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LICENSE, JOINT DEVELOPMENT, AND MANUFACTURING ASSISTANCE AGREEMENT

Development Agreement

LICENSE, JOINT DEVELOPMENT, 
AND MANUFACTURING ASSISTANCE AGREEMENT | Document Parties: Animas Corporation | Debiotech S.A You are currently viewing:
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Animas Corporation | Debiotech S.A

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Title: LICENSE, JOINT DEVELOPMENT, AND MANUFACTURING ASSISTANCE AGREEMENT
Governing Law: Pennsylvania     Date: 3/31/2005

LICENSE, JOINT DEVELOPMENT, 
AND MANUFACTURING ASSISTANCE AGREEMENT, Parties: animas corporation , debiotech s.a
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EXHIBIT 10.24

Portions of this exhibit were omitted and filed separately with the Secretary of the Commission pursuant to an application for confidential treatment filed with the Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934. Such portions are marked by a series of asterisks.

LICENSE, JOINT DEVELOPMENT,
AND MANUFACTURING ASSISTANCE AGREEMENT

Recitals .

Parties . This Agreement is entered into as of October 29, 2004 between Debiotech S.A., a Swiss company having a place of business at 28 Avenue de Sevelin, CH-1004 Lausanne, Switzerland, and Animas Corporation, a Delaware corporation having a place of business at 200 Lawrence Drive, West Chester, PA 19380, USA.

Development Funding and License . Debiotech is prepared to undertake the development of an externally worn micro-pump for the delivery of insulin based upon Debiotech’s Micro Electro-Mechanical Systems technology and related know-how. Animas desires to have exclusive rights to make, use sell and/or import such a pump and to obtain exclusive license rights to all of Debiotech Intellectual Property useful for such purpose for all uses relating to the administration of insulin.

Confidentiality Agreement. Debiotech and Animas entered into a confidential disclosure agreement dated July 6, 2004. Upon execution of this Agreement, the Confidentiality Agreement shall be terminated and replaced with the terms of this Agreement.

Term Sheet. Debiotech and Animas signed on August 31, 2004 a Term Sheet containing most of the material terms upon which they intended to agree and providing a basis for this Agreement. Upon execution of this Agreement, the Term Sheet shall be terminated and replaced with the terms of this Agreement.

Parallel Agreement. Simultaneously with the execution of this Agreement, Debiotech and Animas shall enter into a parallel License, Joint Development and Manufacturing Assistance Agreement in connection with a micro-needle product of Debiotech.

Due-Diligence Prior to Agreement Signed . Prior to signature of this Agreement, Animas has conducted a due diligence review of Debiotech’s relevant technology and related manufacturing, Debiotech having provided all information requested by Animas, as well as a further due diligence review relating to such relevant technology, including intellectual property.

Consideration . In consideration of the mutual promises and obligations contained herein, the parties agree as set forth in this Agreement.

 


 

1. Definitions

The following capitalized terms are used in this Agreement with the meanings indicated or referred to below.

1.1 Affiliate: any corporation, partnership, limited liability company or other enterprise or organization that directly or indirectly through one or more intermediaries controls, is controlled by, or is under common control with a party, where “control” means beneficial ownership of at least fifty percent (50%) of the then outstanding voting shares or equity interests in the party in question or the power to direct or otherwise cause the direction of the management and policy of the party in question (for the avoidance of doubt, Existing Shareholders listed under Exhibit D shall not be considered Affiliates given their current ownership of Animas).

1.2 Agreement: this LICENSE, JOINT DEVELOPMENT, AND MANUFACTURING ASSITANCE AGREEMENT and all attached exhibits, together with any future amendments entered into in accordance with Section 16.13 of this Agreement.

1.3 Agreement Date: the date on which this Agreement is entered into by the Parties.

1.4 Animas: Animas Corporation, a Delaware corporation having a place of business at 200 Lawrence Drive, West Chester, PA 19380, USA.

1.5 Animas Group: Animas and its Affiliates.

1.6 Annual Royalties Statement: a statement prepared by Animas at the end of each Year in accordance with Section 4.6 of this Agreement, setting forth the Net Revenue relating to Pump Products subject to a royalty in that Year. The Annual Royalty Statement shall set forth (i) the number of Pump Products placed or sold to end-users, by product and by country, and the Net Revenue, by product and by country, associated with such Pump Products; (ii) the number of Pump Products placed or sold to distributors, by product and by country, and the Net Revenue, by product and by country, associated with such Pump Products; (iii) the number of Pump Products placed or sold by Sub-licensees, by product and by country, and Net Payments received by Animas from Sub-licensees associated with such Pump Products; and (iv) the royalties payable by Animas with respect to such Net Revenue for that Year and the Sublicense Fees payable by Animas with respect to such Net Payments from Sub-licensees for that Year, if any, and the royalties and Sublicense Fees previously shown due in the Quarterly Royalties Statements for that Year.

1.7 Change of Control: a change of control of Animas Group shall be deemed to have occurred at such time as any third party, other than an Existing Shareholder listed


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under Exhibit D, acquires more than 50% of the voting stock of Animas or Animas merges with a third party except where Animas is the surviving entity. A Change of Control will be deemed to have occurred if this Agreement is assigned directly or indirectly to a third party, excluding an Animas Affiliate, including without limitation the sale of substantially all of the assets of Animas in accordance with Section 16.6 of this Agreement.

1.8 Commercial Launch: the date at which the first Pump Product is sold to an end-user in any country, directly or indirectly, by a Licensee.

1.9 Debiotech: Debiotech S.A., a Swiss company having a place of business at 28 Avenue de Sevelin, CH-1004 Lausanne, Switzerland (together with successors and assigns, and those Affiliates who (i) own Debiotech Intellectual Property or (ii) have license rights therein in the Field, or (iii) employ any personnel having been involved as an employee of Debiotech (including successors and assigns) or an Affiliate in the development of an externally worn micro-pump utilizing MEMS technology).

