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MANUFACTURING SERVICES AGREEMENT Among

Manufacturing Agreement

MANUFACTURING SERVICES AGREEMENT Among | Document Parties: NABI BIOPHARMACEUTICALS | 12276 Wilkins Avenue, Rockville, MD 20852, BIOTEST PHARMACEUTICALS CORPORATION | Nabi, Biotest and Biotest AG You are currently viewing:
This Manufacturing Agreement involves

NABI BIOPHARMACEUTICALS | 12276 Wilkins Avenue, Rockville, MD 20852, BIOTEST PHARMACEUTICALS CORPORATION | Nabi, Biotest and Biotest AG

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Title: MANUFACTURING SERVICES AGREEMENT Among
Governing Law: New York     Date: 2/28/2008
Industry: Biotechnology and Drugs     Law Firm: Hogan Hartson     Sector: Healthcare

MANUFACTURING SERVICES AGREEMENT Among, Parties: nabi biopharmaceuticals , 12276 wilkins avenue  rockville  md 20852  biotest pharmaceuticals corporation , nabi  biotest and biotest ag
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Exhibit 10.33

MANUFACTURING SERVICES AGREEMENT

Among

NABI BIOPHARMACEUTICALS,

BIOTEST PHARMACEUTICALS CORPORATION

And

BIOTEST AG

 


TABLE OF CONTENTS

 

     Page
1. DEFINITIONS    1
2. SCOPE OF WORK; ORDERS FOR PRODUCTS    5
3. PROGRAM PERFORMANCE    8
4. PROGRAM MATERIALS    9
5. USE OF SUBCONTRACTORS    9
6. COMPLIANCE WITH GOVERNMENT REGULATIONS    10
7. RESIDUAL ACTIVITIES    11
8. COMPENSATION    11
9. CHANGE ORDERS    12
10. CONFIDENTIAL INFORMATION/LEGAL PROCEEDINGS    12
11. TRANSFER TO SUCCESSOR MANUFACTURER    14
12. INVENTIONS AND PATENTS; TECHNOLOGY TRANSFER    14
13. INDEPENDENT CONTRACTOR    15
14. INSURANCE    15
15. SHIPPING; RISK OF LOSS; INSPECTION    16
16. DEFAULT    17
17. DISPUTE RESOLUTION    17
18. INDEMNIFICATION; LIMITATION OF LIABILITY    18
19. REPRESENTATIONS, WARRANTIES AND COVENANTS    22
20. FORCE MAJEURE    23
21. USE OF NAMES    24
22. TERM; TERMINATION    24
23. MISCELLANEOUS    25

 

Exhibit A    Products
Exhibit B    Manufacturing Cost Classification
Appendix 1-1    Initial Scope
Appendix 2    Pre-Approved Subcontractors

 

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MANUFACTURING SERVICES AGREEMENT

This MANUFACTURING SERVICES AGREEMENT, effective as of December 4, 2007 (the “ Effective Date ”), is entered into by and among NABI BIOPHARMACEUTICALS, a Delaware corporation (“ Nabi ”), having its principal place of business at 12276 Wilkins Avenue, Rockville, MD 20852, BIOTEST PHARMACEUTICALS CORPORATION, a Delaware corporation (“ Biotest ”), having its principal place of business at 5800 Park of Commerce Boulevard, Boca Raton, Florida 33487, and solely for purposes of Section 23(k), BIOTEST AG, a company organized under the laws of Germany (“ Biotest AG ”, and with Nabi and Biotest, each a “ Party ”, and collectively the “ Parties ”).

