might have a
material adverse effect on the Product Registration or the general regulatory strategy for the
Product in the Territory.

	3.	 	Trademarks and Trade Names.

     As between CTS and Distributor, CTS shall own or control all trademarks and trade names to the
Product held by CTS that Distributor may determine to use in the marketing, promotion and sales of
the Product in the Territory and shall register and maintain such trademarks at its own cost. CTS
hereby grants Distributor an exclusive, royalty-free license for the Territory to the trademarks
“Propess” and “Cervidil” for use exclusively in connection with the Product during the term of this
Agreement. In addition to other specifications and/or requirements, CTS represents and warrants
that the Product shall be of at least the same level of quality as products distributed under the
same trademarks in other jurisdictions. The parties agree to cooperate on the selection,
registration and maintenance of any other trademark or name under which Distributor may choose to
market the Product.

	4.	 	Product.

	 	4.1	 	Purchase and Sale.

          (a) Purchase and Sale of Product. From and after the Commencement Date and during the
term of this Agreement and subject to the provisions of Article 5 hereof, (i) CTS shall sell to
Distributor; and (ii) Distributor shall purchase from CTS such quantities of Product as Distributor
shall require for the marketing and sale of the Product in the Territory, provided, that
CTS shall not be obligated to sell to Distributor during any Quarter quantities of Product in
excess of 125% of the quantities specified by Distributor in its forecast provided pursuant to
Section 5.4 hereof, so long as CTS uses reasonable commercial efforts to supply such excess
quantities. In the event of a Product shortage, CTS shall allocate its available supply among
Distributor and its other distributors on a basis at least as favorable to Distributor as to CTS’s

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other customers, Affiliates and/or own requirements. All Product sold by CTS to Distributor
hereunder shall be packaged in bulk finished form as described below, in compliance with all
applicable law and regulatory requirements in the Territory. For purposes of this Agreement, bulk
finished form shall mean the Product in its finished form, packaged in a foil overwrap, ready for
packaging in its final commercial package by Distributor. Distributor shall supply any artwork
required for labeling of the foil overwrap.

          (b) Responsibilities. CTS shall (i) be responsible as provided in this Agreement for
all Product supplied by it even if such Product is manufactured, in whole or in part, for CTS by
third parties or its Affiliates, and (ii) guarantees and warrants the related performance of any
responsibilities so delegated, and assumes full vicarious liability for any such Affiliate or third
party sublicensee, subcontractor or permitted designee.

          (c) Sales Restriction. Distributor shall not solicit nor accept orders for the
Product from outside the Territory. If Distributor receives an order for Product from a
prospective purchaser other than customers whose principal place of business is within the
Territory, Distributor shall immediately refer that order to CTS. Distributor shall not accept any
such orders. Without limiting the generality of the foregoing, Distributor may not deliver or
tender (or cause to be delivered or tendered) Product outside the Territory, nor sell any Product
to a purchaser within the Territory if Distributor knows that such purchaser intends to remove such
Product from the Territory.

          (d) Overdue Payments. Any undisputed amount not paid when due under this Agreement,
including, without limitation, under Section 5.1 hereof, shall bear interest at the lesser of (i)
1.5% per month, compounded monthly, or (ii) the highest rate permitted by applicable law.

          (e) Set-off Rights. Any amount payable to CTS under this Agreement including, without
limitation, under Section 4.1(d) and Section 5.1 hereof, may be reduced due to any counterclaim,
set-off, adjustment or other right which Distributor might have against CTS, any other party or
otherwise.

	 	4.2	 	Limited Warranties.

          (a) CTS warrants to Distributor that the Product delivered to Distributor: (i) shall conform
with the Specifications and shall have a shelf life of not less than 24 months from the date of
manufacture; (ii) shall be manufactured, stored, packaged and shipped in accordance with the
Product Registration and all laws and regulations applicable thereto (including, without
limitation, a manufacturer’s authorization and an export certificate (“Certificate of a
Pharmaceutical Product”) issued by the U.K. Medicines and Healthcare Products Regulatory Agency
(“MHRA”), a pro forma copy of which is attached hereto as Exhibit 4.2); and (iii) shall be
manufactured in a facility or facilities which comply with all applicable regulatory requirements,
including current GMP regulations of the U.S. FDA, the MHRA and the relevant regulatory authorities
in the Territory.

          (b) CTS’ liability for breach of its obligations under this Section 4.2 shall be as set forth
in Section 4.3 hereof. EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY
MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, CONCERNING THE
SUCCESS OR POTENTIAL SUCCESS OF THE DISTRIBUTION OR SALE OF THE

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PRODUCT. EXCEPT FOR THE CONTRACTUAL PROVISIONS EXPRESSLY SET FORTH IN THIS AGREEMENT, CTS
EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, WRITTEN OR ORAL, WITH RESPECT TO THE
PRODUCT, INCLUDING, BUT NOT LIMITED TO, ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.

	 	4.3	 	Inspection; Replacement or Credit.

          (a) Claims relating to quality defects in the Product supplied by CTS shall be submitted to
CTS within a reasonable time, not to exceed 90 days, after Distributor or any of its Affiliates or
sub-distributors hereunder has accepted delivery of the Product. CTS shall use its best efforts to
replace free of charge the defective quantities of the Product within 30 days from the date of
Distributor’s request for replacement or, at Distributor’s option, to provide a credit against
future purchases of the Product.

          (b) In the case of Product with defects not readily discoverable (1) prior to the shipment of
any Product to Distributor or (2) within the 90 day period specified in Section 4.3(a), each party
shall notify the other party of any such defects discovered by such party promptly following such
party’s discovery thereof. Such Products shall be treated the same as the non-conforming Products
set forth in Section 4.3(a).

     4.4 Manufacturing Facilities. CTS shall not change or alter the facilities at which the
Product is manufactured pursuant to the Product Registration, without giving Distributor reasonable
prior written notice of, and obtaining the prior approval of the applicable regulatory agencies to,
such change or alteration. CTS shall be responsible for the performance of all tests or studies
and related regulatory work and costs incurred as a result of any change or alteration described in
this Section 4.4.

     4.5 Labeling; Secondary Packaging. Distributor shall suitably label the Product in accordance
with the applicable laws of the Territory, shall reasonably note on such packaging that the Product
is manufactured by CTS and, after consultation with CTS, shall mark packaging or pack inserts with
patent numbers and appropriate additional information, consistent with the administrative guidance
of the Ministry of Health of the People’s Republic of China (“MHPRC”), unless such additional
information is not allowed under the administrative guidance of the MHPRC. Any trade dress (and
all goodwill associated therewith) utilized by Distributor to use in the marketing, promotion and
sales of the Product in the Territory (the “Secondary Packaging”) shall be solely owned by
Distributor, who shall be responsible for complying with the applicable laws in connection with
such Secondary Packaging. Distributor hereby grants to CTS the right to use the Secondary
Packaging solely for the purpose of performing its obligations under this Agreement; provided that
such right shall automatically terminate upon the termination or expiration of this Agreement.

	5.	 	Purchase Price; Terms of Purchase; Annual Forecasts; Taxes.

     5.1 Purchase Price. The price per unit to be paid by Distributor is set out in Exhibit 5.1
and is subject to annual increases beginning in 2006 of an amount not to exceed the annual increase
in the United Kingdom Consumer Price Index for the preceding calendar year, as published in the
Financial Times or other mutually-agreed source. All sums due under this Agreement shall
be payable in British Pounds.

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     5.2 Samples. CTS shall supply Distributor with such quantities of Product free of charge
necessary for Distributor to conduct a reasonable number of seeding or promotional trials.
Distributor shall conduct any such trials in accordance with a protocol approved by CTS and shall
make all data available for use by CTS. In addition, during the first Contract Year, CTS shall
provide samples of the Product to Distributor at no charge in support of Distributor’s marketing
efforts equal to the number of obstetricians on whom Distributor calls (not to exceed 300 units of
Product). In addition, during the second Contract Year, CTS shall provide quantities of the
Product to Distributor at no charge equal to five percent (5%) of Distributor’s purchases of
Product. Such samples shall be marked clearly as such and shall be used as samples, not as Product
for resale.