1.10 Debiotech Intellectual Property: all patents, copyrights, trade secrets, know-how and other intellectual property related to or useful to an externally-worn micro-pump utilizing MEMS technology owned by, developed by or licensed to Debiotech, now or until such time as the license granted pursuant to this Agreement is terminated in accordance with Section 15 of this Agreement or becomes a fully paid-up license in accordance with Section 2.2 of this Agreement (including, without limitation, the intellectual property described more specifically in Exhibit A). Debiotech Intellectual Property includes, without limitation, all ideas, methods, concepts, design features, diagrams, schematics, flowcharts, specifications, code (source and object) and any other intellectual property necessary or useful for Animas to fully exercise its rights and perform its obligations under this Agreement or otherwise commercialize Pump Products in the Field. Notwithstanding the foregoing, Debiotech Intellectual Property shall include intellectual property developed jointly by Debiotech and a third party unless Debiotech is prohibited by contractual agreement with such third party to license such intellectual property to another party.

1.11 Debiotech Pump: an externally worn micro-pump system for the delivery of insulin incorporating a MEMS Chip and based upon Debiotech Intellectual Property. In its initial configuration, a Debiotech Pump will comprise both a MEMS Pump and a Pump Controller according to the Specifications.

1.12 Debiotech Pump System: a system incorporating Debiotech Pump including Pump Accessories.


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1.13 Development Program: the development program described more fully in Article 5 of this Agreement pursuant to which Debiotech is to use commercially reasonable efforts to develop fully functional prototypes of the Debiotech Pump which meet the Specifications.

1.14 Distributors: Third parties (outside Animas Group) that distribute Pump Products sold to them by a Licensee.

1.15 FDA Approval: 510(k) clearance by the Food and Drug Administration (FDA) for sale in the United States of the Debiotech Pump.

1.16 FDA Submission: filing for FDA Approval.

1.17 Field: all uses of an externally worn micro-pumps relating to the administration of insulin which insulin may be administered through a single pump, alone or in combination with other medications (such as glucagon and insulin).

1.18 Filling System: all the components necessary to fill and refill the Debiotech Pump with insulin, such as insulin vial adaptor(s), syringes to apply pressure or vacuum, external cartridge (if any), needles, caps, cleaning and sterilizing supplies and the like.

1.19 Infusion Accessories: all components used together with the Debiotech Pump System, such as Infusion Sets, prolongation sets, automatic placement tool for Infusion Sets, carrying case, PC software and interface, printer, and the like.

1.20 Infusion Sets: all sterile infusion sets to be used in conjunction with the Debiotech Pump.

1.21 Knowledge: “to the best knowledge of Debiotech” shall mean to the actual or implied knowledge, as of the Agreement Date, of the officers, directors, owners and management of Debiotech; provided that, “implied knowledge” shall mean only the knowledge readily obtainable from all information available in the books, records and files of Debiotech.

1.22 License: the exclusive license granted to Animas pursuant to Section 2.1 of this Agreement (including further extensions to future rights, in particular in accordance with Section 13.1 of this Agreement and Section 13.2 of this Agreement).

1.23 Licensed Patents: all patents, patent applications and patent rights included in Debiotech Intellectual Property as well as patents, patent applications and patent rights resulting from joint inventions under Section 13.1 of this Agreement. A


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comprehensive list of such Licensed Patents, as of the Agreement Date, is described in Exhibit A.

1.24 Licensees: Animas, Affiliates of Animas and Sub-licensees.

1.25 License Shares: 400’000 shares of restricted Animas Common Stock to be delivered by Animas to Debiotech in accordance with Section 3.2 of this Agreement.

1.26 Major Countries: France, Germany, United Kingdom and United States.

1.27 Manufacturing Program: The manufacturing program as defined in Section 7.3 of this Agreement.

1.28 MEMS: Micro Electromechanical Systems using fabrication techniques similar to those utilized in the micro-electronics industry.

1.29 MEMS Chip: the silicon/Pyrex micro-chip pump utilizing Debiotech Intellectual Property.

1.30 MEMS Pump: replaceable/disposable housing containing MEMS Chip, piezo actuator, insulin reservoir (if any) and related internal components.

1.31 MEMS Pump Business: the business of Debiotech relating specifically to the design, development and production of externally worn micro-pumps utilizing MEMS technology and all licensing, consulting and investment activities and operations relating thereto, whether in the Field or outside the Field.

1.32 Micro-Needle Agreement: a parallel agreement entered into between Debiotech and Animas in connection with a micro-needle product of Debiotech, entitled Micro-Needle License, Joint Development and Manufacturing Assistance Agreement and all attached exhibits, together with any future amendments entered into in accordance with such parallel agreement.

1.33 Net Revenue: gross revenue of Animas Group on a consolidated basis (excluding all revenue from Sublicensees) from the sale of Pump Products to distributors and end-users minus contractual allowances and discounts, as calculated in accordance with US Generally Accepted Accounting Principles, as such principles are in effect at that time, and as recognized in accordance with Animas’ standard accounting practices in effect for the relevant period, consistently applied (“GAAP”).

1.34 Patient Installed Base: Installed base of patients under Debiotech Pump System estimated as of July 1 of any Year considered.


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1.35 Pump Accessories: Filling Systems, Infusion Sets and all other Infusion Accessories.

1.36 Pump Controller: long-term use (about ******) module, containing all the hardware and firmware necessary to control and monitor the MEMS Pump and also providing user interface means, as well as any other device related therewith (e.g. remote programming system, including as the case may be a strip blood glucose monitoring device, and the like).

1.37 Pump Products: products constituting Debiotech Pump System, i.e. MEMS Pump, Pump Controller and Pump Accessories collectively or separately, including components therein and assemblies into such products.

1.38 Quarterly Royalties Statement: a statement prepared by Animas for a calendar quarter in accordance with Section 4.5 of this Agreement, setting forth the Net Revenue of products subject to a royalty in that quarter (with relevant figures of units placed to end-users and to distributors and Net Revenues, product by product and country by country), the Net Payments received by Animas from Sub-licensees in that quarter and the royalties and Sub-license Fees due by Animas with respect to such Net Revenues and such Net Payments from Sub-licensees.

1.39 Royalties Term: the period during which at least one Licensed Patent is Valid in at least one Major Country.

1.40 ******-License : the non-exclusive license from ****** in favor of Debiotech with regard to certain patents, including the right to sub-license.

1.41 Specifications: the specifications set forth in Exhibit B, as such specifications may be amended, pursuant to this Agreement.

