EXHIBIT 10.3
AGREEMENT
Between
Elan Corporation, plc
AND
Xxxxxx Xxxxxxxx, plc
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[REDACTED] Confidential treatment has been requested for certain portions of
this document which have been omitted and filed separately with the
Secretary of the Securities and Exchange Commission. Omitted
portions are indicated by [REDACTED].
AGREEMENT (the "Agreement") made this 24th day of June, 1999 BETWEEN Elan
Corporation, plc having its registered office at Xxxxxxx Xxxxx, Xxxxxxx Xxxxx,
Xxxxxx 0, Xxxxxxx ("Elan" which expression shall include any of its Subsidiary
or Affiliate companies and its successors, but for the avoidance of doubt
excluding Xxxxxx Xxxxxxxx) and Xxxxxx Xxxxxxxx, plc having its registered office
at Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0 ("Xxxxxx Xxxxxxxx" which expression
shall where the context requires include any of its Subsidiary or Affiliate
companies and its successors, but for the avoidance of doubt excluding Elan).
WHEREAS
A Elan is beneficially entitled to the use of certain patents which have been
granted or are pending in relation to drug specific dosage forms for
pharmaceutical products.
B Xxxxxx Xxxxxxxx is a developer and marketer of prescription pharmaceutical
products. Xxxxxx Xxxxxxxx is beneficially entitled to the use of certain
patents which have been granted or are pending in relation to drug specific
dosage forms for pharmaceutical products.
C Xxxxxx Xxxxxxxx and Elan have agreed to amend and terminate a number of
agreements between the Parties in the manner set forth in this Agreement.
NOW IT IS HEREBY AGREED AS FOLLOWS:
Article 1 Definitions
1.1. In this Agreement, including the Recitals and Appendices hereto, between
the parties hereto, the following terms shall have the following meanings,
unless the context requires otherwise:
"Affiliate" shall mean any Person, or any other entity that directly or
indirectly through one or more intermediaries Controls, is Controlled by,
or is under common Control with, such Person.
"Agreement" shall mean this Agreement.
"ANDA" any Abbreviated New Drug Application made to the FDA seeking
permission to market a Product.
"[REDACTED] Agreement" means the agreement entered into between Elan and
[REDACTED] on the [REDACTED] a copy of which is attached as Schedule 1.
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"Control" of any Person shall mean:
ownership of at least [REDACTED] of the shares or stock entitled to
vote for the election of directors in the case of a company or
corporation and at least [REDACTED] of the interest in profits and
losses in the case of a Person other than a company or a corporation;
or
the ability otherwise to direct and control the actions of such Person.
"Development and License Agreements shall mean the Development and License
Agreements entered into between the Parties dated 10th November 1994, 10th
March, 1995, 5th July 1995, 20th December, 1995 and 30th September 1996.
"FDA" shall mean the United States Food and Drug Administration or any
successors or agency the approval of which is necessary to market a Product
in the United States of America.
"FDA Approval" shall mean the final approval of the ANDA granted by the FDA
covering the Nifedipine CC Product in the United States of America (for the
avoidance of doubt, including the expiration of the [REDACTED] Waxman Hatch
patent stay).
"In Market" shall mean the sale of the Nifedipine CC Product by Elan or its
Affiliates, agents, licensees, distributors and/or partners, to an
unaffiliated third party, including but not limited to a wholesaler, chain
store, distributor, managed care organization, hospital or pharmacy.
"IS5MN Agreement" means the agreement entered into between the Parties on
the 5th day of July 1995.
"IS5MN-PM Agreement" means the agreement entered into between the Parties
on the 30th day of September 1995.
"Master Agreement" means the Master Development and Licence Agreement
entered into between the Parties on the 17th day of October 1984.
