Document:

<PAGE>

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                                                   EXHIBIT 10.19

                       MANUFACTURING AND SUPPLY AGREEMENT

Entered into this 6th day of August 1997 (hereinafter "Effective Date") by and
between

              JPI PHARMACEUTICA INTERNATIONAL, a division of Cilag AG
              International Zug, a company duly organized and existing under the
              laws of Switzerland, having its principal office in CH-6300 Zug,
              Kollerstrasse 38, Switzerland (hereinafter referred to as "JPI")
              and

              JANSSEN PHARMACEUTICA Inc., 1125 Trenton-Harbourton Road,
              Titusville, NJ 08560, USA (hereinafter referred to as "JANSSEN
              US") (JPI and JANSSEN US collectively referred to herein as
              "JANSSEN")

and

              Alkermes Controlled Therapeutics Inc. II, a company organized and
              existing under the laws of the Commonwealth of Pennsylvania,
              having its principal office at 64 Sidney Street, Cambridge, MA
              02139-4136, U.S.A. ( hereinafter referred to as "ACT II").

                                   WITNESSETH

WHEREAS, JPI and ACT II (as assignee of Medisorb Technologies International LP
("MTI")) have entered into an agreement dated December 23, 1993 for the
development of a Risperidone depot formulation incorporating ACT II's
proprietary technology concerning bioabsorbable polymer technologies as duly
amended by the Second Amendment on March 8, 1997 (hereinafter "Development
Agreement"); and

WHEREAS, JANSSEN and ACT II (an assignee of MTI) have entered into two License
agreements dated February 21, 1996 granting JANSSEN certain exclusive rights
with respect to the use of ACT II's proprietary technology in the development,
manufacturing, promotion and sale of Risperidone depot formulations (hereinafter
"License Agreements"); and
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

WHEREAS, further to the provisions of Article 4 (b) of the License Agreements,
ACT II has a right of first refusal with respect to the manufacture of such
Risperidone depot formulations and JANSSEN has further to such provision agreed
to entrust the manufacturing of Products (as hereinafter defined) to ACT II
under the terms and conditions set forth hereinafter.

ARTICLE 1 : DEFINITIONS

The following terms shall, for the purpose of this Agreement, have the following
meaning unless the context clearly requires otherwise and the singular shall
include the plural and vice versa :

1.1    "Affiliate" shall mean any company controlling, controlled by, or under
       common control with a party by ownership, directly or indirectly, of
       fifty percent (50%) or more of the total ownership or by the power to
       control the policies and actions of such company.

1.2    "Compound" shall mean the active ingredient risperidone.

1.3    "Final Product" shall mean the final presentation form of the Product
       registered and marketed by Janssen, their Affiliates and licensees, ready
       for sale to the final customer.

1.4    "Janssen GMP Manual" shall mean the Janssen Pharmaceutical GMP Policies
       Manual, a numbered copy of which has been provided to ACT II and which
       Manual, together with any possible amendment and/or addition is deemed to
       constitute an integral part of this Agreement.

1.5    "Licensed Net Selling Price" shall mean the [***] JANSSEN, their
       Affiliates or licensees in a given calendar year to independent third
       parties for the Final Product for sale in the Territory, less deductions
       for (i) transportation charges, including insurance; (ii) sales and
       excise taxes paid by JANSSEN, their Affiliates or licensees and any other
       governmental charges imposed upon the production, importation, use or
       sale of the Final Product; (iii) trade, cash and ordinary business
       discounts allowed and (iv) allowances or credits to customers on account
       of rejection or return of Final Product (v) and managed care rebates or
       allowances and mandatory price allowances imposed by governments.

       If JANSSEN, its Affiliates or licensees sell Final Product in a country
       in such a manner that the net sales value of the same is not readily
       identifiable then the net sales determination for that
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       country shall be whichever is the higher of (i) the fair market value of
       such Final Product or (ii) the proportion of the bundled price attributed
       to the Final Product by JANSSEN, its Affiliates or licensees whenever
       Product is sold as part of a package of products or services.

       For the purpose hereof "fair market value" shall mean, without
       limitation, the value of Final Products sold to similar third parties in
       similar quantities. If the fair market value can not be determined in any
       given country, the fair market value will be determined by the value of
       the Final Product sold to similar customers in countries with similar
       pricing and reimbursement structures and for similar quantities.

1.6    "Manufacture, Manufacturing" shall mean all steps and operations involved
       in the production of Product, starting from Compound, including supply of
       the polymers or other critical excipients, pharmaceutical formation,
       packaging, in process and quality control and storage of Compound and
       Product, until delivery for shipment of the Product to JANSSEN US, JPI or
       their designee.

1.7    "Manufacturing Fee" shall mean the fee to be paid by JPI and JANSSEN US
       to ACT II in consideration for the Manufacture of Products supplied to
       each of them in accordance with the terms hereof and which fee will be
       calculated as a percentage of the Licensed Net Selling Price per unit of
       Product in accordance with the mechanism set forth in Article 6.

1.8    "Manufacturing Process" shall mean the process and environment required
       to Manufacture Product as described in regulatory filings.

1.9    "Materials" shall mean all or any of the materials, except for Compound,
       required for the Manufacture of Product (including but not limited to
       inactive ingredients, diluents, excipients, vials, containers).

1.10   "Product" shall mean a depot formulation of Risperidone, based on ACT II
       technologies utilizing polymers of lactic and glycolic acids which are
       designed to deliver Compound over an extended period, in appropriately
       labeled siliconized vials or any other immediate container agreed by both
       parties and as set forth in the Specifications.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

1.11   "Specifications" shall mean the agreed specifications of the Product, to
       be attached hereto as Exhibit A, including quality control tests to be
       performed by JANSSEN and a list of the methodologies to be used in
       performing those tests.

1.12   "Territory" shall mean worldwide.

ARTICLE 2: PROGRAM OF COMMERCIAL MANUFACTURE AND SUPPLY OF PRODUCTS

2.1    Subject to the terms and conditions of this Agreement, JANSSEN hereby
       appoints ACT II as their exclusive supplier of Product for their entire
       requirements in Territory and ACT II agrees to Manufacture Product in its
       own premises for the exclusive purpose to supply Product to JANSSEN or
       their designee.

2.2    ACT II will provide [***], all equipment and machinery for the
       Manufacture of the Product, except for those capital items owned by
       JANSSEN US and identified in Exhibit B attached hereto. ACT II will only
       use such equipment and machinery which complies with the Manufacturing
       Process and any other requirements, such as the DMF, agreed with JANSSEN.
       ACT II shall maintain such equipment and machinery in good condition and
       properly validated.

2.3    In order to assist ACT II in its production planning, both parties will
       discuss and agree at the latest upon finalisation of the Phase III
       Clinical Trials in accordance with the Development Agreement on a rolling
       ordering and forecast mechanism [***] duly considering amongst others the
       required leadtimes to Manufacture the Product and to acquire the primary
       container or any other Material. In principle the first period of such
       rolling forecast will be considered a firm commitment, the other periods
       being indicative and non binding. Such forecast will be periodically
       updated at the moment of sending the orders for the next period. To the
       extent required such a forecast mechanism may include a buffer mechanism
       providing for an upper and lower variation limit of the eventual orders
       against the latest forecast and a reasonable buffer mechanism in
       connection with required delivery dates and ordered quantities of
       Product.

