EXHIBIT 10.34
ASSET PURCHASE AGREEMENT
dated February 11, 1998
between
ROCHE HEALTHCARE LIMITED
and
CENTOCOR, INC.
TABLE OF CONTENTS
1. DEFINITIONS............................................................................2
2. ASSETS BEING SOLD......................................................................6
2.1. Patents.......................................................................6
2.2. Licenced Patents..............................................................7
2.3. Patent Applications...........................................................7
2.4. Fujisawa Patent Licence.......................................................8
2.5. Trademarks....................................................................8
2.6. Registrations.................................................................8
2.7. Manufacturing Technology and Know-How.........................................9
2.8. Research and Development Materials............................................9
2.9. Clinical Data................................................................10
2.10. World-wide Safety Reports....................................................10
2.11. Marketing and Promotional Documents..........................................10
2.12. Inventory....................................................................10
2.13. Assumed Agreements...........................................................11
2.14. Other Assets.................................................................11
2.15. Tangible Assets..............................................................11
2.16. Non-exclusive Licences.......................................................11
2.17. Limitation of Sale of Assets.................................................12
3. PURCHASE PRICE........................................................................12
3.1. Purchase Price...............................................................12
3.2. Allocation of Purchase Price.................................................12
3.3. Payment for Inventory........................................................12
3.4. Refund of Purchase Price.....................................................13
3.5. Royalty Payments.............................................................14
4. REPRESENTATIONS AND WARRANTIES OF PARENT..............................................17
4.1. Organisation.................................................................17
4.2. Authority....................................................................17
4.3. No Violation or Conflict.....................................................17
4.4. No Government Restrictions...................................................17
4.5. Title to Assets..............................................................17
4.6. Patents......................................................................18
4.7. Trademarks...................................................................18
4.8. Registrations................................................................18
4.9. Know-How and Know-How Licence................................................19
4.10. Inventory....................................................................19
4.11. Taxes........................................................................19
4.12. Absence of Certain Changes...................................................19
4.13. Violations of Law............................................................19
4.14. Financial Information........................................................19
4.15. Litigation...................................................................20
4.16. Sufficiency of Assets........................................................20
4.17. Conduct of Business..........................................................20
4.18. Retavase Business............................................................21
5. REPRESENTATIONS AND WARRANTIES OF BUYER...............................................21
5.1. Organisation.................................................................21
5.2. Authority....................................................................21
5.3. No Violation or Conflict.....................................................21
5.4. No Government Restrictions...................................................21
5.5. Litigation...................................................................21
5.6. Financing....................................................................22
5.7. Assets.......................................................................22
6. PARENT'S COVENANTS....................................................................22
6.1. Maintenance of Assets/Conduct of Business....................................22
6.2. Compliance with Laws.........................................................23
6.3. Access.......................................................................23
6.4. Patent Maintenance and Defence...............................................23
6.5. Sale of Retavase by the Roche Group..........................................24
6.6. Sales Force..................................................................24
6.7. Further Assurances...........................................................24
6.8. Nonassertion.................................................................25
6.9. Genentech Disclosure.........................................................25
6.10. Control of Genentech, Inc....................................................25
6.11. Keep Well Agreement..........................................................26
7. BUYER'S COVENANTS.....................................................................26
7.1. Approvals and Registrations for Transfer of Distribution of
Products.....................................................................26
7.2. Labelling....................................................................26
7.3. References to Parent.........................................................27
7.4. Further Assurances...........................................................27
7.5. Financing....................................................................27
7.6. Notification.................................................................27
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8. COVENANTS BY BUYER AND PARENT.........................................................28
8.1. Assignment of Patents and Trademarks.........................................28
8.2. Assignment of Registrations..................................................28
8.3. Clinical Studies Transfer....................................................29
8.4. Access to Information........................................................29
8.5. Press Releases...............................................................29
8.6. Customer Information.........................................................30
8.7. Hospital and Other Purchasing Contracts......................................30
8.8. Reconciliation with the Agreement Containing Consent
Order; Canadian Filings......................................................30
8.9. Genentech Patent Suits.......................................................30
8.10. Transition Services..........................................................32
8.11. Returns......................................................................32
8.12. Chargebacks and Rebates......................................................32
8.13. Confidentiality..............................................................32
8.14. Consents.....................................................................32
8.15. Cooperation on Safety Reports................................................32
8.16. Manufacturing Improvements...................................................32
8.17. Importation..................................................................33
8.18. Product Recall; Product Liability............................................33
9. MANUFACTURING.........................................................................33
9.1. Supply Agreement.............................................................33
9.2. Parent's Representations and Warranties for its Supplies.....................33
9.3. Technology Transfer..........................................................34
9.4. Approvals....................................................................34
10. CONDITIONS PRECEDENT TO CLOSING.......................................................35
10.1. Conditions to Obligations of Buyer and Parent................................35
10.2. Conditions to Obligations of Buyer...........................................36
10.3. Conditions to Obligations of Parent..........................................36
11. THE CLOSING...........................................................................37
11.1. The Closing..................................................................37
11.2. Deliveries by Parent.........................................................37
11.3. Deliveries by Buyer..........................................................38
11.4. Effects of Closing...........................................................38
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12. TERMINATION...........................................................................39
12.1. Termination..................................................................39
12.2. Effect of Termination........................................................40
12.3. Termination by the FTC.......................................................40
13. SURVIVAL; REMEDIES; CLAIMS; INDEMNIFICATION...........................................41
13.1. Remedy for Breach............................................................41
13.2. Indemnification by Parent....................................................41
13.3. Indemnification by Buyer.....................................................42
13.4. Notice.......................................................................42
13.5. Participation in Defence.....................................................42
13.6. Settlements..................................................................43
13.7. Other Claims.................................................................43
14. NOTICES...............................................................................44
15. ARBITRATION AND GOVERNING LAW.........................................................45
16. ADDITIONAL TERMS......................................................................45
16.1. Brokers......................................................................45
16.2. Expenses, Taxes and Fees.....................................................46
16.3. Entire Agreement.............................................................46
16.4. Successors and Assigns.......................................................46
16.5. Amendments; No Waiver........................................................46
16.6. Counterparts.................................................................46
16.7. Captions.....................................................................46
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ASSET PURCHASE AGREEMENT
This ASSET PURCHASE AGREEMENT (this "Agreement") is made and entered
into on February 11, 1998 by and between Roche Healthcare Limited, Xxxxxxxx,
Bermuda ("Parent") and Centocor, Inc., a Pennsylvania corporation
("Buyer").
Whereas Parent entered into a Stock Purchase Agreement (the "Stock
Purchase Agreement") dated 24 May 1997 with the owners of Corange Limited,
Xxxxxxxx, Bermuda ("Corange") providing for the acquisition by Parent of all
shares of Corange (the "Corange Transaction"), which among other things owns the
BM Group (as hereinafter defined);
Whereas, pursuant to an Agreement Containing Consent Order to be
entered into by Parent with the Federal Trade Commission (the "FTC") in order to
permit consummation of the Corange Transaction, a copy of which will be provided
to Buyer as soon as accepted by the FTC, Parent will be required to cause BM
Group companies to divest RETAVASE in the United States and Canada;
Whereas the Corange Transaction is further subject to the approval of
other merger control authorities, including the Director of Investigation and
Research in Canada (the "Director") appointed under the Competition Act (Canada)
as well as approval under the Investment Canada Act, if required;
Whereas, Buyer desires to purchase the Assets (as defined below) from
the BM Group companies and Parent desires to cause Sellers (as hereinafter
defined) to sell the Assets to Buyer, upon the terms and subject to the
conditions hereinafter set forth;
Now, therefore, in consideration of the foregoing and of the mutual
promises, covenants, representations, warranties and agreements contained
herein, and intending to be legally bound, the parties hereto agree as follows:
1. DEFINITIONS
1.1. "Active Ingredient" means recombinant reteplase; (rPA), a
recombinant, nonglycosylated plasminogen activator, containing amino
acids 1-3 and 176-527 of the amino acid sequence of the tissue-type
plasminogen activator.
1.2. "Affiliate" of an entity means any corporation or other
business entity controlled by, controlling or under common control
with, such entity. For this purpose "control" shall mean direct or
indirect beneficial ownership of more than fifty percent (50%) of the
voting or income interest in such corporation or other business entity;
provided, however, Genentech, Inc. and its subsidiaries shall not be
considered an Affiliate of Parent.
1.3. "Assets" has the meaning ascribed to such term in
Section 2.
1.4. "Assumed Agreements" has the meaning ascribed to such
term in Section 2.13.
1.5. "best of Parent's knowledge" means the best knowledge of
Parent and Sellers.
1.6. "BM" means Boehringer Mannheim GmbH, Mannheim, Germany.
1.7. "BMC" means Boehringer Mannheim Corporation, Indianapolis,
Indiana, USA.
1.8. "BM Canada" means Boehringer Mannheim Ltd., Laval, Quebec,
Canada.
1.9. "BM Group" means BM, BMC and BM Canada and any Affiliates
of such companies, and any other company in the Boehringer Mannheim
group involved in the Business.
1.10. "BM Labelling" means the printed labels, labelling and
packaging materials, including printed carton, container label and
package inserts, as currently used by BMC or its Affiliates or
promotion partners for the Product in the Territory.
1.11. "BM Monthly Sales Statements" means the BM Net Sales by
Product (including units) in the Territory in local currency, on a
monthly
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basis for each month beginning with January 1997 until the end of the
month in which Closing occurs.
1.12. "BM Net Sales" means gross sales of BMC of the Product in
the Territory after deduction of returns, sales rebates (price
reduction) and volume (quantity) discount as well as sales taxes (e.g.,
value added taxes) and other taxes directly linked to the sales (e.g.,
excise taxes).
1.13. "Business" means the business as conducted at the Closing
Date by Sellers with respect to the Product, whether approved for sale
or in research or development, in the Territory. "Retavase Business"
means the business with respect to each presentation of any
pharmaceutical preparation (including future formulation changes and
production intermediates) containing the Active Ingredient, whether
approved for sale or in research or development in the Territory.
1.14. "Clinical Data" has the meaning ascribed to such term in
Section 2.9.
1.15. "Closing" has the meaning ascribed to such term in
Section 11.1.
1.16. "Closing Date" has the meaning ascribed to such term in
Section 11.1.
1.17. "Damages" has the meaning ascribed to such term in Section
13.2.1.
1.18. "DHC" means Department of Health Canada.
1.19. "Disclosure Schedule" means the disclosure schedule
delivered as of the date hereof to Buyer by Parent in connection with
this Agreement. The sections of the Disclosure Schedule correspond to
the sections of this Agreement, but information disclosed in any
section of the Disclosure Schedule shall be deemed to be disclosed as
to all relevant sections thereof, except as otherwise specifically
provided herein.
1.20. "DPM Agreement" has the meaning ascribed to such term in
Section 2.13.
1.21. "FDA" means the United States Food and Drug Administration.
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1.22. "FTC" means the United States Federal Trade Commission.
1.23. "Genentech Patent Suits" means (a) with respect to the
United States the patent infringement suit against BM filed by
Genentech, Inc. in the United States District Court for the District of
Massachusetts (Judge Saris) based on the Genentech patents USP
5,221,619 (Itakura), USP 4,342,832 (Goeddel and Heyneker), USP
4,511,502 (Builder), USP 5,185,259 (Goeddel, Xxxx) and USP 5,034,225
(Xxxxxxx); and (b) with respect to Germany (i) the patent infringement
suit versus BM filed by Genentech, Inc. and Boehringer Ingelheim
International GmbH in the District Court (Landgericht) of Dusseldorf
([docket number] 4 O 178/96) in May 1996 based on the patent EP 0 093
619 (Goeddel Patent) and (ii) the extension filed versus BM by
Genentech, Inc. and Boehringer Ingelheim International GmbH in the
District Court (Landgericht) of Dusseldorf ([docket number] 4 O 25/97)
in November 1996 including the patent EP 0 217 379 (Mochida Patent) and
the patent EP 0 228 862 (Xxxxxxx Patent), (iii) the nullity suit versus
the patent EP 0 093 619 (Goeddel Patent) filed by BM in October 1996 in
the German Federal Patent Court in Munich, (iv) the nullity suit versus
the patent EP 0 217 379 (Mochida Patent) filed by BM in the German
Federal Patent Court in January 1997 and (v) the appeal of BM filed 7
September 1995 versus the decision of the European Patent Agency (EPA)
on BM's opposition against the European Patent 0 228 862 (Xxxxxxx).
1.24. "HSR Act" means the Xxxx-Xxxxx-Xxxxxx Antitrust
Improvement Act of 1976, as amended.
1.25. "Indemnifiable Claims" has the meaning ascribed to such
term in Section 13.2.1 and 13.3.
1.26. "Indemnified Party" has the meaning ascribed to such term
in Section 13.4.
1.27. "Indemnifying Party" has the meaning ascribed to such term
in Section 13.4.
1.28. "Inventory" has the meaning ascribed to such term in
Section 2.12.
1.29. "Keep Well" has the meaning ascribed to such term in
Section 6.11.
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1.30. "Know-How" and "Know-How Licence" have the meanings
ascribed to such terms in Section 2.7.
1.31. "Licenced Patent Applications" has the meaning ascribed to
such term in Section 2.3.
1.32. "Licenced Patents" has the meaning ascribed to such term
in Section 2.2.
1.33. "Marketing and Promotional Documents" has the meaning
ascribed to such term in Section 2.11.
1.34. "Material Adverse Effect" means a material adverse effect
on the Assets and the Business taken as a whole.
1.35. "Xxxxxx Xxxxxxx" has the meaning ascribed to such term in
Section 5.6.
1.36. "Patents" has the meaning ascribed to such term in
Section 2.1.
1.37. "PCI Agreement" has the meaning ascribed to such term in
Section 2.13.
1.38. "Product" means each presentation of any pharmaceutical
preparation (including formulation changes and production
intermediates) containing the Active Ingredient, whether registered,
marketed or in development by Sellers, as of the Closing Date.
1.39. "Purchase Price" means such term as used in Section 3.
1.40. "Registrations" has the meaning ascribed to such term in
Section 2.6.
1.41. "Research and Development Materials Licence" has the
meaning ascribed to such term in Section 2.8.
1.42. "Roche Group" means Roche Holding Ltd, a Swiss
corporation, and its Affiliates (excluding Genentech, Inc. and
subsidiaries thereof).
1.43. "Supply Agreement" means the agreement referred to in
Section 9.1.
5
1.44. "Territory" means the United States of America and Canada
and their respective possessions or territories.
1.45. "Trademarks" has the meaning ascribed to such term in
Section 2.5.
1.46. "Transition Services Agreement" has the meaning ascribed
to such term in Section 8.10.
1.47. "World-wide Safety Reports" has the meaning ascribed to
such term in Section 2.10.
2. ASSETS BEING SOLD
Subject to Section 2.17 and the other terms and conditions of
this Agreement, at Closing, Parent shall cause the relevant companies
of the BM Group to be designated (collectively, the "Sellers") to sell,
transfer, assign, licence or sublicence, as specified below, to Buyer
and to deliver to Buyer the assets listed below (the "Assets"), and
Buyer shall assume all the rights, titles and interest in the Assets
and all obligations and responsibilities associated therewith as stated
in this Agreement; provided, however, that except as specifically
stated herein, Buyer shall not assume any liabilities, contingent or
otherwise, arising out of or related to the conduct of the Business
prior to the Closing Date.
It is intended by the parties that the sale, transfer, assignment,
conveyance, delivery or licence or sublicence to Buyer pursuant to this
Agreement of all assets and rights of Sellers relating to the Business
shall, together with the Supply Agreement, the Transition Services
Agreement and Buyer's own resources, permit Buyer as of the Closing
Date to conduct the Retavase Business in the same manner as is
currently conducted by Sellers.
Prior to Closing, Buyer may designate one or more Affiliates of
Buyer to which the Assets shall be transferred at Closing by Sellers.
At Closing, Parent shall cause the following to occur:
2.1. Patents. Sellers shall sell, transfer, assign, convey and
deliver to Buyer all of Sellers' rights, title and interest in the
patents and patent rights set forth in Schedule 2.1 hereto (the
"Patents"), and patents of addition, re-examinations, reissues,
extensions, granted supplementary
6
protection certificates, substitutions, confirmations, registrations,
revalidations, revisions, additions and the like, of or to said patents
and patent rights and any and all continuations and
continuations-in-part.
2.2. Licenced Patents. Sellers shall grant and deliver to Buyer
a perpetual, paid-up, irrevocable, royalty-free, unlimited (other than
as provided in this Agreement) licence for the Territory under the
patents set forth in Schedule 2.2 hereto (the "Licenced Patents"), with
the right to sublicence; such licence (and any sublicence thereunder)
shall be exclusive for use in the Retavase Business (or outside the
Territory solely and exclusively with respect to the manufacture of, or
research, development, or the conduct of clinical trials with respect
to, the Active Ingredient or the Product for sale in the Territory),
and the Roche Group (including without limitation the BM Group
companies) shall not retain any right to use or licence such Licenced
Patents for use in the Retavase Business. Except for use in the
Retavase Business and as set forth in Section 2.16, the Roche Group
(including without limitation the BM Group companies) retains, and is
not transferring hereunder, the exclusive right to use or to licence
such patents for use with any other products in or outside the
Territory as well as for the Active Ingredient or the Product outside
the Territory.
2.3. Patent Applications.
2.3.1. Sellers shall grant and deliver to Buyer a perpetual, paid-
up, irrevocable, royalty-free, unlimited (other than as provided in
this Agreement) licence for the Territory under the patent applications
set forth in Schedule 2.3 hereto (the "Licenced Patent Applications"),
and any and all divisions, continuations and continuations-in-part,
with the right to sublicence, such licence (and any sublicence
thereunder) shall be exclusive for use in the Retavase Business (or
outside the Territory solely and exclusively with respect to the
manufacture of, or research, development or the conduct of clinical
trials with respect to, the Active Ingredient or the Product for sale
in the Territory), and the Roche Group (including without limitation
the BM Group companies) shall not retain any right to use or licence
such Licenced Patent Applications for use in the Retavase Business.