"Net Sales Price" shall mean in the case of the Nifedipine CC Product ,
that sum determined by deducting from the aggregate gross In Market sales
proceeds billed for the Nifedipine CC Product the following deductions:
(a) ordinary course trade, quantity and cash discounts, credits and
allowances;
(b) credits or refunds allowed for rejected, outdated or returned product;
(c) customs duties or excise taxes (excluding income or corporation tax),
directly related to the sale of the Nifedipine CC Product to the
extent that such items are included in the gross invoice price
payable by Elan or its Affiliates, agents, distributors and/or
partners; and
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(d) transport, and freight insurance premiums absorbed by Elan or its
Affiliates, agents, licensees, distributors and/or partners.
If the Nifedipine CC Product is sold for compensation other than cash, Net
Sales Price shall be calculated based on the fair market value of such
product in cash.
"Nifedipine CC Agreement" means the agreement entered into between the
Parties on the 10th day of March 1995.
"Nifedipine CC Product" means the product which is the subject of the
Nifedipine CC Agreement bearing ANDA number [REDACTED] and being a
[REDACTED] dosage strength.
"Person" shall mean any individual, firm, partnership, company,
corporation, Government Authority or other entity.
"[REDACTED] Agreements" shall mean the distributor agreements, each dated
[REDACTED], entered into between Xxxxxx Xxxxxxxx and [REDACTED] copies of
which are attached hereto as Schedule 2 (covering the United States of
America) and Xxxxxx Xxxxxxxx and [REDACTED] (covering Mexico and Canada).
"US$" shall mean United States Dollars.
2. IS5MN Agreement
2.1. Subject to the terms of this Agreement (including but not limited to
Section 3.1. herein), Elan and Xxxxxx Xxxxxxxx shall have no further
obligations or liabilities of any kind whatsoever to the other and Xxxxxx
Xxxxxxxx shall have no further rights of any kind whatsoever under the
IS5MN Agreement. Xxxxxx Xxxxxxxx represents and warrants to Elan that save
and except for the [REDACTED], Xxxxxx Xxxxxxxx has not granted any
sub-licences or any other rights of any nature to any third parties
pursuant to the IS5MN Agreement.
Xxxxxx Xxxxxxxx shall return all confidential information and documentation
in its possession to Elan and shall keep such information confidential for
a period of [REDACTED] years following the date hereof.
2.2. Xxxxxx Xxxxxxxx hereby formally consents in writing to the conclusion by
Elan of the [REDACTED] Agreement in the terms attached as Schedule 2
hereto. Xxxxxx Xxxxxxxx'x verbal consent was furnished on 29th October
1998. In consideration for the irrevocable sub-license hereby granted by
Xxxxxx Xxxxxxxx to Elan Pharma Limited to the Elan Patents (as such term is
defined in the IS5MN Agreement) to enable it to supply [REDACTED], Elan
shall make the royalty payments to Xxxxxx Xxxxxxxx as referred to in
Section 2.4. on sales of the IS5MN Product (as defined in the [REDACTED]
Agreement and hereinafter referred to as the "IS5MN Product") by Elan to
[REDACTED] up to and including 31st March 1999. No further consideration
shall be payable by Elan, whether in relation to sales of the IS5MN Product
by Elan on or after 1st April, 1999 or otherwise. The sub-license granted
by Xxxxxx Xxxxxxxx to Elan is irrevocable and is not subject to
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any restrictions, e.g. Elan may grant further sub-licenses. Elan hereby
confirms that it is aware of the provisions of the [REDACTED] Agreements.
2.3. In consideration of Elan's consenting to conclude the agreement with
[REDACTED] and in particular to granting a license to the applicable Elan
patents, Xxxxxx Xxxxxxxx has paid the sum of [REDACTED] to Elan.
