1
Exhibit 10.4
CONFIDENTIAL TREATMENT REQUESTED
SUPPLY AGREEMENT
BETWEEN
SMITHKLINE XXXXXXX CORPORATION
AND
CONNECTIVE THERAPEUTICS, INC.
FOR
RIDAURA
(AURANOFIN)
2
FINAL FINISHED PHARMACEUTICALS SUPPLY AGREEMENT
RIDAURA(R)
This is a Supply Agreement for final finished pharmaceuticals
("Agreement") effective as of January 7, 1997 by and between SmithKline Xxxxxxx
Pharmaceuticals, a division of SmithKline Xxxxxxx Corporation, a Pennsylvania
corporation having a place of business at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx, XX
00000 ("SB" or "SELLER"), and Connective Therapeutics, Inc., a Delaware
corporation having a place of business at 0000 Xxxx Xxxxxxxx Xxxx, Xxxx Xxxx, XX
94303("BUYER");
BACKGROUND
A. The Parties hereto have entered into an Asset Purchase Agreement dated
December 2, 1996 ("the Asset Purchase Agreement") and a Transitional
Services Agreement, dated as of January 7, 1997 pursuant to which SB is
transferring to BUYER certain rights to products known as Ridaura(R)
containing auranofin as the sole active ingredient and assets relating
thereto, including the FDA-approved New Drug Application for Ridaura
("NDA");
B. SB has manufactured Ridaura and has the appropriate registrations,
approvals, facilities and the ability to continue to manufacture
products pursuant to the NDA;
C. In connection with Asset Purchase Agreement, BUYER desires to purchase
Ridaura from SB in final finished package form as specified in Exhibit
A ("Products");
D. SB desires to manufacture and supply Product to BUYER, subject to the
terms and conditions of this Agreement;
NOW, THEREFORE, in consideration of the foregoing premises and the
promises herein, the parties, intending to be legally bound, agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 Affiliate of an entity means, for so long as one of the following
relationships is maintained, any corporation or other business entity controlled
by, controlling, or under common control with no other entity; with "control"
meaning direct or indirect beneficial ownership of more than fifty percent (50%)
of the voting stock of such corporation, or more than fifty percent (50%)
interest in the decision-making authority of such other unincorporated business
entity;
1.2 Final Finished Pharmaceutical(s) shall mean the Product(s)
packaged in final form and ready for sale by BUYER to BUYER's ultimate customer.
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1.3 cGMP shall mean current good manufacturing practices of the FDA,
as set forth in 21 C.F.R. Parts 210 and 211 and all applicable rules,
regulations, guides and guidances.
1.4 FDA shall mean the United States Food and Drug Administration or
comparable state or local authority.
1.5 Product(s) shall mean the Final Finished Pharmaceutical(s) listed
in EXHIBIT A.
1.6 SB Quality Assurance Requirements shall mean the requirements set
forth in EXHIBIT C.
1.7 Specifications shall mean the requirements and standards
pertaining to the Product as set forth in EXHIBIT A.
1.8 Price shall mean the prices set forth in EXHIBIT B.
1.9 Adverse Reactions shall mean the definitions as set forth in
EXHIBIT D.
1.10 Territory shall mean the United States, its possessions and
territories, including Puerto Rico, and Canada.
ARTICLE 2 - ORDERS, PRICING, PAYMENT AND CONFORMANCE
2.1 Exclusivity and Requirements
SB shall sell Product exclusively to BUYER for sale in the
Territory and shall supply all of BUYER's reasonable requirements of Product in
the Territory.
2.2 Forecasts and Orders
(a) Orders for Product shall be in full lot sizes, as defined in
Exhibit A, or full multiples thereof.
(b) Simultaneously with the execution of this Agreement for the
period remaining in the current calendar year and then by October 1st of each
year during the term of this Agreement, BUYER shall provide SB with a 12 month
forecast to run from January 1st to December 31st of the next calendar year of
BUYER's estimated requirements of the Product, which forecast may be updated
every three (3) months. The first three (3) months of each rolling 12-month
forecast or updated forecast shall be a binding order against which SB is
authorized to manufacture.