     5.3 Terms of Purchase. The Purchase Price shall be on the basis F.O.B. East Kilbride,
Scotland (Incoterms 2000 Invoices shall be rendered at the time of shipment. Payments by
Distributor shall be by wire transfer to an account designated by CTS from time to time and shall
be net 30 days from the shipment date, it being understood that the shipment date shall mean
delivery into the hands of a common carrier selected by Distributor from among CTS’s known and
approved carriers. CTS shall arrange for the delivery of Product to Distributor’s (or its
agent’s) designated facilities as stated on the purchase order and in a manner consistent with good
commercial practices, and in accordance with any agreed-upon shipping specifications. With each
shipment of Product, CTS shall provide Distributor with commercially appropriate shipping
documentation, including bills of lading, and with such certificates of analysis and other
appropriate documentation identifying the applicable batch numbers, indicating conformance of the
shipment with the Specifications, and all regulatory standards, and, at Distributor’s request, CTS
shall provide Distributor with reasonable access to any applicable supporting data

     5.4 Forecasts; Orders. Distributor’s projected sales of the Product during the initial term
of this Agreement are set out in Exhibit 5.4. Distributor shall, from and after the Commencement
Date, deliver to CTS not later than 60 days before the beginning of each Quarter a written
declaration containing a good faith estimate of (i) Distributor’s requirements of Product for the
ensuing four Quarters; and (ii) the quantity of Product to be shipped to Distributor during each
Quarter during such period. Distributor shall submit its estimate for the first Contract Year on
the Commencement Date and shall order not less than 5,000 single units of Product, a quantity
estimated by Distributor as sufficient to cover the first six months of sales. All subsequent
orders shall be in lots of not less than 1,000 single units. Not later than 60 days before the
beginning of each Quarter, Distributor shall furnish CTS with a binding order stating the
quantities of Product to be purchased hereunder during such Quarter and Product shall be shipped in
such manner to assure its arrival at the facilities of Distributor by the delivery dates specified
in such written declaration.

	6.	 	Representations, Warranties and Covenants.

     6.1 CPSI and CTS Representation and Warranties. CPSI and CTS hereby represent and warrant to
Distributor as follows:

          (a) The execution and delivery by CTS of this Agreement and the performance by CTS of its
obligations hereunder have been duly authorized by all necessary

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corporate action on the part of CTS, and do not conflict with the terms of any other contract,
agreement, arrangement or understanding to which CTS is a party.

          (b) The BTG License Agreement remains in full force and effect in accordance with its terms
and CTS has a right to manufacture and sell the Product and to grant the distributorship
exclusively to Distributor in accordance with the terms hereof. CTS is not and will not be in
material breach of the BTG License Agreement. As of the Commencement Date, (i) the license granted
to CTS under the BTG License Agreement is valid and enforceable and CTS has no knowledge that any
third party is infringing any of its rights under the BTG License Agreement, and (ii) with respect
to the Product, to the best of CTS’s knowledge, there are no blocking patent rights or similar
intellectual property rights of a third party that could prevent the marketing, promotion or sale
of the Product by Distributor in the Territory and CTS has no knowledge that the making, using or
selling of the Product as a product would infringe the patent rights of any third party.

          (c) Except as set forth herein, no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or filing with, any federal, state or local
governmental authority is required on the part of CTS in connection with the valid execution,
delivery and performance of this Agreement, where the failure to obtain any of the foregoing would
not have a material adverse impact on the ability of CTS to meet its obligations hereunder.

          (d) CTS (i) has furnished Distributor with all material information requested by Distributor
concerning the quality, toxicity, safety and/or efficacy concerns that may materially impair the
utility and/or safety of the Products and (ii) is and will be in compliance through the term of
this Agreement in all material respects with all laws, rules and regulations applicable to its
performance under this Agreement.

          (e) CTS will not, during the term of this Agreement, grant any rights inconsistent with the
rights and licenses granted to Distributor herein.

     6.2 Distributor Representations and Warranties. Distributor hereby represents and warrants to
CTS as follows:

          (a) The execution and delivery by Distributor of this Agreement and the performance by
Distributor of its obligations hereunder have been duly authorized by all necessary corporate
action on the part of Distributor, and do not conflict with the terms of any other contract,
agreement, arrangement or understanding to which Distributor is a party.

          (b) Distributor has received from CTS such information with respect to the Product as
Distributor has deemed necessary to make its decision to proceed to enter into this Agreement. The
foregoing shall not be deemed a limitation upon any representation or warranty of CTS set forth
herein.

          (c) Except as set forth herein, no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or filing with, any federal, state or local
governmental authority is required on the part of Distributor in connection with the valid
execution, delivery and performance of this Agreement, where the failure to obtain any of the
foregoing would not have a material adverse impact on the ability of Distributor to meet its
obligations hereunder.

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          (d) Distributor is and will be in material compliance throughout the term of this Agreement
with all of the applicable regulatory requirements relating to the Product in the Territory,
including, without limitation and where relevant and applicable, all guides, guidelines and
guidance documents published by regulatory authorities and trade associations.

     6.3 Regulatory Cooperation.

          (a) The parties shall disclose to each other all reports or other knowledge they receive with
respect to adverse drug experiences in accordance with the Standard Operating Procedure attached
hereto as Exhibit 6.3, as the same shall be amended from time to time in writing by mutual
agreement, and reports of mislabeling, stability failures or microbiological contamination.

          (b) In addition to and without limiting the requirements of Section 6.3(a) above, Distributor
and CTS agree, throughout the duration of this Agreement, to notify the other party immediately, of
any information concerning any serious or unexpected side effect, injury, toxicity or sensitivity
reaction, or any unexpected incidents, and the severity thereof, associated with the clinical uses,
studies, investigations, tests and marketing of the Product, whether or not determined to be
attributable to the Product. “Serious”, as used in this Section 6.3(b), refers to an experience
which is life-threatening or results in death, permanent or substantial disability, in-patient
hospitalization, or prolongation of hospitalization, or produces a congenital anomaly.
“Unexpected”, as used in this Section 6.3(b), is one that is not listed in the current labeling for
the Product and includes an event that may be symptomatically and pathophysiologically related to
an event because of increased frequency, greater severity or specificity. Each party shall
cooperate with the other to resolve complaints received by the other party with respect to any
Product.

          (c) Each of Distributor and CTS shall promptly deliver to the other all material
correspondence that such party may receive, directly or indirectly, from regulatory authorities in
jurisdictions where such party has rights to market the Product, except for procedural,
non-substantive communications which do not relate to the safety or efficacy of the Product.
Distributor and CTS also shall immediately notify the other party about any information such party
receives regarding any threatened or pending action by a governmental agency that may affect the
safety and efficacy claims of the Product or the continued marketing, promoting, distribution, sale
or manufacture of the Product. Upon receipt of any such information, the parties shall consult in
an effort to arrive at a mutually acceptable procedure for taking appropriate action,
provided, that nothing contained herein shall be construed as restricting either party’s
right to make a timely report of such matter to any governmental or regulatory agency or take other
action that it deems to be appropriate or required by applicable law or regulation. It is
Distributor’s responsibility to report adverse events in accordance with local laws and
requirements to governmental or regulatory agencies in the Territory

          (d) Without limiting the foregoing, it is also understood that each party may notify any of
its Affiliates, distributors or sub-distributors of any incident or event reported by either party
under this Section 6.3. In addition, each party shall, and shall require its respective Affiliates
to: (i) to the extent permissible under time constraints and reporting requirements, provide to
the other party in advance of initial or periodic submission to the applicable regulatory
authorities any and all adverse event reports from clinical trials and commercial experiences with
the Product; (ii) provide such adverse event reports to the other party contemporaneously with

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the provision of such reports to the applicable regulatory authority; and (iii) adhere to all
requirements of applicable laws, rules and regulations which relate to the reporting and
investigation of adverse events and keep the other party informed of such events. If a party
contracts with a third party for research to be performed by such third party on any of the
Products, that party shall require such third party to report to the contracting party the
information set forth above.

     6.4 Product Recalls. In the event (i) any governmental or regulatory authority issues a
request, directive, or order that any Product be recalled or withdrawn, (ii) a court of competent
jurisdiction in a final, non-appealable judgment orders a recall or withdrawal of any Product, or
(iii) CTS or Distributor determines that a Product should be recalled or withdrawn, in its sole
judgment exercised in good faith, the parties shall take all appropriate corrective actions to
effect the recall or withdrawal in the Territory. The costs and expenses of notification and
destruction or return of the recalled or withdrawn Product shall be borne by Distributor if the
cause of the recall or withdrawal is attributable to Distributor and by CTS if the cause of the
recall or withdrawal is attributable to CTS and if there is a dispute as to the cause which cannot
be resolved by mutual consultation, such dispute shall be submitted to arbitration pursuant to
Section 18.2 hereof. In the event that Distributor fails to recall or withdraw the Product as
required by this Section 6.4, Distributor shall indemnify CTS from any incremental claims, damages
or losses of any nature which CTS incurs as a direct result of such failure to withdraw or recall
such Product. In the event that CTS fails to recall or withdraw the Product as required by this
Section 6.4, CTS shall indemnify Distributor from any claims, damages or losses of any nature which
Distributor incurs as a direct result of such failure to withdraw or recall such Product.