WHEREAS, on September 11, 2007, Nabi, Biotest and Biotest AG, entered into that certain Asset Purchase Agreement (the “ Asset Purchase Agreement ”), pursuant to which, simultaneously herewith, Biotest is purchasing assets used in, necessary for or related to Nabi’s biologics strategic business unit, including Nabi’s vaccine manufacturing facility located in Boca Raton, Florida (the “ Facility ”), as and to the extent set forth in the Asset Purchase Agreement;

WHEREAS, Nabi now desires Biotest to perform certain manufacturing services previously performed by Nabi at the Facility and to perform additional manufacturing services at the Facility in accordance with the terms of this Agreement and any executed Scope (as hereinafter defined), and Biotest desires to perform such services on behalf of Nabi;

WHEREAS, Nabi also desires that, upon the request of Nabi, Biotest transfer to Nabi, a Nabi Affiliate or a to-be-identified Third Party manufacturer certain materials and information related to the Products, Program and Process to enable Nabi or such third-party manufacturer to perform the manufacturing services performed hereunder by Biotest;

NOW, THEREFORE, in consideration of the above statements and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties hereto agree as follows:

1. DEFINITIONS.

Terms defined elsewhere in this Agreement shall have the meanings set forth therein for all purposes of this Agreement unless otherwise specified to the contrary. The following terms shall have the meanings set forth below in this Section 1 :

Action ” means any claim, action, suit, arbitration, inquiry, audit, proceeding or investigation by or before any Governmental Authority, arbitrator or arbitral panel.

Affiliate(s) ” means, with respect to any Person, any other Person directly or indirectly controlling or controlled by, or under direct or indirect common control with, such Person. For purposes of this definition, a Person shall be deemed, in any event, to “control” another Person if it owns or controls, directly or indirectly, more than twenty-five percent (25%) of the voting equity securities of the other Person.

 

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Agreement ” means this document as signed by the Parties including the Scope and any referenced attachments and any amendments to this document.

Batch ” means a Lot of Drug Substance.

Batch Record ” means a complete manufacturing record for a Batch generated by Biotest in the same manner as generated by Nabi prior to the Effective Date or approved by Nabi and made concurrently with the performance of each step of the production process for the Drug Substance, Drug Substance testing, and Lot release data, such that successive steps in such processes may be traced.

“Binding Portion” has the meaning set forth in Sections 2(b)(i), 2(b)(ii) and 2(c)(i).

Biotest Confidential Information ” means any information, business, technical or financial data related to a Program that is provided by Biotest to Nabi.

Biotest Indemnitees ” has the meaning set forth in Section 18(b) .

Biotest IP ” has the meaning set forth in Section 12(a) .

Biotest Program Manufacturing Know-How ” has the meaning set forth in Section 12(a) .

Biotest SOP ” means the written standard operating procedures (SOPs) and methods of Biotest, as the same may be amended, in Biotest’s sole discretion, from time to time with reasonable prior notice to Nabi, but in any event, such SOPs will comply with all applicable laws in the United States.

Business Day ” means any day other than a Saturday, Sunday or a legal holiday under the laws of the State of New York.

Certificate of Analysis ” means a document signed by an authorized representative of Biotest, describing the Specifications for, and testing methods applied to, any Drug Substance, samples or other Materials, and the results thereof.

cGMP ” means current good manufacturing practices, as specified in regulations promulgated from time to time by the FDA for the manufacture and testing of pharmaceutical products.

Claim ” means any claim, complaint, charge, action, proceeding, dispute, investigation, lawsuit, demand or assessment.

Debarred Entity ” means an entity that has been debarred by the FDA pursuant to 21 U.S.C. § 335(a) or (b).

 

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Debarred Individual ” means an individual that has been debarred by the FDA pursuant to 21 U.S.C. § 335(a) or (b).

Drug Product ” means the final dosage form pharmaceutical product containing Drug Substance that Nabi or its Affiliates will use for clinical trials or for commercial supply, as applicable.

Drug Substance ” is any bulk purified Product produced using the Materials and the Process.

Facility ” has the meaning provided in the Recitals.

FDA ” means the United States Food and Drug Administration, or any successor agency thereto.

GAAP ” means United States generally accepted accounting principles as in effect as of the Effective Date.

