EXHIBIT 10.13(c)
TOLL MANUFACTURING AND PACKAGING AGREEMENT
This Toll Manufacturing and Packaging Agreement (this "Agreement") is made
as of this 31st day of October, 2000, by and between Cephalon, Inc., 000
Xxxxxxxxxx Xxxxxxx, Xxxx Xxxxxxx, XX 00000-0000 ("CEPHALON") and Xxxxxx
Laboratories, 000 Xxxxxx Xxxx Xxxx, Xxxxxx Xxxx, XX 00000-0000 ABBOTT
("ABBOTT").
WHEREAS, CEPHALON holds certain rights to manufacture, market and sell in
the United States the pharmaceutical product, which is marketed and sold as
Gabitril(R);
WHEREAS, CEPHALON wishes to engage ABBOTT to formulate and package
Gabitril tablets in dosage form for subsequent commercial sale by CEPHALON in
the United States and for certain clinical and other purposes; and
WHEREAS, ABBOTT has suitable facilities and equipment and sufficient
qualified personnel to formulate and package commercial quantities of Gabitril
in dosage form, and is willing to provide such services on the terms and
conditions set forth below.
NOW, THEREFORE, the parties hereto, intending to be legally bound, agree
as follows:
I. DEFINITIONS
As used in this Agreement:
1.1 "Active Drug Substance" means the compound N-(4, 4-di
(3-methyl-2-thienyl) but-3-en-1-yl) nipecotic acid, which is more
commonly known as tiagabine having those specifications as set forth
on Schedule A hereto.
1.2 "Adverse Experience" or "AE" shall mean any unfavorable and
unintended change in the structure, function, or chemistry of the
body temporally associated with any use of a Product or of a
derivative thereof, whether or not the adverse experience is
considered to be related to the use of the Product, including but
not limited to any of the following: an unexpected side effect,
injury, toxicity or sensitivity reaction, which may include an
experience of unexpected incidence and severity; an adverse
experience occurring in the course of the use of a drug product in
professional practice; an adverse experience occurring in clinical
studies; an adverse experience occurring from drug overdose, whether
accidental or intentional; an adverse experience occurring from drug
abuse; an adverse experience occurring from drug withdrawal; and any
significant failure of expected pharmacological action.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
1.3 "Affiliate" means any corporation or other business entity which,
directly or indirectly, is controlled by, controls, or is under
common control with CEPHALON or ABBOTT. For this purpose, "control"
shall be deemed to mean ownership of fifty percent (50%) or more of
the stock or other equity of such entity.
1.4 "Commodities" means the raw materials necessary to package the
Product as set forth in Schedule A hereto.
1.5 "Components" means the raw material necessary to formulate the
Product as set forth in Schedule A hereto.
1.6 "Confidential Information" means all information, data, know-how and
all other business, technical and financial data disclosed hereunder
by one party or any of its Affiliates to the other party or any of
its Affiliates, except any portion thereof which:
(a) at the time of disclosure, is public knowledge;
(b) after disclosure, becomes public knowledge by publication or
otherwise, except by breach of this Agreement by the
recipient;
(c) the recipient can demonstrate by its written records was in
the recipient's possession at the time of such disclosure, and
which was not acquired, directly or indirectly, from the
disclosing party;
(d) is lawfully disclosed to the recipient on a non-confidential
basis by a third party who is not obligated to the disclosing
party or any other third party to retain such Confidential
Information in confidence;
(e) results from research and development by the recipient
independent of such disclosure as shown by competent evidence;
or
(f) is required to be disclosed by legal process; provided, in
each case the party so disclosing information timely informs
the other party and uses its reasonable efforts to limit the
disclosure and maintain confidentiality to the extent possible
and, if possible, permits the other party to attempt by
appropriate legal means to limit such disclosure.
Written Confidential Information shall be identified by the
disclosing party as being confidential by stamping the cover pages
of such information "Confidential." Confidential Information
disclosed orally, visually and/or in another tangible form shall be
identified by the disclosing party to the receiving
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
party as confidential at the time of such disclosure and confirmed
to the receiving party within thirty (30) days after such disclosure
in a writing marked "Confidential."
1.7 "Net Sales" means the gross invoice price of Product actually billed
in the Territory by CEPHALON, a CEPHALON Affiliate or a CEPHALON
sublicensee to independent third party customers less: (i) any
direct or indirect credits and allowances or adjustments granted to
customers including, without limitation, credits and allowances on
account of price adjustments or on account of rejection or return of
Product previously sold; (ii) any trade and cash discounts, rebates
and distributor fees; (iii) any sales, excise, turnover or similar
taxes and any duties and other governmental charges imposed upon the
production, importation, use or sale of the Product; and (iv)
applicable transportation, insurance and handling charges.
1.8 "Product" means Gabitril in final packaged dosage forms meeting the
Product specifications set forth in Schedule A hereto.
1.9 "Quality Manual" means the form of quality assurance/quality control
agreement to be entered into by CEPHALON and ABBOTT as set forth in
Schedule B
110. "Territory" means the United States of America, including Puerto
Rico and the territories and possessions of the United States of
America.
1.11 "Trademark" or "Trademarks" shall mean Gabitril(R), as well as any
other trademark owned or used by CEPHALON in connection with the
Product, including, but not limited to, those trademarks listed on
Schedule A hereto.
II. APPOINTMENT AND TERM
2.1 Appointment. CEPHALON hereby appoints ABBOTT, and ABBOTT hereby
accepts appointment, as a toll manufacturer to formulate and package
the Product.
2.2 Manufacturing and Packaging Services. During the term of this
Agreement, ABBOTT shall formulate Product, and prepare the Product
for CEPHALON commercial sale to customers and for clinical and other
purposes. In addition, ABBOTT shall label and package Product in
accordance with those specifications and instructions set forth in
Schedule A hereto, or otherwise as may be provided by CEPHALON and
reasonably agreed to by ABBOTT in writing. CEPHALON will supply
approved artwork for labels, package inserts and packaging. The
content of the labels, package inserts and packaging shall be the
sole and exclusive responsibility of CEPHALON. Notwithstanding the
above, until XXXXXX'x existing stock of Product is depleted, but for
no longer than One Hundred Eighty (180) days from the effective date
of this Agreement, Abbott shall
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
continue to use the existing labeling for the Product which has
XXXXXX'x name and logo on Product for sale and XXXXXX'x and
CEPHALON's name and logo on Product for samples. As soon as
practical after the depletion of such existing Product, Abbott shall
label and package the Product as described above.
2.3 Cooperation. CEPHALON and ABBOTT will cooperate with each other as
may be necessary and customary in consideration of industry
practice, and will disclose all material information necessary to
enable each other to perform under this Agreement in a timely
fashion.
2.4 Specific Duties. In addition to its general obligations relating to
formulating and packaging, ABBOTT shall perform the following
services at XXXXXX'x cost, except where indicated:
(i) placing orders for, acquiring and storing all Active Drug
Substance, Commodities and Components;
(ii) quality control and testing of all Active Drug Substance,
Commodities and Components, in process materials, bulk tablets
and finished dosage Product, in order to monitor compliance
with all applicable standards and specifications required by
this Agreement, including any Schedules hereto;
(iii) conducting stability testing of Product in accordance with the
procedures set forth in the Quality Manual;
(iv) summarizing implemented changes and supplying latest versions
of approved critical documentation, and providing other
information necessary for CEPHALON to prepare, submit, obtain
and maintain all regulatory filings relating to the
manufacture of the Product under the terms of this Agreement;
and
(v) performing such other services as agreed upon in writing by
the parties.
2.5 Term. Unless terminated in accordance with the provisions of Article
XXIII, this Agreement will become effective and remain in effect for
a period of five (5) years from the Effective Date as defined in
that certain Gabitril Product Agreement (the "Gabitril Agreement")
by and between ABBOTT and CEPHALON dated as of October 31, 2000 (the
"Initial Term"), and, unless either party gives written notice of
non-renewal at least one hundred eighty (180) days prior to the end
of the Initial Term (or any renewal term), this Agreement shall be
renewed for consecutive terms of two years.
III. PRODUCT QUANTITY, QUALITY AND MANUFACTURING PROCESSES
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
3.1 Quantity. Subject to the terms and conditions of this Agreement,
ABBOTT will manufacture, package and supply to CEPHALON quantities
of Product ordered by CEPHALON or an Affiliate thereof for
subsequent sale by CEPHALON or an Affiliate or sublicensee thereof
or for certain clinical or other purposes in the Territory. ABBOTT
agrees to reserve capacity for the quantities of Product as defined
in Schedule X. XXXXXX shall have no obligation to supply quantities
in excess of those set forth in Schedule C, but shall use its
commercially reasonable efforts to accommodate CEPHALON demand for
excess quantities. ABBOTT agrees to supply CEPHALON with samples of
Product in the amounts set forth in Schedule C.
3.2 Quality. All Product manufactured and packaged by ABBOTT for
CEPHALON under this Agreement will meet the Product, Component and
Commodities specifications set forth in Schedule A hereto (the
"Specifications"), as well as the quality assurance standards
established in the Quality Manual. Such Specifications, as well as
the terms and conditions of the Quality Manual , are subject to
modification from time to time by mutual written agreement of the
parties. Prior to implementation of any Specification changes, the
Parties agree to negotiate in good faith in an attempt to reach
agreement on (a) the new price for any Product manufactured
hereunder by ABBOTT which embodies such changes, based solely on the
effect of such changes on XXXXXX'x manufacturing costs for the
Product and (b) any other amendments to this Agreement which may be
necessitated by such changes (i.e., an adjustment to the lead time
for purchase orders). CEPHALON agrees to reimburse ABBOTT for the
reasonable, documented expenses incurred by ABBOTT as a result of
such changes, including, but not limited to, reimbursing ABBOTT for
its validation and development costs, capital expenditure costs and
costs for any packaging components or other materials and in-process
materials rendered unusable as a result of such changes. If during
the term of this Agreement CEPHALON amends or is required by law to
amend the Specifications so as to render Active Drug Substance,
Commodities and/or Components or in-process materials for the
Product obsolete, CEPHALON shall purchase from ABBOTT, [**], that
amount of inventory of Active Drug Substance, Commodities and/or
Components, in-process materials and/or Product, as the case may be,
so rendered obsolete.
