1
Exhibit 10.42
CONFIDENTIAL TREATMENT REQUESTED UNDER
17.C.F.R. SECTIONS 200.80(b) (4), 200.83 and 240.24b-2
DEVELOPMENT AND SUPPLY AGREEMENT
Gd-Tex
This Agreement is entered into as of this 16th date of June, 1998, by and
between Pharmacyclics Inc., having a principal place of business at 000 X.
Xxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 ("Pharmacyclics") and Xxxxxx Laboratories,
having a principal place of business at 000 Xxxxxx Xxxx Xxxx, Xxxxxx Xxxx,
Xxxxxxxx 00000-0000 ("Abbott").
WITNESSETH:
WHEREAS, Pharmacyclics either owns or has a license to certain rights
relating to the proprietary compound gadolinium texaphyrin, a human
pharmaceutical agent for the treatment of certain diseases;
WHEREAS, Pharmacyclics desires to develop such agent and wishes to market
and commercially distribute such agent;
WHEREAS, Abbott has the experience and expertise necessary to perform
development, final formulation, analytical testing and quality assurance
services for the manufacturing, labeling and packaging of such pharmaceutical
agent on behalf of Pharmacyclics; and
WHEREAS, Pharmacyclics desires that Abbott perform such services, and
Abbott desires to perform such services for such finished pharmaceutical agent.
NOW, THEREFORE, in consideration of the premises and the mutual promises
and agreements contained herein, Pharmacyclics and Abbott agree as follows:
2
1. DEFINITIONS.
1.1 "Contract Year" shall mean the twelve-month period commencing on the
first day of the month of either January, April, July, or October, whichever one
is the first to follow the first month that Pharmacyclics makes its first bona
fide sale of Product in the U.S. to a non-affiliate customer after Pharmacyclics
has received an approved NDA from the FDA.
1.2 "Delivery Systems" shall mean [***]
1.3 "Drug" shall mean the proprietary compound gadolinium texaphyrin, a
human pharmaceutical agent used for the treatment of certain diseases.
1.4 "Drug Substance" shall mean the Drug in bulk form that Pharmacyclics
(or its third party supplier) delivers to Abbott for incorporation into Product
which meets the Drug Substance Specifications.
1.5 "Drug Substance Specifications" shall mean the detailed analytical
description of the Drug Substance, which shall be set forth on Exhibit 1.5.
1.6 "Effective Date" shall mean the date first above written.
1.7 "FD&C Act" shall mean the United States Federal Food, Drug and
Cosmetic Act, as may be amended from time to time.
1.8 "FDA" shall mean the United States Food and Drug Administration or any
successor entity.
1.9 "GMPs" shall mean the practices set out in the guidelines and
regulations published as the Current Good Manufacturing Practices of the FDA, as
amended from time to
*** Indicates that material has been omitted and confidential treatment
requested therefor. All such omitted material has been filed separately with
the Commission pursuant to Rule 24b-2.
2
3
time, as well as all applicable federal, state and local laws, rules and
regulations in the United States.
1.10 "Health Authority" shall mean the health regulatory agency of a
country in the Territory or the European Union.
1.11 "NDA" shall mean a New Drug Application, as defined in the FD&C Act
and applicable regulations promulgated thereunder, as amended from time to time
or equivalent application to the Health Authority of a country other than the
United States.
1.12 "Product" shall mean the Drug in final dosage form packaged as a
finished product in the Delivery Systems, and conforming to the Product
Specifications.
1.13 "Product Specifications" shall mean the detailed analytical
description of the Product, which the parties shall develop mutually and which
the parties may amend from time to time based on written mutual agreement which
shall be set forth on Exhibit 1.13.
1.14 "Territory" shall mean the United States of America and Canada.
2. PRODUCT DEVELOPMENT PROJECT.
Promptly after the execution of this Agreement, the parties shall
undertake a product development project consisting of the specific research and
development activities detailed in Articles 3 and 4 hereof. The parties shall
use best reasonable efforts to complete successfully the product development
project. It is understood and agreed that there is no guarantee that the product
development project will be successful and no warranty or guarantee of any kind
is given by either party that a marketable product will result from the project.
The parties shall conduct
3
4
the project in accordance with a product development project timetable that the
parties shall develop and which shall be set forth on Exhibit 2.
3. XXXXXX'X RESEARCH AND DEVELOPMENT RESPONSIBILITIES.
The objective of the product development project shall be for Abbott to
develop the Drug in the Delivery Systems and to assist Pharmacyclics in
obtaining an approved NDA in the Territory and foreign equivalents covering the
Product. Abbott shall manufacture clinical and commercial supplies of the
Product and deliver the Product to Pharmacyclics, which Pharmacyclics shall then
sell such commercial supplies as a human pharmaceutical product, as herein
provided. To that end, Abbott shall have the following responsibilities:
a. Identify or obtain compatible FDA approved materials, including, but
not limited to, components, containers, closures and labeling
materials, for use in developing and manufacturing the Product;
where the parties shall agree mutually to such materials.
b. Manufacture, label and package clinical batches, stability supplies
and process validation batches of Product in accordance with current
GMP's and perform, as required, the Drug solution extractable
studies set forth on Exhibit 3, the protocols of which the parties
shall agree to mutually.
c. Develop optimal terminal sterilization cycles for the Product which
the parties shall agree to mutually.
d. Prepare suitable manufacturing instructions and manufacturing
controls for inclusion in regulatory submissions which the parties
shall agree to mutually.
4
5
e. Provide appropriate Health Authority with letters of authorization
referencing Xxxxxx'x Drug Master File containing microbiological
data, process validation data, batch documents and other data
required to support regulatory submissions.
f. Provide Pharmacyclics and appropriate Health Authority with letters
of reference to Xxxxxx'x applicable NDAs, including NDA supplements,
ANDAs and Drug Master Files ("DMFs") needed to support
Pharmacyclics' worldwide regulatory submissions and assist
Pharmacyclics in responding to questions from government regulatory
agencies concerning the Product.
g. Conduct manufacturing equipment, material contact and cleaning
validation studies, sterilization process validation studies, filter
compatibility studies, container closure kinetics and, in a timely
manner, develop data required to pass FDA pre-approval and other
appropriate Health Authority inspections and to support the
manufacture of the Product in the Abbott manufacturing facility.
h. Permit Pharmacyclics or its designee to conduct all necessary GMP
and Quality Assurance ("QA") reviews of Abbott facilities, systems,
documentation, including review and receipt of copies of Abbott
manufacturing batch records and QA/QC release documentation.
i. Provide Pharmacyclics with acceptable environmental impact
statements for inclusion with regulatory submissions, if required.
j. Assist Pharmacyclics in the development of instructions for use,
which will be submitted as labeling in regulatory submissions
relating to the Product.