          (a) Compliance with Laws. Both parties shall materially comply with all applicable laws,
rules and regulations of the Territory applicable to the supply, development, testing, marketing,
promotion, storage, import, distribution and sale of Product.

     6.5 Access to Facilities. The Parties shall grant to each other’s representatives and/or the
governmental or regulatory authorities of the Territory reasonable access from time to time from
and after the Commencement Date to (a) areas of facilities (or facilities of contractors,
subcontractors and Affiliates) in which the Product is or is to be manufactured, packaged, tested,
labeled, stored or shipped and (b) the records (including batch records) being maintained in
connection with the manufacture or packaging of the Product at the facilities (the “Manufacturing
Records”) for the purpose of confirming the readiness of such facilities for the manufacturing or
packaging operations contemplated hereby and compliance of such operations with the representations
made herein. Such inspections and audits shall be conducted at the inspecting Party’s sole cost and
expense and in a manner so as to minimize disruption of the other Party’s business operations.
Except as required by any applicable law or as otherwise provided in this Agreement, neither Party
shall not be entitled to conduct more than one inspection and audit during each Contract Year of
the manufacturing or packaging facility and of the Manufacturing Records, without the prior written
approval of of the other Party, such approval not to be unreasonably withheld. The inspecting Party
shall be responsible for ensuring that each designee or representative of of such Party that
conducts an inspection and audit of the manufacturing or packaging facility or the Manufacturing
Records shall comply with the confidentiality obligations set out in Article 7 of this Agreement.

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     6.6 Sales and Inventory Reporting. Not later than thirty (30) days after the end of each
Quarter, Distributor shall report sales of the Product, in units and values, in the Territory for
that Quarter. In addition, the report shall provide a reconciliation of units of the Product
purchased from CTS, unit sales, samples or free goods distributed and beginning and ending
inventory.

     6.7 Compliance with BTG License Agreement. CTS shall promptly take all steps necessary or
desirable to comply with CTS’s obligations under the BTG License Agreement. Upon reasonable and
timely request from CTS, Distributor shall promptly take all reasonable steps required hereunder
necessary to enable CTS to meet its obligations (other than financial obligations) to BTG under the
BTG License Agreement.

     6.8 Notices. Distributor shall promptly provide CTS with a summary in English of any notices
directly or indirectly given or received by Distributor in connection with any subject matter of
this Article 6.

	7.	 	Confidentiality.

     7.1 Obligations of Confidentiality. Subject to Article 2, the parties shall keep in strictest
confidence all Confidential Information and shall not disclose such Confidential Information to any
third person except directors, officers, employees, consultants or other agents who need to receive
such Confidential Information for the purpose of achieving an objective of this Agreement and who
are bound by obligations of confidentiality with respect thereto, as necessary in connection with
the transactions provided for or contemplated hereby, or as otherwise may be required by law. Each
such party shall exercise reasonable precautions to safeguard the secrecy of Confidential
Information and to prevent the unauthorized disclosure thereof. Nothing contained herein shall be
deemed to prevent any party from responding to requests or inquiries of or from any regulatory
authority in the Territory, provided that such party has notified the other parties in advance of
such request or inquiry and the nature and substance of any proposed reply. The parties shall be
obligated to resolve any matter relating to any such proposed reply prior to its submission to the
regulatory authority in question in the event any party objects to any aspect thereof.

     7.2 Use of Confidential Information. Subject to Section 7.1, Distributor shall have the
right to use all Confidential Information hereafter developed by, or coming into the possession of,
CTS for use in marketing, promotion and distribution of the Product in the Territory.

     7.3 Disclosure of Confidential Information by CTS. Notwithstanding any other provision of
this Article 8, Distributor acknowledges and agrees that CTS has certain obligations to disclose
Confidential Information to BTG under the BTG License Agreement and that such disclosures are
permitted hereunder and shall not constitute a breach of Section 7.1 hereof; provided that BTG is
subject to the same confidentiality obligations (as set forth in Section 8.1) to Distributor.

     7.4 Certain Confidential Information. Notwithstanding anything to the contrary, if a
disclosing party has not filed a necessary patent application with respect to any applicable
Confidential Information, it may require the receiving Party to delay the proposed authorized or
required disclosure (to the extent the disclosing party may legally do so), for up to ninety (90)
days, to allow for the filing of such an application.

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	8.	 	Marketing Obligation; Covenant not to Compete; Indemnity.

     8.1 Marketing Obligations. At all times during the term hereof following the Commencement
Date, Distributor shall, at its own expense, use reasonable commercial efforts, subject to material
compliance with all applicable laws and regulations, to promote and market the Product in the
Territory.

     8.2 Covenant Not to Compete. During the term hereof following the Commencement Date for so
long as its distributorship rights hereunder remain exclusive, Distributor shall not market
directly in the Territory products that are competitive with the Product. For purposes of this
Section 8.2, a product shall only be deemed “competitive” with the Product if it is (a) labeled for
the same indication as the Product is approved in the Territory and (b) sold in the same marketing
channel as the Product. Notwithstanding the provisions of this Section 8.2 or any other provisions
hereof, Distributor may conduct research and development of any competitive product and, if
successful, may produce and market such product provided that Distributor shall, prior to receipt
of regulatory approval in the Territory, notify CTS of its intention to market such product in the
Territory. Distributor agrees, at the request of CTS, to discuss in good faith the possible grant
of licenses for such product to CTS outside the Territory, or another contractual arrangement,
including the amendment of this Agreement, to reasonably compensate CTS for the effect such
competitive product has on CTS’ rights hereunder.

     8.3 Indemnity.

          (a) CPSI and CTS shall indemnify and hold Distributor harmless from and against any direct
costs, expenses (including, without limitation, reasonable attorneys fees) or damages which arise
from breach by CTS of any of its representations, covenants, warranties or obligations set forth
herein, including without limitation, any claims in connection with (i) sales of the Product
outside of the Territory, (ii) any patent infringement relating to the manufacturing of the
Product, (iii) Products sold by CTS’s prior distributor in the Territory, (iv) CTS’s breach of the
BTG License Agreement, (v) CTS’s prior distributor in the Territory against Distributor and (v) the
Product prior to the Commencement Date; except to the extent such damages are caused by or arise
from: (x) the negligence or willful misconduct of Distributor; or (y) any matter as to which
Distributor has agreed to indemnify CTS hereunder.

          (b) Distributor shall indemnify and hold CTS harmless from and against any direct costs,
expenses (including, without limitation, reasonable attorneys fees) or damages which arise from the
breach by Distributor of any of its representations, covenants, warranties or obligations set forth
herein or from the marketing, sale or distribution of the Product by Distributor and its Affiliates
and sub-distributors, except to the extent such damages were caused by or arise from: (i) the
negligence or willful misconduct of CTS; or (ii) any matter as to which CTS has agreed to indemnify
Distributor hereunder. The party obligated to provide indemnity pursuant to this Section 8.3 is
hereinafter referred to as the “Indemnifying Party”.

     8.4 Indemnification Procedure

          (a) Promptly after the receipt by any party hereto of notice of (a) any claim or (b) the
commencement of any action or proceeding, such party will, if a claim with respect thereto is to be
made against any party obligated to provide indemnification pursuant to Section 8.3 hereof, give
such Indemnifying Party written notice of such claim or the commencement of such action or
proceeding. Such Indemnifying Party shall have the right, at its option, to

11

 

compromise or defend, subject to Section 8.4(c) below, at its own expense and by its counsel,
any such matter involving the asserted liability of the party seeking such indemnification. Such
notice, and the opportunity to compromise or defend, shall be a condition precedent to any
liability of the Indemnifying Party under the indemnification provisions of Section 8.3. In the
event that any Indemnifying Party shall undertake to compromise or defend any such asserted
liability, it shall promptly notify the party seeking indemnification of its intention to do so,
and the party seeking indemnification agrees to cooperate fully with the Indemnifying Party and its
counsel in the compromise of, or defense against, any such asserted liability. In any event, the
indemnified party shall have the right, at its own expense, to participate in the defense of such
asserted liability, provided, that the Indemnifying Party’s counsel shall make all final
decisions concerning the defense or, subject to Section 8.4(c) below, compromise or settlement of
such litigation.

          (b) Each of the parties hereto shall be entitled to be represented at any proceedings brought
against the other party under this Article 8 by its own counsel, at its own expense, and shall
cooperate fully with the other party in any such proceeding, provided, it is adequately
reimbursed for its out-of-pocket costs and expenses, excluding attorneys’ fees.