3.3 Manufacturing Processes. ABBOTT has furnished to CEPHALON a copy of
its production procedures and in the Quality Manual the parties will
agree upon the equipment to be used to produce the Product. Costs
incurred by ABBOTT as a result of any such changes or modifications
requested by the FDA or by CEPHALON and relating solely to the
production of the Product will be borne by CEPHALON; costs for other
changes affecting XXXXXX'x cGMP compliance or affecting other
products generally will be borne by ABBOTT.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
3.4 Documentation. ABBOTT shall provide CEPHALON with initial methods
and specifications for manufacturing and packaging the Product as
set forth in the attached Schedule X. XXXXXX shall also promptly
provide CEPHALON with all available safety data and information
concerning the Product, process and related materials, including
without limitation all MSDS's.
3.5 Communication. ABBOTT and CEPHALON will respond to requests for
support, information and approvals within [**] days. If a complete
response is not possible within such [**] period, the party owing
the response shall communicate within such [**] period the reason
for the delay and when the response will be available.
3.6 Quality Manual. Within sixty (60) days after the date of this
Agreement, representatives of the parties' Quality Assurance
departments shall meet to develop, agree and approve a Quality
Manual outlining responsibilities and key contacts for quality and
compliance related issues. ABBOTT will provide CEPHALON with certain
production and control information for review prior to release as
specified in the Quality Manual. The Quality Manual will also
address, without limitation, annual product reviews, returned goods,
regulatory audits, compliance with FDA current Good Manufacturing
Practices, and such other quality related concerns deemed
appropriate. The final agreed Quality Manual will use the form
attached to this Agreement as Schedule B as a template and will be
attached to and deemed a part of this Agreement when completed.
IV. CONFIDENTIAL INFORMATION
4.1 The parties acknowledge that they have provided Confidential
Information to each other in connection with the formulation and
packaging of the Product, and further acknowledge that all such
Confidential Information (as well as any additional Confidential
Information provided by one party to the other hereunder) shall be
subject to the provisions of this Article V. Any and all
information, knowledge, technology, and trade secrets relating to
the Product and provided by CEPHALON shall be deemed Confidential
Information.
4.2 ABBOTT will disclose to CEPHALON all Confidential Information
concerning the Product developed by or for ABBOTT during the term of
this Agreement, promptly as it is developed.
4.3 During the term of this Agreement and for [**] thereafter, all
Confidential Information disclosed or confirmed in writing and
designated as confidential by the disclosing party, shall be held in
confidence by the receiving party, shall not be used by the
receiving party for any purpose except as provided hereunder and
shall not be disclosed to third parties except for disclosure to its
Affiliates or
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
governmental authorities, or except as otherwise necessary to carry
out the receiving party's obligations under this Agreement. If a
receiving party finds it necessary to disclose such Confidential
Information to a third party, the receiving party will not do so
without first obtaining the written consent of the disclosing party
(which shall not be unreasonably withheld) and entering into an
agreement with the third party which binds the third party to the
same obligations of restricted use and disclosure as are undertaken
by the parties in this Agreement.
4.4 Neither party shall distribute any Confidential Information of the
other except to its employees or agents who have a need to know in
connection with the performance of their duties in satisfying the
obligations of such party hereunder. Any employee or agent who
receives Confidential Information shall be advised as to the
confidential nature thereof and the prohibitions contained herein.
All copies of any portions of any Confidential Information
distributed as provided in this section will be identified as
confidential. Upon termination of this Agreement, and upon the
request of the disclosing party, the receiving party shall return or
destroy all such Confidential Information and any copies thereof in
its possession, except that each party may retain one copy of
Confidential Information solely for archival purposes.
4.5 Termination of this Agreement shall not operate to extinguish either
party's obligation to treat Confidential Information as provided
herein, and the same shall continue in effect in accordance with
this Article for [**] from the termination or expiration of this
Agreement with respect to such Confidential Information.
4.6 Nothing contained herein shall be deemed to grant either party,
either expressed or implied, a license or other right or interest in
the Confidential Information of the other or in any patent,
trademark or other similar property of the other, except as
expressly provided hereunder.
4.7 Neither party shall use the name of the other, nor disclose the
existence of this Agreement for any purpose, without the prior
written consent of the other, which shall not be unreasonably
withheld or delayed.
V. ACTIVE AND COMPONENT SUPPLY
5.1 Active Drug Substance, Commodities and Components. ABBOTT will
obtain at its expense Active Drug Substance, Commodities and
Components which meets the specifications established in Schedule X.
XXXXXX assumes full responsibility and liability for the storage and
handling of all Active Drug Substance, Commodities and Components.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
5.2 Commodities. ABBOTT will label and package the Product in accordance
with instructions and specifications provided by CEPHALON. ABBOTT
will submit to CEPHALON for CEPHALON's approval, which shall not be
unreasonably withheld or delayed, artwork proofs of all labels,
package inserts and packaging prior to use by ABBOTT.
VI. FORECASTS AND ORDERS
6.1 Orders and Forecasts. Upon the execution of this Agreement, ABBOTT
shall deliver to CEPHALON or CEPHALON's designee an approximately
[**] supply (based on historical usage) of Product, including
samples. At the same time, CEPHALON shall provide ABBOTT with a
purchase order with CEPHALON's Product requirements, including
samples for the [**] period commencing with the month which contains
the effective date of this Agreement. CEPHALON shall also provide a
forecast of its requirements for Product, including samples, for an
additional [**] period following the initial [six (6) month] period.
The [**] forecast shall represent CEPHALON's reasonable estimates
only, not purchase orders, to facilitate XXXXXX'x planning.
6.2 Forecasts Changes and Forecast Updates. On or before the [**] of
each month thereafter, CEPHALON shall provide ABBOTT with an
additional [**] purchase order to supplement the remaining [**] of
firm purchase orders, thereby establishing a new [**] period of
purchase orders, and shall provide an updated forecast of its
estimated requirements of Product for the [**] succeeding such new
[**] period of firm purchase orders. Provided CEPHALON's purchase
orders do not exceed XXXXXX'x reserve capacity set forth in Schedule
E, ABBOTT shall accept all CEPHALON purchase orders and shall supply
CEPHALON in accordance with them. CEPHALON can increase or decrease
its firm order quantities with XXXXXX'x prior agreement and ABBOTT
can adjust its shipping quantities with CEPHALON's prior agreement.
Both parties shall use their commercially reasonable efforts to
accommodate reasonable change requests from the other.
VII. PRICE, SHIPMENT AND PAYMENT
7.1 XXXXXX'x Responsibilities. ABBOTT will properly prepare the Product
so that it may be lawfully and safely shipped to CEPHALON or its
designee in the United States. ABBOTT will prepare and execute all
reasonably necessary shipping documents, consisting of Packing List,
Dangerous Goods Declaration, and MSDS. CEPHALON will choose the
carrier by indicating the same on its purchase order provided to
ABBOTT.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
7.2 Terms of Shipment. ABBOTT will ship Product F.O.B. XXXXXX'x
facility. Shipment shall be made by common carrier designated by
CEPHALON to the shipping point designated by CEPHALON. If CEPHALON
does not designate a common carrier, Abbott may select the common
carrier. Risk of loss shall pass from ABBOTT to CEPHALON when the
Product is delivered to the common carrier. All transport costs will
be borne by CEPHALON.
7.3 Price. ABBOTT shall invoice CEPHALON a toll fee for all Product
(except samples and titration packs) delivered at a transfer price
equal to [**]. The parties agree that until Cephalon has sold the
Product [**], the toll fee payable hereunder shall be as set forth
in Schedule D. For samples of Product, including titration packs,
ABBOTT shall invoice CEPHALON at a [**].
7.4 Terms of Payment. CEPHALON will pay ABBOTT the toll fee within
thirty (30) days after the date on which CEPHALON receives said
invoice from ABBOTT, together with copies of all documentation
required for Product release as provided in the Quality Manual. Late
payments shall bear interest at the rate of 1 1/2 % per month, or if
less, the highest rate permitted under applicable law.
7.5 Audit. ABBOTT and its Affiliates and CEPHALON and its Affiliates
will maintain complete and accurate books and records in sufficient
detail to enable verification of the Net Sales and other costs
hereunder. Upon reasonable prior notice, each party )or its
independent public accountants) shall have access to relevant books
and records of the other party to conduct a review or audit thereof.
Such access shall be available during normal business hours for a
period of two (2) years after the termination of this Agreement.
VIII. INSPECTION AND ANALYSIS
8.1 Inspection by XXXXXX. XXXXXX will analyze each Product lot for
compliance with the Specifications set forth in Schedule X. XXXXXX
will send to CEPHALON a certificate of analysis and a certificate of
release (together with any other documentation required under the
Quality Manual ) prior to, or together with, each shipment of
Product. In this regard, ABBOTT agrees to retain all records and
documents necessary to fulfill the requirements established by all
applicable regulatory agencies.