       The eventually agreed forecast mechanism ("hereinafter Forecast
       Mechanism") will be attached hereto as Exhibit E and will be used both by
       JPI and by JANSSEN US, it being understood that Janssen US and JPI may
       use a slightly different Forecast Mechanism format reflecting potential
       differences in the flow of goods.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

2.4    JPI and JANSSEN US will each, in accordance with the Forecast Mechanism,
       send firm orders to ACT II indicating the requirements for Products,
       together with the required delivery dates and destination, and shall at
       the same time advise ACT II of the estimated requirements for the
       following periods in accordance with the Forecast Mechanism. JPI and/or
       JANSSEN US will ship Compound to ACT II in quantities sufficient and with
       sufficient lead time to enable ACT II to manufacture the ordered
       Products. Together with the batch(es) of Compound, JPI and/or JANSSEN US
       will send all required documents and certificates. The Compound shipped
       to ACT II will comply with agreed specifications to be attached hereto as
       Exhibit F. In order to insure an adequate supply of Compound, ACT II will
       provide inventory data for each batch of Product shipped to Janssen as
       well as quarterly summaries of inventory transactions.

2.5    Upon receipt of the Compound, ACT II will inspect the batch(es) in
       accordance with to be agreed test procedures. Within thirty (30) business
       days following receipt of a shipment of Compound, ACT II shall inform JPI
       or JANSSEN US, depending on who was responsible for the shipment, in
       writing of any qualitative and/or quantitative shortcomings of the
       supplied Compound. In the event of a justifiable claim, JPI or JANSSEN US
       as the case may be shall replace or cause to have replaced such
       quantities of Compound in the shortest possible time and dispose of any
       defective batch(es) at its own expense.

       Upon receipt and control of the Compound, ACT II will proceed with the
       Manufacture of the Products in accordance with the time schedule required
       to meet the requested delivery dates.

2.6    All Product Manufactured by ACT II under this Agreement shall be
       manufactured and packed strictly in accordance with the Specifications
       and Manufacturing Process and in accordance with the provisions of the
       applicable Drug Master File to which JANSSEN is granted access in
       accordance with the provisions of Article 5.3.

       ACT II shall be responsible for obtaining Materials in such quantities as
       are necessary for the manufacturing of the amounts of Product ordered by
       JANSSEN.

       ACT II shall be responsible for the quality, purity, identity and potency
       of the Materials used and shall only buy and use such Materials in the
       Manufacturing of the Product, which strictly comply with the applicable
       quality requirements and Specifications.

       ACT II shall not change the validated Manufacturing process of the
       Product or use any different material in the processing thereof that may
       have an impact on any regulatory approval in
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       connection with the Product without JANSSEN US' (in connection with the
       United States) and/or JPI's (in connection with the rest of the
       Territory) explicit prior written approval and shall give the assistance
       reasonably required by JANSSEN US or JPI in preparing the supplement to
       any regulatory approval in connection with any change previously approved
       by JANSSEN US or JPI.

2.7    ACT II shall Manufacture Product in batches as specified in the
       Specifications [***].

2.8    To minimize the likelihood of a supply deficiency with respect to
       Products, by the end of Phase III clinical trials in the development of
       the Product in accordance with the Development Agreement, both parties
       shall discuss and agree on a Disaster Recovery and Back-Up plan to be
       prepared by ACT II. Such plan shall consider the possibility of
       (re)building (including validation and approval) a plant within an
       acceptable period of time (such period to be determined in common
       agreement) in case ACT II's current premises would be destroyed as well
       as transferring the Manufacture to a manufacturing facility of JANSSEN or
       any of their Affiliates or the facilities of a third party. Such third
       party will be an industry recognized reputable manufacturer having
       experience in making injectable pharmaceutical products.

2.9    The parties hereto will at regular instances review the long term
       capacity of ACT II's plant taking into account the most current forecast
       of the Final Product with a view to determine the need to have additional
       manufacturing capacity, either at the existing facility of ACT II or in
       any other manufacturing facility and either with ACT II or any of its
       Affiliates or with JANSSEN or any of their Affiliates.

2.10   The parties hereto acknowledge that after ACT II has supplied the Product
       for Phase III clinical trial supplies and prior to the start of the
       commercial Manufacturing of the Product, ACT II's manufacturing facility
       for the Product should be kept in a manufacturing ready condition so as
       to minimize the risk of supply deficiencies at the moment of start up of
       the commercial Manufacturing. In order to do so ACT II will commit such
       resources and undertake such maintenance activities and training programs
       as agreed by both parties in a Manufacturing Readiness Plan. Such
       Manufacturing Readiness Plan will be attached to this Agreement as
       Exhibit H. In consideration of such maintenance activities, JANSSEN will
       each pay a monthly fee to ACT II of [***]. ACT II will send monthly
       invoices to JPI or JANSSEN US in connection
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       with such fees in accordance with timely provided instructions and JPI
       and/or JANSSEN US will pay such invoices within thirty days date of
       invoice. The parties hereto will use good faith efforts to investigate
       the possibility to utilize ACT II's manufacturing facility for other
       manufacturing requirements of JANSSEN or any of their Affiliates during
       such interim period. To the extent any such project would be identified
       and agreed by the parties, the parties will in good faith negotiate an
       appropriate reduction of the monthly [***] fee payable by JANSSEN.

2.11   The parties hereto agree that during the term of this Agreement, JANSSEN
       will order and purchase a minimum number of Product during any given
       calendar year starting on the first commercial launch of the Final
       Product (the year of first commercial launch to be calculated on a pro
       rata basis). Such minimum numbers are expressed in kilograms of bulk
       Product (excluding for this purpose the vials) and are set forth in
       Exhibit C attached hereto. In the event that JANSSEN does not achieve the
       applicable minimum quantity of the Product to be Manufactured during a
       given calendar year, the parties hereto will in good faith renegotiate an
       adjusted Manufacturing Fee, duly considering the effect of the shortfall.
       In the event the parties can not agree an adjusted Manufacturing Fee, ACT
       II will be entitled to terminate this Agreement upon giving a one year
       prior notice. Act II shall provide such commercially reasonable
       assistance and other information in order for JANSSEN to manufacture or
       have Manufactured the Product after such one year notice period.

ARTICLE 3: QUALITY ASSURANCE - GMP COMPLIANCE

3.1    ACT II will Manufacture the Product in accordance with current Good
       Manufacturing Practices ("GMP") standards, including, but not limited to
       the requirements set forth in Janssen's GMP Manual, the requirements
       imposed by the Food and Drug Administration of the United States ("FDA"),
       the Japanese health authorities and EU GMP guidelines.

3.2    ACT II shall perform in process and final quality control on Product. For
       each batch of Product, ACT II shall take a sample or samples as specified
       in the JANSSEN GMP Manual. Such sample(s) and records shall be retained
       in accordance with the provisions of the Janssen GMP Manual. In addition
       ACT II will on an annual basis submit revalidation data to JANSSEN or
       their designee in compliance with the provisions of the Sterilization
       Policy in the Janssen GMP Manual.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

3.3    JANSSEN shall have the right, upon reasonable advance notice and during
       regular business hours, to send its quality control inspectors to inspect
       and audit the processes, facilities and equipment being used by ACT II in
       the Manufacturing of the Product and the polymers used in Product to
       assure compliance with Articles 2 and 3 of this Agreement as well as any
       applicable laws, rules and regulations, provided that such quality
       control inspectors shall be subject to the confidentiality provisions
       provided for in Article 7. Such inspection and audit shall be conducted
       at JPI's or JANSSEN US' (as the case may be) sole cost and expense and in
       a manner so as to minimize disruption of ACT II's business operations.
       The above audit right shall also extend to ACT II's supplier of the
       siliconized vials.