          (c) Distributor may not settle a claim described in this Article 8 in a manner which would
impose upon CTS or BTG any monetary obligation or require CTS or BTG to submit to an injunction or
otherwise limit its rights in respect of any patents, in each case, without the prior written
consent of CTS or BTG, which consent shall not be unreasonably withheld, conditioned, or delayed.

9. Term.

     This Agreement shall be deemed to expire upon the date which is five (5) years from the
Commencement Date (the “Initial Term”), provided, however, that this Agreement shall be
automatically renewed for additional consecutive periods of two (2) years each (the “Renewal Term”)
unless either party gives notice to the other not less than six (6) months prior to the end of the
Initial Term or of any Renewal Term.

	10.	 	Termination.

     10.1 Termination for Breach. In the event of any material default by either party in the
performance of any of the terms and conditions of this Agreement, the other party may terminate
this Agreement upon ninety (90) days written notice; provided, that (i) if during such
ninety (90) day period the party against whom the material default is claimed cures such default,
(ii) if such breach cannot be cured within such ninety (90) day period, such party takes reasonable
steps to commence and proceeds diligently thereafter to cure such default and, in fact, cures such
default within a reasonable period of time, or (iii) if such default is cured in any other manner
satisfactory to the other party as a substitute for full performance, then this Agreement will
continue in full force and effect until it expires as provided in Article 9.

     10.2 Termination for Bankruptcy, etc. Either party shall be entitled to terminate this
Agreement immediately:

               (i) if any creditor of the other party or any other person levies or attempts to levy any
distress, execution, sequestration or other process over the business assets of

12

 

the other party or an encumbrancer takes or attempts to take possession over the business or
assets of the other party;

               (ii) if a petition shall be presented for the winding up of the other party or if a meeting is
convened for the purpose of passing a resolution for the winding up of the other party;

               (iii) if a receiver, administrative receiver, manager, trustee or administrator shall be
appointed over all or any part of the business or assets of the other party;

               (iv) if the other party or any director or creditor of such other party shall present a
petition to the court for an administrative order in respect of such other party;

               (v) if the other party shall convene a meeting of its creditors or shall make any proposal for
or enter into any compromise, composition or scheme of arrangement with its creditors or make any
assignment for the benefit of its creditors;

               (vi) if the other party shall be deemed to be unable to pay its debts within the meaning of
any relevant insolvency law or any relevant insolvency decree or regulation (or any statutory
amendment or re-enactment thereof); or

               (vii) if any event analogous to the foregoing shall occur under the laws of any relevant
jurisdiction.

     10.3 Termination for Force Majeure Event. Notwithstanding anything to the contrary contained
in this Agreement, in the event a force majeure event shall have occurred and be continuing for one
hundred eighty (180) consecutive days, the party not suffering such force majeure event shall be
entitled to terminate this Agreement effective immediately upon written notice to the party
suffering such force majeure event.

     10.4 Termination by Distributor.

          (a) In the event that CTS fails to provide the documents set forth in Sections, 2.2, 2.4 and
2.5 on or prior to December 31, 2005, Distributor may terminate this Agreement upon 30 days’
written notice to CTS. Notwithstanding the above, the deadline provided in the previous sentence
shall be extended by the occurrence of an event of force majeure as described in Section 11.2
(subject to Section 10.3). The deadline may also be extended with the consent of Distributor, if
the delay is inevitable despite CTS’s bona fide efforts (though not constituting an event of force
majeure), in which event Distributor shall not withhold such consent unreasonably.

     10.5 Termination by CTS

          (a) In the event Distributor materially breaches any of its obligations under this Agreement,
CTS may terminate this Agreement upon 30 days’ written notice to Distributor. Notwithstanding the
above, the deadline provided in the previous sentence shall be extended by the occurrence of an
event of force majeure as described in Section 11.2 (subject to Section 10.3). The deadline may
also be extended with the consent of CTS, if the delay is inevitable despite Distributor’s bona
fide efforts (though not constituting an event of force majeure), in which event CTS shall not
withhold such consent unreasonably.

          (b) CTS shall also have the right to terminate this Agreement upon 30 days’ written notice in
the event Distributor fails to purchase Product representing less than 75% of the

13

 

projected sales set out in Exhibit 5.4 during any two consecutive Contract Years during the
term of this Agreement.

     10.6 Effect of Expiration or Termination.

          (a) No expiration or termination of this Agreement pursuant to Article 9 hereof or this
Article 10 shall relieve either party of obligations accrued to such date of expiration or
termination or of obligations which continue by the terms hereof beyond such expiration or
termination, including but not limited to any payment obligations hereunder and any obligations
under Sections 4.1c, 4.1d, 4.1e,8.3, 8.4, 11.1 and Article 7.

          (b) Except in cases of the termination of this Agreement for a force majeure event or as
otherwise expressly set forth in this Agreement, the termination of this Agreement shall not affect
purchase orders placed by Distributor and accepted by CTS at the time notice of termination is
given and until the time any such termination becomes effective. Except as expressly set forth in
this Agreement, Distributor shall have no liability to CTS for any costs that CTS may have incurred
(or to which CTS may be committed) in connection with materials used by CTS in the manufacturing or
packaging of Product prior to the effectiveness of any notice of termination.

          (c) Payments of undisputed amounts owing to either party under this Agreement as of its
expiration or termination shall be due and payable within sixty (60) days after the date of such
expiration or termination.

          (d) Within thirty (30) days following the of termination of this Agreement, each party shall
destroy or return to the other party all tangible items bearing, containing or contained in any of
the Confidential Information of the other party, and shall provide the other party written
certification of such destruction or return.

          (e) Distributor shall cease manufacturing, processing, producing, using, or selling Products;
provided, however, that Distributor may continue to sell in the ordinary course of business for a
period of six (6) months reasonable quantities of Products which are fully manufactured and in
Distributor’s normal inventory at the date of termination. CTS shall purchase thereafter any
remaining Product in Distributor’s inventory at the original purchase price, together with any
shipping costs and applicable taxes.

11. Specific Performance; Force Majeure.

     11.1 Equitable Relief. Each party agrees that a violation by it of any of its covenants and
undertakings contained in this Agreement will cause irreparable injury to the other, and that such
other party shall be entitled, in addition to any other rights and remedies it may have hereunder
at law or at equity, to an injunction or similar equitable remedy enjoining and restraining any
such violation or threatened violation thereof.

     11.2 Force Majeure. Subject to Section 10.3, neither CTS nor Distributor shall be held liable
or in default for failure of performance for any cause beyond its reasonable control including, for
example, Acts of God, declared or undeclared war, fire, flood, interruption of transportation,
embargo, insurrections, accident, explosion, governmental laws, orders, regulations, or
restrictions interfering with the production or transportation of the Product.

14

 

12. Further Assurances.

     Each of the parties shall, from time to time during the term of this Agreement, upon request
by the other, execute and deliver all such further documents or instruments as may be required in
order to give effect to the purpose and intent of this Agreement. Without limiting the generality
of the foregoing, the obligations of the parties hereunder are undertaken with a principal
objective of complying with all pertinent provisions of applicable laws, orders and regulations
relating to the manufacture, use or sale of pharmaceutical products, and the parties shall take all
necessary action as may be required to comply with such provisions.

13. Assignment.

     This Agreement shall be binding upon and inure to the benefit of the parties hereto and their
respective assignees and successors in interest. Neither party shall assign its rights or
obligations hereunder, except with the prior written consent of the other party, which consent
shall not be unreasonably withheld, conditioned, or delayed, except in connection with the sale of
all or substantially all of its assets. Any purported assignment in violation of this Section 14
shall be void. Any permitted assignee shall assume all obligations of its assignor under this
Agreement. No assignment shall relieve either party of responsibility for the performance of any
accrued obligation that such party then has hereunder.

14. Choice of Law.

     This Agreement shall be governed by, and construed in accordance with, the laws of the State
of Delaware, USA, without giving effect to its principles of conflicts of laws.

15. Notices.

     Any notice, request or other communication required or permitted by this Agreement to be given
by any party to another party shall be in writing and either mailed by registered or certified
mail, return receipt requested, by express delivery service or by facsimile transmission, addressed
to such party, Attention: the Managing Director, at its address indicated above or to such other
address as such party previously may have designated by like written notice. Notice shall be
deemed to have been given upon receipt. Facsimile transmission numbers for the parties are as
follows:

If to Distributor:                      + 1 610 940 1676

If to CPSI/CTS:                      +(610) 687-4340

16. Threatened Litigation

The parties agree to notify each other promptly of any threatened or pending litigation related to
the Product in the Territory.

17. Miscellaneous.

     17.1 Entire Agreement. This Agreement constitutes the entire agreement between the parties
with respect to the subject matter hereof and supersedes all prior written or oral agreements or
understandings regarding the subject matter hereof or in conflict with its terms.

