CIMA LABS INC
EX-10.3 SUPPLY AGREEMENT
<DOCUMENT>
<TYPE>EX-10.3
<SEQUENCE>5
<FILENAME>c71161exv10w3.txt
<DESCRIPTION>EX-10.3 SUPPLY AGREEMENT
<TEXT>
<PAGE>

                                                                    EXHIBIT 10.3

                                SUPPLY AGREEMENT

                                     BETWEEN

                                 CIMA LABS INC.

                                       AND

                                      WYETH

                               ACTING THROUGH ITS

                       WYETH CONSUMER HEALTHCARE DIVISION

                                       FOR

              NON-PRESCRIPTION RAPID DISSOLVING LORATADINE TABLETS
<PAGE>
                                TABLE OF CONTENTS

<TABLE>
<S>                                                                            <C>
ARTICLE I DEFINITIONS........................................................   1

ARTICLE II SUPPLY AND MANUFACTURING..........................................   4

ARTICLE III  [INTENTIONALLY OMITTED].........................................  13

ARTICLE IV  REGULATORY COMPLIANCE............................................  13

ARTICLE V  PAYMENT PROVISIONS................................................  13

ARTICLE VI  REPRESENTATIONS AND WARRANTIES...................................  14

ARTICLE VII  INDEMNIFICATION.................................................  15

ARTICLE VIII  CONFIDENTIALITY................................................  16

ARTICLE IX  TERM AND TERMINATION.............................................  17

ARTICLE X  PUBLICATIONS......................................................  18

ARTICLE XI MISCELLANEOUS.....................................................  18

EXHIBIT A - PRICE

EXHIBIT B - PACKAGING

EXHIBIT C - QUALITY AGREEMENT

EXHIBIT D - ADVERSE EXPERIENCE REPORTING PROCEDURES
</TABLE>
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                                SUPPLY AGREEMENT

         THIS AGREEMENT dated the 18th day of June 2002 between CIMA LABS INC.,
a corporation organized and existing under the laws of the State of Delaware
with offices located at 10000 Valley View Road, Eden Prairie, Minnesota
55344-9361 (hereafter, together with its Affiliates, referred to as "CIMA"), and
WYETH (formerly known as American Home Products Corporation), acting through its
Wyeth Consumer Healthcare division, a corporation organized and existing under
the laws of the State of Delaware with offices located at Five Giralda Farms,
Madison, New Jersey 07940 ("WCH").

                               W I T N E S S E T H

         WHEREAS, CIMA and Wyeth, acting through its ESI Lederle Division, have
entered into a Supply Agreement, dated January 14, 2000 (the "Original Supply
Agreement"); and

         WHEREAS, CIMA and WCH wish to amend the Original Supply Agreement to
remove the OTC Field (as defined herein) and to enter into this Supply Agreement
which relates only to the OTC Field, all on the terms and subject to the
conditions set forth herein.

         NOW, THEREFORE, in consideration of the representations, warranties and
covenants set forth herein, the parties hereto agree as follows:

                                    ARTICLE I
                                   DEFINITIONS

         1.1     "ACTIVE INGREDIENT" means ethyl 4-(8-chloro-5,6-dihydro-11
H-benzo [5,6] cyclohepta [1,2-b] pyridin-11-ylid-ene)-1 piperidine carboxylate,
known as loratadine.

         1.2     "ADVERSE DRUG EXPERIENCE" means the definition in the current
21 CFR Sections 312.32 and 314.80, as in effect from time to time.

         1.3     "AFFILIATE" means (i) any Person which at the time of
determination is directly or indirectly controlled by any party hereto; (ii) any
Person which at the time of determination directly or indirectly controls any
party hereto; or (iii) any Person which is under the direct or indirect control
of any such Person as described in subparagraphs (i) or (ii). "Control" shall in
this Section mean ownership of greater than fifty percent (50%) of the voting
stock or other voting interests in the Person in question.

         1.4     "AGENCY" means any governmental regulatory authority
responsible for granting approvals, including Regulatory Approvals and/or
Pricing Approvals, for the sale of a Product in the OTC Field in a country in
the Territory.

         1.5     "ANDA" means an Abbreviated New Drug Application, as defined in
the United States Food, Drug and Cosmetic Act, as amended, and applicable FDA
rules and regulations.
<PAGE>
         1.6     "API COST PER TABLET" means the actual net price paid per kilo
by CIMA to its Active Ingredient supplier (the "AI Price") plus [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] of the AI Price (to reflect a [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] price yield factor), plus [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] of the AI Price (to cover all related expenses, including
handling and testing), the sum of which is divided by 100,000 (to reflect 10mg
Active Ingredient per tablet). For example, assuming CIMA's cost of Active
Ingredient is [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], the API Per Tablet
Cost would be [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per tablet.

         1.7     "CIMA'S MANUFACTURING COST" means CIMA's manufacturing costs
for Finished Product based on a four hundred twenty (420) kilogram batch size
comprised of raw materials (including packaging, but excluding Active
Ingredient), direct labor, and overhead costs allocable to such Finished
Product, as determined in accordance with United States generally accepted
accounting practices consistently applied.

         1.8     "COMMERCIALLY REASONABLE EFFORTS" means efforts and resources
normally used by a party for a compound or product owned by it or to which it
has rights, which is of similar market potential at a similar stage in its
product life, taking into account the competitiveness of the marketplace, the
proprietary position of the compound or product, the regulatory structure
involved, the profitability of the applicable products, and other relevant
factors. It is anticipated that the level of effort and resources may change at
different times during the product life cycle of a compound or product.

         1.9     "CONTROL" or "CONTROLLED" in the context of intellectual
property rights means rights to intellectual property sufficient to allow a
grant of rights without any obligation to any Third Party.

         1.10    "DEVELOPMENT AND LICENSE AGREEMENT" means the Development and
License Agreement for the OTC Field between the parties signed contemporaneously
with this Agreement.

         1.11    "EFFECTIVE DATE" means January 14, 2000.

         1.12    "FACILITY" means CIMA's manufacturing facility located at
10000 Valley View Road, Eden Prairie, Minnesota or any other facility approved
in writing by WCH for the manufacture of Product.

         1.13    "FDA" means the United States Food and Drug Administration,
or any successor thereto.

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         1.14    "FINISHED PRODUCT" means fully finished and packaged Product
meeting the Specifications.

         1.15    "GOOD MANUFACTURING PRACTICE" or "GMP" means the then current
standards for the manufacture of pharmaceuticals, as set forth in the United
States Federal, Food, Drug and Cosmetic Act and applicable regulations
promulgated thereunder, as amended from time to time, and such standards of good
manufacturing practices as are required by the European Union and other
organizations and governmental agencies in countries in which Product is
intended to be sold, to the extent such standards are not inconsistent with
United States GMP.

         1.16    "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Test" means the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] for Active Ingredient and Product
provided in writing by WCH to CIMA, as the same may be amended from time to time
by the mutual agreement of the parties.

         1.17    "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria" means the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] provided in writing by WCH to CIMA, as
the same may be amended from time to time by the mutual agreement of the
parties.

         1.18    "LABOR" has the meaning set forth in Section 2.16(a).

         1.19    "LAUNCH DATE" means the date of first commercial shipment of a
Product in the OTC Field by WCH or its Affiliates or their respective
subdistributors of Product to Third Parties in a country of the Territory.

         1.20    "NDA" means a New Drug Application, as defined in the United
States Federal Food, Drug and Cosmetic Act, as amended, and applicable FDA rules
and regulations.

         1.21    "OTC Field" means the area of non-prescription (i.e., not
requiring, by law or regulation, a prescription from a medical doctor) and/or
over-the-counter sales for all human pharmaceutical uses.

         1.22    "OVERHEAD" has the meaning set forth in Section 2.16(a).

         1.23    "PERSON" means an individual, a corporation, a partnership, an
association, a trust or other entity or organization, including a government or
political subdivision or an agency thereof.

                                      -3-
<PAGE>
         1.24    "PRICING APPROVAL" means any approval for price or
reimbursement as may be necessary or appropriate as a prerequisite for marketing
Product in the OTC Field in a particular country of the Territory.

         1.25    "PRODUCT" means rapid dissolving tablets containing 10
milligrams Active Ingredient meeting the Specifications.

         1.26    "PROFIT" has the meaning set forth in Section 2.16(a).

         1.27    "RAW MATERIALS" has the meaning set forth in Section 2.16(a).

         1.28    "REGULATORY APPROVAL" means the product license or marketing
approval necessary as a prerequisite for marketing Product in the OTC Field in a
particular country in the Territory.

         1.29    "REGULATORY DOCUMENTS" means all regulatory submissions,
Regulatory Approvals and Pricing Approvals.

         1.30    "SPECIFICATIONS" means the specifications for the Product as
set forth in ANDA 75-822 and NDA 21-375, as may be amended from time to time by
the parties in the course of Product development and in accordance with the
regulatory submissions and/or Regulatory Approvals, or as otherwise required by
an Agency.

         1.31    "TECHNICAL INFORMATION" means (a) techniques and data,
including ideas, inventions (including patentable inventions), practices,
methods, knowledge, know-how, trade secrets, skill, experience, documents,
apparatus, clinical and regulatory strategies, test data, including
pharmacological, toxicological and clinical test data, analytical and quality
control data, manufacturing, patent data or descriptions relating to Product,
and (b) chemical formulations, compositions of matter, product samples and
assays relating to Product.

         1.32    "TERM" shall have the meaning set forth in Section 9.1.

         1.33    "TERRITORY" has the meaning set forth in the Development and
License Agreement, as the same may be amended from time to time in accordance
with the provisions thereof.

         1.34    "THIRD PARTY" means any Person other than a party to this
Agreement or an Affiliate of a party to this Agreement.

         1.35    "$" means United States dollars.