Except for use in the Retavase Business and as set forth in Section
2.16, the Roche Group (including without limitation the BM Group
companies) retains, and is not transferring hereunder, the exclusive
right to use or to licence such patent applications and patents that
may result therefrom for use with any other products in or outside the
Territory as well as for the Active Ingredient or the Product outside
the Territory.
7
2.3.2. If based on a Licenced Patent Application a patent should
issue which is solely used in the Retavase Business, Parent shall
inform Buyer when a notice of allowance is issued and such patent shall
be assigned to and assumed by Buyer in accordance with the principles
set forth in Section 8.1 below.
2.4. Fujisawa Patent Licence. BM shall assign or sublicence to
Buyer the Licence Agreement between Fujisawa Pharmaceutical Co., Ltd.,
Osaka, Japan, and Boehringer Mannheim GmbH, Mannheim, Germany, dated 9
September 1997/15 September 1997, relating to the Business ("Fujisawa
Patent Licence") and Buyer shall, in the event of an assignment, assume
the Fujisawa Patent Licence. In the event that after good faith
negotiations among Parent, Buyer and Fujisawa, the parties agree that
Buyer, upon assumption of the Fujisawa Patent Licence, will pay a
licence fee in excess of 3%, Parent agrees that it will pay for any
such fee in excess of 3%. In connection with the payment by Parent of
any fee pursuant to this provision, Parent shall ensure that it does
not obtain any confidential information from Buyer.
2.5. Trademarks. Sellers shall sell, transfer, assign, convey
and deliver to Buyer all of Sellers' rights, title and interest in the
trademark/service xxxx applications for the Business, which are set
forth on Schedule 2.5 (the "Trademarks"), together with the pertaining
documents, such as registration and renewal confirmations, trademark
agreements and consent letters, etc. "Trademarks" also includes any
copyrights and any unregistered trade dress that are owned by Sellers
which are associated solely with the Business and (only as to trade
dress) currently used on or in association with the Business.
"Trademarks" shall not include copyrights and trade dress associated
with the divisions, companies or corporate entities of Parent, BM Group
or their Affiliates or distributors. "Trademarks" also does not include
copyrights and trade dress associated with the Product and also
associated with products not being transferred to Buyer.
2.6. Registrations. Sellers shall sell, transfer, assign,
convey and deliver to Buyer all of Sellers' rights, title and interest
in the regulatory files and approvals, registrations and governmental
authorisations, PLAs (product licence applications), DINs, compliance
notices, licences and permits, and any applications to the FDA or the
comparable Canadian body or bodies pending at the Closing Date,
contractual rights, materials and information relating to FDA and other
government or regulatory approvals, all of which relate to the Business
and that are held by Sellers,
8
which are set forth on Schedule 2.6 as well as the information contained
therein (the "Registrations").
2.7. Manufacturing Technology and Know-How. Sellers shall sell,
transfer and deliver to Buyer the ownership and beneficial interest of BM in
all BM manufacturing technology and know-how and trade secrets that is
solely and exclusively used in the Business, all as set forth in Schedule
2.7 (the "Know-How"); and a perpetual, paid-up, irrevocable, royalty-free
licence, with right to sub-licence, to use any manufacturing technology and
know-how that are used in the Retavase Business (or outside the Territory
solely and exclusively with respect to the manufacture of the Active
Ingredient or the Product (or a future formulation of the Product) for sale
in the Territory) (but not exclusively used thereto or usable for other
purposes as well) (the "Know-How Licence"); such licence (and any sublicence
thereunder) shall be exclusive for use in the Retavase Business, and the
Roche Group (including without limitation the BM Group companies) shall not
retain any right to use or licence such know-how for use in the Retavase
Business. Except as set forth in Section 2.16, the Roche Group (including
without limitation the BM Group companies) retains, and is not transferring
hereunder, the exclusive right to use or to licence such licenced
manufacturing technology and know-how for use with any other products in or
outside the Territory as well as for the Active Ingredient or the Product
outside the Territory. The parties hereby acknowledge and agree that Know-
How shall not include, and any limitation in the Know-How Licence shall not
be binding on Buyer as to, any information Buyer can demonstrate (i) was in
the public domain prior to the date of this Agreement or thereafter enters
the public domain through no fault of Buyer, its affiliates or their
respective representatives, (ii) was available to Buyer on a non-
confidential basis prior to its disclosure to Buyer by Parent, Sellers,
their affiliates or their respective representatives, (iii) is later
lawfully acquired by Buyer from sources other than Parent, Sellers, their
affiliates or their respective representatives who are not, to the best of
knowledge of Buyer, subject to any legally binding obligation to keep such
information confidential, or (iv) independently developed by Buyer without
reference to the Know-How or Know-How Licence.
2.8. Research and Development Materials. Sellers shall sell, transfer
and deliver to Buyer copies of all the BM research and development reports
existing as of the Closing Date which relate to the Business, a list of
which is set forth on Schedule 2.8, and shall grant and deliver to Buyer a
perpetual, paid-up, irrevocable, royalty-free licence, with a right to sub-
licence, to use any such materials in the Retavase
9
Business (the "Research and Development Materials Licence"). Such licence
shall be exclusive for use in the Retavase Business (or outside the
Territory solely and exclusively with respect to the manufacture of, or the
conduct of clinical trials with respect to, the Active Ingredient or the
Product in the Territory), and the Roche Group (including without limitation
the BM Group companies) shall not retain any right to use or licence such
materials for use in the Retavase Business. Except as set forth under
Section 2.16, the Roche Group (including without limitation the BM Group
companies) retains, and is not transferring hereunder, the exclusive right
to use or to licence such materials for use with any other products in or
outside the Territory as well as for the Active Ingredient or the Product
outside the Territory.
2.9. Clinical Data. Sellers shall sell, transfer and deliver to Buyer a
copy of all Clinical Data contained in Seller's clinical databases referring
to the Active Ingredient or the Product in the form of the SAS data sets
(the "Clinical Data").
2.10. World-wide Safety Reports. Sellers shall sell, transfer and
deliver to Buyer a hard copy and an electronic copy in the form existing as
of the Closing Date of all world-wide safety reports of BM and its
Affiliates with respect to the Active Ingredient or the Product existing as
of the Closing Date (the "World-wide Safety Reports").
2.11. Marketing and Promotional Documents. Sellers shall sell, transfer
and deliver to Buyer all hard copies and electronic copies existing as of
the Closing Date of the marketing and promotional documents owned by
Sellers, such as customer lists, marketing and promotional plans, documents
and materials, field force training manuals and materials, and placebo or
demonstration kits that are exclusively used in the Business (the "Marketing
and Promotional Documents"). All such documents shall be shipped FOB
Sellers' location. To the extent documents exist which contain marketing and
promotional materials relating both to the Product in the Territory and to
other products or the Product outside the Territory, Sellers shall transfer
and not retain all portions of such documents relating to the Product in the
Territory to Buyer.
2.12. Inventory. Sellers shall sell, transfer and deliver to Buyer all
inventory consisting of Product (including samples and placebo kits), that
are owned by Sellers for the Territory and that have been approved or are
subsequently approved as meeting specifications, have a minimum of 12 months
of expiration dating and are otherwise saleable in the ordinary and normal
course of business as of the Closing Date (the "Inventory"), the
10
prices of which are set forth on Schedule 2.12(a) hereto; the location of
which are set forth on Schedule 2.12(b); the quantity of which shall be set
forth in a document delivered by Parent at Closing.
2.13. Assumed Agreements. Subject to consent of the other parties to
such agreements, Parent agrees to cause to be assigned, and Buyer agrees to
assume, all rights and obligations of Sellers, under the Agreements listed
below (the "Assumed Agreements").
2.13.1. DPM Agreement. The Copromotion Agreement between BMC and The
DuPont Merck Pharmaceutical Company, Philadelphia, dated 20 December, 1996
for the copromotion of the Product in the United States of America (the "DPM
Agreement").
2.13.2. PCI Agreement. The Packaging Agreement between BMC and Packaging
Coordinators, Inc., Philadelphia, dated 29th June, 1995 for the assembling
and packaging of the kits as defined in that agreement (the "PCI
Agreement").
2.13.3. Other Agreements. The agreements set forth on Schedule 2.13.3.
2.14. Other Assets. Sellers shall sell, transfer and deliver to Buyer
(i) trade secrets, customer and supplier lists of Sellers to the extent
related to the Business and (ii) files of Sellers to the extent related to
the Genentech Patent Suits.
2.15. Tangible Assets. Sellers shall sell, transfer and deliver to Buyer
certain tangible assets related solely to the Business as agreed by the
parties in good faith prior to the Closing Date to be selected from the list
set forth on Schedule 2.15, provided that Sellers shall not be obligated to
transfer any such assets not owned by Sellers.
2.16. Non-exclusive Licences. Subject to Section 3.5, Sellers shall
grant and deliver to Buyer a non-exclusive, perpetual, paid-up, irrevocable,
unlimited (except as provided in this Agreement) licence in the Territory
under the Licenced Patents, the Licenced Patent Applications (and any and
all divisions, continuations and continuations-in-part), the Know-How
Licence and the Research and Development Materials Licence, with the right
to sublicence, for use in the human pharmaceutical field.
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2.17. Limitation of Sale of Assets. Buyer expressly acknowledges that
the Roche Group is retaining certain information identical to that contained
in the Patents, Registrations, Know-How, Research and Development Materials
Licence, Clinical Data, World-wide Safety Reports, Marketing and Promotional
Documents and the other assets pursuant to Section 2 which is relevant for
the research, development, manufacture, control, packaging or release,
marketing or sale of products similar or identical to the Active Ingredient
or the Product outside the Territory for their own and/or authorised third
parties' use outside the Territory. Buyer further expressly acknowledges
that except as provided in Section 2.16 the Roche Group is retaining (and
are not transferring hereunder) any and all assets used solely in the
research, development, manufacture, control, packaging or release, marketing
or sale of other products or projects in the Territory or outside the
Territory and may use, licence or dispose of such assets in their discretion
and Buyer shall not have any right to any such assets.
3. PURCHASE PRICE
3.1. Purchase Price. Subject to the terms and conditions of this
Agreement, in reliance on the representations, warranties, covenants and
agreements of Parent contained herein and the representations and warranties
of Sellers to be made to Buyer at Closing, and in consideration of the sale,
conveyance, assignment, transfer and delivery of the Assets provided for in
Section 2 hereof, Buyer will deliver at Closing in full payment for the
aforesaid sale, conveyance, assignment, transfer and delivery, the Purchase
Price of US $335 million; US $315 million of which shall be paid to Sellers,
by bank wire transfer at such banking institutions as have been designated
by Parent not less than five (5) days prior to Closing and US$ 20 million of
which shall be deposited in an escrow account pursuant to arrangements to be
negotiated in good faith by Parent and Buyer prior to the Closing Date. This
amount (together with interest thereon) shall be returned to Buyer upon the
meeting of manufacturing milestones consistent with the manufacturing
arrangements set forth in Section 9.4. In the event such manufacturing
milestones are not met by Buyer, such amount shall be paid to Sellers.
3.2. Allocation of Purchase Price. The parties shall negotiate in good
faith an allocation of the Purchase Price.
3.3. Payment for Inventory. In addition to the Purchase Price according
to Section 3.1 above, Buyer shall pay to Parent, acting on behalf of
Sellers, in US dollars for the Inventory, based on the quantity document
12
delivered pursuant to Section 2.12 by Parent at Closing; provided that, at
the request of Parent, any such payment may be made directly to the relevant
Seller. Buyer shall effect such payment by bank wire transfer so that Parent
or relevant Seller shall receive it in its designated bank account within 10
(ten) days from Closing.
3.4. Refund of Purchase Price. (a) In the event Buyer, without any
breach of this Agreement, as a result of (i) a binding determination
(including a permanent, temporary or preliminary injunction for so long as
such injunction is not stayed or vacated) in connection with the Genentech
Patent Suits or (ii) a settlement of the Genentech Patent Suits; provided
that such settlement is commercially reasonable for Buyer under the
circumstances in absence of Parent's reimbursement obligations pursuant to
this Section 3.4:
(A) becomes unable during the life of the relevant Genentech patents
to engage in the manufacture or sale of the Product in the Territory,
Parent, acting on behalf of Sellers, shall (1) in the event Buyer's
inability to engage in the manufacture or sale of the Product in the
Territory continues for a period of three months or less, reimburse
Buyer for lost profits during such period in an amount not to exceed
the Purchase Price (not including the escrow amount), (2) in the event
Buyer's inability to engage in the manufacture or sale of the Product
in the Territory continues for a period of greater than three months
but less than or equal to six months, Parent shall refund 25% of the
Purchase Price (not including the escrow amount) to Buyer, (3) in the
event Buyer's inability to engage in the manufacture or sale of the
Product in the Territory continues for a period of greater than six
months but less than or equal to 12 months, Parent shall reimburse 75%
of the Purchase Price (not including the escrow amount) to Buyer and
(4) in the event Buyer's inability to engage in the manufacture or sale
of the Product in the Territory continues for a period of greater than
12 months, Parent shall reimburse 100% of the Purchase Price (not
including the escrow amount) to Buyer, in each case net of payments to
Buyer made pursuant to the clauses (1), (2) and (3), as the case may
be; provided that in the event a binding determination occurs within
six months prior to the expiration of the relevant Genentech patent or
patents, Parent shall have no obligation to make a further refund of
the Purchase Price to Buyer;
(B) becomes obligated to make payments to Genentech, Inc. or an
affiliate thereof (1) for damages (including lost profits) or (2)
13
for a reasonable royalty, in either case by reason of any award or
agreement, Parent shall refund to Buyer any such payments actually made
by Buyer;
(C) it being understood that the total payments to Buyer pursuant to
paragraphs (A) and (B) above shall in no event exceed 125% of the
Purchase Price (and in no event shall include any portion of the escrow
amount that has already been returned to Buyer).
(b) Parent, acting on behalf of Sellers, shall pay 50% of all reasonable
fees and expenses of attorneys (who are not employees of Buyer) and fees
paid to agents, experts and courts incurred in connection with the defence
(including counterclaims, nullity actions, opposition proceedings and
appeals) of the Genentech Patent Suits, subject to audit of such fees and
expenses by a nationally recognised independent auditor to be mutually
agreed to by Parent and Buyer. The statements that are provided by such
auditor to Parent setting forth the fees and expenses due shall not reveal
any detailed confidential information regarding Buyer's conduct of, or
strategy with respect to, the Genentech Patent Suits. Any expenses relating
to in-house attorneys shall be paid by the party incurring such expenses.
(c) Buyer agrees to pursue vigorously the defence of the Genentech Patent
Suits, including, subject to applicable law, to pursue in good faith any
appeal of an adverse determination thereof.
3.5. Royalty Payments.
3.5.1. Buyer shall be required to make royalty payments and other
arrangements under the circumstances described below for products other than
the Product (and for the Product in the circumstance described in subsection
(D)(x) of this Section 3.5.1), if following the Closing Date Buyer
(i) commercialises any product (other than the Product or a future
formulation of the Product) using any of the Licenced Patents, the
Licenced Patent Applications (and any and all divisions, continuations
and continuations-in-part), the Know-How Licence or the Research and
Development Materials Licence; or
(ii) sublicences or cross-licences any of the Licenced Patents, the
Licenced Patent Applications (and any and all divisions,
14
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS
AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT
THE PLACES INDICATED BY ASTERICKS (*); AND HAVE BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION
continuations and continuations-in-part), the Know-How Licence or the
Research and Development Materials Licence, then the Roche Group shall
receive value for such commercialisation, sublicencing or cross-
licencing arrangements in accordance with the following principles:
(A) if Buyer commercialises a product (other than the Product or a
future formulation of the Product) that uses any of the Licenced
Patents, the Licenced Patent Applications (and any and all
divisions, continuations and continuations-in-part), the Know-How
Licence or the Research and Development Materials Licence Buyer
shall pay to the Roche Group an aggregate royalty of [*] of the
net sales of such product;
(B) if Buyer sublicences any of the Licenced Patents, the Licenced
Patent Applications (and any and all divisions, continuations and
continuations-in-part), the Know-How Licence or the Research and
Development Materials Licence to a third party in return for a
royalty payment, Buyer shall pay to the Roche Group [*] of such
royalty payment;
(C) if Buyer cross-licences any of the Licenced Patents, the
Licenced Patent Applications (and any and all divisions,
continuations and continuations-in-part), the Know-How Licence or
the Research and Development Materials Licence to a third party
and receives any right to such third party's products or products
in development, and Buyer commercialises such products, then Buyer
shall pay to the Roche Group an aggregate royalty of [*] of the
net sales of such products;
(D) if Buyer cross-licences to a third party any of the Licenced
Patents, the Licenced Patent Applications (and any and all
divisions, continuations and continuations-in- part), the Know-How
Licence or the Research and Development Materials Licence and
receives the right to use any of such third party's manufacturing
technology, then if such manufacturing technology is
(x) specifically applicable to the Product (or a future
formulation of the Product) and Buyer obtains a
15
Confidential Treatment Requested
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS
AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT
THE PLACES INDICATED BY ASTERICKS (*); AND HAVE BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION
worldwide sublicence therefor, Buyer shall grant to the Roche
Group a non-exclusive, perpetual, paid-up, irrevocable,
royalty-free licence for use in the manufacture of the
Product (or a future formulation of the Product) outside the
Territory;
(y) applicable to products other than the Product (or a
future formulation of the Product) and Buyer obtains a
worldwide licence therefor, the Roche Group shall have the
option to receive (1) a non-exclusive, perpetual, paid-up,
irrevocable, royalty-free sublicence to such manufacturing
technology for use in the manufacture of any such products or
(2) [*] of the gross margin benefit achieved by Buyer as a
result of Buyer's application of such manufacturing
technology to any such products; or
(z) applicable to products other than the Product (or a
future formulation of the Product) and Buyer obtains a
licence therefor limited to the Territory, the Roche Group
shall receive [*] of the gross margin benefit achieved by
Buyer as a result of Buyer's application of such
manufacturing technology to any such products;
(E) if Buyer enters into any sublicence or cross-licence
arrangement in connection with any of the Licenced Patents, the
Licenced Patent Applications (and any and all divisions,
continuations and continuations-in-part), the Know-How Licence or
the Research and Development Materials Licence not specifically
described in clauses (A) through (D), Parent and Buyer agree to
negotiate in good faith an arrangement based upon the principles
set forth above.
