Document:

ex10_44a.htm

EXHIBIT 10.44A

 

[*] indicates that a confidential portion of the text of this agreement has been omitted.

	
 

AMENDED AND RESTATED TRADEMARK LICENSE AGREEMENT

 

 

Entered into between the undersigned as of January 11,  2012 (the “Effective Date”):

 

	
BIOFARMA,

A company duly organized and existing under the laws of France

and having its office at:

22 rue Garnier,

92200 NEUILLY-SUR-SEINE

FRANCE

(hereinafter referred to as “BIOFARMA”)

AND

 

	
XOMA IRELAND LIMITED,

A company duly organized and existing under the laws of the Republic of Ireland

and having its office at:

 

26 Upper Pembroke Street

 

DUBLIN 2

IRELAND

 

(hereinafter referred to as “XOMA”)

BIOFARMA and XOMA are hereinafter individually referred to as the “Party” or collectively referred to as the “Parties”.

 

  

  

  

 

SUMMARY

 

	 	PAGE
	 	 
	ARTICLE I DEFINITIONS	 1
	 	 
	ARTICLE II GRANT	 5
	 	 
	ARTICLE III REPRESENTATIONS AND WARRANTIES OF BIOFARMA	 6
	 	 
	ARTICLE IV REPRESENTATIONS AND WARRANTIES OF XOMA 	 7
	 	 
	ARTICLE V TRADEMARK AND QUALITY CONTROL 	 8
	 	 
	ARTICLE VI ROYALTIES 	 10
	 	 
	ARTICLE VII INFRINGEMENT/ENFORCEMENT 	 11
	 	 
	ARTICLE VIII TERM AND TERMINATION 	 13
	 	 
	ARTICLE IX MISCELLANEOUS 	 13

 

  

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PREAMBLE

 

WHEREAS, BIOFARMA is the owner of certain Trademarks (as hereinafter defined) in the Territory (as hereinafter defined);

 

WHEREAS, XOMA LS LIMITED (“XOMA LS”) approached BIOFARMA, an Affiliate of LES LABORATOIRES SERVIER (“SERVIER”), in order to acquire an exclusive license to use the Trademarks in the Territory in connection with the commercialization of the Licensed Products (as hereinafter defined) in the Territory, and BIOFARMA agreed to grant such license;

 

WHEREAS, BIOFARMA and XOMA LS entered into a Trademark License Agreement (the “Original Agreement”), dated July 7, 2010 (the “Original Agreement Effective Date”);

 

WHEREAS, XOMA LS assigned the Original Agreement to XOMA on March 14, 2011;

 

WHEREAS, XOMA and SERVIER are parties to that certain License and Commercialization Agreement, dated July 7, 2010 (the “License and Commercialization Agreement”), as amended, pursuant to which SERVIER is exclusively licensing to XOMA certain intellectual property rights so as to enable XOMA to commercialize the Licensed Products in the Territory;

 

WHEREAS, XOMA and SERVIER are entering into an Amended and Restated License and Commercialization Agreement, dated of even date herewith, pursuant to which, among other things, SERVIER is expanding the license grant to XOMA to include an additional Licensed Product, currently commercialized in the Territory under the trade name ACEON® (the “Amended and Restated Agreement”); and

 

WHEREAS, in connection with the execution of the Amended and Restated Agreement, XOMA desires to receive a license grant to the ACEON trademark used for such additional Licensed Product, and the Parties desire to amend and restate the Original Agreement as set forth herein

 

 (hereinafter this “Agreement”).NOW, THEREFORE, IN CONSIDERATION OF THE FOREGOING AND OF THE UNDERTAKINGS CONTAINED HEREIN, THE PARTIES, INTENDING TO BE LEGALLY BOUND HEREBY, AGREE AS FOLLOWS:

 

ARTICLE I

DEFINITIONS

 

As used in this Agreement, the following terms have the following meanings, capitalized terms used but not defined herein shall have the meaning set forth in the Amended and Restated Agreement:

 

1.1           “ACEON” means all pharmaceutical preparations, in all dosage strengths, formulations and methods of administration, that contain ACEON API as the sole active ingredient for use in the treatment of humans for hypertension or other cardiovascular diseases, including without limitation those being marketed in the Territory as of the Effective Date under the trade name ACEON®.

 

  

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1.2           “ACEON API” means the active pharmaceutical ingredient known under the INN perindopril associated with the erbumine salt.

 

1.3           “Additional Combination Product(s)” means all pharmaceutical preparations, in all dosage strengths, formulations and methods of administration, that combine (i) the Perindopril API and (ii) one or more other active pharmaceutical ingredients, including the Indapamide API alone and the Indapamide API together with the Amlodipine API, in each case as active pharmaceutical ingredients for use in the Field.  Notwithstanding the foregoing, “Additional Combination Product(s)” shall not include the Initial Licensed Product or any pharmaceutical preparation that combines the Perindopril API and any active pharmaceutical ingredient other than Amlodipine API or Indapamide API that becomes the subject of one or more SERVIER research programs after the Original Agreement Effective Date.

 

1.4           “Affiliate” of a Party means:

 

	
  

	
(i)

	
any company or other entity in which more than (50%) of the voting rights, shares or other equity interests are owned or controlled, directly or indirectly (including pursuant to any option, warrant or similar arrangement), by said Party, and/or

 

	
  

	
(ii)

	
any company or other entity which owns or controls, directly or indirectly (including pursuant to any option, warrant or similar arrangement), at least fifty percent (50%) of the voting rights, shares or other equity interests of said Party, and/or

 

	 	
(iii)

	
any company or other entity in which at least fifty percent (50%) of the voting rights, shares or other equity interests are owned or controlled, directly or indirectly (including pursuant to any option, warrant or similar arrangement), by a company or other entity referred to in clause (ii) hereinabove.

 

1.5           “Amlodipine API” means the active pharmaceutical ingredient known under the INN amlodipine and any salt, derivative, chelate, clathrate, polymorph, isomer (either structural or optical), acid, base, pro-drug or metabolite thereof.

 

1.6           “API” means, collectively or singularly as the context dictates, the Perindopril API, the Amlodipine API, the ACEON API and, upon exercise by XOMA of the Option with respect to any Additional Combination Product containing the Indapamide API, the Indapamide API.

 

1.7           “Business Day” means a day that is not a Saturday, Sunday or a day on which banking institutions in San Francisco, California U.S.A.  and/or Paris, France, are authorized by Law to remain closed.

 

1.8           “Commercialization” means, with respect to the Licensed Products, any and all processes and activities conducted to establish and maintain sales for such Licensed Products, including maintaining Marketing Approval, manufacturing or having manufactured Licensed Products from API, selling, offering for sale, detailing, marketing, promoting, storing, transporting, supporting, distributing, and importing the API.  “Commercialize” and “Commercializing” shall have their correlative meanings.

 

  

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1.9           “FDA” means the United States Food and Drug Administration or any successor entity thereto.

 

1.10         “Indapamide API” means the active pharmaceutical ingredient known under the INN indapamide and any salt, derivative, chelate, clathrate, polymorph, isomer (either structural or optical), acid, base, pro-drug or metabolite thereof.

 

1.11         “Indemnitees” means BIOFARMA, its Affiliates, their respective directors, representatives, agents, officers, employees, direct and indirect beneficial owners, successors and assigns.

 

1.12         “Initial Licensed Product” means all pharmaceutical preparations, in all dosage strengths, formulations and methods of administration, that combine the Amlodipine API and the Perindopril API as active ingredients for use in the Field.

 

1.13         “Law” means, individually and collectively, any and all laws, ordinances, rules, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable jurisdiction.

 

1.14         “Licensed Product(s)” means (i) the Initial Licensed Product, (ii) ACEON and (iii) upon exercise by XOMA of the Option with respect to any Additional Combination Product, such Additional Combination Product.

 

1.15         “Marketing Approval” means all approvals, licenses, registrations or authorizations necessary for the Commercialization by XOMA, its Sublicensees or designees of a Licensed Product in the Territory, including, if applicable, the pricing thereof.  Marketing Approval shall be deemed to have been received upon first receipt by XOMA, its Sublicensees or designees of notice from the FDA that Commercialization of a Licensed Product has been approved in the Territory.

 

1.16         “NDA” means a New Drug Application (or any foreign equivalent), including all supplements and amendments thereto, for the approval of the Licensed Product as a new drug by the FDA.

 

1.17         “Net Sales” are recorded according to GAAP (including invoices and accruals).  Net Sales means adjusted gross amount invoiced on all sales (“Gross Sales”) of the Licensed Products (including, but not limited to, hospital sales, mail orders and retail sales) by XOMA or through or by its Sublicensees in the Territory, through customary commercial channels of distribution to an independent Third Party in bona fide arms length sales, less the following deductions:

 

	
  

	
(i)

	
customs tariffs and duties, insurance charges (in each case, when invoiced as additional charges) , allowances for bad debts; and

 

	
  

	
(ii)

	
Returns (including additional returns accrual) and rebates excluding cash discounts, which Returns shall not exceed [*] percent ([*]%) of Gross Sales on a quarterly basis; and

 

  

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(iii)

	
discounts actually given for managed care rebates, Medicaid rebates, Medicare rebates, chargebacks, TRICARE rebates and patient assistance program rebates; and

 

	
  

	
(iv)

	
Recalls;

 

provided, that deductions pursuant to clauses (i), (ii) and (iii) shall not exceed in the aggregate [*] percent ([*]%) of Gross Sales on a quarterly basis.

 

For purposes of clarification, if a particular deduction falls under more than one category set forth above, such deduction shall only be taken once.

 

Any recalls falling out of the definition of Recalls shall be excluded from the determination of Net Sales.

 

Sales taxes, value added taxes and any other taxes when invoiced as additional charges are excluded from Net Sales.