8.2 Inspection by CEPHALON. CEPHALON or its authorized representative
will inspect all shipments upon their receipt and will report any
reasonably discernible defects in the Product to ABBOTT [**]. Any
defects not reasonably discernible will be reported to ABBOTT by
CEPHALON [**].
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
8.3 Non-Conforming Product. If any Product does not meet the warranties
set forth in Section 10, as determined by CEPHALON's testing and
inspection of the Product, then solely at its option CEPHALON may,
as its sole remedy, either (i) require that ABBOTT remanufacture or
repackage (as appropriate) said Product at no charge to CEPHALON and
pay all round-trip shipping charges to and from the destination of
the original shipment, or (ii) be relieved of any obligation to pay
ABBOTT the toll fees otherwise payable for the manufacture of said
Product, and ABBOTT shall reimburse CEPHALON for the reasonable
costs incurred by CEPHALON in properly disposing of such
non-conforming Product. Any notice given hereunder shall specify the
manner in which the Product fails to conform to the purchase order
therefor or fails to meet such warranty or the Specifications. If it
is determined that the nonconformity (a) is due to damage to the
Product (i) caused by CEPHALON or its agents or (ii) which occurs
subsequent to delivery of such Product to the carrier at the point
of origin, ABBOTT shall have no liability to CEPHALON with respect
thereto and CEPHALON shall pay for such Product in accordance with
the terms of this Agreement.
8.4 Independent Testing. If CEPHALON notifies ABBOTT that any Product
does not meet the warranties in Section 10, and ABBOTT does not
agree with CEPHALON's position, the parties will attempt to reach a
mutually acceptable resolution of the dispute. If they are unable to
do so after a reasonable period of time (such period not to exceed
one month from the date of original notification), the matter will
be submitted to an independent testing laboratory acceptable to both
parties. Both parties will accept the judgment of the independent
laboratory. The cost of such testing will be borne by the party
whose position is determined to have been in error. If the Product
is determined by said independent laboratory to have been
conforming, then the provisions of Section 8.3 hereof shall not
apply, and CEPHALON shall not be relieved of its obligations to pay
ABBOTT for the production of such Product.
IX. REGULATORY MATTERS; REGULATORY FILINGS AND APPROVALS
General. ABBOTT shall be responsible for obtaining and maintaining
all site licenses for the manufacture of the Product and shall
comply on behalf of CEPHALON with other applicable regulations
promulgated by, but not limited to, the Food and Drug Administration
("FDA") in connection with XXXXXX'x manufacture of the Product.
X. REPRESENTATIONS AND WARRANTIES
10.1 General. ABBOTT represents and warrants to CEPHALON that (i) it has
and will maintain throughout the pendency of this Agreement, the
expertise, with respect to personnel and equipment, to fulfill the
obligations established hereunder, and has
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
obtained all requisite material licenses, authorizations and
approvals required by federal, state or local government authorities
including, but not limited to, the FDA, Environmental Protection
Agency ("EPA"), Occupational Safety and Health Administration
("OSHA"), etc. to manufacture the Product; (ii) the production
facility, equipment and personnel to be employed to formulate and
package the Product will be qualified to manufacture product
according to current Good Manufacturing Practices ("cGMP") at the
time each such batch of Product is produced, and that the production
facility to be employed is in compliance with all applicable
material laws and regulations; (iii) there are no pending or
uncorrected citations or adverse conditions noted in any inspection
of the production facility to be employed which would cause the
Product to be misbranded or adulterated within the meaning of the
federal Food, Drug and Cosmetic Act, as amended; (iv) the execution,
delivery and performance of this Agreement by XXXXXX does not
conflict with, or constitute a breach of any order, judgment,
agreement, or instrument to which XXXXXX is a party; (v) the
execution, delivery and performance of this Agreement by XXXXXX does
not require the consent of any person or the authorization of (by
notice or otherwise) any governmental or regulatory authority (other
than those relating to the granting of approval to commercialize the
Product); and (vi) ABBOTT has not been debarred by the United States
Food and Drug Administration under the Generic Drug Enforcement Act
of 1992 (or by any analogous agency or under any analogous law or
regulation), and neither it nor, to its knowledge, any of its
officers or directors has ever been convicted of a felony under the
laws of the United States for conduct relating to the development or
approval of a drug product or relating to the marketing or sale of a
drug product, and further, to its knowledge, that no individual or
firm debarred by any governmental authority will participate in the
performance, supervision, management or review of the production of
Product supplied to CEPHALON under this Agreement. CEPHALON
represents and warrants to XXXXXX that (i) the execution, delivery
and performance of this Agreement by CEPHALON does not conflict
with, or constitute a breach of any order, judgment, agreement, or
instrument to which CEPHALON is a party; and (ii) the execution,
delivery and performance of this Agreement by CEPHALON does not
require the consent of any person or the authorization of (by notice
or otherwise) any governmental or regulatory authority (other than
those relating to the granting of approval to commercialize the
Product).
10.2 Manufacturing Warranty. XXXXXX warrants that all Products supplied
to CEPHALON will be manufactured in accordance with cGMPs and the
Quality Manual in effect at the time of manufacture.
10.3 Product Warranty. XXXXXX hereby warrants that all Product delivered
to CEPHALON (i) will not be adulterated, misbranded, or otherwise
prohibited within the meaning of any national, state or local law or
regulation in the
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Territory, (ii) have a current shelf life of not less than [**]
months; and (iii) will conform to Specifications as established in
Schedule A hereto.
10.4 Warranty Disclaimer. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT,
EACH PARTY EXPRESSLY DISCLAIMS ANY WARRANTIES, INCLUDING ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE..
XI. QUALITY CONTROL, RECORDS AND INSPECTIONS
11.1 Product and Component Samples. XXXXXX will maintain a sample of each
chemical component (including Active Drug Substance) as required by
applicable regulatory standards or as otherwise mutually agreed by
CEPHALON and XXXXXX. XXXXXX will be responsible for maintaining
retention samples of the Product as may be required by applicable
regulatory standards.
11.2 Validation. XXXXXX will validate all process, methods, equipment,
utilities, facilities and computers used in the formulation,
packaging, storage, testing and release of Product in conformance
with all applicable laws and regulations. CEPHALON will have the
right to review the results of said validation upon request.
11.3 Quality Compliance. XXXXXX will provide CEPHALON with timely
notification of all significant deviations, notes to file, and other
deficiencies that may reasonably be expected to impact the quality
of the Product, as well as all FDA reports regarding testing,
manufacture, packaging or labeling of the Product.
11.4 Manufacturing Records. XXXXXX will maintain complete and accurate
records relating to the Product and the manufacture, packaging,
labeling and testing thereof for the period required by applicable
regulatory standards, and XXXXXX shall provide copies thereof to
CEPHALON upon CEPHALON's request. The records shall be subject to
audit and inspection under this Article XI.
11.5 Batch Records. Records which include the information relating to the
manufacturing, packaging and quality operation for each lot of
Product will be prepared by XXXXXX at the time such operations
occur. XXXXXX will prepare such records in accordance with cGMP's,
the Specifications and the Quality Manual.
11.6 Records Retention. XXXXXX will retain records and documents for
periods meeting all applicable regulations of the FDA.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
11.7 Regulatory Inspections. XXXXXX will promptly inform CEPHALON of any
contact, inspection or audit by any governmental agency (other than
EPA and OSHA inspections), related to or affecting the Product
(other than contacts, inspections or audits affecting products
generally). XXXXXX will promptly provide CEPHALON with copies of any
government-issued inspection observation reports (including without
limitation FDA Form 483s and equivalent forms from other regulatory
bodies) and agency correspondence, that may reasonably be expected
to adversely affect the Product. XXXXXX and CEPHALON will cooperate
in resolving any concerns with any governmental agency. XXXXXX will
also inform CEPHALON of any action taken by any governmental agency
against XXXXXX or any of its officers and employees which may
reasonably be expected to adversely affect the Product or XXXXXX'x
ability to supply Product hereunder within 24 hours after the action
is taken.
11.8 CEPHALON Inspections. CEPHALON employees or CEPHALON authorized
representatives will have the right during normal business hours, at
reasonable intervals and on reasonable prior notice, to conduct [**]
inspection per [**], at CEPHALON's sole expense, of XXXXXX'x
facilities used in the manufacturing, packaging, storage, testing,
shipping or receiving of Product Commodities and Components. All
such employees and representatives shall be qualified to conduct
such inspections, shall be escorted by XXXXXX employees or
representatives at all times while at XXXXXX'x facility, shall be
bound by the same confidentiality obligations as contained herein,
and shall abide at all times with XXXXXX'x rules and regulations,
including without limitation safety rules and regulations. Such
inspections may include GMP inspections and system audits. Persons
conducting such inspections will have access only to documents,
records, reports, data, procedures, facilities, regulatory
submissions, and all other information required to be maintained by
applicable government regulations relating directly to the Product.
XXXXXX shall take appropriate actions to adopt reasonable
suggestions of CEPHALON to correct any deficiencies identified by
such inspection or audit. In addition, CEPHALON shall have the right
to observe from time to time the manufacture, packaging and quality
control testing of the Product by XXXXXX. No testing of the Product
by CEPHALON and no inspection or audit by CEPHALON of the XXXXXX
production facility under this Agreement shall operate as a waiver
of or otherwise diminish XXXXXX'x responsibility with respect to
Product quality under this Agreement. The duration of an audit will
be limited to no more than [**] (audits that last over [**] will be
charged at XXXXXX'x specified FTE rates), and audits may not
interfere with XXXXXX'x normal operations.
