Exhibit 10.1
Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as (----) . A complete, unredacted version of this
exhibit has been filed separately with the Securities and Exchange Commission.
- --------------------------------------------------------------------------------
PACKAGING AGREEMENT
-------------------
TABLE OF CONTENTS
-----------------
ARTICLE 1. DEFINITIONS......................................................................3
ARTICLE 2. PROCESSING AND PACKAGING AND PRICE...............................................5
ARTICLE 3. FORECASTS AND ORDERS.............................................................7
ARTICLE 4. SPECIFICATIONS...................................................................8
ARTICLE 5. PACKAGING MATERIALS..............................................................8
ARTICLE 6. QUALITY CONTROL; ADVERSE EXPERIENCES AND RECALLS.................................9
ARTICLE 7. WARRANTIES......................................................................11
ARTICLE 8. INDEMNIFICATION.................................................................12
ARTICLE 9. CONFIDENTIALITY.................................................................13
ARTICLE 10. TERM AND TERMINATION............................................................13
ARTICLE 11. GOVERNING LAW...................................................................14
ARTICLE 12. MISCELLANEOUS...................................................................14
PACKAGING AGREEMENT
-------------------
THIS AGREEMENT made as of this 15th day of February , 2002, (the
---- ----------
"Effective Date"), (the "Agreement") by and between SEARLE & CO., a Delaware
corporation ("SEARLE"), and WATSON LABORATORIES, INC., a Nevada corporation
("WATSON");
WHEREAS, WATSON has obtained rights to certain Products (as hereinafter
defined) and desires to have the Products packaged by SEARLE;
NOW, THEREFORE, the parties agree as follows:
ARTICLE 1. DEFINITIONS
1.1. "Affiliate" of a party means any corporation or other business entity
controlled by, controlling or under common control with, such party. For
this purpose "control" shall mean direct or indirect beneficial ownership
of more than fifty percent (50%) of the voting or income interest in such
corporation or other business entity.
1.2. "Assets" has the meaning ascribed to such term in Section 2 of the Asset
Purchase Agreement entered into between G.D. Searle & Co., SCS
Pharmaceuticals and Watson Laboratories, Inc. dated September 30, 1997 and
the Asset Purchase Agreement entered into between G.D. Searle & Co. and
Watson Laboratories Inc. dated September 18, 1998.
1.3. "ANDA" means an abbreviated new drug application that is submitted to the
FDA for approval to manufacture and/or sell a pharmaceutical product in
the United States.
1.4. "Asset Purchase Agreement(s)" mean the Asset Purchase Agreement entered
into between G.D. Searle & Co., SCS Pharmaceuticals and Watson
Laboratories, Inc. dated September 30, 1997 and the Asset Purchase
Agreement entered into between G.D. Searle & Co. and Watson Laboratories
Inc. dated September 18, 1998.
1.5. "Batch" means one (1) production lot of a Product as listed for each
Product on Schedule 1.5.
1.6. "Bulk Tablet Testing Specifications" means the procedures, requirements,
standards, and other items related to testing of the Products in bulk
tablet form attached as Schedule 1.6 as amended from time to time in
accordance with the
3
provisions hereof.
1.7. "Contract Year" shall mean each consecutive twelve (12) month period
commencing on January 1, 2002 and ending on the first anniversary of such
date and each consecutive twelve (12) month period ending on an
anniversary of such date during the term hereof.
1.8. "FDA" means the United States Food and Drug Administration.
1.9. "FTC" means the United States Federal Trade Commission.
1.10. "Law" means any federal, state or local law, ordinance, rule, regulation,
or governmental requirement or restriction of any kind, and any rules,
regulations, and orders promulgated thereunder.
1.11. "NDA" means a New Drug Application that is submitted to the FDA in order
to obtain approval to manufacture and/or sell a pharmaceutical product in
the United States.
1.12. "Ogestrel Agreement" means the Supply Agreement entered into between G.D.
Searle & Co. and Watson Laboratories, Inc. dated October 16, 1997 and the
Letter dated March 29, 2001, notifying Searle that Watson was extending
this Supply Agreement solely for the products, Low-Ogestrel and Ogestrel.
1.13. "Packaging" means filling, inspecting, labeling, packaging and packing of
the Products or any part thereof in accordance with the Packaging
Specifications. The terms "Package," "Packaged" and "Packaging" in this
Agreement shall have the identical meaning.
1.14. "Packaging Specifications" mean the procedures, requirements, standards
and other items related to Packaging of the Products attached hereto as
Schedule 1.14, as amended from time to time in accordance with the
provisions hereof.
1.15. "Product(s)" means the pharmaceutical products listed on Schedule 1.5,
meeting the Specifications.
1.16. "Public Information" means information that is publicly available or is
generally known in the pharmaceutical industry.
1.17. "Searle Labeling" means the printed labels, labeling and packaging
materials, including printed carton, container label and package inserts,
as currently used by
4
SEARLE for each Product.
1.18. "Specifications" shall mean both the Bulk Tablet Testing Specifications
and the Packaging Specifications.
1.19. "Territory" means the United States and its possessions.
1.20. "Watson Labeling" means the printed labels, labeling and packaging
materials, including printed carton, container label and package inserts,
used by Watson and bearing Watson's name for each Product.
ARTICLE 2. PROCESSING AND PACKAGING AND PRICE
2.1. Undertaking.
-----------
(a) Subject to the limitations contained herein, SEARLE or its
Affiliates hereby agrees to Package or to have Packaged WATSON's
orders for the Products in the Territory and WATSON agrees to pay
SEARLE for the quantity of Products so Packaged in accordance with
this Agreement. However, for the Product, Nor Q.D., SEARLE hereby
only agrees to conduct the required testing according to the Quality
Responsibilities in Schedule 6.1. WATSON is responsible for all
other aspects of Packaging Nor Q.D. SEARLE shall not be obligated to
Package Products in excess of the capacity limitations described in
Sections 3.1 and 3.2. For the duration of this Agreement, WATSON
hereby grants to SEARLE a royalty-free license and right in the
Territory to use such of the Assets as are necessary or useful to
SEARLE in fulfilling its obligations under this Agreement.
(b) In addition, SEARLE or its Affiliates agree to conduct bulk tablet
testing of the Products or to have such testing conducted and will
report the results of these tests to WATSON within five (5) working
days of receiving the results of these tests. SEARLE or its designee
will conduct the tests in accordance with the Bulk Tablet Testing
Specifications contained in Schedule 1.6.
(c) WATSON will review the results of the bulk tablet tests and in
WATSON's sole discretion determine which lots of bulk Product are
acceptable for release to SEARLE for Packaging. For each lot of bulk
Product that WATSON releases to SEARLE for Packaging, WATSON shall
provide SEARLE with written authorization to accept those lots of
bulk Product. Without such written authorization from WATSON, SEARLE
will not accept shipment of these lots of bulk Product.
(d) The parties acknowledge that any of SEARLE's obligations hereunder
may be carried out, at SEARLE's election, by third party
manufacturers appropriately qualified under all Laws to perform the
Packaging obligations hereunder in compliance with the
Specifications and all Laws; provided that SEARLE's use of any third
party manufacturer shall require WATSON's
5
prior written consent, which consent shall not be unreasonably
withheld, and the written agreement by the third party to abide by
and comply with the terms of this Agreement. Notwithstanding the
above, the use of any third party manufacturer shall not relieve
SEARLE of its obligations under this Agreement.
(e) WATSON will supply SEARLE, free of charge, with sufficient released
Product in bulk form at least sixty (60) days before any finished
Product delivery date set pursuant to Article 3 for SEARLE to comply
with its Packaging commitments to WATSON under this Agreement.
2.2. Price and Payment.
-----------------
(a) During the first Contract Year, the prices for Packaging the
Products are set out in Schedule 2.2(a). Thereafter, the prices
shall be adjusted as provided in subsection (c) below.
(b) Except as otherwise provided herein, including an event of Force
Majeure affecting either party, during each Contract Year of this
Agreement, WATSON shall purchase a minimum quantity of Products
equal to US $(----) ("Minimum Quantity"). If in any such Contract
Year, WATSON fails to purchase such Minimum Quantity, then WATSON
shall pay SEARLE an amount equal to (----)% of the difference
between US $(----) and the total price for all Products purchased by
WATSON for delivery in such Contract Year. Purchase Orders issued by
WATSON in 2001 for Product to be delivered in 2001 will not be
included in the Minimum Quantity for 2002 even if Product so ordered
is not delivered until 2002. Such Minimum Quantity will include the
purchases made by WATSON under the Ogestrel Agreement for Ogestrel
and Low-Ogestrel during the applicable Contract Year. It is agreed
and understood that these liquidated damages are intended to
compensate SEARLE for its lost profits and overhead costs which are
difficult to calculate and project due to uncertainties in
scheduling its manufacturing operations, and in no way are such
liquidated damages to be construed as a penalty for WATSON's breach.
(c) By December 1st of each Contract Year, SEARLE shall provide WATSON
with written notice of the prices for the following Contract Year.
Effective January 1 of each year, SEARLE may increase its prices for
the Product by an amount equal to increases in the Producer Price
Index for Pharmaceutical Preparations, PCU2834, as published by the
U.S. Bureau of Labor Statistics, over the previous twelve (12) month
period, September to October. Price increases for the Product shall
not exceed (----)% annually. Price changes will take effect January
1 of each year and shall be effective for one year. These price
changes will apply to any Purchase Orders issued by WATSON in the
previous Contract Year provided the Purchase Order specifies a
delivery date after January 1 of the current Contract Year. In the
event the verifiable cost of SEARLE's packaging materials increases
by more than (----)%
6
in a Contract Year, however, SEARLE may adjust the Product(s) price
to WATSON to reflect these increased packaging component costs.
(d) The Products will be shipped to a location in the Territory
designated by WATSON, FCA (Incoterms 2000) SEARLE's manufacturing
plant. Title and risk of loss shall pass to WATSON upon delivery of
the Products to the common carrier.
(e) WATSON will pay in US currency for each shipment of Products within
(----) days after the shipment of the Product(s).
ARTICLE 3. FORECASTS AND ORDERS
3.1. Forecasts.
---------
(a) On a monthly basis, WATSON will provide SEARLE with a written (----)
month non-binding rolling forecast of the quantities of each Product
that WATSON expects to purchase during each of the next (----) months
(the "(----) Month Forecast"), or the remaining months of the
contract, if less than (----) months left in the contract. Except as
may be provided otherwise in this Section 3, the forecast for each
Contract Year will be limited to an amount not greater than (----)%
of the forecast for the prior Contract Year.
