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TRADEMARK LICENSE AGREEMENT

Trademark Concurrent Use Agreement

TRADEMARK LICENSE AGREEMENT | Document Parties: CEPHALON INC | Anesta, AG | Cephalon, Inc | ImmuPharma AG | ImmuPharma France SA You are currently viewing:
This Trademark Concurrent Use Agreement involves

CEPHALON INC | Anesta, AG | Cephalon, Inc | ImmuPharma AG | ImmuPharma France SA

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Title: TRADEMARK LICENSE AGREEMENT
Date: 10/28/2009
Industry: Biotechnology and Drugs     Law Firm: Ballard Spahr     Sector: Healthcare

TRADEMARK LICENSE AGREEMENT, Parties: cephalon inc , anesta  ag , cephalon  inc , immupharma ag , immupharma france sa
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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



 

WHEREAS:

 

1

 

 

1.

Definitions

3

 

 

 

2.

Payment of the Decision Fee and Effective Date of Agreement

8

 

 

 

3.

Grant

9

 

 

 

4.

Trademark Milestone Payments

10

 

 

 

5.

Running Royalties

10

 

 

 

6.

Timing and Statement of Royalty and Trademark Milestone Payments

11

 

 

 

7.

Accounting and Other Financial Provisions Relating to Royalties and Other Payments

11

 

 

 

8.

Remittance, Currency and Taxes

12

 

 

 

9.

Manufacturing and Marketing of Finished Goods

14

 

 

 

10.

General Diligence of Anesta

15

 

 

 

11.

Trademark Protection

15

 

 

 

12.

Infringement of the Licensed Trademarks

15

 

 

 

13.

Infringement of Independent Third Party Rights

16

 

 

 

14.

Confidentiality

17

 

 

 

15.

Public Announcements

18

 

 

 

16.

ImmuPharma Switzerland Representations and Warranties

19

 

 

 

17.

Anesta Representations and Warranties

21

 

 

 

18.

Indemnification between the Parties

22

 

 

 

19.

Insurance

23

 

 

 

20.

Disclaimer

23

 

 

 

21.

Ordinary Termination

24

 

 

 

22.

Specific Performance and Extraordinary Termination

25

 

 

 

23.

Effect of Extraordinary Termination

27

 

 

 

24.

Further Consequences of Extraordinary Termination.

27

 

 

 

25.

Assignments

29

 

 

 

26.

Affiliates, Sub-Licensees and Sub-Contracting

29

 

 

 

27.

Oversight Committee

29

 

 

 

28.

General Dispute Resolution

29

 

 

 

29.

Waiver

30

 

 

 

30.

General Assurances

30

 

 

 

31.

Severability

31

 

 

 

32.

Entire Agreement

31

 

 

 

33.

Titles and Headings

31

 

 

 

34.

Costs of Preparation

31

 

 

 

35.

Notices

31

 

 

 

36.

Force Majeure

33

 

 

 

37.

No Agency, Partnership or Joint Venture

33

 

 

 

38.

Benefit to Third Parties

33

 

 

 

39.

Governing Law

34

 

 

SCHEDULE 1

 

 

 

 

 

SCHEDULE 2

 

 

 

**   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.

 

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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.

 

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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.

 

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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


 
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