3.5.2. If the Roche Group is entitled to receive payments pursuant to
Section 3.5.1, Buyer shall promptly inform the Roche Group of its
entitlement to such payments and an independent auditor may, upon the
request of the Roche Group, be appointed to verify the amount of any such
payment properly due to the Roche Group and the Roche Group and Buyer shall
implement procedures to ensure that no confidential information is shared
between the parties in connection with the calculation or verification of
such payments.
16
Confidential Treatment Requested
4. REPRESENTATIONS AND WARRANTIES OF PARENT
Parent hereby represents and warrants as follows:
4.1. Organisation. Parent is a corporation duly organised, validly
existing and in good standing under the laws of Bermuda, with full
corporate power and authority to consummate the transactions contemplated
hereby.
4.2. Authority. The execution, delivery and performance of this
Agreement by Parent have been duly and validly authorised by all necessary
corporate proceedings, and this Agreement has been duly authorised,
executed, and delivered by Parent and, assuming the enforceability against
Buyer, will constitute the legal, valid and binding obligation of Parent,
enforceable in accordance with its terms.
4.3. No Violation or Conflict. The execution, delivery and performance
of this Agreement by Parent (a) do not and will not conflict with, violate
or constitute or result in a default under any law, judgement, order,
decree, the memorandum of association of Parent or any contract or
agreement to which Parent or Sellers are a party or by which Parent or
Sellers are bound or (b) will not result in the creation or imposition of
any lien, charge, mortgage, claim, pledge, security interest, restriction
or encumbrance of any kind on, or liability with respect to, the Assets
except as otherwise provided herein or otherwise disclosed on the
Disclosure Schedule.
4.4. No Government Restrictions. Except as required pursuant to the HSR
Act or as otherwise contemplated by this Agreement, no consent, approval,
order or authorisation of, or registration, declaration or filing with, any
governmental agency is required to be obtained or made by or with respect
to Parent in connection with the execution, delivery and performance of
this Agreement by Parent.
4.5. Title to Assets. Except as set forth in Section 4.5 of the
Disclosure Schedule, Sellers have good and marketable title to all the
Assets and will, subject to other provisions of this Agreement and the
Disclosure Schedule, convey good and marketable title at Closing, free and
clear of any and all liens, encumbrances, charges, claims, restrictions,
pledges, security interests, or impositions of any kind (including those of
secured parties). Except as set forth in Section 4.5 of the Disclosure
Schedule, Sellers beneficially own all of the rights, title or other
interests
17
to be transferred to Buyer with respect to all the Assets and none of the
Assets is leased, rented, licenced, or otherwise not owned by Sellers.
Parent also represents that the Roche Group will not retain any copies of
customer lists exclusively used in the Business.
4.6. Patents. The Patents and the patents underlying the Licenced
Patents and the patent applications underlying the Licenced Patent
Applications have been applied for by and/or granted to BM. Except as
disclosed on Section 4.6 of the Disclosure Schedule, to the best of
Parent's knowledge (i) the manufacture, use or sale of the Product does not
infringe on any other patent in any material respect which would prohibit
the manufacture of the Product in the Territory or in Germany or the use or
sale of the Product in the Territory; (ii) there are no claims, demands or
proceedings instituted, pending or seriously threatened by any third party
pertaining to or challenging BM's rights to any Patents or patents
underlying the Licenced Patents or any patent application underlying the
Licenced Patent Applications; (iii) Parent and Sellers are not aware of any
facts which would render any of the Patents or patents underlying the
Licenced Patents or any patent application underlying the Licenced Patent
Applications, invalid or unenforceable. It is understood that a disclosure
made in any section of the Disclosure Schedule is made solely for the
purpose of this Agreement and does not imply any acknowledgment of Parent
or Sellers that any third party rights exist or that the Product infringes
any third party right.
4.7. Trademarks. Sellers own the Trademarks set forth in Schedule 2.5
which are formally registered or applied. All Trademark applications set
forth in Schedule 2.5 have been duly filed and maintained. Except as
disclosed on Section 4.7 of the Disclosure Schedule, to the best of
Parent's knowledge (i) the use of the Trademarks for the Product in the
Territory does not infringe on any other trademark in any material respect
which would prohibit the use of the Trademarks for the Product in the
Territory, and (ii) there are no claims, demands or proceedings instituted,
pending or seriously threatened by any third party pertaining to or
challenging Sellers' rights to any Trademark in the Territory.
4.8. Registrations. All Registrations held by Sellers in the Territory
are listed on Schedule 2.6. The Registrations (a) are in the name of
Sellers, (b) constitute all licences, permits, approvals, qualifications,
and governmental specifications, authorisations or requirements which
Sellers have in connection with the marketing and sale of the Product in
the Territory, and (c) to the best of Parent's knowledge, constitute all
such licences, permits, approvals, qualifications, and governmental
18
specifications, authorisations, and requirements necessary for the
marketing and sale of the Product in the Territory as currently conducted
by Sellers.
4.9. Know-How and Know-How Licence. The Know-How and Know-How Licence
together with the Buyer's own resources will be sufficient to permit Buyer
(or a third party designated by Buyer) to manufacture, control, package or
release (as applicable) the Active Ingredient or the Product to the same
standards as Sellers currently enjoy or will enjoy as of the termination of
the Supply Agreement.
4.10. Inventory. As of the Closing, the Inventory shall meet the
specifications therefor as set forth in the manufacturing documentation and
Registrations for such Product with the competent authorities in the
country concerned of the Territory. The Inventory will be in good
condition, properly stored, having a minimum of 12 months of expiration
dating from the Closing Date and in compliance with applicable laws, usable
and saleable in the ordinary course of business.
4.11. Taxes. As of the date hereof, there are no liens for taxes upon
the Assets except for liens for current taxes not yet due and payable.
4.12. Absence of Certain Changes. As of the date hereof and as of the
Closing Date and except as set forth on Section 4.12 of the Disclosure
Schedule, there has not been any material adverse change in the Assets or
the Business and Parent and Sellers are not aware of any facts or
circumstances that would have a Material Adverse Effect after Closing.
4.13. Violations of Law. Except as set forth in Section 4.13 of the
Disclosure Schedule or otherwise in this Agreement and the Disclosure
Schedule, to the best of Parent's knowledge, the utilisation of the Assets
and the conduct of the Business by Sellers (i) does not violate or conflict
with any law, governmental specification, authorisation, or requirement, or
any decree, judgement, order, or similar restriction in any material
respect, or (ii) has not been the subject of an investigation or inquiry by
any governmental agency or authority regarding violations or alleged
violations, or found by any such agency or authority to be in violation, of
any law, other than investigations, inquiries or findings that have not
had, or are reasonably likely not to have, a Material Adverse Effect.
4.14. Financial Information.
19
4.14.1. The BM Monthly Sales Statements have been and will be accurate
and complete in all material respects, reflect only actual bona fide
transactions, are consistent with the accounting records of the BM Group
legal entities, contain or will be made to contain information to enable
Buyer to determine the nature and amounts of all deductions from gross
sales necessary to calculate BM Net Sales, and were and will be prepared in
a manner consistent with principles applied under U.S. generally accepted
accounting principles (GAAP) consistently applied.
4.14.2. None of Sellers and their Affiliates have any material
liabilities, contingent, absolute, accrued or otherwise, relating to the
Assets.
4.15. Litigation. Except as set forth on Section 4.15 of the
Disclosure Schedule or otherwise in this Agreement and the Disclosure
Schedule, to the best of Parent's knowledge, the Assets are not the subject
of (i) any outstanding judgement, order, writ, injunction or decree of any
arbitrator or administrative or governmental authority or agency, limiting,
restricting or affecting the Assets in a way that would have a Material
Adverse Effect, (ii) any pending or, to the best of Parent's knowledge,
seriously threatened claim, suit, proceeding, charge, inquiry,
investigation or action of any kind, and (iii) any court suits filed with
respect to the Assets since 1 January 1996. Subject to other provisions of
this Agreement, to the best of Parent's knowledge, there are no claims,
actions, suits, proceedings or investigations pending or threatened by or
against Sellers or Parent with respect to the transactions contemplated
hereby, at law or in equity or before or by any federal, state, municipal
or other governmental department, commission, board, agency,
instrumentality or authority that would have a Material Adverse Effect.
4.16. Sufficiency of Assets. The Patents, Licenced Patents, Licenced
Patent Applications, Registrations, Know-How and Know-How Licence being
transferred to Buyer are all of the patents, licenced patents, licenced
patent applications, registrations, know-how and know-how licences
necessary to enable Buyer to produce the Product in the Territory.
4.17. Conduct of Business. Subject to applicable laws and regulations
and the Stock Purchase Agreement, Sellers have conducted the Business in
accordance with customary business practices and the 1997 marketing plan or
the 1998 marketing plan, as applicable, and have taken all reasonable steps
to maintain the Business, including reasonable incentives to maintain the
marketing and sales personnel relating to sales of the Product in the
United States.
20
4.18. Retavase Business. Nothing in this Section 4 shall be construed as
a representation or warranty by Parent with respect to the Retavase
Business as conducted by Buyer following the Closing Date.
5. REPRESENTATIONS AND WARRANTIES OF BUYER
Buyer represents and warrants as follows:
5.1. Organisation. Buyer is a corporation duly organised, validly
existing and in good standing under the laws of the Commonwealth of
Pennsylvania, has all corporate powers and material governmental licences,
authorisations, permits, consents and approvals required to carry on its
business as currently conducted and has full corporate power and authority
to consummate the transactions contemplated hereby.
5.2. Authority. The execution, delivery and performance of this
Agreement by Buyer have been duly and validly authorised by all necessary
corporate proceedings, and this Agreement has been duly authorised,
executed, and delivered by Buyer and, assuming the enforceability against
Parent, constitutes the legal, valid and binding obligation of Buyer,
enforceable in accordance with its terms.
5.3. No Violation or Conflict. The execution, delivery and the
performance of this Agreement by Buyer do not and will not conflict with,
violate or constitute or result in a default under any law, judgement,
order, decree, the articles of incorporation or bylaws of Buyer, or any
contract or agreement to which Buyer is a party or by which Buyer is bound.
5.4. No Government Restrictions. Except as required pursuant to the HSR
Act or as set forth in Schedule 5.4 no consent, approval, order or
authorisation of, or registration, declaration or filing with, any
governmental agency is required to be obtained or made by or with respect
to Buyer in connection with the execution, delivery and performance of this
Agreement by Buyer.
5.5. Litigation. There are no claims, actions, suits, proceedings or
investigations pending or, to the best of Buyer's knowledge, threatened by
or against Buyer with respect to the transactions contemplated hereby, at
law or in equity or before or by any federal, state, municipal or other
governmental department, commission, board, agency, instrumentality or
authority.
21
5.6. Financing. Buyer has received, and furnished a copy to Parent of,
a commitment letter signed by Buyer and Xxxxxx Xxxxxxx & Co. Incorporated
("Xxxxxx Xxxxxxx") in a form satisfactory to Parent (the "Commitment
Letter") to provide the financing for the Purchase Price and the Commitment
Letter is in full force and effect. Buyer shall have at Closing sufficient
funds to pay the Purchase Price.
5.7. Assets. Buyer is, and/or has engaged expert advisors, experienced
in the evaluation and purchase of property and assets such as the Assets as
contemplated hereunder. Buyer has undertaken such investigation and has
been provided with and has evaluated such documents and information as it
has deemed necessary to permit it to make an informed and intelligent
decision with respect to the execution, delivery and performance of this
Agreement. Buyer has satisfied itself that the Assets will, if transferred
to Buyer as provided in Section 2, permit Buyer, together with the
activities to be performed by Parent and its Affiliates pursuant to the
Supply Agreement, the Transition Services Agreement and the resources to be
provided by Buyer, as contemplated by Buyer's plan for the Retavase
Business presented to the FTC, to conduct the Retavase Business immediately
after the Closing Date.
6. PARENT'S COVENANTS
Parent covenants and agrees as follows:
6.1. Maintenance of Assets/Conduct of Business. Parent agrees that from
the date hereof until the Closing Date, except as specifically disclosed in
Section 6.1 of the Disclosure Schedule or unless otherwise consented to by
Buyer in writing, Parent shall, subject to applicable laws and regulations,
use its efforts to cause Sellers to preserve the Assets and to conduct the
Business in the ordinary course as set forth in the Stock Purchase
Agreement. From the closing of the Stock Purchase Agreement, Parent
undertakes as follows:
6.1.1. except as set forth in this Agreement or disclosed on the
Disclosure Schedule to cause Sellers and their Affiliates to maintain the
Assets in good status and condition and not sell or dispose of any of the
Assets except in the ordinary course of business;
6.1.2. to cause Sellers and their Affiliates to not make or institute any
unusual or novel methods of purchase, manufacture, sale, wholesale
inventory build-up, management, operation, or other business practice in
the conduct of the Business inconsistent with past practices; wholesale
22
inventory build-up at the Closing Date shall not materially exceed two
month's supply, except as otherwise agreed by Parent and Buyer;
6.1.3. to cause Sellers not to enter into any material contract or
commitment, engage in any transaction, extend credit or incur any
obligation with respect to the Business, in each case not in the usual and
ordinary course of business and consistent with normal business practices;
and
6.1.4. to inform Buyer promptly of any change in the Assets or the
Business that would have a Material Adverse Effect.
6.2. Compliance with Laws. Except as otherwise disclosed on the
Disclosure Schedule, Parent shall comply or begin to remedy any non-
compliance or cause Sellers to comply or begin to remedy, any non-
compliance upon notification thereof in all material respects with all laws
and orders of any court or federal, state, local or other governmental
entity applicable to the Assets or the Business except where such that any
non-compliance will not have a Material Adverse Effect at or after Closing.
6.3. Access.
6.3.1. From and after the date hereof and up to the Closing Date (except
as otherwise provided herein) subject to applicable laws and regulations,
Parent shall use reasonable efforts to cause Sellers to grant Buyer and its
authorised agents, officers, and representatives access to the Assets
during normal business hours upon reasonable prior notice and at a time and
manner mutually agreed upon between Buyer and Parent in order to conduct
such examination and investigation of the Assets as is reasonably
necessary, provided that such examinations shall not unreasonably interfere
with the operations and activities of Sellers.
6.3.2. Parent will not, and will cause Sellers not to, disclose any
confidential information relating to the Business to other entities of the
Roche Group from and after the closing of the Stock Purchase Agreement up
to the Closing Date.
6.4. Patent Maintenance and Defence. As to any patents and patent
applications licenced to Buyer pursuant to this Agreement, Parent shall
assume, or cause Sellers to assume the following obligations for the
Territory: (a) to pay all prosecution cost for any pending patent
application; (b) to pay all maintenance fees; (c) to keep Buyer advised of
the status of all patent documents embraced by items (a) and (b) above;
23
(d) to advise Buyer of any actual or, to the best of Parent's knowledge,
potential acts of infringement by any party; (e) to pursue and pay for all
available extensions; and (f) not to abandon any patent or patent
application underlying the Licenced Patents or Licenced Patent Applications
without giving Buyer written notice of at least 6 (six) months in advance
of any action toward abandonment in order for Buyer to take responsibility
for maintenance of such patent. To the extent Buyer has a licence under
this Agreement for a patent of Sellers, Buyer shall be solely responsible
for the defence of any patent suit relating to the Product in the
Territory. Buyer shall not abandon or interfere with any other aspect of
such patents.
6.5. Sale of Retavase by the Roche Group. During the term of the Supply
Agreement the Roche Group will not sell any assets used by the Roche Group
to supply Buyer with the Active Ingredient pursuant to the Supply
Agreement. If during the one year period following commencement by Buyer or
a third party designated by Buyer of the manufacture of the Product for
sale in the Territory, the Roche Group desires to sell all of the assets
relating solely to the research, development, manufacture, control,
packaging or release, marketing or sale of the Active Ingredient and the
Product outside the Territory to a third party, the Roche Group shall give
written notice to Buyer that the Roche Group desires to effect such a sale.
Buyer shall have a 30-day period in which to make an offer (the "Offer") to
purchase all of the assets relating solely to the research, development,
manufacture, control, packaging or release, marketing or sale of the Active
Ingredient and the Product outside the Territory by giving a written notice
to Parent or its Affiliate containing the proposed price and any other
material terms prior to the expiration of such 30-day period. The Roche
Group shall have the right in its sole discretion to accept or reject the
Offer. In the event Parent or its Affiliate rejects the Offer, the Roche
Group shall have the right to effect a sale of such assets to a third party
on substantially the same or more favourable terms from the perspective of
the Roche Group as set forth in the Offer.
6.6. Sales Force. Parent agrees to continue the currently implemented
stay-bonus program for the sales and marketing employees of the Business
through the earlier of (i) April 20, 1998 or (ii) the Closing Date.
6.7. Further Assurances. Parent shall use all reasonable efforts to
implement the provisions of this Agreement, and for such purpose Parent, at
the request of Buyer, at or after Closing, will, without further
consideration, execute and deliver, or cause to be executed and delivered,
24
to Buyer such deeds, assignments, bills of sale, consents and other
instruments in addition to those required by this Agreement, in form and
substance satisfactory to Buyer, as Buyer may reasonably deem necessary or
desirable to implement any provisions of this Agreement.