XII. COMPLAINTS, ADVERSE EXPERIENCES AND RECALLS
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
12.1 Product Complaints and AE's. CEPHALON shall maintain complaint files
with respect to the Product in accordance with cGMPs. XXXXXX will
promptly notify CEPHALON by facsimile transmission of all Product
complaints and AEs received by XXXXXX within [**] days of its
receipt thereof. All such notices shall be sent to the attention of
the Director, Medical Affairs at CEPHALON, facsimile number (610)
738-6313. CEPHALON shall promptly provide XXXXXX with copies of any
complaints received by CEPHALON relating to the manufacture or
packaging of the Product. CEPHALON shall have responsibility for
responding to all complaints, and for promptly providing XXXXXX with
a copy of any responses to complaints relating to the manufacture or
packaging of the Product. CEPHALON or its affiliates shall have
responsibility for reporting all complaints relating to the Product
to the FDA and any other regulatory authorities, including, but not
limited to, complaints relating to the manufacture or packaging of
the Product as well as adverse experience (AE) reports. CEPHALON
will correspond with complainants as to any complaints associated
with Product, whether received during or after the term hereof.
XXXXXX will assist CEPHALON in investigating Product complaints
relating to the manufacture or packaging of the Product by analyzing
Product, manufacturing processes and components to determine the
nature and cause of an alleged Product manufacturing defect or
alleged Product failure. XXXXXX will also assist CEPHALON in the
investigation of any Adverse Experience (AE) reported to either
party when such AEs are reasonably believed to be attributable to
the manufacture or packaging of the Product. If CEPHALON determines
that any reasonable physical, chemical, biological or other
evaluation should be conducted in relation to an AE or Product
complaint relating to the manufacture or packaging of the Product,
XXXXXX will conduct the evaluation and provide CEPHALON with a
written report of such evaluation within thirty (30) days from
receipt of CEPHALON's written request for same, together with
samples of the Product from the relevant lot.
12.2 Recall Action. If CEPHALON should elect or be required to initiate a
Product recall, withdrawal or field correction because of (i) supply
by ABBOTT of Product that does not conform to the Specifications and
warranties established by this Agreement or (ii) the negligent or
intentional wrongful act or omission of ABBOTT, CEPHALON will notify
ABBOTT and provide ABBOTT a copy of its recall letter prior to
initiation of the recall. ABBOTT will assist CEPHALON (and its
designated Affiliate) in an investigation to determine the cause and
extent of the problem. All regulatory authority contacts and
coordination of any recall activities will be initiated by, and will
be the sole responsibility of, CEPHALON.
12.3 Recall Expenses. If any Product is recalled as a result of (i)
supply by ABBOTT of Product that does not conform to the warranties
contained in Sections 10.1, 10.2 and 10.3 hereof or (ii) the
negligent or intentional wrongful act or omission
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
of ABBOTT, then ABBOTT will bear all reasonable costs and expenses
of such recall. Recalls for any other reason will be at CEPHALON's
sole expense. Notwithstanding the foregoing or any other provision
of this Agreement, XXXXXX'x aggregate liability with regard to
Product recalls shall not exceed the amount of consideration
received by ABBOTT from CEPHALON hereunder.
12.4 Recall Records. ABBOTT will maintain complete and accurate records
for such periods as may be required by applicable law or regulation.
XIII. INSURANCE
13.1 During the term hereof, XXXXXX shall maintain product
liability/completed operations insurance, providing coverage of not
less than [**] per occurrence and in the aggregate, insuring XXXXXX
against all costs, fees, judgments, and liabilities arising out of
or alleged to arise out of its obligations and representations and
warranties under this Agreement. In addition, XXXXXX will maintain
at all times sufficient property casualty insurance to cover the
total quantity of Active Drug Substance and Product on hand at its
full cost of replacement. XXXXXX will provide to CEPHALON, upon
request, evidence of such insurance coverages. XXXXXX further agrees
to cause such policies to name CEPHALON as an additional insured at
no cost to CEPHALON.
13.2 During the term hereof, CEPHALON agrees to maintain, and upon
request, to provide evidence of product liability insurance for and
providing coverage of not less than [**] per occurrence and in the
aggregate providing a defense for and insuring CEPHALON against all
costs, fees, judgments and liabilities arising out of or alleged to
arise out of its obligations and representations and warranties
under this Agreement. CEPHALON will provide to XXXXXX, upon request,
evidence of such insurance coverages. CEPHALON further agrees to
cause such policies to name XXXXXX as an additional insured at no
cost to XXXXXX.
XIV. TRADEMARKS
14.1 XXXXXX shall have the non-exclusive right to use the Trademarks in
packaging the Product in connection with fulfilling its obligations
hereunder. The rights granted XXXXXX hereunder to use the Trademarks
shall in no way affect CEPHALON's ownership of such Trademarks. No
other right, title or interest in the Trademarks is established
hereby, and nothing herein shall be construed to grant any right or
license to XXXXXX to use the CEPHALON trademark or the name
CEPHALON, other than as specifically set forth herein.
14.2 XXXXXX will only market the Product using the relevant Trademarks as
listed in Schedule A during the term of this Agreement. Upon
termination of this
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Agreement, XXXXXX will cease all use of the Trademarks and cancel
any license to such Trademarks granted hereunder.
14.3 XXXXXX will use the Trademarks in strict accordance with the
instructions given by CEPHALON, and shall refrain from making any
changes in connection therewith without first obtaining CEPHALON's
written consent.
14.4 In the event of any claim or litigation by a third party against
XXXXXX alleging that any of the Trademarks imitates or infringes a
trademark of such third party or is invalid, XXXXXX shall promptly
give notice of such claims or litigation to CEPHALON and CEPHALON
shall assume responsibility for and control of the handling,
defense, or settlement thereof. XXXXXX shall cooperate fully with
CEPHALON during the pendency of any such claim or litigation, at
CEPHALON's expense. CEPHALON shall keep XXXXXX notified of the
current status of any trademark claim, litigation or infringement of
any of the Trademarks and shall permit XXXXXX to assume the
handling, defense or settlement thereof if CEPHALON declines to do
so, at XXXXXX'x expense. CEPHALON may at any time modify, adopt or
withdraw from use any Trademark without any liability to XXXXXX.
XV. INVENTIONS
Any inventions, discoveries, improvements, or trade secrets made by XXXXXX
in the performance of this Agreement as they may specifically relate to the
Product or its manufacture (including any new use or any change in the method of
producing, testing or storing the Product) shall be owned by CEPHALON, and
XXXXXX shall have a non-exclusive, perpetual, royalty-free worldwide license to
use any such invention, discovery, improvement, or trade secret. XXXXXX shall
execute such instruments as shall be required to evidence or effectuate the
other party's ownership of any such inventions, and shall cooperate upon
reasonable request (and at the expense of the requesting party) in the
prosecution of patents and other intellectual property rights related to any
such invention.
XVI. INDEMNIFICATION
16.1 By XXXXXX. XXXXXX will indemnify and hold CEPHALON, its Affiliates,
directors, officers, employees, agents, successors, and assigns
harmless from any and all liability, damage, loss, cost, or expense
(including reasonable attorneys' fees) arising out of third-party
claims, which arise from i) XXXXXX'x breach of any of the
warranties, and representations contained in Article X hereof, or
ii) XXXXXX'x negligence or other willful misconduct. .
16.2 By CEPHALON. CEPHALON will indemnify and hold XXXXXX, its
Affiliates, directors, officers, employees, agents, successors, and
assigns harmless from any
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
and all liability, damage, loss, cost, or expense (including
reasonable attorneys' fees) arising out of third party claims
relating to this Agreement, other than that arising from i) XXXXXX'x
breach of any of the warranties and representations contained in
Article X hereof or ii) XXXXXX'x negligence or other willful
misconduct.
16.3 By Each Party. In the event that negligence or willful misconduct of
both XXXXXX and CEPHALON contribute to any such loss, damage, claim,
injury, cost or expense, XXXXXX and CEPHALON will each indemnify and
hold harmless the other with respect to that portion of the loss,
damage, claim, injury, cost or expense attributable to its
negligence or willful misconduct.
16.4 Procedures. In the event that one party receives notice of a claim,
lawsuit, or liability for which it is entitled to indemnification by
the other party, the party receiving notice shall give prompt
notification to the indemnifying party. The party being indemnified
shall cooperate fully with the indemnifying party throughout the
pendency of the claim, lawsuit or liability, and the indemnifying
party shall have complete control over the conduct and disposition
of the claim, lawsuit, or liability including the retention of legal
counsel engaged to handle such matter. The indemnifying party
hereunder will not be liable for any costs associated with the
settlement of any claim or action brought against it or the other
party unless it has received prior notice of the settlement
negotiations and has agreed to the settlement.
XVII. LIMITATION OF LIABILITY
IN NO EVENT SHALL XXXXXX OR CEPHALON BE LIABLE TO THE OTHER FOR ANY
SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING IN ANY WAY OUT OF
THE MANUFACTURE AND SUPPLY OF THE PRODUCT TO THE OTHER HOWEVER CAUSED AND BASED
ON ANY THEORY OF LIABILITY; PROVIDED HOWEVER, THIS LIMITATION SHALL NOT APPLY TO
THIRD PARTY CLAIMS FOR WHICH THE OTHER PARTY IS INDEMNIFIED HEREUNDER.
XVIII. CEPHALON SUPPLY OF PRODUCT TO XXXXXX
Upon the termination of this Agreement, Cephalon agrees to negotiate in
good faith with Xxxxxx with respect to CEPHALON supplying XXXXXX, XXXXXX
Affiliates and XXXXXX sublicensees with their respective requirements of Product
and samples for sale, distribution and use outside of the Territory. This
provision shall survive the termination of this Agreement.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
XIX. TERMINATION
19.1 Without Cause. Either party may terminate this Agreement, effective
on the [**] anniversary of the date hereof or on subsequent [**]
anniversary date(s), if applicable, by giving [**] prior written
notice to the other party.