(c) SB agrees to deliver the Product in such quantities and on
such delivery dates as are specified in BUYER's forecast. SB agrees to meet
BUYER's revised forecasts and
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orders up to a [*]% increase over the most recent forecasted requirements for
the Product for said period.
BUYER will bear the reasonable out-of-pocket costs incurred by SB
in connection with any delay in the shipment of the Product caused by BUYER's
rescheduling of shipping dates.
(d) BUYER is not obligated to buy any specific amount of Product
under this Agreement and shall be obligated to purchase only those quantities
for which it has submitted a binding order.
(e) Notwithstanding the foregoing, BUYER agrees to purchase all
remaining inventory of lot numbers 3025R79 and 3016R79 of Product in SB's
possession (which lots are the same lots identified in Schedule 5.6 of the Asset
Purchase Agreement), as of the date one year after the effective date of the
Transitional Services Agreement at the price set forth in Exhibit A.
2.3 Price; Payment; Shipment.
(a) The price for the Product ordered is set forth in EXHIBIT B,
F.O.B. SB manufacturing site, freight collect. Risk of loss in transit shall lie
with BUYER. SB may adjust the price annually to account for any reasonable
increase in the direct cost of labor and materials, with such increase not to
exceed the cumulative percentage increase in the Consumer price Index, as
published by the U.S. Department of Labor on a national basis using 1996 as the
base year. If any increase exceeds this amount the parties agree to discuss such
increases.
(b) BUYER agrees to pay SB for the Product as set forth above, net
thirty (30) days from the receipt of invoice. All payments hereunder shall be
made in U.S. Dollars.
2.4 Acceptance - Within thirty (30) days of receipt of any Product,
BUYER shall perform such samplings and tests as it deems appropriate, if any,
using validated test methods described in the NDA to determine whether the
Product meets the Specifications. If BUYER wishes to reject any shipment, BUYER
shall within such thirty (30) days' time, inform SB in writing of its refusal to
accept the lot(s), and the reasons therefor. Any Product not timely rejected
shall be deemed accepted. In the event that BUYER rejects any shipment, SB, upon
confirmation of the reasons for rejection, shall either replace the defective
Products or refund the purchase price, as SB may elect. If SB and BUYER do not
agree on the rejection of Product, then either party may refer the matter for
final analysis to a specialized laboratory of national reputation reasonably
acceptable to both parties for the purpose of determining whether the Product
meet Specifications. Any determination by such laboratory shall be binding upon
both parties.
2.5 Testing; Certificate of Analysis and Conformance - SB shall
provide a certificate of analysis and Conformance ("COA") to BUYER for each
shipment of Product.
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* Confidential Treatment has been requested for the language which has been
omitted. All such omitted material has been filed separately with the SEC.
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ARTICLE 3 - WARRANTIES, COVENANTS AND INDEMNIFICATION
3.1 General Warranty and Indemnification.
(a) SB warrants that the Product is and will be manufactured in
accordance with cGMPs, and, at the time of delivery of the Product, the Product
will be free from defects in materials and workmanship and shall not be
adulterated or misbranded within the meaning of the U.S. Federal Food, Drug, and
Cosmetic Act, and is not an article which may not, under the Act, be introduced
into interstate commerce. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, SB MAKES
NO EXPRESS OR IMPLIED WARRANTY AS TO THE MERCHANTABILITY OF THE PRODUCT, OR AS
TO ITS FITNESS FOR A PARTICULAR PURPOSE AND DISCLAIMS ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED. BUYER shall not be entitled to incidental, indirect or
consequential damages, including damages from loss of profits, loss of use or
loss of goodwill as a result of any breach of warranty by SB.
(b) In the event that any Product is quarantined or recalled, or
is subject to stop-sale action, whether voluntary or by governmental action, it
is agreed and understood that any expenses, including reasonable fees of any
experts or attorneys that may be utilized by either party, government fines or
penalties, related to such recall, quarantine or stop-sale, shall be borne by
BUYER unless it is determined that SB has breached its obligations under this
Agreement and such breach is the sole basis upon which said recall, quarantine
or stop-sale was initiated. Said determination may be made by the governmental
agency involved, or by mutual agreement of the parties following examination and
review of all records pertinent to the manufacture of the Product subject to
such recall.