 

1.18         “Perindopril API” means the active pharmaceutical ingredient known under the INN perindopril associated with the arginine salt.

 

1.19         “Promotional Materials” means all Licensed Product packaging and labeling, and all written, printed, graphic, electronic, audio or video matter, including journal advertisements, sales visual aids, leave behind items, formulary binders, reprints, direct mail, direct-to consumer advertising, broadcast advertisements and sales reminder aids, for example, scratch pads, pens and other like items, in each case created by XOMA or directly on its behalf and used or intended for use in connection with any promotion of a Licensed Product.

 

1.20         “Recalls” means Licensed Products recalled by XOMA (i) for quality, safety or other issues pertaining to the manufacture of API, if supplied by SERVIER, or (ii) following SERVIER’s request.

 

1.21         “Returns” means all Licensed Products returned to XOMA by any independent Third Party.

 

1.22         “Territory” means the United States of America and its territories and possessions.

 

1.23         “Third Party” means any entity other than BIOFARMA or XOMA, or their respective Affiliates.

 

1.24         “Trademarks” means (a) with respect to the Initial Licensed Product, the trademark selected by XOMA for the Initial Licensed Product, which as of the Effective Date is [*], provided that such trademark is approved by the applicable regulatory authorities and successfully registered with the U.S. Patent and Trademark Office, and if such trademark is not so approved and so registered, the trademark selected by XOMA from those other trademarks listed on Schedule 1.24 hereto or otherwise proposed by XOMA and agreed to by BIOFARMA, (b) with respect to ACEON, the trademark ACEON® No. 3351617 of March 27, 2007 and all the common law rights in the ACEON mark in the Territory and (c) with respect to the Additional Combination Products and/or any Replacement Trademarks, such other trademarks as may be agreed upon in accordance with the terms of this Agreement from time to time.  Once a trademark has been selected by the Parties as provided herein, approved by the regulatory authorities and successfully registered with the U.S. Patent and Trademark Office for the Initial Licensed Product, the other trademarks listed in Schedule 1.24 may be used by BIOFARMA for other products after having notified XOMA.

 

  

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1.25         Interpretation.  References to Articles and Sections contained herein shall refer to Articles and Sections of this Agreement as applicable unless otherwise specifically set forth herein.  The words “including”, “includes” and words of similar import shall be deemed to be followed by “without limitation.”

 

1.26         Additional Definitions.  Each defined term used in this Agreement but not set forth in the preceding Sections of this Article I is defined in the body or recitals of this Agreement as indicated below.

 

	
Term

	
Section

	 	 
	
“Additional Trademark”

	
2.3

	
“Agreement”

	
Recitals

	
“Amended and Restated Agreement”

	
Recitals

	
“Defaulting Party”

	
8.2

	
“knowledge”

	
3.2

	
“License and Commercialization Agreement”

	
Recitals

	
“Original Agreement”

	
Recitals

	
“Original Agreement Effective Date”

	
Recitals

	
“Replacement Trademarks”

	
5.1

	
“Royalties”

	
6.1

	
“SERVIER”

	
Recitals

	
“Transfer”

	
9.2

	
“XOMA LS”

	
Recitals

 

ARTICLE II

GRANT

 

2.1           BIOFARMA hereby grants to XOMA, and XOMA hereby accepts, during the term of this Agreement and subject to its terms and conditions, an exclusive (even as to BIOFARMA), royalty-bearing, sublicensable (with the consent of BIOFARMA, such consent not to be unreasonably withheld or delayed) license to use the Trademarks in the Territory solely in connection with the Commercialization of the Licensed Products in the Territory.  All goodwill resulting from XOMA’s, its Sublicensees’ and their subcontractors’ use of the Trademarks shall inure solely to the benefit of BIOFARMA.  BIOFARMA retains all rights not specifically granted to XOMA in this Section 2.1.  No implied licenses are set forth herein.  XOMA acknowledges that no other trademarks other than the Trademarks are being licensed to XOMA pursuant to this Agreement.  In furtherance of the foregoing, the Parties acknowledge that XOMA shall have no right or license to use or otherwise refer to “SERVIER” or “BIOFARMA,” other than as required by any applicable law or regulation.

 

  

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2.2           To the extent not previously provided, BIOFARMA shall immediately provide to XOMA all current trademark search reports for pharmaceutical products which BIOFARMA shall have ordered with respect to the trademarks for the Initial Licensed Product listed on Schedule 1.24 or as otherwise proposed by XOMA and agreed to by BIOFARMA.

 

2.3           Upon request by XOMA and reasonably in advance of any exercise by XOMA of the Option, pursuant to Section 2.2 of the Amended and Restated Agreement, to include in the licenses thereunder one or more Additional Combination Products, BIOFARMA shall submit to XOMA a reasonable number of candidates for trademark(s) to be used in the Commercialization of such Additional Combination Product(s) in the Territory and shall provide to XOMA all current trademark search reports for pharmaceutical products which BIOFARMA shall have ordered with respect to those of the trademark(s) selected by XOMA from such list or as otherwise proposed by XOMA and agreed to by BIOFARMA (each such additional trademark, hereinafter an “Additional Trademark”).  Once an Additional Trademark has been so agreed upon, the Parties shall promptly supplement Schedule 1.24 hereto to include such Additional Trademarks and BIOFARMA shall (a) promptly file in its name, and diligently pursue, the registration of (and thereafter maintain) each such Additional Trademark in accordance with its obligations hereunder at BIOFARMA’s cost, and (b) provide XOMA with copies of any filings and responses.  XOMA shall provide reasonable assistance, at BIOFARMA’s request and cost, in connection with such registration and maintenance.  For the purposes of this Agreement, all references to Trademarks shall be deemed to include Additional Trademarks.

 

ARTICLE III

REPRESENTATIONS AND WARRANTIES OF BIOFARMA

 

3.1           BIOFARMA hereby represents and warrants, as of the date hereof, to XOMA as follows:

 

3.1.1           No Third Party has any rights in the Trademarks in the Territory except for Abbott (as defined in the Amended and Restated Agreement) solely with respect to ACEON as provided in the Abbott Termination Agreement (as defined in the Amended and Restated Agreement).  BIOFARMA has terminated all prior agreements relating to use of the Trademarks in the Territory except solely with respect to ACEON as provided in the Abbott Termination Agreement.  There is no pending or, to the knowledge of BIOFARMA after due inquiry, threatened challenge, action, claim, demand, suit, proceeding, arbitration, grievance, citation, summons, inquiry or investigation of any nature, civil, criminal, regulatory or otherwise, in law or in equity that would prevent BIOFARMA from hereby performing under this Agreement, or that relates to the ownership or usage or other rights of BIOFARMA to the Trademarks in the Territory.  BIOFARMA has not entered into any current or subsisting agreement granting any right or interest in the Trademarks with respect to the Territory.  None of the rights of BIOFARMA under the Trademarks have been licensed to BIOFARMA from a Third Party.

 

3.1.2           BIOFARMA has the corporate power and authority to execute and deliver this Agreement and to perform its obligations hereunder, and the execution, delivery and performance of this Agreement by BIOFARMA have been duly and validly authorized and approved by proper corporate action on the part of BIOFARMA, and BIOFARMA has taken all other actions required by Law, its certificate of incorporation or by-laws or any agreement to which it is a party or to which it may be subject, required to authorize such execution, delivery and performance.  Assuming due authorization, execution and delivery on the part of XOMA, this Agreement constitutes a legal, valid and binding obligation of BIOFARMA, enforceable against BIOFARMA in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, receivership, moratorium and similar Laws.

 

  

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3.2           For purposes of this Article III and Article IV, “knowledge” shall mean a Party’s or its Affiliates’ actual knowledge as of the date hereof.

 

ARTICLE IV

REPRESENTATIONS AND WARRANTIES OF XOMA

 

4.1           XOMA hereby represents and warrants, as of the date hereof, to BIOFARMA as follows:

 

4.1.1           XOMA has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder, and the execution, delivery and performance of this Agreement by XOMA have been duly and validly authorized and approved by proper action on the part of XOMA, and XOMA has taken all other actions required by Law, its constitutional documents or any agreement to which it is a party or to which it may be subject required to authorize such execution, delivery and performance.  Assuming due authorization, execution and delivery on the part of BIOFARMA, this Agreement constitutes a legal, valid and binding obligation of XOMA, enforceable against XOMA in accordance with its respective terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, receivership, moratorium and similar Laws.

 

4.1.2           It is financially capable of undertaking the business operations that it conducts and of performing its obligations hereunder.

 

4.1.3           There is no action, claim, demand, suit, proceeding, arbitration, grievance, citation, summons, subpoena, inquiry or investigation of any nature, civil, criminal, regulatory or otherwise, pending in law or in equity that would prohibit XOMA from fully performing under this Agreement.

 

4.1.4           Any Licensed Product marketed by XOMA will comply with all applicable Law, as well as any regulatory and governmental agency that has jurisdiction and industry codes and standards including current Good Manufacturing Practices related to manufacturing, labeling and advertising, records and reports, and drug listing, assuming, with respect to any Licensed Product containing API supplied by SERVIER, that the representations and warranties of SERVIER with respect to such API set forth in Section 8.1 of Schedule 6 of the Amended and Restated Agreement are true and correct.

 

4.1.5           XOMA will have conducted a basic search of the U.S. Patent and Trademark Office database of registered and pending trademark applications for any trademarks that are confusingly similar to each Trademark prior to XOMA’s use of such Trademark in the Territory.

 

4.1.6           XOMA will indemnify, defend and hold harmless Indemnitees against all damages, claims, liabilities, losses and other expenses, including reasonable attorneys’ fees and costs, whether or not a lawsuit or other proceeding is filed, that arise out of or relate to a breach by XOMA of any representation, warranty, covenant, or term of this Agreement; provided, that the foregoing indemnity shall not apply to damages, claims, liabilities, losses or other expenses incurred as a result of BIOFARMA’s or any of its Affiliates’ gross negligence, willful misconduct or violation of Law (it being understood that XOMA’s defense obligations shall remain in effect).