19.2 Breach. If either party hereto commits a material breach of any of
its obligations hereunder, the non-breaching party may, at its
option, terminate this Agreement by giving the other party at least
ninety (90) days prior written notice of its intent to terminate
this Agreement, which notice shall specify the breach and the
termination date, unless the breaching party cures said breach prior
to the specified termination date (or prior to the expiration of a
longer period as may be reasonably necessary to cure a breach,
provided that the breaching party is making diligent efforts to cure
such breach, and provided further that such longer period shall not
in any event exceed [**] from the date of notice).
19.3 Insolvency. Either party may terminate this Agreement immediately in
its entirety if the other Party files a petition of bankruptcy, is
adjudged bankrupt, takes advantage of any insolvency act, or
executes a xxxx of sale, deed of trust, or assignment for the
benefit of creditors.
19.4 Survival. The rights and obligations contained in sections covering
representations and warranties, indemnification and confidentiality
will survive termination of this Agreement, as will any rights to
payment or other rights or obligations that have accrued under this
Agreement prior to termination. Termination will not affect the
liability of either party by reason of any act, default, or
occurrence prior to said termination.
19.5 Transfer. If either party terminates this Agreement, XXXXXX will
upon request and at CEPHALON's expense provide reasonable assistance
in transferring production of Product to a facility owned by
CEPHALON or a third party selected by CEPHALON.
19.6 Return of Product and Components. Upon termination under this
Article, XXXXXX shall, at CEPHALON's expense, return promptly to
CEPHALON all Product, Active Drug Substance, Commodities, Components
and in process materials in its possession on the effective date of
termination. CEPHALON shall [**] for all such Product, Active Drug
Substance, Commodities, Components and in-process materials.
XX. ALTERNATE DISPUTE RESOLUTION
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Any dispute concerning or arising out of this Agreement or concerning the
existence or validity hereof, shall be determined by the following procedure.
20.1 Both parties understand and appreciate that their long term mutual
interest will be best served by effecting a rapid and fair
resolution of any claims or disputes which may arise out of services
performed under this contract or from any dispute concerning
contract terms. Therefore, both parties agree to use their best
efforts to resolve all such disputes as rapidly as possible on a
fair and equitable basis. Toward this end both parties agree to
develop and follow a process for presenting, rapidly assessing, and
settling claims on a fair and equitable basis.
20.2 If any dispute or claim arising under this contract cannot be
readily resolved by the parties pursuant to the process described in
Section 20.1, the parties agree to refer the matter to a panel
consisting of one (1) senior executive employed by each party who is
not directly involved in the claim or dispute for review and
resolution. A copy of the contract terms, agreed upon facts (and
areas of disagreement), and concise summary of the basis for each
side's contentions will be provided to both such senior executives
who shall review the same, confer, and attempt to reach a mutual
resolution of the issue.
20.3 If the matter has not been resolved utilizing the process set forth
in this Article XX, and the parties are unwilling to accept the
non-binding decision of the panel, either or both parties may elect
to pursue resolution through litigation, or other legal remedies
available to the parties.
XXI. MISCELLANEOUS
21.1 Headings. The headings and captions used herein are for the
convenience of the parties only and are not to be construed to
define, limit or affect the construction or interpretation hereof.
21.2 Severability. In the event that any provision of this Agreement is
found to be invalid or unenforceable, then the offending provision
shall not render any other provision of this Agreement invalid or
unenforceable, and all other provisions shall remain in full force
and effect and shall be enforceable, unless the provisions which
have been found to be invalid or unenforceable shall substantially
affect the remaining rights or obligations granted or undertaken by
either party.
21.3 Entire Agreement. This Agreement, including all those Schedules
appended hereto, contains the entire agreement of the Parties
regarding the subject matter hereof and supersedes all prior
agreements, understandings or conditions (whether oral or written)
regarding the same. Further, this Agreement may not
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
be changed, modified, amended or supplemented except by a written
instrument signed by both parties.
21.4 Assignability. This Agreement and the rights hereunder may not be
assigned or transferred by either party without the prior written
consent of the other party, provided however, that either party may
assign this Agreement to an Affiliate, and provided further that in
the event of a merger, acquisition or sale of substantially all of
the assets of either party, the rights and obligations of such party
under this Agreement may be assigned to the survivor or purchaser in
that transaction. In the event that this Agreement is assigned, it
shall be binding upon and inure to the benefit of the parties and
their respective successors and assigns.
21.5 Further Assurances. Each party hereto agrees to execute, acknowledge
and deliver such further instruments, and to take such other
actions, as may be necessary or appropriate in order to carry out
the purposes and intent of this Agreement.
21.6 Waiver. The waiver by either party of a breach of any provisions
contained herein shall be effective only if made in writing and
shall in no way be construed as a waiver of any succeeding breach of
such provision or the waiver of the provision itself.
21.7 Force Majeure. A party shall not be liable for nonperformance or
delay in performance (other than of obligations regarding any
payments or of confidentiality) caused by any event reasonably
beyond the control of such party including, without limitation,
wars, hostilities, revolutions, riots, civil disturbances, national
emergencies, strikes, lockouts, unavailability of supplies,
epidemics, fires, floods, earthquakes, other forces of nature,
explosions, embargoes, or any other Acts of God, or any laws,
proclamations, regulations, ordinances, or other acts or orders of
any court, government or governmental agency. Any occurrence of
Force Majeure shall be reported promptly to the other party. A party
whose performance has been excused will perform such obligation as
soon as is reasonably practicable after the termination or cessation
of such event or circumstance.
21.8 Remedies. Each party agrees and acknowledges that its disclosure of
Confidential Information in breach of this Agreement may cause
irreparable harm to other party, and therefore that any such breach
or threatened breach may entitle such party to injunctive relief, in
addition to any other legal remedies available in a court of
competent jurisdiction.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
21.9 Governing Law. This Agreement shall in all respects be construed and
enforced in accordance with the law of the State of Illinois.
21.10 Independent Contractors. The parties are independent contractors
under this Agreement. Nothing contained in this Agreement is to be
construed so as to constitute CEPHALON and ABBOTT as partners,
agents or employees of the other, including with respect to this
Agreement. Neither party hereto shall have any express or implied
right or authority to assume or create any obligations on behalf of,
or in the name of, the other party or to bind the other party to any
contract, agreement or undertaking with any third party unless
expressly so authorized in writing by the other party.
21.11 Counterparts. This Agreement may be executed in multiple
counterparts, each of which shall be considered and shall have the
force and effect of an original.
21.12 Notices. Except as set forth in Section 12.1 above, or as otherwise
stated herein, all notices, consents or approvals required by this
Agreement shall be in writing and sent by certified or registered
air mail, postage prepaid or by facsimile or cable (confirmed by
such certified or registered mail) to the parties at the following
addresses or such other addresses as may be designated in writing by
the respective parties. Notices shall be deemed effective on the
date of mailing.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
If to CEPHALON:
Sr. Director, Technical Operations
CEPHALON, Inc.
000 Xxxxxxxxxx Xxxxxxx
Xxxx Xxxxxxx, XX 00000-0000
Facsimile: (000) 000-0000
All ABBOTT invoices and/or charges in billing should be directed to
the Accounting Department at:
CEPHALON, Inc.
000 Xxxxxxxxxx Xxxxxxx
Xxxx Xxxxxxx, XX 00000-0000
Attention: Accounts Payable
If to XXXXXX:
Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, XX 00000-0000
Facsimile:
All CEPHALON purchase orders shall be sent to:
Xxxxxx Laboratories
PPD Manufacturing Services
Dept. 53T, Building A-3
0000 Xxxxxxxx Xx.
Xxxxx Xxxxxxx, XX 00000-0000
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
IN WITNESS WHEREOF, the undersigned parties have caused this Agreement to
be executed as of the date first above written.
CEPHALON, INC.
By: /s/ Xxxxx Xxxxxxx, Xx.
------------------------------------
XXXXXX LABORATORIES
By: /s/ Xxxxxx X. Xxxxxxx
-------------------------------------
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Schedule A
Active Drug Substance, Commodities and Components Specifications
The parties have agreed upon all those applicable specifications for the Active
Drug Substance, Commodities and Components as set forth in the following
documents. The parties shall agree upon any modifications to any such
specifications.
[**]
TRADEMARKS
[GRAPHIC OMITTED][GRAPHIC OMITTED]
Gabitril(R)
Cephalon(R)
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
Schedule B
Form of Quality Manual
XXXXXX LABORATORIES
[GRAPHIC OMITTED]
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 1
DOCUMENT GP. 0074
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ISSUE DATE SUPERCEDES
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TITLE QUALITY MANUAL TEMPLATE FOR PRODUCTS MANUFACTURED FOR THIRD PARTY
--------------------------------------------------------------------------------
REFERENCE DOCUMENTS
N/A
--------------------------------------------------------------------------------
DISTRIBUTION
N/A
--------------------------------------------------------------------------------
NC PLANT QA/QC API PLANT QA/QC AP16 PLANT QA/QC
NAME: X. XXXXXXXXX X. XXXXXXXXX X. XXXXX
DATE: 03/02/2000 02/16/2000 02/24/2000
QA DOCUMENTATION PARD MFG SVCS
NAME: X. XXX-XXXXXXXX X. XXXXXXX X. XXXXXXXXX
DATE: 05/01/2000 04/24/2000 03/06/2000
SUPPLIER QA VALIDATION DIV QA
NAME: X. XXXXX X. XXXXXX X. XXXXX
DATE: 02/11/2000 04/19/2000 04/14/2000
--------------------------------------------------------------------------------
ATTACHMENTS
COMPUTERIZED A-3
--------------------------------------------------------------------------------
APPLICABLE DOCUMENTS
GP.0086
--------------------------------------------------------------------------------
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 26
DOCUMENT GP.0074
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ISSUE DATE SUPERCEDES
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--------------------------------------------------------------------------------
I. PURPOSE
To establish a procedure for Quality Manual preparation and revision.