Losses ” means, with respect to any Claim, all losses, expenses, obligations and other liabilities or other damages (whether absolute, accrued, contingent, fixed or otherwise, or whether known or unknown, or due or to become due or otherwise), diminution in value, monetary damages, fines, fees, penalties, interest obligations, deficiencies, losses and expenses (including amounts paid in settlement, interest, court costs, costs of investigators, fees and expenses of attorneys, accountants, financial advisors and other experts, and other expenses of litigation).

Lot ” means the Drug Substance produced in a single Production Run of the size specified in the applicable Scope with respect to the particular Drug Substance, which may be contained in one or more containers thereof.

Materials ” means any item necessary to produce Drug Substance using the Process other than the technical information and intellectual property provided by Nabi pursuant to Sections 4(a) and 4(b) .

Modification ” has the meaning set forth in Section 9 .

Nabi Confidential Information ” means any information, business, technical or financial data related to a Program that is provided by Nabi to Biotest.

Person ” means an individual, partnership, corporation, limited liability company, joint stock company, unincorporated organization or association, trust or joint venture, or a governmental agency or political subdivision thereof.

Process ” means (i) the production methods, purification processes and other know-how as provided by Nabi for use by Biotest in the manufacture of Drug Substance, and (ii) any modifications, enhancements or improvements to such methods or processes that may be made by Biotest, its employees, agents, consultants or contractors, solely or jointly with Nabi, from time-to-time that are

 

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generated by Biotest as a result of performing the activities described in this Agreement (though Biotest will promptly notify Nabi of, and obtain consent of Nabi for, any material modifications, enhancements or improvements).

Process Consumables ” means raw materials, filters, membranes, disposable analytical test kits, tubing, filling needles, disposable bags, disposable glass/plasticware, cleaning supplies and other changeover parts consumed during the manufacture of Drug Substance.

Product ” means any of the biopharmaceutical products described on Exhibit A .

Product-Dedicated Equipment ” means equipment, if any, that is acquired by Biotest after the Effective Date with Nabi’s approval and at Nabi’s sole expense, in accordance with this Agreement, to be used by Biotest solely for the manufacture of Drug Substance pursuant to a Scope under this Agreement.

Product Invention ” means any improvement or invention relating to a Product that is discovered by Biotest, its employees, agents, consultants or contractors, solely or jointly with Nabi, solely in connection with the activities described in this Agreement.

Production Run ” means a full production of a Product pursuant to a Program, from fermentation through Drug Substance.

Program ” means the services to be performed by Biotest for Nabi as described in a particular Scope.

Quality Agreement ” has the meaning set forth in Section 3(c) .

Representatives ” means, with respect to any Person, the directors, officers, managers, employees, independent contractors, agents or consultants of such Person.

Scope ” means a detailed scope-of-work document entered into by the Parties for the performance by Biotest of certain services on behalf of Nabi relating to Drug Substance, which shall be governed by, made part of, and be subject to this Agreement as an appendix hereof.

Specification ” means the requirements for tests, analysis, test procedures and acceptable test results to which Drug Substance, raw materials and excipients shall conform as set forth in a Scope, as amended from time-to-time by mutual consent of the Parties, which consent shall not be unreasonably withheld.

Third Party ” means any Person other than Nabi, Biotest and their respective Affiliates.

 

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2. SCOPE OF WORK; ORDERS FOR PRODUCTS.

(a) Scopes . From time to time, the Parties will prepare and enter into detailed Scopes for a Program. The Scopes shall be prepared by Nabi with Biotest’s cooperation and shall be subject to the final approval of Biotest, which shall not be unreasonably withheld, and shall be attached as an Appendix 1 to this Agreement. The first Scope document (“ Scope #1 ”) shall be delivered to Biotest within thirty (30) days following the Effective Date and shall be attached hereto as Appendix 1-1 . Each additional Scope, if any, shall be sequentially numbered (i.e., Scope #2, Scope #3, etc.) and shall be attached as an additional appendix and numbered as follows: Appendix 1-2 , Appendix 1-3 , etc.; provided , however , that no additional Scopes shall be executed within the first twelve (12) calendar months following the Effective Date. Biotest will perform the services for Nabi in accordance with each executed Scope. Each Scope will specify the relevant Products, Program design, estimated duration of a Program and Production Runs, and all other matters pertinent to completion of such Program, and will be deemed to be a part of this Agreement and incorporated herein by reference. Any Scope may be amended from time-to-time with the mutual agreement of the Parties as described in Section 9 . To the extent that any provision of this Agreement conflicts with a Scope, the terms and provisions of the applicable Scope will apply with respect to the subject matter contained within such Scope.