                                   ARTICLE II
                            SUPPLY AND MANUFACTURING

         2.1     MANUFACTURING. During the Term of this Agreement, CIMA shall
manufacture and supply WCH with, and WCH shall purchase from CIMA, Product in
accordance with the

                                      -4-
<PAGE>
terms specified in this Article II. Subject to Section 2.9, WCH shall
exclusively purchase all of WCH's requirements of Product for the OTC Field in
the Territory from CIMA and CIMA shall exclusively supply Product for the OTC
Field to WCH in the Territory.

         2.2      SUPPLY PRICE.

                  (a)     Quantities of Product shall be delivered to WCH F.O.B.
Origin Freight Collect (latest edition of incoterms) and risk of loss shall pass
at the time of such delivery.

                  (b)     The price for Finished Product (the "Finished Product
Supply Price"), in the packaging set forth in Exhibit B attached hereto, for all
countries of the Territory shall be [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] per tablet (which amount is comprised of the Raw Materials,
Labor, Overhead and Profit components set forth on Exhibit A attached hereto,
based on a four hundred twenty (420) kilogram batch size) plus the API Per
Tablet Cost. For Finished Product shipped to WCH after December 31,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] and each calendar year thereafter, the
Finished Product Supply Price shall be adjusted for such calendar year for
changes in Raw Materials and Labor costs, but not Overhead or Profit until
January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], as provided in
Section 2.16. The Finished Product Supply Price for each country in the
Territory, except the United States, shall be increased for packaging variant
costs, including pre-printed lidding foil costs (if any), at CIMA's actual cost
as determined under Section 2.16. CIMA shall purchase Active Ingredient with
sufficient lead times to fill WCH's firm orders based on forecasts given
pursuant to Section 2.3. CIMA shall provide WCH in writing with the API Cost Per
Tablet (specifying the per kilo AI Price and quantity ordered or to be ordered
at such AI Price) as soon as possible.

                  (c)      WCH may place firm orders for Product having
imprinting, labeling or packaging variants or in less than full batch sizes
(four hundred twenty (420) kilograms), provided that the price for Finished
Product ordered in such variants less than full batch sizes shall be increased
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] per tablet to reimburse CIMA for making
modifications to labeling, imprinting or packaging to accommodate such partial
batch size variants.

                  (d)      Notwithstanding any provision herein to the contrary,
if at any time CIMA makes sales of Product to any person at a price lower than
the price then in effect hereunder for Product, or on payment and delivery terms
more favorable than those in effect hereunder, such lower price and/or more
favorable terms shall be made available to WCH hereunder, with respect to WCH's
inventory of Product as well as future purchases of Product, for so long as CIMA
continues to make sales to such person at such lower price and/or on such more
favorable terms.

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         2.3      FORECASTS.

                  (a)      Upon first NDA submission, WCH shall provide to CIMA
a non-binding rolling three (3) year Product forecast (based on calendar years
and updated at least semi-annually) for long-term manufacturing planning
purposes.

                  (b)      Thereafter, during the Term of this Agreement, WCH
shall provide CIMA on a calendar quarter basis, with a non-binding one (1) year
rolling forecast, providing CIMA with a written estimate of the quantities of
Product required during the next four (4) calendar quarters. Each such quarterly
estimate shall contain an update of the immediately preceding estimate with
respect to the calendar quarters referred to in such preceding estimate.

         2.4      FIRM ORDERS.

                  (a)      WCH shall place a firm order with CIMA for Product
requirements at least one hundred twenty (120) days in advance of the delivery
date for Product for sales by WCH in the United States. WCH shall place a firm
order with CIMA for Product requirements at least six (6) months in advance of
the delivery date for Product for the first order placed for Product in any
country of the Territory other than the United States, or for any order for
Product which would require any modification to the labeling or packaging
thereof; otherwise WCH may place a firm order at least ninety (90) days in
advance of the delivery date for Product. A firm order is a purchase order
authorizing manufacture of the Product. Notwithstanding the foregoing, if a
modification to Product or to the Specifications (exclusive of labeling) is
required for any country in the Territory, CIMA shall have at least six (6)
months from the approval of such modification by the applicable Agency to fill
any firm order for modified Product placed by WCH prior to such required
modification. CIMA shall supply Product to WCH as required hereunder, provided
that WCH provides CIMA with label copy which has been agreed to by both parties
as required hereunder and WCH's order for Product is in accordance with the
terms and conditions of this Agreement. Such order for Product placed by WCH
shall be in accordance with the provisions of this Agreement and made pursuant
to a purchase order in a form mutually acceptable to the parties. CIMA shall
ship Product in such quantities and on the dates specified in WCH's purchase
orders.

                  (b)      Notwithstanding the foregoing, CIMA has the right to
satisfy WCH's firm order requirements pursuant to this Article II by supplying
WCH with Product in full batch quantities provided that CIMA may round up or
down WCH's actual order for Product to the nearest full batch.

         2.5      LIMITS ON FIRM ORDERS. If a firm order made pursuant to
Section 2.4 is greater than one hundred fifty percent (150%) of the one (1) year
rolling forecast received by CIMA for such ninety (90) day period, then CIMA
shall use Commercially Reasonable Efforts, but shall not be obligated, to ship
that portion of the excess over one hundred fifty percent (150%).

         2.6      CANCELLATIONS OF ORDERS. If WCH cancels a firm order made
pursuant to Section 2.4, then WCH shall reimburse CIMA for all costs incurred by
CIMA as a result of such cancellation of such order, including materials, labor,
work in progress, obsolete inventory (including the AI Price for up to the
quantity of Active Ingredient purchased by CIMA to cover

                                      -6-
<PAGE>
such canceled purchase order plus an additional two months supply based on WCH's
most recent forecast), disposal and overhead; but this obligation shall not
cover capital costs.

         2.7      PAYMENT TERMS. WCH shall pay invoices for Products delivered
hereunder thirty (30) days after the invoice date. WCH shall pay a penalty on
unpaid amounts overdue by more than thirty (30) days of one and one-half percent
(1.5%) per month for each month a payment is past due. Such penalty shall not
exceed eighteen percent (18%) per year.

         2.8      QUALITY ASSURANCE.

                  (a)      CIMA shall provide samples from each batch of Active
Ingredient to be used in the manufacture of Product and samples from each batch
of Product to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (or such other
contract laboratory specified by WCH) to perform the [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Tests to ensure that such Active Ingredient and Product, as the
case may be, meets the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria,
until WCH notifies CIMA in writing that such practice may be suspended. CIMA
shall provide WCH with the results of such [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] Tests. [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall bill WCH
directly for such services, and such amounts shall not be included in CIMA's
Manufacturing Cost. If any batch of Active Ingredient or Product fails to meet
the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria, the parties shall be
relieved of their respective obligations hereunder to supply and accept delivery
of Product relating to such failed batch. CIMA shall not use any Active
Ingredient in the manufacture of Product that does not meet the [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Criteria and shall not ship any Product to WCH that
does not meet the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria. Any batch
of Active Ingredient or Product that does not meet the [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] Criteria shall be disposed of by CIMA as directed by
WCH. WCH shall reimburse CIMA the AI Price for Active Ingredient and the
Finished Product Supply Price for Product (less any amount allocated to Raw
Materials, Labor and Overhead not actually incurred by CIMA in the Manufacture
of such Product) that is deemed unacceptable hereunder solely by reason of its
failure to meet the [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Criteria as
determined by such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED

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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] Testing; provided
that CIMA assigns to WCH all of its rights and interest in and to any claim that
it may have against the supplier of Active Ingredient for breach of warranty or
otherwise and CIMA fully cooperates with WCH in pursuing any claim by WCH
against the supplier of Active Ingredient. WCH shall be entitled to retain any
recovery it may receive from the supplier of Active Ingredient with respect to
any such claim.

                  (b)      Prior to the shipment of Product to WCH, CIMA shall
test representative samples of each of the batch(es) to be shipped in accordance
with validated, approved methods of analysis defined in the Specifications. CIMA
shall provide WCH with a Certificate of Analysis for each batch of Product
shipped to WCH stating that the Product so shipped conforms to the
Specifications. The Certificate of Analysis shall be in a format agreed upon by
the parties.

                  (c)      CIMA shall retain production samples and batch
records from each batch of Product for the longer of (i) two (2) years after the
expiry date of each such batch of Product or (ii) the time period required under
GMP. Upon request, CIMA shall provide WCH's Quality Control Department with
production samples of Product and/or copies of completed Batch records.

                  (d)      Master batch process documentation will be prepared
and approved by CIMA as per its normal procedures. The parties agree that
deviations from master batch process documentation may be necessary from time to
time. Such deviations shall be discussed with WCH before any proposed shipment
of Product. Individual batch process documentation shall be photocopied from the
approval master and issued for each batch as per CIMA's routine system. Original
batch records will be filed securely by CIMA. CIMA will perform all in-process
control tests demanded by the approved batch process. The parties shall execute
and deliver to each other a Quality Agreement substantially in the form of
Exhibit C. Each party agrees to perform is respective obligations in accordance
with this Agreement.

                  (e)      (i)    WCH shall have the right to test Product to
verify compliance with Specifications and applicable Regulatory Approvals and
CIMA shall supply WCH with its testing procedures. WCH may, by written notice
provided to CIMA within sixty (60) days of WCH's receipt of a shipment of
Product, reject all or part of such shipment of Product if, based upon the
testing of such Product conducted under this Section 2.8(e), such Product does
not comply with the Specifications or applicable Regulatory Approvals. If WCH
fails to notify CIMA within such sixty (60) day period, that it is rejecting
such Product, WCH shall be deemed to have accepted such Product.

                           (ii)   If CIMA, after good faith consultation with
WCH, disputes any finding by WCH that Product does not comply with the
Specifications or applicable Regulatory Approvals, samples of such Product shall
be forwarded to a Third Party jointly selected by WCH and CIMA for analysis,
which analysis shall be performed in compliance with applicable regulatory
requirements. The findings of such Third Party regarding whether Product
complies with the Specifications and the applicable Regulatory Approvals shall
be binding upon the parties for purposes of this Section 2.8(e). The cost of
such analysis by such Third Party shall be borne by the party whose findings
differed from those generated by such Third Party.

