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Genentech - Toll Manufacturing Agreement BY And Between Wyeth, Acting Through Its Wyeth Pharmaceuticals Division, And Genentech, Inc. Dated September 15, 2004
EXHIBIT 10.32
TOLL MANUFACTURING AGREEMENT
By and Between
WYETH,
Acting through its Wyeth Pharmaceuticals Division
and
GENENTECH, INC.
TABLE OF CONTENTS
ARTICLE 1.
DEFINITIONS
2
ARTICLE 2.
COMMITMENT TO MANUFACTURE; DEDICATED FACILITY
12
ARTICLE 3.
MANAGEMENT OF PROJECT
13
ARTICLE 4.
TECHNOLOGY TRANSFER; MANUFACTURING PROCESS
IMPLEMENTATION AND OPERATION
20
ARTICLE 5.
COMMERCIAL PRODUCTION AND SUPPLY; DELIVERIES
25
ARTICLE 6.
FINANCIAL TERMS
28
ARTICLE 7.
MANUFACTURER WARRANTIES
30
ARTICLE 8.
SPECIFICATIONS AND MANUFACTURING -- PROCESS CHANGEs
30
ARTICLE 9.
NON-CONFORMING PRODUCT
33
ARTICLE 10.
MANUFACTURING AUDITS; CERTIFICATE OF COMPLIANCE; AND
REGULATORY MATTERS
34
ARTICLE 11.
RECALLS
36
ARTICLE 12.
QUALITY ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY
37
ARTICLE 13.
WYETH'S OBLIGATIONS AS MANUFACTURER
37
ARTICLE 14.
LICENSES
39
ARTICLE 15.
OWNERSHIP OF INTELLECTUAL PROPERTY, MATERIALS AND
EQUIPMENT
40
ARTICLE 16.
REPRESENTATIONS AND WARRANTIES
43
ARTICLE 17.
INDEMNIFICATION AND INSURANCE
44
ARTICLE 18.
LIABILITY
45
ARTICLE 19.
CONFIDENTIALITY
46
ARTICLE 20.
PRESS RELEASES; USE OF NAMES
48
ARTICLE 21.
TERM; TERMINATION
49
ARTICLE 22.
ASSIGNMENT
52
ARTICLE 23.
DISPUTE RESOLUTION
52
ARTICLE 24.
FORCE MAJEURE
53
ARTICLE 25.
MISCELLANEOUS
53
Exhibit A Excluded Patents
58
Exhibit B Countries in Territory
59
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TOLL MANUFACTURING AGREEMENT
This TOLL MANUFACTURING AGREEMENT (the " Agreement ") is made effective as of September 15, 2004 (the " Effective Date "), by and between Wyeth, a Delaware corporation acting through its Wyeth Pharmaceuticals Division having its principal place of business at Five Giralda Farms, Madison, New Jersey 07940 (" Wyeth "), and Genentech, Inc., a Delaware corporation, having its principal place of business at One DNA Way, South San Francisco, California 94080 (" Genentech "). Wyeth and Genentech may each be referred to herein individually as a " Party " and collectively as the " Parties ."
RECITALS
WHEREAS, Genentech markets and sells a certain proprietary biological pharmaceutical product known as Herceptin, and Genentech desires to obtain additional supply of commercial quantities of Herceptin bulk drug substance.
WHEREAS, Wyeth has experience and expertise necessary to perform the manufacturing and related services needed to supply Herceptin bulk drug substance, and Wyeth owns a facility that, with some modifications, would be suitable for production of commercial quantities of Herceptin bulk drug substance.
WHEREAS, Genentech desires to retain Wyeth on a nonexclusive basis, to convert Raw Materials (as defined below) into commercial quantities of Herceptin bulk drug substance, and Wyeth desires to perform such services, all on the terms and conditions set forth in this Agreement.
WHEREAS, on August 11, 2004 the Parties entered into a Letter of Intent (the "LOI") contemplating their entry into this Agreement and the other Transaction Agreements (as defined below) and preliminary activities relating to the Technology Transfer (as defined below) have been initiated by the Parties pursuant thereto.
WHEREAS, on even date herewith, Wyeth and Genentech are entering into a Quality Agreement for the purpose of further effectuating the intent of the Parties hereunder.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1.