(b) The first (----) months of each (----) Month Forecast (the "(----)
Forecast") shall be firm and shall not have been changed from the
forecasted amounts for the same calendar months contained in the
prior (----) Month Rolling Forecast.
3.2. Permitted Amount to be Ordered. WATSON shall submit a purchase order to
------------------------------
SEARLE referencing this Agreement each month as required, with a delivery
date of not less than (----) days after the date thereof. SEARLE will
use its commercially reasonable efforts, but will be under no obligation,
to supply Product in excess of (----)% of the (----) Month Forecast.
3.3. Minimum Order Size. The minimum size of any order for any Product shall be
------------------
(----) Batch of such Product with larger orders being in whole number
multiples of a Batch. A Batch of bulk Product may be split between trade
and sample presentations as long as the whole Batch is consumed in
packaging within one month's time.
3.4. Failure to Supply.
-----------------
(a) In the event SEARLE fails or is unable to Package or conduct testing
in accordance with the Bulk Tablet Testing Specifications or has
reason to believe that it will be unable to so test or to Package
the quantities of the Products ordered by WATSON to meet WATSON's
requirements (within
7
the limits described in Section 2.1 above and within thirty (30)
days after the delivery date set forth in the applicable purchase
order), WATSON may (i) purchase or obtain so much as to meet its
requirements or any portion thereof from any other source, and/or
(ii) to the extent permitted by law, Package or have Packaged the
same under the applicable Specifications and quality control
procedures. In such event, SEARLE shall provide WATSON or WATSON's
contract manufacturer with all documents, data and other information
necessary or useful for Packaging the Products at no cost for so
long as SEARLE is unable to supply sufficient quantities of the
Products to meet WATSON's requirements. Any such quantities Packaged
by a secondary source pursuant to this Paragraph shall nonetheless
be credited against the WATSON's Minimum Quantity purchase
obligation under Paragraph 2.2(b).
ARTICLE 4. SPECIFICATIONS
4.1 Specifications. The Products shall be tested, Packaged, stored and shipped
--------------
in accordance with the Specifications and all Laws.
4.2 WATSON's Changes. The Specifications may be changed by WATSON, provided
----------------
the Specifications at all times shall be in compliance with the Product
Registration, from time to time with SEARLE's consent which shall not be
unreasonably withheld, but not more often than (----) per year unless
required by the FDA or other US government agency. All such changes shall
be communicated to SEARLE in writing, after which the parties shall agree
on the date of implementation of such changes as soon as reasonably
practicable. If any such change results in increased Packaging, testing
costs or obsolescence of any materials specifically purchased by SEARLE
for Packaging of the Products under this Agreement prior to being notified
in writing by WATSON of the change in the Specifications, WATSON shall
reimburse SEARLE for any such increased costs and the actual out-of-pocket
cost of all such materials except to the extent the quantity of such
materials exceeds requirements greater than the previous (----) months of
WATSON's forecasts. Upon being reimbursed for obsolete material and at
WATSON's written request, SEARLE shall promptly ship any such materials to
a location designated by WATSON or destroy such materials at WATSON's
expense. If any such change or proposed change to the Specifications
results in costs and expenses to SEARLE, WATSON shall promptly reimburse
all such reasonable documented out-of-pocket costs and expenses.
ARTICLE 5. PACKAGING MATERIALS
5.1. Supply. SEARLE will supply all materials required to Package the bulk
------
Product provided by WATSON as described in Section 2.1 (e).
8
5.2. Title and Risk of Loss. Title and risk of loss to all materials provided
----------------------
by SEARLE shall pass to WATSON upon delivery of the finished Products
incorporating such materials to the common carrier at SEARLE's
manufacturing plant. SEARLE shall store and maintain all bulk Product and
Packaging materials in accordance with the Specifications and in
compliance with all applicable Laws.
ARTICLE 6. QUALITY CONTROL; ADVERSE EXPERIENCES AND RECALLS
6.1. Quality Responsibilities. The Quality Responsibilities for SEARLE and
------------------------
WATSON attached as Schedule 6.1 to this Agreement, shall be used by both
Parties to assign the day-to-day responsibilities and manage the
operations of both the WATSON and SEARLE Quality Assurance groups in
regards to the Packaging of the Products by SEARLE for WATSON.
6.2. Testing. SEARLE shall perform quality control tests and assays on the
-------
Products in accordance with the Bulk Tablet Testing Specifications.
Results of such tests and assays as well as specific Batch samples of
Products packaged under this Agreement following the date hereof will be
submitted to WATSON with a Certificate of Analysis.
6.3. Samples. SEARLE shall retain for at least one (1) year after the
-------
expiration date of the applicable lot or batch of Products a file sample
properly stored from each lot or batch of Products Packaged, including
market packages, sufficient to perform each quality control test specified
in the Bulk Tablet Testing Specifications at least two (2) times.
6.4. Quality Issues Bulk Product. Any quality, safety or similar issues related
---------------------------
to the bulk Product supplied by WATSON to SEARLE are WATSON's
responsibility to resolve; provided, however, that any quality, safety or
similar issues related to the bulk Products caused by SEARLE's failure to
comply with the terms of this Agreement or Laws, or SEARLE's negligence or
willful misconduct shall be the responsibility of SEARLE, such
responsibility to include, without limitation, the obligation to reimburse
WATSON for loss or damage to the bulk Product. For any Product which
cannot be released due to quality or safety issue related to the bulk
Product which is the responsibility of WATSON hereunder, WATSON shall
reimburse SEARLE for the direct cost of manufacture of the affected
Product, said direct cost of manufacture to be calculated by adding the
actual cost of : a) Packaging materials and supplies used to Package the
affected Products; b)Wages of those employees directly employed in the
packaging of the affected Products; and, (c) That portion of SEARLE's
fixed overhead expenses directly attributable to the actual Packaging of
the affected products, calculated and apportioned in accordance with
generally accepted accounting principles.
9
6.5. Other Products' Adverse Drug Experiences and Quality Complaints. WATSON
---------------------------------------------------------------
shall be responsible for handling all Product complaints related to all
Products. SEARLE and WATSON shall promptly forward any Product complaints
received by either of them to the other no later than three (3) days
following receipt and shall provide assistance in investigating such
complaints as may be reasonably requested. Each party shall designate a
representative who will handle Product complaint activities for such party
and coordinate such activities with the other party.
6.6. Recalls Relating to Products. Recalls of the Products shall be the
----------------------------
responsibility of WATSON. The party desiring to initiate a recall shall
notify the other and, immediately thereafter, both parties shall discuss
appropriate alternatives, including whether a recall is required and the
method of implementing a recall. SEARLE shall cooperate with WATSON in the
event of any recall, field alert or similar event and provide such
assistance in connection therewith as WATSON may reasonably request. The
costs of any such recall or similar event shall be borne by WATSON, except
if the recall resulted from SEARLE's negligence, or breach of this
Agreement, in which case SEARLE shall reimburse WATSON for the costs and
expenses reasonably borne and paid by WATSON to effect the recall.
6.7. Inspection. SEARLE agrees to permit WATSON's designated representatives to
----------
whom SEARLE has no reasonable objections to inspect SEARLE facilities at
which the Products are Packaged, stored or tested for the purpose of
determining compliance with applicable Law and the Specifications at
reasonable times after reasonable notice during regular business hours.
6.8. Quality Control Evaluation. Within (----) days after receipt of each
--------------------------
shipment, WATSON will inspect and make a quality control evaluation of
such shipment (which shall include a certificate of analysis). In the
event any shipment or part thereof fails, or there is manifest cause for
WATSON to reasonably believe that any shipment or part thereof fails to
conform to the Packaging Specifications or shall have been Packaged or
shipped under conditions which do not comply with the FDA requirements or
the provisions of this Agreement, WATSON may reject the same by giving
written notice to SEARLE within the (----) day period, specifying the
manner in which it fails to meet the requirements. SEARLE shall have
(----) days within which to accept or reject WATSON's claims.
6.9. Disputes. In the event of any dispute as to whether any shipment of
--------
Products fails in whole or part to meet the Packaging Specifications, such
dispute shall be promptly resolved by an independent testing organization
of recognized repute within the US pharmaceutical industry mutually agreed
upon by the parties, the appointment of which shall not be unreasonably
withheld or delayed by either party. Until any dispute is resolved, WATSON
will not dispose of any
10
nonconforming shipment without prior written authorization from and
agreement with SEARLE. The fees and costs of such testing organization
shall be borne by the party whose position is not sustained by the testing
organization.
6.10. Replacement Products. If any Products shipped hereunder are rejected by
--------------------
WATSON, SEARLE agrees to ship as soon as reasonably possible after notice
of such rejection (or if there is a dispute with regard to the rejection,
after notice of the determination of the independent testing organization)
replacement Products either newly packaged or, with the consent of WATSON,
reworked from the rejected shipment using an FDA approved procedure with
respect thereto. SEARLE's requirement to ship replacement Product is
entirely contingent on first receiving sufficient replacement bulk
Products from WATSON to allow SEARLE to package replacement Product, the
cost of such replacement bulk Product to be reimbursed to WATSON within
(----) days if SEARLE does not reasonably and in good faith dispute
Watson's rejection of Product. If SEARLE does so dispute WATSON's
rejection, SEARLE will only be responsible for the cost of such
replacement bulk Product if its position is sustained by the testing
organization as set forth in Section 6.9 above.
6.11. Government Inspections/Communications. Each party shall promptly notify
-------------------------------------
the other part of any government inspections or communications to or from
any governmental agency (including the reporting of adverse drug
experiences or field alerts) that might adversely affect the other
parties' ability to perform its obligations under this Agreement.
ARTICLE 7. WARRANTIES
7.1. SEARLE Warranties. SEARLE warrants that:
-----------------
(a) the Packaging and all materials furnished by SEARLE will comply with
the Packaging Specifications and with all applicable Laws, including
all current Good Manufacturing Practices ("GMPs");
(b) EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, SEARLE
MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
7.2. WATSON Warranties. WATSON warrants that:
-----------------
(a) to the extent that it provides any bulk Product, other materials or
engages in Packaging with respect to the Products, all such bulk
Product, materials and Packaging will comply with the Specifications
and with all applicable Laws, including GMPs; and
11
(b) EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, WATSON
MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 8. INDEMNIFICATION
8.1. In Favor of SEARLE. WATSON shall defend, indemnify and hold SEARLE, its
------------------
Affiliates and the officers, directors and employees of each harmless from
and against any and all claims, demands, losses, damages, liabilities,
settlement amounts, costs or expenses whatsoever (including reasonable
attorneys' fees) arising from or related to any claim, action or
proceeding made or brought against such party by a third party (i) as a
result of WATSON's use, promotion, sale and/or distribution of the
Products except to the extent such liability arises from SEARLE's breach
of any warranty or representation herein, SEARLE's failure to perform any
covenant herein, or the negligent act or omission of SEARLE in performing
its obligations under this Agreement or (ii) as a result of WATSON's
breach of any warranty or representation herein, WATSON's failure to
perform any covenant herein, or the negligent act or omission of WATSON in
performing its obligations under this Agreement.