15

 

     17.2 Arbitration. Except as otherwise provided in Section 11.1, the parties hereto hereby
agree to perform the terms of this Agreement in good faith, and to attempt to resolve any
controversy, claim a dispute arising hereunder in good faith. Any dispute regarding the validity,
construction, interpretation or performance of this Agreement (other than any provisions, hereof
relating to any intellectual property, rights, or the confidentiality obligations contained in
Article 7 hereof) shall be submitted first to the Parties’ respective chief executive officers. If
such officers are unable to resolve the dispute within a reasonable time, but in no case longer
than sixty (60) days, then the matter shall be submitted to binding arbitration in the State of
Delaware, U.S.A. to be conducted in accordance with the Arbitration Rules of the American
Arbitration Association (“AAA”); provided however, that nothing in this Section shall be construed
to preclude either party from seeking provisional remedies, including, but not limited to,
temporary restraining orders and preliminary injunctions, from any court of competent jurisdiction,
in order to protect its rights pending arbitration, but such preliminary relief shall not be sought
as a means of avoiding arbitration. Any arbitration hereunder shall be submitted to an arbitration
tribunal made up of three (3) members experienced in or knowledgeable of the biotechnology and
pharmaceuticals industries, one of whom shall be selected by Distributor, one of whom shall be
selected by CTS, and one of whom shall be selected by the other two arbitrators. All arbitration
proceedings shall be conducted in English. The order or award of the arbitrators shall be final
and may be enforced in any court of competent jurisdiction in the Territory or the United States.
The prevailing party in any legal or arbitration action brought by one party against the other
shall be entitled, in addition to any other rights and remedies it may have, to reimbursement for
its expenses incurred thereby, including court costs and reasonable attorneys’ fees. The parties
shall have the right of limited prehearing discovery, including (i) exchange of witness lists, (ii)
exchange of documentary evidence and reasonably related documents, (iii) written interrogatories,
and (iv) subject to the reasonable discretion of the arbitrators and upon good cause shown
depositions under oath of any witnesses who are to be called to testify at the arbitration hearing.
As soon as the discovery is concluded, the arbitrators shall hold a hearing in accordance with the
aforesaid AAA rules.

     17.3 Amendments; Waivers. No modification of any of the terms of this Agreement shall be
deemed valid unless it is in writing and signed by the party against whom such modification is
sought to be enforced. The failure of either party to insist upon the strict performance of any
term of this Agreement or the waiver by either party of any breach under this Agreement shall not
prevent the subsequent strict enforcement of such term nor be deemed a waiver of any subsequent
breach.

     17.4 Severability. In the event any court declares illegal or unenforceable, as written or
applied, any provision of this Agreement, such provision shall be severed and the remaining
provisions of this Agreement shall continue in full force and effect as if such provision had been
deleted or made inapplicable to the situations to which such provision cannot be legally applied.
The parties shall use their best efforts to agree upon a valid and enforceable provision as a
substitute for the severed provision, taking into account the intent of this Agreement.

     17.5 Publicity. No party shall publicly disclose the subject matter or terms and conditions
hereof without the prior consent of the other, except to the extent of disclosure which such party
may be required to make by any applicable law or regulations.

16

 

     17.6 Affiliates. To the extent any obligations or agreements are imposed upon Affiliates of a
party under this Agreement, such party shall cause such Affiliates to fulfill such obligations and
agreements.

     17.7 No Agency. Nothing herein shall be deemed to constitute either party as the agent or
representative of the other party, or both parties as joint venturers or partners for any purpose.
Except as set forth herein, neither party shall be responsible for the acts or omissions of the
other party, and neither party will have authority to act on behalf of, represent or obligate the
other party in any way without prior written authority from the other party.

     17.8 Counterparts. This Agreement may be executed by fax and in one or more counterparts,
each of which shall be deemed to be an original but all of which together shall constitute one and
the same instrument.

     17.9 Language. All written material, correspondence, technical information, notices and all
other written or oral communication supplied by either party hereunder shall be in the English
language.

     17.10 Headings. The headings used in this Agreement have been inserted for convenience of
reference only and do not define or limit the provisions hereof.

*** Reminder of Page Intentionally Left Blank; Signature Page Follows ***

17

 

     IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the day and year
first written above.

	 	 	 	 	 
	 

	 	BEIJING MED PHARM CORPORATION	 	 
	 
	 	 	 	 
	 

	 	MARTYN GREENACRE	 	 
	 

	 	 	 	 
	 

	 	By:	 	 
	 

	 	Name: Martyn Greenacre	 	 
	 

	 	Title: Chairman	 	 
	 
	 	 	 	 
	 

	 	CONTROLLED THERAPEUTICS (SCOTLAND) LIMITED	 	 
	 
	 	 	 	 
	 

	 	DENNIS F. WILLSON	 	 
	 

	 	 	 	 
	 

	 	By:	 	 
	 

	 	Name: Dennis F. Willson	 	 
	 

	 	Title: Director	 	 
	 
	 	 	 	 
	 

	 	CYTOKINE PHARMASCIENCES, INC.	 	 
	 
	 	 	 	 
	 

	 	DENNIS F. WILLSON	 	 
	 

	 	 	 	 
	 

	 	By:	 	 
	 

	 	Name: Dennis F. Willson	 	 
	 

	 	Title: President & CEO	 	 

 

 

Exhibit 1.8

Specifications

10 mg dinoprostone retrievable vaginal insert (delivery system)

	 	 	 	 	 	 	 
	 	 	QUANTITY	 	REFERENCE TO
	INGREDIENT	 	(MG PER INSERT)	 	STANDARDS
	Active Constituent
	 	 	 	 	 	 
	 
	Dinoprostone (Prostaglandin E2)

	 	 	10
± 10	%	 	EP
	Other Constituent(s)
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Hydrogel Polymer Insert, measuring 0.8mm
in thickness, manufactured with:

	 	 	241	 	 	 
	 
	 	 	 	 	 	 
	*Polyethylene Glycol 8000

	 	 	217	 	 	USP — NF
	 
	 	 	 	 	 	 
	1,2,6 Hexanetriol

	 	 	5	 	 	 
	 
	 	 	 	 	 	 
	Dicyclohexylmethane 4,4’-diisocyanate

	 	 	19	 	 	 
	 
	Ferric Chloride

	 	 	0.024	 	 	 
	 
	Polyester Retrieval System

	 	 	245	 	 	 

 

			
	*	 	EU name: macrogol 8000(EP)

19

 

Exhibit 4.2

Copy of Manufacturer’s Authorization and Certificate of a Pharmaceutical Product

(Attached)

20

 

Department of Health

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

Market Towers, 1 Nine Elms Lane, London, SW8 5NQ

Telephone 020-7084-2000          Facsimile 020-7084-2595

Date 13/08/2004

Controlled Therapeutics (Scotland) Ltd

Attn: Mrs S Jeffrey

1 Redwood Place, Peel Park Campus

East Kilbride

Scotland G74 5PB

COMMERCIAL IN CONFIDENCE

Dear Mrs Jeffrey

			
	 	 	 
	MEDICINES ACT 1968:	 	 
	MANUFACTURER’S LICENCE
	 	LICENCE NO. ML/8731/1

	1.	 	A manufacturer’s licence for the purpose of section 8(2) of the Medicines Act 1968
is renewed in accordance with the application dated 14 June 2004. The formal
documents are enclosed.
	 
	2.	 	This licence authorises manufacture and assembly by the licence holder named; if the
business should change hands, the company or person taking over the business will have to
obtain a new licence before commencing the manufacture or assembly of products.
	 
	3.	 	This licence is subject to the limitations specified in the licence and to the statutory
provisions contained in the Regulations listed in Part III of the enclosed documents.
	 
	4.	 	Manufacture and assembly may only be carried out in accordance with the terms of the
relevant product licence, unless a specified exemption applies which allows manufacture and
assembly to take place otherwise than in accordance with a product licence.
	 
	5.	 	This licence relates to the manufacture and assembly of products on the premises and under
the supervision of the persons specified. If any change of premises or of those persons take
place, prior approval must be sought from the Licensing Authority. Any proposal to make
structural alterations to the premises must also be notified to the Licensing Authority.
	 
	6.	 	The Licensing Authority has power to suspend licences if fees are unpaid.

Yours sincerely

Licence Office Supervisor

 

 

MEDICINES ACTS 1968 AND 1971

MANUFACTURING AND ASSEMBLY

MANUFACTURER’S LICENCE NO. ML/8731/1 has been granted under and subject to the provisions of the
Medicines Acts 1968 and 1971 to

Controlled Therapeutics (Scotland) Limited

1 Redwood Place, Peel Park Campus

East Kilbride

G74 5PB

to authorise the holder of the licence to carry out the processes of manufacture and/or
assembly of medicinal products of the description or general classification specified in Part I, at
the premises therein specified, and in accordance with the particulars set out in Part II. The
licence is subject to the further provisions specified in Part III.

