Exhibit 10.3
Trademark License Agreement
between
ImmuPharma AG
as “ ImmuPharma Switzerland
”
and
Anesta AG
as “ Anesta ”
relating to the trademarks
“ Lupuzor ”, “
Lupusol ” and “ Lupustat
”
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
THIS TRADEMARK LICENSE AGREEMENT
(this “Agreement”) is
made as of the Effective Date as defined hereinafter and is
made
BETWEEN :
(1)
ImmuPharma AG
, (“ ImmuPharma
Switzerland ”), incorporated in Switzerland and having
its registered seat at Kägenstrasse 12, CH-4153 Reinach,
Switzerland; and
(2)
Anesta, AG
, (“ Anesta ”),
incorporated in Switzerland and having its principal place of
business at Barrenstrase 23, 6300 Zug, Switzerland, and an
Affiliate of Cephalon, Inc., incorporated in Delaware, U.S.A.
(“Cephalon”)
(each of ImmuPharma Switzerland and
Anesta hereinafter referred to as “ Party ” and
together referred to as “ Parties ”)
WHEREAS :
(A)
ImmuPharma Switzerland owns or
Controls certain proprietary rights, titles and interest in and to
the use of any trade names or trademarks created by it in respect
of its Lupuzor product, including the registered trademark
“Lupuzor” and any other trademarks ImmuPharma
Switzerland may apply for or register in the future in respect of
ImmuPharma France’s Lupuzor product (the “ Licensed
Trademarks ” as defined);
(B)
Anesta wishes to develop and
commercialise ImmuPharma France’s Lupuzor product in the
Territory (as hereinafter defined) for Lupus and any other
indications for which the Lupuzor product may be developed,
marketed or used on the terms and conditions hereof, however
subject to ImmuPharma France’s obtaining certain positive
results in the clinical trial currently being conducted on behalf
of ImmuPharma France for the Lupuzor product;
(C)
ImmuPharma Switzerland has agreed to
enter simultaneously with the Development and Commercialization
Agreement into this Agreement granting Anesta the right to use
ImmuPharma Switzerland’s Licensed Trademarks for the Lupuzor
product in the Territory subject to the terms and conditions
hereinafter specified;
NOW THEREFORE in consideration of the mutual promises and
covenants set forth herein and for good and valuable consideration,
the sufficiency of which is hereby acknowledged, and intending to
be legally bound hereby, the Parties hereby agree as
follows:
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
1
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WHEREAS:
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1
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1.
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Definitions
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3
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2.
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Payment of the Decision Fee and Effective Date
of Agreement
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8
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3.
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Grant
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9
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4.
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Trademark Milestone Payments
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10
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5.
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Running Royalties
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10
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6.
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Timing and Statement of Royalty and Trademark
Milestone Payments
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11
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7.
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Accounting and Other Financial Provisions
Relating to Royalties and Other Payments
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11
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8.
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Remittance, Currency and Taxes
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12
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9.
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Manufacturing and Marketing of Finished
Goods
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14
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10.
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General Diligence of Anesta
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15
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11.
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Trademark Protection
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15
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12.
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Infringement of the Licensed
Trademarks
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15
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13.
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Infringement of Independent Third Party
Rights
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16
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14.
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Confidentiality
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17
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15.
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Public Announcements
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18
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16.
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ImmuPharma Switzerland Representations and
Warranties
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19
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17.
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Anesta Representations and
Warranties
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21
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18.
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Indemnification between the
Parties
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22
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19.
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Insurance
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23
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20.
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Disclaimer
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23
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21.
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Ordinary Termination
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22.
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Specific Performance and Extraordinary
Termination
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25
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23.
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Effect of Extraordinary
Termination
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27
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24.
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Further Consequences of Extraordinary
Termination.
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27
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25.
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Assignments
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29
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26.
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Affiliates, Sub-Licensees and
Sub-Contracting
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29
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27.
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Oversight Committee
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29
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28.
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General Dispute Resolution
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29
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29.
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Waiver
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30
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30.
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General Assurances
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30
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31.
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Severability
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31
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32.
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Entire Agreement
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31
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33.
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Titles and Headings
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34.
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Costs of Preparation
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31
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35.
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Notices
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31
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36.
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Force Majeure
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33
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37.
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No Agency, Partnership or Joint
Venture
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33
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38.
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Benefit to Third Parties
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33
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39.
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Governing Law
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34
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SCHEDULE 1
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SCHEDULE 2
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** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
2
1.
Definitions
1.1
Definitions
. For the purposes of this Agreement
the following terms shall have the exclusive meaning as defined
below when written in capital letters, whereby all terms in capital
letters not defined herein shall have the same meaning as in the
Development and Commercialization Agreement:
(A)
“ Accounting Period
” means each three-month period ending on 31st March, 30th
June, 30th September or 31st December.