 

  

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4.1.7           The foregoing indemnity shall be subject to the terms of Sections 17.2 and 17.3 of the Amended and Restated Agreement which shall be incorporated into this Agreement by such reference.

 

ARTICLE V

TRADEMARK AND QUALITY CONTROL

 

5.1           Selection of Trademark.  In the event that (a) any Trademark(s) to be used to Commercialize any Licensed Products hereunder is/are finally rejected by the FDA or any other governmental or regulatory authority, or (b) the said Trademark(s) is/are successfully challenged by a Third Party, then, in any case the trademark(s) (“Replacement Trademarks”) to be used by XOMA on the applicable Licensed Product in the Territory shall be mutually agreed upon by the Parties and shall be filed in the name of and owned by BIOFARMA.  Prior to agreeing upon any such Replacement Trademark(s), BIOFARMA shall submit to XOMA a reasonable number of candidates for such trademark(s) and shall provide to XOMA all current trademark search reports for pharmaceutical products which BIOFARMA shall have ordered with respect to the Replacement Trademark(s) selected by XOMA or as otherwise proposed by XOMA and agreed to by BIOFARMA.  BIOFARMA shall pursue the registration (and thereafter maintain) the Replacement Trademarks chosen by the Parties in accordance with its obligations hereunder at BIOFARMA’s cost and will provide XOMA with copies of any filings and responses.  XOMA shall provide reasonable assistance at BIOFARMA’s request in connection with such registration and maintenance.  For the purposes of this Agreement, all references to Trademarks shall be deemed to include Replacement Trademarks.

 

5.2           Registration and Maintenance Costs.  BIOFARMA, at its own expense, will execute, file and record all documents to maintain, preserve and renew applications for registration of the Trademarks (including any Replacement Trademarks and Additional Trademarks) in the Territory, and will take commercially reasonable efforts to obtain registration of any trademark applications for the Trademarks as of the Original Agreement Effective Date.  At BIOFARMA’s request, XOMA will reasonably cooperate with BIOFARMA’s requests in connection with the filing, maintenance, preservation and renewal of all applications and registrations of the Trademarks, including executing all documents as reasonably requested by BIOFARMA in the Territory.  BIOFARMA shall reimburse XOMA’s out of pocket costs incurred in exercising its obligations pursuant to this Section 5.2.

 

5.3           Ownership.  XOMA acknowledges that the Trademarks are the sole and exclusive property of BIOFARMA, and XOMA agrees that nothing in this Agreement shall give XOMA any right, title or interest express or implied in the Trademarks anywhere in the world other than the right to use the Trademarks in accordance with the terms of this Agreement.  XOMA agrees that it shall not, at any time during the term of this Agreement or thereafter, do or suffer to be done any act that would in any way impair the rights of BIOFARMA in and/or to the Trademarks, in the Territory.  In particular, XOMA agrees that it will not at any time, in the Territory, (a) do or cause to be done any act or thing contesting or in any way impairing or tending to impair any part of BIOFARMA’s claimed ownership in the Trademarks; (b) take any action that would interfere with BIOFARMA’s registration and/or use of the Trademarks outside the Territory; (c) take any action that would diminish or dilute the distinctiveness or validity of the Trademarks; or (d) challenge BIOFARMA’s ownership of the Trademarks and/or registration thereof.  In connection with such limited use of the Trademarks as permitted by this Agreement, XOMA acknowledges that use thereof shall inure to the benefit of BIOFARMA and shall not create in XOMA’s favor any right, title or interest in or to the Trademarks.  XOMA further agrees that its own acts or omissions made in connection with or related to the Trademarks shall not form any basis for a challenge of the validity of any BIOFARMA interest in the Trademarks. XOMA shall not grant any other party the right to use the Trademarks, other than in connection with its fulfillment of its obligations under this Agreement and pursuant to the Amended and Restated Agreement.

 

  

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5.3.1           XOMA further agrees that its use of the Trademarks shall conform to the standards set by BIOFARMA and be under the quality control of BIOFARMA, including reasonable inspection by BIOFARMA, and shall be in compliance with all applicable requirements of Law.

 

5.3.2           To the extent that any rights in and to the Trademarks are deemed to accrue to XOMA, XOMA hereby assigns any and all such rights, at such time as they may be deemed to accrue, including the resulting goodwill, to BIOFARMA.

 

5.4           Promotional Materials.  XOMA will provide BIOFARMA with at least one sample of each example of Promotional Materials, packaging (including labeling, boxes, etc.) bearing the Trademarks (prior to implementing on the market of the same and any changes thereto prior to such changes).  Upon the request of BIOFARMA, XOMA shall deliver to BIOFARMA, from time to time, at its request without charge, a reasonable additional number of packaged finished goods and partially finished goods or other materials adequate for BIOFARMA to determine that XOMA is in compliance with the terms of this Agreement and the terms of the Amended and Restated Agreement.

 

5.4.1           XOMA agrees that the use of the Trademarks on Promotional Materials shall conform to the typical quality standards and trademark use standards used by XOMA with respect to other marketing materials distributed by XOMA from time to time.

 

5.4.2           XOMA will use proprietary notices (TM, ® or ©) on each example of Promotional Materials, packaging (including labeling, boxes, etc.) in the form that BIOFARMA provides.

 

5.5           Domain Names.  BIOFARMA agrees that XOMA, as part of fulfillment of its obligations under this Agreement and the Amended and Restated Agreement, may have the need to operate websites using domain names which include the Trademarks as part thereof.  BIOFARMA agrees that it shall retain and maintain ownership of such domain names, and that XOMA may operate such websites, subject to the approval by BIOFARMA of the content of the websites, such approval not to be unreasonably withheld or delayed.

 

5.5.1           To the extent, with respect to ACEON, that one or more domain names are registered in the name of Abbott, XOMA shall cooperate with Abbott to have such domain names, and all rights therein, directly transferred to XOMA.   To the extent, with respect to ACEON, that one or more domain names are registered in the name of BIOFARMA, the Parties shall cooperate with each other to have such domain names, and all rights therein, transferred to XOMA. At termination of the Amended and Restated Agreement, XOMA shall transfer at no cost to BIOFARMA all ACEON domain names and all domain names containing the name ACEON.

 

  

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5.6           Injunctive Relief. In the event of any unauthorized use of the Trademarks, BIOFARMA may, in addition to all other remedies that may be available to it, seek relief in equity (including a temporary restraining order, temporary or prohibitory injunction, and permanent mandatory or prohibitory injunction) to restrain and prohibit the continuation of any such unauthorized use and may seek to compel compliance with the provisions of this Agreement and to restrain and prohibit the unauthorized use.

 

ARTICLE VI

ROYALTIES

 

6.1           Royalty Payments.  As consideration for the Trademarks license granted to XOMA hereunder, and subject to Sections 6.4 and 7.2, XOMA shall pay to BIOFARMA, after the end of each calendar quarter, royalties equal to [*] percent ([*]%) of Net Sales of the Licensed Products (“Royalties”) on a Licensed Product by Licensed Product basis.

 

6.2           Royalty Payment and Reports.

 

6.2.1       Each Royalty shall be payable quarterly only once with respect to the Licensed Products. XOMA shall provide a report to BIOFARMA of the sales estimates within [*] Business Days after the end of each calendar [*] in substantially the form attached as Schedule 11.5 to the Amended and Restated Agreement setting forth (i) the amount of Gross Sales in U.S. Dollars of the Licensed Products in such [*], (ii) any deductions and/or withholding from such amount of Gross Sales as permitted pursuant to the definition of Net Sales, (iii) a calculation of Net Sales in U.S. Dollars of the Licensed Products for such [*], (iv) the amount of aggregate Net Sales in U.S. Dollars of the Licensed Products on a cumulative per year basis for the current year, and (v) the amount of Royalty due in U.S. Dollars on Net Sales with respect to such [*].

 

6.2.2       XOMA shall also provide a report to BIOFARMA of:

 

	
  

	
(i)

	
the sales estimates within [*] Business Days after the end of each calendar [*] with the same information as above, and

 

	
  

	
(ii)

	
the actual sales within [*] days after the end of each calendar [*] with the same information as above.  Upon receipt of each such report that relates to a calendar [*], BIOFARMA will issue an invoice for the amount reflected on such report as being payable with respect to such calendar [*].  Within [*] days after receipt of such invoice but not later than [*] days after the end of each calendar [*], XOMA shall make the royalty payment reflected in such report and invoice with respect to such calendar [*].

 

	
  

	
(iii)

	
XOMA shall provide a report to BIOFARMA of the annual sales no later than [*] of each calendar year.  Such report shall be certified by an executive officer of XOMA as accurate and in accordance with generally accepted accounting principles (to the extent applicable).

 

  

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For the avoidance of doubt, any report required by Section 6.1 or this Section 6.2 may be included in the corresponding report required by Section 11.5 of the Amended and Restated Agreement for the same period so long as such report is provided to both Servier and BIOFARMA.

 

6.3           Payments Generally.  All payments under this Agreement shall be made by wire transfer to a bank account designated by BIOFARMA, in Euros in an amount converted from the U.S. Dollar amount of such payment set forth in or determined in accordance with this Agreement at the exchange rate in effect on the date of payment.  Any payments or portions thereof due hereunder which are not paid when due shall bear interest equal to the lesser of (i) one-month LIBOR plus [*] basis points per annum or (ii) the maximum rate permitted by Law, calculated on the number of days such payment is delinquent.  This Section 6.3 shall in no way limit any other remedies available to either Party.