5
6
k. Provide Pharmacyclics (or its sublicensees) with all information,
data, reports, etc. that Pharmacyclics may reasonably request
relating to manufacturing, documentation, development and stability
reports, etc. for regulatory submissions.
l. Perform stopper extractable studies with Product where the parties
shall agree to such protocols.
4. PHARMACYCLICS' PRODUCT RESEARCH AND DEVELOPMENT RESPONSIBILITIES.
Pharmacyclics shall have the following research and development
responsibilities:
a. Develop Product formulation in consultation with Abbott.
b. Provide approved Drug Substance, with certificates of analysis, at no cost
to Abbott, for formulation studies, stability batches, manufacturing
studies, and development needs as required by Abbott for execution of its
responsibilities under this Agreement. Drug Substance shall conform with
the Drug Substance Specifications.
c. Provide Abbott with assay standards for Drug Substance and any other
proprietary assay standards and certificates of analysis as may be
required to perform quality control testing.
d. Develop, validate and provide to Abbott analytical test methods for Drug
Substance and Product HPLC determination of potency, impurities, and
degradation products to be used for regulatory submissions, as well as for
use in manufacture of Product.
6
7
e. Provide all compendial specifications and testing instructions for Drug
Substance, if such specifications are available.
f. Provide Abbott with technical data on Drug Substance to include: 1)
material safety data sheets with environmental and safety information; and
2) additional detailed data, if necessary, to define potential hazards and
to establish employee exposure levels and equipment cleanability limits.
g. Perform and be responsible for all clinical/efficacy studies necessary to
obtain marketing approval.
h. Conduct all stability testing and compile data for regulatory submissions.
i. Prepare and submit to appropriate Health Authorities information covering
the Product, respond to all questions from the Health Authorities, take
necessary steps to obtain marketing approvals and maintain the approved
regulatory submissions related thereto.
j. Provide Abbott with copies of regulatory filings as necessary for Abbott
to obtain regulatory pre-inspections.
k. Conduct all other research and development and other work required to
submit appropriate regulatory submissions and obtain marketing approvals
covering the Product.
l. Maintain a stability program for and retain samples of the marketed
Product.
7
8
5. PAYMENT FOR XXXXXX'X DEVELOPMENT EFFORTS.
5.1 Research and Development Fee. To reimburse Abbott for its
participation in the product development project, Pharmacyclics shall pay to
Abbott a non-refundable (subject to Section 11.2 hereof) research and
development fee of [***] for Xxxxxx'x research efforts relating to the [***]
Delivery Systems only. The research and development fee shall be paid to Abbott
according to the following milestones; provided, however, if Abbott does not
achieve certain milestones below, no payments shall be due for such milestone:
a. [***] within thirty (30)
days after Abbott receives Drug Substance from Pharmacyclics [***]
and Pharmacyclics receives Xxxxxx'x invoice for the amount due. Any
advance payment made by Pharmacyclics prior to the final execution
of this Agreement for start-up of the product development project
shall be credited against this installment.
b. [***] within thirty (30)
days after receipt and acceptance by Pharmacyclics of NDA stability
supplies (and copies of associated batch records) from Abbott and
receipt of Xxxxxx'x invoice for the amount due.
c. [***] within thirty (30)
days after Pharmacyclics files an NDA or a foreign equivalent
covering the Product and receipt of Xxxxxx'x invoice for the amount
due.
*** Indicates that material has been omitted and confidential treatment
requested therefor. All such omitted material has been filed separately with
the Commission pursuant to Rule 24b-2.
8
9
Supplemental international regulatory work and development work to support
international filings outside the Territory or outside of the European Union
shall be quoted separately on a country-by-country basis.
5.2 Changes in Project Scope. If changes occur in the product development
project or Product Specifications, or if technical difficulties result that
require Abbott to perform either additional work or repeat work and the reasons
for such work are not due to Xxxxxx'x fault or negligence, Pharmacyclics shall
pay Xxxxxx'x costs for such work, subject to Pharmacyclics' prior approval.
Following Pharmacyclics' review and approval of such protocols, Abbott shall
implement such new or modified protocols. Reimbursement for such additional work
shall be at the rate [***] plus out-of-pocket costs for reasonable travel and
substance, materials and supplies. Abbott shall provide Pharmacyclics with a new
or revised test protocol with cost estimates for such work and Pharmacyclics
shall pay Abbott within thirty (30) days of completion of such work.
5.3 Additional Certification Costs. Abbott has several validated terminal
sterilization cycles and each one is documented in a master sterilization
package. If a new master sterilization certification package is required by the
FDA, Pharmacyclics shall pay Abbott for the additional costs. Abbott currently
estimates such cost to be [***].
6. CLINICAL AND STABILITY BATCHES.
After Product formulation, concentration and fill volume have been
specified by Pharmacyclics in consultation with Abbott, and after Abbott has
completed successfully all the
*** Indicates that material has been omitted and confidential treatment
requested therefor. All such omitted material has been filed separately with
the Commission pursuant to Rule 24b-2.
9
10
work required prior to such manufacturing stability and clinical batches in
accordance with the project development project, Pharmacyclics shall place a
purchase order for and Abbott shall provide to Pharmacyclics clinical or
stability supplies consisting of three (3) lots of Product. All lots shall be
manufactured from different production lots of Drug Substance, if possible.
Abbott and Pharmacyclics shall develop mutually a protocol which shall define
the formulation, concentration, fill volume, and the components for each lot.
If additional clinical or stability supplies other than those specified
above or if sample lots from the Abbott manufacturing facility are required by
Pharmacyclics or the FDA or other Health Authority, Pharmacyclics will issue
separate purchase orders for such supplies. The per unit cost of Product
manufactured in connection with this Article 6 shall be as set forth on Exhibit
8.6.1.
7. PHARMACYCLICS' REGULATORY SUBMISSIONS.
Pharmacyclics agrees that Abbott shall have the right to review the
portions of Pharmacyclics' proposed regulatory submissions relating to Xxxxxx'x
packaging or manufacturing procedures before the submissions are filed with the
appropriate Health Authority. Abbott shall complete its review within ten (10)
days after receipt from Pharmacyclics of a proposed regulatory submission or
amendment. Xxxxxx'x failure to comment upon any such submission or amendment
within such ten (10) day period shall be deemed to be approval of submission or
amendment. Abbott shall consult with and advise Pharmacyclics in responding to
questions from the regulatory agencies regarding Pharmacyclics' submission(s)
for Product. Abbott agrees that Pharmacyclics shall be the sole owner of any
regulatory submission filed pursuant to this Agreement. In the event that Abbott
is required to include any Product-specific information in a
10
11
DMF or other regulatory filing, Pharmacyclics shall have the same right and
responsibilities of review and approval of such regulatory filing as are set
forth in this Article 7 for Xxxxxx'x review and approval of Pharmacyclics'
regulatory submissions and amendments.