(c) SB agrees to defend, indemnify and hold BUYER and its
affiliates, directors, employees and agents harmless from and against any
claims, liabilities, damages, costs or expenses (including reasonable attorney's
fees) resulting from any claims by a third party arising solely out of (i) the
fault or negligence of SB; or (ii) any material misrepresentation or breach of
warranty of SB contained in this Agreement or in any exhibit or schedule hereto,
or in any other statement, certificate or document furnished or to be furnished
to BUYER pursuant hereto or in connection with the transactions contemplated
hereby; or (iii) any material breach of a covenant or obligation of SB contained
in this Agreement; provided however that this indemnity shall exclude indirect,
incidental, indirect or consequential damages.
(d) BUYER agrees to defend, indemnify and hold SB and its
affiliates, directors, employees and agents harmless from and against any
claims, liabilities, damage, costs or expenses (including reasonable attorney's
fees) resulting from any claim except to the extent that SB is otherwise
obligated to indemnify BUYER under this Agreement.
(e) No party against whom a claim of indemnity is made under
this Agreement shall be liable unless the party making such claim shall (i)
notify the indemnifying party of such claim promptly upon becoming aware of the
existence or threatened existence of any such claim giving rise to or which may
give rise to a claim of indemnity and (ii) cooperate in the defense of such
claim.
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3.2 Manufacture of the Product.
(a) SB shall manufacture and deliver the Product to BUYER at all
times in full compliance with cGMPs and SB Quality Control Requirements. SB
shall maintain all records as are necessary and appropriate to demonstrate
compliance with cGMPs.
(b) SB may manufacture the Product(s) at any site now or hereafter
identified in the NDA, as amended, including, its facilities at Spring Garden
Street, Philadelphia, Pa and Cidra, Puerto Rico.
(c) Subject to Section 6.6 below, upon SB's request, BUYER agrees
cooperate with SB and to use its best efforts to transfer the technology and
know-how to manufacture the Product to a third party reasonably acceptable to
BUYER and to assign to such third party all rights and obligations under this
Agreement, without recourse to SB.
SB does not guarantee the price that any third party may seek to
charge for the product.
(d) Lonza, the current supplier of bulk active auranofin approved
in the NDA, has decided to stop the manufacture of auranofin. Therefore, subject
to Section 6.6. below, SB intends, at its expense, to perform the necessary
studies to qualify Xxxxxxx Xxxxxxx as an approved supplier by preparing a
supplemental NDA to submit to FDA and then, pursuant to a supply agreement, to
obtain bulk active auranofin from Xxxxxxx Matthey. BUYER agrees to cooperate
with SB to qualify Xxxxxxx Xxxxxxx as an approved supplier under the NDA. BUYER
agrees, to submit to FDA, and diligently pursue approval of, the supplemental
NDA, and to assume BUYER's incidental expenses in connection with such filing.
(e) Subject to Section 6.6 below, if SB desires to transfer the
manufacture of Product, SB will cooperate with BUYER in the selection of to a
third party manufacturer; and, SB will perform, at SB's expense, all studies
required by FDA in connection therewith. SB shall prepare, or have prepared, a
supplemental NDA and/ or a drug master file seeking authorization for the
transfer. BUYER agrees, to submit to FDA, and diligently pursue approval of,
the supplemental NDA, and to assume BUYER's incidental expenses in connection
with such filing. BUYER, at its own expense, may also arrange for the
manufacture of product by a third party and, in such case, SB will provide
reasonable cooperation in any such arrangement.
(f) BUYER shall have the right, on reasonable advance notice and
during normal business hours once per year during the term of this Agreement, to
inspect and audit SB's facilities and operations to confirm compliance with the
covenants contained in this Agreement.
(g) SB shall provide all active and inactive raw materials,
components, packaging, containers, labeling, release testing, quality control,
equipment, labor, and other necessary services and materials, as part of the
price for Product.
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3.3 Regulatory Matters.
(a) BUYER shall maintain the NDA in good standing during the term of
this agreement, and SB shall maintain all regulatory and governmental permits,
licenses and approvals, such as drug establishment registration and drug master
file, that may be necessary to manufacture and ship the Product to BUYER.
(b) SB shall maintain all regulatory and governmental permits,
licenses and approvals that may be necessary to manufacture and ship the Product
to BUYER.