8.2. In Favor of WATSON. SEARLE shall defend, indemnify and hold WATSON and its
------------------
officers, directors and employees harmless from and against any and all
claims, demands, losses, damages, liabilities, settlement amounts, costs
or expenses whatsoever (including reasonable attorneys' fees) arising from
or related to any claim, action or proceeding made or brought against such
party by a third party as a result of SEARLE's breach of any warranty or
representation herein, SEARLE's failure to perform any covenant herein, or
the negligent act or omission of SEARLE in performing its obligations
under this Agreement.
8.3. Notice; Defense. In the event of any claim, action or proceeding for which
---------------
a party is entitled to indemnity hereunder, the party seeking indemnity
("Claimant") shall promptly notify the other party ("Indemnitor") of such
matter in writing, provided that the failure to give timely notice to the
Indemnitor shall not release the Indemnitor from any liability to Claimant
except to the extent the Indemnitor is actually prejudiced thereby.
Indemnitor shall promptly, but in no event later than thirty (30) days
from date of notice, assume responsibility for and shall have full control
of the defense of such matter and Claimant shall fully cooperate in
Indemnitor's handling and defense thereof. Failure to assume the defense
within the aforementioned time period shall constitute a waiver of the
Indemnitor's rights to assume the defense and, except as otherwise
provided herein, the Claimant shall have the full right to conduct the
defense, settle or otherwise dispose of the claim at the Indemnitor's
expense. The Indemnitor shall have the right to settle or
12
compromise claims against the Claimant involving the payment of money by
Indemnitor only in exchange for an unconditional release of Claimant. All
other dispositions of claims must be approved by Claimant, which approval
shall not be unreasonably withheld.
8.4. Limitation. Notwithstanding any provision of this Agreement which might
----------
otherwise be to the contrary, except as expressly set forth in Section
2.2(b), (i) no party shall be entitled to indemnification with respect to
any claim or suit to the extent such claim or suit results from its own
negligence or willful misconduct, or any action to which it has consented
to in writing, and (ii) neither party shall be liable to the other for
punitive, exemplary, indirect or special damages or lost profits or other
consequential damages of any kind.
ARTICLE 9. CONFIDENTIALITY
During the term of this Agreement and for a period of three (3) years thereafter
except as otherwise provided in the Asset Purchase Agreement, no party shall,
without the specific written consent of the other party, disclose to any third
party (except to governmental health or regulatory authorities to obtain and
maintain the registration of the Products or other disclosures required by law)
or use for its own purposes any confidential information which is received from
the other party or its agent(s) pursuant to this Agreement concerning the
Products or the other party's business unless such information:
a. was or becomes public through no fault of the receiving party,
or
b. was obtained from a third party legally entitled to use and
disclose the same, or
c. was known to the party prior to entering into this Agreement.
For this purpose, Assets shall be deemed WATSON's property in the Territory and
not subject to any obligation of confidentiality by WATSON with respect to the
Territory.
ARTICLE 10. TERM AND TERMINATION
10.1. Term. The term of this Agreement shall be, unless terminated earlier as
----
provided herein commencing on the Effective Date and termination on
December 31, 2003.
10.2. Termination by Either Party. Either party shall have the right to
---------------------------
terminate this Agreement immediately upon written notice to the other:
(a) if the other party is dissolved or liquidated, files or has filed
against it a petition under any bankruptcy or insolvency law, makes
an assignment for the benefit of its creditors or has a received
appointed for all or substantially all of its property and is not
withdrawn within sixty (60) days of appointment; or
13
(b) if the other party shall commit any material breach (whether
remediable or not) of its obligations under this Agreement and, if
remediable, shall fail to remedy the breach within sixty (60) days
after receipt of written notice from the non-breaching party
describing such breach.
10.3 Termination With Notice. WATSON shall be entitled to terminate this
-----------------------
Agreement in its entirety, with an effective date of December 31, 2002, by
giving written notice to SEARLE on or before July 1, 2002. In the event,
WATSON submits a written request to SEARLE by July 1, 2002, that it would
like to terminate this Agreement only as related to an individual Product
or Products, effective December 31, 2002, SEARLE will have 1 month to
respond to this request. No later than August 1, 2002 Pharmacia will
notify WATSON in writing if it accepts WATSON's request for termination.
This decision will be at Pharmacia's sole discretion and if WATSON does
not receive a response from SEARLE by August 1, 2002, SEARLE will be
deemed to have rejected WATSON's request for a partial termination.
10.4 Without Prejudice. Termination of this Agreement, due to the fault of
-----------------
either party, shall be without prejudice to any other rights or remedies
then or thereafter available to either party under this Agreement or
otherwise.
10.5 Products and Materials. Promptly after expiration or termination of this
----------------------
Agreement, SEARLE will complete work on all in process Products. WATSON
will pay SEARLE the price determined pursuant to Section 2 for Products
Packaged by SEARLE. In addition, WATSON shall reimburse SEARLE for the
cost of any packaging and labeling materials remaining in SEARLE's
inventory, which packaging and labeling material will be promptly
delivered to WATSON at a place of WATSON's designation. However, in no
event shall the quantity of Products and packaging/labeling materials to
be purchased by WATSON under this provision after expiration or
termination exceed WATSON's forecasts for the preceding six (6) month
period.
ARTICLE 11. GOVERNING LAW
This Agreement shall be governed by and interpreted and enforced in accordance
with the laws of the State of Delaware of the United States of America
regardless of the choice of law principles of Delaware or any other
jurisdiction.
ARTICLE 12. MISCELLANEOUS
12.1. Costs. Each party shall bear its own costs and expenses incurred in
-----
negotiating this Agreement.
14
12.2. Notices. Any notice required or permitted to be given hereunder shall be
-------
deemed sufficient if sent by facsimile letter or overnight courier, or
delivered by hand to SEARLE or WATSON at the respective addresses and
facsimile numbers set forth below or at such other address and facsimile
number as either party hereto may designate. If sent by facsimile letter,
notice shall be deemed given when the transmission is completed if the
sender has a confirmed transmission report. If a confirmed transmission
report does not exist, then the notice will be deemed given when the
notice is actually received by the person to whom it is sent. If delivered
by overnight courier, notice shall be deemed given when it has been signed
for. If delivered by hand, notice shall be deemed given when received.
if to SEARLE, to:
Searle & Co.
Calle Jardines #99
Caguas, Puerto Rico 00725
Attention: Finance Director
Fax number: (787) 286-4034
with a copy to:
Legal Counsel
Pharmacia CentreSource
7000 Portage Road
Kalamazoo, Michigan 49001-0199
Fax number: (616) 833-6310
if to WATSON, to:
Watson Laboratories, Inc.
PO Box 1900
311 Bonnie Circle
Corona CA 91718-1900
Attention: Maria Chow
Fax number: (909) 493-5807
with a copy to:
General Counsel
Watson Laboratories, Inc.
311 Bonnie Circle
Corona, CA 92880
Fax number: (909)279-8094
12.3. Survival. The provisions of Articles 8, 9 and 11 shall survive the
--------
expiration or other termination of this Agreement.
15
12.4. Entire Agreement. This Agreement, together with any Schedules hereto and
----------------
the Asset Purchase Agreement, constitute the entire Agreement between the
parties concerning the subject matter hereof; it may not be modified or
amended except in writing signed by all parties. All agreements or
arrangements (if any) among the parties executed prior to the date hereof
(except for the Asset Purchase Agreement), whether written or oral,
relating to the subject matter hereof are hereby canceled and superseded.
12.5. Schedules. The Schedules (as amended from time to time by agreement of the
---------
Parties in writing) form part of this Agreement and shall have the same
force and effect as if expressly set out in the body of the Agreement and
any reference to the Agreement shall include the Schedules. To the extent
that there is conflict between or ambiguity relating to, on the one hand,
any or all of the Schedules and, on the other, the remainder of this
Agreement, the wording of the Agreement shall prevail.
12.6. Headings. Headings are inserted for convenience and shall not by
--------
themselves determine the interpretation of this Agreement.
12.7. Counterparts. This Agreement may be executed in counterparts, each of
------------
which shall be deemed an original but together constituting one agreement.
12.8. Assignment. Except as otherwise provided in this Section, neither party
----------
may assign or delegate any right or obligation hereunder without the prior
written consent of the other party, which consent shall not be
unreasonably withheld, and any attempted assignment or delegation in
violation hereof shall be void. WATSON and SEARLE may each assign all or
part of its rights and obligations hereunder to an Affiliate on notice to
and without the necessity of securing the other party's consent, subject
to and for so long as such assignee remains an Affiliate of the assignor.
In addition, either party may assign all of its rights and obligations
hereunder to a purchaser of all or substantially all of the assets or
business to which this Agreement relates.
12.9. Waiver of Default. No waiver of any default hereunder by any party or any
-----------------
failure to enforce any rights hereunder shall be deemed to constitute a
waiver of any subsequent default with respect to the same or any other
provision hereof. No waiver shall be effective unless made in writing with
specific reference to the relevant provision(s) of this Agreement and
signed by a duly authorized representative of the party granting the
waiver.
12.10. Not for Benefit of Creditors. The provisions of this Agreement are
----------------------------
intended only for the regulation of relations between the parties. Except
as expressly provided in Article 8 (and then subject to the limitations
stated in such Article), this Agreement is not intended for the benefit of
any person, firm or entity not a party
16
hereto and no rights are granted to such third parties hereunder.
12.11. Force Majeure. If any party is prevented from performing any obligation
-------------
hereunder by reason of fire, explosion, strike, labor dispute, casualty,
accident, lack or failure of transportation facilities, flood, war, civil
commotion, acts of God, any law, order or decree of any government or
subdivision thereof or any other cause beyond the reasonable control of
such party ("Force Majeure), then such party shall be excused form
performance hereunder to the extent and for the duration of such
prevention, provided it first notifies the other party in writing of such
prevention. The foregoing shall not apply to any prevention due to any
governmental regulatory action resulting directly from the fault of
SEARLE.
