|
|
Legal Resources
Business Contracts
MCLE Courses
Projects
Friends
|
Sample Business ContractsHome: Sample Business Contracts: Collaboration Agreement THIS AGREEMENT (Agreement) is made as of the 11th day of October, 2002 (the Effective Date) and is by and between Applera Corporation, a Delaware corporation, acting through its Applied Biosystems Group, with a place of business at 850 Lincoln Center Drive, Foster City, CA 94404, U.S.A. (ABI), and Cepheid, a California corporation with its principal place of business at 904 Caribbean Drive, Sunnyvale, CA 94089 (Cepheid). Cepheid and ABI are sometimes referred to herein individually as a Party, and collectively as the Parties. 1. Background 1.1 Supply to the USPS. ABI and Cepheid will each independently and working collaboratively seek to develop and manufacture Products for use in Bio-Threat Agent Detection Systems. These Bio-Threat Agent Detection Systems are intended to be provided to the USPS through agreements among the USPS, Northrop Grumman Security Services (Northrop Grumman), ETG (Environmental Technology Group, now known as Smiths-Detection Edgewood, Inc.), and/ or Cepheid, and potentially others. These Bio-Threat Agent Detection Systems are intended to be used in conjunction with the mail sorting machines used by the USPS, in order for the USPS to test for particular bio-threat agents identified as being of interest to the USPS. 1.2 ABI Materials. The systems that are being provided are based on an assay called the 5 nuclease detection process, a process employing in part the polymerase chain reaction (PCR), herein called Real-Time PCR. Due to licensing constraints imposed by Roche Molecular Systems, Inc. and F. Hoffman La Roche Ltd (collectively, Roche), the owner of some of the patents for the Real-Time PCR process, certain rules must be followed in order for Cepheid and the USPS to be properly licensed under the Real-Time PCR patents as contemplated by this Agreement. [***]ABI owns other rights related to the Real-Time PCR process [***]. 1.3 Intellectual Property Objectives. It is the Parties intention that through this Agreement and the parties existing Thermal Cycler Supplier Agreement obtained from ABI, under which Cepheid is authorized by ABI under certain of the PCR Rights to manufacture and sell thermal cyclers, and under which Cepheid manufactures and sells its GeneXpert® thermal cycler instrument, the Bio-Threat Agent Detection Systems to be sold to the USPS will be fully licensed or otherwise manufactured and sold with all necessary authority under all PCR related intellectual property rights of ABI as well as Roche. 1.4 Prior Work by Cepheid. Cepheid has been working in collaboration with the USPS and Northrop Grumman to develop an initial assay to be used in conjunction with the GeneXpert Module in order to test for certain strains of Bacillus anthracis (anthrax) of interest to the USPS. Those parties have undertaken significant initial validation studies in order to satisfy the requirements of the USPS and, as part of those development activities, certain Third Party Materials have been and are being used. Cepheid and ABI now wish to develop and employ Products in which ABI PCR Materials will be used instead of such Third Party Materials so that certain anticipated advantages of ABI PCR Materials may be realized, but recognize that the already validated initial assay will be used during the initial period of implementation by the USPS. The parties will use their respective commercially reasonable efforts to demonstrate to the USPS that Products using ABI PCR Materials will meet or exceed all USPS requirements and specifications and that such Products should be accepted instead of those using the initial materials. It should be noted, however, that the ultimate decision as to whether to switch to ABI PCR Materials may be within the discretion of the USPS. The Parties have begun to explore the use of ABI PCR Materials and have determined to engage in the Joint Development Program to The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
develop, qualify and validate them for use as the reagent components of Products, so that a new, validated assay using ABI materials and employing their anticipated advantages may be substituted for the initial assay as soon as feasible, preferably within six months of the Effective Date. 1.5 Special Format Assay. An important feature of this program for the USPS is the special format of the reagent kit for performing the assay. Cepheid has developed a method of drying the liquid reagents into a pelletized form. The dried pellets can be placed into a proprietary self-contained cartridge developed by Cepheid, in which the reagents can be reconstituted at the time that the assay is to be performed. The cartridge itself has significant added value, in that it is the vessel in which the anthrax spores are cracked and in which Real-Time PCR is performed. 1.6 Purpose. The Parties wish to enter into this Agreement to set forth the terms and conditions under which development of the initial validated system described above will be completed, development of second generation Products will be undertaken, and designated systems will be manufactured and supplied to the USPS by ABI, either directly or through Cepheid as a distributor of ABI, or Northrop Grumman or another Third Party or Third Parties distributors or subdistributors. Now therefor, the Parties, in consideration of the mutual obligations hereinafter set forth and intending to be legally bound, hereby agree as follows: 2. Definitions. Within the meaning of this Agreement: 2.1 ABI PCR Materials means reagents or reagent components, including labeled and unlabeled oligonucleotides (such as, without limitation, primers and probes) used in or useful for Real Time PCR, and the polymerase used for the Real Time PCR that ABI supplies to Cepheid as the packer of Cartridges pursuant to the Cartridge Packing Agreement for incorporation and use by the USPS in the Bio-Threat Agent Detection Systems of which