2.4. Pursuant to the [REDACTED] Agreement, Elan has agreed to supply the IS5MN
Product to [REDACTED] at a price equivalent to [REDACTED] of Product
Manufacturing Cost (as defined in the [REDACTED] Agreement). Subsequently
[REDACTED] pays to Elan a royalty equivalent to [REDACTED] of NSP (as
defined in the [REDACTED] Agreement), less the sum which [REDACTED] has
paid for the IS5MN Product. On receipt of the latter amount (in relation to
sales of the IS5MN Product by Elan to [REDACTED] for the period to 31st
March 1999 only), Elan shall promptly remit to Xxxxxx Xxxxxxxx the
difference between [REDACTED] of NSP and [REDACTED] of NSP as a royalty on
sales of the IS5MN Product, if any, provided that Elan shall not be obliged
to pay monies to Xxxxxx Xxxxxxxx to the extent that such payment would
result in Elan retaining no less than [REDACTED] of Product Manufacturing
Costs. The parties recognise that subsequent adjustment may be necessary in
the event of chargebacks, provision of free IS5MN Product etc. by Elan to
[REDACTED] which shall be mutually agreed by the parties and codified in
writing. Schedule 4 sets forth the amounts to be paid to Xxxxxx Xxxxxxxx by
Elan pursuant to this Section 2.4.
2.5. Xxxxxx Xxxxxxxx shall indemnify, defend and hold Elan and its employees,
servants and agents harmless from and against [REDACTED] of any and all
liabilities, claims, demands, actions, suits, losses, damages, costs and
expenses (including reasonable attorney's fees and disbursements, but
excluding any lost profits or other indirect or consequential damages
suffered by Elan) which Elan may incur, suffer or be required to pay by
reason of any patent infringement suit of any third party brought against
Elan in relation to IS5MN Product sold by Elan to [REDACTED] on or before
the [REDACTED]. Elan shall have control over the defense of any such
proceedings, but shall keep Xxxxxx Xxxxxxxx informed of any material
developments in relation to any such proceedings and shall not consent to
judgement or settle such proceedings without informing Xxxxxx Xxxxxxxx in
advance. Xxxxxx Xxxxxxxx shall bear the costs incurred by it if it elects
to retain independent counsel's advice in relation to any such proceedings.
As appears from Article 3.2 of the [REDACTED] Agreement, Elan has agreed to
indemnify [REDACTED] in relation to certain patent infringements suits
which may be brought against [REDACTED] and/or Elan in relation to the
Product. Xxxxxx Xxxxxxxx hereby agrees to indemnify Elan against [REDACTED]
of the Claim (as defined in Article 3.2.2 of the [REDACTED] agreement in
relation to IS5MN Product sold by Elan to [REDACTED] on or before the
[REDACTED]. Elan shall have control over the defense of any Claim, but
shall keep Xxxxxx Xxxxxxxx informed of any material developments in
relation to any Claim and shall not consent to judgement or settle a Claim
without informing Xxxxxx Xxxxxxxx in advance. Xxxxxx Xxxxxxxx shall bear
the costs incurred by it if it elects to retain independent counsel's
advice in relation to any Claim.
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2.6. Elan and Xxxxxx Xxxxxxxx agree that subject to the other provisions of this
agreement, Elan shall be entitled to act as its own discretion in relation
to all matters concerning the [REDACTED] Agreement.
2.7. Xxxxxx Xxxxxxxx hereby grants to Elan (Xxxxxx Xxxxxxxx hereby confirms that
Elan may extend such license to [REDACTED]) such royalty free license as is
required to enable Elan and [REDACTED] to use the "Xxxxxx Xxxxxxxx" and
"WC" name and trademark but only in relation to inventory of the IS5MN
Product manufactured on or before 31st December 1999. Elan shall indemnify,
defend and hold Xxxxxx Xxxxxxxx and its employees, servants and agents
harmless from and against any and all liabilities, claims, demands,
actions, suits, losses, damages, costs and expenses (including reasonable
attorney's fees and disbursements, but excluding any lost profits or other
indirect or consequential damages suffered by Xxxxxx Xxxxxxxx) which Xxxxxx
Xxxxxxxx may incur, suffer or be required to pay by reason of any suit of
any third party brought against Xxxxxx Xxxxxxxx in relation to IS5MN
Product sold by Elan to [REDACTED] where Xxxxxx Xxxxxxxx is a party to such
action due to the product being identified with Xxxxxx Xxxxxxxx and its
trademark. Elan shall have control over the defense of any such
proceedings, but shall keep Xxxxxx Xxxxxxxx informed of any material
developments in relation to any such proceedings and shall not consent to
judgement or settle such proceedings without informing Xxxxxx Xxxxxxxx in
advance. Xxxxxx Xxxxxxxx shall bear the costs incurred by it if it elects
to retain independent counsel's advice in relation to any such proceedings.