(B)
“ Acquiror ”
means as set forth in Clause 22.6 hereof.
(C)
“ Affiliate ”
means, with respect to a Party, any other company, corporation or
other Entity which (directly or indirectly) owns, is owned by or is
under common ownership with such Party or any other Entity actually
controlled by, controlling or under common control with such
Party. For purposes of this definition only,
“ownership” or “control” shall mean where
one Entity owns or controls fifty percent (50%) or more of the
equity conferring voting rights and/or otherwise has the ability to
direct the business affairs of another.
(D)
“ Business Day ”
means any day when the banks in Zurich, London and New York are
open for business.
(E)
“ Anesta Sub-Licensee
” means an Entity, other than an Affiliate of Anesta, that
will have been granted a license by Anesta or Anesta’s
Affiliates to any of the Licensed Patents, Licensed Technical
Information or Licensed Trademarks on the terms and conditions set
forth in Clause 3.2 hereof or that has any enforceable and
unconditional agreement with or commitment from Anesta or its
Affiliates for the grant of such a sub-license.
(F)
“ Cephalon ”
means Cephalon, Inc., incorporated in Delaware, U.S.A. and
having its principal place of business at 41 Moores Road, Frazer,
PA 19355, U.S.A., who is the indirect owner of 100% of the equity
of Anesta.
(G)
“ Clinical Studies
” means:
(1)
any study in man involving the
administration of the Licensed Product or Licensed Molecules to
human beings, including studies in all phases of clinical
development (Phases I, II, III and IV); and
(2)
observational studies concerning the
effects of the Licensed Product or Licensed Molecules in human
beings, including post authorization safety studies, quality of
life studies and pharmacoeconomic studies.
(H)
“ CNRS ” means
the Centre National de la Recherches Scientifiques,
France.
(I)
“ CNRS Agreements
” means collectively the CNRS/ImmuPharma License Agreement
(as defined) as well as any other collaboration agreements, license
agreements, exploitation agreements between CNRS and ImmuPharma (as
amended from time to time) which pertain to the Licensed Molecules,
the Licensed Product or the Licensed Technical
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
3
Information, however only to the
extent they so pertain to the Licensed Molecules, the Licensed
Product or the Licensed Technical Information.
(J)
“ Combination Product
” means any composition which comprises the Licensed
Molecules and at least another active ingredient.
(K)
“ Commercial Year
” means, except with respect to the first Commercial Year,
each successive 12 calendar month period starting from the 01
January of one year and ending on the 31 December of the
same year. The first Commercial Year shall begin on the date of the
First Commercial Sale to occur in the Territory and end on the 31
December of that year.
(L)
“ Commercially Reasonable
Efforts ” [**]
(M)
“ Confidentiality
Agreement ” means the Confidentiality Agreement made as
of 15 June 2007 between ImmuPharma and Cephalon.
(N)
“ Control ”,
“ Controls ” or “ Controlled
” means the possession of the ability to grant the licenses
or sublicenses or disclose information as provided for herein,
without breaching the terms of any prior written agreement or other
arrangement with any Third Party.
(O)
“ Decision Payment
” means an amount equal to thirty million US Dollars
(US$30,000,000).
(P)
“ Development and
Commercialization Agreement ” means the certain
development and commercialization agreement between Anesta and
ImmuPharma France to be signed of even date hereof.
(Q)
“ Dispute ” means
any dispute that arises out of or in connection with this
Agreement, including any question regarding the existence, scope,
validity or termination of this Agreement.
(R)
“ Effective Date
” means the date on which this Agreement became effective
under Clause 2.1 hereof.
(S)
“ Entity ” means,
and includes, any person, firm or company or group of persons or
unincorporated organization.
(T)
“ Finished Goods
” means any product containing Licensed Product, which is
fully formulated in final form packed for ultimate consumer use and
ready for use by or administration to patients in the Territory
including any packaging, labelling and any necessary
inserts.
(U)
“ First Commercial Sale
” means the first commercial sale of Finished Goods in the
Territory by Anesta or an Affiliate or a co-promoter (as defined in
Clause 3.3) in accordance with an NDA which has, prior to such
sale, been approved in the Territory for such Finished
Goods.
(V)
“ GAAP ” means
generally-accepted accounting principles, consistently
applied.
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
4
(W)
“ Generic Equivalent
” [**]
(X)
“ Generic Competition
” [**]
(Y)
“ ImmuPharma ”
means ImmuPharma France and ImmuPharma Switzerland.
(Z)
“ ImmuPharma France
” means ImmuPharma (France) SA, a French corporation, having
its principal place of business at 5, rue du Rhône, F-68100
Mulhouse, France.