       ACT II shall or shall cause its suppliers of the siliconized vials or any
       other primary container to remedy, within the timelimits provided for in
       the GMP audit report or determined in accordance with the Janssen GMP
       Manual any deficiencies reported by such auditor in the audit report
       issued following any such audit and which deficiencies relate to GMP,
       Specifications, Manufacturing Process, applicable laws, rules and
       regulations including JANSSEN's current quality control procedures,
       provided that, with respect to the latter, ACT II received an updated
       version prior to any such audit. ACT II and JANSSEN will reasonably
       collaborate with each other in order to insure that the manufacturer of
       the siliconized vials or any other primary container complies with
       applicable GMP rules (including the JANSSEN GMP Manual) and
       Specifications and Manufacturing Process. Such collaboration includes the
       possibility to organize joint audits or to have such GMP audit performed
       by JANSSEN. During such period, ACT II shall continuously use
       commercially reasonable efforts to remedy such deficiencies as promptly
       as possible. In the event that ACT II does not remedy any of such
       deficiencies within the above-referred timelimits, then JANSSEN shall be
       entitled to cover by Manufacturing themselves or to have a third party
       manufacture the Products. ACT II shall provide such commercially
       reasonable assistance and other information as shall be necessary in
       order for JANSSEN to manufacture itself or have a third party manufacture
       the related Products. In the event that JANSSEN uses a third party
       manufacturer for the Product pursuant to this Article, JANSSEN shall
       require such third party to be bound by the same confidentiality
       provisions as are contained in this Agreement.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

3.4    In the event ACT II receives a deficiency notice from the FDA or any
       other regulatory agency regarding its compliance with any applicable
       laws, rules and regulations regarding its Manufacture of the Product, ACT
       II shall promptly notify JPI and JANSSEN US. ACT II shall use
       commercially reasonable effects to remedy such deficiencies as promptly
       as possible and in any event within the time period requested by the
       agency. In the event that ACT II does not remedy any of such deficiencies
       within the period provided for in the notice of the regulatory agency,
       then JANSSEN shall be entitled to manufacture or have manufactured the
       Products in accordance with the provisions of Article 3.3.

3.5    Upon reasonable request of JANSSEN US, JPI or any of their Affiliates,
       ACT II will enter into a separate Quality Assurance Agreement with
       JANSSEN US, JPI or any such Affiliate, which Quality Assurance Agreement
       will confirm the quality assurance provisions set forth in this Agreement
       and will clearly identify the respective responsibilities of the parties
       in the Manufacturing of the Product.

ARTICLE 4: SHIPMENT - RISK AND TITLE

4.1    By the required delivery date, ACT II will ship the Products to JANSSEN
       or their designee in accordance with the ordering instructions as set
       forth in Article 2 hereof. Together with such shipment ACT II will send
       shipping documents and Certificates of Analysis of the batches shipped.
       Products shall be shipped using a carrier appointed by JANSSEN on the
       basis of FOB, port of shipment. The term "FOB" shall be interpreted in
       accordance with the latest INCOTERMS.

4.2    Upon receipt of a batch of Product JPI , JANSSEN US or their designee
       shall perform or have performed an inspection of the batch documents and
       perform such test on the Product in accordance with procedures to be
       agreed upon. Should a batch of Product fail to meet the established
       standards of quality as set forth in Article 3 or should the Product or
       the Manufacturing Process thereof not comply with the Specifications and
       Manufacturing instructions, JPI or JANSSEN US, as the case may be, shall
       inform ACT II in writing of the alleged shortcomings within fifteen (15)
       business days after receiving such defect and the batch number.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       ACT II shall, at JPI's or JANSSEN US' option, depending who ordered the
       batch (i) re-process or replace in accordance with the Specifications and
       the Manufacture Process, at its own cost (which cost excludes the cost of
       the Compound) the whole or part of the deficient batch of Product so
       rejected, or, if the related Manufacturing Fee due by JPI or JANSSEN US
       in accordance with Article 6 was already paid , provide either (ii) a
       refund of the Manufacturing Fee paid in relation to the rejected
       batch(es) or (iii) issue a credit note for future orders for the full
       amount of the Manufacturing Fee paid in relation to the rejected
       batch(es) and shall destroy upon JPI's or JANSSEN US' instructions the
       rejected batch of Product which can not be corrected or improved.
       Furthermore, ACT II compensate or credit JPI or JANSSEN [***] per
       kilogram of Compound for JPI's or JANSSEN US' cost for the Compound used
       in such deficient batch of Product. If JANSSEN US or JPI request the
       receipt of such [***] payment, such payment will be made within forty
       five (45) days date of invoice.

       Both parties will make good faith efforts to resolve disagreements in
       connection with any such alleged shortcomings. In the event the in-house
       experts of the parties are unable to agree on any alleged shortcoming of
       the Product or the Manufacturing process thereof, then the parties will
       appoint an independent expert skilled in the art who will analyse samples
       of the alleged deficient batch and all process deviations. Both parties
       will supply such expert with copies of specifications, documents,
       test results etc., that the expert may reasonably require in connection
       with such analysis. The expert's decision as to whether such batch has
       met the specifications shall be final and binding to the parties. The
       expenses of such expert shall be borne by the party whose contention is
       rejected by the expert.

4.3    Title in the Compound and Product shall at any time remain with JPI or
       JANSSEN US, depending on which company ordered the Product, whereas title
       to the Material shall remain with ACT II until incorporation in the
       Product. Risk of loss and damage in relation to the Compound and the
       Product shall pass to ACT II upon delivery of the Compound at the ACT II
       premises and shall again pass to JPI and/or JANSSEN US upon delivery of
       the Product to the common carrier. ACT II shall provide adequate and safe
       storage for the Compound and Products while at its premises and shall
       have sufficient insurance coverage in connection with the above risk.

4.4    ACT II represents and warrants that at the time of Manufacture all
       Product supplied hereunder shall be manufactured and supplied by ACT II
       in accordance with the Specifications and
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       Manufacturing Process and in compliance with (i) this Agreement and (ii)
       any applicable law, rule or regulations.

       EXCEPT FOR THE ABOVE WARRANTY, THERE ARE NO WARRANTIES OF MERCHANTIBILITY
       OR FITNESS FOR A PARTICULAR PURPOSE.

ARTICLE 5: REGULATORY PROVISIONS

5.1    JANSSEN and its Affiliates will be responsible for filing any regulatory
       approval application in connection with the Product and the Final
       Product, in their own name and at their own cost, all in accordance with
       the provisions of the Development Agreement and the License Agreement.