6.8. Nonassertion. Notwithstanding the other provisions of this
Agreement, the Roche Group shall not assert or cause to be asserted against
Buyer, the contract manufacturer of Buyer or any customer of Buyer any
cause of action based upon infringement of any patents or patent
applications existing as of the Closing Date or patents issuing on such
patent applications of the Roche Group based on Buyer's conduct of the
Business following the Closing Date. For the avoidance of doubt, nothing
shall prevent the Roche Group or Buyer and its Affiliates from using any
technology that is in or comes into the public domain.
6.9. Genentech Disclosure. During the pendency of the Genetech Patent
Suits, Parent agrees that the Roche Group (including officers, directors
and employees of the Roche Group) will not disclose to any officer,
director or employee of Genentech, Inc., unless compelled to disclose by
judicial or administrative process or by other requirements of law, any
confidential information obtained by the Roche Group in connection with the
Corange Transaction (i) relating solely to the Business, or (ii) not
relating solely to the Business which would disclose to Genetech, Inc. the
application to thrombolytic drugs having essentially the same structure and
functionality as Retavase of any of the matters or know-how licenced to
Buyer pursuant to Section 2.16; provided that such obligation shall not
prevent the Roche Group from disclosing, to the extent necessary, such
confidential information to any person who is an officer, director or
employee of X. Xxxxxxxx-Xx Xxxxx Ltd or its Affiliates who is also a
director of Genentech, Inc. Information shall not be deemed to be
confidential to the extent that such information (i) was in the public
domain prior to the date of this Agreement or thereafter enters the public
domain through no fault of the Roche Group or its representatives, (ii) was
available to the Roche Group on a non-confidential basis, (iii) is later
lawfully acquired by the Roche Group from sources other than the Roche
Group or its representatives who are not subject to any legally binding
obligation to keep such information confidential, or (iv) independently
developed by the Roche Group.
6.10. Control of Genentech, Inc. In the event that (i) the Amended and
Restated Governance Agreement between Genentech, Inc. and Roche Holdings,
Inc. dated October 25, 1995 allows the Roche Group to control Genentech,
Inc. or (ii) the Roche Group obtains 100% of the stock of
25
Genentech, Inc., the Roche Group shall cause to be dismissed, with
prejudice, the Genentech Patent Suits and shall cause Genentech, Inc.
to refrain from instituting any new litigation against Buyer as
provided for in the Agreement Containing Consent Order.
6.11. Keep Well Agreement. On or prior to the Closing Date,
Parent shall enter into a Keep Well Agreement (the "Keep Well") with
Roche Holding Ltd in substantially the form set forth in Exhibit D.
Parent further agrees that it shall not agree to any modification,
amendment or termination of the Keep Well if such modification,
amendment or termination shall have any adverse effect upon the ability
of Parent to meet its obligations under Section 3.4 and Section 13.7 of
this Agreement without the written consent of Buyer.
7. BUYER'S COVENANTS
Buyer covenants and agrees as follows:
7.1. Approvals and Registrations for Transfer of Distribution
of Products. Following Closing, Buyer shall use all reasonable efforts
and, except as otherwise set forth herein, at its own expense obtain as
expeditiously as possible such governmental approvals and registrations
from the competent regulatory authorities in the Territory, as may be
necessary with respect to the conduct of the Retavase Business by Buyer
or its designee (other than Parent or an Affiliate of Parent).
7.2. Labelling. Following Closing, Buyer shall at its own
expense and as expeditiously as possible use all reasonable efforts to
create, and to obtain such approvals of competent government
authorities in the Territory necessary for, Buyer's labelling for the
Product. Buyer may use the BM Labelling on the Inventory until such
Inventory is exhausted, subject to applicable laws and regulations in
the Territory. In addition, Buyer may, subject to applicable laws of
the relevant countries of the Territory, use the BM Labelling on each
Product manufactured by Parent or its Affiliates (including without
limitation the BM Group companies) for Buyer until the competent
authority approves Buyer's Labelling for use on the Product and Buyer,
using all efforts, has obtained sufficient supplies of materials with
Buyer's Labelling for use on such Product. Buyer may, however, use the
BM Labelling only in connection with clearly identifying Buyer as the
responsible person for commercialising the Product in a way approved in
advance by Parent, such approval not to be unreasonably withheld. All
expenses incurred by Buyer
26
in connection with Buyer's labelling and package design of the Product
shall be solely for the account of Buyer.
7.3. References to Parent. Other than as set forth in Section
7.2 above, any reference to Parent or its Affiliates (including without
limitation the BM Group companies) or any use of the trademarks,
tradenames, or logos of Parent or its Affiliates (including without
limitation the BM Group companies) by Buyer in connection with the
Product after Closing must be approved by Parent in writing prior to
such use unless otherwise required by law or regulation; provided that
Buyer may refer to Sellers to the extent necessary to identify Sellers
as having previously sold the Product in the Territory. It is
understood that the Trademarks do not fall under this provision.
7.4. Further Assurances. Buyer shall use all reasonable
efforts to implement the provisions of this Agreement, and for such
purpose Buyer, at the request of Parent, at or after Closing, will,
without further consideration, execute and deliver, or cause to be
executed and delivered, to Parent such consents and other instruments
in addition to those required by this Agreement, in form and substance
satisfactory to Parent, as Parent may reasonably deem necessary or
desirable to implement any provision of this Agreement.
7.5. Financing. Buyer agrees to use its best efforts to
complete the financing referred to in Section 5.6 including, without
limitation, to (i) perform all of Buyer's obligations under the
Commitment Letter; (ii) take all actions necessary to cause the
conditions under the Commitment Letter to be satisfied; (iii) not take
any action which would be reasonably expected to cause such conditions
not to be satisfied; (iv) not amend or waive any provision of the
Commitment Letter without the prior written consent of Parent and (v)
enforce its rights against Xxxxxx Xxxxxxx & Co. Incorporated under the
Commitment Letter.
7.6. Notification. If at any time Buyer becomes aware of any
facts or circumstances which would be reasonably likely to result in a
failure of any condition to Xxxxxx Xxxxxxx'x obligations under the
Commitment Letter, Buyer shall promptly notify Parent in writing
describing the same in reasonable detail.
27
8. COVENANTS BY BUYER AND PARENT
Buyer and Parent covenant and agree as follows:
8.1. Assignment of Patents and Trademarks. By or before
Closing, Buyer and Parent shall prepare in good faith an assignment
pursuant to which Sellers agree the Patents and Trademarks shall be
assigned to Buyer. Following Closing, Buyer shall prepare and Sellers
shall execute such documents as Buyer may reasonably request in order
to assign and record the assignment of the Patents and Trademarks. The
responsibility and expense of preparing and filing such documents and
any actions required ancillary thereto, shall be borne solely by Buyer.
Notwithstanding anything contained elsewhere herein, Buyer shall hold
Parent and its Affiliates (including without limitation the BM Group
companies) harmless from and against any loss or damage, including but
not limited to fees, penalties, fines or third party claims, due to
Buyer's failure to record any assignment of any such Patents or
Trademarks pursuant to this Section 8.1, except if such loss or damage
is solely due to the conduct of Parent (including without limitation
the BM Group companies).
Neither Parent nor any of its Affiliates (including without
limitation the BM Group companies) shall be obliged to maintain any
Trademark after the Closing. Parent will pay or cause to be paid any
fees for renewals of any of the Trademarks as were initiated prior to
the Closing. All other renewal and maintenance fees as well as the cost
and expenses for defending the Trademarks against infringements by
third parties occurring after the Closing Date shall be paid by Buyer.
Parent will arrange for the files relating to the Trademarks to be
handed over to Buyer without delay after the Closing. Until the
termination of the Transition Services Agreement, Parent will promptly
notify Buyer of any infringement or threatened infringement of any of
the Trademarks coming to its attention and will, if the registration of
any of the Trademarks is still in the name of Sellers, at the expense
of Buyer take such action against the infringer as Buyer may reasonably
request to restrain such infringement, or alternatively authorise Buyer
or its nominee to take such action in its own name. In the latter
event, Parent or its Affiliates will at Buyer's expense provide
reasonable assistance to Buyer.
8.2. Assignment of Registrations. Parent and Buyer shall
cooperate to ensure that the Registrations shall be assigned to Buyer,
except where such assignment may be prohibited by law. At or following
Closing, Buyer shall prepare and Sellers shall execute such documents
as
28
Buyer may reasonably request in order to record the assignment of the
Registrations. The responsibility and expense of preparing and filing
such documents and any actions required ancillary thereto shall be
borne solely by Buyer. In addition, Buyer shall pay any user fees
associated with any Product that accrues after Closing but prior to
transfer of such Registration. Notwithstanding anything contained
elsewhere herein, Buyer shall hold Parent and its Affiliates (including
without limitation the BM Group companies) harmless from and against
any loss or damage, including but not limited to fees, penalties, fines
or third party claims, due primarily to Buyer's failure to record any
assignment of any such Registrations pursuant to this Section, except
if such loss or damage is due primarily to the conduct of Parent and
its Affiliates (including without limitation the BM Group companies).
8.3. Clinical Studies Transfer. Parent and Sellers shall
complete ongoing clinical studies which are scheduled to be completed
within two (2) months from the Closing Date and following completion
shall provide electronic copies of the relevant Clinical Data and all
reports relating to such clinical studies to Buyer. Ongoing clinical
studies scheduled to be completed after two (2) months from the Closing
Date shall be transferred to Buyer. Parent and Buyer shall cooperate in
the transfer of such studies and all other materials related thereto.
8.4. Access to Information. Buyer and Parent will, upon
reasonable prior notice, make available to the other, to the extent
reasonably required for the purpose of assisting Parent or Buyer in
obtaining governmental approvals and preparation of tax returns or
other filings required by law or regulation relating to the Assets, and
prosecuting or defending or preparing for the prosecution or defence of
any action, suit, claim, complaint, proceeding or investigation at any
time brought by or pending against Parent or any of its Affiliates
(including without limitation the BM Group companies) or Buyer relating
to the Assets or the Supply Agreement, other than in the case of
litigation between the parties hereto, such information or records (or
copies thereof) in their possession after Closing.
8.5. Press Releases. Except as required by applicable law,
neither Parent nor Buyer, nor any Affiliate thereof, will issue or
cause publication of any press release or other announcement or public
communication with respect to this Agreement or the transactions
contemplated hereby without the prior written consent of the other
party, which consent will not be unreasonably withheld or delayed. To
the extent that any announcement is
29
required by applicable law, Parent and Buyer shall consult with each
other in good faith prior to such announcement.
8.6. Customer Information. Buyer jointly with Parent or their
relevant Affiliates shall be entitled and obliged to announce to the
clients in the Territory, the transfer of the Business to Buyer or its
relevant Affiliate.
8.7. Hospital and Other Purchasing Contracts. Buyer and Parent
shall take such actions as are reasonably necessary to cause the
assignment to Buyer of hospital and other health services provider
purchasing contracts for the purchase of the Product. Those contracts,
if any, that relate to the purchase of the Product as well as other
products shall be terminated by Sellers with respect to the Product as
soon as practicable after closing so as to allow Buyer to enter into
new contracts with respect to the Product.
8.8. Reconciliation with the Agreement Containing Consent
Order; Canadian Filings.
8.8.1. If required by the FTC, Parent and Buyer will cooperate
with one another and will negotiate in good faith to amend any
provision of this Agreement to the extent necessary to make the
provisions hereof consistent with the Agreement Containing Consent
Order; provided that no such amendment shall be required to be made
unless it is acceptable to Buyer and Parent.
8.8.2. The parties hereto shall promptly make or cause to be
made all filings required or deemed advisable under the Competition Act
(Canada). If required by law, the transaction contemplated by this
Agreement is contingent upon (i) the issuance under section 102 of the
Competition Act (Canada) of an Advance Ruling Certificate or (ii) the
expiry of the waiting period under section 123 of the Competition Act
(Canada) and receipt of advice in writing by the Director that he has
determined not to make an application for an order under section 92 or
100 of the Competition Act (Canada) or to commence an inquiry under
section 10 of the Competition Act (Canada). The transaction
contemplated by this Agreement is further contingent upon completion of
any filings and obtaining of any approvals under the Investment Canada
Act if required.
8.9. Genentech Patent Suits.
30
8.9.1. Buyer covenants that, immediately upon Closing, Buyer
will undertake, in good faith, control of the full and complete defence
of the Genentech Patent Suits. Parent represents and Buyer acknowledges
that the Assets to be transferred to Buyer pursuant to this Agreement
include all assets that are currently utilised by BM in its defence of
the Genentech Patent Suits, to the extent such assets are owned by the
BM Group at Closing. Buyer undertakes in good faith to not abandon or
make any concessions in the defence of the Genentech Patent Suits in
Germany which affects the ability of Parent or any of its Affiliates
(including without limitation the BM Group companies) to manufacture or
sell the Active Ingredient or the Product or any product made therewith
outside the Territory or any other product or research or development
project in or outside the Territory. Buyer shall retransfer control of
defence of the Genentech Patent Suits in Germany immediately upon
commencement by Buyer of the manufacture of the Product outside Germany
in the event such suits are still pending at that time.
8.9.2. Parent undertakes that during the pendency of the
Genentech Patent Suits (or any appeals relating to such suits), Parent
will take all steps to make available to Buyer (i) such employees of
the Roche Group that are knowledgeable with respect to the matters at
issue in the Genentech Patent Suits (including without limitation the
BM Group companies) and (ii) such relevant files of the BM Group (which
exist as of the Closing Date and which Parent undertakes to preserve)
that Buyer may reasonably require in connection with the defence of the
Genentech Patent Suits for such period of time as may be reasonably
required by Buyer. In particular, Parent agrees that with respect to
Xxxxxx Xxxxxxx, Xxxxxx Xxxxxx, Xxxx Xxxxx, Xxxxxxxxx Xxxxxxxxx, and
Claus-Xxxx Xxxxxx, Parent will ensure that, for such period of time as
such individuals are employed by the Roche Group, the availability of
such individuals to Buyer in connection with the Genentech Patent Suits
shall not be interfered with by reason of their employment with the
Roche Group. In addition, to the extent that such individuals are not
employed by the Roche Group, Buyer or its Affiliates, Parent shall pay
all reasonable direct out-of-pocket expenses (and reasonable fees, if
permissible) of any such individual who participates in the defence of
the Genentech Patent Suits incurred in connection therewith. Parent
further agrees that it will take no adverse action against any employee
of the Roche Group based on such employee's provision of assistance or
information to Buyer pursuant to this Section 8.9.2. Parent also agrees
that, to the extent relevant and necessary, it will not enforce any
confidentiality agreement against an employee of the Roche Group that
would otherwise prevent or hinder such
31
employee from cooperating with or providing information to Buyer
pursuant to this Section 8.9.2.
8.10. Transition Services. On or prior to the Closing Date,
Buyer and Parent or their Affiliates shall enter into the Transition
Services Agreement substantially in the form attached as Exhibit A
hereto.
8.11. Returns. For a period of two years following the Closing
Date, Sellers shall be responsible for all returns of the Product
within the Territory with respect to lot numbers shipped prior to the
Closing Date, provided that following the Closing Date, Buyer shall not
engage in any action (other than pricing of the Product) to induce any
purchaser of the Product to return Product sold prior to the Closing
Date; provided, however, that to the extent returns of Product result
from changes in pricing by Buyer, Buyer shall be responsible for such
returns. For Product shipped after the Closing Date, Buyer shall be
responsible for all returns of the Product within the Territory.
8.12. Chargebacks and Rebates. Sellers shall be responsible
for all chargebacks and rebates which are reported within 60 days
following the Closing Date. Buyer shall be responsible for all
chargebacks and rebates which are reported after 60 days following the
Closing Date.
8.13. Confidentiality. The Confidentiality Agreement (the
"Confidentiality Agreement") between X. Xxxxxxx-Xx Xxxxx Ltd and Buyer
dated as of October 14, 1997, as it applies to Parent and its
Affiliates, is hereby incorporated by reference into this Agreement.
8.14. Consents. Each of Parent, Sellers and Buyer agree to
cooperate in good faith to obtain any consents from third parties
relating to the assignment of existing contracts.
8.15. Cooperation on Safety Reports. Following the Closing
Date for so long as Sellers and Buyer continue to market the Product,
each of Sellers and Buyer agree promptly to provide the other party
with all information received by it in connection with the occurrence
of serious or unexpected events relating to the Product.
8.16. Manufacturing Improvements. Parent agrees that if,
during the term of the Supply Agreement, the Roche Group implements any
improvement in the manufacturing technology and know-how used in the
manufacture of the Active Ingredient or the Product, it shall grant to
Buyer a perpetual, paid-up, irrevocable, royalty-free, non-exclusive
licence, with
32
right to sub-licence, any such improvement for use in manufacture of
the Active Ingredient or the Product for sale in the Territory.
Buyer agrees that if, during the term of the Supply Agreement,
Buyer or its assignee implements any improvement in the manufacturing
technology and know-how used in the manufacture of the Active
Ingredient or the Product, it shall grant to the Roche Group a
perpetual, paid-up, irrevocable, royalty-free, non-exclusive licence,
with right to sub-licence, any such improvement for use in manufacture
of the Active Ingredient or the Product for sale outside the Territory.
8.17. Importation. Each of Parent and Buyer agrees that,
subject to applicable law, it will not actively support the importation
of the Product into the Territory in the case of Parent and Sellers and
outside the Territory in the case of Buyer.
8.18. Product Recall; Product Liability. Parent and Buyer
agree that in the event prior to the Closing Date of a major recall of
the Product or the occurrence of material product liability issues in
connection therewith which affect the viability of the Business, Parent
and Buyer will negotiate in good faith with respect to an adjustment of
the Purchase Price.