                                      -8-
<PAGE>
                           (iii)  If as determined in accordance with this
Section 2.8(e), a shipment of Product does not conform to the Specifications or
applicable Regulatory Approvals, CIMA shall replace such shipment free of charge
(which includes without limitation CIMA paying for the cost of any Active
Ingredient included therein) with a substitute shipment which meets such
Specifications and applicable Regulatory Approvals according to the following
time frame. If the Product is in inventory then conforming Product will be
shipped so as to arrive as soon as practicable. If the Product is not in
inventory, CIMA will take all reasonable steps to ensure expeditious manufacture
of conforming Product which will be shipped on the next shipping day after
completion of manufacture so as to arrive as soon as possible thereafter. In the
event that testing at WCH indicates that Product does not conform with
Specifications or applicable Regulatory Approvals: (I) WCH shall immediately
notify CIMA; (II) WCH and CIMA shall mutually agree on an investigation program
to determine the cause of the discrepancy and the outcome of this investigation
shall be used to determine disposition of the batch; (III) where appropriate,
given the timetable for the agreed upon investigation program, CIMA shall take
all reasonable steps to ensure expeditious manufacture and shipment of
conforming Product; and (IV) shipment of such replacement Product shall take
place the next shipping day following completion of analytical work to
demonstrate conformance with Specifications and applicable Regulatory Approvals.
Shipment shall be by the quickest agreed route. At CIMA's expense and at WCH's
sole option: the non-conforming shipment shall be (A) returned to CIMA; or (B)
disposed of by WCH, upon final determination in accordance with this Section
2.8(e) that it does not meet the Specifications or applicable Regulatory
Approvals.

         2.9      WCH MANUFACTURE RIGHTS DURING THE TERM. Upon WCH's written
request, made at any time after the first ANDA submission, CIMA shall grant to
WCH the exclusive, irrevocable, transferable right to, and shall use
Commercially Reasonable Efforts to transfer to WCH, the manufacturing know-how
used by CIMA that is reasonably necessary to enable WCH to manufacture Product
for the OTC Field. If WCH exercises this right, except as provided below, WCH
shall pay CIMA (a) a [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] technical transfer
fee upon successful completion of the transfer process (defined as manufacture
of validation batches of Product meeting the Specifications), and (b) out of
pocket expenses incurred by CIMA directly related to the technical assistance
needed to facilitate the transfer process. If WCH exercises this right due to
the inability of CIMA to meet WCH firm orders for Product, for any reason other
than a condition of force majeure that lasts less than sixty (60) days, then WCH
shall pay CIMA only out-of-pocket expenses incurred by CIMA directly related to
the technical assistance needed to facilitate the transfer process.

         2.10     NOTIFICATION OF INSPECTIONS. Each party agrees to notify the
other within two (2) business days of its receipt of notification of any
inquiries, notifications, or inspection activity by any Agency, regulatory
authority or other authority in regard to or affecting Product. The recipient
party shall provide a reasonable description to the other party of any such
governmental inquiries, notifications or inspections promptly (but in no event
later than five (5) calendar days) after notification of completion of such
visit or inquiry. The recipient party shall furnish to the other party, (i)
within two (2) business days after receipt any report or correspondence issued
by the Agency or regulatory authority in connection with such visit or inquiry,
including but not

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limited to, any FDA Form 483, Establishment Inspection Reports or warning
letters and (ii) at the same time it provides to any Agency or regulatory
authority, copies of any and all documents, responses or explanations relating
to items set forth above, in each case purged only of trade secrets of the
recipient that are unrelated to the obligations under this Agreement or are
unrelated to Product. In the event such governmental agency or authority
requests or requires any action to be taken to address any citations, the
recipient agrees, after consultation with the other party, to take such action
as necessary to address such citations, and agrees to cooperate with the other
party with respect to any such citation and/or action taken with respect
thereto.

         2.11     INSPECTION BY WCH. CIMA shall permit WCH (at its own expense)
to visit, during normal business hours and with reasonable advance notice CIMA's
manufacturing facility(ies) and warehouse, subject to the confidentiality
provisions of this Agreement, for the purposes of (a) observing the manufacture,
packaging, testing and warehousing of Product and to inspect for compliance with
GMPs, applicable regulatory requirements, the requirements of any applicable
Regulatory Approvals, and environmental monitoring, (b) solving technical or
quality problems, (c) examining the premises, equipment, procedures and
personnel used when producing, testing or controlling Product and (d) all books
and records relating to (a), (b) or (c). CIMA representatives shall be entitled
to accompany WCH representatives on any such inspection.

         2.12     ENVIRONMENTAL AND OTHER LAWS AND REGULATIONS.

                  (a)     In carrying out its obligations under this Agreement,
CIMA shall comply with all applicable environmental, health and safety laws
(current or as amended or added, collectively "Laws"), and shall be solely
responsible for determining how to comply with same. CIMA represents and
warrants that it has the appropriate skills, personnel, equipment, permits or
approvals necessary to perform its services under this Agreement in compliance
with all applicable Laws.

                  (b)     CIMA shall notify WCH, in writing, no later than one
(1) business day after the event, of any circumstances, including the receipt of
any notice, warning, citation, finding, report or service of process, relating
to compliance with the Laws, or the occurrence of any release, spill, upset or
discharge of "Hazardous Substances" as defined by the Comprehensive
Environmental Response, Compensation and Liability Act of 1980, as amended,
which relates to CIMA's ability to manufacture or supply Product. WCH reserves
the right to conduct an environmental inspection of CIMA's facility(ies), during
normal business hours and with reasonable advance notice, for the purpose of
determining compliance with this Section 2.12(b), no more frequently than once
per year during the term hereof and under conditions of confidentiality as
provided under Article VIII. Upon CIMA's request, WCH shall share the results of
any environmental inspection with CIMA. Such inspection, if it occurs, does not
relieve CIMA of its sole obligation to comply with the Laws and does not
constitute a waiver of any right otherwise available to WCH.

         2.13     SPECIFICATIONS AMENDMENTS. The Specifications shall be amended
or supplemented to comply with GMPs and to comply with any applicable Agency
directive and may also be amended or supplemented (including, without
limitation, for the purpose of

                                      -10-
<PAGE>
incorporating improvements) from time to time. In the event CIMA intends to
amend the Specifications, WCH shall receive prompt advance notice of any such
amendments. No such amendment shall be filed with any applicable Agency or
otherwise become effective without the prior written mutual approval of WCH and
CIMA. In the event that after the parties have initially agreed upon the
Specifications, WCH requests that the Specifications be amended, CIMA shall
receive prompt advance notice of any such amendment for the purpose of
determining what, if any, impact the proposed amendment would have on the
manufacture of Product for WCH hereunder and WCH shall reimburse CIMA for the
actual costs incurred by CIMA (provided that such costs are approved in writing
by WCH prior to being incurred by CIMA) because such amendment requires changes
to be made in the processes, equipment, testing procedures, or components used
to manufacture Product for WCH hereunder. Upon WCH's request, CIMA shall use
Commercially Reasonable Efforts to eliminate animal derived materials from the
Product and WCH shall reimburse CIMA for the actual costs incurred by CIMA
(provided that such are approved in writing by WCH prior to being incurred by
CIMA) in connection therewith. In each case, such costs may include, without
limitation, validation of new processes, equipment and facilities, development
of testing methods and start-up costs. To the extent that any costs incurred by
CIMA in implementing an amendment of the Specifications under this Section have
been reimbursed by WCH such costs shall not be included in CIMA's Direct
Manufacturing Cost.

         2.14     APPROVAL FOR MANUFACTURING CHANGES; THIRD PARTY MANUFACTURING.
CIMA agrees that no changes will be made to any materials, equipment or methods
of production or testing which are specified in the Specifications or any
Regulatory Approval by any Agency for Product without WCH's prior written
approval, which approval shall not be unreasonably withheld. All Product
delivered hereunder shall be manufactured at the Facility. Under no
circumstances will CIMA contract out all or any part of the manufacturing of
Product to a Third Party without prior written approval from WCH.

         2.15     PERMITTED SUBCONTRACTORS. CIMA shall ensure that the permitted
contract manufacturers for the manufacture of Product have sufficient knowledge
and expertise to carry out the manufacture of Product and other subcontracted
responsibilities. In addition, CIMA shall ensure that (i) each such contract
manufacturer shall be in compliance with GMPs and shall be under the inspection
of all relevant Agencies and audited to be in compliance therewith, and (ii) WCH
will have the right to inspect and audit each such subcontractor's facilities
and records as provided in Section 2.11 hereof.

         2.16     CIMA'S MANUFACTURING COST CHANGES.

                  (a)     On January 1, [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], and on each January 1 thereafter during the Term of this
Agreement, the Finished Product Supply Price shall be adjusted [***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] percent [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of any
net change in the cost of (i) raw materials (including

                                      -11-
<PAGE>
packaging but excluding Active Ingredient) necessary to the manufacture of
Product (collectively, the "Raw Materials") and (ii) direct labor (collectively,
the "Labor"), in each case actually incurred by CIMA in producing the Product
during the twelve (12) month period ending on the preceding December 31. On
January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], the Finished
Product Supply Price shall be adjusted [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] percent [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of any net
change in the overhead costs attributable to the manufacture of Products
determined in accordance with United States generally accepted accounting
practices consistently applied (collectively, the "Overhead") during the
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] year period ending on December 31,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***] and a similar adjustment shall be made
on each January 1 after January 1, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] during
the remainder of the Term for the twelve (12) month period ending on the
preceding December 31. Such increases shall be effective with respect to
Finished Product delivered to WCH on or after the January 1 effective date of
the applicable price adjustment. CIMA may not propose any increase in the profit
("Profit") component of Finished Product Supply Price prior to January 1,
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***].