Products are a component, and that ABI manufactures itself or that, on or after the date that Second Generation Products are fully substituted for initial Products as the Products that are manufactured and sold to the USPS pursuant to the Distributor Agreement, ABI sources itself or selects and designates as the Materials to be included in Products. Without limiting the scope of other materials excluded from the definition of ABI PCR Materials, the Parties understand and agree that specifically excluded from ABI PCR Materials are reagent and reagent components (but not the polymerase, which in all cases is included in ABI PCR Materials) that Cepheid has obtained from the supplier or suppliers used by Cepheid for such materials as of the Effective Date, even if ABI obtains such reagents and reagent components from such suppliers or other suppliers and supplies them to Cepheid pursuant to the Cartridge Packing Agreement, except for such of such reagent and reagent components, if any, as ABI specifically selects and designates to be included in Second Generation Products. 2.2 Affiliate of a Party or other person or entity means any corporation, firm, partnership or other entity, whether de jure or de facto, which directly or indirectly owns, is owned by or is under common ownership with such Party or other person or entity to the extent of more than fifty percent of the equity having the power to vote on or direct the affairs of the entity, or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction. 2.3 Authorized Use means use by the USPS for the detection of anthrax, and such other bio-threat agents as the Parties may agree in writing are bio-threat agents to be detected by Products, in the environment in accordance with the label license set forth in Section 6.3, or such other label license or limitations as ABI may designate (provided that the Authorized Use stated on the label license set forth in Section 6.3 is not diminished) or the Parties may agree upon in writing and which is applicable to the USPS use of Products. Authorized use shall not mean use for human diagnostic or therapeutic purposes. The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
2.4 Background ABI Intellectual Property means all Intellectual Property Rights that are owned by, either partially or wholly, ABI, or are licensed to, or otherwise controlled by, ABI, excluding only Collaboration Joint Intellectual Property. 2.5 Background Cepheid Intellectual Property means all Intellectual Property Rights that are owned by, either partially or wholly, Cepheid, or are licensed to, or otherwise controlled by, Cepheid, excluding only Collaboration Joint Intellectual Property. 2.6 Bio-Threat Agent Detection System means the combination of Cartridges, GeneXpert Modules and Materials, and other associated materials, if any, obtained by Cepheid from Third Parties, capable of carrying out Real-Time PCR based analysis for the purpose of environmental detecting or identifying designated pathogens or biological agents, including without limitation viral and bacterial agents. The initial implementation of a Bio-Threat Agent Detection System is intended to be within the system being developed for the USPS by a consortium led by Northrop Grumman. 2.7 Cartridge means a closed or substantially closed plastic device containing, among other things, pelletized or dried reagents that is intended for single or multiple use sample preparation and PCR based DNA analysis and that is intended and suitable for insertion into, or use as a part of, or is a part or component of, or an attachment to, an instrument designed to hold such device and/or facilitate or enable its use, which instrument Cepheid manufactures or has manufactured, including without limitation the instrument currently named Cepheids GeneXpert Instrument that includes one or more GeneXpert Modules, or that can be used alone or with other instruments or devices for such purpose. 2.8 Cartridge Packing Agreement means the cartridge packing agreement to be executed by the Parties concurred with or shortly after the execution and delivery of this Agreement, as more fully described in Section 3.2. 2.9 Collaboration ABI Intellectual Property means all Intellectual Property Rights arising out of work performed under this Agreement or in furtherance of this Agreement during the term of this Agreement that are conceived solely by one or more employees or agents of ABI or its Affiliates, or solely by one or more employees or agents of ABI or its Affiliates and one or more employees or agents of a Third Party. 2.10 Collaboration Cepheid Intellectual Property means all Intellectual Property Rights arising out of work performed under or in furtherance of this Agreement during the term of this Agreement that are conceived solely by one or more employees or agents of Cepheid or its Affiliates, or solely by one or more employees or agents of Cepheid or its Affiliates and one or more employees or agents of a Third Party. 2.11 Collaboration Joint Intellectual Property means all Intellectual Property Rights arising out of work performed by Cepheid under this Agreement or in furtherance of this Agreement, or out of work performed by ABI under this Agreement, that are jointly conceived by one or more employees or agents of Cepheid or its Affiliates and by one or more employees or agents of ABI or its Affiliates. 2.12 Confidential Information means confidential knowledge, Know-how, practices, processes, products, materials, equipment or information that a receiving Party has a reasonable basis to believe is confidential to the disclosing Party or is treated by the disclosing Party as confidential. Notwithstanding the above, Confidential Information will not include, and nothing in Section 9 will in any way restrict the rights of either Party to use, disclose or otherwise deal with, any information which: The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