1.42 Steering Group: a six person committee composed of three senior employees of each party, but not their CEO’s, which shall review in accordance with Section 5.5 of this Agreement all the developmental, logistical and technical aspects of the Development Program.

1.43 Sub-licensees: third party (outside Animas Group) sub-licensees appointed by Animas in accordance with Section 2.3 of this Agreement and distributing Pump Products which have not been sold to them by Animas Group or a Sub-licensee (so that such Pump Products have not yet been taken into account for determining royalties due to Debiotech). Sub-licensees do not include (i) parties that manufacture Pump Products, or components therein, on behalf of Animas, but do not distribute such Pump Products or components therein, or (ii) Distributors. However, the parties acknowledge that, the same person might be a Distributor in connection with certain Pump Products (bought from Animas Group or a Sub-licensee, e.g. Debiotech


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Pumps) and a Sub-licensee in connection with certain other Pump Products (not bought from Animas Group or a Sub-licensee, e.g. Infusion Sets).

1.44 Valid: qualifier for a patent in a determined country, meaning that such patent in such country is valid, not expired and has not been declared unenforceable by a competent body of such country (such as a United States Federal District Court) for any defect related to the patent (such as a failure from patentee to make relevant disclosures) and affecting its validity lato sensu , but not making the patent technically invalid. Whether the validity of the patent is challenged and infringers can effectively be prevented is irrelevant to determine whether any patent is Valid.

1.45 Year: a calendar year, from January 1 to December 31.

2. License to Animas.

2.1 Exclusive License . Debiotech hereby grants to Animas an exclusive, even as to Debiotech, worldwide license, with the right to sublicense in accordance with Section 2.3 of this Agreement, under all Debiotech Intellectual Property, excluding intellectual property jointly developed by Debiotech and a third party, and a non-exclusive sub-license under (i) the ******-License and (ii) Debiotech Intellectual Property jointly developed by Debiotech and a third party, to make, have made, use, sell, offer for sale, or import Debiotech Pump System in the Field. During the term of this Agreement, Debiotech shall not enter into any agreement with any other party to develop an externally-worn micro-pump utilizing MEMS technology for use in the Field.

2.2 Duration . The License shall be perpetual (subject to Article 15 of this Agreement). After the Royalties Term, the License shall become a fully paid-up, royalty free, irrevocable, non-exclusive worldwide license.

2.3 Sublicense . The License shall include the right for Animas to sublicense the licensed rights; provided that Animas obtains Debiotech’s written consent which consent shall not be unreasonably withheld or delayed. Animas’ sub-licensees shall conform to the applicable material terms of this Agreement and Animas shall remain directly liable to Debiotech with regard to any breach of the terms of this Agreement by Animas’ sub-licensees remaining uncured after a 90 day period following a default notice; provided that, Animas shall no longer be considered in breach of this Section 2.3 in the event Animas terminates the sublicense agreement within a reasonable period after the breach.

2.4 Limitation to the Field . Licensees shall not make, use, sell, offer for sale, or import Pump Products outside the Field.


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2.5 Further Documents . Debiotech hereby agrees to execute, or cause its employees, partners, licensors, agents, or consultants to execute all documents and shall take all actions necessary or desirable to effect, confirm and perfect the rights granted to Animas pursuant to the License, including without limitation, assignment to Debiotech of inventions past, present and future from its employees and consultants.

2.6 Promotion . Animas shall use reasonable commercial efforts to commercialize the Debiotech Pump, independent of the economic attractiveness of other competing Animas products.

2.7 Sales, Marketing and Distribution . All sales, marketing, and distribution activities for Pump Products shall be the responsibility of Animas. Animas shall give Debiotech periodic updates on the progress of Animas marketing activities.

3. License Fees.

3.1 Initial License Fee: Part in Cash. Animas shall pay to Debiotech a non-refundable license fee of Twelve Million Dollars ($12,000,000), payable within 10 days following Agreement Date.

3.2 Initial License Fee: Part in Shares . Animas shall deliver to Debiotech the License Shares, deliverable within 10 days following Agreement Date. In the event Debiotech sells any of the License Shares while termination by Animas under Section 15.1(c) of this Agreement would still be permissible, Debiotech shall provide to Animas a bank guarantee, letter of credit, escrow arrangement or such other form of security acceptable to Animas to secure the termination payment payable to Animas pursuant to Section 15.1(c) of this Agreement.

3.3 Restriction for sale of shares . The License Shares shall be issued pursuant to the Subscription Agreement attached hereto as Exhibit E.

3.4 Additional License Fee . Animas shall pay Debiotech a one-time additional license fee (“Additional License Fee”), subject to the provisions of this Section 3.4, at such time as Debiotech provides Animas all deliverables reasonably necessary for Animas to complete the FDA Submission (“FDA Deliverables”). A list of such FDA Deliverables is included in Exhibit I and may be amended by Animas as reasonably necessary, up to the date which is nine (9) months prior to the due date for delivery of FDA Deliverables as set forth in the Development Program. To the extent, at any time, Animas substantially modifies the FDA Deliverables (e.g. based on new requirements by the FDA, changes in the market conditions, or the need to perform clinical studies prior to FDA Submission), the dates below shall be extended to the extent reasonably necessary for Debiotech to deliver additional FDA Deliverables.


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The Additional License Fee shall be Two Million Dollars ($2,000,000) if FDA Deliverables have been received by Animas prior to January 1, 2007 if there has been no Change of Control, or prior to July 1, 2007 if there has been a Change of Control. The Additional License Fee shall be One Million Dollars ($1,000,000) if FDA Deliverables have been received by Animas after January 1, 2007 but prior to July 1, 2007 if there has been no Change of Control, or after July 1, 2007 but prior to January 1, 2008 if there has been a Change of Control. If Animas paid a One Million Dollars Additional License Fee, but a Two Million Dollars Additional License Fee would be due following a Change of Control, the unpaid part of the Additional License Fee shall be due within 30 days following Change of Control. This license fee is payable only one-time even if multiple submissions are made to FDA. The Additional License Fee, to the extent paid by Animas pursuant to this Section 3.4, shall be payable within 30 days after Debiotech provides Animas with FDA Deliverables. Except as set forth in the following two sentences, no Additional License Fee shall be payable if FDA Deliverables are received by Animas after January 1, 2008. The dates of January 1, 2007, July 1, 2007 and January 1, 2008 shall each be extended (i) for such number of days as the Steering Group agrees to extend the Development Program in accordance with Section 5.5, and/or (ii) to the extent delays of the development of the Pump Controllers and/or Infusion Accessories impacts the delivery by Debiotech of the FDA Deliverables, for each day that the development of the Pump Controllers and/or Infusion Accessories in accordance with the Development Program is delayed by Animas. If Animas decides to perform clinical trials prior to FDA Submission, the Additional License Fee shall be Two Million Dollars ($2,000,000) and shall be paid within 30 days after Debiotech provides Animas with FDA Deliverables, irrespective of the deadlines above.