12.12. Publicity. Neither SEARLE nor WATSON, nor any Affiliate thereof, will
---------
issue or cause publication of any press release or other announcement or
public communication with respect to this Agreement or the transactions
contemplated hereby without the prior written consent of the other party,
which consent will not be unreasonably withheld or delayed.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
as of the date first above written.
SEARLE & CO. WATSON LABORATORIES, INC.
By: By:
----------------------------- -----------------------------
Title: Title:
-------------------------- --------------------------
17
SCHEDULES
---------
1.5 Products and Batch Lot Sizes
1.6 Bulk Tablet Testing Specifications
1.14 Packaging Specifications
2.2(a) Purchase Prices
6.1 Quality Agreement and Quality Responsibilities
SCHEDULE 1.5
PRODUCTS AND BATCH LOT SIZES
----------------------------
CODE DESCRIPTION LOT SIZE (Cartons) TABLETS
- ---- ----------- ------------------ -------
25428 Brevicon (----) (----) (----)
X25428 Brevicon (----) Samples (----) (----)
27928 Levora (----) (----) (----)
X27928 Levora (----) Samples (----) (----)
26528 Norinyl 1/50 (----) (----) (----)
25928 Norinyl 1/35 (----) (----) (----)
X25928 Norinyl 1/35 (----) Samples (----) (----)
A023091 NorQD tablets (----) (----)
27428 Tri-Norinyl (----) (----) (----)
X27428 Tri-Norinyl (----) Samples (----) (----)
29128 Trivora (----) (----) (----)
X29128 Trivora (----) Samples (----) (----)
Schedule 1.5 to Packaging Agreement
TRIVORA Tablets
Low Dose: Levonorgestrel 0.05 mg / Ethinyl Estradiol 0.03 mg
Medium Dose: Levonorgestrel 0.075 mg / Ethinyl Estradiol 0.04 mg
High Dose: Levonorgestrel 0.125 mg / Ethinyl Estradiol 0.03 mg
- ------------------------------------------------------------------------------------------------------------------------------------
Bulk Tablet Holding Period (----) days from start of manufacture of the earliest of the Trivora lots
- ------------------------------------------------------------------------------------------------------------------------------------
Expiration Date Assignment (----) months from start of manufacture of the earliest of the Trivora lots
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
IN-PROCESS SPECIFICATION (GRANULATION)
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
TEST SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Blend Uniformity (----)% - (----)% L.S.
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
FINISHED GOODS SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATION REGULATORY SPECIFICATION
------------------------------------------------------------------------------------------------
Low Dose Medium Dose High Dose Low Dose Medium Dose High Dose
- ------------------------------------------------------------------------------------------------------------------------------------
Description Blue, round, White, round, Pink, round, Blue, flat- White, flat- Pink, flat-
flat-faced, flat-faced, flat-faced, faced, faced, faced,
bevel-edge, bevel-edge, bevel-edge, beveled-edge beveled-edge beveled-edge
uncoated. uncoated. uncoated. tablets with tablets with tablets with
Debossed Debossed one Debossed one the company the company the company
one side side side identifier on identifier on identifier on
"WATSON", "WATSON", "WATSON", one side and one side and one side and
other side other side other side the product the product the product
"50/30" "75/40" "125/30" identifier on identifier on identifier on
the other. the other. the other.
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test (HPLC) Retention time of main sample peak Retention time of main sample peak conforms to
correspond to those of the standard. those of the standard.
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test
(Melting Point, Class I) (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
TRIVORA SPECIFICATION
Schedule 1.6 to Packaging Agreement
- ------------------------------------------------------------------------------------------------------------------------------------
Assay Levonorgestrel (HPLC) (----)% - (----)% (----)% - (----)% of the label claim
- ------------------------------------------------------------------------------------------------------------------------------------
Assay Ethinyl Estradiol (HPLC) (----)% - (----)% (----)% - (----)% of the label claim
- ------------------------------------------------------------------------------------------------------------------------------------
Content Uniformity (HPLC)
Levonorgestrel Conforms to current USP criteria Conforms to current USP requirements
- ------------------------------------------------------------------------------------------------------------------------------------
Content Uniformity (HPLC)
Ethinyl Estradiol Conforms to current USP criteria Conforms to current USP requirements
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Levonorgestrel
Q = 80% at 60 min. Conforms to USP Acceptance Table Conforms to current USP requirements
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Ethinyl Estradiol
Q = 75% at 60 min. Conforms to USP Acceptance Table Conforms to current USP requirements
- ------------------------------------------------------------------------------------------------------------------------------------
Residual Methanol (----) (----) (----) (----) (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
6-Keto EE
--------------------
9,11 - DEE
--------------------
6-OH-LNRG
-------------------- (----)% (----)% (----)% (----)% (----)% (----)%
Related 6-OH-EE on any on any on any on any on any on any
Substances -------------------- individual individual individual individual individual individual
6-Keto-LNRG
--------------------
6,7 - DEE
--------------------
6,7 - DLNRG
--------------------
5,6 - Delta LNRG
--------------------
LNRG SYNT. IMP
---------------------------------------------------------------------------------------------------------------------
Total
Related Substances (----) (----) (----) (----) (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic NMT (----) NMT (----) NMT (----) NMT (----) NMT (----) NMT (----)
Microbial Count cfu/g cfu/g cfu/g cfu/g cfu/g cfu/g
- ------------------------------------------------------------------------------------------------------------------------------------
Escherichia coli (----)
- --------------------------------------------------------------------------------
Salmonella (----) No filed requirement
- --------------------------------------------------------------------------------
Coliform bacteria (----) (----) (----)
- --------------------------------------------------------------------------------
Fungi (----) (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
TRIVORA SPECIFICATION
Schedule 1.6 to Packaging Agreement
NORINYL 1 + 35 Tablets
Norethindrone 1 mg / Ethinyl Estradiol 0.035 mg
- ------------------------------------------------------------------------------------------------------------------------------------
Bulk Tablet Holding Period (----) days from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
Expiration Date Assignment (----) months from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
IN-PROCESS SPECIFICATION (GRANULATION)
- ------------------------------------------------------------------------------------------------------------------------------------
TEST SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Blend Assay Norethindrone: (----)% - (----)% l.s.
Ethinyl Estradiol: (----)% - (----)% l.s.
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
FINISHED GOODS SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATION REGULATORY SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Appearance Yellow-green, round, flat-faced, bevel-edged Yellow-green, flat-faced, beveled-edge tablets
tablet. Debossed one side "WATSON"; other with the company identified on one side and the
side, "259". product identifier on the other side.
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test Retention time of main sample peak correspond Conforms to current USP requirements.
(TLC or HPLC) to those of the standard.
Norethindrone
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test (HPLC) Retention time of main sample peak correspond Retention time of main sample peak conforms to
Ethinyl Estradiol to those of the standard. that of the standard.
- ------------------------------------------------------------------------------------------------------------------------------------
Assay Norethindrone (----)% - (----)% (----)% - (----)% of label claim
- ------------------------------------------------------------------------------------------------------------------------------------
Assay Ethinyl Estradiol (----)% - (----)% (----)% - (----)% of label claim
- ------------------------------------------------------------------------------------------------------------------------------------
NORINYL 1+35 SPECIFICATION
Schedule 1.6 to Packaging Agreement
- ------------------------------------------------------------------------------------------------------------------------------------
Uniformity of Dosage Units Conforms to current USP criteria Conforms to USP requirements
Norethindrone
- ------------------------------------------------------------------------------------------------------------------------------------
Uniformity of Dosage Units Conforms to current USP criteria Conforms to USP requirements
(Ethinyl Estradiol)
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Conforms to USP Acceptance Table Conforms to USP
Norethindrone
Q = 75% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution HPLC Conforms to USP Acceptance Table Conforms to USP
Ethinyl Estradiol
Q = 75% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic (----) N/A
Microorganisms
- ------------------------------------------------------------------------------------------------------------------------------------
Escherichia coli (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Salmonella (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Fungi (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Coliform bacteria (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
NORINYL 1+35 SPECIFICATION
Schedule 1.6 to Packaging Agreement
NORINYL 1 + 50 Tablets
Norethindrone 1 mg / Mestranol 0.05 mg
- ------------------------------------------------------------------------------------------------------------------------------------
Bulk Tablet Holding Period (----) days from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
Expiration Date Assignment (----) months from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
IN-PROCESS SPECIFICATION (GRANULATION)
No filed requirement for blend uniformity or blend assay.
- --------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
FINISHED GOODS SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATION REGULATORY SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Appearance White, round, flat-faced, bevel-edged tablet. White, round, flat-faced, beveled-edge tablet;
Debossed one side "WATSON"; other side, debossed "WATSON" on one side and "265" on
"265". the other side.
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test Retention time of main sample peak correspond Conforms to current USP requirements.
(TLC or HPLC) to those of the standard.
Norethindrone
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test B HPLC Retention time of main sample peak correspond Retention time of main sample peak conforms to
Mestranol to those of the standard. that of the standard.
- ------------------------------------------------------------------------------------------------------------------------------------
Assay Norethindrone (----)% - (----)% (----)% - (----)% of label claim
- ------------------------------------------------------------------------------------------------------------------------------------
Assay Ethinyl Estradiol (----)% - (----)% (----)% - (----)% of label claim
- ------------------------------------------------------------------------------------------------------------------------------------
Uniformity of Dosage Units Conforms to current USP criteria Conforms to current USP requirements
Norethindrone
- ------------------------------------------------------------------------------------------------------------------------------------
NORINYL 1+50 SPECIFICATION
Schedule 1.6 to Packaging Agreement
- ------------------------------------------------------------------------------------------------------------------------------------
Uniformity of Dosage Units Conforms to current USP criteria Conforms to current USP requirements
Mestranol
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Norethindrone Conforms to USP Acceptance Table Conforms to USP requirements
Q = 75% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Ethinyl Estradiol Conforms to USP Acceptance Table Conforms to USP requirements
Q = 75% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic (----) N/A
Microorganisms
- ------------------------------------------------------------------------------------------------------------------------------------
Escherichia coli (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Salmonella (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Fungi (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Coliform bacteria (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
NORINYL 1+50 SPECIFICATION
Schedule 1.6 to Packaging Agreement
BREVICON 0.5/35 Tablets
Norethindrone USP 0.5 mg / Ethinyl Estradiol 0.035 mg
- ------------------------------------------------------------------------------------------------------------------------------------
Bulk Tablet Holding Period (----) days from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
Expiration Date Assignment (----) months from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
IN-PROCESS SPECIFICATION (GRANULATION)
- ------------------------------------------------------------------------------------------------------------------------------------
TEST SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Blend Assay Norethindrone: (----)% - (----)%
Ethinyl Estradiol: (----)% - (----)%
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
FINISHED GOODS SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATION REGULATORY SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Appearance Blue, round, flat-faced, bevel-edged tablet. Blue, flat-faced, beveled-edge tablets with
Debossed one side "WATSON"; other side, company identifier on one side and product
"254". identifier on the other,
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test Retention time of main sample peak correspond Passes test.
