Exhibit 4.6
AMENDING AGREEMENT
THIS AGREEMENT is made as of March 31, 0000
X X X X X X X:
DRAXIS HEALTH INC., a corporation incorporated under the laws of
Canada
(hereinafter referred to as "Draxis")
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ELAN PHARMA INTERNATIONAL LIMITED, a corporation incorporated under
the laws of Ireland
(hereinafter referred to as "Elan Pharma")
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ELAN PHARMACEUTICALS, INC., a corporation incorporated under the laws
of the State of Delaware
(hereinafter referred to as "EPI" and hereinafter collectively with
Elan Pharma referred to as "Elan").
Recitals:
A. Draxis and Elan entered into a License, Distribution and Supply Agreement
dated as of June 17, 1999 (the "License Agreement"), which provided Draxis
with certain license and distribution rights with respect to the Products
in the Territory on the conditions and terms contained in the License
Agreement;
B. Elan assigned certain rights and obligations with respect to Diastat(R) to
Xcel Pharmaceuticals, Inc. pursuant to the Diastat Asset Purchase Agreement
dated March 31, 2001 including without limitation, Elan's rights under the
License Agreement as it relates to Diastat(R), as a result of which Draxis
and Elan have no ongoing relationship regarding Diastat; and
C. Subject to the terms and conditions set forth herein, Elan and Draxis
desire to (i) terminate the License Agreement with respect to certain of
the Products and (ii) amend the License Agreement with respect to certain
of the Products.
For good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties agree as follows:
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1. Defined Terms
Capitalized terms used in this Amending Agreement and not otherwise defined
herein shall have the meanings ascribed thereto in the License Agreement.
2. Products
(a) As of the date hereof, Section 1.17 of the License Agreement is hereby
amended to state, in its entirety, as follows:
"Product(s)" means any or all of the following products, to the extent
of the rights owned, licensed or controlled by Elan in the Territory:
Zanaflex(R) and Mysoline(R) and any Improvements to any of the
Products which Elan owns or under which Elan is licensed with the
right to sublicense in the Territory.
(b) As of the date hereof, Section 1.24 shall be added to the License
Agreement and shall state, in its entirety, as follows:
"Excluded Product(s)" means any or all of the following products,
Neurobloc(TM) (botulinum toxin type B), frovatriptan, Zelapar(TM)
(selegiline hydrochloride flashtab), Zonegran(TM) (zonisamide),
Zanaflex(R) MR (tizanidine hydrochloride) and ziconotide, including,
without limitation, any regulatorily-approved commercial brand names
of the above noted products, such as Frovelan(R), MyoBloc(R) and
Prialt(R).
(c) As of the date hereof, the only provisions of the License Agreement
that shall apply to the Excluded Products are the following: Sections
5, 6, 13.3, 14, 15.4 (only as to facts existing on or before the date
hereof), 15.6, 16, 21.1, 23.1, 23.2, 23.4, 23.5, 23.6, 23.8 and 23.9.
Sections 15.1, 15.3 and 15.7 shall continue to apply but only with
respect to MyoBloc supplied by Draxis in Canada. Section 15.5 shall
continue to apply to the Excluded Products but only with respect to
the obligations of Draxis provided for therein and Elan shall have no
further obligations thereunder.
(d) As of the date hereof, Attachment A is hereby amended to delete any
references to any patents, patent applications or trademarks relating
to the Excluded Products.
3. Other Provisions
(a) As of the date hereof, the License Agreement is hereby amended to
delete Sections 7.2, 7.6, 13.1, 13.2 and 20.2.
(b) Notwithstanding anything to the contrary in the License Agreement,
including without limitation Article 7, the Project Committee shall
consist of one representative from each party who will meet on an as
needed basis to perform the functions of the Project Committee set out
in the License Agreement, except to the extent such functions are
amended hereby.
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(c) Notwithstanding anything to the contrary in the License Agreement, no
further Performance Incentives are payable under the License
Agreement.
4. Consideration
In consideration of the amendments to the License Agreement, Elan shall, on
the date hereof, pay U.S. $6,500,000 in immediately available funds to Draxis by
way of wire transfer. Neither party shall be required to pay the Termination Fee
in connection with this Amending Agreement or the transactions contemplated
hereby. Notwithstanding anything to the contrary in the License Agreement, as of
the date hereof, the Termination Fee shall not be applicable to any future
termination of the License Agreement.
5. Transitional Support
Elan shall be solely responsible and liable for taking all actions, paying
all fees to, and conducting all communication with, the appropriate governmental
or regulatory authority relating to any Excluded Product after the date hereof,
including preparing and filing all reports and submissions (and prosecuting such
submissions) with the appropriate governmental or regulatory authority; provided
that for one month from the date hereof Draxis will provide, at the reasonable
request of Elan, transitional support for the orderly transition of Canadian
regulatory issues. Elan shall reimburse Draxis for all out of pocket costs
incurred in providing such transitional support, including without limitation,
regulatory fees, disbursements and file transfer costs incurred with respect
thereto.
6. Inventory
Draxis shall return forthwith all Myobloc inventory in its possession and
Elan waives any amounts owing for outstanding invoices for Myobloc. Draxis
confirms that it holds no other inventory with respect to the Excluded Products.