3.5 Advance on Royalties. In the event of a Change of Control, Animas (or its successor) shall pay Debiotech, a non-refundable advance on future royalties of Five Million Dollars ($5,000,000), which payment shall be made within 180 days following a Change of Control. No advance payment shall be due if, within 180 days following a Change of Control, this Agreement is terminated in accordance with Section 15.1 or 15.2(c) of this Agreement.

Such advance payment shall be credited against 50% of actual royalty payments made pursuant to Section 4.1 of this Agreement until such credit has been fully utilized.

3.6 Sublicense Fees . Except to the extent a Sub-licensee Royalty Rate is applicable, Animas shall pay to Debiotech ****** of any Net Payments Animas receives from Sub-licensees and Distributors (“Base Sub-licensee Rate”) . Net Payments equal the gross cash (including royalties) received by Animas Group from Sub-licensees pursuant to any sub-license agreement between Animas Group and such Sub-licensee relating to Debiotech Intellectual Property and the gross cash received by Animas


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Group from Distributors pursuant to any agreement between Animas Group and such Distributor relating to Debiotech Intellectual Property but excluding any cash received by Animas Group from sales of Pump Products to such Distributors (provided that, to the extent Debiotech can demonstrate that a substantial portion of the sales price of Pump Products sold by Animas Group to Distributors includes what should be characterized as a sublicense fee or royalties due to Animas Group, Debiotech may require that such part of the sales price be included in the Net Payments instead of in the Net Revenue), minus applicable import, export and excise duties and sales tax (including VAT), and minus any taxes withheld from the gross cash (excluding any taxes that were withheld after the gross cash payable to Animas Group was increased to provide that after the withholding of the taxes Animas Group was to receive the same amount of payment it would have received but for the withholding) to the extent not recoverable by Animas Group within two years of the receipt of the gross cash. In the event either (i) the total aggregate number of Debiotech Pumps sold by all Sub-licensees and sold by Animas Group to Distributors for resale outside the USA in a Year exceeds ****** of all Debiotech Pumps sold by Animas Group (including those to Distributors) and its Sub-licensees in such Year, or (ii) the total aggregate number of Infusion Sets sold by all Sub-licensees and sold by Animas Group to Distributors for resale outside the USA in a Year exceeds ****** of all Infusion Sets sold by Animas Group (including those to Distributors) and its Sub-licensees in such Year, Animas shall pay to Debiotech a Sub-licensee License Fee equal to the greater of (i) a royalty equal to ****** of net revenues of Pump Products sold by all Sub-licensees (“Sub-licensee Royalty Rate”), or (ii) Base Sub-licensee Rate.

3.7 Currency . All payments under this Agreement shall be made in US Dollars, and all references in this Agreement to “Dollars” shall mean “US Dollars”. Payments to be made to Debiotech shall be made by SWIFT bank transfer to Debiotech’s bank account.

4. Royalties.

4.1 Base royalties . Animas agrees to pay Debiotech a royalty equal to a percentage of Net Revenue of Pump Products sold or placed by Animas Group. The royalty rate shall vary (based on Patient Installed Base) and shall be fixed each Year as set forth on Exhibit H, except for certain adjustments as provided in Sections 4.3 and 4.4, in this Agreement, when applicable.

4.2 Allocation of Net Revenues. In the event the Pump Products are sold in combination with a product(s) that is not a Pump Product, such as insulin, a continuous glucose monitoring device and related accessories (“Non-Pump Products”), the applicable royalty on Pump Products shall be based on the Net Revenue of Pump Products as if


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they were sold on a stand-alone basis (excluding additional net revenue for Non-Pump Products).

In such case, Animas will give written notice to Debiotech of a proposed allocation of the Net Revenue attributable to Pump Products sold with Non-Pump Products. Following such notice, to the extent Debiotech does not agree with Animas’ proposed allocation, the parties shall negotiate in good faith for a period of ninety (90) days. If the parties are unable to agree on an allocation, either party may require that the matter be determined by binding baseball arbitration pursuant to Section 16.2 of this Agreement.

4.3 Net Revenue Adjustment. In the event that less than ****** of Debiotech Pumps placed to end-users or sold by Animas Group in any given Year are placed to end-users or sold through its direct sales force, the parties shall negotiate in good faith an appropriate correction factor of the Net Revenue for that Year, which correction factor shall increase royalty payments payable to Debiotech to compensate, in part, for the reduced average selling prices of Debiotech Pumps, and hence royalties to Debiotech, as a result of the lower percentage of direct sales. The parties in such negotiations shall consider a correction factor to provide for what the average selling price of Pump Products would have been had Animas Group sold at least ****** of Debiotech Pumps through its direct sales force; provided that the gross margin percentage of Pump Products, in aggregate, sold by Animas Group after the increased royalties does not fall below customary gross margin percentages for manufacturers in the med-tech industry that provide similar levels of customer service, have similar mix of direct versus indirect sales, and perform similar levels of R&D activities. Following any Change of Control, the correction factor shall apply without regard to its impact on gross margin. If the parties are unable to agree on a correction, either party may require that the matter be determined by binding baseball arbitration pursuant to Section 16.2 of this Agreement.

4.4 Royalties reduction . During the Royalties Term, if none of the Licensed Patents covering any Pump Product is Valid in any Major Country, the royalty rate as set forth in Exhibit H shall be reduced to ****** of such rate in those countries in which Pump Products are sold, but Licensed Patents are not Valid; provided that such reduction in royalty rates shall only occur if (i) there is another competing pump product utilizing MEMS pump technology being sold in such country and, (ii) the Pump Products sold in such country are not manufactured in a country where a Licensed Patent covering any Pump Product is Valid.