Norethindrone to those of the standard.
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test Retention time of main sample peak correspond Passes test.
Ethinyl Estradiol to those of the standard.
- ------------------------------------------------------------------------------------------------------------------------------------
Assay (Norethindrone) (----)% - (----)% (----)% - (----)% L.S.
- ------------------------------------------------------------------------------------------------------------------------------------
Assay (Ethinyl Estradiol) (----)% - (----)% (----)% - (----)% L.S.
- ------------------------------------------------------------------------------------------------------------------------------------
Uniformity of Dosage Units Conforms to current USP criteria Conforms to USP requirements
Norethindrone
- ------------------------------------------------------------------------------------------------------------------------------------
BREVICON SPECIFICATION
Schedule 1.6 to Packaging Agreement
- ------------------------------------------------------------------------------------------------------------------------------------
Uniformity of Dosage Units Conforms to current USP criteria Conforms to USP requirements
Ethinyl Estradiol
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Norethindrone Conforms to USP Acceptance Table Conforms to USP requirements
Q = 75% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Ethinyl Estradiol Conforms to USP Acceptance Table Conforms to USP requirements
Q = 75% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic (----) N/A
Microorganisms
- ------------------------------------------------------------------------------------------------------------------------------------
Escherichia coli (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Salmonella (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Fungi (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Coliform bacteria (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
BREVICON SPECIFICATION
Schedule 1.6 to Packaging Agreement
LEVORA 0.15/30 Tablets
Levonorgestrel 0.15 mg / Ethinyl Estradiol 0.03 mg
- ------------------------------------------------------------------------------------------------------------------------------------
Bulk Tablet Holding Period (----) days from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
Expiration Date Assignment (----) months from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
IN-PROCESS SPECIFICATION (GRANULATION)
- ------------------------------------------------------------------------------------------------------------------------------------
TEST SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Blend Assay Levonorgestrel: (----)% - (----)% L.S.
Ethinyl Estradiol: (----)% - (----)% L.S.
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
FINISHED GOODS SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATION REGULATORY SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Description White, round, flat-faced, beveled edge tablet, White, flat-faced, beveled-edge tablets with the
uncoated. Debossing one face, "15/30"; other company identifier on one side and the product
face "WATSON". identifier on the other.
- ------------------------------------------------------------------------------------------------------------------------------------
*Identification Test (HPLC) Retention time of main component peaks in the Retention time of main sample peak conforms to
sample compares to that of the corresponding that of the standard.
peaks in the standard.
- ------------------------------------------------------------------------------------------------------------------------------------
*Identification Test (----) (----)
(Melting Point, Class I)
- ------------------------------------------------------------------------------------------------------------------------------------
Assay (Levonorgestrel) (----)% - (----)% (----)% - (----)% of the label claim
- ------------------------------------------------------------------------------------------------------------------------------------
Assay (Ethinyl Estradiol) (----)% - (----)% (----)% - (----)% of the label claim
- ------------------------------------------------------------------------------------------------------------------------------------
Content Uniformity HPLC Conforms to current USP criteria Conforms to current USP requirements
Levonorgestrel
- ------------------------------------------------------------------------------------------------------------------------------------
LEVORA SPECIFICATION
Schedule 1.6 to Packaging Agreement
- ------------------------------------------------------------------------------------------------------------------------------------
Content Uniformity HPLC Conforms to current USP criteria Conforms to current USP requirements
Ethinyl Estradiol
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Conforms to USP Acceptance Table Conforms to current USP requirements
Levonorgestrel
Q = 80% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Dissolution Conforms to USP Acceptance Table Conforms to current USP requirements
Ethinyl Estradiol
Q = 75% at 60 min.
- ------------------------------------------------------------------------------------------------------------------------------------
Disintegration (----) N/A
- ------------------------------------------------------------------------------------------------------------------------------------
Residual Methanol (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
6-Keto EE (----)
---------------------------------------------------------------------------------
9,11 - DEE (----)
---------------------------------------------------------------------------------
6-OH-LNRG (----)
---------------------------------------------------------------------------------
6-OH-EE (----)
*Related ---------------------------------------------------------------------------------
Substances 6-Keto-LNRG (----) (----)
---------------------------------------------------------------------------------
6,7 - DEE (----)
---------------------------------------------------------------------------------
6,7 - DLNRG (----)
---------------------------------------------------------------------------------
5,6 - Delta LNRG (----)
---------------------------------------------------------------------------------
LNRG SYNT. IMP (----)
---------------------------------------------------------------------------------
Total (----) (----)
Related Substances
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic (----) (----)
Microorganisms
- ------------------------------------------------------------------------------------------------------------------------------------
Escherichia coli (----)
- ----------------------------------------------------------------------------------------------------
Salmonella (----) Not a filed requirement
- ----------------------------------------------------------------------------------------------------
Fungi (----)
- ----------------------------------------------------------------------------------------------------
Coliform bacteria (----)
- ------------------------------------------------------------------------------------------------------------------------------------
*Identification and Related Substances testing performed by PHARMACIA; all other
results derived from Certificate of Analysis provided by (----).
- --------------------------------------------------------------------------------
LEVORA SPECIFICATION
Schedule 1.6 to Packaging Agreement
NOR-QD Tablets
Norethindrone, USP 0.35 mg
- ------------------------------------------------------------------------------------------------------------------------------------
Bulk Tablet Holding Period (----) days from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
Expiration Date Assignment (----) months from start of manufacture
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
IN-PROCESS SPECIFICATION (GRANULATION)
- ------------------------------------------------------------------------------------------------------------------------------------
TEST SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Assay (Norethindrone) (----)% - (----)% L.S.
- ------------------------------------------------------------------------------------------------------------------------------------
Content Uniformity Passes Test
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic Microorganisms (----)
- ------------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
FINISHED GOODS SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATION REGULATORY SPECIFICATION
- ------------------------------------------------------------------------------------------------------------------------------------
Appearance Yellow, round, flat-faced, bevel-edged tablet. Yellow, flat-faced, beveled edge tablets
Debossed one side "WATSON" and "235"; debossed with "Watson 235" on one side, and
the other side blank. blank on reverse.
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Rf values of standard and sample compare. Rf values of standard and sample compare.
- ------------------------------------------------------------------------------------------------------------------------------------
Assay (Norethindrone) (----)% - (----)% (----)% - (----)% L.S.
- ------------------------------------------------------------------------------------------------------------------------------------
Content Uniformity Conforms to current USP criteria Conforms to current USP requirements
- ------------------------------------------------------------------------------------------------------------------------------------
Disintegration (without disks) (----) (----) the use (----)
- ------------------------------------------------------------------------------------------------------------------------------------
NOR-QD SPECIFICATION
Schedule 1.6 to Packaging Agreement
PLACEBO TABLETS, 50 mg
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATIONS REGULATORY SPECIFICATIONS
- ------------------------------------------------------------------------------------------------------------------------------------
Description Round, flat-faced, disc, beveled edged Flat-faced, discoid, beveled edged tablets, no
tablets. 3/16 inch diameter, uncoated. scoring, debossed with company identifier on
Debossed: One face "WATSON"; "P1" on one side.
the other side
Orange colored, 50 mg tablet 40-0996-XX Orange / pale orange / peach
colored, 50 mg tablet
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test (TLC) Absence of steroids No steroids present
- ------------------------------------------------------------------------------------------------------------------------------------
Disintegration (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Hardness (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Residual Methanol (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic Microbial Count (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Coliform bacteria (----) No filed requirement
- ----------------------------------------------------------------------------------
Fungi (----)
- ----------------------------------------------------------------------------------
E. Coli (----)
- ----------------------------------------------------------------------------------
Salmonella (----)
- ------------------------------------------------------------------------------------------------------------------------------------
SPECIFICATION: PLACEBO 50 mg
Schedule 1.6 to Packaging Agreement
PLACEBO TABLETS, 100 mg (for LEVORA)
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATIONS REGULATORY SPECIFICATIONS
- ------------------------------------------------------------------------------------------------------------------------------------
Description Round, flat-faced, beveled edged tablets. Flat-faced, discoid, beveled edged tablets, no
Uncoated, 1/4 inch diameter. Debossed: One scoring, debossed with company identifier on
face "WATSON"; "P1" on the other side one side.
Pale orange / Peach colored, 100 mg tablet
40-0997-XX Orange / pale orange / peach
colored, 100 mg tablet
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test (TLC) Absence of steroids No steroids present
- ------------------------------------------------------------------------------------------------------------------------------------
Disintegration (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Hardness (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Residual Methanol (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic Microbial Count (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Coliform bacteria (----)
- ----------------------------------------------------------------------------------
Fungi (----)
- ---------------------------------------------------------------------------------- No filed requirement
E. Coli (----)
- ----------------------------------------------------------------------------------
Salmonella (----)
- ------------------------------------------------------------------------------------------------------------------------------------
SPECIFICATION: PLACEBO 100 mg (for Levora)
Schedule 1.6 to Packaging Agreement
PLACEBO TABLETS, 100 MG (for TRIVORA)
-------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------------
TEST INTERNAL SPECIFICATIONS REGULATORY SPECIFICATIONS
- ------------------------------------------------------------------------------------------------------------------------------------
Round, flat-faced, beveled edged tablets. Flat-faced, discoid, beveled edged tablets,
Uncoated, 1/4 inch diameter. Debossed: One no scoring, debossed with company identifier
face "WATSON"; "P1" on the other side on one side.