8. MANUFACTURE AND SUPPLY OF PRODUCT.
8.1 Purchase and Sale of Product. Pursuant to the terms and conditions of
this Article 8, during the term of this Agreement Abbott shall manufacture (at
its manufacturing facility in North Chicago, Illinois or such other Abbott
manufacturing plant that the parties may mutually agree to), sell and deliver
Product exclusively to Pharmacyclics (or its sublicensees) and Pharmacyclics (or
its sublicensees) shall purchase Product exclusively from Abbott and take
delivery of Pharmacyclics' (or its sublicensees) total requirements of Product
for sale in the Territory. In addition, Abbott shall manufacture, sell and
deliver Product exclusively to Pharmacyclics for all of Pharmacyclics' (or its
sublicensees') total worldwide requirements of the Product. Product shall be
manufactured in accordance with the Product Specifications. Product
Specifications may be altered from time to time by written agreement of the
parties without the necessity of amending this Agreement.
8.2 Pharmacyclics' Purchase Requirement. During the term of this
Agreement, Pharmacyclics shall purchase from Abbott and take delivery of
Pharmacyclics' total requirements of Product for sale in the Territory, but not
less than one (1) batch of Product each Contract year where a batch shall be
approximately twenty-five thousand (25,000) units. In lieu of taking delivery of
Product, Pharmacyclics may pay for its minimum purchase requirement at the
prices set forth on Exhibit 8.6.1 and waive Xxxxxx'x manufacture and delivery
obligations for Product.
11
12
In the latter event, Abbott shall invoice Pharmacyclics for the amount payable,
and Pharmacyclics shall pay Abbott within thirty (30) days after receipt of
Xxxxxx'x invoice.
8.3 Minimum Orders and Delivery Variances. The minimum quantity of Product
ordered hereunder in any one order shall be the minimum batch size of the Abbott
manufacturing facility which is estimated to be approximately twenty-five
(25,000) units. Delivery of Product by Abbott may vary plus/minus five percent
(+5%) from unit quantities ordered by Pharmacyclics and such delivery shall be
in full compliance with this Agreement.
8.4 Government Approvals. Notwithstanding any other provision of this
Agreement, Abbott shall have no obligation to manufacture, sell or deliver
Product to Pharmacyclics and Pharmacyclics shall have no obligation to purchase
and take delivery of Product for commercial purposes until Pharmacyclics has
obtained necessary government approvals required to sell Product in the then
relevant territories of the United States or selected international markets.
8.5 Manufacture of Product.
8.5.1 Abbott shall manufacture Product for Pharmacyclics from Drug
Substance and Product package inserts that Pharmacyclics shall supply to Abbott
at no cost to Abbott. Pharmacyclics shall supply Drug Substance and Product
package inserts in quantities sufficient to satisfy Xxxxxx'x xxxxx manufacturing
requirements. Drug Substance and Product package inserts shall be delivered
F.O.B. Xxxxxx'x plant pursuant to no-cost purchase orders issued by Abbott to
Pharmacyclics. Pharmacyclics warrants to Abbott that Drug Substance supplied to
Abbott hereunder shall meet the Drug Substance Specifications. It is agreed that
Xxxxxx'x use of Drug Substance received from Pharmacyclics shall be limited to
research and development contemplated by this Agreement and the manufacture of
Product for Pharmacyclics. Within
12
13
thirty (30) days after receipt of Drug Substance supplied by Pharmacyclics
hereunder, Abbott shall 1) examine the shipment in order to determine whether it
meets the Drug Substance Specifications, and 2) notify Pharmacyclics of any
claim that any portion of that shipment fails to meet the agreed upon Drug
Substance Specifications. In the event of such claim, Pharmacyclics shall have
the right to confirm such findings at Xxxxxx'x manufacturing location, and upon
such confirmation, Pharmacyclics shall replace, at no cost to Abbott, the
portion of the Drug Substance shipment which does not conform to the Drug
Substance Specifications. If due to an intentionally wrongful act or any
negligent act or omission on Xxxxxx'x part, and as a result thereof, Product
manufactured hereunder fails to conform with Product Specifications, Xxxxxx'x
sole liability, with respect to replacement of Product, in such case shall be
limited to replacement of Product, at no cost to Pharmacyclics, with conforming
Product using Drug Substance purchased from Pharmacyclics at Pharmacyclics'
purchase cost/kg as evidenced by Pharmacyclics' invoices provided by notice to
Abbott from time to time.
8.5.2 Title to Drug Substance supplied by Pharmacyclics hereunder shall
remain with Pharmacyclics. Abbott shall assume all responsibility and risk for
the safekeeping, storage and handling for all shipments of Drug Substance
delivered hereunder. In the event of loss or damage, Pharmacyclics shall supply
to Abbott Drug Substance required for replacement at Pharmacyclics' purchase
cost/kg as evidenced by Pharmacyclics' invoices provided by notice to Abbott
from time to time. The consumption of Drug Substance for the manufacture of
Product shall be in accordance with the maximum consumption factors to be
mutually agreed upon in writing as promptly as practicable by Abbott and
Pharmacyclics and subject to change from time to time.
13
14
8.5.3 If non-standard, specialized equipment is required to manufacture
Product for Pharmacyclics, the cost of such equipment shall be paid by
Pharmacyclics, subject to Pharmacyclics' prior approval of such costs, which
approval shall not be unreasonably withheld. Abbott shall advise Pharmacyclics
of specialized equipment required and the estimated cost(s) associated with the
purchase and installation of such equipment. Pharmacyclics shall be billed for
all approved costs after installation and acceptance of the equipment by Abbott.
Pharmacyclics shall make payment no later than thirty (30) days after receipt of
an invoice. Title to the equipment shall be in Xxxxxx'x name. Upon termination
or expiration of this Agreement, Abbott shall, at its option, transfer ownership
of such specialized equipment to Pharmacyclics or purchase the equipment by
paying Pharmacyclics the then current book value of the equipment. If Abbott
uses the specialized equipment for manufacture of a product other than Product
for Pharmacyclics, Abbott shall promptly notify Pharmacyclics and purchase the
equipment by paying Pharmacyclics the then current book value of the equipment
based on an amortization schedule in accordance with current United States
Federal Tax Codes. This provision shall not apply to any standard equipment
normally used or required for the manufacture of Product or for additional
standard equipment required to increase production capacity or efficiency at
Xxxxxx'x manufacturing plant.
