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Document Preview Agreement Relating to the North American Frova Assets of Elan |
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Title: |
Agreement Relating to the North American Frova Assets of Elan |
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Entities: |
Barclays Bank plc; Elan Corp., plc; Elan Pharmaceuticals, Inc.; Express Scripts, Inc.; Express Scripts, Inc.; Medco Health Solutions Inc.; Medco Health Solutions Inc.; Vernalis plc; Allen & Overy |
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Date: |
2004 |
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Size: |
Preview shows 29KB of 178KB total |
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Price: |
$53 |
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ID: |
#331274 |
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ELAN CORPORATION, PLC
ELAN PHARMA INTERNATIONAL LIMITED
ELAN PHARMACEUTICALS, INC.
VERNALIS DEVELOPMENT LIMITED
AND
VERNALIS PLC
-----------------------------------------------
AGREEMENT RELATING TO THE NORTH AMERICAN
FROVA ASSETS OF ELAN
-----------------------------------------------
{PAGE}
CONTENTS
{TABLE}
{CAPTION}
CLAUSE PAGE
{C} {S} {C}
1. Interpretation..........................................................2
2. Termination of Existing Agreements.....................................12
3. Sale and Purchase......................................................15
4. Conditions.............................................................16
5. Purchase Price.........................................................17
6. Completion.............................................................19
7. Warranties and Pre Completion Conduct..................................20
8. Vernalis's Warranties..................................................21
9. Vernalis Guarantee and Indemnity.......................................21
10. Transfer of the Product Registrations..................................23
11. Use of Elan Name.......................................................23
12. Contracts..............................................................25
13. Liabilities and Apportionments.........................................26
14. Returns Rebates and Chargebacks........................................27
15. Value Added Tax........................................................27
16. Post Completion Obligations............................................28
17. Further Undertakings by the Sellers....................................28
18. Records and Assistance.................................................30
19. Legal Disclosure.......................................................32
20. Confidential Information...............................................32
21. Announcements..........................................................33
22. Costs..................................................................34
23. Set Off................................................................34
24. Indemnification........................................................34
25. General................................................................35
26. Entire Agreement.......................................................36
27. Assignment.............................................................36
28. Notices................................................................37
29. Governing Law and Jurisdiction.........................................38
30. Counterparts...........................................................39
Schedule 1 PURCHASE PRICE...........................................40
{/TABLE}
{PAGE}
CONTENTS
{TABLE}
{CAPTION}
CLAUSE PAGE
{C} {S} {C}
Schedule 2 COMPLETION STATEMENT.....................................41
Schedule 3 COMPLETION REQUIREMENTS..................................44
Schedule 4 WARRANTIES...............................................46
Schedule 5 LIMITATIONS ON THE SELLERS' LIABILITY....................49
Schedule 6 ACTION PENDING COMPLETION................................52
Schedule 7 RESIDUAL CONTRACTS.......................................54
Schedule 8 RETURNS, REBATES AND CHARGEBACKS.........................56
Schedule 9 FROVA LOGO...............................................62
Schedule 10 PRODUCT IMAGE............................................63
{/TABLE}
AGREED FORM DOCUMENTS
1. US Registered Trade Mark Assignment (Clause 3.3)
2. Canadian Registered Trade Mark Assignment (Clause 3.3)
3. Deed of Assignment of Unregistered Intellectual Property (Clause 3.4)
4. Resolution (Clause 4.1.1)
5. Form of Novation for Supply Agreements (Clause 4.1.3)
6. Form of Assignment for Supply Agreements (Clause 4.1.3)
7. Recommendation (Clause 4.2.2)
8. Announcement by Elan Corp (Clause 21)
9. Announcement by Vernalis (Clause 21)
10. Transfer letters to FDA (paragraph 2(c) of Part A of Schedule 3)
11. Transfer letter to Health Canada (paragraph (2(d) of Part A of Schedule 3)
12. Transitional Services Agreement (paragraph 2(e) of Part A of Schedule 3)
13. Floating Charge (paragraph 3 of Part A of Schedule 3)
14. Amendment to API Supply Agreement (paragraph 3 of Schedule 6)
15. Customer Information Letter (paragraph 5 of Schedule 6)
16. Physician Information Letter (paragraph 5 of Schedule 6)
{PAGE}
THIS AGREEMENT is made on March 2004
BETWEEN:
(1) ELAN CORPORATION PLC, a company incorporated in Ireland (registered No.