8.19. Confirmation of Financing. Upon the written request by
Parent at any time and from time to time, (a) Buyer shall use its best
efforts to obtain (and deliver to Parent within 5 business days after
such request) a waiver by Xxxxxx Xxxxxxx in the form set forth in
Exhibit C hereto, in favor of Buyer, of any right to terminate the
Commitment Letter or to assert that any condition to Xxxxxx Xxxxxxx'x
obligations under the Commitment Letter has not been satisfied at the
time of such waiver, based upon facts and circumstances at the time of
such waiver which are publicly known or, after due inquiry by Xxxxxx
Xxxxxxx, known to Xxxxxx Xxxxxxx and (b) in the event Xxxxxx Xxxxxxx
fails or refuses to provide such waiver within such period, Buyer shall
deliver to Parent within 6 business days after such request a full
written explanation of such failure or refusal and the reasons
therefor.
9. MANUFACTURING
9.1. Supply Agreement. Consistent with the terms of the
Agreement Containing Consent Order, on or prior to the Closing Date,
Parent and Buyer or their Affiliates shall enter into the Supply
Agreement for the supply of the Product (as that term is defined in
Section 1.3 of the Supply Agreement) substantially in the form attached
hereto as Exhibit B.
33
9.2. Parent's Representations and Warranties for its
Supplies. As provided in the Supply Agreement:
Parent shall make representations and warranties to Buyer that
the bulk labelled lyophilized vials or bulk Active Ingredient that is
manufactured by the Roche Group (including without limitation the BM
Group companies) for Buyer pursuant to the Supply Agreement meets the
FDA and DHC approved specifications therefor. Parent shall agree to
indemnify, defend and hold Buyer harmless from any and all suits,
claims, actions, demands, liabilities, expenses or losses that may be
alleged to result from the failure of the bulk labelled lyophilized
vials or bulk Active Ingredient manufactured by the Roche Group for
Buyer pursuant to the Supply Agreement to meet FDA and DHC
specifications. This obligation shall be contingent upon Buyer giving
Parent prompt, adequate notice of such claim, cooperating fully in the
defence of such claim, and permitting Parent to assume the sole control
of all phases of the defence and/or settlement of such claim, including
the selection of counsel. This obligation shall not require Parent to
be liable for any negligent act or omission of Buyer or for any
representations and warranties, express or implied, made by the Buyer
that exceed the representations and warranties made by Parent to Buyer.
9.3. Technology Transfer. To the extent Buyer undertakes the
manufacture of the Product in the Territory and subject to the
obligations under the Supply Agreement, upon reasonable notice and
request from Buyer, the Roche Group (including without limitation the
BM Group companies) shall provide to Buyer or a third party contract
manufacturer designated by Buyer in a timely manner: (a) for a period
not to exceed four years following the Closing Date, assistance and
advice to enable Buyer or a third party contract manufacturer
designated by Buyer to obtain all necessary approvals to manufacture
the Product for sale in the Territory; (b) for a period not to exceed
one (1) year from the date of such approvals, assistance to enable
Buyer or a third party contract manufacturer designated by Buyer to
manufacture the Product in substantially the same manner and quality
employed or achieved by Sellers as of the date Buyer obtains such
approvals; and (c) until the date of such approvals (or earlier if
Buyer abandons its efforts to obtain such approvals), consultation with
knowledgeable employees of the Roche Group and training at the request
of and at the manufacturing facility of Buyer or a third party contract
manufacturer designated by Buyer (or of the Buyer's choosing),
sufficient to satisfy the management of Buyer that its personnel (or
the personnel of a third party contract manufacturer
34
designated by Buyer) are adequately trained in the manufacture of the
Product for sale in the Territory. Such assistance shall include
on-site inspections, at Buyer's request, of the facility that is
producing the Active Ingredient for supply under the Supply Agreement.
Parent shall be entitled to reimbursement from Buyer for all the Roche
Group's direct out-of-pocket expenses incurred in providing the
services and assistance described above. Buyer shall be responsible for
the construction of the facilities associated with the manufacture of
the Product.
9.4. Approvals. In the manner and form required by the Agreement
Containing Consent Order, Buyer shall submit to the FTC a certification
attesting to the good faith intention of Buyer, including a plan of
Buyer, to obtain in an expeditious manner all necessary approvals to
manufacture the Product for sale in the Territory. Furthermore, in
accordance with the terms of the Agreement Containing Consent Order,
Buyer shall submit to the trustee appointed pursuant to the Agreement
Containing Consent Order, periodic verified written reports setting
forth in detail the efforts of Buyer to sell the Product obtained
pursuant to the Supply Agreement in the United States and to obtain all
approvals necessary to manufacture the Product for sale in the
Territory. The first such report shall be submitted within sixty (60)
days from the date this Agreement is approved by the FTC and every
ninety (90) days thereafter until all necessary approvals are obtained
by Buyer for manufacturer of the Product for sale in the Territory.
Buyer shall also report to the FTC and the trustee referred to above
within ten (10) days of its ceasing the sale in the United States of
the Product obtained pursuant to the Supply Agreement for any time
period exceeding sixty (60) days or abandoning its efforts to obtain
all necessary approvals to manufacture the Product for sale in the
Territory.
10. CONDITIONS PRECEDENT TO CLOSING
10.1. Conditions to Obligations of Buyer and Parent. The
obligations of Buyer and Parent to complete the transactions
contemplated hereby are subject to the satisfaction on or prior to the
Closing Date of the following conditions:
10.1.1. No provision of any applicable law or regulation and no
judgement, injunction, order or decree shall prohibit the consummation
of the Closing.
10.1.2. Agreement Containing Consent Order. The Agreement
Containing Consent Order (in the form provided to Buyer) shall have
been
35
accepted for public comment by the FTC, and the transactions
contemplated by this Agreement shall be permitted under the terms of
the Agreement Containing Consent Order.
10.1.3. To the extent required by law or as deemed advisable by
the parties, an Advance Ruling Certificate under section 102 of the
Competition Act (Canada) shall have been issued for the transaction
contemplated by this Agreement or the waiting period under section 123
of the Competition Act (Canada) shall have been expired and advice in
writing by the Director shall have been received that he has determined
not to make an application for an order under section 92 or 100 of the
Competition Act (Canada) or to commence an inquiry under section 10 of
the Competition Act (Canada) and the transaction contemplated by this
Agreement shall have obtained of any approvals under the Investment
Canada Act if required; provided that if all other conditions shall
have been satisfied, Parent and Buyer agree to close that portion of
the transaction pertaining to the United States prior to the
satisfaction of the conditions set forth in this Section and to close
that portion of the transaction pertaining to Canada at such later
date, and on terms and conditions, as mutually agreed.
10.1.4. The Corange Transaction shall have been consummated in
accordance with the terms of the Stock Purchase Agreement.
10.1.5. Any applicable waiting period under the HSR Act relating
to the transactions contemplated hereby shall have expired or been
terminated.
10.2. Conditions to Obligations of Buyer. The obligation of
Buyer to complete the transactions contemplated hereby is subject to
the satisfaction on or prior to the Closing Date of the following
conditions (all or any of which may be waived in whole or in part by
Buyer);
10.2.1. Representations and Warranties. The representations and
warranties made by Parent in this Agreement shall have been true and
correct (without regard to materiality or Material Adverse Effect
qualifications set forth therein) as of the Closing Date with the same
force and effect as though said representations and warranties had been
made on the Closing Date, except for representations and warranties
made as of a specified date, which will be true and correct in all
respects as of the specified date, and except for breaches of any such
representations or warranties that would not have, individually or in
the aggregate, a Material Adverse Effect. Each Seller shall have
delivered to Buyer at Closing a
36
representation and warranty that each of Parent's representations and
warranties in Section 4 with respect to such Seller were true and
correct as of the date thereof, and such representation and warranty
shall be true and correct as of the Closing Date except for breaches
that would not have, individually or in the aggregate, a Material
Adverse Effect.
10.2.2. Performance. Parent shall have performed and complied in
all material respects with all agreements, obligations and conditions
required by this Agreement to be so performed or complied with by it
prior to or at Closing.
10.3. Conditions to Obligations of Parent. The obligation of
Parent to complete the transactions contemplated hereby is subject to
the satisfaction on or prior to the Closing Date of the following
conditions (all or any of which may be waived in whole or in part by
Parent):
10.3.1. Representations and Warranties. The representations and
warranties made by Buyer in this Agreement shall have been true and
correct in all material respects as of the Closing Date with the same
force and effect as though said representations and warranties had been
made on the Closing Date (except for representations and warranties
made as of a specified date, which will be true and correct in all
respects as of the specified date).
10.3.2. Performance. Buyer shall have performed and complied in
all material respect with all agreements, obligations and conditions
required by this Agreement to be so performed or complied with by it
prior to or at Closing.
37
11. THE CLOSING
11.1. The Closing. Subject to the satisfaction of all of the
conditions to each party's obligations set forth in Section 10 hereof
(or, with respect to any condition not satisfied, the waiver in writing
thereof by the party or parties for whose benefit the condition exists)
and subject to Section 12.1.2, the closing of the transactions
contemplated by this Agreement (the "Closing") shall take place at 9
a.m. (local time) on the first business day which is at least 30 days
following public announcement of this Agreement (assuming the last
condition precedent under Section 10 herein above has been fulfilled)
or earlier or later, if mutually agreed by the parties, in accordance
with the Agreement Containing Consent Order and any applicable law or
regulation (the "Closing Date") at the offices of Parent in Xxxxxxxx,
Bermuda. The transfer of the Assets shall be deemed to have occurred as
of 0.01 a.m. of the Closing Date.
11.2. Deliveries by Parent. At Closing, Parent shall deliver or
cause to be delivered to Buyer:
11.2.1. the conveyance, assignment, and assumption agreement with
respect to the Assets and the Assumed Agreements and all obligations
and responsibilities associated therewith;
11.2.2. the assignments of the Patents and Trademarks as set forth
in Section 8.1;
11.2.3. the assignments of the Registrations as set forth in Section
8.2;
11.2.4. the Supply Agreement;
11.2.5. the Transition Services Agreement;
11.2.6. the Inventory and the statement of the quantity of the
Inventory as set forth in Section 2.12;
11.2.7. to the extent available and practicable, hard copies of the
documents as set forth in Section 2 herein above; all such documents,
which cannot be delivered to Buyer at Closing, shall be delivered by
Parent to Buyer as soon as practicable after Closing;
11.2.8. except as otherwise provided herein, such agreements,
licences, notices, and authorisations as may be necessary and
sufficient to
38
permit Buyer to use or operate under the Registrations (if legally
permissible) and Know-How and that Buyer has requested from Parent;
11.2.9. a receipt for the Purchase Price; and
11.2.10. the licences or sublicences set forth in Sections 2.2,
2.3, 2.7, 2.8 and 2.16.
11.3. Deliveries by Buyer. At Closing, Buyer shall deliver or
cause to be delivered to Parent:
11.3.1. the Purchase Price payable in accordance with Section
3.1; and
11.3.2. the conveyance, assignment and assumption agreement with
respect to the Assets and the Assumed Agreements and all obligations
and responsibilities associated therewith;
11.3.3. the Supply Agreement; and
11.3.4. the Transition Services Agreement;
11.4. Effects of Closing. Upon Closing the ownership of the
Assets as well as the full responsibility for the use of the Assets and
the conduct of the Business comprising the use of the Assets shall pass
from Sellers to Buyer. Sellers shall remain exclusively responsible for
the conduct of the Business prior to Closing (including any
consequences therefrom which may appear after the Closing). Buyer shall
be exclusively responsible for the conduct of the Retavase Business
from Closing. Buyer acknowledges that as per the Closing the product
liability insurance of Sellers will terminate on the Closing Date and
Buyer shall be responsible for proper insurance of the product
liability and other risks relating to the Retavase Business. The
Closing shall further have the other effects provided for in this
Agreement.
12. TERMINATION
12.1. Termination. This Agreement and the transactions
contemplated hereby may be terminated at any time prior to the Closing
Date:
12.1.1. By the mutual written consent of Parent and Buyer;
39
12.1.2. By either Parent or Buyer if Closing shall not have
occurred on or before April 20, 1998; or
12.1.3. By either Parent or Buyer if consummation of the
transactions contemplated hereby shall violate any non-appealable final
order, decree or judgement of any court or governmental body having
competent jurisdiction.
12.1.4. By either Parent or Buyer if there has been a material
violation or breach by the other party of any of the agreements,
representations or warranties contained in this Agreement that has not
been waived in writing, or if there has been a material failure of
satisfaction of a condition to the obligations of the other party that
has not been waived in writing, and such violation, breach, or failure
has not been cured within fifteen (15) days (but in no event later than
April 20, 1998) of written notice to the other party; or
12.2. Effect of Termination. If this Agreement is terminated
pursuant to this Section 12, all obligations of Parent and Buyer under
this Agreement shall terminate without further liability of Parent or
Buyer except (a) for the obligations of Buyer and Parent under Sections
8.13, 15, and 16.2; and (b) that such termination shall not constitute
a waiver by any party of any claim it may have for damages caused by
reason of a breach by the other party of a representation, warranty,
covenant or agreement.
12.3. Termination by the FTC. (a) As set forth in Paragraph
II.B.9 of the Agreement Containing Consent Order, the FTC may terminate
this Agreement if Buyer: (i) voluntarily ceases for sixty (60) days or
more the sale in the United States of, or otherwise fails to pursue
good faith efforts to sell, the Product obtained pursuant to the Supply
Agreement prior to obtaining all necessary FDA approvals to manufacture
its own Product for sale in the United States; (ii) fails to pursue
good faith efforts to obtain all necessary FDA approvals to
manufacture, or have manufactured by third parties other than Parent or
its Affiliates, its own Product for sale in the United States; or (iii)
fails to obtain all such FDA approvals within four (4) years from the
date the FTC grants final approval to the Agreement Containing Consent
Order; provided, however, that this time period may be extended as
provided in Paragraph II.B.9 of the Agreement Containing Consent Order.
If this Agreement is terminated in accordance with the provisions of
this section, the Assets shall revert back to Sellers and shall be
divested in the manner provided in Paragraph IV of the Agreement
Containing Consent Order.
40
(b) In the event the FTC withdraws its acceptance of the
Agreement Containing Consent Order after expiration of the sixty (60)
day public comment period referred to in paragraph 4 of the Agreement
Containing Consent Order, this Agreement shall forthwith become null
and void and the Buyer shall immediately transfer back to Sellers all
assets, properties and rights conveyed to it hereunder and, upon
receipt of said assets, properties and rights, Sellers shall pay to
Buyer the Purchase Price. Buyer agrees that (i) during the pendency of
the sixty (60) day public comment period it shall, subject to its sale
of inventory purchased under the Supply Agreement, preserve intact all
assets, properties and rights conveyed to it hereunder and shall take
no action that would individually or in the aggregate have a material
adverse effect on those assets and (ii) Buyer and its Affiliates will
not disclose any confidential information concerning the Retavase
Business; provided that information shall not be deemed to be
confidential that Buyer can prove (A) was in the public domain prior to
the date of this Agreement or thereafter enters the public domain
through no fault of Buyer, its Affiliates or their respective
representatives, (B) was available to Buyer on a non-confidential basis
prior to its disclosure to Buyer by Parent, Sellers, their Affiliates
or their respective representatives, (C) is later lawfully acquired by
Buyer from sources other than Parent, Sellers, their Affiliates or
their respective representatives who are not, to the best of knowledge
of Buyer, subject to any legally binding obligation to keep such
information confidential, or (D) independently developed by Buyer
without reference to confidential information covered hereunder.
13. SURVIVAL; REMEDIES; CLAIMS; INDEMNIFICATION
13.1. Remedy for Breach. After the Closing, the sole and
exclusive remedy of Buyer and Parent for any breach or inaccuracy of
any representation or warranty under this Agreement by the other party
hereto or by Sellers shall be the remedies contained in this Section 13
and shall be enforceable only as provided in Section 15.1. Any claims
that a party may have arising out of the other party's or Sellers'
breach of its representations and warranties hereunder shall be
notified to the other party no later than 12 (twelve) months following
Closing (without affecting either party's right to start arbitration
proceedings in accordance with Section 15.1 thereafter if the
notification for the pertaining matter has been given prior to the
expiration of such 12 month period). Parent and Buyer agree to use all
reasonable efforts to mitigate any loss or damage for which they may
seek a remedy under this Article 13.
13.2. Indemnification by Parent.
41
13.2.1. Claims. Subject to the limitations set forth in Section
13.2.2, Parent shall indemnify Buyer and its Affiliates against and
agrees to hold Buyer and its Affiliates harmless from any and all
damage, loss, liability, third party claims, and expense (collectively,
"Damages") (including, without limitation, reasonable expenses of
investigation and attorneys' fees and expenses in connection with any
action, suit or proceeding brought against Buyer or its Affiliates)
incurred or suffered by Buyer or its Affiliates arising out of (a) any
breach of a representation or warranty or covenant made by Parent or
Sellers herein, (b) the maintenance of the Assets by Sellers prior to
Closing or (c) the conduct of the Business by Parent or its Affiliates
prior to Closing (collectively, "Indemnifiable Claims").
13.2.2. Limitations. Notwithstanding anything to the contrary
set forth elsewhere herein, Buyer and its Affiliates shall not be
entitled to indemnification hereunder with respect to any Indemnifiable
Claim for breaches of representations and warranties asserted pursuant
to Section 13.2.1(a) unless the amount of Damages with respect to such
Indemnifiable Claim exceeds US$500,000. However, Parent shall in no
event be required to pay Buyer and its Affiliates more than 33% of the
Purchase Price in respect of aggregate Damages for Indemnifiable Claims
for breaches of representations and warranties asserted pursuant to
Section 13.2.1(a).