2.8. The Parties hereby confirm for the avoidance of doubt that Elan shall be
entitled to license or otherwise use the Patent Rights, the Know-How, or
the data and other know-how, whether generated by or on behalf of Elan or
Xxxxxx Xxxxxxxx, pursuant to the Development Programme (as such terms are
defined in the IS5MN Agreement). As stated at Section 2.2. above, Elan is
aware of the provisions of the [REDACTED] Agreements.
3. [REDACTED] Agreements
3.1. Elan has been furnished with copies of the [REDACTED] Agreements pursuant
to which Xxxxxx Xxxxxxxx granted [REDACTED] an option to a non-exclusive
right to market, sell and distribute the IS5MN Product in the Territory. In
[REDACTED] letter of 9th November 1998 to Xxxxx Xxxxxxxxxxxxx, [REDACTED],
[REDACTED] confirmed that it has elected not to exercise its option to
launch the [REDACTED] product in the US market. Xxxxxx Xxxxxxxx shall use
its reasonable efforts to procure the termination of the [REDACTED]
Agreements as soon as is practicable and shall notify Elan of such
termination. In the event Xxxxxx Xxxxxxxx, despite its reasonable efforts,
is unable to procure termination of the [REDACTED] Agreements, Elan shall
supply Xxxxxx Xxxxxxxx with such dosage strengths of the IS5MN Product for
which Elan has obtained final approval of the FDA which is adequate to
satisfy Xxxxxx Xxxxxxxx'x obligations pursuant to the [REDACTED] Agreements
and on terms consistent with the IS5MN Agreement and in particular on the
basis that Elan shall supply Xxxxxx Xxxxxxxx on the basis of [REDACTED] of
Product Manufacturing Cost and such additional terms as the parties shall
negotiate in good faith.
3.2. Xxxxxx Xxxxxxxx shall indemnify, defend and hold Elan and its employees,
servants and agents harmless from and against any and all liabilities,
claims, demands, actions, suits, losses, damages, costs and expenses
(including reasonable attorney's fees and disbursements, but excluding any
lost profits or other indirect or consequential damages suffered by Elan)
which Elan
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may incur, suffer or be required to pay by reason of any suit of [REDACTED]
or any of its affiliates in relation to Xxxxxx Xxxxxxxx'x performance or
breach of the [REDACTED] Agreements, or the termination or purported
termination of the [REDACTED] Agreements by Xxxxxx Xxxxxxxx (for the
avoidance of doubt including any lost profits or other indirect or
consequential damages suffered by [REDACTED]). Xxxxxx Xxxxxxxx shall have
control over the defense of any such proceedings, but shall keep Elan
informed of any material developments in relation to any such proceedings
and shall not consent to judgement or settle such proceedings without
informing Elan in advance. Elan shall bear the costs incurred by it if it
elects to retain independent counsel's advice in relation to any such
proceedings.
4. IS5MN-PM Agreement
4.1. For the avoidance of doubt, Xxxxxx Xxxxxxxx acknowledges that the licence
royalty of [REDACTED] is due and payable to Elan pursuant to Article 3.1 of
the IS5MN-PM Agreement. Xxxxxx Xxxxxxxx has paid the said sum of [REDACTED]
on or before 24th June 1999.
4.2. In accordance with the provisions of the IS5MN-PM Agreement, Xxxxxx
Xxxxxxxx hereby confirms that it does not wish to proceed further with the
Development Programme (as such term is defined in the IS5MN-PM Agreement)
and the parties hereby agree that the IS5MN-PM Agreement expired as of 31st
March 1999. Subject to the terms of this Agreement, Elan and Xxxxxx
Xxxxxxxx shall have no further obligations or liabilities of any kind
whatsoever to the other and Xxxxxx Xxxxxxxx shall have no further rights of
any kind whatsoever under the IS5MN-PM Agreement. Xxxxxx Xxxxxxxx
represents and warrants to Elan that Xxxxxx Xxxxxxxx has not granted any
sub-licences or any other rights of any nature to any third parties
pursuant to the IS5MN-PM Agreement.