The licence, unless previously suspended, revoked or varied as to the period of its validity, will
continue in force until 12 August 2009.

Date granted 13 August 2004.

Medicines and Healthcare products Regulatory Agency

(On behalf of the Department of Health)

Market Towers

1 Nine Elms Lane

Vauxhall

London SW8 5NQ

Page 1

 

MEDICINES ACTS 1968 AND 1971

MANUFACTURING AND ASSEMBLY

MANUFACTURER’S LICENCE NO. ML/8731/1

			
	PART I — 	 	Particulars of the premises, the Manufacturing, and Assembly operations, and the
personnel to which the licence relates. 

	1.	 	The premises at which operations are carried out including those premises where any
testing associated with the operations takes place. 

Controlled Therapeutics (Scotland) Ltd

1 Redwood Place, Peel Park Campus

East Kilbride

Scotland

G74 5PB

	1.1	 	Use of products manufactured and/or assembled on the premises.
	 
	 	 	Products for human use only
	 
	1.2	 	General classification of products manufactured and assembled on the
premises.
	 
	1.2.1	 	Sterile products 

	 	 	 	None

	1.2.2	 	Non-sterile products 

	 	 	 	Solid non-sterile unit-dose forms suppositories/ pessaries
	 
	 	 	 	Non-compressed buccal dose forms. This dosage form is used in clinical
trials only.

	1.2.3	 	Active Ingredients (Biological) produced or handled and appearing in the finished product

	 	 	 	None

	1.2.4	 	Other Active Ingredients produced or handled and appearing in the finished product

	 	 	 	Dinoprostone

Page 2

 

MEDICINES ACTS 1968 AND 1971

MANUFACTURING AND ASSEMBLY

MANUFACTURER’S LICENCE NO. ML/8731/1

PART I (Continued)

	1.3	 	Assembly (only) activities

	 	 	 	None
	 
	 	 	 	Dosage forms assembled

	 	 	 	None

	1.4	 	Other specific processes/activities

	 	 	 	Strip and/or blister packing
	 
	 	 	 	Manufacture for export

 

Except in so far as may be expressly indicated the categories of manufacture or assembly above
do not include the manufacture or assembly of biological products (ie the products the purity and
potency of which cannot be adequately tested by chemical or physical means) or of antibiotics,
sterile products or products for administration by parenteral injection.

 

Page 3

 

MEDICINES ACTS 1968 AND 1971

MANUFACTURING AND ASSEMBLY

MANUFACTURER’S LICENCE NO. ML/8731/1

PART I (Continued)

	 	 	 
	Personnel responsible for operations	 	Name, qualifications
	on the premises	 	and membership of professional body
	on behalf of the licence holder	 	 
	 
	 	 
	1.5 Responsible for
supervising the production operations
	 	 
	 
	 	 
	 

	 	Mr J Jess
	 

	 	B.Sc (Pharm).,
A.R.C.S.T.., 
M.R. Pharm. S
	 
	 	 
	1.6 Responsible for quality control
	 	 
	 
	 	 
	 

	 	Mrs S Jeffrey
	 

	 	B.Sc (Hons)
Microbiology.,
C.I.Biol.,
M.I.Biol.
	 
	 	 
	1.7 Available as “qualified person(s)”
	 	 
	 
	 	 
	 

	 	Mrs S Jeffrey
	 

	 	B.Sc (Hons)
Microbiology., 
C.I.Biol.,
M.I.Biol.
	 
	 	 
	 

	 	Mrs L Wark
	 

	 	B.Sc (Hons) Immunology and

Pharmacology., C.I.Biol., M.I.Biol.

Page 4

 

MEDICINES ACTS 1968 AND 1971

MANUFACTURING AND ASSEMBLY

MANUFACTURER’S LICENCE NO. ML/8731/1

PART II - Other relevant particulars 

	1.	 	Premises used by the licence holder
for storage and handling of materials
and products

Controlled Therapeutics (Scotland) Ltd

1 Redwood Place, Peel Park Campus

East Kilbride

Scotland

G74 5PB

	2.	 	Premises at which analytical testing
takes place

International Laboratory Services

Shardlow Business Park

London Road

Shardlow

Derbyshire

DE72 2GD

Page 5

 

MEDICINES ACTS 1968 AND 1971

MANUFACTURING AND ASSEMBLY

MANUFACTURER’S LICENCE NO. ML/8731/1

PART III - Further provisions 

	1.	 	All the provisions of Schedule 2 of the Medicines (Standard Provisions for Licences
and Certificates) Regulations 1971 (SI 1971 No 972) as amended shall apply to the
licence*.
	 
	2.	 	The responsibilities referred to in Part I shall be undertaken by the persons named therein
or by such other person as may be approved from time to time by the Licensing Authority.
	 
	3.	 	The licence holder’s arrangements for -

	 	(a)	 	the identification and storage of materials and ingredients before and during
manufacture, and for the storage of medicinal products after manufacture or assembly;
	 
	 	(b)	 	ensuring a satisfactory turn-over of stocks of medicinal products;
	 
	 	(c)	 	maintaining records of production, of analytical and other testing procedures, and
a register certified by a qualified person for each batch of proprietary medicines
manufactured;
	 
	 	(d)	 	keeping reference samples of materials used in the manufacture of any medicinal products
and of the medicinal products;

	 	 	shall be in accordance with the particulars contained in or furnished in connection
with the application for this licence, or shall be in accordance with such other
arrangements as may from time to time be approved by the Licensing Authority.

Page 6

 

MEDICINES ACTS 1968 AND 1971

MANUFACTURING AND ASSEMBLY

MANUFACTURER’S LICENCE NO. ML/8731/1

PART III - Further provisions (Continued)

	4.	 	The holder of the licence shall conduct all manufacturing operations in respect of those
products for which a product licence is not required, so as to ensure that the products shall
conform to the standards of strength, quality and purity applicable to them in accordance
with the specification made by the person to whose order they are manufactured or the
specification under which the products are sold or supplied.
	 
	 	 	In relation to such products the holder of the licence shall either:-

	 	(a)	 	provide and maintain such staff, premises and plant as are necessary for carrying out
in accordance with such specification any tests of the strength, quality or purity as
required by that specification or,
	 
	 	(b)	 	make arrangements with a person approved by the Licensing Authority for such tests to
be carried out on his behalf by that person, and
	 
	 	(c)	 	make arrangements for a qualified person to be at all times available for the purpose
of checking that each batch of medicinal products has been manufactured and assembled in
accordance with the appropriate provisions and to certify accordingly in a register.

	5.	 	The manufacture or assembly of any proprietary medicinal product pursuant to this licence
shall not commence until the approval of the Licensing Authority has been given on the
appropriate product licence to use of the site(s) named on this licence for the manufacture
of that product.

 

	*	 	By virtue of section 47 of the Medicines Act 1968 when new standard provisions are made by
regulation, such provisions shall be deemed to be incorporated in existing licences as from
the end of the three months from the date on which the regulations come into operation, but it
is provided that at any time before the end of that period the holder may apply to the
Licensing Authority to direct that the new provisions should not be incorporated.

 

Page 7

 

Exhibit 5.1

Price

     The price for the Product shall be based on F.O.B., East Kilbride, Scotland and calculated as
follows:

     The greater of 25% of Distributor’s net selling price (“NSP”) and a minimum price based upon
the following volumes per individual order:

	 	 	 
	Order Quantity	 	Minimum Price
	1,000 to 3,500 units

	 	£12.00 per unit
	 
	 	 
	Orders of 3,500 units or more

	 	£10.00 per unit

[Note: This minimum price is based upon the 0.8 mm presentation of the Product];

     For purposes of calculating order quantities, the parties shall take into account samples and
free goods supplied by CTS to Distributor in accordance with Section 5.2.

     For purposes of making payments to CTS, Distributor shall make payments based upon the NSP or
minimum price (based upon the greater of the NSP for the prior quarter or on the minimum price for
the order in question) at the time of submission of Distributor’s purchase order. At the
conclusion of each quarter, the NSP and minimum price shall be calculated for such quarter and the
parties shall make payments as necessary to adjust for over or under payments.