2.13 Distributor Agreement means the distributor agreement to be entered into by the Parties concurrently with or promptly after the execution of this Agreement, which will provide, among other terms and conditions, the terms and conditions set forth in Section 3.3. 2.14 Dry Down Process means the dry down and pelletization process utilized by Cepheid to dry down and insert or pack Materials into Cartridges. 2.15 FTEs shall mean full time employee equivalents of labor, based on a standard work day. One FTE shall be one employee of a Party working one day, or eight hours worked collectively by more than one employee of a Party. One FTE for a year shall be one employee working each work day in a year, exclusive of holidays and vacation time determined in accordance with the employers customary policies and procedures. For the purposes of this definition of FTEs only, the term employee shall include an individual who is a consultant to a Party who is subject to a written agreement with such Party that assigns to such Party all of such individuals right, title and interest in and to his or her work product, including without limitation all Intellectual Property Rights arising out of work performed for such Party. 2.16 GeneXpert® Module means a thermally controlled fluorometric thermal cycling or other type of instrument capable of carrying out or facilitating a sample preparation procedure, as well as a Real Time PCR assay, in or with the use of a Cartridge. The GeneXpert Module comprises the instrument portion of Cepheids Bio-Threat Agent Detection System. 2.17 Intellectual Property Rights means all intellectual property rights worldwide arising under statutory or common law, whether or not perfected, including, without limitation, all (1) patents, patent applications and patent rights; (2) rights associated with works of authorship including copyrights, copyright applications, copyright registrations, mask works, mask work applications and mask work registrations; (3) rights relating to the protection of trade secrets and confidential information; (4) any right analogous to those specifically set forth in this definition and any other proprietary rights relating to intellectual property (other than trademark, trade dress, or service mark rights); (5) divisions, continuations, continuations-in-part, renewals, reissues, re-examinations, continuing prosecution, and extensions of the foregoing existing at a time in question, or thereafter filed, issued or acquired; and (6) Know-how. 2.18 Joint Development Program means the joint development program of the Parties under which the Parties, pursuant to Section 4 of this Agreement, will use commercially reasonable efforts to further develop to the extent deemed necessary by the Parties initial Products, and to develop Second Generation Products that employ ABI PCR Materials. Initially, under the Joint Development Program the Parties shall explore the use of TaqMan® reagents as substitutes for the reagents used in the initial Products. The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
2.19 Know-how means confidential and/or proprietary technical information, techniques, processes, methods, data, assays, substances and materials, and other information in a partys possession that is not generally available to the public. 2.20 Liability has the meaning set forth in Section 11.2. 2.21 Manufacturing Cost means the fully-burdened manufacturing cost of a product as determined using a Partys customary practices and procedures and, to the extent applicable, in accordance with Generally Accepted Accounting Principles in the United States (GAAP), including the following: direct material cost, material overhead cost, direct labor cost, fixed manufacturing overhead cost, variable manufacturing overhead cost, cost of quality control and product testing, manufacturing variance cost and other costs that may be properly attributed to inventory as manufacturing costs pursuant to GAAP, but excluding royalties or similar consideration paid to Third Parties for rights to Intellectual Property Rights, including up-front payments for such rights, even if any such royalties or other payments are included in fully burdened manufacturing cost in accordance with a Partys customary practices and procedures and, to the extent applicable, GAAP). In determining Manufacturing Cost, the manufacturing Party shall take into account, in accordance with GAAP to the extent applicable and in accordance with such Partys normal and customary practices and procedures, including without limitation consideration of risks and uncertainties associated with projections related to the Products in question, projections of sales of such Products for at least a twelve month period made in good faith by ABI, in consultation with Cepheid, in accordance with its normal and customary procedures. Manufacturing Cost of Products will be established and reestablished based upon projections for a period of not less than the next upcoming twelve month period, may be changed no more frequently than Quarterly (and any new Manufacturing Cost will be effective only as of the first day of a Quarter), and any new Manufacturing Cost of Products will not be applied except upon a minimum of sixty (60) days prior notice from the manufacturing Party to the other Party, unless the Parties otherwise agree. 2.22 Materials means reagents and reagent components, including without limitation labeled and unlabeled oligonucleotides (such as, without limitation, primers and probes) used in or useful for Real Time PCR and the polymerase used for the Real Time PCR reaction, including without limitation ABI PCR Materials, reconstitution buffers or solutions, and any other consumable products, limited life products or other products that are contained in or are a part of and are sold with a Cartridge, and any such items and any other consumable products or limited life products, if any, that are not contained in or are a part of, or are not sold with Cartridges, that are used in connection with the use of a Cartridge when the Cartridge is used for Real-Time PCR analysis. Specifically excluded from the definition of Materials is the GeneXpert Module, which Cepheid will sell to USPS either directly or by way of the Smiths Industries/Northrop Grumman supply chain or other Third Parties. 