 

6.4           Taxes.  In the event that any Royalties or other payments due from XOMA to BIOFARMA under this Article VI are subject to withholding tax required by Law to be paid to the taxing authority of any country, the amount of such tax may be withheld from the applicable Royalties or other payment due BIOFARMA.  XOMA shall pay such tax on behalf of BIOFARMA and shall furnish BIOFARMA with evidence of withholding tax paid.  Any such payments made by XOMA to an applicable taxing authority shall constitute payments made to BIOFARMA under this Article VI and in no event shall XOMA be liable for any payments in excess of amounts due to BIOFARMA under this Article VI, whether or not in the form of any taxes, duties, levies or other similar charges, including related interest, additions to tax and penalties, in respect of any payments pursuant to this Article VI.

 

6.5           Audit Rights.  BIOFARMA shall have the right, at its own expense, no more than once per calendar year, to inspect XOMA’s relevant financial books and records through an independent internationally recognized auditor designated by BIOFARMA and approved by XOMA, such approval not to be unreasonably withheld or delayed, and subject to reasonable obligations of confidentiality, upon at least [*] days advance written notice for the purpose of confirming XOMA’s compliance with the terms hereof.  In the event that the foregoing audit reveals an underpayment by XOMA, within [*] days of the receipt of the auditor’s report, XOMA shall remit payment to BIOFARMA of the amount of the underpayment plus interest as set forth in Section 6.3 above.  BIOFARMA shall bear the costs incurred in connection with such inspection and audit, all in accordance with the terms and conditions of this Agreement.  Any overpayments shall promptly be refunded to XOMA.

 

ARTICLE VII

INFRINGEMENT/ENFORCEMENT

 

7.1           Each Party will promptly notify the other, in writing, if it becomes aware of any infringement or suspected or threatened infringement of the Trademarks.  Subject to Section 7.4, XOMA agrees to take no further steps with respect to such infringement pending instructions from BIOFARMA.

 

Nothing in this Section shall prevent the Parties from compliance with any and all laws or regulations requiring notification of infringements or counterfeiting activities involving the Trademark to the proper authorities.

 

  

11

  

 

7.2           BIOFARMA may in its sole discretion, but shall not be required to, bring legal action against any infringement or threatened infringement of the Trademarks or defend against any claim that the Trademarks infringe any rights of a Third Party of which it is aware or which is brought to its attention; in the event BIOFARMA brings such action, which shall be at its own cost, XOMA shall cooperate fully with BIOFARMA, at BIOFARMA’s cost including if required to bring such action, furnishing a power of attorney and furnishing documents and information and executing all necessary documents as BIOFARMA may request.  Any recovery in action or defense described in this Section 7.2 obtained shall belong to BIOFARMA.  BIOFARMA shall not settle any such action or defense that imposes any obligation on XOMA without XOMA’s prior written consent.  If BIOFARMA declines to bring or defend a legal action under this Section 7.2 and XOMA exercises its option under Section 7.4 to bring or defend such action, then no Royalties shall be due under this Agreement for the Trademark that is the subject of such action while such action is pending or thereafter unless and until XOMA prevails in such action.

 

7.3           Should BIOFARMA decide to bring legal action to prosecute such infringement, XOMA shall be entitled to join the action so long as BIOFARMA retains at all times the right to direct the action (including the choice of its counsel and litigation and settlement strategy) subject to the limitation set forth in Section 7.2.

 

In case XOMA and BIOFARMA mutually agree to prosecute such infringement jointly, or defend jointly against any such claim all costs and expenses of, as well as any recovery obtained from such action or defense shall be divided equally between BIOFARMA and XOMA.

 

7.4           If BIOFARMA has failed to bring or defend an action relating to any infringement in the Territory under Sections 7.2 or 7.3 above,

 

	
  

	
(i)

	
[*] weeks after it has been notified in writing by XOMA of such alleged infringement, or

 

	
  

	
(ii)

	
[*] weeks before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such action, whichever comes first,

 

XOMA may at its option, bring legal action against any infringement or threatened infringement to the Trademarks or defend against any claim that the Trademarks infringe the right of a Third Party.  XOMA shall act in its own name and at its own cost.  In such event, BIOFARMA shall cooperate fully with XOMA, at XOMA’s cost, including, if required in order to bring such an action, joining such an action, the furnishing to XOMA of a power of attorney and furnishing documents and information and executing all necessary documents as XOMA may request.  Any recovery obtained in any action or defense described in this Section 7.4 shall belong to XOMA.

 

7.5           Should the Trademarks not be registered or be invalidated for any reasons whatsoever, or if BIOFARMA fails to bring any action and XOMA opts not to bring any action against any infringement, the Parties shall agree to the selection at XOMA’s discretion, registration at BIOFARMA’s expense and use by XOMA of a Replacement Trademark(s) in accordance with the procedures of Section 5.1 and which shall belong to BIOFARMA and which shall be governed by the terms of this Agreement.

 

  

12

  

 

ARTICLE VIII

TERM AND TERMINATION

 

8.1           Term.  This Agreement commenced on and as of the Original Agreement Effective Date and shall continue until the expiration or termination of the Amended and Restated Agreement, at which time this Agreement shall automatically terminate.

 

8.2           Termination.  Either Party shall have the right to terminate this Agreement upon notice to the other Party (the “Defaulting Party”) at any time if the Defaulting Party breaches, in any material respect, any of its representations, warranties or obligations under this Agreement, and such breach is not cured within [*] days after the Defaulting Party’s receipt of written notice of such breach.

 

8.3           Rights and Obligations of Parties upon Termination

 

8.3.1           Any termination (i) shall be on a trademark-by-trademark basis without prejudice to any other damage or legal redress that a Party hereto may be entitled to, and (ii) shall not release a Party hereto from any indebtedness, liability or other obligation incurred hereunder by such Party prior to the date of termination or expiration.

 

8.3.2           Upon termination, XOMA shall discontinue the use of and refrain thereafter from using or registering the Trademarks and any trademark(s) confusingly similar thereto, and further agrees to refrain from using trade names, slogans, package designs, labels, advertising copy or other indicia of origin associated with the Trademark or with BIOFARMA.

 

8.3.3           Upon termination, XOMA shall use commercially reasonable efforts to return to BIOFARMA (or certify to BIOFARMA that it has destroyed) all documents and Promotional Materials (including copies) of any kind concerning the Trademark communicated to it by BIOFARMA.

 

8.3.4           The following provisions of this Agreement will survive expiration or termination of this Agreement:  Articles I, III, IV and IX and this Section 8.3.

 

ARTICLE IX

MISCELLANEOUS

 

9.1           EXCEPT AS SPECIFICALLY PROVIDED HEREIN, NEITHER BIOFARMA NOR XOMA MAKES ANY OTHER WARRANTIES OR REPRESENTATIONS UNDER THIS AGREEMENT.  EACH PARTY HEREBY DISCLAIMS ALL IMPLIED REPRESENTATIONS AND WARRANTIES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.  EACH PARTY ACKNOWLEDGES THAT THE OTHER PARTY, EXCEPT AS SPECIFICALLY SET FORTH IN THE REPRESENTATIONS AND WARRANTIES CONTAINED IN ARTICLES 3 AND 4 OF THIS AGREEMENT, SHALL HAVE NO LIABILITY FOR ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT.

 

  

13

  

 

9.2           Assignment.  This Agreement and any rights granted or obligations imposed hereunder are personal to each Party and shall not be sold, assigned, delegated or otherwise transferred (each a “Transfer”), directly or indirectly, by operation of law or otherwise, by either Party without the prior written consent of the other Party, which consent may be granted or withheld in such other Party’s sole discretion; provided, however, that either Party, at any time for any reason, may Transfer (a) this Agreement or any right or obligation hereunder, in whole or in part, to any of its Affiliates who agree to be bound by the applicable terms and conditions of this Agreement, or (b) this Agreement in whole to any successor of such Party by merger or sale of all or substantially all of its business assets to which this Agreement relates who agrees to be bound by the applicable terms and conditions of this Agreement.  Any attempted Transfer of this Agreement or any of the rights granted hereunder in violation of this Section 9.2 shall be void ab initio.  Any transaction that results in an entity to which this Agreement, or any rights or obligations hereunder, were Transferred in reliance on clause (a) above ceasing to be an Affiliate shall be deemed a Transfer subject to this Section 9.2.  The consent by any Party to any Transfer shall not constitute a waiver of the necessity for such consent in any subsequent Transfer.  XOMA shall remain jointly and severally liable to BIOFARMA with respect to any obligations under this Agreement Transferred by XOMA to (i) any of its Affiliates, or (ii) any Third Party that does not have comprehensive general liability insurance at the level indicated in Article 10 of the Amended and Restated Agreement, in each case unless BIOFARMA consents to such Transfer, such consent not to be unreasonably withheld.  This Agreement shall be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.

 

9.3           Notices.  Any notices, requests, reports, approvals, designations, responses, or other communications provided for in this Agreement to be made by either of the Parties to the others shall be in writing to the other at its/their address set forth below.  Any such notice or communication may also be given by hand or by e-mail or facsimile.  Either Party may by like notice specify an address to which notices and communications shall thereafter be sent.  Any such notice, instruction or communication shall be deemed to have been delivered upon receipt if delivered by hand, three (3) Business Days after it is sent by mail, one (1) Business Day or when transmitted with electronic confirmation of receipt, if transmitted by facsimile (if such transmission is on a Business Day; otherwise, on the next Business Day following such transmission).

 

	
In the case of BIOFARMA:

 

BIOFARMA

22 Rue Garnier

92200 Neuilly sur Seine

France

 

Attention:  Head of Trademark Department

 

Facsimile:  + 33 1 55 72 32 69

	
With a required copy to:

 

LES LABORATOIRES SERVIER

22 Rue Garnier

92200 Neuilly Sur Seine

France

 

Attention:  USA Zone Manager

 

Facsimile:  + 33 1 55 72 52 05.