                  (b)     On or before July 1, [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***], and on or before each July 1 thereafter during the Term of this
Agreement, CIMA shall provide WCH with a non-binding estimate of the amount by
which the price will increase pursuant to this Section 2.16 on the succeeding
January 1. CIMA shall determine the final amount of any such price increase by
no later than the following February 28, and CIMA shall notify WCH of such
amount in writing at that time. Product delivered to WCH between January 1 and
February 28, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] (or the same
two-month period thereafter during each year of this Agreement) shall be
invoiced by WCH at the price applicable to Product delivered to WCH during the
immediately preceding calendar year. Then on or about February 28 of each year,
CIMA shall transmit to WCH a corrected invoice for Product delivered between
January 1 and February 28 of each year, taking into account the final amount of
any such price increases, and setting forth the applicable additional charges.

                  (c)     To determine the amount by which the cost of Raw
Materials, Labor and/or Overhead have increased during a period, the Raw
Materials, Labor and/or Overhead

                                      -12-
<PAGE>
costs at the beginning of the period shall be compared to the Raw Materials,
Labor and/or Overhead costs at the end of the period, without regard to
intervening fluctuations.

                  (d)     In no event shall any increase in price pursuant to
Section 2.16(a) for Labor, Overhead and Profit exceed, on a percentage basis,
the percentage which the Producer's Price Index, published by the U.S.
Department of Labor, Bureau of Labor Statistics, increased during the period
since the last adjustment under Section 2.16(a).

                  (e)     At WCH's request, the parties shall informally discuss
the factors that contributed to any price adjustment hereunder.

                                   ARTICLE III
                             [INTENTIONALLY OMITTED]

                                   ARTICLE IV
                              REGULATORY COMPLIANCE

         4.1      ADVERSE DRUG EXPERIENCES. In order for the parties to comply
with their respective responsibilities under this Article IV and otherwise
relating to the reporting of Adverse Drug Experiences, to the extent either
party receives any information regarding Adverse Drug Experiences related to use
of Product, such party shall promptly provide the other party with such
information in accordance with the Adverse Event Reporting Procedures set forth
in Exhibit D hereto (as may be amended from time to time upon written agreement
of the parties).

         4.2      PRODUCT COMPLAINTS. WCH shall be solely responsible for
interacting with the public with respect to customer complaints regarding
Product quality. With respect to any such complaints, each party shall have the
responsibility for promptly conducting an investigation of any activities
conducted by it under this Agreement which may be relevant to the complaint.
Each party shall inform the other party of the nature, scope and details of any
such complaint which requires an investigation by the other party, and each
party shall promptly report the results of such investigation to the other
party. Either party shall cooperate in any investigation by the other party of
each such complaint which involves the parties' duties under this Agreement.

         4.3      COMPLIANCE ISSUES. The parties acknowledge that the export of
technical data, materials or products is subject to the exporting party
receiving the necessary export licenses and that the parties cannot be
responsible for any delays attributable to export controls which are beyond the
reasonable control of either party. The parties agree that regardless of any
disclosure made by the party receiving an export of any ultimate destination of
any technical data, materials or products, the receiving party will not
re-export either directly or indirectly, any technical data, material or
products without first obtaining the applicable validated or general license
from the United States Department of Commerce.

                                    ARTICLE V
                               PAYMENT PROVISIONS

                                      -13-
<PAGE>
         5.1      INSPECTION OF RECORDS. The parties shall maintain at their
offices, accurate and complete books and records consistent with sound business
and accounting practices and in such form and in such detail as to enable the
amount of payments payable under this Agreement by the respective party to be
determined. WCH and CIMA shall permit an independent certified accountant
(subject to obligations of confidentiality) appointed by the other party and
reasonably acceptable to WCH or CIMA (as applicable), at the other party's
expense, to examine such books and records at all reasonable times for the sole
purpose of (i) verifying WCH's or CIMA's (as applicable) reports and accounting
submitted to the other party hereunder and (ii) determining the correctness of
payments. In the event of any underpayment of any payment by at least five
percent (5%), the costs of such inspection shall be borne by the party who made
such underpayment and such underpayment shall be forthwith paid by such party to
the other party with a penalty at the rate specified in Section 2.7 from the
date such payment was originally due until payment.

                                   ARTICLE VI
                         REPRESENTATIONS AND WARRANTIES

         6.1      REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each of CIMA and
WCH hereby represents and warrants to the other party hereto as follows:

                  (a)     it is a corporation or entity duly organized and
validly existing under the laws of the state or other jurisdiction of
incorporation or formation;

                  (b)     the execution, delivery and performance of this
Agreement by such party has been duly authorized by all requisite corporate
action and does not require any shareholder action or approval;

                  (c)     it has the power and authority to execute and deliver
this Agreement and to perform its obligations hereunder; and

                  (d)     the execution, delivery and performance by such party
of this Agreement and its compliance with the terms and provisions hereof does
not and will not conflict with or result in a breach of any of the terms and
provisions of or constitute a default under (i) a loan agreement, guaranty,
financing agreement, agreement affecting a product or other agreement or
instrument binding or affecting it or its property; (ii) the provisions of its
charter or operative documents or bylaws; or (iii) any order, writ, injunction
or decree of any court or governmental authority entered against it or by which
any of its property is bound.

         6.2      REPRESENTATIONS AND WARRANTIES OF CIMA. In addition to the
representations and warranties made by CIMA under Section 6.1 above, CIMA hereby
further represents and warrants to WCH that:

                  (a)     At the time of delivery of Product to the specified
point of delivery, Product shall (i) have been manufactured, stored and shipped
in accordance with GMPs, as applicable, and all other applicable laws, rules,
regulations or requirements in effect at the time of manufacture in the country
of manufacture (for example, in accordance with the procedures

                                      -14-
<PAGE>
described in the applicable Regulatory Approval); (ii) conform to the
Specifications; (iii) meet the provisions of the Specifications; (iv) not be
adulterated or misbranded as provided for under any applicable law, order or
regulation in effect in the country of manufacture and the country in which
Product is being sold; (v) have a minimum shelf life of approved expiry minus
three (3) months; and (vi) have been shipped in accordance with approved
procedures agreed between WCH and CIMA.

                  (b)    It shall have good and marketable title to all Product
delivered to WCH.

         6.3      NO INCONSISTENT AGREEMENTS. Neither party has in effect and
after the Effective Date neither party shall enter into any oral or written
agreement or arrangement that would be inconsistent with its obligations under
this Agreement.

         6.4      REPRESENTATION BY LEGAL COUNSEL. Each party hereto represents
that it has been represented by legal counsel in connection with this Agreement
and acknowledges that it has participated in the drafting hereof. In
interpreting and applying the terms and provisions of this Agreement, the
parties agree that no presumption shall exist or be implied against the party
which drafted such terms and provisions.

                                   ARTICLE VII
                                 INDEMNIFICATION

         7.1      INDEMNIFICATION BY WCH. WCH shall indemnify, defend and hold
harmless CIMA and its Affiliates, and each of its and their respective
employees, officers, directors and agents (each a "CIMA Indemnified Party") from
and against any and all liability, loss, damage, cost and expense (including
reasonable attorney's fees) (collectively, a "Liability") which the CIMA
Indemnified Party may incur, suffer or be required to pay resulting from or
arising in connection with (i) the breach by WCH of any representation, warranty
or covenant contained in this Agreement, or (ii) subject to Sections 9.3(c) and
9.3(d) of the Development and License Agreement, the manufacture, promotion,
distribution, use, testing, marketing, sale or other disposition of Product by
WCH, its Affiliates or sublicensees. Notwithstanding the foregoing, WCH shall
have no obligation under this Agreement to indemnify, defend or hold harmless
any CIMA Indemnified Party with respect to claims, demands, costs or judgments
which result from either (x) the failure of Product supplied by CIMA or its
Affiliates to comply with the Specifications or the applicable Regulatory
Approvals or (y) the willful misconduct or negligent acts or omissions of CIMA,
its Affiliates, or any of their respective employees, officers, directors or
agents.

         7.2      INDEMNIFICATION BY CIMA. CIMA shall indemnify, defend and hold
harmless WCH and its Affiliates, and each of its and their respective employees,
officers, directors and agents (each, an "WCH Indemnified Party") from and
against any Liability which the WCH Indemnified Party may incur, suffer or be
required to pay resulting from or arising in connection with the breach by CIMA
of any representation, warranty or covenant contained in this Agreement.
Notwithstanding the foregoing, CIMA shall have no obligation under this
Agreement to indemnify, defend, or hold harmless any WCH Indemnified Party with
respect to claims, demands, costs of judgments which result from the willful
misconduct or negligent acts

                                      -15-
<PAGE>
or omissions of WCH, its Affiliates, or sublicensees or any of their respective
employees, officers, directors or agents.

         7.3      CONDITIONS TO INDEMNIFICATION. The obligations of the
indemnifying party under Sections 7.1 and 7.2 are conditioned upon delivery of
written notice to the indemnifying party of any potential Liability promptly
after the indemnified party becomes aware of such potential Liability, provided,
however, that the failure to give such notice promptly shall not impair a
party's rights to indemnification under this Article VII unless the delay in
providing such notice has a material adverse effect on the ability of the
indemnifying party to defend against such Liability. The indemnifying party
shall have the right to assume the defense of any suit or claim related to the
Liability if it has assumed responsibility for the suit or claim in writing;
however, if in the reasonable judgment of the indemnified party, such suit or
claim involves an issue or matter which could have a materially adverse effect
on the business operations or assets of the indemnified party, the indemnified
party may waive its rights to indemnity under this Agreement and control the
defense or settlement thereof, but in no event shall any such waiver be
construed as a waiver of any indemnification rights such party may have at law
or in equity. If the indemnifying party defends the suit or claim, the
indemnified party may participate in (but not control) the defense thereof at
its sole cost and expense.