2.23 Net Sales means the actual amount received from sales of Products to Third Parties and, unless sold for resale, Affiliates of a Party, less: trade, cash and quantity discounts, if any, actually allowed, other allowances actually applied, amounts refunded for faulty or defective product, returns, rejections, bad debt determined and applied in accordance with the selling Partys normal and customary policies and procedures and, to the extent applicable, GAAP, freight, insurance and other transportation costs, tariffs, duties, sales tax, and similar governmental charges paid (except income taxes) paid with respect to the Products sold. It is understood and agreed that sales or other distribution of Products may only be made to the USPS or to a Third Party or an Affiliate of a Party for sale to and use by the USPS. 2.24 Other Chemical Materials means reagents and reagent components, used in or useful for Real Time PCR (but not the polymerase used for Real Time PCR, which is in all cases an ABI PCR Material), reconstitution buffers or solutions, and any other consumable chemical products, limited life chemical products or other chemical products that are contained in or are a part of and are sold with a Cartridge, and any such chemical items and any other consumable chemical The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
products or limited life chemical products that are not contained in or are a part of, or are not sold with, Cartridges, that are used in connection with the use of a Cartridge when the Cartridge is used for Real Time PCR, excluding, in every case, ABI PCR Materials. 2.25 PCR Rights means the following patents: those of Roche Molecular Systems, Inc. and F. Hoffmann-La Roche Ltd : United States Patent Nos. 4,683,202, 4,683,195, 4,965,188, 5,210,015, 5,487,972, 5,476,774, and 5,219,727, and corresponding foreign counterpart patent claims, and Roches United States Patent No. 5,804,375 (Claims 1-12) and foreign counterpart claims, covering 5 Nuclease reaction mixtures; and those of Applera Corporation: United States Patent Nos. 5,538,848, 5,876,930, 6,030,787, 6,258,569 B1 and 5,656,493, and corresponding foreign counterpart patent claims. 2.26 Products means Cartridges containing or employing Materials, including without limitation, in all cases, the polymerase necessary to perform a PCR assay constituting an Authorized Use in combination with all such other reagents, enzymes and other materials as are necessary to perform such PCR assay. 2.27 Quarter means a fiscal quarter of a Party, in each case an approximately three month period beginning on or about the first day of January, April, July or October next following the Effective Date, and each three month period thereafter, except that the first Quarter will include the period from the Effective Date to the first day of the nearest such three month period after the Effective Date. Precise dates for the beginning and ending of Quarters may vary in accordance with a Partys customary accounting practices and procedures in accordance with GAAP. Upon a Partys request, the other Party will provide the requesting Party with a schedule of the replying Partys fiscal Quarters. 2.28 Real Time PCR means using the 5 nuclease detection process in the practice of PCR as is described and claimed in ROCHEs United States Patents Nos. 5,210,015 and 5,487,972. 2.29 Residual Revenue means [***] from sales of Products during a Quarter by Cepheid, less (i) unless otherwise expressly set forth in this Agreement, [***] and (ii) [***] (iii) such other amounts as the Parties expressly agree in writing are to be deducted from Net Sales for the purpose of determining Residual Revenues. 2.30 Second Generation Products means Products containing and employing for the identification of bio-threat agents dyes and quenchers that are manufactured by ABI or, if not manufactured by ABI, that are specifically identified as second generation dyes and quenchers by ABI in a writing to Cepheid. 2.31 Third Party means a person or entity that is not a Party or an Affiliate of a Party. 2.32 Work Plan means a plan of action to accomplish the goals of the Joint Development Program. 3. The Initial Reagent Product Supply 3.1 Initial Product Unchanged. Until such time as the parties have completed their joint development of Second Generation Products, the initial Products manufactured for the USPS will be the validated initial Products described above under Background. It is intended that ABI will source the labeled oligos component of such initial Products from the supplier used by Cepheid as of the Effective Date. ABI will also use commercially reasonable efforts to provide[***], or its equivalent, as required for the manufacture of Products. ABI, through Cepheid as its contract packer of Cartridges, will then dry and pelletize the oligos and [***]or equivalent and seal the Cartridges for shipment. The parties will jointly work out a delivery schedule for the oligos and [***]commensurate with the manufacturing capabilities of the supplier used by Cepheid as of the Effective Date and the delivery schedule desired by the USPS. The specifications for the initial The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