8.5.4 Abbott shall manufacture Product in conformance with the Product
Specifications. Abbott shall xxxxx Pharmacyclics reference rights to all DMFs
(or equivalent information) necessary to support Pharmacyclics' applications for
marketing authorizations for the Product. To effect this, Abbott shall execute
Letters of Authorization to regulatory authorities worldwide permitting such
regulatory authorities to consult Xxxxxx'x DMFs in their
14
15
review of Pharmacyclics' Product marketing applications and marketing
authorizations. Copies of such Authorization Letters shall be sent to
Pharmacyclics. Abbott shall keep its DMFs up-to-date at all times and shall
inform Pharmacyclics prior to any modifications in order to permit Pharmacyclics
to amend or supplement any affected regulatory applications and files for the
Product. Abbott shall label Product in accordance with label copy Pharmacyclics
shall provide to Abbott. The parties may modify, by mutual agreement, such copy
from time to time. Pharmacyclics shall reimburse Abbott for Xxxxxx'x actual
costs of making any label copy changes that Pharmacyclics requests. In the event
that the Health Authority or other regulatory authority does not accept DMFs,
Abbott shall provide Pharmacyclics with all necessary information contained in
the DMFs, including manufacturing, process and proprietary information, in order
that Pharmacyclics may file a complete marketing authorization application
directly with such Health Authority or regulatory agency.
8.5.5 Xxxxxx'x quality control procedures and in-plant quality control
checks on manufacturing the Product for Pharmacyclics shall be applied in the
same manner as Abbott applies such procedures and checks to products Abbott
manufactures and sells for itself. In addition, Abbott will test and release to
Pharmacyclics Product in accordance with the test methods set forth on Exhibit
8.5.5 to assure that Product conforms to the Product Specifications. Both the
Product test methods and the Product Specifications may be changed from time to
time by agreement of the parties.
8.5.6 Pharmacyclics (or its designated agent) shall have the right, upon
reasonable written notice to Abbott, to conduct during normal business hours a
GMP quality assurance audit and inspection of Xxxxxx'x records and production
facilities relating to the manufacture of
15
16
Product, and follow-up audits as necessary. Such audits and inspections may be
conducted prior to production of the first commercial Product order placed by
Pharmacyclics and thereafter once each calendar year. In addition, Abbott shall
permit Pharmacyclics (or its designated agent), upon reasonable written notice,
to enter those areas of Xxxxxx'x production and quality control facilities
devoted to the Product and to examine production and quality control records
relating to the Product at reasonable times, and accompanied by an authorized
Abbott representative, in order to audit production of the Product or as
required to complete timely investigations of Product quality. Visits by
Pharmacyclics to Xxxxxx'x production facilities may involve the transfer of
Confidential Information and shall be subject to the terms of Article 12 hereof.
The results of such audits and inspections shall be considered Confidential
Information under Article 12 and shall not be disclosed to third persons,
including, but not limited to, the FDA and other government regulatory agencies,
unless required by law and upon prior written notice to Abbott.
8.5.7 All Product shipped to Pharmacyclics shall include a Certificate of
Analysis. Pharmacyclics shall have a period of sixty (60) days from the date of
receipt of Product to inspect and reject any shipment of Product on the grounds
that it does not conform with Product Specifications. Pharmacyclics shall have
the right to return at Xxxxxx'x cost any Product which does not conform. All or
part of any shipment shall be held for Xxxxxx'x disposition and at Xxxxxx'x
expense if found to be not in conformance with Product Specifications, provided
Abbott confirms such nonconformance through test methods described in Exhibit
8.5.5 and other mutually acceptable quality control procedures and provided
further that such nonconformance is not due to Drug Substance supplied by
Pharmacyclics hereunder. Any Product not rejected by Pharmacyclics pursuant to
this Subparagraph 8.5.7 shall be deemed accepted and all claims with
16
17
respect to Product not conforming with Product Specifications waived by
Pharmacyclics, except as to latent defects which are not reasonably
discoverable.
Provided, however, if Pharmacyclics rejects any shipment of Product
pursuant to this Section 8.5.7 (including for latent defects) and Abbott
disagrees that the rejection was reasonable and the parties can not agree within
five (5) days of initiating good faith negotiations, the parties shall use a
mutually agreed upon third party to test the Product and any relevant
information to determine whether the Product meets the Product Specifications.
The findings of such third party shall be binding on both parties. If the third
party determines that the Product meets the Product Specifications,
Pharmacyclics shall pay the cost of employing such third party and Pharmacyclics
shall be deemed have accepted the Product shipment. Alternatively, if the third
party determines that the Product does not meet the Product Specifications,
Abbott shall pay the cost of employing such third party and Abbott shall credit
Pharmacyclics' account for the cost of the Drug Substance.
8.5.8 Pharmacyclics shall notify Abbott of any Product complaints
involving Xxxxxx'x packaging in sufficient time to allow Abbott to evaluate the
complaints and assist Pharmacyclics in responding to such complaints. Abbott
shall notify Pharmacyclics of any Product complaints in sufficient time to allow
Pharmacyclics to evaluate the complaints and assist Abbott in responding to such
complaints.
8.5.9 Recalls. Pharmacyclics shall notify Abbott promptly if any Product
is the subject of a recall, market withdrawal or correction, and Pharmacyclics
and/or its designee shall have sole responsibility for the handling and
disposition of such action(s). Pharmacyclics and/or its designee shall bear the
costs of all recalls, market withdrawals or corrections of Product unless
17
18
such action(s) shall have been the result of Xxxxxx'x breach of any of the
warranties set forth in Paragraph 8.9 hereof, in which case Abbott shall bear
the cost of such action(s), including the transportation and destruction of the
Product, and shall also credit Pharmacyclics for the price paid by Pharmacyclics
for the Product; provided, however, Xxxxxx'x liability for product recall
expense hereunder shall in no event exceed the total value of monies
Pharmacyclics has paid (to date) to Abbott hereunder. Pharmacyclics and/or its
designee shall serve as the sole point (for so long as Abbott determines, in its
reasonable discretion, that Abbott does not have a significant business interest
at stake) of contact with the FDA or other Health Authority concerning any
recalls, market withdrawals or corrections with respect to the Product.
8.6 Price and Payment
8.6.1 Product shall be delivered by Abbott at prices set forth in Exhibit
8.6.1 of this Agreement.
8.6.2 Abbott shall invoice Pharmacyclics upon delivery of Product for
quantity shipped. Payment shall be made by Pharmacyclics net thirty (30) days
from the date of receipt of Xxxxxx'x invoice.
8.6.3 Pharmacyclics shall pay any federal, state, county or municipal
sales or use tax, excise, customs charges, duties or similar charge, or any
other tax assessment (other than that assessed against income), license, fee or
other charge lawfully assessed or charged on the manufacture, sale or
transportation of Product sold pursuant to this Agreement.
8.7 Delivery
Product shall be delivered to Pharmacyclics, F.O.B. Xxxxxx'x plant at
North Chicago, Illinois or other plant agreed upon by Pharmacyclics and Abbott.