4.5 Quarterly Calculation and Payment of Royalties . Royalties shall be due and payable with respect to the Net Revenue made in each calendar quarter within 45 days following the end of such calendar quarter ( a “ Payment Date ”), except for after the fourth quarter in which case, Section 4.6 applies. On or before each Payment


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Date on which royalties are due, Animas shall prepare and deliver to Debiotech a Quarterly Royalties Statement. The royalty rate for the second through fourth quarters of a Year shall be determined by the applicable Patient Installed Base. The royalty rate for the first quarter of a Year shall be provisionally calculated based on the sum of the estimated patient installed base as of December 31 of the prior Year plus two times the increase in patient installed base during the first quarter of the current Year. In the event the royalty rate so determined initially for the first quarter is different (whether higher or lower) than the royalty rate after the second quarter of that Year, the correction shall be made to the previously issued Quarterly Royalties Statement from the first quarter and the difference added to or deducted from the second Quarterly Royalties Statement prepared by Animas. Information provided to Debiotech in the Quarterly Royalties Statement shall remain confidential and not disclosed by Debiotech to other parties.

4.6 Annual Calculation and Payment of Royalties . Within 45 days following the end of the Year, Animas shall prepare and deliver to Debiotech an Annual Royalties Statement, applying the royalty rate applicable pursuant to the Patient Installed Base of that Year, subject to modifications as set forth in Sections 4.2-4.4. Information provided to Debiotech in the Annual Royalties Statement shall remain confidential and not disclosed by Debiotech to other parties.

4.7 Records and Audits . Licensees shall maintain detailed books and records containing information sufficient to verify the completeness and accuracy of the information presented in each Royalty Statement for a period of at least five years after the period to which such Royalty Statement relates.

Debiotech shall have the right, not more than once each Year, on reasonable advance notice to Animas, during usual business hours, to cause the examination of relevant records of Licensees for the period since the last period covered by any previous examination (including records which are more than five years old, if then available) and ending with the calendar quarter covered by the most recent Payment Date for the sole purpose of verifying the completeness and accuracy of the Quarterly Royalty Statements and Annual Royalty Statements, including any specific calculation relevant under this Agreement (such as with regard to Sections 3.6, 4.3 and 15.1(c)(ii)of this Agreement). At Debiotech’s election, any such examination shall be conducted by Animas’s auditors, if allowed by law and agreeable to such auditors, or by independent public accountants selected by Debiotech and reasonably acceptable to Animas.

As a condition to such examination, Animas may require such independent public accountants to execute a confidentiality agreement in form and substance reasonably satisfactory to Animas pursuant to which such independent public accountants will agree to retain in confidence all information learned by them in the course of such


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examination, except that any discrepancy in any information included in a Quarterly Royalty Statement or an Annual Royalty Statement, or being a relevant information under this Agreement, may be disclosed to Debiotech.

Debiotech shall pay the costs of conducting such audit unless the final results of an audit reveal an underpayment by Animas of five percent (5%) or more during the audited period, in which case Animas shall pay the costs of conducting such audit.

4.8 Duration . Royalties are to be paid on the sale of all Pump Products sold by Licensees throughout the world during the Royalties Term. Following the Royalties Term, the provisions of Section 2.2 of this Agreement shall apply.

5. The Development Program and Debiotech Pump System.

5.1 Responsibilities of Debiotech . Debiotech shall use reasonable commercial efforts to complete the Development Program (including without limitation the MEMS Pump and the Filling System) and provide to Animas, in accordance with the milestones set forth in Exhibit B, fully functional prototypes of (a) the MEMS Pump, including MEMS Chip, and (b) Pump Accessories (except for the Infusion Accessories). Such prototypes shall (i) meet the Specifications, (ii) be sufficient for FDA Submission, and (iii) be in a form which permits redesign for manufacturing and scaling up for large scale industrial manufacturing. Debiotech shall furnish to Animas and any manufacturer designated by Animas all documentation necessary for the redesign for manufacturing of the Pump Products. Debiotech shall cooperate with such designated manufacturer to assist in any redesign necessary for manufacturing Pump Products.

To the extent that such prototypes of the MEMS Pump fail to meet the requirements set forth above (and on Exhibit B), Debiotech shall, at its sole expense, use reasonable commercial efforts to continue development work to satisfy such requirements; provided that Debiotech shall not be required to continue development if Animas has commenced marketing of the Debiotech Pump.

Without limiting Debiotech’s ability to demonstrate how it uses reasonable commercial efforts, Debiotech shall in any event be deemed to use reasonable commercial efforts to fulfill its responsibilities under this Section 5.1 to the extent Debiotech’s efforts represent at least ****** in average each Year during 3 Years following Agreement Date in global development costs, including investments costs, consulting and external development costs and internal engineering costs calculated based upon rates provided in Exhibit C.


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5.2 Responsibilities of Animas . Animas shall use reasonable commercial efforts to complete the Development Program (including without limitation the Pump Controller and the Infusion Accessories) and provide, in accordance with the milestones set forth in Exhibit B, fully functional examples of the Pump Controller and Infusion Accessories. The Pump Controller and Infusion Accessories shall (i) meet the Specifications, (ii) be sufficient for FDA Submission, and (iii) be in a form which permits redesign for manufacturing and scaling up for large scale industrial manufacturing.

Animas shall be responsible for establishing the large scale manufacturing and Debiotech shall propose appropriate materials to be used to manufacture the MEMS Pump and Filling System and shall assist by supplying engineering support necessary to facilitate production of the Debiotech Pump System in large scale by Animas or suppliers designated by Animas.

5.3 Development Expenses . Each party shall be responsible for bearing its own costs of the Development Program. Debiotech shall be solely responsible for all expenditures of any nature required to complete the development of (a) the MEMS Pump, including MEMS Chip, and (b) Pump Accessories (except for the Infusion Accessories) in a form which in fact permits scaling up for large scale industrial manufacturing and which satisfies the requirements set forth in 5.1 above. Animas shall be solely responsible for all expenditures of any nature required to complete the development of the Pump Controller and Infusion Accessories in a form which in fact permits scaling up for large scale industrial manufacturing and which satisfies the requirements set forth in 5.2 above. Animas shall be responsible for the costs of any tooling and equipment for manufacturing of the Debiotech Pump System as well as for the cost of all required redesign for manufacturing.