5.2    ACT II will give reasonable regulatory support in connection with
       regulatory approvals filed by JANSSEN in relation to the Product and/or
       the Final Product and will do so [***]. Amongst others, ACT II will
       prepare and maintain all the necessary supporting documentation requested
       by JANSSEN such as certificates or other administrative documents
       required for reference in any regulatory filing, if necessary in a format
       requested by JANSSEN. Notwithstanding the above, it is agreed that if any
       such request from JANSSEN or the health authorities in a given country
       entails extraordinary costs beyond the normal and ordinary regulatory
       support efforts in connection with the filing and maintenance of the
       regulatory approvals directed to the Product or Final Product, the
       parties will in good faith discuss and agree on a sharing mechanism with
       respect to such extraordinary costs related to such support activities in
       such country or countries.

5.3    ACT II shall be responsible for obtaining and maintaining all necessary
       permits and approvals to Manufacture the Products and in general to
       perform its responsibilities as set forth in this Agreement.

       Amongst others ACT II shall submit a Drug Master File ("DMF") with the
       health authorities identifying ACT II's method of manufacture, release
       specifications and testing methods used in the manufacture of the
       polymers and shall cause the supplier of the siliconized vials or any
       other primary container to do the same in relation to such vials or such
       other primary container. Similarly ACT II shall prepare and file an
       appropriate facility DMF with respect to the facilities where ACT II
       Manufactures the Product and the polymers. ACT II shall cause the
       supplier of the siliconized vials (or any other primary container) or any
       other Material used in the Manufacture of Product to do the same.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       Upon request by JPI or JANSSEN US, ACT II agrees to provide JPI, JANSSEN
       US or their Affiliates or licensees with a Letter of Authorisation
       permitting the Health Authorities to refer to ACT II's DMF in its review
       of JANSSEN's or their Affiliates' applications for Product manufactured
       by ACT II. ACT II shall cause the supplier of the siliconized vials (or
       any other primary container) or any other Material used in the
       Manufacture of Product to do the same. A representative of JANSSEN will
       be entitled to review at ACT II's facilities those parts of the polymer
       DMF and the appropriate facility DMF pertaining to the Manufacture of the
       Product. ACT II shall maintain its Manufacturing facilities,
       Manufacturing records and its DMF's in such a manner as required to live
       up to the above obligation during the entire term of this Agreement.

5.4    JANSSEN shall inform ACT II promptly (and whenever possible within 24
       hours of receipt by JPI and/or JANSSEN US) of any information or request
       for information received from the FDA or any other regulatory agency
       relating to the NDA and/or registration of Product whenever such
       information or communication is related to ACT II technology. Parties
       shall promptly discuss such information and in the event that a reply is
       required to such form question from the FDA or any other regulatory
       agency or any communication has to be made with respect to Product and
       related to ACT II technology, Parties will agree on the content of any
       communication before it is made.

5.5    ACT II shall inform JANSSEN promptly (and whenever possible within 24
       hours of receipt by ACT II) of any information or request for information
       received from the FDA or any other regulatory agency relating to ACT II
       technology whenever such information or communication is relevant to
       Product. It being understood that ACT II shall not disclose to JANSSEN
       any third party confidential information or trade secrets. Parties shall
       promptly discuss such information and in the event that a reply is
       required to such formal question from the FDA or any other regulatory
       agency or any communication has to be made that involves Product, Parties
       will agree on the content of such communication before it is made.

ARTICLE 6: MANUFACTURING FEE

6.1    In consideration of the manufacturing activities to be performed by ACT
       II hereunder, JPI and JANSSEN US will pay the Manufacturing Fee for the
       Products supplied to each of them. The Manufacturing Fee will be
       calculated as a certain percentage of the Licensed Net Selling Price. The
       actual percentage that shall apply with respect to a given calendar year
       will be
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       determined in a function of the total volume of Products Manufactured by
       ACT II and invoiced to JANSSEN during such calendar year and will be
       calculated in accordance with the brackets set forth in Exhibit D
       attached hereto.

       The actual Manufacturing Fee due during any given calendar year will be
       calculated as follows;

       6.1.1  The Manufacturing Fee for the initial batches of Product
              Manufactured and invoiced by ACT II prior to the expiration of the
              first calendar year following the first commercial launch of the
              Final Product shall be calculated as a percentage of the estimated
              weighted average price offered by JANSSEN, its Affiliates or
              licensees to independent unrelated third parties for the Final
              Product. Such weighted average price will be calculated by
              multiplying the forecasted net selling price of the Final Product
              (expressed in USD at the exchange rates then applied by JANSSEN in
              accordance with its normal accounting procedures) in each country
              of Territory where JANSSEN intends to launch the Final Product in
              the calendar year following the calendar year of the first
              commercial launch of the Final Product times the total number of
              units of the Final Product JANSSEN forecasts to sell in those
              countries during such period.

              The actual percentage to be paid as Manufacturing Fee in such
              period will be calculated on the basis of the total number of
              units of the Product ACT II is required to Manufacture and ship to
              JANSSEN during such period based on the forecast provided by
              JANSSEN in accordance with Article 2.3.

              Within [***] following the end of every calendar quarter either
              party may request a recalculation of the then applicable
              Manufacturing Fee whenever there is a deviation of more than [***]
              in the total number of Products actually Manufactured and shipped
              by ACT II to JANSSEN during such quarter and the number of units
              forecasted by JANSSEN. The parties will at such moment recalculate
              and adjust the Manufacturing Fee based on (i) the revised supply
              forecast and (ii) the then current Licensed Net Selling Price.

              In the month of January following such first full calendar year
              adjustment shall be made if there is deviation between (i) the
              estimated weighted average price and the actual Licensed Net
              Selling Price of the Final Product (expressed in USD at the
              exchange rates then applied by JANSSEN in accordance with its
              normal accounting procedures) and /or
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

              (ii) the total volume of units of Product actually Manufactured
              and invoiced by ACT II during such period.

              Any corrective payment to be made resulting from such
              reconciliation will be paid by the party owing such a payment
              within [***] after such reconciliation and in accordance with the
              provisions of Article 6.4.

       6.1.2  The Manufacturing Fee for any calendar year following the initial
              period as specified under Article 6.1.1 above will be calculated
              on the basis of the forecasted (i) Licensed Net Selling Price
              (expressed in USD at the exchange rates then applied by JANSSEN in
              accordance with its normal accounting procedures) and (ii) the
              amount of Product expressed in units to be Manufactured and
              shipped by ACT II for such calendar year.

              Within [***] following the end of every calendar quarter either
              party may request a recalculation of the then applicable
              Manufacturing Fee whenever there is a deviation of more than [***]
              in the total number of Products actually Manufactured and shipped
              by ACT II during such quarter and the number of units forecasted
              by JANSSEN. The parties will at such moment recalculate and adjust
              the Manufacturing Fee for the remainder of the calendar year based
              on (i) the revised supply forecast and (ii) the then current
              Licensed Net Selling Price.

              In the month of January following any calendar year adjustment
              shall be made if there is deviation between (i) the estimated
              weighted average price and the actual Licensed Net Selling Price
              of the Final Product (expressed in USD at the exchange rates then
              applied by JANSSEN in accordance with its normal accounting
              procedures) and/or (ii) the total volume of units of Product
              actually Manufactured and invoiced by ACT II during such calendar
              year. Any corrective payment to be made resulting from such
              reconciliation will be paid by the party owing such a payment
              within [***] after such reconciliation and in accordance with the
              provisions of Article 6.4.