  

14

  

	
In the case of XOMA:

 

XOMA IRELAND LIMITED

 

26 Upper Pembroke Street

Dublin 2

Ireland

Attention: Alan Kane

Facsimile: +353 1 637 3989

	
With required copies (which shall

not constitute notice) to:

 

Cahill Gordon & Reindel llp

80 Pine Street

New York, NY 10005

United States of America

Attention:  Geoffrey E. Liebmann

Facsimile:  +1 212 269 5420

 

and to:

 

XOMA Ltd.

2910 Seventh Street

Berkeley, California 94710

United States of America

Attention: General Counsel

Facsimile: +1 510 649 7571

9.4           Governing Law.  This Agreement shall be governed by and construed and enforced in accordance with the laws of Germany to the exclusion of its conflict of law provisions.

 

9.5           Dispute Resolution.  The Provisions of Article 16 “Dispute Resolution” of the Amended and Restated Agreement shall be incorporated herein by reference and shall apply mutatis mutandis to this Agreement.

 

9.6           No Waiver.  None of the provisions of this Agreement can be waived except in a writing signed by the Party granting the waiver.  No failure by a Party to exercise any right under this Agreement shall operate as a waiver of such right, nor shall any single or partial exercise of any right preclude any other or further exercise of that right or the exercise of any other rights.  The waiver by any Party of any breach of this Agreement shall not be deemed a waiver of any prior or subsequent breach.  All remedies of either Party shall be cumulative and the pursuit of one remedy shall not be deemed a waiver of any other remedy.

 

9.7           Severability.  If any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions hereof shall not in any way be affected or impaired thereby.  In the event any provisions shall be held invalid, illegal or unenforceable, the parties shall use best efforts to substitute a valid, legal and enforceable provision, which, insofar as practical, implements the purposes hereof.

 

9.8           Entire Agreement.  This Agreement, as well as the Amended and Restated Agreement signed on the same date, constitute the entire understanding between the Parties relating to the subject matter hereof and thereof, and no amendment or modification to this Agreement shall be valid or binding upon the Parties unless designated as such, made in writing and signed by the representatives of such Parties.

 

  

15

  

 

9.9           No Third-Party Beneficiaries.  Nothing in this Agreement is intended or shall be construed to give any other person or entity any legal or equitable right, remedy or claim under or in respect of this Agreement or any provision contained herein, other than Indemnitee and any assignee permitted under Section 9.2 above.

 

9.10         Relationship of the Parties.  The relationship of the Parties under this Agreement shall be solely that of independent contractors and nothing herein shall be construed to create or imply any relationship of employment, agency, joint venture, partnership or any relationship other than that of independent contractors.  BIOFARMA and XOMA acknowledge and agree that each of them is engaged in a separate and independent business and neither shall state, represent or imply any interest in or control over the business of the other.

 

9.11         Further Assurances.  Each Party shall execute, acknowledge and deliver, without additional consideration, such further assurances, instruments and documents, and shall take such further actions, as the other Party shall reasonably request in order to fulfill the intent of this Agreement and the transactions contemplated hereby.

 

9.12         Force Majeure.  Neither Party hereto shall be liable for any failure to perform an obligation under this Agreement, other than a payment obligation, by reason of force majeure.  For the purposes of this Agreement, the term “force majeure” shall mean circumstances that are not within the reasonable control of such Party, such as requisition or interference by any government, state or local authorities, war, strikes, lockout or other labor disputes, civil disorders or commotions, act of aggression, acts of God, energy or other conservation shortages, disease, or occurrences of a similar nature.

 

9.13         Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, and all of which together, shall constitute one and the same instrument.

 

9.14         Privileges.  If a Party is entitled to attorney-client or attorney work product privileges from disclosure established under public policy provisions, such privileges shall apply and may be invoked by the other Party

 

  

16

  

 

IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly authorized representatives as of the Effective Date.

 

 

	BIOFARMA	 	
XOMA IRELAND LIMITED

	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	By:	 	 	
By: 

	 	 
	 	Name: Christian Bazantay	 	 	Name: Christopher J. Margolin	 
	 	Title: Proxy	 	 	Title: Director	 
	 	 	 	 	 	 
	By:	 	 	 	 	 
	 	Name: Yves Langourieux	 	 	 	 
	 	Title: Proxy	 	 	 	 
	 	 	 	 	 	 
	By: 	 	 	 	 	 
	Name: Jean-Philippe Seta	 	 	 	 
	Title: Proxy	 	 	 	 

 

  

17

  

SCHEDULE 1.24

Trademarks

[*]

 

 

 1ex10_45.htm

EXHIBIT 10.45

 

MEDPACE  

Master Services Agreement

 

[*] indicates that a confidential portion of the text of this agreement has been omitted.

MASTER SERVICES AGREEMENT

 

 

Between

 

 

Medpace Inc.

an Ohio Corporation

4620 Wesley Avenue

Cincinnati, Ohio 45212

 

 

(“MEDPACE”)

 

 

and

 

 

XOMA (US) LLC

a Delaware company with limited liability

2910 Seventh Street

Berkeley, California 94710

 

 

(“SPONSOR”)

 

  

Page 1

  

 

MEDPACE  

Master Services Agreement

 

This MASTER SERVICES AGREEMENT (the “Agreement”), dated as of November 9, 2009 (the “Effective Date”), is between MEDPACE and SPONSOR.  MEDPACE and SPONSOR are sometimes referred to herein individually as a “Party” and together as the “Parties”.

 

RECITALS:

 

WHEREAS, SPONSOR is in the business of developing and obtaining regulatory approval of the marketing and sale of pharmaceutical products and or biological products, and or medical devices; and

WHEREAS, MEDPACE is engaged in the business of providing services related to the design and execution of clinical development programs involving drugs, biologics, and medical devices through engagement by its clients, the sponsors of clinical development programs, to perform such services; and

 

WHEREAS, SPONSOR desires to engage MEDPACE to perform certain services (“Services”) as set forth hereinafter in connection with certain clinical trials, all in accordance with and subject to the terms of this Agreement;

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants and conditions hereinafter set forth, the Parties agree as follows:

 

1.            PROJECT SPECIFICATIONS

 

	
  

	
1.1.

	
MEDPACE hereby agrees to perform Services for SPONSOR from time to time.  The precise Services to be performed by MEDPACE shall be mutually agreed upon by the Parties and set forth in one or more task orders (each a “Task Order”), a form of which is attached hereto as Exhibit A.  Each Task Order shall be signed by an authorized representative of each Party and shall include detailed information concerning a given project, including a description of the specific services to be provided (“Scope of Work”), project milestones and target completion dates (“Project Schedule”), a detailed budget (“Project Budget’), and a schedule of payments related to the Project Schedule and the Project Budget (“Payment Schedule”).  Each Task Order shall contain a Transfer of Obligations list (“Transfer of Obligations”) in conjunction with the relevant Task Order and consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D (Responsibilities of Sponsors and Investigators).

 

	
  

	
1.2.

	
To the extent the Services include a clinical investigation (to be performed in accordance with the details provided in the applicable Task Order), MEDPACE shall require each Study Site to execute SPONSOR’s Clinical Site Agreement, attached hereto as Exhibit B.  Any changes to the Clinical Site Agreement requested by the Study Site shall be submitted to SPONSOR for review.  SPONSOR shall have sole and final approval of each Clinical Site Agreement.

 

  

Page 2

  

 

MEDPACE  

Master Services Agreement

 

2.            PROJECT SCHEDULE

 

	
  

	
2.1.

	
Each Task Order shall contain project timelines, milestones or target dates for completion of a project or a portion thereof, and all such schedules shall be reasonable for the Services to be provided.  In all events, the Parties shall use their reasonable best efforts to comply with each Task Order.

 

	
  

	
2.2.

	
If at any time either Party anticipates a delay in meeting the timelines for a given Task Order as set forth in its Project Schedule, either due to changes to the Services requested by SPONSOR, or other causes (including, but not limited to, FDA approval of a competitor’s NDA for the same drug, which may adversely affect patient enrollment), then the anticipating Party shall promptly notify the other Party in writing, specifying the reason for the delay and the anticipated effect upon the timelines, milestones or other deliverables.

 

3.           CHANGE ORDERS

 

	
  

	
3.1.

	
Any change in the details of a Task Order or the assumptions upon which the Task Order is based may require changes in the Project Budget, Payment Schedule or Project Schedule.  Every such change shall require a written amendment to the Task Order (a “Change Order”).  Each Change Order shall detail the requested changes to the applicable task, responsibility, duty, budget, timeline or other matter.  The Change Order will become effective upon the execution of the Change Order by both Parties, and the Change Order will specify the period of time within which MEDPACE must implement the changes.  Both Parties agree to act in good faith and promptly when considering a Change Order requested by the other party but neither party is obligated to execute a Change Order.  No Change Order shall become effective unless and until it is signed by both Parties.  Any such changes that result in additional charges shall be reflected in the Change Order to the affected Task Order, Project Budget or Payment Schedule.

 

4.            PROJECT BUDGET, PAYMENT SCHEDULE, AND TERMS

 

	
  

	
4.1.

	
The SPONSOR agrees to pay MEDPACE for Services rendered pursuant to the Project Budget and Payment Schedules included in each Task Order.

 

	
  

	
4.2.

	
The SPONSOR agrees to reimburse MEDPACE for reasonable pass-through expenses identified in the Task Order and incurred by MEDPACE in providing the Services in accordance with the relevant Task Order.  All expenses billed to SPONSOR by MEDPACE must be accompanied by appropriate documentary evidence, such as receipts or other documentation reasonably acceptable to SPONSOR.