13.3. Indemnification by Buyer. Buyer shall indemnify Parent
and its Affiliates (including without limitation the BM Group
companies) against and agrees to hold Parent and its Affiliates
harmless from any and all Damages (including without limitation
reasonable expenses of investigation and attorneys' fees and expenses
in connection with any action, suit or proceeding brought against
Parent or its Affiliates) incurred or suffered by Parent or its
Affiliates arising out of (a) any breach of a representation or
warranty or covenant made by Buyer herein; (b) the conduct of the
Retavase Business by Buyer and its Affiliates from Closing or (c) the
use of the licences granted pursuant to Section 2.16 of this Agreement
(collectively, "Indemnifiable Claims"). Notwithstanding anything to the
contrary set forth elsewhere herein, Parent and its Affiliates shall
not be entitled to indemnification hereunder with respect to any
Indemnifiable Claim for breaches of representations and warranties
asserted pursuant to this Section 13.3 unless the amount of Damages
with respect to such Indemnifiable Claim exceeds US$ 500,000, provided
that such limitation shall not apply to a breach by Buyer in connection
with Buyer's obligations pursuant to Sections 3.1 and 3.3.
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13.4. Notice. A party seeking indemnification or to be held
harmless pursuant to Section 13.2 or 13.3 (an "Indemnified Party")
shall give prompt notice to the party from whom such relief is sought
(the "Indemnifying Party") of the assertion of any claim, or the
commencement of any action, suit or proceeding, in respect of which
relief is or may be sought hereunder (whether or not the limits set
forth in Section 13.2.2 and Section 13.3 have been exceeded) and will
give the Indemnifying Party such information with respect thereto as
the Indemnifying Party may reasonably request, but failure to give such
notice shall not relieve the Indemnifying Party of any liability
hereunder (except to the extent the Indemnifying Party has suffered
actual prejudice thereby).
13.5. Participation in Defence. The Indemnifying Party may, at
its expense, participate in or assume the defence of any such action,
suit or proceeding involving a third party. In such case the
Indemnified party shall have the right (but not the duty) to
participate in the defence thereof, and to employ counsel, at its own
expense, separate from counsel employed by the Indemnifying Party in
any such action and to participate in the defence thereof. The
Indemnifying Party shall be liable for the fees and expenses of one
firm as counsel (and appropriate local counsel) employed by the
Indemnified Party if the Indemnifying Party has not assumed the defence
thereof. Whether or not the Indemnifying Party chooses to defend or
prosecute any claim involving a third party, all the parties hereto
shall, and shall cause their respective Affiliates to, cooperate in the
defence or prosecution thereof and shall furnish, or cause to be
furnished, such records, information and testimony, and attend such
conferences, discovery proceedings, hearings, trials and appeals, as
may be reasonably requested in connection therewith.
13.6. Settlements. The Indemnifying Party shall not be liable
under this Section for any settlement effected without its consent of
any claim, litigation or proceedings in respect of which relief may be
sought hereunder, unless the Indemnifying Party refuses to acknowledge
liability for indemnifying or holding the Indemnified Party harmless
under this Section 13 and/or declines to defend the Indemnified Party
in such claim, litigation or proceeding.
13.7. Other Claims. In the event that any third party
(including Genentech) commences (in the Territory or in Germany) a
patent infringement action (with respect to a patent that has been
issued or a patent application that has been published as of the date
hereof) with respect to the Product in the Territory, Buyer shall be
solely responsible
43
for the control of the defence of such action and Buyer further
covenants to undertake, in good faith, the full and complete defence of
any such action. Buyer shall not abandon or make any concessions in the
defence of such patent suits which affect Parent's or its Affiliates'
ability to manufacture or sell the Active Ingredient or any product
made therewith outside the Territory or any other products or research
or development projects in or outside the Territory. Parent shall
reimburse Buyer with respect to such actions in the same manner and to
the same extent as set forth in Section 3.4 hereof, provided, that (i)
if the action has been instituted by Genentech, Inc. or a subsidiary or
licensee of Genentech, Inc., Parent shall not be obligated to make any
payment to Buyer as a result of any settlement thereof unless such
settlement is commercially reasonable for Buyer under the circumstances
in absence of Parent's reimbursement obligations pursuant to this
Section 13.7 and (ii) in the case of any other action, Parent shall not
be obligated to make any payment to Buyer as a result of any settlement
thereof unless in the judgement of Parent such settlement is reasonable
under the circumstances.
14. NOTICES
Any notice required or permitted to be given hereunder shall be deemed
sufficient if sent by facsimile letter or overnight courier, or
delivered by hand to Parent or Buyer at the respective addresses and
facsimile numbers set forth below or at such other address and
facsimile number as either party hereto may designate. If sent by
facsimile letter, notice shall be deemed given when the transmission is
completed if the sender has a confirmed transmission report and if the
sender has sent a confirmation copy by registered mail. If a confirmed
transmission report does not exist, then the notice will be deemed
given when the notice is actually received by the person to whom it is
sent. If delivered by overnight courier, notice shall be deemed given
when it has been signed for. If delivered by hand, notice shall be
deemed given when received.
If to Buyer, to:
Centocor, Inc.
000 Xxxxx Xxxxxx Xxxxxxx
Xxxxxxx, XX 00000-0000
Attention: Corporate Secretary
Fax: 000-000-0000
44
if to Parent, to:
Roche Healthcare Limited
P.O. Box HM 905
Xxxxxxxx XX DX
Bermuda
Attention: President
Fax: xx0 000 000-0000
with a copy to:
X. Xxxxxxxx-Xx Xxxxx Ltd
XX-0000 Xxxxx, Xxxxxxxxxxx
Attention: Corporate Law Department
Fax: xx00 00 000 0000
15. ARBITRATION AND GOVERNING LAW
15.1. Except for the right of either party to apply to a court
of competent jurisdiction for a temporary restraining order to preserve
the status quo or prevent irreparable harm pending the selection and
confirmation of a panel of arbitrators, any dispute, controversy, or
claims arising under, out of or relating to this Agreement (and
subsequent amendments thereof), its valid conclusion, binding effect,
interpretation, performance, breach or termination, including tort
claims, shall be referred to and finally determined by arbitration, to
the exclusion of any courts of law, in accordance with the Rules of
Arbitration of the International Chamber of Commerce as in force at the
time when initiating the arbitration. The arbitral tribunal shall
consist of three arbitrators. The place of arbitration shall be
Hamilton, Bermuda. The language to be used in the arbitral proceedings
shall be English. The arbitration decision shall be final and binding
upon the parties and the parties agree that any award granted pursuant
to such decision may be entered forthwith in any court of competent
jurisdiction. This arbitration clause and any award rendered pursuant
to it shall be governed by the United Nations Convention on the
Recognition and Enforcement of Foreign Arbitration Awards signed in New
York as of 10 June, 1958. The party to whom a favourable ruling is
awarded shall be entitled to reimbursement of all its reasonable costs
and expenses in arbitration by the other party.
15.2. The present Agreement shall be subject to the
substantive law of Bermuda (regardless of its or any other
jurisdiction's choice of law principles).
45
16. ADDITIONAL TERMS
16.1. Brokers. Buyer represents to Parent that it has not
employed any investment banker, broker, finder or intermediary in
connection with the transactions contemplated hereby who might be
entitled to a fee or any commission from Parent upon consummation of
the transactions contemplated hereby. Parent represents to Buyer that
it has not employed any such person in connection with the transactions
contemplated hereby who might be entitled to a fee or any commission
from Buyer upon consummation of the transactions contemplated hereby.
16.2. Expenses, Taxes and Fees. Except as otherwise expressly
provided in this Agreement, all legal, accounting and other costs and
expenses incurred in connection herewith and the transactions
contemplated hereby shall be paid by the party incurring such costs and
expenses. Any possible value added, excise or transfer taxes or merger
control filing fees or similar filing fees levied in connection with
the present Agreement shall be paid and borne solely by Buyer and are
not included in the Purchase Price or the payment for the inventory
according to Section 3.
16.3. Entire Agreement. This Agreement, the Exhibits, the
Schedules (including Disclosure Schedule), and the Confidentiality
Agreement embody the entire agreement of the parties hereto with
respect to the subject matter hereof and supersede and replace all
previous negotiations, understandings, representations, writings, and
contract provisions and rights relating to the subject matter hereof.
16.4. Successors and Assigns. This Agreement shall be binding
upon and shall inure to the benefit of the parties and their respective
successors and assigns; provided that this Agreement may not be
assigned by any party without the written consent of the other party.
16.5. Amendments; No Waiver. No provision of this Agreement
may be amended, revoked or waived except by a writing signed and
delivered by an authorised officer of each party. No failure or delay
on the part of either party in exercising any right hereunder will
operate as a waiver of, or impair, any such right. No single or partial
exercise of any such right will preclude any other or further exercise
thereof or the exercise of any other right. No waiver of any such right
will be deemed a waiver of any other right hereunder.
46
16.6. Counterparts. This Agreement may be executed in one or
more counterparts all of which shall together constitute one and the
same instrument and shall become effective when a counterpart has been
signed by Buyer and delivered to Parent and a counterpart has been
signed by Parent and delivered to Buyer.
16.7. Captions. The captions herein are included for
convenience of reference only and shall be ignored in the construction
or interpretation hereof.
IN WITNESS WHEREOF, this Agreement has been signed by duly authorised
representatives of each of the parties hereto as of the date first above
written.
Roche Healthcare Limited Centocor, Inc.
By /s/ Xxxx X. Xxxxxx By /s/ Xxxxx X. Xxxxxxx
--------------------------- ---------------------------
Name Xxxx X. Xxxxxx Name Xxxxx X. Xxxxxxx
------------------------- --------------------------
Title: President Title: Chief Executive Officer
------------------------ -------------------------
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List of Exhibits
----------------
48
Exhibit 10.35
Exhibit A
---------
TRANSITION SERVICES AGREEMENT
THIS TRANSITION SERVICES AGREEMENT (the "Agreement") is made and entered
into on ____________ ,1998 by and between Boehringer Mannheim Corporation
("Seller") on the one hand and Centocor, Inc. ("Buyer") on the other hand.
WHEREAS Roche Healthcare Limited ("Parent") and Buyer have entered into an
Asset Purchase Agreement dated February 11, 1998 (the "Asset Purchase
Agreement") relating to RETAVASE (the "Product"), and
WHEREAS the parties agree that Buyer or its Affiliates shall take over the
distribution of the Product as soon as possible when Buyer or its Affiliate has
obtained the pertaining necessary government approvals for the distribution of
the Product. Parent and Buyer have agreed in the Asset Purchase Agreement that
Parent or its Affiliates shall provide certain transition services to Buyer or
its Affiliates for the Product under a transition services agreement for a
certain transition period after Closing.
Now, therefore the parties hereto agree as follows:
ARTICLE 1. DEFINITIONS
1.1. "Affiliate" of a party means any corporation or other business entity
controlled by, controlling or under common control with, such party. For
this purpose "control" shall mean direct or indirect beneficial ownership
of more than fifty percent (50%) of the voting or income interest in such
corporation or other business entity; provided, however, Genentech, Inc.
and its subsidiaries shall not be considered an Affiliate of Parent.
1.2. "Fully Loaded Costs" means all direct expenses and, with respect to time
spent on a project by employees, an hourly rate which equals salary
(including benefits) plus overhead allocated on the basis of time spent.
1.3. "Net Sales" means gross sales occurring after the Closing Date after
deduction of returns, distributor discounts, sales rebates (price
reduction) and volume (quantity) discount as well as sales taxes (e.g.
value added taxes) and other taxes directly linked to the sales (e.g.
excise taxes) attributed to those sales.
1
1.4. "Services Fee" means a rate which equals 4% of Net Sales for the first
month, 3% of Net Sales for the second month and 2% of Net Sales for the
third month (and thereafter) following the Closing Date.
1.5. "Services" means any and all services with respect to the Product provided
by Seller to Buyer pursuant to this Agreement.
1.6. "Territory" means the United States and Canada and respective possessions
or territories.
1.7. Other Terms. The term "Product" as well as other defined terms used
herein and not defined above shall have the respective meanings assigned to
such terms in the Asset Purchase Agreement.
ARTICLE 2. RESPONSIBILITY OF PARTIES
2.1. Provision of Services. Subject to the terms hereof, Seller and/or its
designated Affiliate(s) shall (a) cooperate with Buyer or its Affiliate and
assist in the orderly transition of the Business in the Territory to Buyer,
and (b) provide the Services described herein that are requested by Buyer.
2.2. Cooperation and Assistance. Seller or its designated Affiliate(s) shall
make available knowledgeable employees/the individuals identified on
Schedule I, or their qualified designees, for consultation with Buyer's
representatives who shall be designated in writing to Seller via telephone,
correspondence or in person at Seller's or its designated Affiliate's
facilities for the purpose of conveying and transferring information
relating to the operation of the Business in the Territory. Such
consultation shall occur for reasonable periods of time upon reasonable
notice during normal business hours. Seller may appoint substitutes for the
individuals listed on Schedule I. Notwithstanding any other provision of
this Agreement, the individuals listed on Schedule I (or their substitutes)
shall be available for reasonable consultation but only for a period of six
(6) months following Closing.
2.3. Distribution Agency Services. With respect to the Product in the
Territory, Seller or its designated Affiliate(s) shall provide all services
(including warehousing and distribution, order taking, shipping, invoicing
and collecting) customarily performed by a distribution agent and as
currently conducted by Seller in connection with the sale of the Product in
the Territory, including the following:
2
(a) accepting orders and invoicing purchasers on behalf of Buyer;
(b) processing all Product returned by customers in accordance with Section
3 of this Agreement;
(c) order entry and billing services;
(d) recording sales and collecting amounts due in accordance with Section 4
of this Agreement;
(e) making appropriate payments for charge-backs and rebates subject to
Section 3.1; and
(f) customer complaint and inquiry services;
it being understood that in providing such services Seller and/or its
Affiliates shall continue to use certain tangible assets not transferred to
Buyer at Closing including, without limitation, AUDIUS system, electronic
mail, computer hardware and call reporting.
2.4. Customer Information. In order to inform customers of the transfer of
the Business to Buyer, and otherwise transition same, Seller and/or its
Affiliates and Buyer shall notify all contracted customers, trade customers
and wholesalers of the transfer of the Product to Buyer by a method and at
a time mutually agreed to by the parties. Notice to wholesalers shall
allow adequate transition time for the wholesalers. The parties hereby
agree that Seller and its Affiliates shall not be responsible for providing
Buyer with any sales or promotion support.
2.5. Government Contracts. The parties shall mutually agree on the timing and
method of notifying applicable federal agency customers and the Health Care
Financing Administration ("HCFA") of the sale of the Product to Buyer, and
shall take whatever action is necessary to simultaneously add the Product
to Buyer's federal supply schedule and Medicaid rebate agreement and delete
the Product from the federal supply schedule and Medicaid rebate agreement
of Seller or its Affiliates, as applicable.
2.6. Reports. Seller shall submit in writing to Buyer (i) within four (4)
business days after the end of each month a report setting forth total
Sales, and (ii) within fifteen (15) days after the end of each calendar
month a report as set forth on Schedule II and such other information as
Buyer shall reasonably request and that the BM Group had in place prior to
the Closing Date.
2.7. NDC Numbers. Promptly following the Closing, Buyer shall take any and all
action necessary to change the National Drug Code number for the Product,
which change shall be implemented under Section 7.1 of the Asset Purchase
Agreement; and if such number shall be obtained during the term of this
Agreement, the
3
parties will discuss the appropriate implementation thereof with respect to
the Services provided hereunder. Payments with respect to rebates shall be
consistent with the Asset Purchase Agreement.
2.8. Payment of Net Sales. Four days following the end of each month, Seller
will wire transfer to Buyer an amount equal to total Net Sales collected
for such month less the amount of the Services Fee portion of the fee
calculated for such month under Section 5.2.
2.9. Medical Safety and Reporting. Following Closing, Buyer, will be responsible
to provide all drug safety services for the Product in the Territory, such
as handling medical and safety inquiries regarding the Product, receiving
adverse event inquiries and report preparation, and the preparation and
submission of two required quarterly reports, namely the Drug Safety
Periodic Report and the Drug Safety Increased Frequency Report. Buyer
represents to Seller that it will employ a trained physician to handle such
inquiries and report preparation and filing. Following Closing, Seller and
Buyer shall cooperate in good faith, as defined by the regulatory and drug
safety reporting transition teams, to respond to all such questions, calls
or inquiries. Seller shall during the term of this Agreement forward
medical safety information concerning the Products in the Territory
received by Seller or its Affiliates to Buyer.
ARTICLE 3. PRODUCT RETURNS
3.1. Returns. The responsibility for Product returns in the Territory
shall be governed by Section 8.11 of the Asset Purchase Agreement. During
the term of this Agreement, Seller and its Affiliates process and pay all
claims received by them for returns of Product in accordance with the
provision of their return goods policy attached hereto as Schedule III.
Buyer shall not engage in any action (other than pricing of the Product) to
induce any purchaser of the Product to return Product sold prior to Closing
Date; provided, however, that to the extent returns of Product result from
changes in pricing by Buyer, Buyer shall be responsible for such returns.
For Product shipped after the Closing Date, Buyer shall be responsible for
all returns of the Product within the Territory. Buyer shall reimburse
Seller and its Affiliates for all cost of returns handled by Seller and its
Affiliates hereunder for which Buyer is responsible according to Section
8.11 of the Asset Purchase Agreement.
3.2. Disposition of Returned Product. Returned Product will be handled in
accordance with the provisions of the disposition of returned goods policy
4
Seller, a copy of which is attached hereto as Schedule IV.
ARTICLE 4. ACCOUNTS RECEIVABLE
So long as it continues to provide Services, Seller or its designated
Affiliate(s) shall use reasonable efforts (except for instituting third
party collection or legal proceedings) to collect accounts receivable with
respect to the Product.