(AA)
“ ImmuPharma Patents
” means (i) any and all Patents owned or co-owned by
ImmuPharma on or after the Effective Date, including any and all
Patents added to the Licensed Patents either (x) pursuant to
Clause 20.6 of the Development and Commercialization Agreement, or
(y) under the CNRS Agreements (as defined); (ii) any
Patents owned or co-owned by ImmuPharma which claim priority to
such Patents; and (iii) any Patents which would be infringed
by the manufacture, use or sale of the Licensed Molecules or the
Licensed Products which are owned or Controlled by ImmuPharma, all
of (i), (ii) and (iii) however only to the extent they
relate to the Licensed Molecules, the Licensed Product or the
Licensed Technical Information.
(BB)
“ ImmuPharma
Sub-Licensee ” means an Entity, other than an Affiliate
of ImmuPharma, that will be granted a license by ImmuPharma or
ImmuPharma’s Affiliates to any of the Licensed Patents,
Licensed Technical Information or Licensed Trademarks outside the
Territory upon termination in single countries on the terms and
conditions hereof.
(CC)
“ ImmuPharma
Switzerland ” means ImmuPharma AG, a Swiss corporation,
having its present principal place of business at Kägenstrasse
12, CH-4153 Reinach, Switzerland, which is an Affiliate of
ImmuPharma.
(DD)
“ IND ” means any
approval, consent, clearance or exemption necessary to carry out,
sponsor, distribute or supply investigational drugs or medicinal
products for a Clinical Trial which is obtained through
notification to or grant or confirmation by a regulatory authority
in any country or jurisdiction of the Territory.
(EE)
“ Independent Third
Party” means any person or Entity other than ImmuPharma
or Anesta, their Sub-Licensees, or their sub-contractors under
Clauses 9.1 or 26.1 or any Affiliates of the foregoing.
(FF)
“ Late Payment Interest
” means as set forth in Clause 7.4 hereof.
(GG)
“ Licensed Molecules
” means any molecule that is a chemical derivative of a
peptide corresponding to the sequence 131-151 of the 70k-snRNP
protein (i.e., RIHMVYSKRSGKPRGYAFIEY, which is SEQ ID NO: 1 of U.S.
patent application serial number 10/236,468), including derivatives
in which a Lysine (in position 138 or 142) is acetylated or a
Serine (in position 137 or 140) is phosphorylated, any combination
thereof and in particular Lupuzor, and the esters, amides, salts,
hydrates and solvates thereof.
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
5
(HH)
“ Licensed Product
” means any formulations or dosages that contain the Licensed
Molecules, including but not limited to any Combination Product,
for any and all uses.
(II)
“ Licensed Trademarks
” means the marks LUPUZOR, LUPUSOL and LUPUSTAT and any other
word marks, designs or logos that ImmuPharma may apply for,
register, create, own or use in the future in respect of the
Licensed Products or Licensed Molecules, including but not limited
to, those marks listed on Schedule 1 of this Agreement and
any amendments thereto.
(JJ)
“ Lupuzor ” means
IPP-201101, otherwise known as P140, which is the peptide
corresponding to the sequence 131-151 of the 70k-snRNP protein with
a phosphorylated “Ser” in position 140, the chemical
structure of which is given in Schedule 3 , and the esters,
amides, salts, hydrates and solvates thereof.
(KK)
“ Mediation Notice
” shall have the meaning given to it in Clause 28.4
hereof.
(LL)
“ NDA ” means any
application or notification made to and accepted by a Regulatory
Authority for approval for Finished Goods to be placed on the
market or sold for public consumption as drugs or medicinal
products, including without limitation a “shonin”
granted by the MHLW.
(MM)
“ Net Sales ” for
any given period shall mean the gross aggregate amount invoiced on
account of sales of Finished Goods by Anesta or any of its
Affiliates, Anesta Sub-Licensees or their co-promoters (as defined
in Clause3.3) to an Independent Third Party in the Territory (but
not including sales between Anesta, its Affiliates, Anesta
Sub-licensees or their co-promoters where the Licensed Product or
Licensed Molecules is intended for resale) less the following
reductions directly relating to such sales of Finished
Goods:
(a) trade and quantity
discounts or rebates given in the ordinary course of business which
are not already reflected in the amount invoiced;
(b) any adjustments or
allowances on account of price adjustments, billing errors,
rejected goods, damaged goods and returns;
(c) credits, volume rebates,
charge-back and prime vendor rebates, fees, reimbursements or
similar payments granted or given to wholesalers and other
distributors, buying groups, health care insurance carriers,
pharmacy benefit management companies, health maintenance
organizations or other institutions or health care organizations,
which are not already reflected in the amount invoiced;
(d) any tax associated with the
sales of goods such as VAT, sales tax, tariff, customs duty, excise
or other duty or other governmental charge (other than a Tax on
income) levied on the sale, transportation or delivery of the
Licensed Molecules or Licensed Product and borne by the seller
thereof, itemized on the applicable invoice and remitted to the
applicable taxing authority;
(e) payments or rebates paid in
connection with sales of the Licensed Product or Licensed Molecules
to any governmental or regulatory authority in respect of any state
or federal Medicare, Medicaid or similar programs, which are not
already reflected in the amount invoiced;
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
6
(f) any invoiced charge for
freight, insurance or other transportation costs charged to the
customer, in each case only when separately shown on the invoice;
and
(g) amounts allocated to bad
debts.