6.2    JANSSEN will keep accurate records of the Licensed Net Selling Price with
       a view to determine the accuracy of the Manufacturing Fee calculation for
       a period of at least two (2) years after expiry of the year they concern.
       ACT II shall have the right to nominate an independent certified public
       accountant acceptable to and approved by JANSSEN US or JPI as the case
       may be who
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       shall have access, on reasonable notice, to JPI's or JANSSEN US' records
       during reasonable business hours for the purpose of verifying the
       calculation of the Licensed Net Selling Price. This right may not be
       exercised more than once in any calendar year, and once a calendar year
       is audited it may not be reaudited, and said accountant shall disclose to
       ACT II information relating solely to the accuracy of the Licensed Net
       Selling Price calculation.

6.3    ACT II shall invoice JPI or JANSSEN US for the Manufacturing Fee due with
       respect to each batch of Product supplied to each of them or their
       respective designee when shipped pursuant to Article 4. JPI and JANSSEN
       US shall be pay such invoice within [***] after the date of the invoice.

6.4    All payments required to be paid hereunder shall be made in United States
       Dollars by wire transfer of immediately available funds to the financial
       institution, account number, account party's name and wire transfer
       information designated in writing by ACT II to JPI and JANSSEN US as the
       place of payment.

6.5    No party shall have the right to reduce, by set off, counterclaim,
       adjustment or otherwise, any amount owed by it to the other party
       pursuant to this Agreement, unless explicitly provided for otherwise.

ARTICLE 7: CONFIDENTIALITY

The parties refer to Article to the confidentiality provisions of Article 9 of
the License Agreements which provisions are incorporated by reference herein.

ARTICLE 8: RECALL

In the event of a Product recall ("Recall"), JPI or JANSSEN US, as the case may
be, shall be responsible for the coordination of Recall activities. Where the
Recall is caused by ACT II's negligence or willful misconduct or breach of this
Agreement and without prejudice to the provisions of Article 10, ACT II agrees
to pay the following costs and expenses of any Recall: (i) costs of retrieving
the Product previously delivered to JPI's or JANSSEN US' agents or customers,
(ii) costs and expenses that JPI and/or JANSSEN US is required to pay for
reasonable notification, shipping and handling charges, provided JPI
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       and/or JANSSEN US provides ACT II with supporting documentation of all
       such reimbursable costs and expenses, and (iii) cost of replacing
       Products that are unsalable as a result of the Recall. If the Recall is
       not primarily caused by ACT II's negligence, willful misconduct or
       breach, JPI and/or JANSSEN US shall pay all of the costs and expenses
       described above for such Recall.

ARTICLE 9: INDEMNIFICATIONS

9.1    JANSSEN shall indemnify, defend and hold ACT II and its Affiliates, and
       each of their officers, directors, employees, agents and consultants
       (each an "ACT II Indemnitee") harmless from, against and in respect of
       any damages, claims made by third parties, losses, liabilities, charges,
       actions, suits, proceedings, penalties and reasonable costs and expenses
       (including without limitation reasonable attorneys' fees) (collectively,
       the "Losses"), arising out of or resulting from the use by or
       administration to any person of Product or Final Product of JPI, its
       Affiliates or licensees, except to the extent such Losses arose or
       resulted from the failure of ACT II or its Affiliates to Manufacture
       Products in accordance with GMP, the Specifications and Manufacturing
       Process for such Product(s) or from ACT II's failure to comply with its
       obligations or covenants contained herein, so long as (i) the ACT II
       Indemnitee allows JANSSEN to participate in or, at JANSSEN's sole option
       but without any obligation, to conduct at JPI's expense the defense of a
       claim or action for which indemnification is sought under this Article
       9.1. (provided that the ACT II Indemnitee may participate in such defense
       at its own expense), and (ii) neither party may compromise or settle such
       claim or action without the other party's prior written consent, which
       shall not be unreasonably withheld ; provided, however, that a ACT II
       Indemnitee shall not be indemnified under this Article 9.1 to the extent
       that actions taken or failed to have been taken by JANSSEN under the
       direction of, or at request of, the ACT II Indemnitee were the primary
       cause of the events giving rise to the ACT II Indemnitee's claim for
       indemnification.

9.2    ACT II shall indemnify, defend and hold JANSSEN, their Affiliates and
       Licensees and each of their officers, directors, employees, agents and
       consultants (each a "JANSSEN Indemnitee") harmless from and against all
       Losses to the extent such losses arise out of or result from the failure
       of ACT II or its Affiliates to Manufacture the Product(s) in accordance
       with the Specifications and Manufacturing Process, or, its failure to
       comply with its obligations or covenants contained herein, unless such
       failure was the result of actions taken or failed to have
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       been taken by the ACT II under the direction of, or at the request of
       JANSSEN. The JANSSEN Indemnitee shall allow ACT II to participate in, or,
       at ACT II's sole option, to conduct at ACT II's expense the defense of a
       claim or action for which indemnification is sought under this Article
       9.2. (provided that the JANSSEN Indemnitee may participate in such
       defense at its own expense), and neither party shall compromise or settle
       such claim or action without the other party's prior written consent,
       which shall not be unreasonably withheld.

9.3    In no event shall either party be liable for any consequential or
       indirect damages of the other party, including but not limited to lost
       profits.

9.4    Both parties shall obtain, and shall maintain at all times during the
       term of this Agreement, an insurance policy or policies providing
       coverage against product liability claims related to the above
       indemnification.

ARTICLE 10: TERM AND TERMINATION

10.1   The term of this Agreement shall be commensurate with the term of the
       License Agreements, unless sooner terminated as provided hereinafter.

10.2   This Agreement may be terminated:

       10.2.1 by mutual agreement of JANSSEN and ACT II in a writing signed by
              the parties;

       10.2.2 by written notice of one party in the event of a material breach
              by the other party in the performance of any of its obligations
              hereunder, if the party not in default shall have given the
              defaulting party written notice specifying such default within 45
              days after the occurrence of such breach and the defaulting party
              has not made substantial and diligent progress in remedying or
              correcting the default within 60 days after such notice is given,
              with such termination becoming effective at the end of such 60
              days;

       10.2.3 by written notice of JANSSEN or ACT II in the event that the other
              party makes an assignment for the benefit of its creditors, files
              a petition under bankruptcy or insolvency laws, a receiver or
              custodian is appointed for such party's business, proceedings are
              instituted against such party under bankruptcy or insolvency laws
              that
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

              have not been stayed within 90 days, all or substantially all or
              such party's business or assets become subject to attachment,
              garnishment or other process, or such a party becomes unable to
              pay its obligations as they become due;

       10.2.4 by JANSSEN prior to any commercial Manufacturing upon giving
              thirty days prior written notice and following the commencement of
              the commercial manufacturing upon giving a six month prior written
              notice, provided that with respect to the latter the Agreement
              shall not be terminated by JANSSEN without cause during the first
              two calendar years following the commencement of the commercial
              Manufacturing, unless JANSSEN decides also to terminate the
              License Agreements.

       10.2.5 by ACT II in accordance with the provisions of Articles 2.11

10.3   Upon termination of this Agreement for any reason whatsoever ACT II will
       cease the Manufacturing of the Products. Termination of this Agreement
       shall not affect the rights and obligations of the parties accrued prior
       to the termination hereof. Notwithstanding the termination of this
       Agreement, the confidentiality provisions of Article 3.3, the obligations
       set forth in Articles 7, 8, 9, and 12.9 shall continue and survive the
       termination hereof.