(c) During the term of this Agreement, SB will be responsible for any
reporting of matters regarding the manufacture of Product to the FDA in
accordance with pertinent laws and regulations. SB shall furnish copies of such
reports to BUYER. SB shall also advise BUYER of any occurrences or information
which arises out of SB's manufacturing activities which have or could reasonably
be expected to have adverse regulatory compliance and/or reporting consequences
concerning Product.
(d) SB shall be responsible for handling and responding to any FDA or
other governmental agency inspections with respect to the manufacture of the
Product during the term of this Agreement. SB shall provide to BUYER any
information reasonably requested by BUYER and all information requested by any
governmental agency in connection with any governmental inspection related to
the Product.
(e) Except as otherwise provided herein, SB will obtain the advance
written consent of BUYER for changes relating to the manufacturing process of
the Product or relating to any of the materials, functions, or controls of the
Product.
(f) In the event SB is inspected by the FDA, or any similar or related
state or federal health authority, SB shall promptly notify BUYER of any written
alleged violations or deficiencies relating to the manufacturing facility at
which Products are manufactured, packaged or stored.
3.5 Complaints and Recalls
(a) Product Complaints - Product complaint reports concerning
manufacture of Product received by BUYER will be faxed within 2 business days
to:
SmithKline Xxxxxxx Pharmaceuticals,
Xxx Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attn: Xxxxx Xxxxxxxxxx
Fax:000-000-0000
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Product complaint reports received by SB will be faxed within 2
business days to:
Connective Therapeutics, Inc.
0000 Xxxx Xxxxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attn: Xxxxxxx X. Xxxxxx
Fax: (000) 000-0000
(b) SB will promptly investigate all complaints associated with the
manufacture of Product and provide a written summary to BUYER. BUYER will
investigate all other Product Complaints associated with the Product regarding
and provide a written summary to SB. BUYER also will provide a written response
on each complaint to each complainant with a copy to SB.
(c) Recalls - In the event SB should be required to initiate a recall,
field alert, Product withdrawal or field correction pursuant to any Product
provided under this Agreement, SB shall immediately notify BUYER in writing. In
the event that BUYER believes that a recall, field alert, Product withdrawal, or
field correction is necessary for Product provided under this Agreement, BUYER
shall so notify SB. SB will be responsible for all costs and expenses associated
with any recall field alert, Product withdrawal or field correction arising
solely from SB's negligence
3.6 Adverse Reaction Reports BUYER and SB shall observe the procedures and
notification requirements with respect to adverse reactions described in the
attached EXHIBIT D.
3.7 Insurance. During the term of this Agreement, SB and BUYER shall
maintain their own respective comprehensive general liability, property damage
insurance, and product liability insurance with respect to the Product, in such
amounts and with such scope of coverage as are adequate to cover the obligations
under this Agreement and as are appropriate for companies of like size, taking
into account the scope of activities contemplated herein. BUYER shall, at the
request of SB, provide SB with proof of such insurance.
ARTICLE 4 - TERM AND TERMINATION
4.1 This Agreement shall have an initial term of five (5) years commencing
on the date first set forth above, and, unless terminated as provided in this
Agreement
4.2 Either party may terminate this Agreement by giving sixty (60) days
notice to the other party if the other party is in material breach of any term
of this Agreement and fails to cure that breach within such sixty (60) day
period.
4.3 This Agreement may be canceled upon thirty (30) days' prior written
notice by either party at any time during this Agreement if the other party
shall file in any court pursuant to any statute of any government in any country
a petition in bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of the party
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or of its assets; or if any other party proposes a written agreement of
composition for extension of its debts; or if the other party shall be served
with an involuntary petition against it, filed in any insolvency proceeding, and
such petition shall not be dismissed within sixty (60) days after filing
thereof; or if the other party shall be a party to any dissolution or
liquidation, or if the other party shall make a general assignment for the
benefit of its creditors; or if the other party is subject to any final order of
debarment which can be expected to have a material adverse effect on the sales
of the Product.
4.4 Upon termination, SB will deliver and BUYER shall promptly pay SB for
all inventory of Products, raw materials, components and works in progress
together with copies of records relating to the NDA and to the manufacture of
Product that have not already been provided pursuant to the Asset Purchase
Agreement.