PROVIDED THAT in any event
deductions may only be made under (a) to (g) to the
extent they are truly, fairly and equitably allocated to the Net
Sales of Finished Goods of Licensed Product or Licensed Molecules
so that such do not bear a disproportionate portion of such
deductions. For purposes of this definition, the Licensed Product
or Licensed Molecules shall be considered “sold” and
“reductions” allowed when recorded as invoiced in
Anesta’s, its Affiliates’, Anesta Sub-licensees’
or co-promoters’ financial statements prepared in accordance
with US generally accepted accounting principles. “
Ordinary Termination ” means as set forth in Clause
21.1 hereof.
(NN)
“ Non-Exclusive ”
or “ Non-Exclusivity ” means that ImmuPharma and
its Affiliates shall have the right pursuant to Clause 33.5 of the
Development and Commercialization Agreement to evaluate, develop,
keep, use, make, have made, market, sell, have sold, import, have
imported, export, have exported or otherwise exploit or grant any
licenses or sublicenses to any Third Parties to the Licensed
Patents or the Licensed Technical Information for the Licensed
Product or Licensed Molecules in one or more specific countries of
the Territory to the extent such right of ImmuPharma is required as
a result of any applicable antitrust act or competition law
regulation.
(OO)
“ Option ” means
the option granted by ImmuPharma to Cephalon and Anesta under the
Option Agreement.
(PP)
“ Option Agreement
” means a certain option agreement between Immupharma on the
one hand as well as Cephalon and Anesta on the other hand, dated
November 21, 2008.
(QQ)
“ Ordinary Termination
” means as set forth in Clause 21.1 hereof.
(RR)
“ Oversight Committee
” means the committee established in accordance with Clause
27.1.
(SS)
“ Parent Guarantee
Agreement ” [**]
(TT)
“ Positive Decision
Notice ” shall have the meaning as set forth in Clause
2.1 hereof.
(UU)
“ Regulatory
Authorities ” means any and all governmental or
supra-national agencies, ministries, authorities or other bodies
having responsibility for the regulation or control of drugs or
medicinal products.
(VV)
“ Relevant Conditions
” shall have the meaning set forth in Clause
13.2(C) hereof.
(WW)
“ Running Royalties
” means as set forth in Clause 5 hereof.
(XX)
“ Significant Generic
Competition ” means a level of Generic Competition
[**]
(YY)
“ Sub-Licensee ”
and “ Sub-Licensees ” means as the context
requires either or both of an Anesta Sub-Licensee or an ImmuPharma
Sub-Licensee or Anesta Sub-Licensees and ImmuPharma Sub-Licensees
if referred to collectively.
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
7
(ZZ)
“ Tax ” or
“ Taxes ” means all of the following:
(i) any net income, alternative or add-on minimum tax, gross
income, gross receipts, sales, use ad valorem, transfer, franchise,
profits, license, excise, severance, stamp, occupation, employment,
payroll, production, withholding, value added, premium, property,
environmental, or windfall profits tax or other tax, custom, duty
or other tax, governmental fee or other like assessment or charge
of any kind whatsoever together with interest or penalty additional
to tax that may be imposed by any Governmental or Regulatory
Authority and (ii) any liability for the payment of amounts
described in (i) above as a result of being a member of an
affiliated, consolidated, combined or unitary group for any taxable
period.
(AAA)
“ Territory ”
means all the countries of the world, other than those countries
which cease to be a part of the Territory or become
Non-Exclusive.
(BBB)
“ Third Party ”
means any party, person or Entity, other than a Party hereto or an
Affiliate, Sub-Licensee, permitted sub-contractor or co-promoter of
a Party hereto.
(CCC)
“ Third Party Claim
” shall have the meaning as set forth in Clause 13.1
hereof.
(DDD)
“ Third Party Patents
” means (i) the CNRS Lupuzor Patents and any and all
other Patents Controlled by ImmuPharma on or after the Effective
Date that relate to the Licensed Molecules or the Licensed Product
and only to the extent that they relate to the Licensed Molecules
and the Licensed Product, including any and all Patents added to
the Licensed Patents pursuant to Clause 20.6 of the Development and
Commercialization Agreement, but not including the ImmuPharma
Patents, (ii) any patents Controlled by ImmuPharma which claim
priority to such patents and (iii) any patents which would be
infringed by the manufacture, use or sale of the Licensed Molecules
or the Licensed Product which are Controlled by
ImmuPharma.