         7.4      SETTLEMENTS. Neither party may settle a claim or action
related to a Liability without the consent of the other party, if such
settlement would impose any monetary obligation on the other party or require
the other party to submit to an injunction or otherwise limit the other party's
rights under this Agreement. Any payment made by a party to settle any such
claim or action shall be at its own cost and expense except in the event that
such payment was made with the prior written consent of the indemnifying party,
in which case such payment will be subject to the indemnification obligations of
the parties as set forth in this Article VII.

         7.5      INSURANCE. CIMA shall obtain and carry in full force and
effect product liability insurance in respect of Product in the amount of One
Million Dollars ($1,000,000) per occurrence and in the aggregate and policies of
Ten Million Dollars ($10,000,000) of excess coverage in the aggregate. WRH shall
obtain and carry in full force and effect product liability insurance, or be
self insured, in respect of Product in the amount of One Million Dollars
($1,000,000) per occurrence and in the aggregate and policies of Ten Million
Dollars ($10,000,000) of excess coverage in the aggregate.

                                  ARTICLE VIII
                                 CONFIDENTIALITY

         8.1      NONDISCLOSURE. During the Term of this Agreement and for a
period of five (5) years thereafter, all proprietary and confidential business,
technical, scientific and/or regulatory information, including Technical
Information, disclosed to the receiving party or its Affiliates (herein
collectively, the "Receiving Party") by the other party or its Affiliates
(herein collectively, the "Disclosing Party") hereunder or under the existing
Confidentiality Agreement between the parties, which is marked as confidential
at the time of disclosure, or if disclosed or obtained orally or visually (or
otherwise in a non-written form), was described or summarized in a writing or
other tangible form and identified as Confidential and forwarded to the
Receiving

                                      -16-
<PAGE>
Party within thirty (30) days of such disclosure (collectively, "Confidential
Information"), shall be deemed to be confidential and shall be treated as such
by the Receiving Party and shall not be disclosed, in whole or in part, by the
Receiving Party to any other Person except as expressly set forth herein, and
shall be used only for the purposes of this Agreement. Notwithstanding the
foregoing, these mutual obligations of confidentiality shall not apply to any
information to the extent that such information is:

                  (i)      independently developed by such party as documented
                           by prior written records outside the scope and not in
                           violation of this Agreement;

                  (ii)     legally in the public domain at the time of its
                           receipt or thereafter legally becomes part of the
                           public domain through no fault of the recipient;

                  (iii)    received without an obligation of confidentiality
                           from a Third Party having the right to disclose such
                           information;

                  (iv)     released from the restrictions of this Article VIII
                           by the express written consent of the Disclosing
                           Party; or

                  (v)      as may be required for securing Regulatory Approval,
                           or as may be required to be disclosed to an Agency or
                           as otherwise required by a court order or any law or
                           regulation (including, as may be required in
                           connection with any filings made with the Securities
                           and Exchange Commission or by the disclosure policies
                           of a major stock exchange in the Territory);
                           provided, however, that at the other party's request,
                           the disclosing party shall request that the relevant
                           legal or regulatory authority, or major stock
                           exchange, treat as confidential any Confidential
                           Information of either party included in any such
                           disclosure and generally use diligent efforts to seek
                           confidential treatment where available.

         8.2      SCOPE OF CONFIDENTIALITY. CIMA and WCH agree to limit the
disclosure of any Technical Information and other Confidential Information
received hereunder to such Affiliates, employees, consultants and distributors
as are necessary to carry out the provisions of this Agreement and who are
likewise bound by provisions equivalent to this Article VIII, except that, WCH
may disclose Confidential Information to actual or potential sublicensees and
subdistributors, provided that they are likewise bound by confidentiality
provisions similar to, or more stringent than, those set forth in this Article
VIII. The parties shall take reasonable measures to assure that no unauthorized
use or disclosure is made by Persons to whom access to such Confidential
Information is granted.

                                   ARTICLE IX
                              TERM AND TERMINATION

         9.1      TERM. This Agreement shall be effective as of the Effective
Date, and, unless sooner terminated by mutual agreement or pursuant to any other
provision of this Agreement, shall continue in full force and effect in each
country of the Territory for a period of ten (10)

                                      -17-
<PAGE>
years after the Launch Date of Product in the United States which shall be
deemed to occur no later than six (6) months after obtaining Regulatory Approval
in the United States. If the Development and License Agreement is terminated for
any reason other than expiration, then this Agreement shall automatically
terminate.

         9.2      TERMINATION FOR DEFAULT. Each party may terminate this
Agreement as a whole if the other party commits a material breach of any
material obligation under this Agreement and fails to remedy such breach within
sixty (60) days after receipt of notice in writing from such party, or such
longer period of time if mutually agreed.

         9.3      TERMINATION BY WCH. WCH shall have the right, in its sole
discretion, to terminate this Agreement at any time during the Term of this
Agreement upon six (6) months' prior written notice to CIMA.

         9.4      NO DAMAGES UPON EXPIRATION OR TERMINATION. Except as otherwise
set forth in this Agreement, neither party shall be entitled to any compensation
whatsoever as a result of expiration or termination of this Agreement, but
without limiting either party's damages for any breach of this Agreement.

         9.5      CONTINUING OBLIGATIONS. Termination or expiration of this
Agreement for any reason shall be without prejudice to any obligations which
shall have accrued to the benefit of either party prior to such termination or
expiration. Upon termination or expiration of this Agreement, any payments owed
to the other party on or before the effective date of termination shall be due
within thirty (30) days of the effective date of such termination or expiration.
The following provisions of this Agreement shall survive expiration or
termination hereof: Articles VII, VIII, IX and XI.

                                    ARTICLE X
                                  PUBLICATIONS

         10.1     PUBLICATIONS. The parties shall mutually agree upon
publications and the publication strategy with respect to work undertaken by the
parties relating to Product, and neither party shall publish any result or study
generated or developed under this Agreement except upon review by the other
party at least sixty (60) days prior to submission of an abstract or manuscript
for publication.

                                   ARTICLE XI
                                  MISCELLANEOUS

         11.1     FORCE MAJEURE. Neither party shall be liable for delay or
failure to perform its obligations hereunder for so long as that failure or
delay is the result of an event beyond its control which it could not have
avoided by the exercise of reasonable diligence, (a "Force Majeure Event"),
provided that such party uses Commercially Reasonable Efforts to comply with the
terms of this Agreement as soon as practicable. A party asserting a Force
Majeure Event shall notify the other party promptly, giving an indication of the
likely extent and duration thereof.

                                      -18-
<PAGE>
         11.2     ASSIGNMENT; SUCCESSORS AND ASSIGNS. Neither party shall at
any time, without obtaining the prior written consent of the other party, assign
or transfer this Agreement to any Person. Notwithstanding the foregoing, each
party shall be permitted to assign this Agreement to its Affiliates or to
perform this Agreement, in whole or in part, through its Affiliates, provided
that such party shall be primarily liable and responsible for performance by
such Affiliate hereunder; and each party may also assign this Agreement to any
successor by merger or upon a sale of all or substantially all of its assets or
business to which this Agreement relates. This Agreement shall be binding upon
and shall inure to the benefit of the parties and their successors and permitted
assigns.

         11.3     NOTICES. Any notices required or permitted to be given
hereunder shall be in writing in the English language and shall be delivered by
international courier service (requiring signature upon receipt) or sent by
first class air mail, postage prepaid, or telefax (confirmed by phone
conversation with the recipient) to the addresses set forth below. The parties
may change the address at which notice is to be given by giving notice to the
other party as herein provided. All notices shall be deemed effective upon
receipt by the party to whom it is addressed.

         If to CIMA:

                  CIMA Labs. Inc.
                  10000 Valley View Road
                  Eden Prairie, Minnesota 55344
                  Attention:    President and CEO
                  Telephone:    612-947-8762
                  Telefax:      612-947-8770

         If to WCH:

                  Wyeth Consumer Healthcare Division
                  Wyeth
                  Five Giralda Farms
                  Madison, New Jersey 07940
                  Attention:    President
                  Telephone:    973-660-5773
                  Telefax:      973-660-7199

         With a copy to:

                  Wyeth
                  5 Giralda Farms
                  Madison, New Jersey 07940
                  Attention:    General Counsel
                  Telephone:    973-660-6040
                  Telefax:      973-660-7050

                                      -19-
<PAGE>
         11.4     GOVERNING LAW AND JURISDICTION. This Agreement and its
execution, validity and interpretation shall be governed in all respects in
accordance with the laws of the State of New York, excluding conflicts of law
rules.

         11.5     SEVERABILITY. In the event that any provision of this
Agreement shall be held to be unenforceable, invalid or in contravention of
applicable law, such provision shall be of no effect, and the parties shall
negotiate in good faith to replace such provision with a provision which effects
to the extent possible the original intent of such provision.

         11.6     COMPLETE AGREEMENT; MODIFICATIONS. This Agreement, together
with the Development and License Agreement and all Exhibits attached hereto and
thereto, constitutes the entire Agreement between the parties with respect to
the present subject matter, all prior negotiations, agreements and
understandings being expressly canceled hereby. This Agreement may be amended
only by a written agreement embodying the full terms of the amendment signed by
authorized representatives of both parties.

         11.7     NO AGENCY. Neither party shall by virtue of this Agreement
have any power to bind the other to any obligation nor shall this Agreement
create any relationship of agency, partnership or joint venture.

         11.8     NO WAIVER. No term or condition of this Agreement shall be
considered waived unless reduced to writing and duly executed by an officer of
the waiving party. Any waiver by any party of a breach of any term or condition
of this Agreement will not be considered as a waiver of any subsequent breach of
this Agreement, of that term or condition or any other term or condition hereof.

         11.9     COUNTERPARTS. This Agreement may be executed in counterparts,
each of which together shall constitute one and the same Agreement.