Animas agrees to spend not less than ****** to develop Debiotech Pump System prior to January 2007 unless both parties agree, in good faith, that the Debiotech Pump System is not feasible as a commercial product.

5.4 Reports. Debiotech shall keep Animas fully informed with regard to the progress of the development of the Debiotech Pump System.

Not later than fifteen (15) days prior to the meetings with CEOs contemplated by Section 5.5, Debiotech shall submit to Animas a written report including all information regarding progress on the Development Program, disclosing any inventions or other improvements in technology, whether or not patentable, discovered or created in the course of the Development Program. The reports will also include a confirmation from Debiotech that Debiotech believes that the


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Development Program can be completed consistent with the schedule contemplated by Exhibit B, or Debiotech shall submit to Animas a revised schedule setting forth the revised estimated time to complete the Development Program.

If reasonably necessary in addition to the above, and to the extent it would not be unreasonably burdensome on Debiotech, upon request from Animas, Debiotech shall allow Animas’ representatives and, where Animas shows a reasonable business purpose, third party guests (subject to appropriate confidentiality agreements with Debiotech), to visit the development facilities where the Development Program is conducted, to attend presentations by Debiotech representatives of the current state of the Development Program and to receive additional written reports addressing specific issues.

5.5 Program Management . Each party shall appoint three senior employees, but not their CEOs, to form the Steering Group, which shall review all the developmental, logistical and technical aspects of the Development Program. In addition, major financial issues shall be discussed when they arise.

At least two members of the Steering Group from each side shall meet in person at least once every two months. Each party may invite additional participants from its own party to attend. Minutes of the meetings shall be prepared by Debiotech, indicating, in particular, the steps believed to be satisfactorily performed by the parties and the next steps to be performed. Minutes shall be reviewed and approved or rejected and amended at the next meeting of the Steering Group. Minutes of the Steering Group shall not constitute amendments of this Agreement or the Specifications even if signed by representatives of the parties or the CEOs of each Party.

The Steering Group shall be charged with managing the Development Program with a view to completing development of the Debiotech Pump System as rapidly as possible. In addition, the Steering Group shall insure that such development be completed in accordance with the Specifications and that the manufacturing cost of the Debiotech Pump System be consistent with the levels set forth in the Specifications. The Steering Group shall make recommendations to either Party regarding design and engineering issues and shall make recommendations to Animas regarding the most appropriate supplier(s) to manufacture the Debiotech Pump System or any part thereof. Debiotech employees shall be primarily responsible for issues relating to design, engineering and intellectual property with regard to the MEMS Pump and Pump Accessories (excluding Infusion Accessories). Animas employees shall be primarily responsible for issues relating to design, engineering and intellectual property with regard to the Pump Controller and Infusion Accessories as well as manufacturing and selection of suppliers. Animas shall also be responsible


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for facilitating any incorporation of Animas’ technology, if any, in the Debiotech Pump System.

Either Party’s members on the Steering Group may recommend modifications to the Specifications and the Development Program by submitting a written request to the other Party’s members on the Steering Group detailing the nature of the modification, the reason for the modification and the anticipated costs associated with implementing the modification. Any modification must be approved in writing by each Party’s CEO. Each Party agrees not to unreasonably withhold their approval to a modification suggested by the other Party so long as the consenting Party cannot demonstrate with written documentation that the modification (i) materially adversely affect the marketability and desirability of the Debiotech Pump System, (ii) materially affects the cost of the development effort, or (iii) materially affects the timing of the availability on the market of the Debiotech Pump System.

Each Party’s members on the Steering Group shall keep their respective CEOs informed as necessary. The Steering Group shall meet in person with the CEOs as a group of eight at least once every 4 months. The Steering Group shall attempt to resolve issues without the involvement of the CEOs; provided that, in the event the parties cannot agree, the issue shall be put before the CEOs who shall use commercially reasonable efforts to resolve the issue.

Meetings of the Steering Group (other than those to attended by the CEOs) shall be held at the location where the most active development work is being conducted, which the parties anticipate will be in Lausanne Switzerland through the early and middle stages of the Development Program, and may be the site of anticipated manufacturing facilities later in the Development Program. Meetings of the Steering Group attended by the CEOs shall alternate between locations designated by the CEO of Animas and the CEO of Debiotech.

5.6 Obligations to develop Product . Debiotech agrees that it will devote the resources as reasonably necessary to ensure development of the MEMS Chip and Pump Accessories (excluding the Infusion Accessories) by June 30, 2007. In the event Debiotech is not successful in developing the MEMS Chip and Pump Accessories (excluding the Infusion Accessories) by June 30, 2007, Animas may terminate this Agreement in accordance with Section 15.1(c) of this Agreement or, Animas may, in its sole discretion, extend the Development Program by up to an additional eighteen (18) months; provided, however, the June 30, 2007 date shall be extended (i) for such number of days as the Steering Group agrees to extend the Development Program in accordance with Section 5.5, and/or (ii) for each day that the development of the Pump Controllers and/or Infusion Accessories in accordance with the Development Program is delayed by Animas.


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Animas agrees that it will devote the resources as reasonably necessary to ensure development of the Pump Controller and Infusion Accessories in time for Debiotech to complete the Development Program by June 30, 2007.

5.7 Failure to complete Development Program. Because of the uncertainties associated with the development work, neither party warrants that it will successfully complete the Development Program.

5.8 Choice of Suppliers under Development Program . Debiotech and Animas must jointly agree on choice of suppliers for any part or process of the Development Program if Non-recurring Engineering Expense (NRE) or tooling charge exceeds $20,000.

6. Regulatory Responsibility.

6.1 Regulatory Filings . Animas shall use commercially reasonable efforts to file regulatory approvals, including to the FDA, pending completion of test results and other documentation required for such submission.

6.2 Documentation for regulatory submission . In connection with preparation by Animas of the FDA Submission and during the review by FDA of the FDA Submission, Debiotech shall: a) furnish all test results and documentation on MEMS Pump and Pump Accessories (except for Infusion Accessories) required by FDA and, b) remain available for responding to questions by FDA relating to such FDA Submission.