(EEE)
“ Trademark License
Agreement ” means this Agreement.
(FFF)
“ Trademark Milestones
” mean as set forth in Clause 4.1 hereof.
1.2
Sections and Clauses
. The “ Clauses ”
of this Agreement are the numbered provisions of this
Agreement.
1.3
Singular and Plural
. The singular includes the plural
and vice versa, words denoting any gender include all
genders.
1.4
Parties’
References . Where the
context so admits or requires references to
“ImmuPharma” and “Anesta” and their
“Affiliates”, Sub-Licensees”, sub-contractors or
co-promoters, such terms shall include their respective employees,
officers, directors and agents.
2.
Payment of the Decision Fee and Effective Date of
Agreement
2.1
Conditions Precedent
. This Agreement shall only become
effective upon the occurrence of all of the following:
(i) Cephalon acting also on behalf and for the account of
Anesta has sent a written notice to ImmuPharma Switzerland,
indicating a final decision to exercise the Option (“
Positive Decision Notice ”), and (ii) payment by
Cephalon, and receipt by ImmuPharma Switzerland, of the Decision
Payment. For the avoidance of doubt, this Agreement shall be
executed by all Parties required to execute this Agreement at the
time of execution of the Option Agreement, in advance of the
satisfaction of each of the foregoing subsections (i) and
(ii), but this Agreement
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
8
shall only be in full force and
effect after the occurrence of any and all of (i) and
(ii) above. All signed copies hereof shall be deposited with
the Escrow Agent who shall hold all the signed agreements in escrow
for the Parties hereto. Upon the occurrence of all of (i) and
(ii) above, the Escrow Agent shall release one fully executed
copy of this Agreement, signed by ImmuPharma Switzerland, Cephalon
and the Escrow Agent, to each of the signatories hereof. Should
either (i) or (ii) not occur within the Option Period,
the Escrow Agent shall destroy all Signed Agreements.
3.
Grant
3.1
Licensed Trademarks
. ImmuPharma Switzerland hereby
grants on the terms and conditions hereof to Anesta an exclusive
(as set forth hereinafter and even as to ImmuPharma Switzerland and
its Affiliates) license under the Licensed Trademarks to use the
Licensed Trademarks in conjunction with the development, use,
manufacture, distribution, marketing, promotion and sale of the
Licensed Products or the Licensed Molecules in the Territory.
Anesta shall be the sole and exclusive licensee in respect of the
Licensed Trademarks for Finished Goods of the Licensed Products or
Licensed Molecules within the Territory. “Exclusive”
shall mean that for as long as this Agreement is in full force and
effect in any such country of the Territory, neither ImmuPharma
Switzerland nor its Affiliates shall make, use or sell, or grant
any licenses to any Third Parties for the manufacture, use or sale,
of any product in conjunction with the Licensed Trademarks, other
than for the manufacture and use of the Licensed Product or
Licensed Molecules in a Territory pursuant to termination or
Non-Exclusivity under Clause 33.5 of the Development and
Commercialization Agreement.
3.2
Sub-Licenses
. Anesta may (i) sub-license
the rights granted to it hereunder to its Affiliates and
Cephalon’s Affiliates and (ii) sub-license any and all
rights granted hereunder to Third Parties to produce or use the
Licensed Product or Licensed Molecules in the Territory.
Sub-Licenses to Third Parties by Anesta shall be subject to the due
fulfilment of all the following prerequisites:
(A)
[**]
(B)
[**]
(C)
[**]
(D)
[**]
ImmuPharma Switzerland shall use
Commercially Reasonable Efforts to facilitate the grants of
sublicenses by Anesta on the terms and conditions
hereof.
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
9
3.3
Co-Promoting
. Clause 3.2 shall not prevent
Anesta, its Affiliates or Sub-Licensees from selling Finished Goods
in the Territory in conjunction with a co-promoter. For these
purposes, a “co-promoter” shall mean an Independent
Third Party which sells Finished Goods.
4.