validated Products shall be those agreed upon by the Parties, and shall be based on and include the validated specifications accepted by the USPS, except to the extent the Parties otherwise agree. Cepheid will use commercially reasonable efforts to pack Cartridges and ensure that Products meet such specifications. Cepheid will purchase Materials for such initial Products from ABI, unless ABI is unable to supply such Materials to Cepheid, in which case Cepheid may purchase such Materials, except polymerase, from Third Parties. 3.2 Cepheid Appointed as ABI Contract Packer of Cartridges. ABI will engage Cepheid to be its exclusive packer of Cartridges for sale to or for the use of the USPS for USPS use in Bio-Threat Agent Detection Systems, pursuant to the Cartridge Packing Agreement. ABI and Cepheid will execute the Cartridge Packing Agreement, containing such terms upon which the Parties may mutually agree in each of their sole discretion, concurrently with or promptly after the Effective Date. In general, under the Cartridge Packing Agreement, Cepheid will dry down and pelletize the necessary Materials, pack them into Cartridges, complete packaging of the Cartridges, and store and maintain same subject to the order of ABI. ABI will manufacture or source and furnish to Cepheid for packing all necessary polymerase and all reagents, enzymes and other materials necessary to perform the anthrax assay or such other assays as the Parties agree Products will perform. All Products shall labeled as ABI Products as more fully set forth in Section 5.6 and will be labeled and distributed with appropriate label licensing statements, as provided in Section 6.3. The price Cepheid may charge ABI for its packing services shall be capped as set forth in Section 7.7. 3.3 Cepheid Appointed Distributor. ABI will engage Cepheid to be its exclusive distributor of Cartridges and associated Materials for sale to the USPS or a Third Party for resale to the USPS, and use by the USPS in Bio-Threat Agent Detection Systems, pursuant to the Distributor Agreement. The Distributor Agreement shall contain such terms and conditions upon which the Parties may agree in each of their sole discretion, and shall provide that the transfer price of finished Products sold by ABI to Cepheid as distributor [***], provided that such price charged to Cepheid as distributor shall not exceed [***]. The Distributor Agreement shall also provide that Cepheid must inform ABI of the price of Products to the USPS, the end-user, as ABIs royalty to Roche is based on such price. 3.4 Initial Product Intellectual Property Issues. In order to avoid unnecessary liability, the parties will work together to seek to identify any Intellectual Property Rights required to manufacture and distribute Products and seek to resolve same to their mutual satisfaction. [***] 4. Joint Development Program for Second Generation and Later Products 4.1 Costs; Diligence
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
4.3 Joint Steering Committee
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
5. General Intellectual Property 5.1 Ownership of Intellectual Property, Certain Infringement Actions Regards Collaboration Joint Intellectual Property.
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
5.2. Filing of Patent Applications.
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
5.3 Interfering Third Party Intellectual Property. If a Party believes that any activities within the Joint Development Program infringe any Intellectual Property Rights of a Third Party, that Party will promptly notify the other Party, and the Joint Steering Committee will seek to agree upon the appropriate response to be taken. 5.4 Patent Litigation.
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
5.5 Effect of Bankruptcy. All rights and licenses granted under this Agreement by one Party to the other Party are, and will irrevocably be deemed to be, intellectual property as defined in Section 101(56) of Title 11, U.S. Code (Bankruptcy Code). In the event of the commencement of a case by or against either Party under any Chapter of the Bankruptcy Code, this Agreement will be deemed an executory contract and all rights and obligations hereunder will be determined in accordance with Section 365(n) thereof. 5.6 Branding, Trademarks and Non-Proprietary Names. Products distributed to end users will be branded in such a manner that both Partys logotypes will appear with approximately equal weight and size on all packaging, product inserts and accompanying literature, except to the extent the Parties otherwise agree. Unless otherwise agreed, the logotypes and brands on Products will appear approximately as follows on all packaging, labels and product inserts:
All representations of a Partys Marks that the other Party intends to use will first be submitted to such other Party for approval (which will not be unreasonably withheld or delayed) of design, color and other details. The Joint Steering Committee, at equally shared expense between each Party, will be responsible for the selection, registration and maintenance of all trademarks that it employs to name or identify Products, and both Parties will own and control such trademarks jointly. Each Party hereby grants to the other Party a non-exclusive right and license to use the marks, trade names (including without limitation the names Cepheid and Applied Biosystems) and logos (collectively, Marks) that the Parties by mutual agreement may employ from time to time with respect to Products in connection with Cepheids contract manufacture and ABIs sale and distribution of Products. Except as set forth in this Section 5.6, nothing contained in this Agreement will grant to either Party any right, title or interest Marks of the other Party. Each Party hereby agrees to defend and indemnify the other Party and hold it harmless against claims by a Third Party that the use by the other Party of a Mark owned by a Party in a manner expressly authorized by such Party in writing infringes intellectual property rights of such Third Party. 6. PCR and Thermal Cycler Licensing, Royalties to Roche, to ABI, and to Third Parties 6.1 General Explanation of ABIs Licensing Program. PCR is a proprietary technology covered by several U.S. patents, including U.S. Patent Nos. 4,683,195, 4,683,202, and 4,965,188, and by issued and pending counterpart patents outside the U.S that are licensed to ABI or its Affiliates. These patents are owned by Roche Molecular Systems, Inc. a wholly owned subsidiary of the F. Hoffmann La Roche Company, and are exclusively licensed to the Applera Corporation for automated practice in the field of research and other applications other than human diagnostics. Certain sublicenses to these patents are administered through Applera Corporations ABI Group. These sublicenses under the PCR process patents are for automated performance of the PCR process for research and for other designated fields, and include as one component an up-front fee payable for each thermal cycler used to perform the PCR process. This establishes a The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