ARTICLE: 11 FORCE MAJEURE

Each party shall be relieved of its obligations to the extent that fulfillment
of such obligations shall be prevented by acts beyond the reasonable control of
such party affected, including, without limitation, acts of God, fire,
explosion, flood, drought, war, riot, sabotage, embargo, strikes or other labor
trouble, prohibitions against imports or exports of Products, impossibility of
obtaining or shortages in supply of raw materials, or compliance with any order
or regulation of any government entity acting under color of right. If such
cause continues unabated for a period of thirty (30) days, both parties will
promptly meet to discuss the possibilities to overcome such case of Force
Majeure and the potential implications on the further performance under this
Agreement.

ARTICLE: 12 MISCELLANEOUS
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

12.1   Status. Neither JANSSEN or ACT II shall make any representation or incur
       any obligation in the name of or in behalf of the other party, except as
       explicitly authorized hereunder. Nothing in this Agreement shall be
       deemed to establish a relationship of principal and agent between ACT II
       and JPI or JANSSEN US, nor any of their agents or employees for any
       purpose whatsoever. Nothing in this Agreement shall be deemed to
       constitute the parties as a partnership, association or other
       relationship.

12.2   Public Announcements. No public announcement with respect to the Product
       or the existence of this Agreement may be made by either party without
       the prior written approval of the other party.

12.3   Modifications. Any amendment or supplement to this Agreement shall be
       effective only if contained in a writing signed by each of the parties
       hereto.

12.4   Assignments. Except as otherwise provided herein, this Agreement shall
       not be assignable by any party, without the other party's written
       consent, such consent not to be unreasonably withheld, except that such
       consent is not required in connection with the assignment of either
       party's obligations to an affiliate of such party ; provided, however,
       that any such assignment shall not relieve the parties hereto from any
       obligations under this Agreement.

12.5   Prior Agreements. The parties hereto acknowledge that this Agreement
       contains the entire agreement between the parties pertaining to the
       Manufacturing and supply of Product in Territory and terminates and
       supersedes all prior agreements, understandings, letters or other
       instruments whatsoever, whether written or oral, between the parties or
       any of their affiliates with respect to such matters.

12.6   Waiver. No waiver by JANSSEN or ACT II of any breach of this Agreement
       will constitute a waiver of any subsequent breach, and no exercise by
       either JANSSEN or ACT II of any right of termination will constitute a
       waiver of any right of such party for recovery of any monies then due it
       hereunder or any other right or remedy such a party may have at law, in
       equity or otherwise.

12.7   Representations. Each party represents and warrants that it has the right
       to enter into this Agreement and that it is under no obligation to any
       third party, express or implied, conflicting with the terms and
       conditions of this Agreement.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

12.8   Separability. Any term or provision of this Agreement which is invalid or
       unenforceable in any jurisdiction shall, as to such jurisdiction, be
       ineffective to the extent of such invalidity or unenforceability without
       rendering invalid or unenforceable the remaining terms and provisions of
       this agreement where affecting the validity or enforceability of any of
       the terms or provisions of this Agreement in any other jurisdiction.

12.9   Governing Law; Dispute Resolution.

       12.9.1 In the event a dispute ("Dispute") arises between the parties
              arising out of or relating to this Agreement, the parties shall
              use all reasonable efforts to resolve the Dispute through direct
              discussions for a period of sixty (60) days, unless and to the
              extent this Agreement provides for other and shorter periods. The
              senior management of each party commits itself to respond to any
              such Dispute. Subsequent to such sixty (60) day period either
              party may, but shall not be required to resort to the binding
              arbitration procedures set out hereinafter in this Article 12.9.

       12.9.2 If the parties are unable after exerting all reasonable efforts to
              resolve a Dispute between the parties, the Dispute shall be
              resolved through binding arbitration pursuant to the Commercial
              Arbitration Rules of the American Arbitration Association in
              accordance with the following provisions:

              (a)    If a Dispute arises between the parties, the place of
                     arbitration shall be New York, New York.

              (b)    To the extent the parties can not immediately agree on a
                     single arbitrator, the arbitration shall be conducted by a
                     panel of three neutral arbitrators ("Arbitrators"). One
                     member shall be appointed by each party and the third
                     member shall be appointed by the two arbitrators appointed
                     by the parties. The parties will select an arbitrator
                     within fifteen (15) business days following the demand for
                     arbitration. The two arbitrators selected by the parties
                     will appoint the third member within ten (10) days
                     following their appointment.

              (c)    The language to be used in the arbitration shall be
                     English.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

              (d)    Any arbitrator selected by the parties may be of any
                     nationality, and need not be a lawyer or hold any other
                     professional status or membership but will be selected on
                     the basis of his or her qualifications and expertise with
                     respect to the matter under dispute.

              (e)    The Arbitrators shall resolve the Dispute on the basis of a
                     written record consisting of an initial and rebuttal
                     submission by each party (together with documentary
                     evidence (including affidavits) supporting the positions
                     taken in such submissions); provided that the Arbitrators
                     shall have the right to require the parties to make or
                     participate in such other written or oral submissions,
                     presentations, or examinations as the Arbitrators shall
                     deem necessary for the proper resolution of such Dispute,
                     all of which shall be made or submitted directly to the
                     Arbitrators and shall become part of the record in the
                     proceeding.

              (f)    The specific pleading schedule for each proceeding shall be
                     determined by the parties in consultation with the
                     Arbitrators within fifteen business days after the date on
                     which the Arbitration panel is constituted, but it shall in
                     each case provide that the parties' respective initial
                     submissions shall be filed simultaneously with the
                     Arbitrators, as shall the parties' respective reply
                     submissions.

              (g)    Unless the parties otherwise agree at the time a particular
                     Dispute is submitted for arbitration, the Arbitrators shall
                     be required as a condition to their engagement to agree to
                     render a decision within 30 days of the date on which the
                     record in the proceeding is completed, but in no case more
                     than 90 days after the date of the last hearing on the
                     substantive issues.

              (h)    The parties shall use reasonable efforts to schedule and
                     make their submissions, and to take all other necessary
                     actions in connection with the proceeding, at a time and in
                     a manner which will permit the Arbitrators to render its
                     decision in accordance with the schedule set forth herein.

              (i)    All communications with the Arbitrators during the pendency
                     of the proceeding shall be made in writing, with a copy
                     thereof delivered simultaneously to the other party to the
                     proceeding, or if made orally, made only in the presence of
                     the other party to the proceeding or its representative.
                     The existence of the Dispute
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                     and the related proceedings shall be kept confidential in
                     accordance with the provisions of Article 7.

              (j)    All decisions by the Arbitrators shall be done by majority
                     vote. The arbitration award shall be rendered in writing
                     and shall state the reasons for the award, and shall be
                     final and binding upon the parties. In rendering their
                     decision, the Arbitrators shall apply the substantive law
                     of the state, of New York, without regard to its conflict
                     of law provisions, provided that the Arbitrators shall base
                     their decision on the express terms and conditions of this
                     Agreement.

              (k)    The Arbitrators are empowered to award any remedy allowed
                     by law, including money damages and to grant final or
                     interlocutory relief. Notwithstanding the foregoing
                     punitive or multiple damages may not be awarded and the
                     express terms of this Agreement may not be altered.

              (l)    Each party shall bear its own expenses and attorneys' fees
                     in connection with the arbitration.