Trademark Milestone
Payments
4.1
Events . Anesta shall make the following irrevocable
and non-conditional payments to ImmuPharma Switzerland upon the
occurrence of the following trademark milestone events (each a
“ Trademark Milestone ” and collectively, the
“ Trademark Milestones ”):
(A)
[**] the end of the first Commercial
Year in which Net Sales of the Licensed Product in conjunction with
the Licensed Trademark in any and all countries of the Territory
for such Commercial Year exceed [**]; and
(B)
[**] the end of the first Commercial
Year in which Net Sales of the Licensed Product in conjunction with
the Licensed Trademark in any and all countries of the Territory
for such Commercial Year exceed [**]; and
(C)
[**] the end of the first Commercial
Year in which Net Sales of the Licensed Product in conjunction with
the Licensed Trademark in any and all countries of the Territory
for such Commercial Year when sales exceed [**];
4.2
Payment Terms
. For the avoidance of
doubt:
(A)
The
Trademark Milestone payments under Clause 4.1 (A), (B) and
(C) shall be cumulative, but each Trademark Milestone payment
shall be due and payable only once in respect of the first time
that the relevant Trademark Milestone event occurs in relation to
the Licensed Product; and
(B)
The
payment of each Trademark Milestone payment is not conditional or
dependant in any way upon whether or not any application or
registration of the Licensed Trademarks occurred in any country of
the Territory in which Net Sales of the Licensed Product in
conjunction with the Licensed Trademarks occurred prior to the
reaching of such Trademark Milestone.
(C)
The
payment of each Trademark Milestone payment is not conditional or
dependent in any way upon whether or not any approvals for price or
reimbursement are obtained for the Licensed Product in conjunction
with the Licensed Trademarks in any country of the
Territory.
(D)
If
more than one Trademark Milestone is achieved for the first time in
any given calendar year following the end of any Commercial Year
therein, then the Trademark Milestone payments in respect of each
such Commercial Milestone shall become due and payable.
5.
Running
Royalties
5.1
Rates . As further consideration for the licenses and
rights hereby granted, Anesta shall pay to ImmuPharma Switzerland
running royalties based on the Net Sales for each Commercial Year
as set out below (the “ Running Royalties
”):
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
10
(A)
in respect of the portion, if any,
of all Net Sales of Licensed Product in conjunction with the
Licensed Trademark in any and all countries of the Territory of
less than [**] in any given Commercial Year, the Running Royalties
shall be [**]; and
(B)
in respect of the portion, if any,
of all Net Sales of Licensed Product in conjunction with the
Licensed Trademark in any and all countries of the Territory over
[**] and in any given Commercial Year, the Running Royalties shall
be [**] and
for as long as no Ordinary
Termination of the Development and Commercialization Agreement (as
defined in Clause 32.1 of the Development and Commercialization
Agreement) has occurred in any country of the Territory. Upon
Ordinary Termination of the Development and Commercialization
Agreement as a whole or in any country of the Territory, Anesta
shall pay to ImmuPharma Switzerland [**] marketed in conjunction
with the Licensed Trademark in the entire Territory or, if the
Ordinary Termination is for a specific country, in such country of
the Territory.
5.2
Significant Generic
Competition .
[**]
5.3
Combination Products
. In the event a Combination Product
is sold by Anesta in conjunction with the Licensed Trademarks, the
Net Sales from the Combination Product, for the purposes of
determining Running Royalties and the Trademark Milestone payments,
shall be determined by multiplying the Net Sales of the Combination
Product (as defined in the standard Net Sales definition), during
the applicable reporting period, by the fraction, A/A+B, where A is
the weighted (by sales volume) average sale price of the Licensed
Product or Licensed Molecules when sold separately in finished form
and B is the weighted (by sales volume) average sale price of the
other product(s) included in the Combination Product when sold
separately in finished form, in each case during the applicable
reporting period or, if sales of both the Licensed Product or
Licensed Molecules and the other product(s) did not occur in
such period, then in the most recent reporting period in which
sales of both occurred. In the event that such average sale price
cannot be determined for both the Licensed Product or Licensed
Molecules and all other products(s) included in the
Combination Product, Net Sales for the purposes of determining
Trademark Milestone payments and Running Royalties shall be
mutually agreed by the Parties based on the relative value
contributed by each component, such agreement not to be
unreasonably withheld.
6.
Timing and Statement of Royalty
and Trademark Milestone Payments
6.1
Timing . Payment of Running Royalties shall be made by
Anesta to ImmuPharma Switzerland on a quarterly basis within sixty
(60) calendar days after the end of each Accounting Period in
respect of all Net Sales occurring in such Accounting
Period.
6.2
Statement . However, within thirty (30) calendar days
after the end of each such Accounting Period, Anesta shall provide
ImmuPharma Switzerland with the written statement referred to in
Clause 7.3.
7.
Accounting and Other Financial
Provisions Relating to Royalties and Other
Payments
7.1
Trademark Milestone
Notification . Anesta
undertakes to notify ImmuPharma Switzerland in writing of each
Trademark Milestone event referred to in Clause 4 within fourteen
(14) calendar days of its occurrence.
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
11
7.2
Accounting
. Anesta shall, and shall procure
that each Affiliate and each Anesta Sub-Licensee shall, keep at its
usual place of business complete proper records and books of
account showing the quantity, description and Net Sales (including
gross invoiced prices and any deductions made therefrom) of
Finished Goods sold and/or used in conjunction with the Licensed
Trademarks hereunder on a product presentation-by-product
presentation basis.