ARTICLE 5 - CONFIDENTIALITY
5.1 SB shall use the same efforts to maintain the confidentiality of any
proprietary or confidential information regarding the manufacture or sale of the
Products as SB uses with respect to its own prescription pharmaceutical
products; provided, however, that any such confidential or proprietary
information (a) may be used by SB in performing its obligations under the Supply
Agreement, (b) may be shared, subject to execution of a confidentiality
agreement, with potential third party manufacturers of the Products and (c) may
be disclosed, subject to execution of a confidentiality agreement, with
potential purchasers of rights outside the Territory to product lines for which
auranofin is an active ingredient; provided that no information specific to
Purchaser shall be disclosed in such context.
5.2 SB's obligations hereunder shall not apply to information which: (i)
is already in the public domain at the time of disclosure; (ii) becomes part of
the public domain through no action or omission of SB after disclosure to the
receiving party; (iii) has been or is disclosed to SB in good faith by a third
party who was or is not, at the time of disclosure, under any obligation of
confidence to BUYER at the time the third party disclosed such information; or
(v) is required to be disclosed by law.
5.3 This Article 5 shall survive expiration or termination of this
Agreement for a period of ten (10) years.
ARTICLE 6 - MISCELLANEOUS
6.1 Corporate Organization and Authority. Each party represents and
warrants that it is a company duly organized, validly existing, and in good
standing under the laws of the jurisdiction wherein it is organized, and that it
has all necessary power and authorization to assume the obligations under this
Agreement, and to discharge them pursuant to the terms hereof.
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6.2 Public Announcements.
The parties hereto agree that no disclosure or public announcement with
respect to this Agreement or any of the transactions contemplated by this
Agreement shall be made by any party hereto without the prior written consent of
SB or Buyer provided, however, that nothing herein contained shall restrict SB
or BUYER from making any public announcement of the transactions contemplated by
this Agreement to the extent that it, in its sole discretion reasonably
exercised, is of the view that such announcement is required or deemed advisable
in order to meet its obligations under the securities laws or stock exchange
requirements in the United Kingdom or the United States of America; provided
further that prior to making such announcement, the party making it shall
provide particulars thereof in writing to the other party. Notwithstanding the
foregoing, BUYER may disclose this Agreement and the transactions contemplated
hereby, to the extent reasonably necessary, in connection with (a) a private
placement of securities for the purpose of obtaining the financing necessary to
pay the Purchase Price (as defined in the Asset Asset Purchase Agreement) and
the fees and expenses related to the Asset Purchase Agreement, the transactions
contemplated thereby and such financing, (b) BUYER's filing and disclosure
obligations under the Securities Act of 1934, as amended, including the filing
of the Asset Purchase Agreement and all exhibits with the Securities and
Exchange Commission, and/or (c) any registration of one or more of the Products
with any state or Federal agency.
6.3 Force Majeure. Neither party shall be liable to the other if, and to
the extent, that the performance or delay in performance of any of its
obligations under this Agreement is prevented, restricted, delayed or interfered
with due to circumstances beyond the reasonable control of such party,
including, but not limited to, government legislation, fires, floods,
explosions, epidemics, accidents, acts of God, wars, riots, strikes, lockouts or
other concerted acts of workers and/or acts of government. The party claiming an
event of force majeure shall promptly notify the other party in writing, and
provide full particulars of the cause or event and the date of first occurrence
thereof, as soon as possible after the event and also keep the other party
informed of any further developments. The party so affected shall use its best
efforts to remove the cause of non-performance, and both the parties shall
resume performance hereunder with the utmost dispatch when such cause is removed
unless this Agreement is previously expired or terminated under Article 4
hereof.
6.4 Amendment and Waiver. This Agreement may be amended only by a writing
which specifically states that such an amendment is its purpose and which is
signed by both parties. No course of dealing between the parties or failure by
either party to exercise any right or remedy hereunder shall constitute an
amendment to this Agreement or a waiver of any other right or remedy or the
later exercise of any right or remedy.
6.5 Governing Law. This Agreement shall be governed by and construed in
accordance with the substantive law of the Commonwealth of Pennsylvania without
regard to its rules for conflicts of law.