Title shall pass to
18
19
Pharmacyclics at Xxxxxx'x North Chicago, Illinois plant . Shipment shall be via
a carrier that Pharmacyclics designates and to such destination that
Pharmacyclics requests in writing.
8.8 Orders and Forecasts
8.8.1 Pharmacyclics shall, within one hundred twenty (120) days after
filing its NDA for the Product, provide Abbott with a written estimate of
Pharmacyclics' quarterly requirements for commercial Product for the first year.
Abbott acknowledges that such quantities are estimates only. Provided, further,
Pharmacyclics shall have the right to order Product for clinical trials prior to
filing an NDA.
8.8.2 Abbott and Pharmacyclics shall cooperate fully in estimating and
scheduling production for the first commercial order that Pharmacyclics shall
place in anticipation of regulatory approval of the Product.
8.8.3 Pharmacyclics shall place its first firm commercial order within
three (3) months following its receipt of its first approved Product NDA. At the
same time, Pharmacyclics shall provide to Abbott Pharmacyclics' estimate of its
quarterly requirements for the next succeeding nine (9) calendar month period.
8.8.4 Prior to expiration of the first three (3) calendar month period
following the first Product regulatory approval date, Pharmacyclics shall place
a firm order for the next consecutive three (3) month period. Thereafter,
Pharmacyclics shall place its firm quarterly orders no later than ninety (90)
days prior to the commencement of each succeeding three (3) calendar month
period. At the time firm quarterly orders are placed, Pharmacyclics shall give
Abbott Pharmacyclics' estimate of its quarterly requirements for the next
succeeding nine (9) calendar month period.
19
20
8.8.5 Each purchase order for Product shall be governed by the terms of
this Agreement and none of the provisions of such purchase order shall be
applicable except those specifying quantity ordered, delivery dates, special
shipping instructions and invoice information.
8.9 Guarantees and Warranties
8.9.1 Pharmacyclics guarantees to Abbott that all Drug Substance delivered
to Abbott pursuant to this Agreement shall at the time of delivery not be
adulterated or misbranded within the meaning of the Federal Food, Drug and
Cosmetic Act, as amended, or within the meaning of any applicable state or
municipal law in which the definitions of adulteration and misbranding are
substantially the same as those contained in the Federal Food, Drug and Cosmetic
Act, as such act and such laws are constituted and effective at the time of
delivery and will not be an article which may not under the provisions of
Sections 404 and 505 of such Act be introduced into interstate commerce.
8.9.2 Abbott guarantees to Pharmacyclics that Product delivered to
Pharmacyclics pursuant to this Agreement shall, at the time of delivery, not be
adulterated or misbranded within the meaning of the Federal Food, Drug and
Cosmetic Act, as amended, or within the meaning of any applicable state or
municipal law in which the definitions of adulteration and misbranding are
substantially the same as those contained in the Federal Food, Drug and Cosmetic
Act, as such Act and such laws are constituted and effective at the time of
delivery and will not be an article which may not under the provisions of
Sections 404 and 505 of such Act be introduced into interstate commerce.
8.9.3 Abbott represents and warrants to Pharmacyclics that Product shall
be free from defects in material and workmanship and shall be manufactured and
provided by Abbott (i) in
20
21
accordance and conformity with the Product Specifications and in compliance with
this Agreement and (ii) in compliance with all applicable statutes, laws, rules
or regulations, including those relating to the environment, food or drugs and
occupational health and safety, including, without limitation, those enforced or
promulgated by the United States Food and Drug Administration (including,
without limitation, compliance with GMPs). Abbott shall also use reasonable
commercial best efforts to comply with European Union GMP requirements.
The foregoing warranties shall not extend to any nonconformity or defect
which relates to or is caused by the Drug Substance that Pharmacyclics supplies
to Abbott. Notwithstanding Subparagraph 8.9.4, solely with respect to
replacement Product the provisions of Subparagraphs 8.5.1 and 8.5.7 shall be
Pharmacyclics' sole and exclusive remedy for non-conforming or defective
Product. ABBOTT MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO
PRODUCT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION,
THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE
ARE HEREBY DISCLAIMED BY ABBOTT. Neither party shall be liable to the other for
indirect, incidental or consequential damages resulting from any breach of this
Agreement.
8.9.4 Abbott shall indemnify and hold Pharmacyclics, its affiliates,
officers, directors and employees harmless from and against all claims, causes
of action, settlement costs, including reasonable attorney's fees, losses or
liabilities of any kind related to this Agreement and asserted by third persons
which arise out of or are attributable to 1) any intentional wrongful act or any
negligent act or omission on the part of Xxxxxx'x employees, agents or
representatives, 2) the lack of safety or efficacy of the I.V. bags glass
bottles supplied by Abbott resulting from the
21
22
manufacture or sterilization performed by Abbott hereunder or 3) Xxxxxx'x
intellectual property rights relating to the manufacturing methods and processes
Abbott employs to manufacture the Product, including those rights associated
with the attendant bottles, bag, and/or Delivery Systems. Pharmacyclics shall
indemnify and hold Abbott, its affiliates, officers, directors and employees
harmless from and against all claims, causes of action, settlement costs,
including reasonable attorney's fees, losses or liabilities of any kind related
to this Agreement and asserted by third persons which arise out of or are
attributable to 1) any intentional wrongful act or any negligent act or omission
on the part of Pharmacyclics' employees, agents or representatives, 2) involve
the use of or lack of safety or efficacy of Drug Substance, Drug or Product or
3) Pharmacyclics intellectual property rights relating to the Drug. Provided,
however, neither party shall indemnify the other party for any claim, cause of
action, settlement costs, loss or liability arising out of or attributable to
such other party's breach of its obligations under this Agreement.
8.9.5 Each indemnified party agrees to give the indemnifying party prompt
written notice of any matter upon which such indemnified party intends to base a
claim for indemnification (an "Indemnity Claim") under this Subparagraph. The
indemnifying party shall have the right to participate jointly with the
indemnified party in the indemnified party's defense, settlement or other
disposition of any Indemnity Claim.
With respect to any Indemnity Claim relating solely to the payment of
money damages and which could not result in the indemnified party becoming
subject to injunctive or other equitable relief or otherwise adversely affect
the business of the indemnified party in any manner, and as to which the
indemnifying party shall have acknowledged in writing the obligation to
indemnify the indemnified party hereunder, the indemnifying party shall have the
sole right to
22
23
defend, settle or otherwise dispose of such Indemnity Claim, on such terms as
the indemnifying party, in its sole discretion, shall deem appropriate, provided
that the indemnifying party shall provide reasonable evidence of its ability to
pay any damages claimed and with respect to any such settlement shall have
obtained the written release of the indemnified party from the Indemnity Claim.