Peach colored, 100 mg tablet
40-0997-XX Orange / pale orange / peach
Description colored, 100 mg tablet
- ------------------------------------------------------------------------------------------------------------------------------------
Identification Test (TLC) Absence of steroids No steroids present
- ------------------------------------------------------------------------------------------------------------------------------------
Disintegration (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Hardness (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Residual Methanol (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Total Aerobic Microbial Count (----) (----)
- ------------------------------------------------------------------------------------------------------------------------------------
Coliform bacteria (----)
- ----------------------------------------------------------------------------------
Fungi (----) No filed requirement
- ----------------------------------------------------------------------------------
E. Coli (----)
- ----------------------------------------------------------------------------------
Salmonella (----)
- ------------------------------------------------------------------------------------------------------------------------------------
SPECIFICATION: PLACEBO 100mg (for Trivora)
Schedule 1.6 to Packaging Agreement
SCHEDULE 1.14
PACKAGING SPECIFICATIONS
------------------------
Schedule 1.14 to Packaging Agreement
Applicable 'Product Assembly Specification'
25428 Brevicon (----) PAS # 9467
X25428 Brevicon (----) Samples PAS # 9467
Brevicon Blister PAS # 9448
27928 Levora (----) PAS # 9445
X27928 Levora (----) Samples PAS # 9492
Levora Blister PAS # 9482
26528 Norinyl 1/50 (----) PAS # 9459
Norinyl 1/50 Blister PAS # 9450
25928 Norinyl 1/35 (----) PAS # 9459
X25928 Norinyl 1/35 (----) Samples PAS # 9467
Norinyl 1/35 Blister PAS # 9449
27428 Tri-Norinyl (----) PAS # 9477
X27428 Tri-Norinyl (----) Samples PAS # 9518
Tri-Norinyl Blister PAS # 9476
29128 Trivora (----) PAS # 9441
X29128 Trivora (----) Samples PAS # 9491
Trivora Blister PAS # 9466
Schedule 1.14 to Packaging Agreement
SCHEDULE 2.2(a)
WATSON PHARMACEUTICALS, INC.
PRODUCT PRICING
DESCRIPTION / UNIT OF MEASURE PRICE
- ----------------------------- -----
Trivora 28 168 (X29128) / CN $(----)*
Trivora 28 168 (29128) / CN $(----)*
Norinyl 1/35 28 84 PTP ((X25928) / CN $(----)*
Norinyl 1/35 28 W 168 (25928) / CN $(----)*
Norinyl 1/50 28 W 168 (26528) / CN $(----)*
Brevicon .5/35 28 84 PTP (X25428) / CN $(----)*
Brevicon .5/35 28 W 84 (25428) / CN $(----)*
Tri-Norinyl 28 84 PTP (X27428) / CN $(----)*
Tri-Norinyl 28 W 168 (27428) / CN $(----)*
Nor QD Tablets (A023091) / FULL LOT $(----)**
Levora 28 84 PTP (X27928) / CN $(----)***
Levora 0.15/30 28 168 (27928) / CN $(----)***
Levora 28 84 PTP (X27928) / CN $(----)****
Levora 0.15/30 28 168 (27928) / CN $(----)****
* Includes packaging, tablet release, stability and micro testing.
** Includes only tablet release, bulk stability and micro testing.
*** Represents Pharmacia continuing with the (----) bulk contract through April
15, 2002 and includes tablet manufacture, packaging, tablet release, stability
and micro testing.
**** Represents Pharmacia packaging bulk tablets provided from Watson, tablet
release, stability and micro testing after expiration of the (----) bulk
contract.
Schedule 2.2(a) to Packaging Agreement
CONTRACT MANUFACTURER
QUALITY AGREEMENT
THIS QUALITY AGREEMENT made as of this 15th day of February , 2002, (the
---- ---------------
"Quality Agreement") by and between SEARLE & CO., a Delaware corporation, and
its Affiliates ("SEARLE"), and WATSON LABORATORIES, INC., a Nevada corporation
("WATSON"). This Quality Agreement supplements the Packaging Agreement signed by
both parties on the 15th day of February , 2002.
---- ---------------
1.0 QUALITY REQUIREMENTS
This Quality Agreement defines requirements to be followed when finished
Product is packaged and/or tested for WATSON to ensure compliance with
current Good Manufacturing Practice guidelines ("cGMPs"), and other
regulatory requirements.
2.0 DEFINITIONS
Product Testing - includes analytical and microbiological testing, when
required, of in-process granulation and finished product testing.
Internal Specifications - statistically based in-house action limits;
these specifications cannot exceed registered specifications.
Registered Specifications - Product specifications as submitted in the
approved Product's (s) NDA/ANDA.
1
Schedule 6.1 to Packaging Agreement
3.0 PRODUCT
Refer to Attachment 1 for the list of products and the services to be
provided by SEARLE for each of the products. The list is limited to the
Products covered by the referenced Packaging Agreement.
4.0 PROCESSES
4.1 Premises
4.1.1 SEARLE will package and/or test the products at its Caguas,
Puerto Rico facility and will not use or transfer at a later
date any of the operations/testing for the products to third
parties or other sites without the prior written agreement of
WATSON. Approval by WATSON shall not be unreasonably withheld.
4.1.2 The premises and equipment used to package and/or test must be
in compliance with cGMPs, current regulatory requirements, and
in accordance with the documentation approved by WATSON.
4.2 GMP Guidelines
The cGMP guidelines to be applied are the United States cGMPs listed
in Code of Federal Regulations ("CFR") Parts, 210 and 211 and
associated Compliance Guidance.
4.3 Materials
SEARLE is responsible for ensuring that all materials procured for
use in production or in analytical and microbiological testing are
in full compliance with the registered specifications.
4.4 Documentation
4.4.1 SEARLE will provide on request packaging, analytical and
microbiological testing documents which have been approved by
its Quality and Compliance unit. Routinely, SEARLE will
provide Watson with Certificates of Quality (C of Q) and
Certificates of Analysis (C of A) for products packaged and/or
tested by SEARLE.
4.4.2 SEARLE will maintain original documentation according to the
record retention procedure consistent with cGMP requirements.
2
Schedule 6.1 to Packaging Agreement
4.4.3 WATSON shall be responsible for providing SEARLE with the
relevant portions of the most current NDA/ANDA's listed in
Attachment 1, including but not limited to the Registered
Specifications, so that SEARLE may fully comply with its
responsibilities under this Quality Agreement.
4.5 Methods
The Product must be packaged and/or tested exactly as specified
within the Specifications. No changes may be made to these methods
without the prior written authorization of WATSON.
4.6 Packaging Specifications
The current, approved Packaging Specifications will be utilized. No
changes may be made to these Packaging Specifications without the
prior written authorization of WATSON.
4.7 Batch Numbering
Products manufactured by a facility other than SEARLE: The batch
numbering system of the company that manufactured the Product will
be used. At its discretion, SEARLE may assign a SEARLE batch number
but all documents must cross-reference the batch number assigned by
the facility that manufactured the product.
4.8 Expiration Date Assignment
Established expiry dating shall be used for all products packaged by
SEARLE. Expiration date assignment will be calculated as follows:
date of manufacture plus established expiry dating. For calculation
of expiration dating, the date of manufacture is defined as the date
in the manufacturing process when the active ingredient is added.
4.9 Rework.
Rework is not permitted without prior authorization by WATSON.
Routine corrective actions performed in process do not require prior
authorization by WATSON.
4.10 Manufacturing and Equipment Data
SEARLE is responsible for keeping records of machine usage, raw
materials
3
Schedule 6.1 to Packaging Agreement
batch numbers and certification, in process results and parameters,
and previous Product used in machinery if non-dedicated machinery is
used.
5.0 QUALITY ASSURANCE
5.1 Testing
5.1.1 Packaging components. SEARLE will ensure that all materials
used are in compliance with the approved Packaging
Specifications.
5.1.2 Finished Product. SEARLE will test all Product batches to the
Specifications. Test results failing the internal
specifications require an investigation and must be reported
to WATSON. WATSON concurrence on disposition of the product is
required.
5.2 Release Procedures
5.2.1 SEARLE is responsible for ensuring and documenting conformance
with the approved Specifications for those operations/testing
performed by SEARLE.
5.2.2 WATSON has responsibility for ensuring proper documentation
and conformance with the approved NDA/ANDA requirements for
those operations performed at facilities other than SEARLE.
5.2.3 Product Acceptance. WATSON will inspect each delivery of
Product prior to release for distribution. WATSON will provide
written notification to the appropriate facility when defects
are found. Transfer of product into inventory shall be deemed
Product acceptance by WATSON.
5.2.4 Release to the Market. The Quality Assurance Department of
WATSON will release the Product for distribution based on
inspection results and C of A / C of Q documents.
5.2.5 Certificate of Analysis and Certificate of Quality. SEARLE
will sign a C of A confirming that the Product has been
tested, and meets the registered specifications. Test
specifications and test results must be included for each
test. SEARLE will also provide a C OF Q , see Attachment 2 for
example, stating the Product has been packaged in accordance
with the approved batch record. The C of Q will contain
language that confirms any and all deviations and
investigations related to the lot were completed in compliance
with applicable SOP's, and the Quality Agreement. Both the C
of A and of C of Q shall accompany each batch of Product
shipped from SEARLE. When appropriate, the language contained
in the C of Q example may be consolidated onto the C of A
document.
4
Schedule 6.1 to Packaging Agreement
5.3 Product Refusal
Product that have been inspected and fails to meet WATSON acceptance
criteria will be rejected. Written notification will be supplied to
the appropriate contract manufacturer detailing the reason(s) for
the refusal of the Product.
5.4 Documentation
Requests for full documentation. SEARLE commits to providing a full
documentation package by fax within 24 hours or within a reasonable
period if requested by WATSON for Product quality concerns, any
regulatory reasons (e.g., batch recall) or unsatisfactory audit
report.
5.5 Retained samples
Finished Product. SEARLE will retain, at minimum, sufficient samples
of the Product, to carry out two full specification tests for the
expiry period of the Product plus one year. This section is
applicable to those products packaged by SEARLE.
5.6 Stability
SEARLE is responsible for maintaining a stability-testing program
for the Product and will provide a stability report to WATSON
annually. Any problem, which arises as a result of this program once
confirmed, will be notified immediately to WATSON Quality Assurance.
A minimum of one batch per year of the Product shall be included in
the stability program..
5.7 Regulatory Inspections
SEARLE will inform WATSON of any Regulatory Inspections, which may
involve the Product and permit a representative from WATSON Quality
Assurance to be present if required by WATSON. A copy of any
reports, notices issued by a Regulatory Authority, which relates to
the Product shall be provided to WATSON.
5.8 Audits
SEARLE shall agree to a facility site compliance audit with prior
written notification given by WATSON to access manufacturing and
control systems used to produce the Product. Such audits shall be
conducted within regular business hours.
5
Schedule 6.1 to Packaging Agreement
5.9 Corrective Actions from Audits
5.9.1 Critical defects. In the case of any "Critical" defects
arising during audits by WATSON or Regulatory Authorities, no
further deliveries of Product may be delivered to WATSON until
corrective actions have been completed to the satisfaction of
WATSON.