6.6 Successors and Assigns. The provisions of this Agreement shall be
binding upon and inure to the benefit of the parties hereto and their respective
successors and assigns; provided, however, that no party may assign, delegate or
otherwise transfer any of its rights or obligations
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under this Agreement without first receiving the prior written consent of the
other party hereto which consent shall not be unreasonably withheld, except that
either party may assign and delegate its rights and duties hereunder without
obtaining such consent (i) to any Affiliate or subsidiary of such party, or (ii)
to any party or entity which acquires substantially all of the business or
assets of such party if such party guarantees the performance of the acquiring
party and the acquiring party expressly assumes the assigning party's
obligations hereunder.
6.7 Nature of Agreement. In operating under the Agreement, each party
shall act independently and this Agreement shall not be construed as creating
any partnership, joint venture or incorporated business entity. Neither party
shall have any authority to incur any liability or obligation whatsoever on
behalf of the other.
6.8 Notice. Any notice, direction or other instrument required or
permitted to be given to Vendor hereunder shall be in writing and may be given
by delivering the same or sending the same by telecommunication addressed to SB
as follows:
To: SmithKline Xxxxxxx Pharmaceuticals
Xxx Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attn: Xxxxxxx Xxxxxxxxxx
Fax: 000-000-0000
Copy to: SmithKline Xxxxxxx Corporation
Xxx Xxxxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attn: General Counsel, U.S.
Fax: 000-000-0000
Any notice, direction or other instrument required or permitted to be
given to BUYER hereunder shall be in writing and may be given by delivering the
same or sending the same by telecommunication addressed to BUYER as follows:
To: Connective Therapeutics, Inc.
0000 X. Xxxxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attn: Chief Executive Officer
Fax:(000) 000-0000
Copy to: Venture Law Group
0000 Xxxx Xxxx Xxxx
Xxxxx Xxxx, XX 00000
Attn: Xxxxxx X. Xxxxx
Fax: (000) 000-0000
Any such notice, direction or other instrument, if delivered, shall be
deemed to have been given on the date on which it was delivered and if
transmitted by telecommunication
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shall be deemed to have been given at the opening of business in the office of
the addressee on the Business Day next following the transmission thereof.
Any party hereto may change its address for service from time to
time by notice given to the other parties hereto in accordance with the
foregoing.
6.9 Entire Agreement. This Agreement and the agreements and documents
referred to herein constitute the entire agreement between the parties
pertaining to the subject matter hereof, and supersede, on the effective date
hereof, all prior and contemporaneous agreements, representations and
understandings of the parties in connection herewith. No agent of either party
is authorized to make any representation, promise, or warranty not contained in
this Agreement.
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IN WITNESS WHEREOF, the parties hereto have affixed hereunto their
authorized signature as follows:
SMITHKLINE XXXXXXX
PHARMACEUTICALS,
DIVISION OF SMITHKLINE XXXXXXX CORPORATION
By: /s/ Xxxxxx Xxxxxx (signature)
---------------------------------
Name: Xxxxxx Xxxxxx
-------------------------------
Title: Vice President
------------------------------
CONNECTIVE THERAPEUTICS, INC.
By: /s/ Xxxxxx X. Xxxxxxx (signature)
---------------------------------
Name: Xxxxxx X. Xxxxxxx
-------------------------------
Title: President and CEO
------------------------------
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EXHIBIT A
RIDAURA
(AURANOFIN)
I. PRODUCT(S) (list each Product) LOT SIZE
Ridaura 60s 5,200,000 capsules
II. SPECIFICATIONS
DOCUMENT DATE OF DOCUMENT
Product Specifications 6/15/93
Manufacturing Specifications 1/17/89 (mix)
1/23/89 (filled capsules)
Packaging Specifications Packaging Job Order
60s 6/28/94
Raw Material Specifications [date to follow]
Testing Methods and Protocols [date to follow]
Packaging Configurations [date to follow]
(bottle size, quantity, etc.)
Copies of the above documents have been previously supplied to the BUYER and are
not attached hereto.
15
EXHIBIT B
PRICES (FOB SB manufacturing site)
RIDAURA, 3MG CAPSULES
(AURANOFIN)
PRICES
(US Dollars)
(FOB SB Philadelphia, PA and Cidra, Puerto Rico manufacturing site)
PRODUCT PACKAGE SIZE PRICE PER UNIT*
Ridaura, 3mg capsule 60's $[**]
--------
** Confidential Treatment has been requested for the language which has been
omitted. All such omitted material has been filed separately with the SEC.