         11.10    AMENDMENT OF THE ORIGINAL SUPPLY AGREEMENT. The parties agree
that, with effect from the Effective Date, the Original Supply Agreement is
hereby amended to exclude the OTC Field from its scope and that this Agreement
and the Development and License Agreement constitutes the entire agreement
between the parties with respect to the subject matter hereof and thereof for
the OTC Field.

                                      -20-
<PAGE>
         IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first above written.

                       CIMA LABS INC

                       By:    /s/ John Hontz
                             --------------------------------------------------
                             Name: John Hontz
                             Title:   Chief Operating Officer

                         WYETH,
                         acting through its Wyeth Consumer Healthcare Division

                         By:  /s/ Gregory F. Bobyock
                             --------------------------------------------------
                             Name: Gregory F. Bobyock
                             Title: Vice President, Global Business Development

                                      -21-
<PAGE>
                                    EXHIBIT A

                                      PRICE

Finished Product Supply
  Price per Tablet                                   Components
                          API Cost Per    Raw
                             Tablet *   Materials    Labor   Overhead    Profit

[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
                    SECURITIES AND EXCHANGE COMMISSION.***]

* Assumes a net purchase price of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] per
kilo of Active Ingredient.
<PAGE>
                                    EXHIBIT B

                                    PACKAGING

[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
 SECURITIES AND EXCHANGE COMMISSION.***]
<PAGE>
                                    EXHIBIT C

                                QUALITY AGREEMENT

                                  [Wyeth LOGO]

                                QUALITY AGREEMENT

Quality Agreement for:

This document constitutes the quality agreement for purchase of PRODUCT, a
pharmaceutical product manufactured for Wyeth. Also described is the FDA
approved product application under which the product will be manufactured as
well as the operations to blister, label, carton, test, release and distribute
the product to Wyeth.

It defines the individual responsibilities of Wyeth and the Supplier, and in
particular defines who is responsible for the cGMP aspects of manufacturing and
specifies the way in which the Qualified Person releasing product batches for
sale ensures that they comply with the FDA approved product application.

The quality agreement takes the form of a detailed check list of all the
activities associated with pharmaceutical production, analysis, release,
distribution. Responsibility for each activity is assigned to either Wyeth,
Supplier or Not Applicable in the appropriate tick box. It is then appended to
the legal contract which covers the commercial and other aspects of the
agreement between the parties.

WYETH CONSUMER HEALTHCARE,             SUPPLIER
DIVISION OF WYETH
555 East Lancaster Avenue
St. David's, PA 19087, USA

Position: _______________________      Position: _______________________

Name:____________________________      Name:____________________________

Signature:_______________________      Signature:_______________________

Date:____________________________      Date:____________________________

Position: _______________________      Position:

Name:____________________________      Name:____________________________

Signature:_______________________      Signature:_______________________

Date:____________________________      Date:____________________________
<PAGE>
<TABLE>
<CAPTION>
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                                          RESPONSIBILITIES                                     NOT          WYETH      SUPPLIER
                                                                                           APPLICABLE
---------------------------------------------------------------------------------------------------------------------------------
<S>      <C>                                                                               <C>              <C>        <C>
1        COMPLIANCE REQUIREMENTS
---------------------------------------------------------------------------------------------------------------------------------
1.1      Warrant that PRODUCT will be manufactured, tested, packaged, and held
         in accordance with all applicable FDA requirements and/or applicable
         regulatory agencies.

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1.2      Manufacture and package product in strict adherence to the approved drug
         application.

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1.3      Permit audits of all relevant premises, procedures, and documentation by Wyeth,
         and permit inspection by Regulatory Authorities.

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1.4      Not to subcontract any of the work to a third party without prior agreement.

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1.5      Have copies available for inspection of all supplements, annual
         reports, annual product reviews, correspondence to approved drug
         application on CMC or labeling issues for products supplied to WA
         during periodic inspections of Suppliers facilities and systems.

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1.6      Supplier shall not file any amendment or supplement to it's ANDA that
         would significantly impact Supplier's ability to supply the PRODUCT to
         Wyeth in the manner described in the supply agreement, without prior
         written notice to Wyeth for their product.

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1.7      Supplier shall notify Wyeth of any FDA Form 483s, Warning Letters or
         the like from applicable regulatory agencies within seven (7) days of
         receipt and subsequent responses(s) relating to the product or
         facilities used to produce, test, or package the product.

---------------------------------------------------------------------------------------------------------------------------------
1.8      Copies of responses to regulatory agencies request(s) for product
         sample, batch records, or notice of inspections for product supplied
         for Wyeth will be provide within seven (7) days of correspondence
         forwarded to the agency.

---------------------------------------------------------------------------------------------------------------------------------
1.9      Notify Wyeth within 24 hours of any recall and / or confirmed stability
         failure for product supplied to Wyeth.

---------------------------------------------------------------------------------------------------------------------------------
1.10     Represent that it is not debarred under the U. S. Generic Drug Enforcement Act of
         1992 or employ or use the services of any individual who is debarred or who has
         engaged in activities that could lead to being debarred.

---------------------------------------------------------------------------------------------------------------------------------
1.11     Perform and maintain all validation current including but not limited to: process,
         analytical method, cleaning, computer, packaging, sanitization.

---------------------------------------------------------------------------------------------------------------------------------
1.12     Conduct operations in compliance with applicable environmental, occupational
         health and safety laws and regulations.

---------------------------------------------------------------------------------------------------------------------------------
1.13     Investigate and resolve all medical and non-medical product complaints. (Refer to
         Schedule "Reporting Adverse Drug Experiences").

---------------------------------------------------------------------------------------------------------------------------------
1.14     Notify Wyeth of any requests for information, notices of violations or
         other communication from a government agency relating to environmental,
         occupational health and safety compliance.

---------------------------------------------------------------------------------------------------------------------------------
1.15     Notify Wyeth of any incident affecting compliance to environmental, occupational
         health and safety laws.

---------------------------------------------------------------------------------------------------------------------------------
1.16     Conduct stability testing according to ANDA protocol

---------------------------------------------------------------------------------------------------------------------------------
1.17     Product Stability Monitoring as filed in ANDA and "Annual Stability
         Reports" will be made available for annual inspection by WA.

---------------------------------------------------------------------------------------------------------------------------------
1.18     Issue and follow up on FDA Field Alerts

---------------------------------------------------------------------------------------------------------------------------------
</TABLE>

                                       -C-2-
<PAGE>
<TABLE>
---------------------------------------------------------------------------------------------------------------------------------
<S>      <C>                                                                               <C>              <C>        <C>
1.19     Complaints - Product Quality and Adverse Drug Experience

---------------------------------------------------------------------------------------------------------------------------------
                  Collection and logging

---------------------------------------------------------------------------------------------------------------------------------
                  Investigation and issue of reports

---------------------------------------------------------------------------------------------------------------------------------
                  Follow up corrective action

---------------------------------------------------------------------------------------------------------------------------------
1.20     Annual product review:  Manufacturing and Analytical Testing

---------------------------------------------------------------------------------------------------------------------------------
1.21     Final Annual Product Review that includes results from 1.19 and 1.20.

---------------------------------------------------------------------------------------------------------------------------------
1.22     Product Recall

---------------------------------------------------------------------------------------------------------------------------------
                  Decision to initiate recall

---------------------------------------------------------------------------------------------------------------------------------
                  Communicate decision to initiate recall

---------------------------------------------------------------------------------------------------------------------------------
                  Approval of wording of notification to appropriate regulatory agencies

---------------------------------------------------------------------------------------------------------------------------------
                  Notification to appropriate regulatory agencies

---------------------------------------------------------------------------------------------------------------------------------
                  Management of recall

---------------------------------------------------------------------------------------------------------------------------------
                  Reconciliation of returned product

---------------------------------------------------------------------------------------------------------------------------------
1.23     Responsibility to Authorities

---------------------------------------------------------------------------------------------------------------------------------
               Liaison with Regulatory Authorities on product inquires

---------------------------------------------------------------------------------------------------------------------------------
               Maintain safety /hazard and handling data on product and raw materials

---------------------------------------------------------------------------------------------------------------------------------
               Liaison with Heath and Safety Authorities

---------------------------------------------------------------------------------------------------------------------------------
               Liaison with Environmental Protection Authorities (Pollution Prevention)

---------------------------------------------------------------------------------------------------------------------------------
2        PRODUCTION AND TESTING OF BULK TABLET PRODUCT
---------------------------------------------------------------------------------------------------------------------------------
2.1      Master Formula

---------------------------------------------------------------------------------------------------------------------------------
2.2      Product specification

---------------------------------------------------------------------------------------------------------------------------------
2.3      Batch identification system for bulk tablet product manufacture

---------------------------------------------------------------------------------------------------------------------------------
2.4      Qualification, approval of additional active pharmaceutical ingredient (API)
         supplier(s).

---------------------------------------------------------------------------------------------------------------------------------
2.5      Procurement of API's,  (include. Certificates of analysis, COA).

---------------------------------------------------------------------------------------------------------------------------------
2.6      Storage of API's.

---------------------------------------------------------------------------------------------------------------------------------
2.7      Sampling of API's

---------------------------------------------------------------------------------------------------------------------------------
2.8      Test method for API's, including method validation.

---------------------------------------------------------------------------------------------------------------------------------
2.9      Analysis of API's (include documentation, COA)

---------------------------------------------------------------------------------------------------------------------------------
2.10     Release of API's

---------------------------------------------------------------------------------------------------------------------------------
2.11     Retain reference samples of API's, including samples of periodic
         re-tests, for one (1) year beyond product expiry date.
---------------------------------------------------------------------------------------------------------------------------------
</TABLE>

                                       -C-3-
<PAGE>
<TABLE>
---------------------------------------------------------------------------------------------------------------------------------
<S>      <C>                                                                               <C>              <C>        <C>
2.12     Qualification, approval of inactive substance suppliers.