30356), whose registered office is at Lincoln House, Lincoln Place, Dublin
2, Ireland ("ELAN CORP");
(2) ELAN PHARMA INTERNATIONAL LIMITED, a company incorporated in Ireland
(registered no. 222276), whose registered office is at WIL House, Shannon
Business Park, Shannon, County Clare, Ireland ("EPIL");
(3) ELAN PHARMACEUTICALS, INC., a company incorporated in the State of
Delaware, whose principal office is at 800 Gateway Boulevard, South San
Francisco, CA 94080, USA ("EPI");
(4) VERNALIS DEVELOPMENT LIMITED, a company incorporated in England and Wales
(registered no. 02600483), whose registered office is at Oakdene Court,
613 Reading Road, Winnersh, Berkshire RG41 5UA ("VDL"); and
(5) VERNALIS PLC, a company incorporated in England and Wales (registered no.
2304992), whose registered office is at Oakdene Court, 613 Reading Road,
Winnersh, Berkshire RG41 5UA ("VERNALIS").
WHEREAS:
(A) On 15 March 2002, EPIL and VDL (then registered as Vernalis Limited)
entered into:
(i) the Second Amended and Restated Licence Agreement to develop, market
and sell the Product in the Territory (each as defined below) (the
"LICENCE AGREEMENT"); and
(ii) the Amended and Restated Development Agreement to undertake further
clinical development of the Product (as defined below) (the
"DEVELOPMENT AGREEMENT").
(B) EPIL and VDL have agreed to terminate the Licence Agreement and the
Development Agreement on the terms of this Agreement.
(C) EPI has agreed to sell and VDL has agreed to buy certain of EPI's rights
under the Contracts (as defined below) to which it is a party.
(D) Elan Corp, EPIL and EPI (each a "SELLER" and together the "SELLERS") have
agreed to sell and VDL has agreed to buy all of the Sellers' other rights
and assets relating to the development, production, marketing,
distribution, sales and supply of the Product in the Territory (each as
defined below) on the terms of this Agreement.
(E) Vernalis has agreed, inter alia, to guarantee the due and punctual
performance of VDL's obligations under this agreement.
- 1 -
{PAGE}
THE PARTIES AGREE as follows:
1. INTERPRETATION
1.1 In this Agreement:
"ACT" means the Companies Act 1985;
"ACTUAL STOCK VALUE" means the value of the Stock at Completion as
specified in the Completion Statement;
"API SUPPLY AGREEMENT" means the supply agreement between EPIL and Evotec
OAI Limited (then named Oxford Asymmetry International plc), dated 28
December 2000 (as amended prior to Completion);
"ASSETS" means all the property and assets agreed to be sold and purchased
under Clause 3.1 of this Agreement;
"BUSINESS DAY" means a day other than a Saturday or Sunday or public
holiday in England and Wales;
"CIRCULAR" means the circular to be despatched by Vernalis to its
shareholders in relation to the proposed acquisition by VDL of the Assets
pursuant to this Agreement;
"COMPLETION" means completion of the sale and purchase of the Assets in
accordance with this Agreement;
"COMPLETION DATE" means the date which is three Business Days after the
date on which the last of the Conditions is satisfied or waived;
"COMPLETION STATEMENT" means the statement of the quantity and value of
Stock as at Completion agreed by EPI and Vernalis (or determined) in
accordance with Schedule 2;
"COMPOUND" means the compound known as frovatriptan being
R(+)6-carboxamido-3-N-methylamino-1,2,3,4 tetrahydrocarbazole succinate
(1:1) monohydrate and "Compound" shall include any physiologically
acceptable salts thereof;
"CONDITION" means a condition set out in Clause 4.1 and "CONDITIONS" means
all those conditions;
"CONFIDENTIAL INFORMATION" means all the Know-How and all other
information which is not in the public domain and which is used in or
otherwise relates to the Product, the Assets or customers or financial or
other affairs of the Sellers in relation to the Product and the Assets
including, without limitation, information relating to:
(a) the marketing of goods or services including, without limitation,
customer names and lists and other details of customers, sales
targets, sales statistics, market share statistics, prices, market
research reports and surveys, and advertising or other promotional
materials;
(b) future projects, business development or planning, commercial
relationships and negotiations; or
- 2 -
{PAGE}
(c) regulatory matters (including pharmacovigilance and medical
affairs); and
(d) clinical development (including in relation to preventing
menstrually-associated migraine headaches);
"CONTRACTS" means the Supply Agreements and the Residual Contracts;
"COPYRIGHT" means all (if any) right, title and interest of the Sellers
(or any of them) at Completion in copyright subsisting in (i) the