     For purposes of this pricing provision, NSP shall mean the gross proceeds from the sale of an
individual unit by Distributor to an unaffiliated third party, expressed in British pounds and
recorded in accordance with generally accepted accounting principles, less (i) allowances for
returns, chargebacks and discounts actually given to customers; and (ii) taxes, duties (other than
customs or import duties) and rebates collected on such sale. The NSP shall not take into account
Product distributed as samples.

     Distributor shall be permitted to place orders for 3,500 or more units with multiple shipments
and invoices, provided that no shipment shall be for fewer than 1,000 units and no order shall
require shipments in more than one Contract Year.

21

 

Exhibit 5.4

Projected Sales

	 	 	 	 	 
	Contract Year	 	Projected Unit Sales
	Year 1
	 	 	10,000	 
	 
	 	 	 	 
	Year 2
	 	 	40,000	 
	 
	 	 	 	 
	Year 3
	 	 	55,000	 
	 
	 	 	 	 
	Year 4
	 	 	65,000	 
	 
	 	 	 	 
	Year 5
	 	 	75,000	 

22

 

Exhibit 7.3

Standard Operating Procedure “Adverse Event

Reporting Procedures between Controlled Therapeutics

(Scotland) Ltd. and its Trading Partners”

(Attached)

23

 

CONTROLLED THERAPEUTICS (SCOTLAND) LTD

Standard Operating Procedure

SOP/REG/005

Adverse Event Reporting Procedures

Between Controlled Therapeutics (Scotland) Ltd

and its Trading Partners

	 	 	 	 	 	 	 
	Effective Date

	 	6 June 2004
	 	Cover Page
	 

	 	 

	 	 
	 
	 	 	 	 	 	 
	Supersedes

	 	22 January 2001
	 	 
	 

	 	 

	 	 
	 
	 	 	 	 	 	 
	Revision No.

	 	 	03	 	 	 
	 

	 	 

	 	 

Table of Contents 

(i) Purpose

(ii) Scope

(iii) Responsibilities

(iv) Definitions

(v) Procedure

(vi) References

(vii) Appendices

	 	 	 	 	 	 	 
	Prepared By

	 	/s/ (ILLEGIBLE)
	 	Date
	 	31 May 04
	 

	 	 

	 	 	 	 

	 
	 	 	 	 	 	 
	Departmental Approval

	 	/s/ (ILLEGIBLE)
	 	Date
	 	31 May 04
	 

	 	 

	 	 	 	 

	 
	 	 	 	 	 	 
	Quality Approval

	 	/s/ (ILLEGIBLE)
	 	Date
	 	31 May 04
	 

	 	 

	 	 	 	 

 

 

SOP/REG/005

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	(i)	 	PURPOSE

	 	1.	 	To ensure that Controlled Therapeutics (Scotland) Ltd. (CTS) is promptly made
aware of adverse events, reactions and lack of effect reports reported in
association with the use of a CTS medicinal product that is sold, or is intended for sale by a
trading partner of CTS.
	 
	 	2.	 	To ensure that CTS informs its trading partners in a timely fashion of
worldwide adverse events, reactions and lack of effect reports reported on its product(s), so
that information may be submitted to local regulatory authorities and, where
applicable, ethics committees and clinical trial investigators in accordance with
local legal and regulatory requirements.

	(ii)	 	SCOPE
	 
	 	 	This SOP applies to adverse events, reactions and lack of effect reports arising from
clinical trials sponsored by CTS or its trading partners, post authorisation studies,
spontaneous reports from health professionals, consumers, regulatory authorities and
literature sources.
	 
	(iii)	 	RESPONSIBILITIES

	 	1.	 	The Regulatory Department at CTS is responsible for the receipt, evaluation and
collation of all adverse events and reactions that involve a CTS medicinal product
(described in SOP/REG/003). CTS is responsible for transmitting appropriate
information regarding adverse events and reactions to licensed trading partners in a
timely fashion. Where CTS is the licence holder, it is also the responsibility of
CTS to report / adverse reactions to the relevant regulatory authorities.
	 
	 	2.	 	Trading partners of CTS are responsible for submitting reportable adverse
reactions to their respective local regulatory authorities in accordance with local regulatory
requirements.
	 
	 	 	 	Trading partners are responsible for keeping CTS informed in a timely manner of all
adverse events and reactions that they receive. Each trading partner is responsible
for translation of all information into English before sending it to CTS.

	(iv)	 	DEFINITIONS

	 	1.	 	Adverse Drug Reaction (ADR)
	 
	 	 	 	Pre-marketing - All noxious and unintended responses to an investigational
medicinal product related to any dose should be considered adverse drug reactions.
	 
	 	 	 	Post Marketing - A response to a drug which is noxious and unintended and which
occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of
disease or for modification of physiological function. Therefore, a causal
relationship between the medicinal product and the adverse event is at least a
reasonable possibility, i.e. the relationship cannot be ruled out.
	 
	 	2.	 	Adverse Event (AE):
	 
	 	 	 	Any untoward medical occurrence in a patient or clinical investigation subject
administered a medicinal product and which does not necessarily have a causal
relationship with this treatment.
	 
	 	 	 	Therefore an AE can be any unfavourable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated with the use of
medicinal products, whether or not considered related to the medicinal product.

 

 

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	 	 	 	A valid report of an adverse event must contain the following minimum information:

	 	•	 	patient identification i.e. one or more of the following: initials;
identification number such as clinical trial number; age or date of birth; gender
	 
	 	•	 	an identifiable source (reporter’s name or initials and/or address and/or
qualifications e.g. physician, dentist, pharmacist, nurse)
	 
	 	•	 	suspected drug(s)
	 
	 	•	 	a specific adverse event

	 	3.	 	Case Safety Report
	 
	 	 	 	A document providing the most complete information related to an individual case
available at a certain point of time.
	 
	 	4.	 	Causal Relationship/Suspected ADR
	 
	 	 	 	There is reasonable evidence to suggest that the event is related to the medicinal product
as judged by the reporting health care professional or trial investigator or sponsor or
manufacturer. If the reporter does not provide a causal assessment on a spontaneous
report, the report will be treated as an ADR even if CTS believes there is no causal
relationship.
	 
	 	5.	 	Company Core Safety Information (CCSI)
	 
	 	 	 	All relevant safety information contained within a company core data sheet or SmPC
prepared by the Marketing Authorisation Holder (MAH) and which the MAH requires to be
listed in all countries where the drug is marketed.
	 
	 	6.	 	Expedited
	 
	 	 	 	Serious adverse reactions which qualify for very rapid reporting to regulatory authorities
(time-frames dependant upon type of report and local regulatory authority legal
requirements).
	 
	 	7.	 	Health Professional
	 
	 	 	 	Medically qualified doctors, coroners, dentists, pharmacists, nurses. Reports from
pharmacists and nurses should be followed up if possible to obtain information from a
medically qualified doctor responsible for the patient.
	 
	 	8.	 	Increased Frequency
	 
	 	 	 	Increased frequencies of serious adverse reactions qualify for expedited reporting between
CTS and the trading partners and regulatory authorities. The method of determining an
increased frequency should be provided and reporting time-frames will begin from when the
increase in frequency was first determined.
	 
	 	9.	 	Lack of Effect Report
	 
	 	 	 	Any report of a product failing to produce the expected pharmacologic effect.
	 
	 	10.	 	Literature Report
	 
	 	 	 	A case report describing an adverse event or reaction in a patient given a medicinal
product which has been identified from the scientific literature.
	 
	 	 	 	CTS scans the Medline literature database on a regular basis. Suspected adverse reactions
associated with the use of the active substance(s) for the same indication(s) of CTS
medicinal products will also be identified and reported, as applicable.
	 
	 	11.	 	Post-authorisation Safety Study (PASS)
	 
	 	 	 	A pharmacoepidemiological study or clinical trial carried out in accordance with the SmPC
with the aim of identifying or quantifying a safety hazard related to an authorised
medicinal product. PASS may also be conducted to confirm the

 

 

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	 	 	 	expected safety profile of a medicinal product under marketed conditions, where the number
of patients to be included will add significantly the existing product safety data.
	 
	 	12.	 	Post-authorisation Study
	 
	 	 	 	Any study conducted within the conditions of the approved SmPC or under normal conditions
of use. A post-authorisation study may fall within the definition of a Post-Authorisation
Safety Study (PASS). For ADR and Periodic Safety Update Report (PSUR) reporting purposes,
reference to a post-authorisation study means any post-authorisation study of which the
marketing authorisation holder is aware.
	 