The indemnifying party shall obtain the written consent of the indemnified
party, which shall not be unreasonably withheld, prior to ceasing to defend,
settling or otherwise disposing of any Indemnity Claim if as a result thereof
the indemnified party would become subject to injunctive or other equitable
relief or the business of the indemnified party would be adversely affected in
any manner.
9. PRESS RELEASE.
After execution of this Agreement either party may issue a press release
or other public announcement regarding the Agreement; provided, however, any
such release or announcement shall be submitted prior to its issuance to the
other party for review, approval and release timing. If a party hereto has an
affirmative legal duty to publicize information relating to the subject matter
hereof, the parties agree that this Article 9 shall not be construed to restrict
such party from performing such duty.
10. NO EXPRESS OR IMPLIED LICENSE.
No license, express or implied, is granted to Pharmacyclics to use Abbott
proprietary technology, know-how or rights relating to the Delivery Systems, the
associated administration sets or filters, or formulation of I.V. solutions
other than for the purposes of this Agreement. If
23
24
Abbott deems, in its sole discretion, any improvement or invention patentable
related to Xxxxxx'x proprietary technology, know-how or rights relating to the
Delivery Systems, or formulation of I.V. or glass bottle solutions, and made or
reduced to practice in the course of this Agreement by Abbott, then Abbott shall
be entitled to apply for patent protection on such improvements or inventions at
Xxxxxx'x expense and risk. No license, express or implied, is granted to Abbott
to use Pharmacyclics' proprietary technology, know-how or rights relating to the
Drug, other than for the purposes of this Agreement. If Pharmacyclics in its
sole discretion deems patentable any improvement or invention related to
Pharmacyclics' proprietary technology, know-how or rights relating to the Drug,
then Pharmacyclics shall be entitled to apply for patent protection on such
improvements or inventions at its expense and risk.
11. TERM AND TERMINATION.
11.1 This Agreement shall commence on the Effective Date and the initial
term shall expire at the end of the fifth Contract Year. Thereafter, the term
shall continue automatically until terminated. This Agreement may be terminated
upon expiration of such five-year term upon not less than twenty-four (24)
months prior written notice from one party to the other. Thereafter this
Agreement may be terminated upon not less than twenty-four (24) months prior
written notice from one party to the other.
11.2 Pharmacyclics may terminate the product development project as
described in Article 2 at any time upon one hundred and twenty (120) days prior
written notice if Pharmacyclics determines, in good faith, that the Product is
not technically or commercially feasible. Abbott may terminate the product
development project as described in Article 2 at any
24
25
time upon one hundred and twenty (120) days prior written notice if Abbott
determines, in good faith, that the Product is not technically feasible. If the
product development project is terminated, Abbott shall advise Pharmacyclics of
Xxxxxx'x actual research and development costs on the product development
project. Based upon Xxxxxx'x actual costs and Pharmacyclics' payments to Abbott,
an appropriate adjustment, negotiated in good faith, shall be made. If
Pharmacyclics requests, Abbott shall provide to Pharmacyclics a summary of costs
payable pursuant to this Paragraph. After Pharmacyclics makes full payment of
any adjustment required by this Paragraph, this Agreement shall terminate.
11.3 Either party may terminate this Agreement by giving to the other
sixty (60) days prior written notice as follows:
a. Upon the bankruptcy or the insolvency of the other party; or
b. Upon the breach of any warranty or any other material provision of
this Agreement by the other party if the breach is not cured within
sixty (60) days after written notice thereof to the party in
default.
11.4 Upon termination (not resulting from a breach by Abbott) pursuant to
this Article 11, Pharmacyclics shall reimburse Abbott for Xxxxxx'x cost of all
supplies purchased and on hand or on order, if such supplies were ordered by
Abbott based on firm purchase orders or Pharmacyclics estimates of its
requirements of Product and such supplies cannot be reasonably used by Abbott
for other purposes. Abbott shall invoice Pharmacyclics for amounts due
hereunder. Payment shall be made pursuant to Subparagraph 8.6.2.
11.5 In the event of any termination, Abbott shall return any remaining
inventory of Drug Substance and Product to Pharmacyclics at Pharmacyclics'
expense, unless such
25
26
termination shall have been as a result of a breach of this Agreement by Abbott,
in which case such inventory shall be returned at Xxxxxx'x expense.
12. CONFIDENTIAL INFORMATION.
12.1 It is recognized by the parties that during the term of this
Agreement the parties will exchange Confidential Information. Abbott agrees that
it shall not disclose Confidential Information received from Pharmacyclics, and
shall not use Confidential Information disclosed to it by Pharmacyclics for
Xxxxxx'x benefit (other than as provided herein) or for the benefit of any third
person. Pharmacyclics agrees that it shall not disclose Confidential Information
received from Abbott, and shall not use Confidential Information disclosed to it
by Abbott for Pharmacyclics' benefit (other than as provided herein) or for the
benefit of any third person. For purposes of this Agreement, Confidential
Information shall include all information disclosed hereunder in writing and
identified as being confidential or if disclosed orally is reduced to writing
within thirty (30) days of oral disclosure and identified as being confidential,
except any portion thereof which:
a. is known to the recipient before receipt thereof under this
Agreement;
b. is disclosed in good faith to the recipient after acceptance of this
Agreement by a third person lawfully in possession of such
information and not under an obligation of nondisclosure;
c. is or becomes part of the public domain through no fault of the
recipient;
d. is developed by the recipient independently of information disclosed
hereunder as evidenced by the recipient's written records or other
competent evidence; or
26
27
e. is required by law to be disclosed.
Notwithstanding the above, nothing contained in this Agreement shall
preclude Pharmacyclics or Abbott from utilizing Confidential Information as may
be necessary in prosecuting patent rights of the parties pursuant to Article 12
hereof, or obtaining governmental marketing approvals, or in manufacturing
Product pursuant to this Agreement; provided that each party shall use efforts
to maintain the confidentiality of the other party's Confidential Information at
least commensurate with its own efforts to protect its own Confidential
Information. The obligations of the parties relating to Confidential Information
shall expire ten (10) years after the termination of this Agreement.
13. FORCE MAJEURE.
13.1 Any delay in the performance of any of the duties or obligations of
either party hereto (except the payment of money) shall not be considered a
breach of this Agreement and the time required for performance shall be extended
for a period equal to the period of such delay, provided that such delay has
been caused by or is the result of any acts of God, acts of the public enemy,
insurrections, riots, embargoes, labor disputes, including strikes, lockouts,
job actions, or boycotts, fires, explosions, floods, shortages of material or
energy, or other unforeseeable causes beyond the control and without the fault
or negligence of the party so affected. The party so affected shall give prompt
notice to the other party of such cause, and shall take whatever reasonable
steps are necessary to relieve the effect of such cause as rapidly as possible.