5.9.2 Other defects. In the case of other defects arising during
audits by WATSON or Regulatory Authorities, a satisfactory
corrective action program must be in place to the satisfaction
of WATSON before further deliveries of Product to WATSON may
be made.
5.10 Recall / Field Alert / Complaints
5.10.1 WATSON and SEARLE shall work together to mutually agree on
any recall decision. WATSON shall have the final authority to
initiate a Product recall. Refer to Packaging Agreement,
Article 6.6.
5.10.2 SEARLE shall notify WATSON immediately of any confirmed
failure that meets Field Alert Report criteria. WATSON shall
notify the District office within three (3) days of the
failure.
5.10.3 Product Complaints. Refer to Packaging Agreement, Article
6.5.
5.11 Change Control and Deviations
5.11.1 Change Control. SEARLE will inform WATSON and obtain written
approval in advance, of any proposal to change the following:
. Packaging materials or Packaging Specifications
. Site of packaging and/or testing
. Equipment used in packaging
. Product specifications
. In-process test method and /or instrument
. Laboratory equipment/instruments used in testing
. Testing laboratory
. Structural facilities, HVAC system
. Any other change that could affect the registration
status
6
Schedule 6.1 to Packaging Agreement
5.11.2 Deviations. SEARLE will record any accidental deviations from
the packaging and/or testing of the Product in the
batch/testing records and clearly notify WATSON of any and
all deviations from the Quality Requirements for each batch.
5.12 Annual Product Review
SEARLE is responsible for performing and providing an Annual Product
Review (APR) for the products listed in Attachment 1. APR completion
will be performed following SEARLE schedule. A copy will be provided
to WATSON.
5.13 Signature Authority
A list will be provided by WATSON detailing who has signature
authority ("Quality") for items such as deviations, investigations,
change controls, methods, specifications, master batch records etc.
SEARLE is responsible to assure that only those listed approve
documents. Any document approved by any other WATSON personnel may
not be considered approved.
6.0 PROCESS CAPABILITY - VALIDATION
6.1 Cleaning Validation
SEARLE is responsible for ensuring that adequate cleaning is carried
out between batches of different Products to prevent cross
contamination. The cleaning process will be validated before the
first Product batches are processed for WATSON. The validation will
be updated to cover any new Products packaged in the same equipment
or facilities as those used for WATSON Products.
6.2 Computer System
SEARLE is responsible for ensuring that computer systems, which are
used for the packaging and/or laboratory testing of the batch, must
be validated. Validation protocols and reports shall be available
for WATSON for review on request.
7.0 STORAGE AND SHIPPING
SEARLE will ensure that during packaging, storage and shipping of the
Product that there is no possibility of deterioration, contamination or
admixture with any other materials. SEARLE will only ship goods to WATSON
warehouses or designated locations (listed in Attachment 2).
8.0 PERSONS FOR COMMUNICATION
7
Schedule 6.1 to Packaging Agreement
The persons to whom communication regarding Quality Control and Quality
Assurance matters between WATSON and SEARLE shall be identified.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
day and year set forth below.
WATSON LABORATORIES, INC. SEARLE & CO.
By: By:
------------------------------------ ---------------------------------
Name: Name:
----------------------------------- -------------------------------
Title: Title:
---------------------------------- ------------------------------
Date: Date:
---------------------------------- -------------------------------
8
Schedule 6.1 to Packaging Agreement
Attachment 1
- ---------------------------------------------------------------------------------------------------------------------
PRODUCT NDA/ANDA PRODUCT TESTING PACKAGING
- ---------------------------------------------------------------------------------------------------------------------
TRIVORA ANDA 74-538 X X
- ---------------------------------------------------------------------------------------------------------------------
LEVORA ANDA 73-592 X X
ANDA 73-594
- ---------------------------------------------------------------------------------------------------------------------
NOR-QD NDA 17-060 X
- ---------------------------------------------------------------------------------------------------------------------
BREVICON NDA 17-566 X X
NDA 17-743
- ---------------------------------------------------------------------------------------------------------------------
NORINYL 1+35 NDA 13-625 X X
NDA 16-659
- ---------------------------------------------------------------------------------------------------------------------
NORINYL 1+50 NDA 17-565 X X
- ---------------------------------------------------------------------------------------------------------------------
TRI-NORINYL NDA 18-977 X
- ---------------------------------------------------------------------------------------------------------------------
PLACEBO TABLETS
50 mg and
100 mg --------- X X
- ---------------------------------------------------------------------------------------------------------------------
9
Schedule 6.1 to Packaging Agreement
Attachment 2
CONTACT INFORMATION:
--------------------
WATSON LABORATORIES, INC.
Primary: Secondary:
Al Golfo Jeff Nornhold
- -------------------------------------------- ------------------------------------------
Name Name
Manager, Contract Manufacturing and Director, Contract Manufacturing and
- -------------------------------------------- ------------------------------------------
Business Alliance Quality Business Alliance Quality
- -------------------------------------------- ------------------------------------------
Title Title
311 Bonnie Circle, Corona CA 92880 311 Bonnie Circle, Corona CA 92880
- -------------------------------------------- ------------------------------------------
Address Address
909-493-5318 / agolfo@watsonpharm.com 909-493-5364 / jnornhol@watsonpharm.com
- -------------------------------------------- ------------------------------------------
Phone/eMail address Phone/eMail address
909-493-5819 909-493-5819
- -------------------------------------------- ------------------------------------------
Fax Number Fax Number
SEARLE & CO.
Primary: Secondary:
- -------------------------------------------- ------------------------------------------
- -------------------------------------------- ------------------------------------------
Compliance Advisor Quality & Compliance Team Leader
- -------------------------------------------- ------------------------------------------
Title Title
Calle Jardines #99 Calle Jardines #99
- -------------------------------------------- ------------------------------------------
Caguas, Puerto Rico 00725 Caguas, Puerto Rico 00725
- -------------------------------------------- ------------------------------------------
Address Address
787-746-6201 787-746-6201
- -------------------------------------------- ------------------------------------------
Phone Phone
787-286-4000 787-286-4000
- -------------------------------------------- ------------------------------------------
Fax Fax
WATSON DISTRIBUTION CENTERS:
----------------------------
Watson Laboratories, Inc. Watson Laboratories, Inc.
3400 W. Lake Avenue Mt. Ebo Corporate Park
Glenview, IL 60025 Route 22
Brewster, NY 10509
10
Schedule 6.1 to Packaging Agreement
Attachment 3
CERTIFICATE OF QUALITY
----------------------
Product: _________________________ Product Code: ____________________________
Lot Number: ______________________ Expiration Date: _________________________
Release Date: ____________________ Total Units Released: ____________________
I hereby certify that the above tested finished drug product packaged by SEARLE
was packaged in accordance with all requirements listed in WATSON's Product
Registration and in accordance with current Good Manufacturing Practices for
Finished Pharmaceuticals as specified under 21 Code of Federal Regulations,
Parts 210 and 211, United States of America.
- -----------------------------
Name
- -----------------------------
Title
- -----------------------------
Date
11
Schedule 6.1 to Packaging Agreement
Product: NORQD
QUALITY RESPONSIBILITIES
------------------------
Product: NORQD
Table 1. Quality Responsibilities for Searle and Watson
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Raw Material - Active Ingredient
... Specifications X
--------------
... Supply/procurement X
-----------
... Selection X
---------
... Test
... Sample Retention
... Investigations
. Initiate
--------
. Review X
. Approve X
... Vendor Audits X
-------------
... Vendor Certification Program X
----------------------------
- ----------------------------------------------------------------------------------------------------------------------------
Raw Material - Inert (1) NDA Related
... Specifications X(1)
--------------
... Supply/procurement
-----------
... Selection X
---------
... Test
... Sample Retention
... Investigations
. Initiate
--------
. Review X
. Approve X
... Vendor audits
-------------
... Vendor Certification Program
----------------------------
- ----------------------------------------------------------------------------------------------------------------------------
Mfg. Master Batch Record Watson may initiate changes.