ARTICLE 5. PAYMENTS
5.1. Fees. In consideration of Seller's and its Affiliate(s) Services under
this Agreement, Buyer will pay to Seller a fee equal to the Services Fee.
In addition, Seller and its Affiliate(s) shall be reimbursed their Fully
Loaded Costs for any extraordinary services (i.e., those services beyond
those expected in the context of ordinary business operations) including
without limitation the cost of destruction of returned goods other than
pursuant to on-going, normal business operations and the participation of
Seller and its Affiliates in any recall of Product, "scrap" charges
incurred because of NDC or other labelling or packaging changes,
transportation costs associated with the delivery of inventory and records
upon termination of this Agreement and any other expenses incurred by
Seller and its Affiliates specifically as a result of this Agreement.
Buyer will reimburse Seller and its Affiliates with respect to the
foregoing costs, if any, within thirty (30) days of receipt of Seller's
statement.
5.2. Calculations. As soon as practicable after the end of each calendar month,
Seller and its Affiliates will calculate the total amount of fee payable by
Buyer for such month under Section 5.1.
ARTICLE 6. STANDARD FOR SERVICE
Seller and its Affiliate(s) shall meet the standards of the applicable
profession in performing Services hereunder; provided that neither Seller
and its Affiliate(s) nor their employees shall have any liability to Buyer
in connection with such performance absent bad faith, negligence or wilful
misconduct. As a principle, the parties agree that the quality and quantity
of Services provided hereunder to Buyer (including without limitation the
substance, timeliness and diligence thereof) shall be substantially the
same as the quality and quantity of services previously rendered in
relation to the Product by BMC personnel. Nothing contained in this
5
Agreement shall require Seller and its Affiliate(s) to alter its
operations, policies, procedures, method of doing business, reporting
mechanism or formats or information technology systems in order to provide
Services hereunder or otherwise engage in any extraordinary activities,
except as set forth in this Agreement. If Buyer suffers any loss or damage
caused directly by the bad faith, negligence or wilful misconduct of
Seller, its Affiliates or their employees hereunder, Buyer shall be
entitled to recover its direct costs incurred. Under no circumstances shall
Seller and its Affiliates have to pay or shall Buyer be entitled to recover
any consequential, special, indirect or incidental damages hereunder.
ARTICLE 7. TERM AND TERMINATION
7.1. Term. This Agreement shall commence as of the Closing date under the Asset
Purchase Agreement and shall expire on the later of (i) 3 (three) months
following the Closing Date and (ii) when Buyer or its Affiliate has
obtained the pertaining necessary government approvals for the distribution
of the Product in the country concerned, but in no event later than 6 (six)
months after the Closing Date under the Asset Purchase Agreement. Buyer
shall use best efforts to assume the Services provided by Seller and its
Affiliates hereunder as soon as possible, whenever possible earlier than
the expiry of this Agreement. If Buyer is, despite such best efforts,
unable to assume the services being provided within the term of this
Agreement, Buyer and Seller shall discuss in good faith solutions for the
countries concerned.
7.2. Termination. Either party may terminate this Agreement with immediate
effect upon written notice (a) if the other party is in material breach or
default with respect to any term or provision hereof and fails to cure the
same within twenty-one (21) days of receipt of notice of said breach or
default or (b) if the other party is or will inevitably in the near future
be dissolved, liquidated or bankrupt. Buyer may terminate this Agreement at
any time upon not less than ten (10) days written notice, provided any
transition issues that will require cooperation after termination are
mutually agreed to by the parties.
7.3. Rights and Duties of Parties Upon Termination. Upon expiration or other
termination of this Agreement in accordance with the terms hereof, the
parties shall cooperate in the orderly termination of the Services
hereunder, including without limitation the transfer of Product to Buyer;
and the transfer of other information relating solely to the Product,
including customer information.
6
ARTICLE 8. CONFIDENTIALITY
Seller and its Affiliates shall treat as confidential all information
provided by Buyer hereunder, including but not limited to information
relating to the Services. Buyer shall provide such information only to
those employees of Seller and its Affiliates that require such information
to effect the provisions of this Agreement. Seller shall not use such
information except for the express purposes contemplated by this Agreement
and shall not disclose such information to any individual or entity (except
to such of its employees, Affiliates and subcontractors who reasonably
require same for the purposes hereof and who are bound to Seller by like
obligations as to confidentiality and non-use) without the express written
permission of Buyer. Notwithstanding the foregoing, Seller shall not be
prevented from using or disclosing any portion of such information that
Seller can prove: (a) was in the public domain prior to the date of this
agreement or thereafter enters the public domain through no fault of
Seller, its Affiliates or their respective representatives; (b) was
available to Seller on a non-confidential basis prior to its disclosure to
Seller by Buyer, its Affiliates or their respective representatives; (c) is
later lawfully acquired by Seller from sources other than Buyer, its
Affiliates or their respective representatives who are not, to the best of
knowledge of Seller, subject to any legally binding obligation to keep such
information confidential; (d) independently developed by Seller without
reference to such confidential information; or (e) is required by law,
regulation, rule, act or order of any governmental authority or agency to
be disclosed by Seller; provided, however, that in the case of (e), Seller
gives Buyer sufficient advance written notice to permit Buyer to seek a
protective order with respect to such information and thereafter Seller
discloses only the minimum information required to be disclosed in order to
comply. Should Seller and its Affiliates provide Buyer with any
confidential information, or marked or confirmed in writing as confidential
by Seller, relating to Seller's or its Affiliate(s) products or business,
other than information which pertains to the Product or the Business, Buyer
shall be subject to the confidentiality provisions under this Section 7.
The obligations of each party under this Section shall remain in full force
and effect for five (5) years following termination or expiration of this
Agreement.
ARTICLE 9. INDEPENDENT CONTRACTOR
Each party shall act solely as an independent contractor and nothing in
this Agreement shall be construed to give either the power or authority to
enter into or incur, any commitments, expenses or liabilities whatsoever on
behalf of the other party. Nothing herein shall be construed to create the
relationship of partnership,
7
principal and agent, or joint venture between Buyer and Seller, other than
as expressly set forth herein.
ARTICLE 10. NOTICES
Any notice required or permitted to be given hereunder shall be deemed
sufficient if sent by facsimile letter or overnight courier, or delivered
by hand to Seller or its designates Affiliate(s) or to Buyer at the
respective addresses and facsimile numbers set forth below or at such other
address and facsimile number as either party hereto may designate. If sent
by facsimile letter, notice shall be deemed given when the transmission is
completed if the sender has a confirmed transmission report. If a confirmed
transmission report does not exist, then the notice will be deemed given
when the notice is actually received by the person to whom it is sent. If
delivered by overnight courier, notice shall be deemed given when it has
been signed for. If delivered by hand, notice shall be deemed given when
received.
All correspondence to Seller shall be addressed as follows:
Boehringer Mannheim Corporation
000 Xxxxxxx Xxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Attention: Law Department
Fax: 000-000-0000
with a copy to:
X.Xxxxxxxx-Xx Xxxxx Ltd
XX-0000 Xxxxx, Xxxxxxxxxxx
Attention: Corporate Law Department
Fax: xx00 00 000 0000
8
All correspondence to Buyer shall be addressed as follows:
Centocor, Inc.
000 Xxxxx Xxxxxx Xxxxxxx
Xxxxxxx, XX 00000-0000
Attention: Corporate Secretary
Fax: 000-000-0000
ARTICLE 11. SUCCESSORS AND ASSIGNS
This Agreement shall be binding upon and shall inure to the benefit of
the parties and their respective successors and assigns; provided that
this Agreement may not be assigned by any party without prior written
consent of the other party except that Seller may assign this
Agreement to one or more of its Affiliates with the prior written
consent of Buyer, which consent shall not be unreasonably withheld.
ARTICLE 12. ADDITIONAL TERMS
12.1. Arbitration and Governing Law. Any dispute, controversy or claim
arising out of or relating to this Agreement shall be settled by final
and binding arbitration in accordance with the arbitration provisions
and the governing law of the Asset Purchase Agreement.
12.2. Entire Agreement. This Agreement, along with the Asset Purchase
Agreement, constitutes the entire understanding between the parties
with respect to the subject matter hereof and supersedes and replaces
all previous negotiations, understandings, representations, writings,
and contract provisions and rights relating to the subject matter
hereof. If there is any conflict between this Agreement and the terms
and conditions contained on any purchase order or invoice, the terms
and conditions of this Agreement shall prevail.
12.3. Amendments; No Waiver. No provision of this Agreement may be amended,
revoked or waived except by a writing signed and delivered by an
authorized officer of each party. No failure or delay on the part of
either part in exercising any right hereunder will operate as a waiver
of, or impair, any such right. No single or partial exercise of any
such right will preclude any other or further exercise thereof or the
exercise of any other right. No waiver of any such right will be
deemed a waiver of any other right hereunder.
12.4. Validity. Should any part or provision of this Agreement be held
unenforceable or invalid, the invalid or unenforceable provision shall
be replaced with a provision
9
that accomplishes, to the extent possible, the original business purpose
of such provision in a valid and enforceable manner, and the remainder of
this Agreement shall remain binding upon the parties.
12.5. Counterparts. This Agreement may be executed in one or more counterparts,
each of which shall be deemed to be an original, but all of which together
shall constitute a single agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the day and year first hereinabove written.
Boehringer Mannheim Corporation Centocor, Inc.
By By
------------------------- ---------------------------
Name Name
----------------------- -------------------------
Title: Title:
--------------------- -----------------------
10
SCHEDULE I
SELLER CONTACTS
Key Contacts:
Primary Secondary
------- ---------
Overall questions of policy on major
unresolved issues
General operational questions Xxxxx Xxxxxxxx Xxxxx Xxxxxxxx
Legal Xxxxx Xxxxxxxx Donate Garoner
Sales and marketing Xxxxx Xxxx Xxx Xxxxxxxx
Contracts Xxxx Xxxxxxxx Xxxxx Xxxxxx
Production planning/specific orders Xxxx Xxxxxxxxx Xxxxxxxx Xxxxxx
Accounting/Finance Xxxxx Xxxxxxxx Xxxx Xxxxxx
Inventory Xxxx Xxxxxxxxx Xxx Xxxxxx
Distribution Xxx Xxxxxx Xxxx Xxxxxxxxx
Records transfer/retention Xxxxx Xxxxxxxx Donate Garoner
Regulatory Xxxxx Xxxxxxxxx Xxxxx Xxxxxxxxx
Medicaid Xxxx Xxxxxx Xxxxx Xxxxxx
Clinical Studies Xxxxxxx Xxxxxxx Xxxx Xxxxxxx
Medical Affairs Xxxxxxx Xxxxxx Xxxx Xxxxxxx
Quality Assurance/Quality Control Xxx Xxxxx Xxxx-Xxxxxx Xxxxxxxx
SCHEDULE II
REPORTING FORMAT
$ Amount Units Average
price or cost
SALES:
Gross Sales
(by NDC for finished product or by product for
bulk active)
Adjustments to gross sales:
Sales returns and allowances (by NDC)
Managed Care Rebates
(by NDC)
Medicaid Rebates
(by NDC)
Charge-backs (by NDC)
FINISHED GOOD INVENTORY
Beginning Balance
(by NDC)
Production (by NDC), @ agreed upon unit cost)
Cost of Sales (by NDC)
Ending Balance (by NDC)
EXHIBIT 10.36
Exhibit B
---------
SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (this "Agreement") is made and entered into on
_____, 1998 by and between Boehringer Mannheim GmbH ("Seller") on the one hand
and Centocor, Inc. ("Buyer") on the other hand.
WHEREAS Roche Healthcare Limited ("Parent") and Buyer have entered into
an Asset Purchase Agreement dated February 11, 1998 (the "Asset Purchase
Agreement") relating to RETAVASE (the "Product"), and
WHEREAS Parent and Buyer have agreed in the Asset Purchase Agreement that
Seller and/or its Affiliates shall supply bulk labelled lyophilized vials or
bulk Active Ingredient to Buyer or its Affiliate for a period of four years and
at certain terms and conditions to be set forth in more detail in the present
Supply Agreement;
Now, therefore, the parties hereto agree as follows:
1. DEFINITIONS
1.1. "Active Ingredient" means recombinant reteplase (rPA), a recombinant,
non-glycosylated plasminogen activator containing amino acids 1-3 and
176-527 of the amino acid sequence of tissue-type plasminogen activator.
1.2. "Affiliate" of a party means any corporation or other business entity
controlled by, controlling or under common control with, such party. For
this purpose "control" shall mean direct or indirect beneficial ownership
of more than fifty percent (50%) of the voting or income interest in such
corporation or other business entity; provided, however, Genentech, Inc.
and its subsidiaries shall not be considered an Affiliate of Seller.
1.3. "Product", for purposes of this Supply Agreement only, means either the
Active Ingredient or any pharmaceutical preparation containing the Active
Ingredient (sometimes hereinafter referred to as bulk labelled
lyophilized vials), and including future formulation changes developed
during the term of this Supply Agreement that are used by Seller to
supply Buyer.
1
1.4. "Specifications" has the meaning ascribed to such term in Section 5.1.1.
1.5. "Territory" means the United States and Canada and respective possessions
or territories.
1.6. Other Terms. The defined terms used herein and not defined above shall
have the respective meanings assigned to such terms in the Asset Purchase
Agreement.
2. SUBJECT MATTER
2.1. Subject Matter. Subject to the terms and conditions of this Agreement,
Seller or its designated Affiliate(s) shall supply to Buyer during the
term of the present Agreement Buyer's requirements of the bulk labelled
lyophilized vials or bulk Active Ingredient manufactured by Seller or
Affiliates of Seller, provided that Seller and its Affiliates shall not
be obliged to supply bulk labelled lyophilized vials or bulk Active
Ingredient in excess of its capacity.
3. FORECASTS AND ORDERS
3.1. Forecasts. Buyer shall give Seller or Seller's designated Affiliate(s)
within one month from the date of this Agreement and thereafter at the
beginning of every calendar quarter the estimate by month of its
requirements of bulk labelled lyophilized vials or bulk Active Ingredient
for the following 12 (twelve) months. The first 3 (three) months of each
estimate shall constitute a firm order. Each successive estimate (after
the first such estimate) shall update the estimate previously given for
the last calendar quarter covered by the immediately preceding estimate
and add an estimate for the calendar quarter following immediately
thereafter, such that Seller shall have sufficient information upon which
to schedule its manufacturing operations so as to be able to meet Buyer's
estimated requirements of the bulk labelled lyophilized vials or bulk
Active Ingredient. Seller shall not provide any of the forecast
information set forth above to Genentech, Inc.
3.2. Orders. Buyer shall provide a written firm purchase order to Seller or
its designated Affiliate(s) (at one of Seller's or its Affiliates'
offices designated by Seller) at least 3 (three) months prior to a
requested delivery date. Seller or its designated Affiliate(s) shall
supply the bulk labelled lyophilized vials or bulk Active Ingredient
within 3 (three) months after receipt of a firm order therefor from
Buyer. In the event that the sum of the orders for delivery within any
2
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS
AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT
THE PLACES INDICATED BY ASTERICKS (*); AND HAVE BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION
calendar quarter exceeds 100% (one hundred percent) of the most recent
estimate given by Buyer for such calendar trimester pursuant to Section
3.1 above, and subject to the supply obligation set forth in Section 2.1
above, Seller and Buyer shall consult with each other and Seller shall be
allowed such reasonable time as is needed to arrange for the orderly
manufacture of such additional requirements.
3.3 Minimum Order Size. The minimum size of any order for any bulk labelled
lyophilized vials or bulk Active Ingredient shall be one full batch of
such bulk labelled lyophilized vials (as set forth in Schedule 3.3
hereto) or bulk Active Ingredient with larger orders being in whole
number multiples of such a batch.
4. PRICE, DELIVERY AND PAYMENT CONDITIONS
4.1 Price. Buyer shall purchase the bulk labelled lyophilized vials from the
Seller at DM [*] per vial or DM [*] per amount of bulk Active
Ingredient contained in one such vial or, in the case of formulation
changes, a price to be agreed on by the parties in good faith.
4.2 Delivery Conditions. Title and risk of loss or damage to any bulk
labelled lyophilized vials or bulk Active Ingredient supplied hereunder
shall pass to Buyer upon delivery at Seller's or its Affiliate's
manufacturing plant to a common carrier for delivery of such Product.
Buyer shall be responsible and pay for any and all customs duties, value
added, excise and other taxes, clearances and/or levies of any type
whatsoever with regard to the supply of the Product from Seller or its
Affiliate hereunder Seller may select a common carrier for shipment of
goods; delivery will be per Buyer's instruction.
4.3 Certificate of Analysis. All bulk labelled lyophilized vials or bulk
Active Ingredient supplied to Buyer shall be accompanied by a signed and
dated Certificate of Analysis, which shall be substantially in the form
attached as Schedule 4.3 hereto. A copy of this Certificate of Analysis
will be sent by fax to the appropriate contact person at Buyer. The
original Certificate of Analysis shall be dispatched by airmail, or sent
together with the Product, at the time of shipment in accordance with
Buyer's instructions.
4.4 Invoicing and Payment Conditions. Seller or its designated Affiliate(s)
shall invoice Buyer in German marks for all supplies of bulk labelled
lyophilized vials or bulk Active Ingredient hereunder monthly after
delivery as defined herein. Buyer shall effect payment of such invoices
in German marks to Seller's or its Affiliate(s) designated bank account
within 30 (thirty) days after the date of
3
Confidential Treatment Requested
invoice. Seller and its Affiliate(s) may charge a late payment fee of
1.5% of the outstanding balance for each 30 (thirty) day period
thereafter during which said balance remains unpaid.