13.2 If Abbott becomes subject to an event of force majeure or problems
are encountered which interfere with production of Product at Xxxxxx'x North
Chicago plant, the
27
28
parties shall mutually agree on implementation of an agreed upon action plan to
transfer production to another Abbott plant, contemplated on the date of this
Agreement to be at Xxxxxx'x Rocky Mount, North Carolina plant. However, if
Abbott transfers production of the Product to another Abbott plant for other
than an event of force majeure, Abbott shall be responsible for equipment and
validation expenses. Parties shall meet after the execution of this Agreement
and at the request of either party to discuss and define such an action plan.
14. NOTICES.
All notices hereunder shall be delivered personally, or by registered
or certified air mail, postage prepaid, to the following addresses of the
respective parties:
To: Pharmacyclics:
Xxxx Xxxxxx
VP Business Development
000 X. Xxxxxx Xxx.
Xxxxxxxxx, XX 00000
With copy to: General Counsel
000 X. Xxxxxx Xxx.
Xxxxxxxxx, XX 00000
To: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx 00000-0000 U.S.A.
Attention: General Counsel
With copy to: President,
Hospital Products Division
With copy to: Domestic Legal Operations
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, XX 00000-0000
Attention: Divisional Vice President
28
29
Notices shall be effective upon receipt if personally delivered or
delivered by facsimile, or on the third business day following the date of
mailing. A party may change its address listed above by notice to the other
party.
15. APPLICABLE LAW AND ALTERNATIVE DISPUTE RESOLUTION.
15.1 This Agreement shall be construed, interpreted and governed by the
laws of the State of Illinois, except for its or any other jurisdiction's choice
of law rules.
15.2 Dispute Resolution. The parties recognize that bona fide disputes may
arise which relate to the parties' rights and obligations under this Agreement.
Both parties agree that such disputes (except for those disputes relating to
Product conformance which shall be addressed in the manner described in
Subparagraph 8.5.7 hereof) shall be resolved by Alternative Dispute Resolution
("ADR") in accordance with the procedure set forth in Exhibit 15.2.
16. ASSIGNMENT.
Neither party shall assign this Agreement nor any part thereof without the
prior written consent of the other party; provided, however, 1) either party may
assign this Agreement to one of its wholly owned subsidiaries without the other
party's consent, or 2) either party, without such consent, may assign or sell
the same in connection with the transfer or sale of substantially its entire
business to which this Agreement pertains or in the event of its merger or
consolidation with another company. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. No assignment shall relieve
any party of responsibility for the performance of any accrued obligation which
such party then has hereunder.
29
30
17. ENTIRE AGREEMENT.
This Agreement constitutes the entire agreement between the parties
concerning the subject matter hereof and supersedes all written or oral prior
agreements or understandings with respect thereto.
18. SEVERABILITY.
This Agreement is subject to the restrictions, limitations, terms and
conditions of all applicable governmental regulations, approvals and clearances.
If any term or provision of this Agreement shall for any reason be held invalid,
illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other term or provision hereof, and this
Agreement shall he interpreted and construed as if such term or provision, to
the extent the same shall have been held to be invalid, illegal or
unenforceable, had never been contained herein.
19. WAIVER - MODIFICATION OF AGREEMENT.
No waiver or modification of any of the terms of this Agreement shall be
valid unless in writing and signed by authorized representatives of both parties
hereto. Failure by either party to enforce any such rights under this Agreement
shall not be construed as a waiver of such rights nor shall a waiver by either
party in one or more instances be construed as constituting a continuing waiver
or as a waiver in other instances.
20. EXHIBITS.
All Exhibits referred to herein are hereby incorporated by reference
thereto.
30
31
21. SUBLICENSEES.
Abbott shall negotiate in good faith to enter into a Development and
Supply Agreement with Pharmacyclics' sublicensees which would contain such
representations, warranties, indemnities, covenants and provisions normally
associated with pharmaceutical manufacturing/supply arrangements and be similar
to those contained in this Agreement.
The parties intending to be bound by the terms and conditions hereof
have caused this Agreement to be signed by their duly authorized
representatives on the date first above written.
XXXXXX LABORATORIES PHARMACYCLICS
By /s/ By /s/
------------------------------- ----------------------------
Name (Printed) Xxxxxxx X. Xxxxxxxx Name (Printed) Xxxx Xxxxxx
-------------------- -----------------
Title SVP/ President Title SVP/CFO
----------------------------- --------------------------
Date 7/28/98 Date 24 June 98
------------------------- ---------------------------
31
32
Development and Supply Agreement
Pharmacyclics
and
Xxxxxx Laboratories
Exhibit 1.5
Drug Substance Specifications
Parameter Specification
33
-------------------------------------------------------------------------------
DRUG SUBSTANCE PART NUMBER: [***]
FINAL PRODUCT
SPECIFICATIONS SPECIFICATION REVISION NUMBER: 1
-------------------------------------------------------------------------------
ITEM: [***]
-------------------------------------------------------------------------------
QUALITY APPROVAL DATE EXPIRATION PERIOD: TBD
SAMPLE SIZE: [***]
[SIG] 14 APR 98 RETAINED SAMPLE:[***]
CHEMICAL FORMULA: [***] FORMULA WT:[***]
DESCRIPTION: [***] PRECAUTIONS IN HANDLING: SEE MSDS
STORAGE CONDITIONS: [***]
-------------------------------------------------------------------------------
TESTING REQUIREMENTS METHOD SPECIFICATIONS
[***] [***] [***]
-------------------------------------------------------------------------------
*** Indicates that material has been omitted and confidential treatment
requested therefor. All such omitted material has been filed separately with
the Commission pursuant to Rule 24b-2.
34
PROCEDURE UTILIZING F-0020: SPECIFICATIONS COMMITTEE (QAM-005)
PART NUMBER: FP-LL#. Issued by Quality Assurance Department
SPECIFICATION EDITION NUMBER: First issuance = 1, second = 2, etc...
ITEM: Final Product's name
EXPIRATION DATE: The expiration date is assigned by the PCYC
Quality Assurance Department
RETAINED SAMPLE: A quantity sufficient to perform all required
tests at least twice. Cannot be used without
written authorization from the head of the
Quality Assurance Department
SAMPLE SIZE: A quantity sufficient to perform all required
tests
TESTING REQUIREMENTS: Names of tests performed
METHOD: Designated method numbers (QCM-###)
SPECIFICATIONS: Parameters within which test results must fall in
order to allow the Quality Control Department to
release the Final Product
35
Development and Supply Agreement
Pharmacyclics
and
Xxxxxx Laboratories
Exhibit 1.13
Product Specifications
36
--------------------------------------------------------------------------------
DRUG PRODUCT PART NUMBER: [***]
FINAL PRODUCT [LOGO]
SPECIFICATIONS SPECIFICATION EDITION NUMBER: 2
--------------------------------------------------------------------------------
ITEM: [***]
--------------------------------------------------------------------------------
QUALITY ASSURANCE APPROVAL DATE
[SIG] 7 AUG 96
--------------------------------------------------------------------------------
TESTING REQUIREMENTS METHOD SPECIFICATIONS
[***] [***] [***]
--------------------------------------------------------------------------------
*** Indicates that material has been omitted and confidential treatment
requested therefor. All such omitted material has been filed separately with
the Commission pursuant to Rule 24b-2.