Delivered Records and (ii) the Marketing Materials but does not (in any
case) include any such copyright subsisting in any of the Elan Marks;
"CUSTOMER INFORMATION LETTER" means the letter from EPI to wholesale
customers for the Product, in the agreed form;
"DEED OF ASSIGNMENT OF UNREGISTERED INTELLECTUAL PROPERTY" means an
assignment of the Seller's right, title and interest in the Copyright and
the Unregistered Trade Marks between the Sellers and VDL in the agreed
form to be entered into at Completion;
"DELIVERED RECORDS" means:
(a) all of the clinical files for the Product held by any Elan Group
Undertaking;
(b) the Product Registration Information;
(c) copies (or, where possible, originals) of each of the Contracts;
(d) registration certificates and prosecution history files in respect
of the Registered Trade Marks, in each case that are in the
possession or under the control of an Elan Group Undertaking; and
(e) the Marketing Materials that are in the possession or under the
control of an Elan Group Undertaking,
(f) all batch documentation in relation to the Product;
(g) all retained manufacturing samples in relation to the Product;
(h) all stability test data in relation to the Product;
(i) all CMC reports in relation to the Product, including transit
testing;
(j) monthly reports of sales of the Product by the Sellers in the
Territory broken down by wholesaler;
(k) all documents received by an Elan Group Undertaking concerning the
Product that assert ongoing material lack of compliance with any
applicable laws by any Elan Group Undertaking; and
(l) all:
(i) adverse drug experience reports and associated documents;
- 3 -
{PAGE}
(ii) investigations of adverse drug experience reports;
(iii) customer complaints; and
(iv) investigations of complaints,
in each case in relation to the Product,
other than the Retained Records;
"DISCLOSURE LETTER" means the letter from Elan Corp to VDL in relation to
the Warranties having the same date as this Agreement, the receipt of
which has been acknowledged by VDL;
"DOMAIN NAMES" means the URLs www.frova.com, www.frova.org, www.frova.us,
www.frova.net, www.frova.info, www.frovatriptan.com and
www.frovatriptan.us;
"ELAN GROUP UNDERTAKING" means each of the Sellers or an undertaking which
is, on or at any time after the date of this Agreement, a subsidiary
undertaking of Elan Corporation, plc;
"ELAN MARKS" has the meaning given to it in Clause 11.1;
"ELAN PAYABLE AMOUNT" means any amount:
(a) agreed by EPI in writing as payable pursuant to this Agreement or
the Transitional Services Agreement by any Elan Group Undertaking to
any Vernalis Group Undertaking but not yet paid if due;
(b) ordered by a Court of competent jurisdiction to be paid by any Elan
Group Undertaking to any Vernalis Group Undertaking as a result of a
claim made pursuant to this Agreement or the Transitional Services
Agreement where either:
(i) the order can not be appealed; or
(ii) EPI has notified Vernalis that the relevant Elan Group
Undertaking does not intend to appeal such order; or
(c) payable by EPI pursuant to Schedule 8 save to the extent that the
Elan Companies (as defined in the Transitional Services Agreement)
account to VDL for such amount pursuant to clause 2.9 of the
Transitional Services Agreement;
"ELAN'S ACCOUNTANTS" means KMPG of 1 Stokes Place, St Stephen's Green,
Dublin 2, Ireland;
"ELAN'S SOLICITORS" means Clifford Chance Limited Liability Partnership of
10 Upper Bank Street, London E14 5JJ;
"ENCUMBRANCE" means a mortgage, charge, pledge, lien, option, restriction,
right of first refusal, right of pre emption, third party right or
interest, other encumbrance or security
- 4 -
{PAGE}
interest of any kind, or another type of preferential arrangement (including,
without limitation, a title transfer or retention arrangement) having similar
effect;
"EPL" means Elan Pharma Limited, a company incorporated in Ireland (registered
no. 100382), whose registered office is at Monksland, Athlone, County Westmeath,
Ireland;
"EQUIPMENT" means all (if any) right, title and interest of the Sellers (or any
of them) in any equipment used exclusively in the manufacture of the Product and
located at the premises of Pharmaceutical Development and Manufacturing Services
Limited (as successor in title to Galen Limited) or Sharp Corporation;
"EVENT" means an event, act, transaction or omission including, without
limitation, a receipt or accrual of income or gains, distribution, failure to
distribute, acquisition, disposal, transfer, payment, loan or advance;
"FDA" means the U.S. Food and Drug Administration;
"FINANCING" means any equity-based or equity-linked cash-raising exercise by