6.3 Clinical Studies . Animas shall be responsible for oversight of clinical studies, if any, necessary to obtain FDA Approval, and shall be responsible for the cost of any such studies. Protocol of clinical studies must be approved by Debiotech in advance.

6.4 Material for Clinical Studies . Notwithstanding the provisions of Section 7.1 of this Agreement, Debiotech shall furnish MEMS Pumps and related Pump Accessories (except Infusion Accessories which shall be supplied by Animas), in accordance with Specifications, needed for clinical studies as required in Section 6.3 of this Agreement, provided that ****** MEMS Pumps and related Pump Accessories shall be delivered. The cost of all such deliverables shall be borne solely by Debiotech, provided that, Animas shall be responsible for any investments necessary for manufacturing and redesign for manufacturing, to the extent required.

6.5 Regulatory Obligations . Animas and Debiotech shall cooperate in the preparation of, and shall execute, as part of the Development Program, a Quality Agreement in order


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to meet the requirements of ISO13485, European MDD and FDA QSR (21 CFR 820) requirements for medical devices, to the extent applicable.

7. Manufacturing Program of MEMS Chip.

7.1 Manufacturing Responsibility . Animas shall be responsible for all aspects of manufacturing of Pump Products, and shall bear all corresponding costs, except to the extent specifically stated otherwise.

7.2 Choice of Initial Manufacturer . Debiotech shall recommend not less than three candidates of initial manufacturer for the MEMS Chip. Animas may choose between one of three candidates to be the initial manufacturer. If for whatever reason, Animas finds the three candidates unacceptable, Animas may recommend other candidates, whose endorsement by Debiotech may not be unreasonably withheld.

7.3 Debiotech Assistance. Debiotech, at its own cost, shall provide (i) all documentation of all processes, materials, testing, and assembly instructions necessary for the initial manufacturer to manufacture the MEMS Chip in small-scale manufacturing and further enter into a redesign for manufacturing for large-scale production, (ii) any training required of personnel of the initial manufacturer to manufacture the MEMS Chip, (iii) any additional technical support including for re-design/ revalidation of processes necessary for large-scale manufacturing ((i) to (iii) constituting the Manufacturing Program), and (iv) continued technical support including for re-design/revalidation of processes, until the initial manufacturer has delivered to Animas ****** MEMS Chips to be placed on the market.

7.4 Cost. The cost of all required manufacturing tools and equipments as well as for the redesign for manufacturing shall be borne by Animas.

7.5 Support after Manufacturing Program. Debiotech shall provide employees as reasonably requested by Animas from time to time to support manufacturing and technical issues, as they may arise of MEMS Pump after completion of Manufacturing Program. Animas shall reimburse Debiotech at rates as provided for in Exhibit C, plus out-of-pocket expenses.

7.6 Access to MEMS Chip and MEMS Pump Manufacturer. Subject to the terms and conditions of this Section 7.6 and Section 12.1 of this Agreement, Debiotech shall have the right to buy directly from the manufacturer (the “MEMS Manufacturer”) the MEMS Chips and/or MEMS Pump used in the Debiotech Pump for use outside the Field.


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To the extent Debiotech requires MEMS Manufacturer to use substantially the same tooling and equipment which is either (a) used by and has been specifically paid for by Animas, or (b) is owned by Animas (the “Tooling”), then (i) Debiotech must reimburse Animas for its pro rata share of any non-recurring engineering costs (excluding Animas personnel) and tooling costs incurred by Animas for the manufacture of such MEMS Chips and/or MEMS Pump, irrespective of when such costs were incurred (provided such reimbursement shall not apply to prototypes and ****** in an amount less than ****** requested by Debiotech for development, clinical evaluation and registration purposes so long as the manufacture of such prototypes and small series do not cause delays to Animas deliveries); (ii) Animas shall have priority in the supply of MEMS Chips over Debiotech in the event that the MEMS Manufacturer is unable to provide all quantities of MEMS Chips requested by both Debiotech and Animas unless Animas has failed to provide MEMS Manufacturer an adequate forecast of such requirements as set forth in the agreement between the MEMS Manufacturer and Animas; (iii) any request for a change by Debiotech in the design or manufacturing of Tooling must be approved by Animas prior to any discussion with MEMS Manufacturer, and further any such discussions between MEMS Manufacturer and Debiotech, after such approval by Animas for such discussions, may only be done in the presence of Animas personnel; and (iv) in no case, may any change in the design or manufacturing of such Tooling be made without the explicit approval in writing by Animas, and further Animas is under no obligation to approve a change in the design or manufacture of such Tooling, even if Debiotech believes that Animas is unreasonably withholding its approval.

All rights and obligations of Debiotech in this Section 7.6 shall inure to Debiotech’s licensees outside the Field, provided that, such licensees agree to indemnify Animas from any third party claims in connection with their use of the Tooling as per this Section 7.6, and further provided, that the prior written approval by Animas is obtained, which approval shall not be unreasonably withheld. Debiotech shall indemnify and hold harmless Animas, its successors and assigns, Affiliates, and their respective agents, officers, employees, representatives and directors from any third party claims in connection with Debiotech using the Tooling as per this Section 7.6. In the event Debiotech or its licensees sell product in the Field in a manner which is under the reasonable control of Debiotech or its licensee, in addition to any remedies that may exist under this Agreement, all rights of Debiotech under this Section 7.6 may be terminated, provided (i) sales were made willfully in the Field, or (ii) sales were made negligently in the Field and are materially harmful to Animas. Such termination rights shall not apply to the extent Debiotech or its licensee, following notice from Animas, fails to cure the breach within ******.


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8. Representations, Warranties and Covenants.

8.1 Authorization. Each party represents that it is duly organized, validly existing and in good standing under the laws of the state of its organization, that it has full power to execute, deliver and perform this Agreement, that this Agreement has been duly authorized, executed and delivered by such party and is the legal, valid and binding obligation of such party, enforceable against such party in accordance with its terms, subject as to enforcement, to applicable bankruptcy, insolvency, moratorium, reorganization or similar laws affecting creditors’ rights generally and general principles of equity.