II. SCOPE
This practice applies to all marketed products manufactured by Xxxxxx
Laboratories for a Third Party.
III. DEFINITION
A Quality Manual is a controlled document, the purpose of which is to
address and delineate the responsibilities between contracting parties.
The contents are specific as to products, packages, services, and
Contractors to the Pharmaceutical Products Division (PPD), Xxxxxx
Laboratories.
IV. PROCEDURE
A. A Quality Manual shall be established between Xxxxxx Laboratories
and a Third Party when Xxxxxx Laboratories is acting as a contractor
and is contracted to manufacture, package, or supply product support
for a product or an intermediate step of manufacturing.
B. When establishing a Quality Manual, a template (Attachment A) should
be used as a guideline. Note, that the information and wording in
the template is not absolute but illustrates information and issues
that need to be discussed when developing the working relationship
between Xxxxxx Laboratories and the Third Party.
Attachment A - Xxxxxx Laboratories as the manufacturing company and
a Third Party as the contracting company.
C. Once the Quality Manual has been drafted by Xxxxxx Laboratories and
verbally agreed upon by both parties, the Quality Manual shall
obtain written approval via PPD's document change control process
(GP.0086, Initiation, Review, and Approval of Division Document
Change Requests).
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 27
DOCUMENT GP.0074
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ISSUE DATE SUPERCEDES
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--------------------------------------------------------------------------------
IV. PROCEDURE (Cont.)
D. Approved Quality Manuals shall be registered and released into DMS
by PPD QA Documentation (D-44T).
E. Any subsequent changes/updates to a Quality Manual shall route for
approval via PPD's document change control process (GP.0086).
V. ANNUAL REVIEW
Quality Manuals will be reviewed for current applicability by PPD
Manufacturing Services (D-554), in conjunction with the Third Party, on an
annual basis. A record of this review will be kept in the Quality Manual
file in QA Documentation (D-44T).
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 28
DOCUMENT GP.0074
--------------------------------------------------------------------------------
ISSUE DATE SUPERCEDES
05/08/2000 07/15/1999
--------------------------------------------------------------------------------
ATTACHMENT A-3
TABLE OF CONTENTS
I. PURPOSE
II. SCOPE
III. QUALITY AGREEMENT
IV. POLICIES AND PROCEDURES
A. Document Control
1. Product Specification
2. Testing and Sampling Specification
3. Packaging and Labeling Specifications
4. Batch Record
5. Specification Approval
6. Document Distribution
7. Compendial Compliance
8. Filing Requirements
9. DMF Requirements
10. Annual Update Requirements
B. Materials
1. Third Party Controlled Material (if applicable)
2. Printed Material (if applicable)
C. Specifications, Sampling, Testing, & Release of Product
D. Validation
E. Environment
1. Storage Conditions
2. Controlled Drug Requirements
3. Environmental Monitoring
F. Stability
G. File Samples
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 29
DOCUMENT GP.0074
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ISSUE DATE SUPERCEDES
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--------------------------------------------------------------------------------
H. Deviations
I. Nonconformances
J. Reinspection
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 30
DOCUMENT GP.0074
--------------------------------------------------------------------------------
ISSUE DATE SUPERCEDES
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--------------------------------------------------------------------------------
ATTACHMENT A-3 (Cont.)
TABLE OF CONTENTS (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
K. Reprocessing and Rework
L. Audits and Monitoring
M. Annual Product Review
N. Product Complaints
O. Shipping Instructions
V. APPENDIX
A. Key Contact Information
B. Product Description
C. Definitions
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 31
DOCUMENT GP.0074
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ATTACHMENT A-3 (Cont.)
I. PURPOSE
The Quality Manual defines a working agreement between Xxxxxx Laboratories
Pharmaceutical Products Division (PPD) and [TP NAME], to establish quality
program requirements and delineate quality control responsibilities to
assure that any product manufactured by PPD is processed by procedures
which meet [TP NAME] specifications and applicable government regulations,
including the current Code of Federal Regulations, Current Good
Manufacturing Practices for the Manufacture, Processing, Packing, or
Holding of Drugs, and as defined in applicable Supply Agreements.
II. SCOPE
This Quality Manual applies to all contract operations at Xxxxxx
Laboratories for [TP NAME], for (PRODUCT DESCRIPTION, e.g., oral dosage
form soft elastic gelatin capsule).
III. QUALITY AGREEMENT
The policies and procedures stated herein shall be adhered to in the
supply of and processing of drug products by Xxxxxx Laboratories and [TP
NAME].
[TP NAME] shall notify PPD Supplier Quality Assurance whenever there is a
significant change in management or company ownership.
IV. POLICIES AND PROCEDURES
A. Document Control
1. Production Specifications
The "production" specifications are the documents which specify the
manufacturing and/or finishing instructions and related bills of
material used in the production process. These production
specifications are developed and/or approved by XXXXXX LABORATORIES
and [TP NAME] using [TP NAME] master formulas and technical support.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
A. Document Control (Cont.)
2. Testing and Sampling Specifications
The "testing and sampling" specifications are the documents
which specify the testing procedures and the sampling
instructions necessary to evaluate a commodity, material or
product against applicable acceptance/release requirements
within PPD testing facilities and laboratories. These testing
and sampling specifications are developed and/or approved by
XXXXXX LABORATORIES and [TP NAME].
3. Packaging and Labeling Specifications
The "packaging and labeling" specifications are the documents
which describe the labeling artwork and commodity
specifications and drawings used in the finishing of the
product. These packaging and labeling specifications are
developed and/or approved by XXXXXX LABORATORIES and [TP
NAME].
4. Batch Record
Batch Records will be maintained by the appropriate
organizational unit within XXXXXX LABORATORIES. Batch Records
are available on site for inspection and review by [TP NAME]
and/or its agents.
5. Specification Approval
Specification initiation or revision that affects the
scientific or technical content requires approval before
proposed changes are implemented. This applies to
manufacturing, finishing, testing, storage, labeling of the
product as well as any changes to the material specification
for component and finished product. Editorial or format
changes to applicable specifications, not affecting the
scientific/technical content or intent of the specification,
will not require approval by [TP NAME]. Those documents
requiring [TP NAME] approval are as follows:
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
A. Document Control (Cont.)
5. Specification Approval (Cont.)
S43D Manufacturing Directions (FDA Document)
S43MI Manufacturing Instructions
S43CO Coating Specifications
S43Y Drying Specifications
S43T Technical Specifications
S41 Acceptance/Release Specifications for Final Product
S02 Printed Commodity Specifications
S03 Drug Code Specifications
S42 Standard Test Method for Final Product
PCA Primary Container Approval
PSCN Printed Supplies Control Notice
Document Change Requests (CR) will be forwarded to [TP NAME]
via appropriate mail or facsimile.
When [TP NAME] initiates a change request on an applicable
specification, PPD QAD shall be provided the proposed
specification and appropriate documentation which summarizes
and justifies each change.
6. Documentation Distribution
[TP NAME] shall be on distribution for all applicable
specification documents used in the manufacturing/
finishing/release of the product and in the acceptance of raw
materials going into the finished product.
On a quarterly basis, [TP NAME] will be provided a list of
distributed specifications to verify receipt of most current
version. XXXXXX LABORATORIES shall be on distribution for [TP
NAME] drug product acceptance/release specifications to
maintain consistency between the two facilities.
7. Compendial Compliance
Compliance to compendial requirements is the responsibility of
both [TP NAME] and XXXXXX LABORATORIES.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
A. Document Control (Cont.)
8. Filing Requirements
[TP NAME] is the owner of the product and is responsible for
annual reports and any other regulatory filings. During the
Preapproval Inspection/Postapproval Inspection,
representatives from both [TP NAME] and XXXXXX LABORATORIES
shall be present.
9. DMF Requirements (Use as Applicable)
XXXXXX LABORATORIES shall maintain a Drug Master File. Written
authorization granting permission to reference the Master File
shall be given to [TP NAME], if requested.
10. Annual Update Requirements (Use as Applicable)
XXXXXX LABORATORIES shall, upon request, provide [TP NAME]
with product related documentation for the purpose of updating
regulatory information.
B. Materials
All materials supplied by XXXXXX LABORATORIES for use in the
product(s) covered by this manual, will be purchased, received,
inspected, stored, and handled in accordance with XXXXXX
LABORATORIES' standard operating procedures. All materials shall be
in accordance with the approved specifications or approved
nonconforming material reports (NCMR).
XXXXXX LABORATORIES shall maintain an approved supplier list in
accordance with XXXXXX LABORATORIES' procedures. [TP NAME] approval
will be required for any supplier change for materials used in [TP
NAME] products. Abbott will make the following information available
upon request:
Material Name
Supplier Name
Manufacturing Location
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
B. Materials (Cont.)
1. [TP NAME] Controlled Material (if applicable)
Materials controlled by [TP NAME] may be supplied by [TP NAME]
to XXXXXX LABORATORIES in accordance with the specifications.