37
PROCEDURE UTILIZING F-0012: SPECIFICATIONS COMMITTEE (QAM-005)
PART NUMBER: FP-LL#. Issued by Quality Assurance Department.
SPECIFICATION EDITION NUMBER: First issuance = 1, second = 2, etc.
ITEM: Final Product's name.
COMPOSITION: A listing of the product's components.
% DEFINED AS (W/V): (Weight (grams) of component + unit volume of Final Product)
X 100
EXPIRATION DATE: The expiration date is assigned by the Pharmacyclics Quality
Assurance Department.
RETAINED SAMPLE: A quantity sufficient to perform all required tests at least
twice. Cannot be used without written authorization from the head of the Quality
Assurance Department.
SAMPLE SIZE: A quantity sufficient to perform all required tests.
38
DRUG PRODUCT PART NUMBER: [***]
FINAL PRODUCT
SPECIFICATIONS SPECIFICATION EDITION NUMBER: 2
--------------------------------------------------------------------------------
Item: [***]
--------------------------------------------------------------------------------
EXPIRATION DATE: TBD
QUALITY ASSURANCE APPROVAL DATE STORAGE CONDITIONS: [***]
RETAINED SAMPLE: [***]
[SIG] 7 Aug. 96 SAMPLE SIZE: [***]
--------------------------------------------------------------------------------
COMPOSITION PERCENT DEFINED AS [w/v]
[***] [***]
--------------------------------------------------------------------------------
*** Indicates that material has been omitted and confidential treatment
requested therefor. All such omitted material has been filed separately with
the Commission pursuant to Rule 24b-2.
39
PROCEDURE UTILIZING F-0012: SPECIFICATIONS COMMITTEE (QAM-005)
PART NUMBER: FP-LL#. Issued by Quality Assurance Department.
SPECIFICATION EDITION NUMBER: First issuance = 1, second = 2, etc.
ITEM: Final Product's name.
COMPOSITION: A listing of the product's components.
% DEFINED AS (W/V): (Weight (grams) of component + unit volume of Final
Product) X 100
EXPIRATION DATE: The expiration date is assigned by the Pharmacyclics Quality
Assurance Department.
RETAINED SAMPLE: A quantity sufficient to perform all required tests at least
twice. Cannot be used without written authorization from the head of the
Quality Assurance Department.
SAMPLE SIZE: A quantity sufficient to perform all required tests.
40
Development and Supply Agreement
Pharmacyclics
and
Xxxxxx Laboratories
Exhibit 8.6.1
Product Prices
Premix Bottle 50 mL Fill Volume 200 mL Fill Volume
-------------------------------------------------------------------------
[***] [***] [***]
Premix CR3 Flexible
Container 50 mL Fill Volume 200 mL Fill Volume
------------------------------------------------------------------------
[***] [***] [***]
Prices are firm through 1999. Beginning January 1, 2000 and on each succeeding
January 1 during the term hereof, prices may be adjusted by Abbott. Price
adjustment shall be effective for deliveries beginning January 1 of each year.
Such adjustment shall not exceed the annual percentage increase for the most
recent twelve (12) month period for which figures are available in the Price
Index, Pharmaceutical Preparations, Ethical (Prescription), Commodity Code
06-35, issued by the Bureau of Labor Statistics, U.S. Department of Labor times
a factor of [***].
The price per bottle is for Product packaged twelve (12) unites per corrugate
shipper. The price per flexible container is for Product packaged in twenty-four
(24) units per corrugate shipper.
*** Indicates that material has been omitted and confidential treatment
requested therefor. All such omitted material has been filed separately with
the Commission pursuant to Rule 24b-2.
41
Development and Supply Agreement
Pharmacyclics
and
Xxxxxx Laboratories
Exhibit 8.5.5
Product Test Methods
42
Development and Supply Agreement
Pharmacyclics
and
Xxxxxx Laboratories
Exhibit 3
Drug Solution Extractable Studies
43
Development and Supply Agreement
Pharmacyclics
and
Xxxxxx Laboratories
Exhibit 15.2
Alternative Dispute Resolution
The parties recognize that bona fide disputes may arise which relate to the
parties' rights and obligations under this Agreement. Both parties agree that in
the event of such a dispute, they shall refer the dispute to the respective
presidents or their equivalents (the "Resolution Officers") of the affected
business units. The Resolution Officers will endeavor, in good faith, to resolve
the dispute.
In the event the Resolution Officers are unable to resolve the dispute within
fifteen (15) days of the day the dispute is first referred to the Resolution
Officers and the dispute relates solely to a Technical or Regulatory Matter (as
defined below), the parties shall, within fifteen (15) days of the date on which
the Resolution Officers have determined they are unable to resolve the dispute,
select a mutually agreeable outside consulting firm which they will instruct to
review the details of the dispute and any submissions from the parties. The
consulting firm will then issue a binding ruling on the Technical or Regulatory
Matter. Such binding ruling shall be issued within thirty (30) days of the date
on which the matter is first presented to the consulting firm.
If the consulting firm agrees with Pharmacyclics' position on the Technical or
Regulatory Matter, Xxxxxx will pay the fees and costs of such consulting firm.
If the consulting firm agrees with Xxxxxx'x position on the Technical or
Regulatory Matter, Pharmacyclics will pay the fees and costs of such consulting
firm. If the consulting firm agrees in part with Pharmacyclics' position and in
part with Xxxxxx'x position on the Technical or Regulatory Matter, the
consulting firm will determine how its fees and costs shall be divided between
the parties.
In the event the Resolution Officers are unable to resolve the dispute within
fifteen (15) days of the day the dispute is first referred to the Resolution
Officers and the dispute does not relate solely to a Technical or Regulatory
Matter, the parties will consider in good faith resolving the dispute through
alternative dispute resolution techniques before pursuing litigation.
Notwithstanding the foregoing, neither party shall be precluded, at any time,
from seeking relief of any nature in an applicable court of law.
For purposes of this Section, "Technical or Regulatory Matter" shall mean any
matter concerning whether (i) the relevant specifications are being met; or (ii)
Product is manufactured in accordance with GMP and other applicable statutes,
laws, rules and regulations.