7.3
Running Royalties
Reporting . Within thirty
(30) calendar days after each Accounting Period, Anesta shall
deliver to ImmuPharma Switzerland a detailed written statement of
all Net Sales of Licensed Product in the Territory by Anesta, its
co-promoters under Clause 3.3, Affiliates and Anesta Sub-Licensees,
if any, as well as all Running Royalties due and payable to
ImmuPharma Switzerland for the relevant Accounting Period showing
separately the transactions for which Running Royalties are payable
and (where relevant), the rate of exchange used or, if it be the
case, a statement that no Running Royalties are due, whereby Clause
8.3 remains reserved.
7.4
Late Payment Interest
. Where any Trademark Milestones,
Running Royalties, charges or other sums payable by Anesta to
ImmuPharma Switzerland hereunder remain unpaid after the date on
which they became due and payable, Anesta shall pay to ImmuPharma
Switzerland interest calculated from the date upon which the sums
became due until payment thereof at the ninety-day London Interbank
Offered Rate prevailing on the due date plus [**] (the “
Late Payment Interest ”).
8.
Remittance, Currency and
Taxes
8.1
Payments . All Trademark Milestone payments under Clause
4 and all Running Royalties payments under Clause 5 shall be made
electronically in US Dollars and to such place and account as may
be designated from time to time for that purpose by ImmuPharma
Switzerland to Anesta in writing. Any necessary currency
conversions in connection with Running Royalties payments shall be
made by Anesta in accordance with the financial reports prepared,
and financial reporting procedures operated, in accordance with the
United States GAAP. All payments shall be made by Anesta in
accordance with Clause 8.2.
8.2
Withholding Taxes
. All sums payable by either Party
under this Agreement (including without limitation all Trademark
Milestones and Running Royalties payments) shall be paid in full
and without any Taxes, duties, levies, fees, charges, deduction or
withholding on any ground whatsoever, except as may be required by
law. If it shall appear that any such sum is or is likely to
be or become subject to any such Taxes, duties, levies, fees,
charges, deduction or withholding as aforesaid the Parties shall
consider together to what extent, if at all, it may lawfully be
possible to mitigate the amount of such deduction or withholding or
of the amount required to be paid as aforesaid, including making
Commercially Reasonable Efforts to make timely and procedurally
correct application for relief from withholding Tax in respect of
any such payment. For any Taxes withheld or to be withheld, each
Party agrees to timely deliver all certificates and forms as may be
necessary and appropriate to establish an exemption from Tax or
file Tax returns as would be necessary with respect to such
Taxes.
8.3
Audits . Once each calendar year, Anesta shall permit
any professionally qualified representatives from an independent
firm of accountants appointed by ImmuPharma Switzerland (as to
which Anesta has no reasonable objection) (the “ Contract
Auditor ”), upon [**] calendar days advance written
notice and subject to such representatives undertaking not to
disclose or use any of Anesta’s confidential information
(save for the purposes set out in this Clause 8.3), access during
normal business hours to the premises, accounts, records and
relevant documentation for [**] of Anesta, its Affiliates, Anesta
Sub-Licensees and co-promoters under Clause 3.3, and all
thereof
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
12
shall provide such information and
explanations as the Contract Auditor shall reasonably require for
the purposes of verifying the statements and reporting to
ImmuPharma Switzerland and CNRS whether the provisions of this
Agreement and the Development and Commercialization Agreement are
being complied with and the extent to which Anesta has paid any
sums due and payable on the terms and conditions of this Agreement
or the Development and Commercialization Agreement. ImmuPharma
Switzerland shall pay all costs of the Contract Auditor. For the
avoidance of doubt, Immupharma Switzerland shall only be permitted
to conduct one audit in each calendar year, regardless of whether
it is conducted pursuant to this Agreement or the Development and
Commercialization Agreement. The report by the Contract Auditor to
ImmuPharma Switzerland and CNRS (with a copy to Anesta) shall not
include any confidential information of Anesta or Cephalon, or any
of its Affiliates except to the extent reasonably necessary to
report whether or not Anesta, its Affiliates, Anesta Sub-Licensees
and co-promoters under Clause 3.3, have correctly paid all sums due
and payable under this Agreement or the Development and
Commercialization Agreement and, if not, the specific details of
any discrepancies. Anesta shall keep and retain, and shall ensure
that its Affiliates and Anesta Sub-Licensees and co-promoters under
Clause 3.3 shall keep and retain, such accounts, records and
documentation for at least three (3) calendar years from the
date of their origin, or such longer period as may be required by
applicable law. The Contract Auditor shall also be permitted to
take copies and extracts solely for the purpose of performing the
verification exercise contemplated under this Clause 8.3. Such
copies and extracts shall be returned to Anesta on completion of
the verification exercise and resolution of any issues which have
arisen. If the Contract Auditor shall determine that there is an
underpayment to ImmuPharma Switzerland of [**] of the particular
amount due under either this Agreement or the Development and
Commercialization Agreement for any relevant Accounting Period,
ImmuPharma Switzerland shall provide written notice to Anesta and
Anesta shall, within thirty (30) calendar days of the written
demand by ImmuPharma Switzerland, pay to ImmuPharma Switzerland the
deficient amount (the underpayment) plus Late Payment Interest
calculated pursuant to Clause 7.4. If the Contract Auditor shall
determine that there is an overpayment by Anesta of [**] of the
particular amount due under either this Agreement or the
Development and Commercialization Agreement for any relevant
Accounting Period, Anesta shall provide written notice to
ImmuPharma Switzerland with reasonable detail, ImmuPharma
Switzerland shall, within thirty (30) calendar days of the written
demand by Anesta, pay to Anesta the excess amount (the overpayment)
plus Late Payment Interest described in Clause 7.4. For the
avoidance of doubt, the calculation of any underpayment or
overpayment shall not be an aggregate of any underpayment or
overpayment in this Agreement and any underpayment or overpayment
in the Development and Commercialization Agreement.