Xxxxxx Xxxxxxxx shall return all confidential information and documentation
in its possession to Elan and shall keep such information confidential for
a period of [REDACTED] years following the date hereof.
4.3. Without prejudice to the generality of the provisions of Section 4.2,
Xxxxxx Xxxxxxxx shall have no right to a credit to all or part of the sum
of [REDACTED] payable pursuant to the IS5MN-PM Agreement and Section 3.1.
hereof, whether pursuant to Clause 3.2. of the IS5MN-PM Agreement or
otherwise.
4.4. The Parties hereby confirm for the avoidance of doubt Elan shall be
entitled to license or otherwise use the Patent Rights, the Know-How, or
the data and other know how, whether generated by or on behalf of Elan or
Xxxxxx Xxxxxxxx, pursuant to the Development Programme (as such terms are
defined in the IS5MN-PM Agreement).
5. Nifedipine CC Agreement
5.1 Subject to the terms of this letter, Elan and Xxxxxx Xxxxxxxx shall have no
further obligations or liabilities of any kind whatsoever to the other and
Xxxxxx Xxxxxxxx shall have no further rights of any kind whatsoever under
the Nifedipine CC Agreement. Xxxxxx Xxxxxxxx represents and
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warrants to Elan that Xxxxxx Xxxxxxxx has not granted any sub-licences or
any other rights of any nature to any third parties pursuant to the
Nifedipine CC Agreement.
Xxxxxx Xxxxxxxx shall return all confidential information and documentation
in its possession to Elan and shall keep such information confidential for
a period of five years following the date hereof.
5.2 In consideration for the irrevocable sub-license hereby granted by Xxxxxx
Xxxxxxxx to Elan Pharma Limited to the Elan Patents (as such term is
defined in the Nifedipine CC Agreement), Elan will pay Xxxxxx Xxxxxxxx
[REDACTED] of In Market Net Sales of the Nifedipine CC Product in the
United States of America, provided that Elan shall not be obliged to pay
monies to Xxxxxx Xxxxxxxx under this subsection to the extent that such
payment would result in Elan retaining less than [REDACTED] of Product
Manufacturing Costs. The determination as to the extent that such payment
would result in Elan retaining less than [REDACTED] of Product
Manufacturing Costs, if any, shall be made semi-annually by Elan and Elan
shall furnish details supporting such calculation to Xxxxxx Xxxxxxxx. Elan
shall make the royalty payments to Xxxxxx Xxxxxxxx no less frequently than
semiannually, within [REDACTED] days at the end of the first and last
[REDACTED] months of each calendar year.
5.3 In the event Elan or its Affiliates enter into any transaction or
arrangement of any nature which involve the rights to the Nifedipine CC
Product, which transaction or arrangement results in the elimination or
material disruption or diminution of Xxxxxx Xxxxxxxx'x royalty rights as
set out in Section 5.2 herein, Elan shall promptly provide Xxxxxx Xxxxxxxx
with documentation providing evidence of the transaction or arrangement,
including in particular the consideration received by Elan. The parties
shall then enter into good faith negotiations to agree upon what proportion
of the consideration received by Elan in any such transaction or
arrangement is properly attributable to the elimination or material
disruption or diminution of Xxxxxx Xxxxxxxx'x royalty rights as set out in
Section 5.2 herein and should be paid to Xxxxxx Xxxxxxxx for such loss of
rights. In making such determination of the proportion of the consideration
payable to Xxxxxx Xxxxxxxx hereunder, the parties shall have regard to (a)
Xxxxxx Xxxxxxxx'x royalty rights as set out in Section 5.2 herein, and (b)
if applicable, the proportion of consideration received by Elan in any such
transaction or arrangement for (i) products other than the Nifedipine CC
Product, and/or (ii) rights to the Nifedipine CC Product outside the
Territory. In the event of a dispute between the parties as to the
proportion of the consideration to be paid to Xxxxxx Xxxxxxxx hereunder,
such dispute shall be determined by an independent certified public
accounting firm acceptable to Elan and Xxxxxx Xxxxxxxx and their
determination as to the amount of money to be paid to Xxxxxx Xxxxxxxx shall
be binding and not appealed by either party. The costs of such independent
certified public accounting firm shall be split equally by Elan and Xxxxxx
Xxxxxxxx.