DEFINITIONS
The following terms, whether used in the singular or plural, shall have the meanings assigned to them below for purposes of this Agreement.
1.1 " Affiliate " means, with respect to either Party, any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, the term "control" means direct or indirect ownership of fifty percent (50%) or more of the securities or other ownership interests representing the equity voting stock or general partnership or managing membership interest of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, resolution or otherwise, provided, however, that the term "Affiliate" shall not include subsidiaries or other entities in which a Party or its Affiliates owns a majority of the ordinary voting power necessary to elect a majo rity of the board of directors or other governing body but is restricted from electing such majority by contract or otherwise until such time as such restrictions are no longer in effect. Notwithstanding the foregoing, Roche shall not be considered an Affiliate of Genentech for purposes of this Agreement.
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1.2 " Batch " or " Lot " means the quantity of Product produced from a single Run, and refers to a Commercial Batch or Lot, a Development Batch or Lot, a Pilot Batch or Lot and/or a Qualification Batch or Lot, as the context requires. A given Run may result in more than one sub-batch or sub-lot due to splitting into tanks downstream in the Manufacturing Process, but all such sub-batches or sub-lots shall still constitute the same Batch or Lot.
1.3 "Batch Records" means the documentary evidence (electronic or hard copy) of all activities required to manufacture, process, test, label, store and package a Batch.
1.4 "Bill of Materials" means (i) a list of all Raw Materials (including Specialized Raw Materials) and Genentech Proprietary Materials required to complete a Run and (ii) the corresponding quantities (including appropriate amounts of wastage) of such Raw Materials (including an allocable portion of Raw Materials used for multiple Runs (e.g., resins)) and Genentech Proprietary Materials required to complete a Run.
1.5 " Calendar Year " or " CY " means a one (1) year period commencing on January 1st and ending on December 31st.
1.6 " cGMP " means both the regulatory requirements for current good manufacturing practices promulgated by the FDA under the FD&C Act, 21 C.F.R. Sections 210, 211 and 600 et seq . and under the PHS Act, 21 C.F.R. Sections 600-610 and the ICH Guideline for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, as the same may be amended from time to time.
1.7 " Cell Line " means the proprietary Genentech Chinese Hamster Ovary cell line that expresses the Product.
1.8 " Centrifuge " means the [*] Centrifuge that has been purchased by Genentech [*] for use in the Manufacturing Process at the Facility, [*]
1.9 "Certificate of Analysis" means, as further specified in the Quality Agreement, with respect to each Batch, a document prepared by Wyeth: (a) listing tests performed by Wyeth, specifications, and test results, and (b) certifying the accuracy of the foregoing. The Parties shall from time to time agree upon a format or formats for the Certificate of Analysis to be used under this Agreement.
1.10 " Certificate of Compliance " means, as further specified in the Quality Agreement, with respect to each Batch, a document prepared by Wyeth: (a) listing the manufacturing date, unique Batch number, and quantity of Product in such Batch, and (b) certifying that such Batch was manufactured in accordance with the Manufacturing Documentation, cGMP, the Product Specifications existing as of the time of the inoculation of the [*] bioreactor for such Batch and the warranties set forth in Section 7.1. The Parties shall from time to time agree upon a format or formats for the Certificate of Compliance to be used under this Agreement.
1.11 " Commercial Batch " or " Commercial Lot " means a Batch or Lot produced from a Commercial Run.
1.12 " Commercial Production " means the operation of the Facility after sBLA Filing with [*] of its capacity dedicated to running the Manufacturing Process to manufacture Product that is or is expected to be (following FDA Approval) commercially saleable.
1.13 " Commercial Run " means a Run that is initiated after achievement of PAI Readiness for the purpose of manufacturing Product that is or is expected to be (following FDA Approval) commercially saleable.
1.14 " Commercially Reasonable Diligent Efforts " means: [*] Notwithstanding the foregoing, to the extent that the performance of a Party's obligations hereunder is adversely affected by the other Party's failure to perform its obligations hereunder, such Party would not be deemed to have failed to use its Commercially Reasonable Diligent Efforts in performing the adversely affected obligations.