Thermal Cycler Authorization. The expression Authorized means that the users up-front license fee has been paid. ABI grants rights to thermal cycler manufacturers to include the Authorization with their thermal cyclers, and to permit manufacturers to sell their instruments for PCR and to promote their instruments as Authorized for PCR. Under the terms of ABIs license, manufacturers who pay the fee do not induce infringement by promoting and advertising their instruments for PCR, selling to PCR users and supporting such use. In addition, ABI owns patents that disclose and claim PCR thermal cycler apparatus, automated methods for performing PCR in thermal cyclers, and systems comprising thermal cyclers loaded with PCR reagents and programmed to perform a PCR protocol. A number of these patents have issued to Applera in Europe, the U.S. and elsewhere in the world. The running-royalty component of the PCR license required for a user to perform internal research and development activities is obtained through the users purchase and use of thermostable polymerase purchased from a manufacturer licensed by Roche to sell such polymerase. The rights under this component of this license are conveyed generally through a label license accompanying the polymerase. 6.2 Application of the PCR Licensing Program to this Agreement.
6.3 Label License Statements. The following label license, or such other label license a ABI may designate, shall accompany all Products sold:
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
Product literature or other documents may state that the Cepheid GeneXpert Module is an authorized thermal cycler within the meaning of the foregoing label license, as long as such statement is true. 6.4 Royalty Payments to Roche, ABI, and Third Parties.
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
6.5 No Express or Implied License. It is expressly understood and agreed that nothing contained in this Agreement, the Cartridge Packing Agreement or the Distribution Agreement shall be deemed to grant to Cepheid a right or license to manufacture ABI PCR Materials or to practice any claims of the PCR Rights. The foregoing shall not be deemed to limit Cepheids rights to properly use properly labeled Materials as an end user, or Cepheids rights under its TCSUP with ABI. 7. Exclusivity, No Implied Licenses, Sales, Value Sharing 7.1 Exclusivity. During the term of this Agreement, neither Party nor its Affiliates directly or indirectly will market, sell, or distribute any Products containing ABI PCR Materials, or Products the manufacture, sale or use of which would require PCR Rights, to the USPS or for use by or for the benefit of the USPS for the detection of anthrax or other bio-threat agents that the Parties have agreed in writing are intended to be detected by Products except in accordance with the terms and conditions of this Agreement. 7.2 No Implied Licenses. No license or other right is granted or is to be construed as being granted hereunder by one Party to the other Party, whether express, implied, or by estoppel, to any Intellectual Property Rights, or to trademark, trade dress, or service mark rights, or any other intellectual property rights, owned, used, licensed to, or otherwise controlled by, a Party, except solely for the purposes of manufacturing and selling Products to or for the use of the USPS as expressly set forth in this Agreement. 7.3 Sales of Products; Approval of Sales Agreement. Cepheid shall be responsible for sales of Bio-Threat Agent Detection Systems, including as a distributor of Products purchased from ABI, to the USPS, either directly or through Northrop-Grumman or another Third Party selected by Cepheid. Cepheid will use commercially reasonable efforts to execute a sales agreement covering the sales of Products to or for the use of the USPS (that is, an agreement covering Products but not GeneXpert Modules, which Cepheid will seek to make the subject of a separate agreement). [***] Cepheid shall not under any circumstances enter into any agreement with the The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
USPS or any Third Party or any other party, and any amendment of any such agreement entered into, for the sale or other distribution of Products without the express written consent of ABI. Cepheid will use its reasonable best efforts to cause any such agreement to name ABI as a named third-party beneficiary under the Agreement. Cepheid shall deliver copies of drafts of any proposed agreement covering Products to ABI for review and comment, and shall deliver to ABI, at least [***]before execution thereof by the parties thereto, or such shorter time to which ABI may agree, the final proposed form of such Agreement. [***]Cepheid shall promptly notify ABI of any claim of breach of such agreement by the USPS, Northrop Grumman, or the Thirty Party thereto, and promptly furnish to ABI copies of any writing notifying Cepheid of or relating to any such breach. Any sales agreement shall provide that Cepheid be informed of the price of Products to the USPS, the end-user, so that Cepheid may inform ABI, as ABIs royalty to Roche is based on such price. 7.4 Sales Forecasts. In its role as distributor of Products to the USPS, Cepheid shall immediately prior to the beginning of each Quarter provide to ABI a rolling forecast of projected sales for each of four quarters into the future. These forecasts will be based on reasonable commercial efforts by Cepheid to estimate future sales, and will be updated at the beginning of each month for the current quarter. 