5.4. The parties acknowledge that Elan has full discretion in terms of the
exploitation of the Nifedipine CC Product, the party with whom it contracts
and the nature of the agreement with such party. Elan recognises Xxxxxx
Xxxxxxxx'x economic interest in the royalty payable pursuant to Section 5.2
and in the event Elan or its Affiliates enter into any transaction or
arrangement regarding the Nifedipine CC Product, in circumstances where
Elan is not receiving payment in respect of the supply of the Nifedipine CC
Product and/or a royalty on In Market Net Sales, it will use its reasonable
efforts to ensure continuation of payment of the [REDACTED] royalty set
forth in Section 5.2 above by a successor to the Nifedipine CC
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business, with Elan remaining responsible for payment. The definitions of
`Net Sales' and `In Market' in any agreement Elan may enter into with a
third party with regard to the Nifedipine CC Product shall be consistent
with the definitions set forth in this Agreement or with the definition of
Net Sales per U.S. GAAP.
5.5. Xxxxxx Xxxxxxxx shall be responsible for the discharge of all legal fees
and expenses and other sums due and owing in relation to the Nifedipine CC
Product for the period to 31st March 1999 in which relate solely to the
defense of the lawsuit entitled Xxxxx XX and Bayer Corporation v. Elan
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Pharmaceutical Corp., U.S. District Court, Northern District of Georgia
-----------------------------------------------------------------------
Case No. 97-CV-0143-WCO. The Community of Interest and Joint Defense
-----------------------
Agreement shall remain in full force and effect. The legal fees due and
owing for the period to 31st March 1999 which have not yet been discharged
by Xxxxxx Xxxxxxxx to Elan are set forth in Schedule 3.
5.6. The Parties hereby confirm for the avoidance of doubt Elan shall be
entitled to license or otherwise use the Patent Rights, the Know-How, or
the data and other know how, whether generated by or on behalf of Elan or
Xxxxxx Xxxxxxxx, pursuant to the Development Programme (as such terms are
defined in the Nifedipine CC Agreement).
6. Master Agreement
6.1. The parties agree to terminate the Master Agreement with effect from the
31st day of March 1999. Subject to the terms of this letter, Elan and
Xxxxxx Xxxxxxxx shall have no further obligations or liabilities of any
kind whatsoever to the other and Xxxxxx Xxxxxxxx shall have no further
rights of any kind whatsoever under the Master Agreement. Xxxxxx Xxxxxxxx
represents and warrants to Elan that Xxxxxx Xxxxxxxx has not granted any
sub-licences or any other rights of any nature to any third parties
pursuant to the Master Agreement.
Xxxxxx Xxxxxxxx shall return all confidential information and documentation
in its possession to Elan and shall keep such information confidential for
a period of [REDACTED] years following the date hereof.