Vernalis in the public securities markets;
"FLOATING CHARGE" means the floating charge between VDL and EPIL, in the agreed
form;
"HSR ACT" has the meaning given to it in Clause 4.1.2;
"INTELLECTUAL PROPERTY" means:
(a) patents, trade marks, service marks, registered designs, applications and
rights to apply for any of those rights; unregistered trade marks and
service marks; copyright, database right; rights in knowhow, rights in
designs and inventions; and
(b) rights of the same or similar effect or nature as or to those in paragraph
(a) which now or in the future may subsist,
"IP ASSETS" means the Trade Marks, the Copyright and the Domain Names;
"KEY WHOLESALERS" means Cardinal, McKesson, AmeriSourceBergen, Morris & Dickson
and D&K Healthcare;
"KNOW-HOW" means information in the possession of an Elan Group Undertaking
related exclusively to the regulation, development, sales and marketing of the
Product other than any such information which is in the public domain at
Completion;
"MARKETING MATERIALS" means any packaging, advertising and promotional
literature and materials in each case used exclusively in the advertising and
promotion of the Product in the Territory in the Sellers' possession as at
Completion;
"NOC" means any notice of compliance issued by Health Canada that the Product
has been evaluated and determined to comply with the applicable provisions of
Division 8 of the Food and Drugs Act Regulations (Canada);
- 5 -
{PAGE}
"PHYSICIAN INFORMATION LETTER" means the letter from EPI to physicians, in the
agreed form;
"PARENT PROCEEDING" means any claim made by or against any Elan Group
Undertaking or any officers, directors or employees of any Elan Group
Undertaking in any legal proceeding or governmental investigation by or against
any Elan Group Undertaking or any officers, directors or employees of any Elan
Group Undertaking which is commenced either:
(a) prior to Completion; or
(b) after Completion but based on events occurring prior to Completion;
"PERMITTED ENCUMBRANCES" means:
(a) any encumbrance arising by operation of law;
(b) any third party rights over Stock which has been ordered but not yet
delivered;
(c) any rights of UCB and any advertising agency in relation to Marketing
Materials for the Product, together with any rights of third parties
appearing in Marketing Materials for the Product;
(d) without prejudice to Clause 12 of this Agreement, any right or obligation
of any third parties arising under any of the Contracts; and
(e) any right of UCB in relation to the mark "UCB" as it appears on the Product
packaging;
"PRODUCT" means any and all formulated and packaged pharmaceutical compositions
and dosing units containing Compound including compositions comprising Compound;
"PRODUCT REGISTRATIONS" means:
(a) the New Drug Application number NDA 21-006 filed in respect of the Product
pursuant to 21 C.F.R. Part 314 of the U.S. Food, Drug and Cosmetic Act
1938;
(b) the Investigational New Drug Application number IND 48,933 (encompassing,
inter alia, the identification of intention to study the use of
frovatriptan for the prevention of menstrually-associated migraine) filed
in respect of the Product pursuant to C.F.R Parts 312 of the U.S. Food,
Drug and Cosmetic Act 1938;
(c) the New Drug Submission control number 065221 made pursuant to Division 8
of the Food and Drugs Act Regulations (Canada); and
(d) all supplements or amendments to any of the foregoing,
whether filed before or after the date of this Agreement, but in any case prior
to the Completion Date;
- 6 -
{PAGE}
"PRODUCT REGISTRATION INFORMATION" means:
(a) the complete New Drug Application, Investigational New Drug Application and
New Drug Submission files referred to in or served in relation to the
Product Registration;
(b) any and all regulatory correspondence between the Sellers and any
regulatory authority in the Territory in relation to the Product
Registrations or the Product; and
(c) all dossiers, data, reports and other material in written or electronic
form exclusively relating to the Product Registrations or the Product which
have been filed with any governmental or regulatory authority;
"RECOMMENDATION" means the unanimous recommendation of the Vernalis directors
that Vernalis's shareholders should vote in favour of the Resolution, in the
agreed form;
"REGISTERED TRADE MARK ASSIGNMENTS" means assignments of the Registered Trade
Marks between EPI and VDL in the agreed form to be entered into at Completion;
"REGISTERED TRADE MARKS" means U.S. Federal trade mark application no. 78017693
and Canadian trade mark application no. 1123447, each for 'FROVA';