(b) Forecasts and Purchase Orders . During the Term the parties will undertake the following procedures with respect to submitting forecasts and purchase orders for Production Runs under a Scope:

(i) Scope #1 Forecast and Related Purchase Orders . Nabi will include as part of Scope #1 Nabi’s proposed forecast for the first twelve (12) calendar months of Drug Substance to be manufactured under Scope #1 (the “ Scope #1 Forecast ”), which Scope #1 Forecast shall include all Production Runs scheduled to take place in the first twelve (12) calendar months following the Effective Date. Within ten (10) calendar days after delivery of Scope #1, (A) Biotest shall provide to Nabi a written price quote for Scope #1 setting forth Service Fees calculated as provided in Section 8 (“ Fee Quote ”) and (B) Nabi and Biotest will work together to establish a mutually agreeable Scope #1 Forecast, based on the quoted Service Fees, for the first twelve (12) calendar months following delivery of Scope #1. Within ten (10) calendar days of issuance of the agreed upon Scope #1 Forecast, Nabi will submit to Biotest a binding purchase order for all Production Runs scheduled to take place during the first three (3) calendar months of the Scope #1 Forecast. Nabi and Biotest will meet once per month to discuss the schedule and agree upon any necessary changes. No later than the fifteenth (15 th ) day of each calendar month, an additional forecast month will be agreed upon and added in order to provide a rolling twelve (12) month forecast. Each Party agrees to use reasonable efforts to agree upon each additional forecast month and, upon a failure to agree, Nabi will determine such additional month’s forecast. In the event of a failure of the parties to meet and agree on an additional forecast month, the then fourth (4 th ) month of the current forecast will not become a Binding Portion (as defined below) until ten (10) calendar days after Nabi receives written notice from Biotest that such month’s forecast will become a Binding Portion at such time, in order to provide Nabi with an opportunity to alter such forecast month, subject to Section 2(c) below. Biotest shall

 

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notify Nabi in writing Nabi will submit to Biotest additional binding purchase orders, on a monthly basis no later than the fifteenth (15 th ) day of the calendar month, for Production Runs scheduled to occur on the current forecast within the next three (3) calendar months, provided the purchase orders covering such Production Runs have not been canceled as permitted by Section 22 of this Agreement. Each subsequently submitted purchase order shall include Production Runs scheduled to take place during the three (3) calendar months following the month in which it is submitted. Such three (3) calendar month period of any Forecast following the month in which a purchase order is submitted is referred to hereinafter as a “ Binding Portion ” of each Forecast.