If such material is not sourced from an XXXXXX LABORATORIES
approved supplier, then [TP NAME] shall be responsible to
maintain an Approved Supplier List for each source specified
by [TP NAME]. If suppliers of code materials or product
contact commodities are not specified by Xxxxxx Laboratories,
[TP NAME] shall provide Xxxxxx Laboratories an annual
certification that an acceptable supplier evaluation has been
completed which includes documentation that compliance to cGMP
and [TP NAME] requirements is acceptable. XXXXXX LABORATORIES
must be notified if [TP NAME] changes suppliers of raw
materials or product contact commodities that they are
supplying. XXXXXX LABORATORIES will not be required to receive
materials from any source which it feels will or may have a
negative impact on its operation.
2. Printed Material (if applicable)
[TP NAME] shall be responsible for and shall provide XXXXXX
LABORATORIES all copy content, artwork, and mechanicals for
all printed materials associated with the product. This
includes but is not limited to container labels, containers,
cartons, package inserts, and promotional material. [TP NAME]
shall be responsible for compliance with all federal, state,
and local regulations concerning packaging and labeling
materials and for obtaining any necessary regulatory approvals
of printed materials, artwork, and copy.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
C. Specifications, Sampling, Testing, & Release of Product
[TP NAME] shall supply XXXXXX LABORATORIES with all in-process and
final product release specifications including acceptance limits for
each required test and any appropriate test methods and supporting
test method validation.
All test methodologies will be validated. For those procedures which
appear in the current USP/NF or other recognized standard reference,
a statement indicating the reference shall suffice. For those test
methods which are developed by XXXXXX LABORATORIES, documentation
supporting the validation of the test method shall be supplied, upon
request, to [TP NAME]. For those test methods developed by [TP
NAME], [TP NAME] shall supply XXXXXX LABORATORIES with the
supporting validation documentation. Upon review of Xxxxxx
Laboratories' data, [TP NAME] will provide Xxxxxx Laboratories' with
written authorization verifying Xxxxxx Laboratories ability to
perform such tests.
Each lot of product manufactured or packaged by XXXXXX LABORATORIES
will be sampled and tested in accordance with established Xxxxxx
Laboratories specifications.
A Certificate of Analysis (COA)or applicable documentation shall be
provided to [TP NAME] at (address of [TP NAME]) by XXXXXX
LABORATORIES. The COA or equivalent will be generated upon
completion of all testing requirements. The COA or equivalent shall
contain the items tested, corresponding acceptance criteria, and
test results. [TP NAME] is responsible for the approval and release
of all bulk or packaged product after review of Certificate of
Analysis.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
D. Validation
Process, cleaning, equipment, facilities, utilities and computer
validation protocols unique to [TP NAME] products shall be developed
by [TP NAME] and XXXXXX LABORATORIES. Protocols shall be agreed upon
and approved by both parties. XXXXXX LABORATORIES shall perform
process and cleaning validations using lots of manufactured drug
product. XXXXXX LABORATORIES shall maintain original validation
reports and protocols according to Xxxxxx Laboratories procedure and
provide a copy of the validation reports and protocols to [TP NAME].
[TP NAME] shall be notified of any proposed process changes. The
need for revalidation will be determined by XXXXXX LABORATORIES and
[TP NAME]. The protocol shall be agreed upon and approved by both
parties.
E. Environment (Use sections which apply)
1. Storage Conditions
Drugs and drug products are to be stored in a secure area,
protected from extremes in temperature and humidity in
accordance with environmental requirements specified by [TP
NAME].
2. Controlled Drug Requirements
Controlled Drugs are to be manufactured, processed, and
secured as outlined in the CFR or other applicable local
regulations. Policies and procedures controlling storing and
manufacturing of controlled drug shall be approved by [TP
NAME].
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
E. Environment (Use sections which apply) (Cont.)
3. Environmental Monitoring
Where particulate and/or microbial levels are required for the
drug product, then the facilities used during the
manufacturing and packaging process shall be monitored for
these factors. XXXXXX LABORATORIES will be responsible for the
establishment and institution of a monitoring program to
assure that the drug product will meet the required
particulate and microbial levels and shall provide [TP NAME]
with access to the records obtained from this monitoring
program.
F. Stability
[TP NAME] or XXXXXX LABORATORIES (choose one) shall be responsible
for stability testing (expand as needed).
G. File Samples
Xxxxxx Laboratories shall be responsible for obtaining, maintaining,
and examining drug substance and drug product file samples for
released product as defined in Good Manufacturing Practices. Xxxxxx
Laboratories PPD shall retain samples of materials and product which
is finished by Xxxxxx Laboratories as specified in the Abbott
Sampling Plan Specification. Xxxxxx Laboratories shall notify [TP
NAME] if any non standard conditions exists.
H. Deviations
A deviation will be used to document any change from the approved
manufacturing directions or test method. Any deviation or variance
must be documented and justified in writing.
Deviations shall require Xxxxxx Laboratories and [TP NAME] approval
according to company policy before release/acceptance of any
material.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
H. Deviations (Cont.)
[TP NAME] approval shall be obtained in writing (fax confirmation is
acceptable) for any deviation per Xxxxxx Laboratories standard
procedures.
The deviation will become part of the permanent batch record.
I. Nonconformances
Material or product not meeting established specifications are to be
handled as nonconformances and documented as such, based on XXXXXX
LABORATORIES standard procedures. Actions taken to investigate the
nonconformance and to justify the release of the lot of material
must be fully documented. The nonconformance document (i.e., NCMR)
will be approved by both XXXXXX LABORATORIES and [TP NAME] as stated
below. The approved document will become the specification for the
release of that specific lot of material. Any resulting corrective
actions shall be followed through to timely closure. Approval by the
appropriate Quality Assurance functions are solicited and obtained
via facsimile copy.
------------------------------------------------------------------
Nonconformance Approval Requirements
------------------------------------------------------------------
Finished Product [TP NAME] and XXXXXX
LABORATORIES
------------------------------------------------------------------
Raw Materials sourced and used XXXXXX LABORATORIES.
by XXXXXX LABORATORIES
------------------------------------------------------------------
Drug Substance and Raw Materials [TP NAME] and ABBOTT
sourced by [TP NAME] to be used LABORATORIES
by XXXXXX LABORATORIES.
------------------------------------------------------------------
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
J. Reinspection
A reinspection is performed under conditions where product quality
requires reverification. The reinspection work shall be approved and
performed by XXXXXX LABORATORIES according to established
procedures. The reinspection work must be documented to state
reasons, justification, directions for, and results of reinspection.
K. Reprocessing and Rework
Reprocessing and rework activity must be approved by both XXXXXX
LABORATORIES and [TP NAME]. Reprocessing and rework directions must
be established to define the process. If the product is part of a
regulatory filing, reprocessing parameters must have been developed
and submitted with filing prior to approval. Reprocessing and/or
rework of material or product must be documented to state reason and
justification for processing.
L. Audits and Monitoring
Except with respect to information and operations which constitute
XXXXXX LABORATORIES trade secrets, the [TP NAME] shall have the
right to inspect XXXXXX LABORATORIES batch records and the portions
of XXXXXX LABORATORIES facility used for the manufacturing,
finishing, holding, and testing of [TP NAME] drug products. Audit
visits are to be arranged with the Quality function of the
manufacturing facility to be audited. Responses to observations
written as the result of auditing activities shall be forwarded to
the auditing company within 30 days from their issuance.
XXXXXX LABORATORIES shall notify [TP NAME] within a reasonable
amount of time of any FDA or other applicable regulatory agencies'
(e.g., DEA) inspections which are related to the product, and shall
provide copies of any relevant 483(s) (inspection observation
report) and correspondence as related to the production of [TP NAME]
product(s). XXXXXX LABORATORIES is responsible for compliance to all
Federal, State, and Local laws and regulations as they apply to
XXXXXX LABORATORIES' business.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
IV. POLICIES AND PROCEDURES (Cont.)
M. Annual Product Review
[TP NAME] shall be responsible for evaluating the quality standards
of the drug product to determine the need for changes in the drug
product specifications of manufacturing or control records in
accordance with Good Manufacturing Practices as required. An annual
product review is documented based on [TP NAME] policy. (Indicate
product review schedule.)
XXXXXX LABORATORIES shall provide [TP NAME] access to batch records
on (product name and list numbers) for each lot of drug product
including data analysis and summary of exception documentation.
N. Product Complaints
Complaints files, as required by Good Manufacturing Practices, shall
be maintained by [TP NAME]. All complaints received by XXXXXX
LABORATORIES shall be forwarded to [TP NAME]. [TP NAME] shall be
responsible for the review of the complaint to determine the need
for an investigation as specified in applicable regulations or the
need to report to a regulatory agency. [TP NAME] shall send to
XXXXXX LABORATORIES all product performance or manufacturing related
complaints (nonmedical) and medical complaints. XXXXXX LABORATORIES
shall if requested by [TP NAME] conduct an investigation for each
nonmedical complaint and shall report the findings and follow-up of
each investigation to [TP NAME].
[TP NAME] shall make these complaint files available to XXXXXX
LABORATORIES onsite or electronically within one business day if
they are required during a regulatory agency inspection.
O. Shipping Instructions
Xxxxxx Laboratories will control and coordinate all shipping
activity unless specified by [TP NAME].
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
V. APPENDIX
A. Key Contact Information
XXXXXX LABORATORIES
--------------------------------------------------------------------------------
TITLE INDIVIDUAL PHONE FAX
--------------------------------------------------------------------------------
Mfg. Services Mgr.