8.2 No Conflict . Each party represents that the execution, delivery and performance of this Agreement do not require any approval, license, qualification, consent or filing or exemption therefrom, or other action by any court, governmental authority or other person, and do not contravene or constitute a default under any legal requirement binding on such party, any agreement binding on such party or any of its assets, or any judgment, injunction or order or decree binding on such party or any of its properties. In particular, Debiotech represents that its agreement with Inverness Medical Technology and its successor has been terminated as of January 18, 2004 and Inverness does not retain any rights to any Debiotech Intellectual Property under such agreement.

8.3 No Litigation . Each Party represents that there is no actual, pending or, to the best knowledge of such Party, threatened action, suit, proceeding or investigation against or affecting it or any of its assets (including, with respect to Debiotech, Debiotech Intellectual Property and, with respect to Animas, the License Shares) before or by any court or arbiter or any governmental authority which would prohibit or interfere with such Party performance of its duties under this Agreement.

8.4 No Intellectual Property of Third Parties . Debiotech represents that, to the best knowledge of Debiotech, there is no Valid intellectual property owned by any third party which would restrict Animas from making, using and selling Debiotech Pump System (as defined in the Specifications) in the Field throughout the world under the License in accordance with the terms of this Agreement without payment to third parties. Debiotech further warrants that it has not received any communication from third parties (i) notifying it that the Debiotech Pump System might infringe intellectual property rights of any third party, or (ii) questioning the ability of Debiotech Intellectual Property to adequately prevent third parties from duplicating the Debiotech Pump System without infringing.

8.5 Ownership of Intellectual Property . Debiotech represents that it owns (whether by ownership directly or through licensed rights) the Licensed Patents described in Exhibit A, free and clear of any claims of any third party. Debiotech represents that,


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to the best knowledge of Debiotech, it owns (whether by ownership directly or through licensed rights) all of the intellectual property necessary or useful for the development of the Debiotech Pump System under the Development Program, including without limitation, the Debiotech Intellectual Property, free and clear of any claims of any third party. Debiotech represents (i) that, to the best knowledge of Debiotech, none of such intellectual property infringes or misappropriates any intellectual property rights or other property rights of any third party other than third parties identified in (v) below that have licensed relevant technology to Debiotech; (ii) that no intentional misrepresentations were made in any applications for patents included within Debiotech Intellectual Property; (iii) that all such patent applications have been made in good faith; (iv) that Debiotech does not have any knowledge of any factors which would compromise the validity of any of the Licensed Patents; and (v) that, to the best knowledge of Debiotech, with exception of the license dated August 1992 from ****** to Debiotech (the “ ****** License ”) and the ****** License, Debiotech does not possess, nor does it currently require, any other third party license(s) to make, sell, use and/or import the Debiotech Pump.

8.6 Authorization to License . Debiotech represents that Debiotech is legally authorized to license, on a worldwide basis, all Licensed Patents, including those identified as “****** patents” and covenants to protect Animas from any recourse made by ****** (the patents assignee) as evidenced by the estoppel letter described in Section 8.7 of this Agreement. Debiotech also represents that it is legally authorized to sub-license, on a worldwide non-exclusive basis, the ****** License.

8.7 ****** Intellectual Property. Debiotech, at its sole expense, shall arrange for Animas to receive an estoppel letter, in form and substance reasonably satisfactory to Animas, from the owner of the intellectual property licensed to Debiotech under the ****** License, confirming, among other things, that Animas may use the License without obligation to pay any royalties to ****** or any third party and that such owners will look solely to Debiotech for payment of any royalties owing to them as a result of Animas’ exploitation of the License.

8.8 License under Future Patents . Debiotech represents and covenants that Animas shall be granted exclusive worldwide license rights, under any future patents of Debiotech (in furtherance of Sections 13.1 and 13.2 of this Agreement) or of ****** to the extent such future patents are included within Debiotech Intellectual Property for use in the Field.

8.9 Feasibility of Development Program . Debiotech represents that it reasonably believes that the Development Program can be successfully completed within the timeframes set forth in this Agreement and the manufacturing costs set forth in Exhibit B.


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8.10 Data . Debiotech represents that all test data presented to Animas during the due diligence are correct, accurate and true.

8.11 Indemnification . Debiotech shall indemnify, defend and hold harmless Licensees, their respective successors and assigns, and their respective agents, officers, employees, representatives and directors from and against claims made against them by third parties, including any and all actions, suits, damages, claims, loss or liabilities (including, without limitation, reasonable attorneys’ fees and costs of collection) arising out of or caused by a breach by Debiotech of any of its representations made in this Article 8. Notwithstanding the foregoing, Debiotech’s indemnification obligations set forth in this Section shall not apply with respect to any claims by Licensees that Debiotech Intellectual Property infringes the intellectual property of such Licensee.

Licensee shall promptly notify Debiotech of such claim. Debiotech shall have the right to assume and control the defense, direct the investigation, and control the settlement of each such claim, provided that, Debiotech shall not settle the claim or otherwise consent to a judgment relating to such claim without the prior written consent of the Licensee (such consent not to be unreasonably withheld or delayed). Licensee shall be permitted to participate to any proceedings at its own expense.

Debiotech and Licensee shall fully cooperate with each other in connection with the defense of such claim, including by furnishing all available documentary or other evidence as is reasonably requested by the other.

If Debiotech elects not to settle or defend such claim, the Licensee shall (at the expense of Debiotech) have the right to assume the defense of such claim and shall have the right to settle (with the prior written consent of Debiotech, such consent not to be unreasonably withheld or delayed).


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9. Limitations of Liability

 

9.1   

EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, ORAL OR WRITTEN, EXPRESS OR IMPLIED, ARISING FROM COURSE OF DEALING, COUSE OF PERFORMANCE, USAGE OF TRADE, OR OTHERWISE, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR TITLE.

 

 

9.2   

EACH PARTY’S TOTAL AGGREGATE LIABILITY FOR DAMAGES UNDER THIS AGREEMENT SHALL UNDER NO CIRCUMSTANCES EXCEED $ 5 MILLION, EXCEPT AS PROVIDED BELOW (PROVIDED THAT DEBIOTECH’S LIABILITY FOR DAMAGES SHALL BE


 
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