(ii) Forecasts and Purchase Orders for Subsequent Scopes . Included in each subsequent Scope will be Nabi’s written forecast for the first twelve (12) calendar months of Drug Substance to be manufactured under such Scope (a “ Scope Forecast ”). No subsequent Scope will be executed within the first twelve (12) months following the Effective Date. Within ten (10) calendar days of the date of agreement by the Parties on such Scope, (A) Biotest shall provide to Nabi a Fee Quote for such Scope and (B) Nabi and Biotest will work together to establish a mutually agreeable Scope Forecast based on the quoted Service Fees for the first twelve (12) calendar months following delivery of such Scope. Within ten calendar (10) days of issuance of the agreed upon Scope Forecast, Nabi will submit to Biotest a binding purchase order for all Production Runs scheduled to take place during the first three (3) calendar months of such Scope Forecast. Nabi and Biotest will meet once per month to discuss the schedule and agree upon any necessary changes. No later than the fifteenth (15 th ) day of each calendar month, an additional forecast month will be added in order to provide a rolling twelve (12) month forecast. Each Party agrees to use reasonable efforts to agree upon each additional forecast month and, upon a failure to agree, Nabi will determine such additional month’s forecast. In the event of a failure of the parties to meet and agree on an additional forecast month, the then fourth (4 th ) month of the current forecast will not become a Binding Portion (as defined below) until ten (10) calendar days after Nabi receives written notice from Biotest that such month’s forecast will become a Binding Portion at such time, in order to provide Nabi with an opportunity to alter such forecast month, subject to Section 2(c) below. Nabi will submit to Biotest additional binding purchase orders, on a monthly basis, no later than the fifteenth (15 th ) day of the calendar month, for additional Production Runs scheduled to occur on the current forecast within the next three (3) calendar months, provided the purchase orders covering such Production Runs have not been canceled as permitted by Section 22 of this Agreement. Each subsequently submitted purchase order shall include Production Runs scheduled to take place during the three (3) calendar months following the month in which it is submitted. Such three (3) calendar month period of any Forecast following the month in which a purchase order is submitted is referred to hereinafter as a “ Binding Portion ” of each Forecast.

(c) Binding Purchase Orders .

(i) If, in any rolling twelve (12) month forecast provided under Scope #1 or any subsequent Scope, no Drug Substance is forecast to be manufactured in any of the fourth (4 th ), fifth (5 th ) and sixth (6 th ) months of such rolling twelve (12) month forecast, then such forecast of Drug Substance for such fourth (4 th ), fifth (5 th ) and sixth (6 th ) months shall be firm and binding on Biotest and Nabi,

 

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and constitute a Binding Portion of such Forecast. Each rolling twelve (12) month forecast. Each subsequent rolling twelve (12) month forecast delivered under Scope #1 and any subsequent Scope shall continue to reflect, without alteration, any Binding Portions of any forecast amounts of Drug Substance.

(ii) During the term of this Agreement, if the aggregate number of Production Runs for any three (3) calendar month period in any rolling twelve (12) month forecast increases the forecast number of Production Runs for such three (3) calendar month period from any prior rolling twelve (12) month forecast by more than two (2) Production Runs over such three (3) calendar month period; Biotest shall not be obligated to complete such excess Production Runs beyond such two (2) additional Production Runs, but may complete such excess Production Runs beyond such two (2) additional Production Runs in Biotest’s sole discretion.

(iii) Nabi may notify Biotest at any time in writing of an increase or decrease in any forecast other than any Binding Portion of any forecast and such increase or decrease shall be binding on the parties subject to, in the case of an increase, the limitation in Section 2(c)(ii) above, and in the case of a decrease, that for any three (3) calendar month period in any rolling twelve (12) month forecast, other than a termination pursuant to Section 22 , Nabi may only decrease the forecast number of Production Runs for any three (3) calendar month period from any prior rolling twelve (12) month forecast by no more than two (2) Production Runs over such three (3) calendar month period.

(iv) The forecast number of Production Runs for any Binding Portion in any rolling twelve (12) month forecast shall not deviate whatsoever from the forecast number of Production Runs set forth for such Binding Portion in the immediately preceding rolling twelve (12) month forecast. If Nabi fails to order at least the number of Production Runs forecast in any Binding Portion, then Nabi shall be obligated to compensate Biotest for such shortfall in accordance with the Service Fees set forth in the applicable Scope.

(iv) The Service Fees for any purchase order for Production Runs shall be determined in accordance with, and shall be payable at the times set forth in, Section 8 of this Agreement.

(d) Program Development. The Parties shall consult in developing a Program design in a manner consistent with United States regulatory guidelines, including cGMP. Biotest does not represent or warrant that any Program and/or any Program results will result in obtaining marketing approval for the Drug Substance or Drug Product at the time of submission of a Program’s results to such agencies.