 

  

Page 3

  

 

MEDPACE 

Master Services Agreement

 

	
  

	
The Parties hereby acknowledge and agree that escrow costs (“Escrow Costs”) may include but are not limited to third party advance payments for investigator meetings, vendors, Study Site payments (“Study Site” shall mean the physical location at which a particular investigator conducts a study), and any payments to investigators, institutions, and site maintenance organizations for services performed that relate to a Study.  If SPONSOR and MEDPACE agree that as part of the Services to be provided under this Agreement or any Task Order(s), that MEDPACE is to enter into agreements with third parties and obligate itself to making payments to such third parties for services rendered in conducting a Study, then SPONSOR shall escrow in advance all funds necessary for MEDPACE to meet its current payment obligations and those obligations for the upcoming fiscal quarter (including non-cancelable expenses).

 

	
  

	
The Parties acknowledge and agree that any third parties (including but not limited to investigators, institutions or site management organizations) paid with escrow funds in connection with the performance of Services under this Agreement or any Task Order shall not be considered the agent, employee or subcontractor of MEDPACE.

 

	
  

	
4.3.

	
SPONSOR shall mail payments to MEDPACE within [*] days after receipt of a written invoice and required supporting documentation as applicable.  An annual interest rate of [*]% will be applied to outstanding invoices greater than [*] days.

 

5.            WARRANTIES AND REPRESENTATIONS:

 

	
  

	
5.1.

	
Acknowledgements:

 

	
  

	
MEDPACE acknowledges that the Services to be provided hereunder are for the benefit of, and are subject to the direction of SPONSOR.  MEDPACE acknowledges that SPONSOR is the beneficiary under the terms of this Agreement and each Task Order, and that SPONSOR is entitled to enforce the provisions thereof.

 

	
  

	
5.2.

	
Representations and Warranties of MEDPACE

 

	
  

	
5.2.1.

	
MEDPACE represents and warrants that it is a corporation with its principal office and place of business at 4620 Wesley Avenue, Cincinnati, Ohio 45212, duly organized, validly existing and in good standing in its place of organization, and is in good standing in and duly qualified to do business.

 

	
  

	
5.2.2.

	
MEDPACE warrants that the execution, delivery and performance of this Agreement and each task order has been validly authorized by all corporate action and this Agreement and each Task Order represents the valid binding agreement of MEDPACE enforceable in accordance with its terms.  The execution, delivery and performance of this Agreement and each Task Order will not violate any organizational document governing MEDPACE, any agreement to which MEDPACE is a party, or any law or court or governmental order, holding or writ by which MEDPACE is bound.  MEDPACE further warrants that it shall render the Services requested by SPONSOR in accordance with high professional standards, consistent with Good Clinical Practices and with the standard of care customary in the contract research organization industry.

 

  

Page 4

  

 

MEDPACE  

Master Services Agreement

 

	
  

	
5.2.3.

	
MEDPACE warrants that the personnel assigned to perform services rendered under this Agreement shall be qualified and professionally capable of performing the Services, shall be adequate to effectively perform the Services on the agreed upon schedule and shall devote such time as is necessary to perform the Services on such agreed upon schedule.

 

	
  

	
5.2.4.

	
MEDPACE further warrants that it shall perform the Services in compliance with all applicable laws and regulations including, without limitation, the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and all future amendments during the term.  MEDPACE further warrants that it shall make available to SPONSOR, or to the responsible regulatory authority, relevant records, programs and data as may reasonably be requested by SPONSOR or which is the subject of a Task Order.  SPONSOR shall have the right to monitor the operations of MEDPACE hereunder, and SPONSOR representatives shall have the right to visit any of the facilities where MEDPACE is performing any of the Services and during such visits to inspect the work being done and materials used, to observe the procedures being followed, to examine the books, records and other data relevant to the Services.  If any regulatory agency requests to inspect any books, records, data of MEDPACE relating to the Services, MEDPACE shall immediately notify SPONSOR.

 

	
  

	
5.2.5.

	
MEDPACE represents and warrants that there is no litigation, regulatory investigation or proceeding, administrative hearing or any other similar proceeding pending or to the best of its knowledge threatened against MEDPACE which could adversely affect MEDPACE’s ability to perform the Services.

 

	
  

	
5.2.6.

	
Upon request, MEDPACE shall provide a copy of a certificate evidencing its insurance coverage to SPONSOR.

 

	
  

	
5.3.

	
Representations and Warranties of SPONSOR

 

	 	
5.3.1.

	
SPONSOR represents and warrants that it is a Delaware company with limited liability with its principal office and place of business at 2910 Seventh Street, Berkeley, California 94710, duly organized, validly existing and in good standing in its place of organization, and is in good standing in and duly qualified to do business.

 

	 	
5.3.2.

	
SPONSOR warrants that the execution, delivery and performance of this Agreement and each task order has been validly authorized by all corporate action and this Agreement and each Task Order represents the valid binding agreement of SPONSOR enforceable in accordance with its terms.  The execution, delivery and performance of this Agreement and each Task Order will not violate any organizational document governing SPONSOR, any agreement to which SPONSOR is a party, or any law or court or governmental order, holding or writ by which SPONSOR is bound.

     

  

Page 5

  

 

MEDPACE  

Master Services Agreement

 

	 	
5.3.3.

	
SPONSOR represents and warrants that there is no litigation, regulatory investigation or proceeding, administrative hearing or any other similar proceeding pending or to the best of its knowledge threatened against SPONSOR which could adversely affect SPONSOR’s ability to perform under this Agreement or any Task Order.

           

	 	
5.3.4.

	
Upon request, SPONSOR shall provide a copy of a certificate evidencing its insurance coverage to MEDPACE.

 

6.            TERMINATION

 

6.1           Either Party may terminate this Agreement without cause immediately upon giving the other Party notice of such termination, provided such termination shall not in and of itself affect any then uncompleted Task Order.

 

6.2           SPONSOR may terminate any Task Order without cause immediately upon giving MEDPACE notice of such termination.  As soon as practicable, after receipt of such notice, the Parties shall cooperate in good faith to agree on a plan to expeditiously conclude activities with respect to such matter.  MEDPACE shall transfer to SPONSOR all case report forms, study files, and other data and information in any and all formats available, including electronic format and computer files and programs, in MEDPACE’s possession.

 

6.3           MEDPACE may terminate a Task Order only if SPONSOR has defaulted on its obligations thereunder and has not cured such default (a) within [*] days after receipt of written notice if the default is the failure to pay MEDPACE any amount due thereunder or (b) within [*] days after receipt of written notice in the event of any other default.  As soon as practicable, after receipt of such notice, the Parties shall cooperate in good faith to agree on a plan to expeditiously conclude activities with respect to such matter.  MEDPACE shall transfer to SPONSOR all case report forms, study files, and other data and information in any and all formats available, including electronic format and computer files and programs, in MEDPACE’s possession.

 

6.4           In the event of any-termination of a Task Order before completion, SPONSOR agrees to pay MEDPACE for all Services rendered pursuant to the unfinished Task Order prior to such termination and any non-cancelable expenses incurred in connection with MEDPACE’s performance of Services thereunder.  As soon as reasonably practicable following receipt of a termination notice, MEDPACE shall submit an itemized accounting of Services performed, expenses incurred pursuant to performance of the Services, non-cancelable expenses incurred by MEDPACE relating to any unfinished Task Order, and payments received in order to determine a balance to be paid by either Party to the other.  Such balance shall be paid within [*] days of receipt of such an itemized accounting by SPONSOR.

 

  

Page 6

  

 

MEDPACE  

Master Services Agreement

 

7.            COMMUNICATIONS

 

	
  

	
7.1.

	
Any notice required or permitted under this Agreement shall be in writing and shall be deemed given if delivered personally, mailed by prepaid, first class, certified mail, return receipt requested, or sent by express courier service, to the Party to be notified at the addresses set forth below (or such other address as shall be designated by written notice); provided that all notices shall be effective upon receipt thereof:

 

If to MEDPACE:

 

Medpace, Inc.

4620 Wesley Avenue

Cincinnati, Ohio 45212

Attn:  August J. Troendle

Telephone:  (513) 579-9911 x2278

 

If to SPONSOR:

XOMA (US) LLC

2910 Seventh Street

Berkeley, California 94710

Attn:  Legal Department

Telephone:  (510) 204-7200

 

8.            CONFIDENTIALITY

 

	
  

	
8.1.

	
SPONSOR, may provide confidential information to MEDPACE during the course of this Agreement.  All information disclosed by SPONSOR to, or otherwise acquired or received by, MEDPACE or any of its employees, including, but not limited to, all information developed during the Services, including, but not limited to, the case reports and safety information, and all of SPONSOR’s business information, all sales and operating information, statistical plans, existing and potential business and marketing plans and strategies, financial information, cost and pricing information, media, know-how, designs, source codes, technical information, data, concepts, reports, methods, processes, techniques, operations, devices, and the like, whether or not the foregoing information is patented, tested, reduced to practice, or subject to copyright and whether prepared by SPONSOR, its representatives or others, that contain or otherwise reflect or are based upon, in whole or in part, any of the foregoing information or that reflect MEDPACE’s review of, interest in, or evaluation of all or any portion of the foregoing information and including any information concerning or constituting application, reverse engineering, copying, reverse compiling, duplication, installation, processes, procedures, formulae, trade secret, know-how, technology, and other intellectual property, whether communicated in writing, orally, electronically, photographically, visually or in recorded or any other form, is deemed to be the confidential information of SPONSOR (“SPONSOR Confidential Information”).  MEDPACE shall not disclose SPONSOR Confidential Information to any third party, or use SPONSOR Confidential Information for any purpose other than for the benefit of SPONSOR, without the prior written consent of SPONSOR.

 

  

Page 7

  

 

MEDPACE  

Master Services Agreement

 

	
  

	
8.1.1.

	
MEDPACE shall ensure by binding written agreement that its employees, agents, and approved independent contractors involved in the Services shall comply with the provisions of Article 8 of this Agreement.  MEDPACE shall disclose SPONSOR Confidential Information only to those of its employees, agents, and independent contractors who reasonably need to know SPONSOR Confidential Information.