--------------------------------------------------------------------------------
Schedules & Forecasts
--------------------------------------------------------------------------------
Analytical Laboratory
--------------------------------------------------------------------------------
Plant Quality AP:
NC:
API:
--------------------------------------------------------------------------------
Quality Assurance
Documentation
Label Dev Control
--------------------------------------------------------------------------------
Certs & File Samples
--------------------------------------------------------------------------------
Product Complaints
--------------------------------------------------------------------------------
PARD
--------------------------------------------------------------------------------
Stability
--------------------------------------------------------------------------------
Validation
--------------------------------------------------------------------------------
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
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ATTACHMENT A-3 (Cont.)
V. APPENDIX (Cont.)
A. Key Contact Information (Cont.)
[TP NAME]
--------------------------------------------------------------------------------
TITLE INDIVIDUAL PHONE FAX
--------------------------------------------------------------------------------
Schedules & Forecasts
--------------------------------------------------------------------------------
Product Complaints
--------------------------------------------------------------------------------
Medical
--------------------------------------------------------------------------------
Labeling
--------------------------------------------------------------------------------
Regulatory
--------------------------------------------------------------------------------
Operations
--------------------------------------------------------------------------------
Technical
--------------------------------------------------------------------------------
Documentation
--------------------------------------------------------------------------------
Quality
--------------------------------------------------------------------------------
B. Product Description
Products currently being manufactured by XXXXXX LABORATORIES for [TP
NAME].
Abbott [TP NAME]
List Product Manufacturing
---- ------- -------------
Number Number Product Name Location
------ ------ ------------ --------
C. Definitions
1. Contractor
Any manufacturer, packager, or other product support servicer
who performs processing and/or packaging of a product or any
intermediate step of manufacture, or other product support
service, is a contractor.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
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ATTACHMENT A-3 (Cont.)
V. APPENDIX (Cont.)
C. Definitions (Cont.)
2. Batch Record
The batch record consists of master manufacturing formula,
appropriate packaging xxxx and instructions, and exception
documentation, such as NCMRs, deviations, variance reports,
and additional documentation which may have been processed as
part of the production record of the batch.
3. CRB
Certification Review Board
4. Deviation
The document used to obtain approvals to temporarily modify or
to document excursions from operating, manufacturing, testing
instructions, target/informational test results, or
procedures. The deviation does not permanently change existing
instructions/BOP's or procedures; it is intended to be a
specific/one time use document.
5. Lot Number (This definition may be elaborated on for including
Control Number or other additional supporting information.)
A Lot Number is used to identify a specific lot or batch of
manufactured material.
6. Material
All actives, excipients, printed or unprinted commodities
which are used during the manufacturing or finishing process
for a product.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
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ATTACHMENT A-3 (Cont.)
V. APPENDIX (Cont.)
C. Definitions (Cont.)
7. Nonconforming Materials Report (NCMR)
A document used for recording review and disposition of
nonconforming materials. The NCMR document, when formally
approved with appropriate sign-off, becomes the specification
for the disposition of that specific lot of material only.
Actions taken to investigate the nonconformance and to justify
the release of that lot must be fully documented.
8. PPD
Pharmaceutical Products Division of Xxxxxx Laboratories
9. PARD
Pharmaceutical and Analytical Research and Development. The
research and development group of Xxxxxx Laboratories PPD.
10. Product
Any product manufactured, packaged and/or labeled by Xxxxxx
Laboratories to meet third party requirements for further
processing marketing, and/or sale in accordance with the
executed supply agreement.
11. Reinspection
A visual or mechanical evaluation performed to remove/correct
defective units for which the process is not expected to have
an adverse effect on product quality. Reinspection should
involve the use of a deviation except where standard procedure
allows for such routine activity in the course of normal
processing.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
V. APPENDIX (Cont.)
C. Definitions (Cont.)
12. Reprocessing
Duplication of a step or steps currently in the manufacturing
formula in order to bring the product into conformance with
specifications and which will not alter the safety, identity,
strength, quality, or purity of the drug product beyond the
established requirements. Reprocessing associated with product
having a regulatory submission requires Regulatory Affairs
review.
13. Rework
Any additional steps taken to process a batch (other than
reinspection) to bring it into conformance with the
specifications and which will not alter the safety, identity,
strength, quality, or purity of the drug product beyond the
established requirements. All rework must be documented per
approved rework documentation requirements and appended to a
deviation.
14. Instructions for Outside Packaging
List Number/Label Code/Size Code specific document supplied by
Xxxxxx Laboratories to instruct third parties on how to
perform finishing steps for marketed product.
15. Package Master (PMV)
List Number/Label Code/Size Code specific document specifying
all commodities and corresponding quantities used with
divisional packaging procedures for finishing of manufactured
product.
16. PCA: Primary Container Approval
Document used to list commodities approved for product contact
on a specified list number.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
V. APPENDIX (Cont.)
C. Definitions (Cont.)
17. PSCN: Printed Supplies Control Notice
Document which lists printed supplies used during finishing
operations.
18. S01: Non-Printed Commodity Specification
Document containing a general description of the material,
what it is made of, and what it looks like.
19. S02: Printed Commodity Specification
Document applies to the control of product labeling and
identifies the properties of the material, size, style, color,
and reference marks, as applicable.
20. S03: Drug Code Specification
A description of the chemical, biological, identification,
microbial, and physical requirements of the drug entity with
the appropriate acceptance/release and test method
requirements; Certificate of Analysis requirements; incoming
packing and marking requirements; sampling instructions; and
continuing guarantee requirements.
21. S05: Sampling Plan Specification
Provides sampling instructions related to sample taken, sample
amount, test location, and name of required test(s). Also,
identifies the associated manufacturing stage where sampling
is to occur and requirements for sample packaging and handling
may be indicated.
22. S41: Acceptance/Release Specification
A description of the chemical, biological, identification,
microbial, and physical requirements of the drug entity with
the appropriate acceptance/release and test method
requirements, and sampling instructions.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
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ATTACHMENT A-3 (Cont.)
V. APPENDIX (Cont.)
C. Definitions (Cont.)
23. S43CO: Coating Specification
This document is used by the Plant, when applicable, along
with the S43MI, and includes setup parameters for coating
equipment, (e.g., exhaust temperature, pan speed) and
calculations for amounts of coating liquids.
24. S43D: Manufacturing Directions and Formula
This is a summary document used for regulatory submissions
which consists of the manufacturing directions and formula
sections. The manufacturing directions section includes
individual steps and equipment required to manufacture the
product or material, such as, LOD end points and special
mixing/temperature requirements. Critical process parameters
are included. The formula section includes a list of
ingredients and quantities used in the formulation.
25. S43MI: Manufacturing Instructions and Formula
This is the document that establishes requirements for the
Plant and consists of manufacturing instructions and formula
sections. The manufacturing instructions section includes
critical process parameters and equipment required to
manufacture the product or material, such as, LOD end points
and special mixing/temperature requirements. Typically, this
section contains more detail than the corresponding section in
the S43D. The formula section includes a list of ingredients
and quantities used in the formulation.
26. S43RD: Reprocessing Directions
This is a document submitted to regulatory agencies, which
includes the manufacturing steps necessary to reprocess
product or material (e.g., recoating, regrinding).
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 49
DOCUMENT GP.0074
--------------------------------------------------------------------------------
ISSUE DATE SUPERCEDES
05/08/2000 07/15/1999
--------------------------------------------------------------------------------
ATTACHMENT A-3 (Cont.)
V. APPENDIX (Cont.)
C. Definitions (Cont.)
27. S43S: Sterilization Process Specification
This document is used by the Plant/Suppliers, when applicable.
This includes the steps necessary to apply sterilization
methods to product, material, or commodities (outside
filtration).
28. S43T: Technical Processing
This document is used by the Plant/Suppliers, when applicable.
For manufacturing, the S43T contains technical information not
found in the S43MI, but critical for the manufacturing
process. Calculation worksheets and requirements for
intraplant movement of materials are some examples. For
finishing, the S43T contains technical information for types
of commodities and equipment (e.g., bottle cleaning,
imprinting lot and expiration date).
29. S43Y: Drying Specification
This document is used by the Plant, when applicable, along
with the S43MI and includes set up parameters for drying
equipment, such as temperature and time.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 1
DOCUMENT GP.0074
--------------------------------------------------------------------------------
ISSUE DATE SUPERCEDES
05/08/2000 07/15/1999
--------------------------------------------------------------------------------
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
-1-
[GRAPHIC OMITTED] XXXXXX LABORATORIES
PHARMACEUTICAL PRODUCTS DIVISION
GENERAL PRACTICE PAGE 2
DOCUMENT GP.0074
--------------------------------------------------------------------------------
ISSUE DATE SUPERCEDES
05/08/2000 07/15/1999
--------------------------------------------------------------------------------
DESCRIPTION OF CHANGE:
CR # INITIATOR
0000480 X. XXXXXXXX
--------------------------------------------------------------------------------
D OF C
Clarify Attachment A, Section IV.D. Validation, Add "unique to [TP NAME]
products" to the first sentence after the word "protocols".
--------------------------------------------------------------------------------
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
-2-
Schedule C
Xxxxxx Reserve Capacity
The minimum annual capacity to be reserved by XXXXXX, is as follows for the
Initial Term of this agreement:
Commercial Product
2-mg x 100-count [**] units per month
4-mg x 100-count [**] units per month
12-mg x 100-count [**] units per month
16-mg x 100-count [**] units per month
Product Samples
2-mg x 40-count [**] units per month
4-mg x 40-count [**] units per month
Titration Packs
2-mg x 148-count [**] units per month
-1-
Schedule D
Toll Fee until CEPHALON has sold Product for One Calendar Quarter
Xxxxxx to provide fee which will be based on [**].
-2-