(e) Nabi Technical Information . Biotest’s performance of a Program will be based on Biotest SOP and technical information provided by or for Nabi. This information will be incorporated into Program documents (Batch Records, Specifications, etc.) that will be approved by Nabi prior to use by Biotest. The Parties agree that these Program documents will form the sole basis upon which manufacturing runs will be performed.

 

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(f) Ongoing Meetings . In addition to routine Program meetings, senior representatives of the Parties shall meet on an occasional basis or as necessary, the first meeting being no later than one (1) month from the effective date of a particular Scope, to review progress of a Program relative to the Scope and to agree on any necessary changes to the Scope. Any disagreement between the Parties concerning a Scope (including, without limitation, the failure of the Parties to agree upon any necessary changes to the Scope) shall be resolved in accordance with the dispute-resolution procedures set forth in Section 17 hereof.

(g) Allocation of Manufacturing Capacity . Biotest will allocate fifty percent (50%) of its vaccine manufacturing capacity in the Facility, calculated on an average monthly basis, to the production of the Products, provided that the specific elements (e.g., scheduling of specific manufacturing functions and processes) of such allocation will be set forth in the Scopes.

3. PROGRAM PERFORMANCE.

(a) Subject to Section 2(f), Biotest shall provide the Facility, Materials and staff necessary to complete a Program as provided in a particular Scope, as it may be modified as provided herein, in accordance with the terms of this Agreement.

(b) Biotest will appoint a Biotest representative (the “ Program Manager ”) to be responsible for oversight of a Program pursuant to a Scope by Biotest. The Program Manager will coordinate performance of a Program with a representative designated by Nabi (the “ Nabi Representative ”), which representative shall have responsibility over all matters relating to performance of a Program on behalf of Nabi. Unless otherwise agreed in a Scope, or mutually agreed to by the Parties, all communications between Biotest and Nabi regarding the conduct of a Program pursuant to a Scope shall be addressed to or routed through the Program Manager and Nabi Representative. Biotest may, at its option, substitute the Program Manager during the course of a Program, on the condition that the substitute Program Manager is reasonably acceptable to Nabi, which acceptance will not be unreasonably withheld, delayed or conditioned. Nabi may, at its option, substitute the Nabi Representative during the course of a Program.

(c) The parties have prepared and executed a detailed document (“ Quality Agreement ”) specifying the quality and regulatory procedures and responsibilities of the parties hereunder with respect to the manufacture of Drug Substance.

(d) Biotest shall produce Drug Substance in accordance with the applicable Scope and use commercially reasonable efforts to cooperate with Nabi or its contractor in connection with filling and finishing of the Product.

 

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4. PROGRAM MATERIALS.

(a) Under any Scope, Nabi is responsible for providing Biotest with reference standards as necessary to perform the Program as specified in a particular Scope, as well as all documentation and such other data (including any necessary Process documentation) as may be necessary for Biotest to perform a Program as specified in a particular Scope and to apprise Biotest of the stability of the Process characteristics, proper storage, and manufacturing and safety requirements including, without limitation, the Certificate of Analysis and/or Material Safety Data Sheet, if applicable, relating to a Drug Substance and reference standards as specified in a relevant Scope.

(b) Nabi hereby grants to Biotest a non-exclusive, royalty-free license, with no right to grant sublicenses other than to permitted subcontractors, of any intellectual property of Nabi or its Affiliates necessary for the manufacture of Drug Substance under this Agreement, including but not limited to the Process, and the provision of any other products or services required under this Agreement. Such license is limited and is exclusively for the purpose of the manufacturing of Drug Substance hereunder at the Facility and the provision of any other products or services required under this Agreement, and shall terminate automatically and without further action by the Parties on the termination of this Agreement.