---------------------------------------------------------------------------------------------------------------------------------
2.13     Procurement of inactive substances (include COA)

---------------------------------------------------------------------------------------------------------------------------------
2.14     Storage of inactive substances

---------------------------------------------------------------------------------------------------------------------------------
2.14     Sampling of inactive substances

---------------------------------------------------------------------------------------------------------------------------------
2.15     Test method and method validation for inactive substances

---------------------------------------------------------------------------------------------------------------------------------
2.16     Analysis of inactive substances (include documentation, COA)

---------------------------------------------------------------------------------------------------------------------------------
2.17     Release of inactive substances

---------------------------------------------------------------------------------------------------------------------------------
2.18     Retain reference samples of inactive substances, including samples of
         periodic re-tests, for one (1) year beyond product expiry date.

---------------------------------------------------------------------------------------------------------------------------------
2.19     Process Validation

---------------------------------------------------------------------------------------------------------------------------------
2.20     Cleaning Validation

---------------------------------------------------------------------------------------------------------------------------------
2.21     Bill of Materials (BOM) for bulk tablet manufacturing

---------------------------------------------------------------------------------------------------------------------------------
2.22     Manufacturing Instructions (Production Operating Instructions)

---------------------------------------------------------------------------------------------------------------------------------
2.23     Production of bulk tablet material (include batch documentation)

---------------------------------------------------------------------------------------------------------------------------------
2.24     Document, investigate and resolve deviations from approved
         manufacturing instructions or specifications. All deviations shall be
         recorded and justified. Supply a copy to Wyeth of all incident reviews
         and/or out-of-spec results that correspond with the given batch.

---------------------------------------------------------------------------------------------------------------------------------
2        PRODUCTION AND TESTING OF BULK TABLET PRODUCT

---------------------------------------------------------------------------------------------------------------------------------
2.25     Bulk tablet product sampling plan

---------------------------------------------------------------------------------------------------------------------------------
2.26     Sampling of bulk tablet product

---------------------------------------------------------------------------------------------------------------------------------
2.27     Test method and method validation for bulk tablet product

---------------------------------------------------------------------------------------------------------------------------------
2.28     Analysis of bulk tablet product

---------------------------------------------------------------------------------------------------------------------------------
2.29     Certificate of analysis for bulk tablet product

---------------------------------------------------------------------------------------------------------------------------------
2.30     Equipment and instrument maintenance and calibration.

---------------------------------------------------------------------------------------------------------------------------------
2.31     Stability testing of product in bulk tablet storage according to ANDA protocol

---------------------------------------------------------------------------------------------------------------------------------
2.32     Maintain all batch records for a minimum of one year beyond product expiry date.
         Validation batch production and testing records should be kept permanently

---------------------------------------------------------------------------------------------------------------------------------
2.33     Release of bulk tablet product by QA

---------------------------------------------------------------------------------------------------------------------------------
3.       STORAGE AND TRANSPORTATION OF BULK PRODUCT AND WASTE DISPOSAL

---------------------------------------------------------------------------------------------------------------------------------
3.1      Storage of bulk product up to packaging or delivery to Wyeth

---------------------------------------------------------------------------------------------------------------------------------
3.2      Storage of bulk product tablets.

---------------------------------------------------------------------------------------------------------------------------------
</TABLE>

                                       -C-4-
<PAGE>
<TABLE>
---------------------------------------------------------------------------------------------------------------------------------
<S>      <C>                                                                               <C>              <C>        <C>
3.3      Storage of bulk product according to labeled storage conditions

---------------------------------------------------------------------------------------------------------------------------------
3.4      Transportation of bulk product to Wyeth or designated third party.

---------------------------------------------------------------------------------------------------------------------------------
3.5      Disposal of waste

---------------------------------------------------------------------------------------------------------------------------------
3.6      Disposal of special waste, e.g. toxic waste, solvents, etc. (specify nature of
         waste and special disposal methods required)

         ____________________________________________

         ____________________________________________

         ____________________________________________

---------------------------------------------------------------------------------------------------------------------------------
4.       PACKAGING OF FINISHED PRODUCT

---------------------------------------------------------------------------------------------------------------------------------
4.1      Finished product specification

---------------------------------------------------------------------------------------------------------------------------------
4.2      Batch identification system for finished product

---------------------------------------------------------------------------------------------------------------------------------
4.3      Artwork and labeling text (blister, carton, leaflet, label, etc.)

---------------------------------------------------------------------------------------------------------------------------------
4.4      Labeling review and approval

---------------------------------------------------------------------------------------------------------------------------------
4.5      Specifications for packaging materials

---------------------------------------------------------------------------------------------------------------------------------
4.6      Test methods and method validation for packaging materials

---------------------------------------------------------------------------------------------------------------------------------
4.7      Qualification and approval of packaging components and labeling suppliers

---------------------------------------------------------------------------------------------------------------------------------
4.8      Procurement of packaging materials

---------------------------------------------------------------------------------------------------------------------------------
4.9      Analysis of packaging materials

---------------------------------------------------------------------------------------------------------------------------------
4.10     Release of packaging materials

---------------------------------------------------------------------------------------------------------------------------------
4.11     Retain samples of packaging materials for one year past product expiry date.

---------------------------------------------------------------------------------------------------------------------------------
4.12     Validation of packaging process

---------------------------------------------------------------------------------------------------------------------------------
4.13     Bill of Materials (BOM) for packaging

---------------------------------------------------------------------------------------------------------------------------------
4.14     Packaging Instructions (POI for packaging)

---------------------------------------------------------------------------------------------------------------------------------
4.15     Packaging operations (include documentation)

---------------------------------------------------------------------------------------------------------------------------------
4.16     In-process control instructions

---------------------------------------------------------------------------------------------------------------------------------
4.17     In-process controls during packaging (include documentation)

---------------------------------------------------------------------------------------------------------------------------------
4.18     Finished product sampling plan

---------------------------------------------------------------------------------------------------------------------------------
4.19     Sampling of finished product including retain samples, stability
         sample, release samples, customer sample.

---------------------------------------------------------------------------------------------------------------------------------
4.20     Retain reference samples of finished product for one year past product expiry date

---------------------------------------------------------------------------------------------------------------------------------
</TABLE>

                                       -C-5-
<PAGE>
<TABLE>
---------------------------------------------------------------------------------------------------------------------------------
<S>      <C>                                                                               <C>              <C>        <C>
4.21     Reconciliation of packaging materials

---------------------------------------------------------------------------------------------------------------------------------
4.22     Equipment and instrument maintenance and calibration

---------------------------------------------------------------------------------------------------------------------------------
4.23     Document, investigate and resolve any deviation from approved packaging
         instructions or specifications.

---------------------------------------------------------------------------------------------------------------------------------
5.       TESTING AND RELEASE OF FINISHED PRODUCT

---------------------------------------------------------------------------------------------------------------------------------
5.1      Test method and method validation for finished product

---------------------------------------------------------------------------------------------------------------------------------
5.2      Equipment and instrument maintenance and calibration

---------------------------------------------------------------------------------------------------------------------------------
5.3      Analysis of finished product by QA

---------------------------------------------------------------------------------------------------------------------------------
5.4      Release of finished product by QA

---------------------------------------------------------------------------------------------------------------------------------
5.5      -   Certificate of analysis for finished product testing. Supplier to supply
             Cof A which contains info needed:
         -   Written description of tablet.
         -   Test Name
         -   Release Specification
         -   Results
         -   Bulk hold expiration date
         -   Expiration date when packaged in final container.

---------------------------------------------------------------------------------------------------------------------------------
6.       DOCUMENTATION

---------------------------------------------------------------------------------------------------------------------------------
6.1      -   Provide Certificate of Compliance including: No In Process OOS data.
         -   No Investigation Reports issued against lot or See attached IR# ________.
         -   Batch records have been audited and approved by Supplier QA.
         -   All raw materials used in the MFG of this batch have been QA approved and sourced from
             approved suppliers.
         -   Manufacture Date: ________.
         -   Bulk Retest Date: ________.
         -   Expiration when PKG in final container: ________.
         -   Manufacturing and testing was conducted against approved procedures.

---------------------------------------------------------------------------------------------------------------------------------
6.2      -   Provide the following documentation to Wyeth for batches:
         -   C of A
         -   Cof C as part of the C of A
         -   Packaging Records (Blistering)
                  Line Clearance
                  Assembly instructions
                  In Process test results
                  Component Check-in
                  Yield/reconciliation calculations.
         -   Packaging Records (Cartoning)
         -   Representative Packaged Product Samples (AQL sampling)

---------------------------------------------------------------------------------------------------------------------------------
6.3      Accountabilities for all critical manufacturing steps. Any
         accountability outside pre-established limits must be investigated and
         a copy of the investigation included with batch records.
---------------------------------------------------------------------------------------------------------------------------------
</TABLE>

                                       -C-6-
<PAGE>
                                    EXHIBIT D

                     ADVERSE EXPERIENCE REPORTING PROCEDURES

         The parties hereby agree that the following terms will govern
disclosures of each party to the other with respect to adverse event reporting
relating to Product as clinically tested or marketed by or on behalf of either
party.

1.       DEFINITIONS.

         1.1      ADVERSE EXPERIENCE OR EVENT (AE): An AE is defined by WCH as
                  any untoward, undesired, or unplanned event in the form of
                  signs, symptoms, disease, or laboratory or physiological
                  observations occurring in a human being in a temporal
                  relationship to use of an WCH product regardless of causal
                  relationship. This includes:

                  -  any clinically significant worsening of a pre-existing
                     condition;

                  -  an AE occurring from overdose (i.e., a dose higher than
                     that prescribed by a health care professional for clinical
                     reasons) of an WCH product, whether accidental or
                     intentional;

                  -  an AE occurring from abuse (i.e., use for non-clinical
                     reasons) of an WCH product;

                  -  an AE that has been associated with the discontinuation of
                     the use of an WCH product;

                  -  any failure of expected pharmacological action (for
                     spontaneous reports).