... Issuance
. Initiate
. Approve X
... Change Control
. Initiate
. Approve X
- ----------------------------------------------------------------------------------------------------------------------------
Changes in Specification & Test Methods (1) NDA Related
--------------
(raw materials & bulk)
----
... Initiate X(1)
... Review X
... Approve X
- ----------------------------------------------------------------------------------------------------------------------------
Executed Batch Records (bulk)
... Storage
- ----------------------------------------------------------------------------------------------------------------------------
12
Schedule 6.1 to Packaging Agreement
Product: NORQD
- -------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Bulk Tablets
... Supply Samples for Testing
... Sample Retention
... Investigation
. Review X
. Approve X
- ----------------------------------------------------------------------------------------------------------------------------
Annual Product Review (bulk) /1/ Analytical Related
----
... Provide Data X /1/
... Review/Approve X
... Storage
- ----------------------------------------------------------------------------------------------------------------------------
In-Process Testing
... Physical
... Analytical, if applicable X
- ----------------------------------------------------------------------------------------------------------------------------
REPORTS
... Bulk tablet Drug listing X
... Product Drug listing X
- ----------------------------------------------------------------------------------------------------------------------------
Bulk Tablets *QAN to Watson
(Specification Testing)
... Supply Tablet Samples
... Test X
... Provide results to Watson X
... Disposition for Packaging X
... Investigation (Analytical)
. Conduct X
. Review X/*/ only X
. Approve X MRB's X
- ----------------------------------------------------------------------------------------------------------------------------
Packaging Components
... Specifications
. Establish X
. Change X
. Approve X
... Supply X
... Test X
... Disposition for Use X
- ----------------------------------------------------------------------------------------------------------------------------
Labeling
... Artwork/Approve X
... Master Labels
. Review X
. Approve X
... Printing/Approve for Use X
... Changes X
- ----------------------------------------------------------------------------------------------------------------------------
Packaging In-Process Testing
- ----------------------------------------------------------------------------------------------------------------------------
13
Schedule 6.1 to Packaging Agreement
Product: NORQD
- -------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Finished Product (Packaged)
... Specifications
. Establish X
. Change X
. Approve X
... Product Disposition for Shipment X
... Retained Samples
. Sampling X
. Storage X
- ----------------------------------------------------------------------------------------------------------------------------
Stability Samples
... Storage X
... Specifications/Methods/Protocol X
. Establish X X
. Change X X
. Approve X X
... Testing X
... Report to Watson X
- ----------------------------------------------------------------------------------------------------------------------------
Validation /1/ Packaging Related
(Plans/Protocols/Reports) /2/ Analytical Related
... Initiate X /1/ X /2/
... Approve X /1/ X /2/
... Execute X /1/ X /2/
... Final Approval X
- ----------------------------------------------------------------------------------------------------------------------------
Product Complaints /1/ Packaging Related
... Receipt X /2/ Analytical Related
... Investigation
. Initiate X /1/ X (2)
. Review X X (2)
. Approve X X (2)
. Respond to Complaints X
. Maintenance of Complaints Master File X
. Complaints Trend Analysis X
. Storage of Complaints samples X
. Product recall decision X
. Regulatory affairs X
X
- ----------------------------------------------------------------------------------------------------------------------------
Annual Product Review /1/ Packaging Related
... Compile Package X /1/ X /2/ /2/ Analytical Related
... Review/Approve X /1/ X /2/
... Storage X /1/
- ----------------------------------------------------------------------------------------------------------------------------
14
Schedule 6.1 to Packaging Agreement
Product: NORQD
- -------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Annual Report /1/ Packaging Related
... Provide Documents X /1/
... Submission X
- ----------------------------------------------------------------------------------------------------------------------------
15
Schedule 6.1 to Packaging Agreement
Product: Tri-Norinyl, Norinyls, Brevicon, Trivora
- --------
QUALITY RESPONSIBILITIES
------------------------
Products: Tri-Norinyl, Norinyls, Brevicon, Trivora
Table 1. Quality Responsibilities for Searle and Watson
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Raw Material - Active Ingredient
... Specifications X
--------------
... Supply/procurement X
-----------
... Selection X
---------
... Test
... Sample Retention
... Investigations
. Initiate
--------
. Review X
. Approve X
... Vendor audits X
-------------
... Vendor Certification Program X
----------------------------
- ----------------------------------------------------------------------------------------------------------------------------
Raw Material - Inert /1/ NDA Related
... Specifications X /1/
--------------
... Supply/Procurement X
-----------
... Selection
---------
... Test
... Sample Retention
... Investigations
. Initiate
--------
. Review X
. Approve X
... Vendor audits
-------------
... Vendor Certification Program
----------------------------
- ----------------------------------------------------------------------------------------------------------------------------
Mfg. Master Batch Record
... Issuance
. Initiate
. Approve X
... Change Control
. Initiate
. Approve X
- ----------------------------------------------------------------------------------------------------------------------------
16
Schedule 6.1 to Packaging Agreement
Product: Tri-Norinyl, Norinyls, Brevicon, Trivora
- --------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Changes in Specification & Test Methods /1/ NDA Related
--------------
(raw materials & bulk)
----
... Initiate X /1/
... Review X
... Approve X
- ----------------------------------------------------------------------------------------------------------------------------
Executed Batch Records (bulk)
----
... Storage
- ----------------------------------------------------------------------------------------------------------------------------
Bulk Tablets
... Supply Samples for Testing
... Sample Retention
... Investigation
. Review
. Approve
- ----------------------------------------------------------------------------------------------------------------------------
In-Process Testing
... Physical
... Analytical, if applicable X
- ----------------------------------------------------------------------------------------------------------------------------
Reports
... Bulk tablet Drug listing XX
... Product Drug listing
- ----------------------------------------------------------------------------------------------------------------------------
Bulk Tablets
... Supply tablet samples
... Test X
... Provide results to Watson X X
... Disposition for Packaging
... Investigation (Analytical)
. Conduct X
. Review X X
. Approve /*/only X
MRB's
- ----------------------------------------------------------------------------------------------------------------------------
Packaging Components Watson may initiate changes
... Specifications
. Establish X X
. Change X X
. Approve X X
... Supply X
... Test X
... Disposition for Use X
- ----------------------------------------------------------------------------------------------------------------------------
17
Schedule 6.1 to Packaging Agreement
Product: Tri-Norinyl, Norinyls, Brevicon, Trivora
- --------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Labeling Watson may initiate changes
... Artwork/Approve X
... Master Labels
. Review X X
. Approve X X
... Printing/Approve for Use X
... Changes X X
- ----------------------------------------------------------------------------------------------------------------------------
Packaging
In-Process Testing X
- ----------------------------------------------------------------------------------------------------------------------------
Finished Product (Packaged)
... Specifications
. Establish X X
. Change X X
. Approve X X
... Test X
... Results to Watson X
... Product Disposition for Shipment X
... Retained Samples
. Sampling X
. Storage X
- ----------------------------------------------------------------------------------------------------------------------------
Stability Samples
... Storage X
... Specifications/Methods/Protocol X
. Establish X X
. Change X X
. Approve X X
... Testing X
... Report to Watson X
- ----------------------------------------------------------------------------------------------------------------------------
Validation /1/ Packaging and Analytical
(Plans/Protocols/Reports)
... Initiate X /1/
... Approve X X /1/
... Execute X /1/
... Final Approval X X /1/
- ----------------------------------------------------------------------------------------------------------------------------
18
Schedule 6.1 to Packaging Agreement
Product: Tri-Norinyl, Norinyls, Brevicon, Trivora
- --------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Product Complaints /1/ Packaging
... Receipt X
... Investigation
. Initiate X /1/
. Review X X /1/
. Approve X X /1/
. Respond to Complaints X
. Maintenance of Complaints Master File X
. Complaints Trend Analysis X
. Storage of Complaints samples X
. Product recall decision X
. Regulatory affairs X
- ----------------------------------------------------------------------------------------------------------------------------
Annual Product Review /1/ Packaging
... Compile/Package X /1/
... Review/Approve X /1/
... Storage X /1/
- ----------------------------------------------------------------------------------------------------------------------------
Annual Report /1/ Packaging
... Provide Documents X /1/
... Submission X
- ----------------------------------------------------------------------------------------------------------------------------
19
Schedule 6.1 to Packaging Agreement
Product: Levora
- --------
QUALITY RESPONSIBILITIES
------------------------
Product: Levora
Table 1. Quality Responsibilities for Searle and Watson
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Raw Material - Active Ingredient
... Specifications X
--------------
... Supply/procurement X
-----------
... Selection X
---------
... Test
... Sample Retention
... Investigations
. Initiate
--------
. Review X
. Approve X
... Vendor audits X
-------------
... Vendor Certification Program X
----------------------------
- ----------------------------------------------------------------------------------------------------------------------------
Raw Material - Inert
... Specifications X
--------------
... Supply/procurement
-----------
... Selection X
---------
... Test
... Sample Retention
... Investigations
. Initiate
--------
. Review X
. Approve X
... Vendor audits X
-------------
... Vendor Certification Program X
----------------------------
- ----------------------------------------------------------------------------------------------------------------------------
Mfg. Master Batch Record
... Issuance
. Initiate
. Approve X
... Change Control
. Initiate
. Approve X
- ----------------------------------------------------------------------------------------------------------------------------
20
Schedule 6.1 to Packaging Agreement
Product: Levora
- --------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Changes in Specification & Test Methods
--------------
(raw materials & bulk)
------
... Initiate X
... Review X
... Approve X
- ----------------------------------------------------------------------------------------------------------------------------
Executed batch Records (bulk)
----
... Storage
- ----------------------------------------------------------------------------------------------------------------------------
Bulk Tablets
... Supply Samples for Testing
... Sample Retention
... Investigation
. Initiate
. Review X
. Approve X
- ----------------------------------------------------------------------------------------------------------------------------
Annual Product Review (bulk)
----
... Provide Data
... Review/Approve X
... Storage
- ----------------------------------------------------------------------------------------------------------------------------
In-Process Testing
... Physical
... Analytical, if applicable X
- ----------------------------------------------------------------------------------------------------------------------------
Annual Report
... Provide Data
----
... Submission X
- ---------------------------------------------------------------------------------------------------------------------------
Product Complaints (bulk) /1/ Packaging
... Receipt X
... Investigation
. Initiate X /1/
. Review X
. Respond to Complaints X
... Maintenance of Complaints Master File X
... Complaints Trend Analysis X
... Storage of Complaints samples X
... Product recall decision X
... Regulatory affairs X
- ----------------------------------------------------------------------------------------------------------------------------
21
Schedule 6.1 to Packaging Agreement
Product: Levora
- --------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Process & Cleaning Validation
(Master Plan/Protocols/Reports)
... Initiate
... Approve X
... Execute
... Final Approval X
- ----------------------------------------------------------------------------------------------------------------------------
Reports
... Bulk tablet Drug listing X
... Product Drug Listing X
- ----------------------------------------------------------------------------------------------------------------------------
Bulk Tablets
... Test X
... Provide Results to Watson X
... Disposition for Packaging X
... Investigation (Analytical)
. Conduct X
. Review X
. Approve X
- ----------------------------------------------------------------------------------------------------------------------------
Packaging Components
... Specifications
. Establish X X
. Change X X
. Approve X X
... Supply X
... Test X
... Disposition for Use X
- ----------------------------------------------------------------------------------------------------------------------------
Labeling
... Artwork/Approve X
... Master Labels
. Review X X
. Approve X X
... Printing/Approve for Use X
... Changes X X
- ----------------------------------------------------------------------------------------------------------------------------
Packaging In-Process Testing X
- ----------------------------------------------------------------------------------------------------------------------------
22
Schedule 6.1 to Packaging Agreement
Product: Levora
- --------
- ----------------------------------------------------------------------------------------------------------------------------
Description of task Watson Searle Comments
- ----------------------------------------------------------------------------------------------------------------------------
Finished Product (Packaged) * Only MRB's
... Specifications
. Establish X X
. Change X X
. Approve X X
... Test X
... Results to Watson X
... Product Disposition for Shipment X/*/
... Retained Samples
. Sampling X
. Storage X
- ----------------------------------------------------------------------------------------------------------------------------
Stability Samples
... Storage X
... Specifications/Methods/Protocol X
. Establish X X
. Change X X
. Approve X X
... Testing X
... Report to Watson X
- ----------------------------------------------------------------------------------------------------------------------------
Packaging/Cleaning/Method Validations
(Plans/Protocols/Reports)
... Initiate X
... Approve X
... Execute X
... Final Approval X
- ----------------------------------------------------------------------------------------------------------------------------
Product Complaints
... Receipt X
... Investigation
. Review X X
. Approve X X
. Respond to Complaints X
- ----------------------------------------------------------------------------------------------------------------------------
Annual Product Review Copy to Watson
... Compile Package X /1/ /1/ Packaging
... Review/Approve X X
... Storage X
- ----------------------------------------------------------------------------------------------------------------------------
Annual Report
... Provide Documents X
... Submission X
- ----------------------------------------------------------------------------------------------------------------------------
23
Schedule 6.1 to Packaging Agreement