	 	13.	 	Serious
	 
	 	 	 	A serious adverse event or reaction is any untoward medical occurrence that at any dose has
one or more of the following characteristics:

	 	•	 	results in death
	 
	 	•	 	is life threatening (i.e. the patient was at risk of death at the time of the event
and not that which hypothetically might have caused death if it were more severe)
	 
	 	•	 	requires inpatient hospitalisation or prolongation of existing hospitalisation
	 
	 	•	 	results in persistent or significant disability/incapacity
	 
	 	•	 	is a congenital anomaly/birth defect

	 	 	 	Medical and scientific judgement should be exercised in deciding whether other cases
should be classed as serious such as important medical events that may not be immediately
life-threatening or result in death or hospitalisation but may jeopardise the patient or
may require intervention to prevent one of the other outcomes listed in the definition
above. These should also usually be considered serious.
	 
	 	 	 	Examples of such events are intensive treatment in an emergency room or at home for
allergic bronochospasm; blood dyscrasis or convulsions that do not result in
hospitalisation; or development of drug dependency or drug abuse.
	 
	 	14.	 	Severity
	 
	 	 	 	This term is used to describe the intensity of an event as being mild, moderate, severe or
very severe. The event itself may be of relatively minor medical significance, e.g. severe
headache. This is not the same as ‘serious’, which is based on patient/event outcome or
action criteria usually associated with events that pose a threat to the patient’s life.

	 	•	 	Mild: Does not affect usual daily activities/function
	 
	 	•	 	Moderate: Impairs usual daily activities/function
	 
	 	•	 	Severe: Considerably restricts usual daily activities/function
	 
	 	•	 	Very Severe: Prevents usual daily activities/function

 

 

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	 	15.	 	Spontaneous Report
	 
	 	 	 	A communication describing an adverse event or reaction in a patient given a
medicinal product which does not derive from a study.
	 
	 	16.	 	Unlisted (Unexpected/Unlabelled) AE or AOR
	 
	 	 	 	An adverse event or reaction where the nature, severity or outcome is not consistent
with the applicable product information or Company Core Safety Information (CCSI),
e.g. Investigator’s Brochure for an unlicensed investigational medicinal product, or
the approved product labelling (e.g. data sheet, Summary of Product Characteristics
(SmPC), package insert, etc.) for a licensed product. A listed (expected/labelled)
reaction would be the converse of this.

	(v)	 	PROCEDURE

	 	1.	 	REPORTING OF ADVERSE EVENTS TO CONTROLLED THERAPEUTICS LTD, BY TRADING PARTNERS
	 
	 	 	 	A flow diagram of procedures is provided in Appendix I.

	 	1.1	 	Serious Adverse Events
	 
	 	 	 	Serious adverse event reports should be faxed or emailed within two working days of
receipt by the trading partner to:

Drug Safety Manager

Regulatory Department

Controlled Therapeutics (Scotland) Ltd.

1 Redwood Place

Peel Park Campus

East Kilbride, G74 5PB

U.K

Tele: +44 1355-239166

Fax: +44 1355-263661

	 	 	 	Emails should be sent in the first instance to louise.barr@ctscotland.com, if
unsuccessful, they should be sent to jane.thygesen@ctscotiland.com or
karine.ewert@ctscotiland.com
	 
	 	 	 	If necessary, initial information should be followed up to provide as full a report
as possible. Every effort should be made to provide pertinent follow-up information
within a further 5 working days. If the event is fatal or life threatening, every
effort should be made to report to CTS as fully as possible within a further 3
working days of preliminary notification to CTS.
	 
	 	 	 	Where possible the information should, in addition to the minimum information (iv) 1,
include;

	 	•	 	clinical indication for which the patient was being treated
	 
	 	•	 	name of the product being used and any co-suspect drug and treatment times

 

 

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	 	•	 	details of any relevant past medical history and concurrent conditions
	 
	 	•	 	details of any concurrent medications
	 
	 	•	 	details of the adverse event including start and stop date, severity, causality assessment
	 
	 	•	 	seriousness
	 
	 	•	 	medical intervention to treat event
	 
	 	•	 	outcome of event

	 	1.2	 	Non-Serious Adverse Events
	 
	 	 	 	Spontaneous adverse events which do not meet the definition of “serious” should be
forwarded to CTS at least 3 monthly. Where possible information as stated in
Section 1.1 is required. Events from post marketing trials may be reported in
summary line listing format (separated into events and reactions) at the end of the
study.
	 
	 	1.3	 	Periodic Safety Update Reports (PSURs)
	 
	 	 	 	PSURs produced by trading partners should be copied to CTS.
	 
	 	2.	 	REPORTING OF ADVERSE EVENTS TO TRADING PARTNERS BY CONTROLLED THERAPEUTICS (SCOTLAND) LTD
	 
	 	 	 	A flow diagram of procedures is provided in Appendix I.
Trading Partners will be required to confirm in writing whether they wish to receive
information listed under 2.1, 2.2 and 2.3.
	 
	 	2.1	 	Serious Adverse Events
	 
	 	 	 	Serious adverse events and reactions will be faxed within two working days of
receipt by CTS on an Adverse Event Review Form (Appendix II). Follow-up information
will be forwarded as soon as possible on the Adverse Event Review Form, labelled as
FOLLOW-UP and highlighted, e.g. **. Also, any corrections made to the Adverse Event
Review Form will be highlighted, e.g. *.
	 
	 	2.2	 	Non-Serious Adverse Events
	 
	 	 	 	Non-serious events and reactions will be provided 3 monthly in a summary line
listing (Appendix III). Pertinent follow-up to non-serious events will be forwarded
in the next 3 monthly update. Non-serious events and reactions from post marketing
trials will be provided in the final study reports.
	 
	 	2.3	 	Periodic Safety Update Reports (PSURs)
	 
	 	 	 	All PSURs produced by CTS will be copied to trading partners who request such
reports.

	(vi)	 	REFERENCES

	 	1.	 	Clinical Safety Data Management — Definitions & Standards for Expedited
Reporting (CPMP/ICH/3-77/95)
	 
	 	2.	 	Notice to Applicants, Volume 9 — EU Pharmacovigilance Rules for Human and
Veterinary Medicinal Products, Version December 2001.
	 
	 	3.	 	SOP/REG/003

	(vii)	 	APPENDICES
	 
	 	 	Appendix I            Flow Diagram of Procedures
	 
	 	 	Appendix II           Adverse Event Review Form
	 
	 	 	Appendix III          Adverse Event Line Listing

 

 

SOP/REG/005

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Appendix 1

Adverse Event Reporting Flow Diagram

Spontaneous Sources

Serious events/reactions within 2 working days

Non-serious events/reactions — 3 monthly

	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Adverse events/reactions

from any source
	 	→
	 	Controlled

Therapeutics
	 	↔	Trading

Partners
	 	←	 	Adverse events/reactions

from any source

Post Marketing Trials

Serious events/reactions within 2 working days

Non-serious events/reactions in study report

 

 

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ADVERSE EVENT REVIEW FORM

	 	 	 
	Date Received by CTS:

	 	CTS ADE No.
	 
	 	 
	Date of Adverse event:

	 	Originators Reference No.:
	 
	Patient ID and Age:

	 	Originating Address:
	 
	 	 
	 

	 	Source/Study No:
	 
	 	 
	 
	Product and Dose

	 	Batch No:
	 
	Description of Adverse Event or Reaction:
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	Relevant Medical History and Concomitant Medication:
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	Outcome:
	 	 
	 
	 	 
	Follow-up Information Requested/Reviewed (if

applicable):
	 	 
	 
	Causality and Seriousness Assessment:
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	 	 
	 
	Expedited Reporting to Regulatory Authority: (Y/N)

	 	AE Filed as Line Listing: (Y/N)
	 
	 
	 	 
	Completed By:                                                             

	 	Date                                                            
	 
	 	 
	Regulatory Review:                                                            

	 	Date                                                            

 

 

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	Controlled Therapeutics (Scotland) Ltd.

10 mg Dinoprostone Pessary: Propess/Cervidil

	 	Adverse Events Line Listing
	 	EXAMPLE

Number of records

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	Dose strength	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	CTS Number	 	Source	 	 	 	 	 	 	Dose Units	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Date received	 	Country	 	 	 	 	 	 	Treatment started	 	 	Event	 	 	Event - Verbatim Term	 	 	Event - Preferred Term	 	 	Serlious Listed Related Outcome (Maternal)	 	 	 	 
	Patient I.D.	 	Sex	 	 	Age	 	 	Duration	 	 	Onset	 	 	Event - Intermediate Term	 	 	Event - Low Level Term	 	 	 Comments	 	 	Outcome (Fetal/Neonatal)	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 
	Serious key:

	 	S = Serious
	 	Listed key:
	 	L = Listed
	 	Related key:
	 	R = Related
	 

	 	NS = Non-serious
	 	 	 	UL = Unlisted
	 	 	 	NR = Not related

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00090-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00090-of-00352.parquet"}]]