7.5. Pricing. The price for Products to the USPS, or Northrop-Grumman or other Third Party, as the case may be, shall be determined by Cepheid in its sole discretion. If Products are sold together with GeneXpert Modules, or as part of Bio-Threat Agent Detection Systems, the price paid for Products to be used in the determination of Net Sales shall be deemed to be the higher of any price for the Products that is separately stated in connection with the sale, Cepheids then retail list price for the Products sold, or the Net Sales amount received for the sale less the deemed price of the GeneXpert Modules sold, with such deemed price being the higher of Cepheids retail list price therefor or the average price paid for the then most recent five GeneXpert Modules sold as independent units. 7.6 Value Sharing. Payment to ABI of [***]Promotional Products. Each Party shall be entitled to [***]realized upon the sale of Products. It is understood and agreed that ABI will appoint Cepheid as its distributor of Products to the USPS, or to a Third Party for resale to and use by the USPS, pursuant to the terms of the Distributor Agreement. Accordingly, the Parties agree that to administer the above value sharing agreement, [***]It is understood and agreed that Cepheid may distribute products for no or for de-minimus consideration for promotional or testing purposes. Cepheid agrees that the amount of Products distributed for such purposes in any twelve (12) months period shall not exceed one percent (1%) of the aggregate number of Products sold for more than de-minimus consideration during such twelve (12) month period, unless ABI otherwise agrees. It is also understood and agreed that certain Products or parts thereof may be furnished to the USPS or its designees for validation purposes, with or without consideration, and nothing in this Section 7.6 shall be deemed to restrict Cepheid from providing a reasonable amount or number of Products or parts thereof for such purposes. 7.7 Cap on Manufacturing Cost. Notwithstanding anything contained in this Agreement to the contrary, for the purposes of [***]The Parties understand and agree that the initial Cartridge for the anthrax assay is capable of effectively performing one assay for one bio-threat agent, namely, anthrax. [***]If the Joint Steering Committee fails to agree on [***]shall be deemed a dispute and the matter shall be determined by arbitration as set forth in Exhibit 13,18. [***] 7.8 Reimbursement and Payment Process. Prior to the shipment of any revenue-generating Products, and on or about each anniversary thereafter on a date set by the Joint Steering Committee, and at any time there is a significant change in a Product being shipped, each Party will make a good faith estimate of [***] Within thirty (30) days after the end of each Quarter, Cepheid will submit to ABI a written itemized accounting and report of Products sales, Manufacturing Costs and royalties paid containing such information as ABI may reasonably request from time to time, but at a minimum setting forth the number and types of Products sold The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
during the Quarter, the net amount billed therefor, the revenue received, [***]Based on that report, Cepheid will calculate the actual amount due to each Party and depending on the results either pay any balance due to ABI within forty five (45) days after the end of the Quarter, or issue an invoice to ABI for moneys due, which invoice ABI shall pay within thirty (30) days of receipt. 7.9 Books and Records; Audit. Using a Partys customary practices and procedures in accordance with GAAP, each Party will keep and maintain proper and complete records and books of account sufficient in detail to enable the verification of monies spent and received by each Party, and Manufacturing Cost of and subject royalties paid by each Party, in connection with each Partys obligations under this Agreement. The books and records will be retained for a period of at least 6 years after the end of the period for which such books and records pertain. Each Party will have the right from time to time (not to exceed once per calendar year) during normal business hours and upon 2 weeks prior written notice, to inspect in confidence, or have an agent, accountant or other representative inspect in confidence, such books and records of the other Party. The Party initiating the inspection will bear the costs thereof unless the inspection reveals a discrepancy unfavorable to that Party of at least 10%, in which case the other Party will pay the costs of the inspection. If the inspection results in a final determination that amounts have been overstated or understated, the applicable amount will be refunded or paid promptly by the appropriate Party. The inspecting Party will treat all information learned in the course of any audit or inspection as Confidential Information, and will maintain such Confidential Information in strict confidence, except to the extent necessary for the Party to reveal such information in order to enforce its rights under this Agreement or if disclosure is required by law. Any public accounting firm shall sign a customary confidentiality agreement as a condition precedent to their inspection, and shall report to the inspecting Party only its conclusion with such other information at the firm deems necessary by way of explanation. 