                  If there is any doubt whether the information constitutes an
                  AE, the information will be treated as an AE.

         1.2      SERIOUS AE: A serious AE is defined by WCH as an AE occurring
                  at any dose that: results in death; is life-threatening (see
                  below); requires inpatient hospitalization or prolongation of
                  an existing hospitalization; results in a persistent or
                  significant disability or incapacity (see below); results in
                  cancer; or results in a congenital anomaly or birth defect.
                  Additionally, IMPORTANT MEDICAL EVENTS that may not result in
                  death, be life-threatening, or require hospitalization may be
                  considered a serious AE when, based upon appropriate medical
                  judgment, they may jeopardize the patient or subject and may
                  require medical or surgical intervention to prevent one of the
                  outcomes listed in this definition. Examples of such medical
                  events include allergic bronchospasm requiring intensive
                  treatment in an emergency room or at home; blood dyscrasias or
                  convulsions that do not result in hospitalization; or the
                  development of drug dependency or abuse.
<PAGE>
                  1.2.1    Life-threatening refers to immediate risk of death as
                           the event occurred. A life-threatening experience
                           does not include an experience that, had it occurred
                           in a more severe form, might have caused death but as
                           it actually occurred did not create an immediate risk
                           of death. For example, hepatitis that resolved
                           without evidence of hepatic failure would not be
                           considered life-threatening even though hepatitis of
                           a more severe nature can be fatal. Similarly, an
                           allergic reaction resulting in angioedema of the face
                           would not be life-threatening, even though angioedema
                           of the larynx, allergic bronchospasm, or anaphylaxis
                           can be fatal.

                  1.2.2    Disability is defined as a substantial disruption in
                           a person's ability to conduct normal life functions.

                  1.2.3    For studies, all pregnancies and all overdoses will
                           be reported to GSSE in the same time frame as serious
                           AEs.

                  1.2.4    A serious AE obtained from tests in laboratory
                           animals includes any experience suggesting a
                           significant risk for human subjects, including any
                           findings of mutagenicity, teratogenicity, or
                           carcinogenicity.

                  1.2.5    If there is any doubt whether the information
                           constitutes a serious AE, the information will be
                           treated as a serious AE.

         1.3      NON-SERIOUS AE: is any AE which does not meet the criteria for
                  a serious AE.

         1.4      UNEXPECTED AE: An unexpected AE is one that is not listed in
                  the current product labeling. The current product labeling is
                  either the package insert (for marketed WCH products) or the
                  current investigator's brochure (for investigational WCH
                  products).

                  An unexpected AE includes any event that may be
                  symptomatically and pathophysiologically related to an event
                  listed in the labeling, but differs from the labeled event
                  because of greater severity or specificity. For example,
                  hepatic necrosis would be unexpected (by virtue of greater
                  severity) if the product labeling referred only to elevated
                  hepatic enzymes or hepatitis. Similarly, cerebral
                  thromboembolism and cerebral vasculitis would be unexpected
                  (by virtue of greater specificity) if the labeling only listed
                  cerebral vascular accidents.

         1.5      PRODUCT (DRUG, VACCINE, BIOLOGICAL, DEVICE)-RELATED:  For the
                  purposes of regulatory reporting for investigational products,
                  an AE will be considered "product-related" (i.e.,
                  drug-related, vaccine-related, etc.) for studies if either the
                  investigator, the Medical Monitor, the CR&D Clinical Project
                  Team Medical Monitor (or designee), or the Local Monitor (if
                  applicable) assesses the AE(s) as possibly, probably, or
                  definitely related.

                                      -D-2-
<PAGE>
                  1.       An AE will be considered "not product-related" for
                           studies if the investigator AND the medical
                           monitor(s) AND the local monitor (if applicable)
                           assess the AE(s) as probably not related or
                           definitely not related, or "relationship remote."

                  2.       Whenever the investigator's or monitor's assessment
                           is unknown or unclear, the AE(s) will be treated as
                           product-related for the purposes of reporting to
                           regulatory authorities.

         1.6      PROTOCOL-RELATED: AEs from studies that are not
                  product-related may nevertheless be considered by the
                  investigator or the medical monitor(s) or the local monitor
                  (if applicable) to be protocol-related. For purposes of
                  reporting to GSSE and regulatory authorities, these will be
                  reported in the same manner as product-related events.

         1.7      NDA HOLDER is defined as: An "Applicant" as defined in 21 CFR
                  Part 314.3(b), for regulatory approval of a Product in any
                  regulatory jurisdiction, including a holder of a foreign
                  equivalent thereto.

         1.8      IND HOLDER is defined as: A "Sponsor" as defined in 21 CFR
                  Part 313.1(b) of an investigational new drug in any regulatory
                  jurisdiction, including a holder of a foreign equivalent
                  thereto.

         1.9      Capitalized terms not defined in this Exhibit shall have the
                  meaning assigned thereto in the Agreement.

2.       With respect to the Product or Active Ingredient, the Parties agree as
         follows:

         a.       All initial reports and any follow-up information (oral or
                  written) for any and all Serious AEs as defined above, (other
                  than with respect to animal studies) which become known to
                  either Party (other than from disclosure by or on behalf of
                  the other Party) must be communicated by telephone, telefax or
                  electronically directly to the other Party and/or the NDA
                  Holder, IND Holder (individually and collectively referred to
                  as "Holders") within forty-eight (48) hours of receipt of the
                  information. Written confirmation of the Serious AE received
                  by such Party should be sent to the other Party and/or the
                  Holders as soon as it becomes available, but in any event
                  within forty-eight (48) hours of initial report of the Serious
                  AE by such Party.

         b.       Both Parties shall exchange Medwatch and/or CIOMs forms and
                  other health authority reports within forty-eight (48) hours
                  of submission to any Regulatory Authority.

         c.       All initial reports and follow-up information received for all
                  Non-Serious AEs for marketed Product which become known to a
                  Party (other than from disclosure by or on behalf of the other
                  Party) must be communicated in writing, by telefax or

                                      -D-3-
<PAGE>
                  electronically to the other Party within ten (10) days, on
                  Medwatch or CIOMs forms (where possible).

         d.       Each Party shall coordinate and cooperate with the other
                  whenever practicable to prepare a single written report
                  regarding all Serious and/or Non-Serious AEs, provided,
                  however, that neither Party shall be obligated to delay
                  reporting of any AE in violation of applicable law or
                  regulations regarding the reporting of AEs.

3.       The Parties further agree that:

         a.       A written report be forwarded to the other Party within
                  forty-eight (48) hours of a receipt by the Party making the
                  report, for AEs for animal studies which suggest a potential
                  significant risk for humans;

         b.       Each Party will give the other Party a report via a print-out
                  or computer disk of all AEs reported to it and its Affiliates
                  relating to the Product or Active Ingredient within the last
                  year, within thirty (30) days of receipt of a request from the
                  other Party but not more often than four (4) times a year;

         c.       If either Party wishes access to AE Reports of the other Party
                  relating to the Product or Active Ingredient, upon request of
                  that Party, the other Party shall make available its AE
                  records relating to the Product or Active Ingredient
                  (including computer disks) for viewing and copying by the
                  other Party. The Parties may discuss the transfer of AE
                  Reports by computer disk.

         d.       Disclosure of information hereunder by a Party to the other
                  Party shall continue as long as either Party and/or its
                  Affiliates or designees continue to clinically test or market
                  Product or Active Ingredient.

4.       Each Party shall diligently undertake the following further obligations
         where both Parties are or will be commercializing the Product or Active
         Ingredient pursuant to the Agreement and/or performing clinical trials
         with respect to the Product or Active Ingredient:

         a.       Upon the Effective Date, each Party shall identify individuals
                  who shall be responsible for identifying all AE reporting
                  requirements in all countries of the Territory as set forth in
                  the Agreement, and any amendments thereto;

         b.       To immediately consult with the other Party, with respect to
                  the investigation and handling of any Serious AE disclosed to
                  it by the other Party or by a Third Party and to allow the
                  other Party to review the Serious AE and to participate in the
                  follow-up investigation;

         c.       To immediately advise the other Party of any Product and/or
                  Active Ingredient safety communication received from a health
                  authority and consult with the other Party with respect to any
                  Product and/or Active Ingredient warning, labeling

                                      -D-4-
<PAGE>
                  change or change to an investigators' brochure involving
                  safety issues proposed by the other Party, including, but not
                  limited to the safety issues agreed to by the Parties;

         d.       To diligently handle in a timely manner the follow-up
                  investigation and resolution of each AE reported to it;

         e.       To provide the other Party mutually agreed upon audit rights
                  of its AE reporting system and documentation, upon prior
                  notice, during normal business hours, at the expense of the
                  auditing Party and under the confidentiality obligations set
                  forth in the Agreement;

         f.       To meet in a timely fashion from time to time as may be
                  reasonably required to implement the adverse event reporting
                  and consultation procedures described in this Exhibit D,
                  including identification of those individuals in each Party's
                  Drug Safety group who will be responsible for reporting to and
                  receiving AE information from the other Party, and the
                  development of a written standard operating procedure with
                  respect to adverse event reporting responsibilities, including
                  reporting responsibilities to investigators;

         g.       Where possible, to transmit all data electronically;

         h.       To report to each other any addenda, revisions or changes to
                  the Agreement (e.g., change in territories, local regulations,
                  addition of new licensors/licensees to the Agreement, etc.)
                  which might alter the adverse event reporting responsibilities
                  hereunder;

         i.       To utilize English as the language of communication and data
                  exchange between the Parties;

         j.       To develop a system of exchange of documents and information
                  in the event that the Agreement involves more than two
                  Parties; and

         k.       To work together to develop an electronic system to transmit
                  AE data.

5.       The Parties may meet after the Effective Date of the Agreement to
         establish a separate agreement for adverse event exchange which will
         supersede this Exhibit D.

                                      -D-5-

</TEXT>
</DOCUMENT>