7. License Fee
7.1. In consideration for the irrevocable sub-license hereby granted by Xxxxxx
Xxxxxxxx to Elan Pharma Limited to the Elan Patents (as such term is
defined in the Nifedipine CC Agreement) and the other rights granted by
Xxxxxx Xxxxxxxx to Elan pursuant to this Agreement, Elan will pay Xxxxxx
Xxxxxxxx a license fee of [REDACTED] in the following manner:
7.1.1. [REDACTED] is due as of March 31, 1999, from Elan to Xxxxxx
Xxxxxxxx and shall be paid no later than 24th June, 1999;
7.1.2. [REDACTED] will be due from Elan to Xxxxxx Xxxxxxxx upon execution
of this agreement and shall be paid no later than 24th June, 1999;
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7.1.3. [REDACTED] will be due from Elan to Xxxxxx Xxxxxxxx within
[REDACTED] days after FDA Approval;
7.1.4. [REDACTED] will be due from Elan to Xxxxxx Xxxxxxxx two months
after FDA Approval, provided that there has not been any launch of
a product on or before the expiry of the said period which is A/B
rateable (as the term is defined and accepted by the FDA) in the
same size dose for which is the subject of the ANDA for the
Nifedipine CC Product to Adalat CC (excepting a launch by the
originator of Adalat CC, or a launch of the Nifedipine CC Product
by any of Elan's sublicensees in the United States of America); and
7.1.5. [REDACTED] will be due from Elan to Xxxxxx Xxxxxxxx four months
after FDA Approval, provided that there has not been any launch of
a product on or before the expiry of the said period which is A/B
rateable (as the term is defined and accepted by the FDA) in the
same size dose for which is the subject of the ANDA for the
Nifedipine CC Product to Adalat CC (excepting a launch by the
originator of Adalat CC, or a launch of the Nifedipine CC Product
by any of Elan's sublicensees in the United States of America).
8. Development and License Agreements
8.1. To the extent not already terminated, the parties agree to terminate the
Development and License Agreements (other than the IS5MN Agreement and the
Nifedipine CC Agreement which are dealt with pursuant to Sections 2 and 5
of this Agreement respectively with effect from the 31st day of March 1999.
Subject to the terms of this letter, Elan and Xxxxxx Xxxxxxxx shall have no
further obligations or liabilities of any kind whatsoever to the other and
Xxxxxx Xxxxxxxx shall have no further rights of any kind whatsoever under
the Development and License Agreements. Xxxxxx Xxxxxxxx represents and
warrants to Elan that Xxxxxx Xxxxxxxx has not granted any sub-licences or
any other rights of any nature to any third parties pursuant to the
Development and License Agreements.
Xxxxxx Xxxxxxxx shall return all confidential information and documentation
in its possession to Elan and shall keep such information confidential for
a period of [REDACTED] years following the date hereof.
8.2. The Parties hereby confirm for the avoidance of doubt that Elan shall be
entitled to license or otherwise use the Patent Rights, the Know-How, or
the data and other know-how generated by Elan pursuant to the Development
Programme (as such terms are defined in the Development and License
Agreements).
9. Miscellaneous
9.1. Any income or other taxes which Elan is required by law to pay or withhold
on behalf of Xxxxxx Xxxxxxxx with respect to royalties and
any other monies payable to Xxxxxx Xxxxxxxx under this Agreement shall be
deducted from the amount of such payments, royalties and
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other monies due. Elan shall furnish Xxxxxx Xxxxxxxx with proof of such
payments. Any such tax required to be paid or withheld shall be an expense
of and borne solely by Xxxxxx Xxxxxxxx. Elan shall promptly provide Xxxxxx
Xxxxxxxx with a certificate or other documentary evidence to enable Xxxxxx
Xxxxxxxx to support a claim for a refund or a foreign tax credit with
respect to any such tax so withheld or deducted by Elan. The parties will
reasonably cooperate in completing and filing documents required under the
provisions of any applicable tax treaty or under any other applicable law,
in order to enable Elan to make such payments to Xxxxxx Xxxxxxxx without
any deduction or withholding.
9.2. Any income or other taxes which Xxxxxx Xxxxxxxx is required by law to pay
or withhold on behalf of Elan with respect to royalties and any other
monies payable to Elan under this Agreement shall be deducted from the
amount of such payments, royalties and other monies due. Xxxxxx Xxxxxxxx
shall furnish Elan with proof of such payments. Any such tax required to be
paid or withheld shall be an expense of and borne solely by Elan. Xxxxxx
Xxxxxxxx shall promptly provide Elan with a certificate or other
documentary evidence to enable Elan to support a claim for a refund or a
foreign tax credit with respect to any such tax so withheld or deducted by
Xxxxxx Xxxxxxxx. The parties will reasonably cooperate in completing and
filing documents required under the provisions of any applicable tax treaty
or under any other applicable law, in order to enable Xxxxxx Xxxxxxxx to
make such payments to Elan without any deduction or withholding.