8.4
Amicable Settlement
. Where the Parties disagree over
whether or not any amounts are payable following any verification
by the Contract Auditor under Clause 8.3 their chief financial
officers (or appropriately qualified senior management who are
designated by such chief financial officers) shall discuss the
disagreement in good faith with the Contract Auditor who performed
the verification exercise. If the matter is not resolved within one
(1) calendar month of the date any written demand is made
under the last sentence of Clause 8.3, the matter shall be referred
to the Oversight Committee. If not agreed within the Oversight
Committee within fifteen (15) Business Days of such referral,
either Party may elect to have the matter determined by a senior
professionally qualified representative of the firm of an
independent firm of accountants to be reasonably agreed by the
Parties, which may or may not be the Contract Auditor who performed
the verification exercise, acting as an expert. Such expert
determination shall be final and binding upon the Parties.
Notwithstanding anything to the contrary herein, the resolution of
any Dispute under this Clause shall be made under this Clause 8.4
instead and in lieu of Clause 28.
** Portions of the
Exhibit have been omitted and have been filed separately pursuant
to an application for confidential treatment filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934, as amended.
13
8.5
CNRS Rights
. It is understood and acknowledged
by the Parties that CNRS pursuant to the CNRS Agreements has the
right to inspect and review the Net Sales figures for the purpose
of calculating their Running Royalties due by ImmuPharma
Switzerland and that as a consequence all rights of ImmuPharma
under Clause 8.3 may also be exercised by CNRS in addition to
ImmuPharma Switzerland. To the extent ImmuPharma Switzerland
desires to conduct an audit in any calendar year, ImmuPharma
Switzerland shall use Commercially Reasonable Efforts to agree with
CNRS that in any such calendar years only one audit shall be
conducted. ImmuPharma Switzerland shall not be permitted to conduct
an audit in any calendar year in which CNRS has already conducted
or plans to conduct an audit.
9.
Manufacturing and Marketing of
Finished Goods
9.1
Undertakings
. Anesta shall be responsible to
ensure that for the Finished Goods: (i) all manufacturing
activities are performed in accordance with all applicable laws,
regulations, guidelines and standards, including applicable current
Good Manufacturing Practice; (ii) all manufacturing activities
are performed in facilities approved by the applicable Regulatory
Authorities; (iii) all Finished Goods conform to the
applicable Specifications; and (iv) it informs ImmuPharma
Switzerland of any inspection, the making of observations or other
action by any Regulatory Authority that concerns such manufacturing
activities, provide copies of any relevant documentation and
correspondence and use all Commercially Reasonable Efforts to
enable ImmuPharma Switzerland to comment on any response. In the
event that (a) a material lawsuit or legal proceeding is
instituted against Anesta or ImmuPharma that alleges a significant
manufacturing defect and (b) ImmuPharma provides thirty (30)
days prior written notice to Anesta of its desire to perform an
inspection and the grounds for such inspection, ImmuPharma may, at
a mutually agreeable time, inspect such manufacturing activities
during normal business hours for a reasonable amount of time.
Unless required by law, ImmuPharma shall not disclose in any manner
its observations or any documentation resulting from its
inspection, without the prior written consent of Anesta.
9.2
Branding . Anesta shall market Finished Goods under the
trade name or trademark Lupuzor TM ,
Lupusol TM or Lupustat TM licensed to Anesta under this Agreement,
provided tha