       12.10  Notices. Any notice required or permitted to be given under this
              Agreement shall be mailed by registered or certified air mail,
              postage prepaid, addressed to the party to be notified at its
              address stated below, or at such other address as may hereafter be
              furnished in writing to the notifying party or by telefax to the
              numbers set forth below or to such changed telefax numbers as may
              thereafter be furnished, If to ACT II:

              Alkermes Controlled Therapeutics Inc. II
              64 Sidney Street
              Cambridge
              MA 02139-4136
              U.S.A.
              Telefax: +1-617-494-9263
              attention:  Chief Financial Officer

               If to JANSSEN:

               Janssen Pharmaceutica International, a division of Cilag AG
                International,
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

               CH-6300 Zug, Chollerstrasse 38, Switzerland Telefax: 041
               748 3667

               and

               Janssen Pharmaceutica Inc.
               1125 Trenton-Harbourton Road
               Titusville
               NJ 08560
               U.S.A.
               Telefax:  +1-609-730-2323

               Any such notice shall be deemed to have been received when it has
been delivered in the ordinary course of post or received by telefax.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

IN WITNESS WHEREOF, JPI, JANSSEN US AND ACT II have caused this instrument to be
executed by their respective duly authorized officers, the date of execution to
relate back to the day and year last below written.

                                 Alkermes Controlled Therapeutics, Inc. II

                                 This 8th day of August of 1997

/s/ J. Duncan Higgons            By  /s/  Michael Landine
-----------------------------        -------------------------------------------
(title)  Vice President          (title)  Vice President

                                 JANSSEN PHARMACEUTICA INTERNATIONAL represented
                                  by CILAG INTERNATIONAL

                                 This 27th day of August of 1997

/s/ illegible signature          By  /s/ illegible signature
-----------------------------        -------------------------------------------
(title)                          (title)

                                 Janssen Pharmaceutica Inc.

                                 This 3rd day of September of 1997

/s/ illegible signature          By /s/ illegible signature
-----------------------------       --------------------------------------------
(title)                          (title)  President
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT A

                                 SPECIFICATIONS
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT B

                            EQUIPMENT: CAPITAL ITEMS
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT C

                               MINIMUM QUANTITIES

                                      [***]
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT D

                                MANUFACTURING FEE

                                      [***]
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT E

                             THE FORECAST MECHANISM
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT F

                            SPECIFICATION OF COMPOUND
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT G

                                      [***]
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT H

                          MANUFACTURING READINESS PLAN<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                                                EXHIBIT 10.19(a)

                    Alkermes Controlled Therapeutics Inc. II
                                64 Sidney Street
                             Cambridge, MA 02139 USA

February 1, 2002

JPI Pharmaceutica International,
a division of Cilag AG International Zug
CH-6300 Zug
Kollerstrasse 38
Switzerland

Janssen Pharmaceutica Inc.
11125 Trenton-Harbourton Road
Titusville, NJ  08560  USA

       Re:    Exhibits to Manufacturing and Supply Agreement, dated August 6,
              1997

Gentlemen:

              Pursuant to that certain Manufacturing and Supply Agreement (the
"Agreement"), dated August 6, 1997, among Alkermes Controlled Therapeutics Inc.
II ("ACT II"), JPI Pharmaceutica International, a division of Cilag AG
International Zug, a company organized under the laws of Switzerland ("JPI"),
and Janssen Pharmaceutica Inc. ("Janssen US") (JPI and Janssen US collectively
referred to herein as "Janssen"), as supplemented by that certain Addendum to
Manufacturing and Supply Agreement (the "Addendum"), dated August 1, 2001, among
ACT II, JPI and Janssen, certain exhibits referred to in the Agreement would be
agreed to by the parties in the future. Those exhibits are Exhibits A, B, E, F,
G and H. This letter sets forth the agreement by the parties as to such
Exhibits.

              1.     Exhibit A (Specifications) shall be in the form attached
                     hereto as Exhibit A.

              2.     Exhibit B (Equipment: Capital Items) is, at the current
                     time, intentionally left blank because there are no capital
                     items owned by Janssen.

              3.     Exhibit E (Forecast mechanism) shall be in the form
                     attached hereto as Exhibit E.

              4.     Exhibit F (Specification of Compound) shall be in the form
                     attached hereto as Exhibit F.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

              5.     Exhibit G [***] shall be in the form attached hereto as
                     Exhibit G.

              6.     Exhibit H (Manufacturing Readiness Plan) shall cease to
                     apply from December 1, 2001 in view of the commencement of
                     the commercial manufacture of Product.

              To the extent that the provisions of Exhibit E are in conflict
with Sections 2.3, 2.4, 2.11 or 4.1 of the Agreement, such Sections shall be
deemed to be amended by Exhibit E. To the extent that the provisions of Exhibit
G are in conflict with Sections 2.7 or 4.2 of the Agreement, such Sections shall
be deemed to be amended by Exhibit G.

              If you are in agreement with the foregoing, please have this
letter agreement executed by a duly authorized officer and return one fully
executed copy to me.

                                        Sincerely,
                                        ALKERMES CONTROLLED
                                        THERAPEUTICS INC. II

                                        By:  /s/ Michael Landine
                                             ------------------------
                                        Name:          Michael Landine
                                        Title:         Vice President

Agreed to:

JPI PHARMACEUTICA INTERNATIONAL,
A DIVISION OF CILAG AG INTERNATIONAL ZUG

By:  /s/ Erik Rombouts                                /s/ Heinz Schmid
     -----------------                                ----------------
Name:   Erik Rombouts                                Heinz Schmid
Title:  Vice President Alliance Management           General Manager

JANSSEN PHARMACEUTICA INC.

By:   /s/ Alex Gorsky
     --------------------------
Name:  Alex Gorsky
Title: President
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT A
                                 SPECIFICATIONS

               The specifications for "RISPERDAL CONSTA(tm)" as found in NDA #
21-346 submitted by Janssen on August 31, 2001, all applicable MAA filings, all
applicable supplements to the filings and all subsequent revisions to these
specifications.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT E
                               FORECAST MECHANISM

1.     EFFECTIVE TIME OF THIS EXHIBIT. This Exhibit E (Forecast Mechanism) shall
       only be in effect until December 31, 2002 at which time the parties shall
       review and modify (if needed) the forecast mechanism, which shall then be
       in effect for the remainder of the term of the Agreement, unless the
       parties agree otherwise.

2.     DEFINITIONS. For purposes of this Exhibit E, the following terms shall
       have the following meanings. Any capitalized term not defined below shall
       have the meaning set forth in the Manufacturing and Supply Agreement to
       which this Exhibit is appended (the "Agreement").

       (a)    "Batch" shall mean the quantity produced from one operation of the
              emulsion phase of the manufacturing process.

       (b)    "Dose" shall mean the amount of active ingredient included in each
              Vial of Product. There shall only be three Dose sizes: 25 mg, 37.5
              mg and 50 mg.

       (c)    For purposes of this Exhibit E only, "Janssen" shall include any
              designee of Janssen.

       (d)    "Region" shall mean the geographic region in which certain Vials
              are to be distributed and sold. There shall only be two Regions:
              (i) the United States and (ii) the rest of the world.

       (e)    "Vial" shall mean the primary container filled with finished
              Product in a single dosage form. Vials will be the final Product
              to be shipped by ACT II to Janssen for final packaging into a kit
              before distribution and sale.