7. Return of Regulatory and Proprietary Information
Draxis shall return to Elan as soon as reasonably possible after the date
hereof all relevant regulatory information and documents in Draxis' possession
and any other Elan Proprietary Information, related to the Excluded Products and
shall destroy all internal copies and backups thereof.
8. Regulatory Support
Each party acknowledges that for the purpose of specifying Elan's
regulatory support obligations pursuant to Section 7.4 and 7.5 of the License
Agreement, Elan shall without limitation assist Draxis in the following manner:
(a) Elan shall notify Draxis in advance regarding any contemplated
formulation change to the Products and will continue to supply
original formulated Products until Draxis has obtained approval from
Health Canada for the new formulation or site manufacturing change.
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(b) Elan will cooperate fully with Draxis for all Health Canada related
quality issues that may arise as well as any quality issues arising
from non-compliance with standard operating procedures in the
industry. On request, Elan shall provide all necessary documentation
required by Draxis to perform all quality assurance functions as well
as all quality control functions (these include, without limitation,
certificates of analysis, method transfers, updated master and
executed batch records, change controls and any other such documents).
(c) Elan will provide Draxis with all information that is reasonably
necessary to carry out appropriate pharmacovigilance including,
without limitation:
- safety reports (annual safety updates and/or PSURs) generated by
the safety group at Elan; and
- provide within five (5) working days (or sooner should immediate
action be required) any potential new safety signals that the
Elan safety group detects in its operations.
(d) On request, Elan will provide Draxis with all necessary documents to
meet its requirements to Health Canada and ensure patient safety.
Specifically, Elan will provide:
- all changes made to the package insert (PI) or product monograph
(PM);
- all anticipated changes to the PI must be communicated to Draxis
prior to the final document sign-off at Elan so that Draxis can
liaise in advance with Health Canada (this must be done (i) at
least ten (10) working days prior to Elan sending the final
document to the FDA or other regulatory body or (ii) in the event
that the FDA or regulatory body provides Elan with less than ten
(10) working days to finalize the PI as soon as reasonably
possible); and
- all data and final reports pertaining to PM changes so that
Draxis can make appropriate changes to its own PM in Canada.
(e) All plans for future modifications and development of TIZANIDINE
should be shared expeditiously with Draxis including all final
clinical study reports.
(f) Notwithstanding anything to the contrary provided for herein, in the
event that Elan does not commercialize any Improvement it shall have
no obligation to supply Draxis with Product containing such
Improvement provided that Elan agrees to discuss in good faith
potential Canadian commercialization of such Product without
committing to supply Product.
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9. Waiver of Certain Claims under the License Agreement
Each party waives any claims as of the date hereof it may have against the
other for breach of contract or failure to perform under the terms of the
License Agreement including, without limitation, claims related to failure to
provide timely regulatory assistance and clinical information and breaches of
representations and warranties related to the status of the Patent Rights and
Elan's Cost of Goods and releases the other party, its affiliates and their
respective officers, directors and employees therefrom. Each party represents
and warrants that it has not brought any such claim or proceeding in any legal
or arbitration forum as of the date hereof, and that it has not assigned or
transferred any such claim to any other party. Notwithstanding the foregoing, ,
neither party waives any right to any rights to indemnification under the
License Agreement (a) related to third party claims in tort or contract arising
prior to the date hereof or (b) arising out of any obligations arising after the
date hereof relating to Zanaflex and Mysoline.
10. Reaffirmation of the License Agreement
Except as expressly amended by this Amending Agreement, the provisions of
the License Agreement remain in full force and effect.
11. Further Assurances
Each party must from time to time execute and deliver all such further
documents and instruments and do all acts and things as the other party may
reasonably require to effectively carry out or better evidence or perfect the
full intent and meaning of this Agreement.
12. Benefit of the Agreement
This Agreement will enure to the benefit of and be binding upon the
respective successors and permitted assigns of the parties hereto.
13. Counterparts
This Amending Agreement may be executed in any number of counterparts and
all of such counterparts taken together shall be deemed to constitute one and
the same instrument. Counterparts may be executed either in original or faxed
form and the Parties adopt any signatures received by a receiving fax machine as
original signatures of the Parties; provided, however, that any Party providing
its signature in such manner shall promptly forward to the other Party an
original of the signed copy of this Amending Agreement which was so faxed.
14. Governing Law
This Agreement will be governed by and construed in accordance with the
laws of the state of Delaware, without regard to its choice of law principles.
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IN WITNESS WHEREOF the parties have executed this Agreement.
DRAXIS HEALTH INC.
Per: /s/ Xxxxxx Xxxxxx, M.D.
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Name: Xxxxxx Xxxxxx
Title: President
ELAN PHARMA INTERNATIONAL LIMITED
Per: /s/ Xxxxx Xxxxxx
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Name: Xxxxx Xxxxxx
Title: Authorized Signatory
ELAN PHARMACEUTICALS, INC.
Per: /s/ Xxxxx Xxxxxx
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Name: Xxxxx Xxxxxx
Title: Chief Financial Officer