4.5 Supply. If there is an interruption in the manufacture of the bulk
labelled lyophilized vials or bulk Active Ingredient for a period of more
than 45 days (i) caused by the actions of Seller or its Affiliates, Buyer
shall have first call on the then available supply, or (ii) caused by
actions other than those of Seller or its Affiliates, the then available
supply shall be divided between Seller and Buyer based upon their
respective previous three months' sale.
5. SPECIFICATIONS, WARRANTY AND INDEMNIFICATION
5.1 Warranties; Specifications and Analysis
5.1.1. Seller represents and warrants that the bulk labelled lyophilized vials
or bulk Active Ingredient manufactured by Seller or its Affiliate(s) for
Buyer pursuant meet the FDA approved specifications therefor, as may be
amended from time to time by Seller after reasonable prior notice to
Buyer which is sufficient to enable Buyer to assess the impact of the
amendment on Buyer's manufacturing process, but not exceeding 60 (sixty)
days, and prior approval by the respective registration authorities, if
required (the "Specifications").
Seller or its Affiliate shall send to Buyer with each such shipment a
certificate of analysis specifying, inter alia, the results of each of
the determinations required to show conformance of such shipment with the
Specifications. The figures set forth in the certificate of analysis
shall be accepted as accurate for the purposes of this Agreement unless
Buyer within 30 (thirty) days of the receipt of such shipment notifies
Seller in writing that it has analysed such shipment in accordance with
Seller's or its Affiliates' methods of analysis, as may be amended from
time to time by Seller after reasonable prior notice to Buyer which is
sufficient to enable Buyer to assess the impact of the amendment on
Buyer's manufacturing process, but not exceeding 60 (sixty) days, and
prior approval by the respective registration authorities, if required
and has determined that such shipment does not conform to the
Specifications. In the latter event, Buyer and Seller agree to consult
with each other in order to resolve the discrepancy between each other's
determinations. If such consultations do not resolve the discrepancy,
Buyer and Seller agree to nominate an independent, reputable laboratory,
acceptable to both parties, which shall carry out determinations on
representative samples taken from such shipment, using Seller's or its
Affiliates' methods of analysis, and the resulting determinations shall
be binding on Buyer and Seller for the purposes hereof. The
4
cost of the analysis of such independent laboratory shall be borne by the
party whose testing was in error.
5.1.2. If it is determined that a shipment of bulk labelled lyophilized vials or
bulk Active Ingredient, as of the date shipped, does not conform to the
Specifications, Seller shall replace such shipment with a substitute
shipment that meets the Specifications. The above shall be Seller's and
its Affiliates' sole liability for, and Buyer's sole and exclusive remedy
for the supply of any Product that do not conform to the Specifications.
The non-conforming shipment shall be returned, at Seller's expense by
Buyer to Seller upon final determination in accordance with Section 5.1.1
above that it does not meet the Specifications.
5.2 DISCLAIMER. EXCEPT AS SET FORTH IN SECTIONS 5.1.1 AND 5.1.2 ABOVE, SELLER
MAKES NO REPRESENTATIONS AND DISCLAIMS ANY WARRANTIES OF ANY KIND,
EXPRESS OR IMPLIED, TO BUYER FOR ANY BULK LABELLED LYOPHILIZED VIALS OR
BULK ACTIVE INGREDIENT SUPPLIED BY SELLER OR ITS AFFILIATES HEREUNDER,
INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.
5.3 Recall. Buyer is competent and responsible for deciding about and
effecting a recall of the Product. In case of such a recall, to the
extent necessary or needed, Seller shall cooperate with Buyer as
reasonably required in carrying out any such recall. Buyer shall
reimburse Seller and its Affiliates for any cost reasonably expended by
Seller and its Affiliates to effect the recall, provided that if a recall
is caused by non-compliance of the Product with the Specifications at the
date of shipment, Seller shall reimburse Buyer for (a) any cost
reasonably expended by Buyer to effect the recall, (b) any manufacturing
and shipping fees paid to Seller by Buyer for recalled Product, and (c)
any reasonable disposal costs for such recalled Product.
5.4 Indemnification
5.4.1. Indemnification by Seller. Subject to the following limitations, Seller
shall be liable for and shall indemnify and hold harmless Buyer in
respect of any and all liabilities, losses, damages, claims or lawsuits,
including but not limited to any liabilities, losses, damages, claims or
lawsuits arising out of the manufacture, use, sale or marketing of the
Product, including but not limited to any claims made (directly or
indirectly) by or on behalf of consumers who have purchased or otherwise
obtained and/or used the Product, arising from Seller's (i) failure to
5
supply bulk labelled lyophilized vials or bulk Active Ingredient meeting
FDA specifications upon delivery to Buyer, provided that Buyer gives
Seller prompt, adequate notice of such third party claim and permits
Seller to assume the sole control of all phases of the defense and/or
settlement of such claim, including the selection of counsel, it being
understood that Seller shall not be liable for any negligent act or
omission of Buyer or for any representations and warranties, express or
implied, made by Buyer that exceed the representations and warranties
made by Seller to Buyer under this Agreement, (ii) breach of this
Agreement, (iii) negligence or wilful misconduct, (iv) breach of
statutory duty, or (v) act, omission or default howsoever caused on the
part of Seller, its Affiliates, employees and agents. The indemnity by
Seller set forth in clause (i) above shall include loss of Buyer's
profits unless Seller is able to demonstrate that Seller's failure to
supply bulk labelled lyophilized vials or bulk Active Ingredient meeting
FDA specifications upon delivery to Buyer was entirely beyond Seller's
control and in no part the result of negligence or wilful misconduct on
the part of Seller.
5.4.2. Indemnification by Buyer. Subject to the following limitations, Buyer
shall be liable for and shall indemnify and hold harmless Seller in
respect of any and all liabilities, losses, damages, claims or lawsuits,
including but not limited to any liabilities, losses, damages, claims or
lawsuits arising out of the manufacture, use, sale or marketing of the
Product, including but not limited to any claims made (directly or
indirectly) by or on behalf of consumers who have purchased or otherwise
obtained and/or used the Product, arising from Buyer's (i) breach of this
Agreement, (ii) negligence or wilful misconduct, (iii) breach of
statutory duty or (iv) act, omission or default howsoever caused on the
party of Buyer, its employees and agents. Notwithstanding the foregoing,
Buyer shall not be liable to Seller, whether in contract, tort or
otherwise, for any consequential, indirect, economic or financial loss or
damage (including, without prejudice to the generality of the foregoing,
any loss of turnover, revenue, profits, business or goodwill) howsoever
caused.
6. CONFIDENTIALITY
6.1 Subject to the Asset Purchase Agreement, each party shall during and for
5 (five) years after the term of this Agreement not use for any other
purpose than contemplated under this Agreement and not disclose to any
person (not including a contract manufacturer of Buyer with respect to
manufacture of the Active Ingredient, provided that such contract
manufacturer (i) shall be obligated to keep such confidential information
confidential and (ii) shall not use such information for any purpose
other than with respect to manufacture of the Active Ingredient)
6
any confidential information received from the other party concerning
formulas, manufacturing processes, commercial methods and other activities
of the other party, except to the extent required by government authorities
for the execution of this Agreement or relating to the safety of the
Product.
6.2 It is understood that confidential information shall not include
information which the party receiving the information (in the case of
either Seller or Buyer, their Affiliates and their respective
representatives, "Receiving Party") can prove (a) was in the public domain
prior to the date of this agreement or thereafter enters the public domain
through no fault of Receiving Party; (b) was available to Receiving Party
on a non-confidential basis prior to its disclosure to Receiving Party by
the party providing the information (in the case of either Seller or Buyer,
their Affiliates and their respective representatives, "Providing Party");
(c) is later lawfully acquired by Receiving Party from sources other than
Providing Party who are not, to the best of knowledge of Receiving Party
subject to any legally binding obligation to keep such information
confidential; (d) independently developed by Receiving Party without
reference to such confidential information; or (e) is required by law,
regulation, rule, act or order of any governmental authority or agency to
be disclosed by Receiving Party; provided, however, that in the case of
(e), Receiving Party gives Providing Party sufficient advance written
notice to permit Providing Party to seek a protective order with respect to
such information and thereafter Receiving Party discloses only the minimum
information required to be disclosed in order to comply.
7. TERM AND TERMINATION
7.1 Term. The present Agreement shall become effective at the Closing Date and
shall remain in force for a period which is the earlier of (i) four years
and (ii) three months following the date Buyer obtains all necessary
approvals to manufacture the Active Ingredient, subject to extension with
approval of the FTC.
7.2 Termination. Notwithstanding Section 7.1 above, either party may terminate
this Agreement at any time with immediate effect by written notice to the
other party.
a) if the other party has failed to perform any of its obligations
hereunder and has not corrected such default within 60 (sixty) days
after dispute resolution pursuant to Section 8.1 hereof (provided
that, even following the 60-day period referred to above, the Seller
shall not have a right to terminate pursuant to this Section 7.2 a) as
long as Buyer continues to pay all amounts due to Seller in accordance
with Sections 4.4. and 5.4.2
7
hereof);
b) if the other party is or will inevitably in the near future be
dissolved, liquidated or bankrupt; provided that Seller shall not have
a right to terminate pursuant to this Section 7.2 b) as long as Buyer
continues to pay all amounts due to Seller in accordance with Section
4.4.
8. ARBITRATION AND GOVERNING LAW
8.1 Arbitration. Except for the right of either party to apply to a court of
competent jurisdiction for a temporary restraining order to preserve the
status quo or prevent irreparable harm pending the selection and
confirmation of a panel of arbitrators, any dispute, controversy, or claims
arising under, out of or relating to this Agreement (and subsequent
amendments thereof), its valid conclusion, binding effect, interpretation,
performance, breach or termination, including tort claims, shall be
referred to and finally determined by arbitration, to the exclusion of any
courts of law, in accordance with the Rules of Arbitration of the
International Chamber of Commerce as in force at the time when initiating
the arbitration. The arbitral tribunal shall consist of three arbitrators.
The place of arbitration shall be Xxxxxxxx, Bermuda. The language to be
used in the arbitral proceedings shall be English. The arbitration decision
shall be final and binding upon the parties and the parties agree that any
award granted pursuant to such decision may be entered forthwith in any
court of competent jurisdiction. This arbitration clause and any award
rendered pursuant to it shall be governed by the United Nations Convention
on the Recognition and Enforcement of Foreign Arbitration Awards signed in
New York as of 10 June, 1958. The party to whom a favourable ruling is
awarded shall be entitled to reimbursement of all its reasonable costs and
expenses in arbitration by the other party.
8.2 Governing Law. The present Agreement shall be subject to the substantive
law of Bermuda (regardless of its or any other jurisdiction's choice of law
principles).
9. MISCELLANEOUS
9.1 Force Majeure. If any of the parties hereto finds itself in spite of
ordinary care unable by reason of a duly evidenced case of force majeure,
i.e. an event beyond its control, to carry out its obligations hereunder in
whole or in part, the obligations of such party, to the extent that they
are affected by such force majeure, shall be suspended as long as the
impossibility so caused shall endure.
8
The party affected by force majeure shall immediately inform the other
party and shall make all reasonable efforts to remedy the situation created
by such force majeure as soon as possible.
9.2 Independent Contractor. Each party shall act solely as an independent
contractor and nothing in this Agreement shall be construed to give either
the power or authority to enter into or incur, any commitments, expenses or
liabilities whatsoever on behalf of the other party. Nothing herein shall
be construed to create the relationship of partnership, principal and
agent, or joint venture between Seller and Buyer.
9.3 Quality Control. In connection with the obligations of Seller and Buyer as
set forth in this Agreement, Seller and Buyer shall review the quality
control procedures required by the FDA and the Department of Health Canada
in order to determine the most practical way in which to comply with such
procedures.
9.4 Notices. Any notice required or permitted to be given hereunder shall be
deemed sufficient if sent by facsimile letter or overnight courier, or
delivered by hand to Seller or Buyer at the respective addresses and
facsimile numbers set forth below or at such other address and facsimile
number as either party hereto may designate. If sent by facsimile letter,
notice shall be deemed given when the transmission is completed if the
sender has a confirmed transmission report and if the sender has sent a
confirmation copy by registered mail. If a confirmed transmission report
does not exist, then the notice will be deemed given when the notice is
actually received by the person to whom it is sent. If delivered by
overnight courier, notice shall be deemed given when it has been signed
for. If delivered by hand, notice shall be deemed given when received.
if to Buyer, to:
Centocor, Inc.
000 Xxxxx Xxxxxx Xxxxxxx
Xxxxxxx, XX 00000-0000
Attention: Corporate Secretary
Fax: 000-000-0000
if to Seller, to:
Boehringer Mannheim GmbH
Xxxxxxxxx Xxx. 000
X-00000 Xxxxxxxx
9
Germany
Attention: Claus-Xxxx Xxxxxx
Fax: xx00 000 000 0000
with a copy to:
X.Xxxxxxxx-Xx Xxxxx Ltd
XX-0000 Xxxxx, Xxxxxxxxxxx
Attention: Corporate Law Department
Fax: xx00 00 000 0000
9.5 Assignment. Neither party shall have the right to assign the present
Agreement or any part thereof to any third party without the prior written
approval of the other party. However, all Affiliates of Seller shall not
be deemed to be third parties within the meaning of this provision.
9.6 Amendments: No Waiver. No provision of this Agreement may be amended,
revoked or waived except by a writing signed and delivered by an authorized
officer of each party. No failure or delay on the part or either party in
exercising any right hereunder will operate as a waiver of, or impair, any
such right. No single or partial exercise of any such right will preclude
any other or further exercise thereof or the exercise of any other right.
No waiver of any such right will be deemed a waiver of any other right
hereunder.
9.7 Validity. Should any part or provision of this Agreement be held
unenforceable or invalid, the invalid or unenforceable provision shall be
replaced with a provision that accomplishes, to the maximum possible
extent, the original business purpose of such provision in a valid and
enforceable manner, and the remainder of this Agreement shall remain
binding upon the parties.
9.8 Counterparts. This Agreement may be executed in one or more counterparts
all of which shall together constitute one and the same instrument and
shall become effective when a counterpart has been signed by Buyer and
delivered to Seller and a counterpart has been signed by Seller and
delivered to Buyer.
10
IN WITNESS WHEREOF, this Agreement has been signed by duly authorized
representatives of each of the parties hereto as of the date first above
written.
Boehringer Mannheim GmbH Centocor, Inc.
By: By:
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Name: Name:
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Title: Title:
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THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS
AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT
THE PLACES INDICATED BY ASTERICKS (*); AND HAVE BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 3.3
For bulk labelled vials: One full batch equals [*]
For bulk Active Ingredient: One full batch equals 100g (one hundred grams).
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Exhibit D
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KEEP WELL AGREEMENT
Agreement dated as of , 1998 between Roche Holding Ltd (the
"Parent") and Roche Healthcare Limited (the "Subsidiary").
WHEREAS the Parent owns directly or indirectly all the capital stock of the
Subsidiary; and
WHEREAS the Subsidiary proposes to enter into an Asset Purchase Agreement
with Centocor, Inc. (the "Asset Purchase Agreement").
NOW, THEREFORE, the parties agree as follows:
1. Stock Ownership of the Subsidiary. At all times during the term of
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this Agreement, the Parent shall directly or indirectly own and hold the entire
legal title to and beneficial interest in all the outstanding shares of stock of
the Subsidiary having the right to vote for the election of members of the Board
of Directors of the Subsidiary and will not directly or indirectly pledge or in
any way encumber or otherwise dispose of any such shares of stock, unless
required to dispose of any or all such shares of stock pursuant to a court
decree or order of any governmental authority which, in the opinion of counsel
to the Parent, may not be successfully challenged.
2. Maintenance of Consolidated Net Worth. The Parent agrees that it shall
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cause the Subsidiary to have a Consolidated Net Worth of at least U.S.$1,000,000
at all times.
For purposes of this Agreement, the term "Consolidated Net Worth" shall
mean the excess of total assets of the Subsidiary and its consolidated
subsidiaries over total liabilities of the Subsidiary and its consolidated
subsidiaries, total assets and total liabilities each to be determined in
accordance with generally accepted international accounting principles
consistently applied.
3. Waiver. The Parent hereby waives any failure or delay on the part of
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the Subsidiary in asserting or enforcing any of its rights or in making any
claims or demands hereunder.
4. Not a Guarantee. This Agreement is not, and nothing herein contained
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and nothing done pursuant hereto by the Parent shall be deemed to
constitute, a guarantee by the Parent of the payment of any obligation,
indebtedness or liability, of any kind or character whatsoever, of the
Subsidiary. The only parties to this Agreement are the Subsidiary and the
Parent, and this Agreement shall not confer upon any other person any right or
claim against the Parent.
5. Modification, Amendment or Termination. This agreement may be
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modified, amended or terminated by the written agreement of the parties;
provided, however, that no such modification, amendment or termination shall
have any adverse effect upon the ability of the Subsidiary to meet its
obligations under Section 3.4 and Section 13.7 of the Asset Purchase Agreement
without the written consent of Centocor, Inc.
6. Bankruptcy, Liquidation or Moratorium. Any rights and obligations
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which either of the parties has under this Agreement will remain valid and
binding notwithstanding any bankruptcy or liquidation of, or moratorium
involving, the Subsidiary.
7. Rights of the Subsidiary. It is the intention of the parties in
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entering into this Agreement to benefit the Subsidiary, and accordingly the
obligations of the Parent under this Agreement may be enforced exclusively by
the Subsidiary at any time against the Parent.
8. Successors. The agreements herein set forth shall be mutually binding
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upon, and inure to the mutual benefit of, the Parent and the Subsidiary and
their respective successors.
9. Governing Law. This Agreement shall be governed by the laws of Bermuda
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(regardless of its or any other jurisdiction's choice of law principles).
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed and delivered by their respective officers thereunto duly authorized as
of the day and year first above written.
Roche Holding Ltd Roche Healthcare Limited
By: By:
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By:
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