3.     FULL BATCHES. ACT II shall Manufacture Product and prepare Vials for
       shipment only in Batches and not in less than a full Batch size.

4.     FORECASTS. On or before the 25th calendar day of each month, Janssen will
       provide to ACT II a rolling forecast of Product for the [***] following
       the month in which such forecast is submitted. Each forecast shall
       include the quantity of Vials forecasted in Batch quantity amounts based
       on the estimated Vials per Batch set forth below. The forecast shall also
       state the quantities of Vials by Dose and Region and the estimated Batch
       quantities (by Dose and Region) needed to produce such Vials based on the
       estimated Vials per Batch set forth below.

<TABLE>
<CAPTION>
       Dose Size:                               25 mg             37.5 mg        50 mg
<S>                                             <C>               <C>            <C>
</TABLE>

                                       E-
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

<TABLE>
<S>                                             <C>               <C>            <C>
       Estimated Yield of Vials per Batch       [***]              [***]         [***]
</TABLE>

5.     BINDING FORECASTS; SEMI-FIRM FORECASTS. Months [***] (the "Firm Months")
       of each forecast shall be binding on Janssen and shall constitute a firm
       order. Months [***] (the "Semi-Firm Months") of each forecast shall not
       be binding, but shall be semi-firm, meaning that in any subsequent
       forecast, Janssen may only increase the Batches forecasted in the
       Semi-Firm Months within the limits set forth below, provided, however,
       that ACT II shall use commercially reasonable efforts to meet Janssen's
       requirements for Product. For the avoidance of doubt, Janssen shall be
       entitled to decrease its forecast for the Semi-Firm Months in an
       unlimited fashion. Months [***] of each forecast shall be neither binding
       nor semi-firm, but shall be good faith estimates of Janssen's anticipated
       requirements for Product.

<TABLE>

        Previously                  Allowable Monthly Increase            Allowable Monthly
Forecasted Batch Quantity                                              Forecasted Batch Quantity
<S>                                 <C>                                <C>
          [***]                                [***]                             [***]
</TABLE>

6.     PURCHASE ORDERS. JPI and Janssen US may issue to ACT II formal purchase
       orders for the Regions they are responsible for; provided that the
       aggregate of purchase orders submitted by JPI and Janssen US shall not
       exceed the amount forecasted for the applicable period, unless
       specifically allowed hereunder or agreed by the parties. Even in the
       absence of one or more purchase orders, ACT II may Manufacture and
       prepare for shipment the quantity of Vials, in Doses and for the Regions,
       called for in the forecast for any Firm Month.

7.     MONTHLY FORECAST MAXIMUM; MANUFACTURING SHUT-DOWNS. No forecast may
       require the Manufacture of more than [***] per week. ACT II will be
       allowed up to two (2) manufacturing shut-downs each year and each
       manufacturing shut-down shall last not longer than two (2) weeks. ACT II
       shall provide to Janssen the schedule for manufacturing shut-downs at the
       beginning of each calendar year. The parties will work together to
       schedule delivery of Product in accordance with both the forecasts and
       scheduled shut-downs.

8.     DILIGENCE TO MEET FORECAST. ACT II will use commercially reasonable
       efforts to Manufacture and prepare for shipment Product in the Vial
       quantities, in the Doses, for the Regions and in the time periods
       forecasted by Janssen.

9.     SHORTFALLS. There shall be a shortfall at any time that the cumulative
       amount of Vials for any Dose or Region actually prepared for shipment in
       any [***] period falls below [***] of the amount of Vials forecasted by
       Janssen for such Dose or Region for such [***] period (the difference
       between the amount of such Vials prepared for shipment and [***] of the
       forecasted amount of such Vials shall be the "Shortfall").
       Notwithstanding the foregoing, there shall not be a Shortfall if Janssen
       submits a forecast in which the amount of Vials for a Firm Month are
       greater than what was forecasted in the same Firm Month in a previous
       forecast or the amount of Vials for a Firm Month or a Semi-Firm Month are
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

greater than the allowable increase over what was forecasted in the same
Semi-Firm Month in a previous forecast. In the event of a Shortfall, Janssen
shall notify ACT II that a Shortfall has occurred, stating in what Dose or
Region the Shortfall occurred and requesting that ACT II cure such Shortfall.
Upon receipt of such notice from Janssen, ACT II will use commercially
reasonable efforts to Manufacture and prepare for shipment an amount of Vials in
the particular Dose or Region in order to cure such Shortfall in the month
following receipt of such notice.

10.    NO BREACH. ACT II shall not be considered to be in breach of its
       obligations to supply the requested quantities of Product under the
       Agreement (including the provisions in this Exhibit E) if:

       (a)    there is any Shortfall during the [***] of commercial Manufacture
              of Product under the Agreement;

       (b)    there is a Shortfall after the initial [***] of commercial
              Manufacture of Product under the Agreement, Janssen requests that
              ACT II cure such Shortfall and ACT II uses or is using
              Commercially Reasonable Efforts to cure such Shortfall, all in
              accordance with Section 9 hereof; or

       (c)    a delay in the Manufacture of Product, preparation for shipment or
              actual delivery of Vials is caused by Janssen (for example, due to
              a failure or delay in the supply of bulk Compound, testing of
              Product by Janssen, validation by Janssen of shipping containers,
              receipt of test results, protocols, reports or approvals from
              Janssen required under the Quality Agreement for Manufacture or
              shipment of Product, receipt of delivery instructions from
              Janssen, release of Product by Janssen, etc.);

       provided that, in each case, ACT II is using commercially reasonable
       efforts to Manufacture and prepare for shipment Vials in accordance with
       the forecast.

11.    INVENTORY; SHELF LIFE OF PRODUCT DELIVERED. ACT II may, at its option,
       Manufacture and hold Product in inventory. All Product, including any
       Product that may have been held in inventory, delivered by ACT II to
       Janssen in accordance with Section 4.1 of the Agreement shall have a
       remaining shelf life of at least [***] at the time it is so delivered by
       ACT II, unless otherwise agreed on an ad hoc basis. Notwithstanding the
       foregoing, ACT II shall not be held responsible for, and Janssen shall be
       obligated to purchase (if otherwise meeting Specifications), Product
       whose remaining shelf-life is less than [***] at the time of such
       delivery, if the delivery of Product has been delayed by more than [***]
       from the time that the Product was filled into Vials if such delay is
       caused by Janssen (for example, due to a failure or delay in the testing
       of Product by Janssen, validation by Janssen of shipping containers,
       receipt of test results, protocols, reports or approvals from Janssen
       required under the Quality Agreement for shipment of Product, receipt of
       delivery instructions from Janssen, release of Product by Janssen, etc.).
       This
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

       Section 11 shall be reviewed and modified (if needed) by the parties at
       the end of calendar year 2002.
<PAGE>
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND HAS BEEN FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.

                                    EXHIBIT F
                            SPECIFICATION OF COMPOUND

              The specifications for "Risperidone Drug Substance" as found in
NDA # 21-346 submitted by Janssen on August 31, 2001, all applicable MAA
filings, all applicable supplements to the filings and all subsequent revisions
to these specifications.
<PAGE>
                                    EXHIBIT G
                                      [***]
<PAGE>
                                    EXHIBIT H
                          MANUFACTURING READINESS PLAN

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00040-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00040-of-00352.parquet"}]]