 

	
  

	
8.1.2.

	
MEDPACE shall exercise due care, but no less than a reasonable degree of care, to prevent the unauthorized disclosure and use of SPONSOR Confidential Information associated with the Services.

 

	
  

	
8.2.

	
MEDPACE Confidential Information.

 

	
  

	
MEDPACE may provide confidential information to SPONSOR during the course of this Agreement (“MEDPACE Confidential Information”).  MEDPACE Confidential Information shall include but is not limited to standard operating procedures, pricing, and financial information provided by MEDPACE or its Affiliates to SPONSOR during the course of performance of the Services, and any non public information pertaining to MEDPACE’s business practices or other proprietary information.  SPONSOR shall not disclose MEDPACE Confidential Information to any third party, or use MEDPACE Confidential Information for any purpose other than for those set forth under this Agreement or a Task Order, without the prior written consent of MEDPACE.

 

	
  

	
8.2.1.

	
SPONSOR shall ensure by binding written agreement that its employees, agents, and approved independent contractors involved in the Services shall comply with the provisions of Article 8 of this Agreement.  SPONSOR shall disclose MEDPACE Confidential Information only to those of its employees, agents, and independent contractors who reasonably need to know MEDPACE Confidential Information.

 

	
  

	
8.2.2.

	
SPONSOR shall exercise due care, but no less than a reasonable degree of care, to prevent the unauthorized disclosure and use of Confidential Information associated with the Services.

 

	
  

	
8.2.3.

	
MEDPACE Confidential Information and SPONSOR Confidential Information are referred to herein collectively or individually, with respect to either party, as “Confidential Information.”

 

  

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MEDPACE  

Master Services Agreement

 

	
  

	
8.3.

	
This confidentiality and nondisclosure provision shall not apply to:

 

	
  

	
Information which was known by the Party before the date hereof or which is independently discovered, after the date hereof, without the aid, application or use of the Confidential Information, as evidenced by written records;

 

	
  

	
Information which is in the public domain on the date hereof or subsequently becomes publicly available through no fault or action of the other Party; or

 

	
  

	
Information, which is lawfully obtained by the receiving Party from sources independent of the disclosing Party who, to the receiving Party’s knowledge, have a lawful right to disclose such Confidential Information.

 

	
  

	
8.3.1.

	
If the receiving Party is requested to disclose the Confidential Information of the other Party or the substance of this Agreement in connection with a legal or administrative proceeding or otherwise to comply with a requirement under the law, the receiving Party will give the disclosing Party prompt notice of such request so that the disclosing Party may seek an appropriate protective order or other remedy, or waive compliance with the relevant provisions of this Agreement.  The disclosing Party must notify the receiving Party within [*] days that it intends to take action in response to the request for disclosure.  If the disclosing Party seeks a protective order or other remedy, the receiving Party, at the disclosing Party’s expense, will cooperate with and assist the disclosing Party in such efforts.  Failure of the disclosing Party to intervene shall not relieve the obligations to maintain confidentiality except in so far as the receiving Party must comply with the terms of such process compelling disclosure.

 

	
  

	
8.4

	
The receiving Party will use any Confidential Information received in connection with this Agreement only in the conduct of the Services and will return to the disclosing Party, at the disclosing Party’s expense, all Confidential Information at the request of the disclosing Party.

 

	
  

	
8.5

	
The Parties agree that any breach of this Section would cause irreparable harm - and that in addition to any and all other available remedies, injunctive relief, without the necessity of a bond or other security, shall be appropriate and available.

 

9. RIGHTS IN PROPERTY

 

	
  

	
9.1.

	
All materials, documents, data, software and information of every kind and description supplied to MEDPACE by SPONSOR or any of SPONSOR’s clients, or prepared, developed, or generated by MEDPACE pursuant to this Agreement, (except for the pre-existing MEDPACE procedural manuals, personal data, methods, procedures, and policies) are and shall be the sole and exclusive property of SPONSOR. Further, all data and information generated or derived by MEDPACE as the result of services performed by it under this Agreement shall be and remain the exclusive property of SPONSOR. SPONSOR shall have the right to make whatever use they deem desirable of any such materials, documents, data or software. MEDPACE shall not, without the prior written consent of SPONSOR, publish, disseminate, or otherwise disclose to any third party any such property (except such disclosure as may be required by law), or use any such property for any purpose other than the performance of this Agreement. Any inventions or other intellectual property, including without limitation protectable copyrights and trademarks, that may evolve from the data and information described above or as the result of Services performed by MEDPACE under this Agreement shall belong to SPONSOR and MEDPACE agrees to assign its rights in all such inventions and/or other intellectual property to SPONSOR consistent with the obligations set forth in Article 10 below.

  

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MEDPACE  

Master Services Agreement

 

	
  

	
9.2.

	
SPONSOR acknowledges that all computer programs, software, applications, databases, proposals and other documentation generally used by MEDPACE and not directly related to, derived from or developed solely for SPONSOR are the exclusive and confidential property of MEDPACE or the third parties from whom MEDPACE has secured the right of use.  SPONSOR agrees that any improvement, alteration or enhancement to MEDPACE systems, software, applications or processes which are developed or implemented during the course of any Services performed hereunder, without the use of any SPONSOR data, information, materials or Confidential Information (or derivatives thereof), shall be the property of MEDPACE.

 

10.           PATENT RIGHTS

 

	
  

	
10.1.

	
MEDPACE shall disclose promptly to SPONSOR any and all inventions, discoveries and improvements conceived or made by MEDPACE while providing such services to SPONSOR pursuant to the Agreement and constituting a modification or extension of use relating to SPONSOR’s proprietary rights, and agrees to assign all its interest therein to SPONSOR or its nominee; whenever requested to do so by SPONSOR, MEDPACE shall execute any and all applications, assignments, or other instruments and give testimony which SPONSOR shall deem necessary to apply for and obtain a patent in the United States of America and/or other applicable jurisdiction or of any foreign country or to protect otherwise SPONSOR’s interests and shall compensate MEDPACE for the time devoted to said activities and reimburse it for expenses incurred.

 

11.           PUBLICITY

 

	
  

	
11.1.

	
MEDPACE shall not make any public announcements, publications papers, abstracts or oral presentations concerning this Agreement, the subject matter hereof or any Task Order or the subject matter thereof, without the prior written consent of SPONSOR.

 

  

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MEDPACE  

Master Services Agreement

 

	
  

	
11.2.

	
Neither Party may use the other Party’s name, logo or trademark in any communication, release, notice or other publication without the express prior written consent of the other Party.

 

	
  

	
11.3.

	
The Parties agree that any breach of this Section would cause irreparable harm and that in addition to any and all other available remedies, injunctive relief, without the necessity of a bond or other security, shall be appropriate and available.

 

12.           SECURITY AND DISPOSITION OF STUDY FILES

 

	
  

	
12.1.

	
Except as otherwise provided for in this Agreement, MEDPACE shall use commercially reasonable efforts, including, but not limited to, periodic backup of computer files, to prevent the loss or alteration of SPONSOR’s study data, Confidential Information, documentation, and correspondence.  MEDPACE shall in all respects comply with any Food and Drug Administration regulations concerning the maintenance, creation and storage of records, including electronic records.

 

	
  

	
12.2.

	
At appropriate time points or at completion of Services under a Task Order, MEDPACE shall transfer study materials, documents and correspondence to SPONSOR.  MEDPACE shall have the right to retain one copy of any study materials, documentation, and correspondence necessary solely to meet regulatory or MEDPACE’s own internal audit requirements, so long as it continues to maintain the confidentiality requirements of Article 8.

 

13.           SPONSOR OBLIGATIONS

 

	
  

	
13.1.

	
SPONSOR acknowledges that performance of the Services by MEDPACE will require the co-operative involvement of both Parties, and SPONSOR hereby agrees to provide such assistance as may be reasonably necessary to enable MEDPACE to perform the Services.

 

14.           INDEMNIFICATION

 

	
  

	
14.1.

	
Indemnification by SPONSOR

 

	
  

	
SPONSOR shall indemnify, defend and hold harmless MEDPACE from and against any and all damages, losses, liabilities, costs or expenses (collectively “Damages”), resulting or arising from any third-party claims, demands, assessments, actions, suits, investigations or proceedings (collectively “Claims”), relating to or arising from or in connection with this Agreement or the Services under any Task Order (including but not limited to any Damages arising from or in connection with any study, test, device, product or potential product to which this Agreement relates), to the extent such Claims or Damages have not resulted from (a) the negligence or willful misconduct of MEDPACE, (b) a breach of any applicable FDA, federal, state or local law by MEDPACE, or (c) a material breach of this Agreement or any Task Order by MEDPACE.

  

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MEDPACE  

Master Services Agreement

 

	
  

	
14.2.

	
Indemnification by MEDPACE

 

	
  

	
MEDPACE agrees to indemnify, defend and hold harmless SPONSOR from and against any and all Damages resulting or arising from third-party Claims relating to or arising from or in connection with the Services under any Task Order to the extent that such Claims or Damages are determined to have resulted from (a) the negligence or willful misconduct of MEDPACE, (b) a breach of any applicable FDA, federal, state or local law, or (c) a material breach of this Agreement or any Task Order by MEDPACE.

 

	
  

	
14.3.

	
Any party providing indemnification under this Agreement shall have the right to control the defense and settlement of any Claims or Damages.  The indemnified party shall have the right to obtain separate legal counsel at its own expense if it so chooses.  The indemnifying party shall not unreasonably withhold consent for settlement and the indemnified party shall reasonably cooperate in the defense of any Claims or Damages, at the indemnifying party’s reasonable expense, and provide prompt notice to the indemnifying party of any Claims or Damages for which indemnification is sought.