(c) Nabi shall supply to Biotest, in a timely manner and at no charge to Biotest, sufficient quantities of hapten for use in and completion of a Program and each manufacturing run. Biotest shall procure, subject to Section 8(c) and expect as otherwise set forth herein, all Materials, including Process Consumables, necessary for use in and completion of a Program and each manufacturing run all of which will comply with the Specifications; provided however, that until a Drug Substance has been through at least three (3) at scale Production Runs , the resulting Batch is required to comply with the Batch Records, Process, and Biotest SOPs only and shall not be required to comply with the Specifications applicable thereto. Only after a Drug Substance has completed three (3) at scale Production Runs must the resulting Batch comply with the applicable Specifications.

(d) Upon completion of each Program and/or termination of this Agreement, (i) unless otherwise agreed in writing by the Parties, the applicable Product-Dedicated Equipment will be returned to Nabi or its designee, at Nabi’s expense and (ii) any remaining samples, Materials, Drug Product or Drug Substance, or other substances, documentation or data provided to Biotest or produced by Biotest under this Agreement and solely related to the applicable Drug Product or Drug Substance will be delivered, at Nabi’s request, to Nabi or its designee, or, if not so requested by Nabi, either retained by Biotest in compliance with applicable regulatory requirements or destroyed/disposed of by Biotest, in Biotest’s discretion.

5. USE OF SUBCONTRACTORS.

(a) Biotest reserves the right to employ subcontractors from time-to-time to undertake certain activities related to a Program. All such subcontractors will be pre-approved by Nabi, such approval not to be unreasonably withheld or delayed. All approved

 

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subcontractors for a Program will perform services under a separate written agreement. A list of the pre-approved subcontractors as of the Effective Date is attached hereto as Appendix 2 . Biotest will ensure that each written agreement with a subcontractor for a Program contains (i) obligations of confidentiality and non-use consistent with Section 10 of the Agreement, (ii) obligations regarding compliance with laws consistent with Sections 19(h) , 19(i) and any Scope-specific terms which are mutually agreed to by the Parties in writing, and (iii) assignments, licenses or similar transfers of intellectual property rights to the extent any intellectual property rights are vested in the subcontractor as a result of performing services for Nabi, in each case for the benefit of Nabi (or for the benefit of Biotest, subject to Section 12 ). If Biotest’s written agreements with its subcontractors do not contain these provisions or Biotest is not able to obtain written agreements, then Biotest will notify Nabi prior to commencing work with that subcontractor and Biotest will not commence work with that subcontractor for a Program until Nabi provides its consent. Nabi will be responsible for delays to the performance of a Program resulting from Nabi unreasonably delaying, conditioning or hindering this consent. No subcontracting arrangement will relieve Biotest of its obligations under this Agreement, and Biotest shall remain primarily liable for the performance of all obligations delegated to any subcontractor, provided, however, that if a subcontractor agrees in writing that Nabi is and shall be a Third Party beneficiary of the applicable service agreement(s) between Biotest and such subcontractor, with full right of enforcement, then Biotest shall not be liable for any breach of this Agreement caused by subcontractor.

(b) Biotest will not be held responsible or liable for the performance of any Third Party retained directly by Nabi or its Affiliates to perform services related to a Program, including, without limitation, any distributors, consultants and testing entities.

6. COMPLIANCE WITH GOVERNMENT REGULATIONS.

(a) Biotest will perform each Program in accordance with each applicable Scope. Biotest will comply with applicable government regulatory requirements concerning cGMP appropriate to a particular Program.

(b) Should such government regulatory requirements concerning cGMP applicable to a Program be changed or Nabi require Biotest to comply with regulatory requirements other than those of the United States or states in the European Union, Biotest will comply with the new requirements or foreign requirements, as applicable, subject to the remaining terms of this Section 6(b) . In the event that compliance with such new or foreign regulatory requirements necessitates, in the reasonable discretion of Biotest, a change in the Scope or a Program or the cost of the products or services provided by Biotest, Biotest will submit to Nabi a revised technical and cost estimate proposal for Nabi’s acceptance. Unless the parties agree to a revised Scope or Program or cost estimate, as the case may be, Biotest will not be obligated to continue to perform the Scope or a Program or provide such products or services as Nabi has requested that it be revised.