8. Confidentiality 8.1 Non-Disclosure; Non-Use. Because Cepheid and ABI will be cooperating with each other under this Agreement, each may reveal Confidential Information to the other. The Parties agree, by using the same degree of care as each uses for its own information of like importance, but not less than a reasonable degree of care, to hold in confidence any Confidential Information disclosed by the other Party hereunder, and not to disclose any Confidential Information of the other Party to any Third Party or, except as provided below, to any Affiliate, and not to use any Confidential Information disclosed by the other Party hereunder for any purpose other than carrying out its obligations under this Agreement (including, without limitation, furthering the Joint Development Program and this Collaboration), without the express written consent of the other Party. Each Party will disclose Confidential Information only to its employees or agents who have a need to know same for such purpose. With respect to any Confidential Information that is revealed by a Party to the other Party, the confidentiality and non-use requirements of this Section 8 will remain in force for a period of 5 years following the date the Confidential Information is disclosed, or 2 years after the expiration or termination of this Agreement, whichever is later. 8.2 Responsibility over Employees and Agents. Each Party will assume individual responsibility for the actions and omissions of its respective employees, agents and assigns, and to inform same of the responsibilities for confidentiality and non use under this Agreement, and to obtain their agreement to be bound in the same manner that the Party is bound. 8.3 Affiliates. Nothing herein will be construed as preventing either Party from disclosing any information to an Affiliate of ABI or Cepheid for the purpose of furthering the Joint Development Program or carrying out its obligations under this Agreement, provided such Affiliate has undertaken a similar obligation of confidentiality and non use with respect to the Confidential Information. The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
8.4 Bankruptcy. All Confidential Information disclosed by one Party to the other will remain the intellectual property of the disclosing Party. A bankrupt or insolvent Party will, to the extent permitted by law, take all steps necessary or desirable to maintain the confidentiality of the other Partys Confidential Information and to ensure that any court or other tribunal maintain such information in confidence in accordance with the terms of this Agreement. In the event that a court or other legal or administrative tribunal, directly or through an appointed master, trustee or receiver, assumes partial or complete control over the assets of a Party based on the insolvency or bankruptcy of such Party, the bankrupt or insolvent Party will promptly notify the court or other tribunal
8.5 Publication. Neither ABI nor Cepheid will submit for written or oral publication any manuscript, abstract or the like that includes data or other information generated and provided by the other Party or otherwise developed by either Party under the Joint Development Program without first obtaining the prior written consent of the other Party, which consent will not be unreasonably withheld or delayed. If written consent or written denial is not provided by the other Party within 90 days, the first Party will have the right to publish. But, the foregoing will not apply to customary literature that is prepared for marketing and sales purposes and that does not contain Confidential Information of the non publishing Party. 8.6 Compliance with Statutory Requirements. Nothing in this Agreement will be construed as preventing or in any way inhibiting either Party from complying with statutory or regulatory requirements governing the development, manufacture, use, sale, or other distribution, of Products in any manner that it reasonably deems appropriate, including, for example, by disclosing to regulatory authorities Confidential Information or other information received from a Party or Third Parties. However, the Parties will take reasonable measures to assure that no unauthorized use or disclosure is made by persons or entities to whom access to such information is granted under this Section 8.6. 8.7 Non-Solicitation. During the term of the Agreement, and for a period of one (1) year thereafter, a Party will not solicit any person who is employed by or is an exclusive consultant to the other Party and directly involved with the Joint Development Program or this Collaboration to terminate that persons employment by or consultancy to the other Party. As used herein, the term solicit will mean requesting, directly or indirectly, any employee or consultant to terminate his employment by or consultancy to a Party. 8.8 Compelled Disclosure. In the event that a Party (Disclosing Party) is legally compelled (by deposition, interrogatory, request for documents, subpoena, civil investigation demand or similar process) to disclose any Confidential Information, the Disclosing Party will provide prompt prior written notice of such compulsion to the other Party, so that the other Party may seek a protective order or other appropriate remedy or, if appropriate, waive compliance with the terms of this Agreement. In the event that such protective order or other remedy is not obtained, the Disclosing Party will disclose only that portion of Confidential Information that it is advised by opinion of counsel is legally required to be disclosed, or else stand liable for contempt or suffer other censure or penalty, and will exercise its reasonable best efforts to obtain reliable assurance that confidential treatment required hereby will be accorded such Confidential Information; and the Disclosing Party will not be liable for such disclosure unless such disclosure was caused by or resulted from a previous disclosure by the Disclosing Party not permitted by this Agreement. 9. Term and Termination 9.1 Term. Unless terminated earlier as provided in this Section 9, this Agreement will commence on the Effective Date and will remain in full force and effect until the later of fifteen The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
years from the Effective Date or the last to expire of the PCR Rights or any other issued patent owned or licensed to ABI or Cepheid that would be infringed by the manufacture, sale or importation of Products. The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
The symbol [***] is used to indicate that a portion of the exhibit has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portion.
|