"RELEVANT CLAIM" means a claim by Vernalis for any breach or alleged breach of
any of the Warranties;
"RESIDUAL CONTRACTS" means those contracts listed in Schedule 7;
"RESOLUTION" means the resolution of Vernalis's shareholders approving the
transactions contemplated by this Agreement in the agreed form;
"RETAINED RECORDS" means the originals of:
(a) all quarterly and year-end financial statements prepared between 1 January
1996 and Completion;
(b) all general ledgers, trial balances and adjusting journal entries
(including support for journals), Frango and similar financial submissions
to corporate or divisional management (e.g. Dublin, San Diego, Stevenage)
and related documentation supporting the financial statements of any Elan
Group Undertaking prepared or issued between 1 January 1996 and Completion;
(c) all documents concerning revenue, earnings per share and/or profit
projections for any time period from 1 January 1996 through Completion,
including any documents setting or tracking internal financial goals or
projections and any documents discussing whether Elan Corporation, plc or
any Elan Group Undertaking would meet internal financial goals or
projections;
(d) all original backup tapes of the network system of any Elan Group
Undertaking from the date closest to 13 February 2002 until Completion;
- 7 -
{PAGE}
(e) all documents relating to any joint venture or strategic collaboration
between any Elan Group Undertaking and any third party and any documents
relating to any Elan Group Undertaking's investments in any such third
parties;
(f) all documents identifying reserves or provisions maintained on the books of
any Elan Group Undertaking between 1 January 1996 and 31 December 2002;
(g) all documents concerning the establishment, use, reversal and/or
adjustments to all reserves or provisions identified in sub-paragraph (f)
between 1 January 1996 and 31 December 2002, including budgeted amounts,
journal entries, general ledger accounts, spreadsheets, analyses and
correspondence (including e-mail);
(h) all documents concerning any "Corporate provision release" of any Elan
Group Undertaking between 1 January 1996 and 31 December, 2002;
(i) all documents identifying an instance in which reducing reserves of any
Elan Group Undertaking contributed to any Elan Group Undertaking meeting or
exceeding its: (i) internal financial forecasts or budgets; (ii) strategic
plan objectives; or (iii) consensus analysts' earnings estimates, in each
case between 1 January 1996 and Completion;
(j) all documents concerning any assessment by any Elan Group Undertaking to
increase or decrease trade inventory levels at wholesalers in order for any
Elan Group Undertaking to meet or achieve any: (i) internal financial
forecasts or budgets; (ii) strategic plan objectives; or (iii) consensus
analysts' earnings estimates, in each case between 1 January 1996 and
Completion;
(k) all documents concerning any assessment by any Elan Group Undertaking to
provide discounts and/or incentives to wholesale or chain customers in
order for any Elan Group Undertaking to meet or achieve any: (i) internal
financial forecasts or budgets; (ii) strategic plan objectives; or (iii)
consensus analysts' earnings estimates, in each case between 1 January 1996
and Completion;
(l) all other financial records (whether relating to the Assets, the Product or
otherwise);
(m) all other tax records (whether relating to the Assets, the Product or
otherwise); and
(n) all human resources files;
"STOCK" means the stock of:
(a) Frova 2.5mg Tab, 2 Count Sample Blister;
(b) Frova 2.5mg Tab, 9 Count Blister;
(c) Frova 2.5mg Bulk Tablets;
(d) Frova 2.5mg Tab, Bulk Samples;
- 8 -
{PAGE}
(e) 4-Cyanophenyl Hydrazine, HCL;
(f) Amine Ketal HCL; and
(g) Frovatriptan Succinate,
in each case held by or on behalf of the Sellers (other than that held by or on
behalf of UCB) at Completion or which has been ordered from Sharp Corporation
but not delivered at Completion;
"SUPPLY AGREEMENT" means:
(a) the API Supply Agreement; or
(b) the Frovatriptan supply agreement between EPIL and Galen Limited, dated 1
July 2002,
and "SUPPLY AGREEMENTS" means both of them;
"TAX" means any form of taxation, levy, duty, charge, contribution, withholding
or impost of whatever nature (including any related fine, penalty, surcharge or
interest) imposed, collected or assessed by, or payable to, a Tax Authority;
"TAX AUTHORITY" means any government, state or municipality or any local, state,
federal or other authority, body or official anywhere in the world exercising a
fiscal, revenue, customs or excise function including, without limitation, the
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