 

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7. RESIDUAL ACTIVITIES.

Biotest will complete scheduled residual activities as requested by Nabi relating to two (2) NicVAX Drug Substance Batches. Such activities shall be performed by Biotest without charge and in a manner consistent with Nabi’s SOPs and practices prevailing prior to the Effective Date.

8. COMPENSATION.

(a) Biotest shall be paid service fees (the “ Service Fees ”) to perform the services set forth in each Scope, in an amount equal to Biotest’s cost to manufacture the Drug Substance as described in such Scope, calculated in accordance with GAAP in substantially the same manner as calculated by Nabi prior the Effective Date, in accordance with the manufacturing cost classification as outlined in Exhibit B , which exhibit shall be prepared by the Parties within thirty (30) days of the Effective Date, but specifically excluding depreciation, amortization and other non-cash items. The parties shall refer to the manufacturing cost classification, set forth in Exhibit B , for an example of the manner in which the manufacturing costs are to be calculated hereunder.

(b) The Parties shall agree on estimated Service Fees for each Production Run in each Scope, provided that any estimate of Service Fees, to the extent made in good faith, will not be binding for any purpose, and Biotest shall be relieved of its obligations hereunder with respect to such Production Run in the event of failure of the Parties to agree thereon.

(c) In the event that the Parties agree that the existing equipment is insufficient to produce the Products without further investment and efforts in process development, Biotest will acquire, at Nabi’s sole cost and expense and after Nabi’s prior written approval, any additional equipment necessary to produce the Products in accordance with a Program. In the event that Nabi does not approve of such acquisition of additional equipment, Biotest shall have no obligation to produce Products with the existing equipment that the Parties agree is insufficient. Any portion of the cost of any Product-Dedicated Equipment purchased for such Program will be included in the Service Fee.

(d) Payments shall be made to an account designated by Biotest and are due thirty (30) days from the date of receipt of invoice, except that the Service Fees’ payments are due at the times indicated in the relevant Scope. Late payments are subject to an interest charge of one percent (1%) per month.

(e) No more than once every twelve (12) months and no later than sixteen (16) months after receipt by Nabi of the relevant invoice, Biotest shall permit an independent auditor appointed by Nabi, and reasonably acceptable to Biotest, to conduct an audit of Biotest’s applicable books and records relating to costs to manufacture Drug Substance for the sole purpose of determining whether the correct Service Fees have been charged to or paid by Nabi hereunder. The audits must be conducted upon reasonable advance notice during the regular business hours and in a manner not to interfere unduly with Biotest’s operations. If any audit of Biotest’s

 

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invoices or other records reveals any variance from any invoice to Nabi, Biotest shall immediately refund any excess payment received from Nabi. In addition, if any audit reveals that Nabi has been overcharged by more than three percent (3%) for the period audited, Biotest shall bear the reasonable-costs and expenses of the independent auditor incurred in conducting the audit. Otherwise, Nabi shall bear all costs and expenses of such audit.

9. CHANGE ORDERS.

(a) In the event that the Parties’ expectations regarding Scope and Program design and objectives, timing, capital expenditure requirements, if any, and other matters relating to the completion of a Program as set forth in a Scope change in any material respect due to events outside the reasonable control of the Parties, including, without limitation, the events described in Section 20 or changes to any applicable laws, rules or regulations, such that such Program’s objectives cannot be achieved based on such expectations (each being, a “ Modification ”), then the Scope may be amended as provided in subsection (b) of this Section 9 .

(b) In the event a Modification is identified by Nabi or by Biotest, the identifying Party shall notify the other Party as soon as is reasonably possible. The identifying Party shall provide the other Party with a change order containing the Modifications and an estimate of the required adjustments to the estimated Service Fees within ten (10) business days of receiving or delivering such notice (the “ Change Order ”). The consent of the other Par


 
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