16
EXHIBIT C
SB QUALITY ASSURANCE REQUIREMENTS
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CHECKLIST PAGE: 4
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Form APPLICABLE RESPONSIBLE RESPONSIBLE
Num. SB CONTRACTOR
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A. QUALITY/REGULATORY
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A1 ANNUAL REVIEWS (211)
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A2 AUDITS
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A3 CERTIFICATES OF ANALYSIS/
CONFORMANCE (COA/COC)
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A4 COMPUTER SYSTEMS
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A5 CUSTOMER COMPLAINTS
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A6 DEVIATIONS
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A7 DOCUMENTATION
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A8 DRUG MASTER FILE (DMF)
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A9 FIELD ALERTS/RECALLS
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A10 IN-PROCESS CONTROLS
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A11 INSPECTIONS/MIL. STD.
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A12 LABELING
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A13 LABORATORY ANALYSIS
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A14 LABORATORY STANDARDS
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A15 LOT NUMBER/EXPIRATION DATING
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A16 MATERIAL SEGREGATION
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A17 NDA AND ANNUAL REPORT (314)
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A18 PROMOTIONAL MATERIALS
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A19 REGULATORY AGENCY INSPECTIONS
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A20 REJECTED PRODUCT
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A21 RELEASE
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A22 RESERVE SAMPLES
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A23 STABILITY TESTING
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A24 TRAINING/QUALIFICATION
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A25 GMP STANDARDS
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A26 TECHNICAL DOSSIER CONTENTS
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CHECKLIST (CONT'D.) PAGE: 5
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A27 CERTIFICATION
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A28 WORLDWIDE REGISTRATIONS
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Form APPLICABLE RESPONSIBLE RESPONSIBLE
Num. SB CONTRACTOR
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B VALIDATION
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B1 CALIBRATION/PM MANAGER
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B2 CLEANING
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B3 EQUIPMENT
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B4 FACILITY/ENVIRONMENT
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B5 PROCESS
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B6 REPROCESSING
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B7 STERILIZATION
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C MATERIALS MANAGEMENT
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C1 CONTAINERS
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C2 DISPOSAL
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C3 ENVIRONMENTAL MONITORS
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C4 INVENTORY POLICY
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C5 ORDERING
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C6 RAW MATERIALS
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C7 RECEIVING
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C8 SAFETY DATA SHEETS
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C9 SHIPPING
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C10 SHIPPING LABELS
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C11 SUPPLIERS
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C12 WAREHOUSING
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CHECKLIST (CONT'D.) PAGE: 6
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Form APPLICABLE RESPONSIBLE RESPONSIBLE
Num. SB CONTRACTOR
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D CHANGE CONTROL
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E PACKAGING/LABELING
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E1 COMPONENT SPECIFICATION
SHEETS
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E2 ELECTRONIC DEVICES
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E3 ENVIRONMENTAL MONITORING
DEVICES
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E4 NON PRINTED COMPONENTS
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E5 PRINTED COMPONENTS
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E6 SAMPLE PROCUREMENT
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E7 SPECIFICATIONS
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F MANAGEMENT
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F1 REPORTS
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F2 MANAGEMENT OF THE
CONTRACTOR /LICENSEE
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
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H. EXPORT REQMTS
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19
----------
CONTRACT PROCESS FLOW PAGE: 7
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DRUG SUBSTANCE
--------------------------------------------------------------------------------
CONTRACTOR LOCATION ADDRESS
-------------------------------------------------------------
-------------------------------------------------------------
MANUFACTURING
-------------------------------------------------------------
-------------------------------------------------------------
--------------------------------------------------------------------------------
DRUG PRODUCT
--------------------------------------------------------------------------------
CONTRACTOR LOCATION ADDRESS
-------------------------------------------------------------
-------------------------------------------------------------
MANUFACTURING
-------------------------------------------------------------
-------------------------------------------------------------
--------------------------------------------------------------------------------
-------------------------------------------------------------
-------------------------------------------------------------
-------------------------------------------------------------
FILLING
--------------------------------------------------------------------------------