9.3. Elan shall, not more than once in each calendar year, permit Xxxxxx
Xxxxxxxx or its duly authorised representatives upon reasonable notice and
at any reasonable time during normal business hours to have access to
inspect and audit the accounts and records of Elan and any other book,
record, voucher, receipt or invoice relating to the calculation of the
royalty payments on Net Sales submitted to Xxxxxx Xxxxxxxx. Any such
inspection of Elan's records shall be at the expense of Xxxxxx Xxxxxxxx,
except that if any such inspection reveals a deficiency in the amount of
the royalty actually paid to Xxxxxx Xxxxxxxx hereunder in any calendar
quarter of [REDACTED] or more of the amount of any royalty actually due to
Xxxxxx Xxxxxxxx hereunder, then the expense of such inspection shall be
borne solely by Elan. Any amount of deficiency shall be paid promptly to
Xxxxxx Xxxxxxxx by Elan. If such inspection reveals a surplus in the amount
of royalties actually paid to Xxxxxx Xxxxxxxx by Elan, Xxxxxx Xxxxxxxx
shall reimburse Elan the surplus within [REDACTED] days after
determination.
9.4. For the avoidance of doubt the parties confirm that Elan and Xxxxxx
Xxxxxxxx shall not be liable to the other by reason of any representation
or warranty, condition or other term or any duty of common law, or under
the express terms of this letter agreement, for any consequential or
incidental or punitive loss or damage (whether for loss of profits or
otherwise) and whether occasioned by the negligence of the respective
parties, their employees or agents or otherwise.
9.5. This Agreement may not be assigned by either Party without the prior
written consent of the other party save that each Party may assign this
Agreement to its Affiliate without such consent provided that no such
assignment has adverse tax implications for the other Party. Elan shall
have the right to subcontract all or any portion of its duties hereunder to
third parties, provided however, that in any such event Elan shall continue
to be bound by the terms of this Agreement.
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9.6. This Agreement is governed by and construed in accordance with the laws of
Ireland, and the parties agree to submit to the exclusive jurisdiction of
the courts of Ireland for the resolution of disputes hereunder.
9.7. The section headings contained in this Agreement are included for
convenience only and form no part of the agreement between the parties.
Save as otherwise provided herein, references to articles, Sections,
clauses and appendices are to those contained in this Agreement.
9.8. No provision of this Agreement shall be construed so as to negate, modify
or affect in any way the provisions of any other agreement between the
parties unless specifically referred to, and solely to the extent provided,
in any such other agreement.
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IN WITNESS WHEREOF the parties hereto have executed this Agreement in duplicate
on the date first set forth above.
Signed by /s/ Xxxxxx Xxxxxxxx
-------------------------
for and on behalf of
Elan Corporation, plc
in the presence of Xxxxx Xxxxxxxxx
----------------------------
Signed by /s/ Xxxxx Xxxxxxxxxxxxx
---------------------------------
for and on behalf of
Xxxxxx Xxxxxxxx, plc
in the presence of Xxxx Xxxxx
-------------------------------------
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SCHEDULE 1
The [REDACTED] Agreements
14
SCHDULE 2
The [REDACTED] Agreement
15
SCHEDULE 3
Legal Fees
1. Irell & Xxxxxxx costs to 31st March 1999 [REDACTED] *
2. Bruckhaus Xxxxxxxx Xxxxxx Xxxxx to 31st January 1999 [REDACTED]
* Excluding payment of [REDACTED] which has been invoiced by Elan to Warner
Chilcottt
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SCHEDULE 4
IS5MN Royalty Calculation
Per Section 2.4
Amount
------
Due to
-------
Warner
------
Xxxxxxxx
--------
[REDACTED] Due to WC
Ap ---------
--
Gross Sales Net Sales Cogs
----------- --------- ----
[REDACTED]
17