 

15.           LIMITATION OF LIABILITY

 

	
  

	
15.1.

	
Notwithstanding the terms of Article 14 above, in no event shall SPONSOR or MEDPACE be liable for any indirect, incidental, special, or consequential damages or lost profits arising out of the provision of services hereunder, even if the breaching party has been advised of the possibility of such damages.

 

16.           INSPECTIONS AND AUDITS

 

	
  

	
16.1.

	
Except as otherwise provided for in this Agreement, SPONSOR shall have the right, upon at least [*] business days’ prior written notice to MEDPACE, to examine the standard operating procedures, facilities, books, records, papers, files and documentation, including computer files, data bases and records, at MEDPACE’s facilities and the facilities of clinical investigators contracted by MEDPACE to determine the adequacy of such records, to ensure the Services are being performed in accordance with the approved Task Orders and applicable regulations and/or to examine the financial records of MEDPACE as may be reasonably necessary to verify out-of-pocket expenses incurred during the performance of the Services.  Such inspections and audits shall be conducted during normal business hours.

 

	
  

	
16.2.

	
MEDPACE shall provide reasonable assistance, including making available members of its staff and providing access to all requested records, to facilitate such inspections and audits.

 

  

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MEDPACE  

Master Services Agreement

 

	
  

	
16.3.

	
MEDPACE shall take all reasonable steps required by SPONSOR to cure any deficiencies found in any audit, inspection or investigation.

 

17.           DEBARMENT

 

	
  

	
17.1.

	
MEDPACE hereby represents, warrants, and certifies that neither it nor any of its officers, directors, owners, principals or employees has been or will be at any relevant time hereunder debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or similar local law.  In the event that any such party becomes debarred, MEDPACE shall notify SPONSOR in writing immediately.

 

	
  

	
17.2.

	
MEDPACE hereby represents, warrants, and certifies that it has not and shall not use in any capacity the services of any individual, corporation, partnership, or association which has been debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or similar local law.  In the event MEDPACE becomes aware of or receives notice of the debarment of any individual, corporation, partnership, or association providing services to MEDPACE, which relate to the Services being provided under this Agreement, MEDPACE shall notify SPONSOR in writing immediately.

 

18.           NON SOLICITATION

 

Neither Party and its affiliates shall during the term of this Agreement and for a period of [*] months following its termination, either directly or indirectly, hire any employee of the other Party with whom its comes into contact as a result of providing the Services, or recruit, solicit, or entice any such person to become employed by it or any affiliate and shall not approach any such employee for such purpose or encourage, authorize or approve the taking of such action by any other person; provided, however, that the foregoing shall not prevent either Party from hiring any employee of the other Party who:

(a) responds to a general advertisement or bona fide recruitment campaign or (b) has ceased to be employed by such Party otherwise than pursuant to a solicitation by the other Party.  The Parties agree that any breach of this provision would cause irreparable harm and that in addition to any and all other available remedies injunctive relief, without the necessity of a bond or other security, shall be appropriate and available.

 

19.           ENTIRE AGREEMENT

 

This Agreement contains the full understanding of the Parties with respect to the subject matter hereof and supersedes all existing agreements and all other oral, written or other communications between the Parties concerning the subject matter hereof.  This Agreement shall not be amended, modified or supplemented in any way except in writing and signed by a duly authorized representative of SPONSOR and MEDPACE.

 

  

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MEDPACE  

Master Services Agreement

 

20.           GOVERNING LAW

 

This Agreement and the performance hereof shall be governed, interpreted and construed in all respects by the internal laws of the State of New York.

 

21.           NO WAIVER

 

No waiver of any term, provision, or condition of this Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further or continuing waiver of any such term, provisions, or conditions, or of any other term, provision, or condition of this Agreement.

 

22.           INDEPENDENT CONTRACTOR

 

In fulfilling its obligations pursuant to this Agreement, each Party shall be acting as an independent contractor.  Neither Party is granted any right or authority to assume or to create any obligation or responsibility, expressed or implied, on behalf of or in the name of the other Party.

 

23.           FORCE MAJEURE

 

Neither Party shall be liable or deemed to be in default for any delay due to causes beyond the reasonable control of the Party, such as:  war, acts or threats of terrorism, civil disorders, acts of God, or government action; provided, that the affected Party (a) promptly notifies the other of the cause and its effects on the Services to be performed hereunder, (b) immediately resume performance after the cause of delay is removed, and (c) use all commercially reasonable efforts to minimize the duration of such delay.  Financial difficulty shall never be deemed a force majeure event.

 

24.           SEVERABILITY

 

In the event any provision of this Agreement shall be determined to be void or unenforceable, the remaining provisions shall remain in full force and effect.

 

25.           ASSIGNMENT

 

	
  

	
25.1.

	
Except as set forth herein, neither Party shall assign this Agreement or any Task Order except with the express prior written consent of the other Party.

 

	
  

	
25.2.

	
Notwithstanding anything contained herein:  (i) a Party may assign this Agreement and/or any Task Order to any Affiliate, provided that the assigning Party remains fully liable for all liabilities and obligations under this Agreement and any such Task Order; and, (ii) a Party may assign this Agreement and/or any Task Order to a Successor.

 

  

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MEDPACE 

Master Services Agreement

 

	
  

	
25.3.

	
As used herein, “Affiliate” means in relation to a Party, any entity controlling such Party, controlled by such Party, or under common control with such Party; and “Successor” means any entity which acquires all or substantially all assets of a Party or any entity into which a Party is merged.

 

26.           SUBCONTRACTING

 

MEDPACE may subcontract any portion of the Services hereunder with the prior written consent of SPONSOR, and such consent will not be unreasonable withheld.  MEDPACE shall remain liable for the performance of any such Subcontractor.

 

27.           NO OWNERSHIP OF SPONSOR SHARES

 

In order to avoid potential for conflicts of interest, MEDPACE hereby agrees that during the term of this Agreement it will not hold any shares of SPONSOR or SPONSOR’s parent company or options to purchase shares of SPONSOR or SPONSOR’s parent company without the written consent of I SPONSOR and that it will not purchase or sell, whether for its own account or the account of any other person or entity, shares of SPONSOR or SPONSOR’s parent company.

 

28.           CONFLICTS BETWEEN AGREEMENTS

 

In the event that there is any conflict between the provisions of this Agreement and any duly executed Task Order, this Agreement shall control, unless the Task Order clearly states that in the event of such conflict, it shall control.

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.

 

	
MEDPACE, INC.

	 
	 	 	 
	
Signature:        

	 	 
	 	 	 
	Title: 	 	 
	 	 	 
	Date: 	 	 
	 	 	 
	XOMA (US) LLC	 
	 	 	 
	Signature:     	 	 
	 	 	 
	By:  Daniel P. Cafaro	 
	Title:  Vice President of Regulatory Affairs and Compliance
	 	 	 
	Date:   	 	 

 

  

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MEDPACE 

Master Services Agreement

 

EXHIBIT A

FORM OF TASK ORDER

MEDPACE Task Order Number:  __________

MEDPACE Project Number:  ____________

This Task Order, dated ____________, is between Medpace Inc. (“MEDPACE”), and (“SPONSOR”).

 

RECITAL:

WHEREAS, MEDPACE and SPONSOR have entered into that certain Master Services Agreement dated _____________________“Master Services Agreement”); and

 

WHEREAS, pursuant to the Master Service Agreement, MEDPACE has agreed to perform certain Services in accordance with Task Orders from time to time entered into by the Parties and SPONSOR and MEDPACE now desire to enter into such a Task Order; and

 

WHEREAS, MEDPACE and SPONSOR desire that MEDPACE provide certain services with respect to _________ (the “Study”) for the study of the product _______(“Study Product”) as set out in the Protoco Number _________, which is attached hereto as Appendix 1;

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the Parties hereby agree as follows:

 

	
  

	
1.

	
Scope of Work:  MEDPACE shall perform the services described in the Scope of Work, attached hereto as Appendix 2, in accordance with the Project Schedule, attached hereto as Appendix 3 and any other documents attached to and specifically referenced in this Task Order (“Services”).

 

	
  

	
2.

	
Compensation:  For performance of these Services, SPONSOR shall pay to MEDPACE amount equal to the Project Budget set forth in Appendix 4, which amount shall be payable pursuant to the Payment Schedule set forth in Appendix 5.  The Project Budget is provided for cost analysis purposes.  It is agreed that all fees are fixed prices unless the underlying assumptions (including trial duration, number of sites/patients, services provided) change and all such changes shall be documented in a Change Order.  After staff are assigned, costs are incurred based upon allocation of staff capacity.

 

	
  

	
3.

	
Transfer of Obligations:  Sponsor Obligations transferred to MEDPACE by SPONSOR (consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D) are identified in Appendix 6.

 

	
  

	
4.

	
MSA.  The provisions of the Master Services Agreement are hereby expressly incorporated by reference into and made a part of this Task Order.

 

  

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MEDPACE  

Master Services Agreement

 

IN WITNESS WHEREOF, the Parties have hereunto signed this Task Order effective as of the day and year first written above.

 

	
MEDPACE, INC.

	 
	 	 	 
	
Signature:        

	 	 
	 	 	 
	By: 	 	 
	 	 	 
	Title: 	 	 
	 	(Print Name)	 
	 	 	 
	Date: 	 	 
	 	 	 
	 	 	 
	XOMA (US) LLC	 
	 	 	 
	Signature:     	 	 
	 	 	 
	By:    	 	 
	 	(Print Name)	 
	 	 	 
	Title:	 	 
	 	 	 
	Date:   	 	 

 

List of Appendices:

Appendix 1:  Protocol

Appendix 2:  Scope of Work

Appendix 3:  Project Schedule

Appendix 4:  Project Budget

Appendix 5:  Payment Schedule

Appendix 6:  Transfer of Obligations

 

 

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