1.15 " Commercially Reasonable Efforts " of a Party means those efforts and resources normally used by such Party with respect to a biopharmaceutical product owned by such Party or to which such Party has similar
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rights and that is of similar market potential at a similar stage in the development or life of such product. Notwithstanding the foregoing, to the extent that the performance of a Party's obligations hereunder is adversely affected by the other Party's failure to perform its obligations hereunder, such Party would not be deemed to have failed to use its Commercially Reasonable Efforts in performing the adversely affected obligations.
1.16 " Commissioning " means those activities occurring after Mechanical Completion that are intended to verify that the Facility (and equipment and systems therein) meet pre-established design specifications, installation and operational requirements. Commissioning typically precedes and supports Qualification and includes Factory Acceptance Test (" FAT "), Site Acceptance Test (" SAT "), and full-scale wet-testing (" Water Dummy Runs ") in order to provide reasonable assurance of the successful Qualification of the equipment, systems, and Facility.
1.17 " Completed Development Run " means a Development Run for which Product has been processed through the final purification step and filled and frozen in a Vessel according to the instructions, procedures and requirements described in the Manufacturing Documentation established for said procedures; provided, however, that a Development Run need not be processed through the high temperature short (residence) time skid (" HTST Skid ") to be considered a Completed Development Run.
1.18 " Completed Qualification Run " means a Qualification Run for which Product has been processed through the final purification step and filled and frozen in a Vessel according to the instructions, procedures and requirements described in the Manufacturing Documentation established for said procedures.
1.19 " Confidential Information " means Genentech Confidential Information and/or Wyeth Confidential Information, as the context requires.
1.20 " Control " or " Controlled " means possession of the ability to grant a license or sublicense without violating (a) any law or governmental regulation applicable to such license or sublicense or (b) the terms of an agreement with a Third Party.
1.21 " Conversion Fee " means the conversion fee to be paid by Genentech to Wyeth for Product as determined in accordance with the terms of this Agreement.
1.22 " Development Batch " means a Batch or Lot produced from a Development Run. Development Batches are intended for testing only and are not saleable.
1.23 " Development Run " means a Run that (i) is used for Commissioning the Facility, testing equipment, Manufacturing Process demonstration, confirmation of some or all of the Manufacturing Process steps, finalizing Manufacturing Documentation, and training, as further described in Section 4.6 hereof. Development Runs may also be referred to as "Engineering Runs" or "Trial Runs".
1.24 " Excluded Patents " means [*] as those terms are defined on Exhibit A hereto, as well as any other Patent Rights owned or Controlled by Genentech that are not required for Wyeth to perform its obligations under the Transaction Agreements in accordance with the terms and conditions thereof.
1.25 " Facility " means one or more of the following, as the context requires: the [*] at Wyeth's commercial manufacturing facility located at Andover, Massachusetts and, to the extent used by Wyeth in the Manufacturing Process or the storage of Product hereunder, the Utilities, the Warehouse and the QC Laboratory.
1.26 " Facility Modifications and Services Costs " means all costs and expenses incurred by Wyeth (including, without limitation, Wyeth's internal labor and material costs) for the modifications needed to implement the Manufacturing Process at Wyeth's Andover, Massachusetts facility, including, without limitation, design and engineering services, equipment and/or Utilities installed at or necessary for the operation of the Facility (or any part thereof) or used to modify the Facility (or any part thereof) in accordance with the Technology Transfer Project Plan.
1.27 " Facility Validation " means validation of the Facility, including manufacturing equipment and
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systems, computer systems, testing equipment and including non-Product specific processes such as sterilization, all as required by and in accordance with the Quality Agreement.
1.28 " FD&C Act " means the United States Federal Food, Drug and Cosmetic Act, as the same may be amended from time to time.
1.29 " FDA " means the United States Food and Drug Administration, or any successor agency thereto.
1.30 " Finished Product " means Product that has been formulated, compounded, filled into containers, labeled and placed in final commercial packaging.
1.31 " For Cause Audit " means a non-routine audit of the Facility required and conducted by Genentech's quality compliance organization due to the existence of an Operational Issue that Genentech reasonably believes in good faith may result in a significant quality or cGMP deficiency.
1.32 " Genentech Confidential Information " means the Manufacturing Documentation and all technical and other information, whether patented or unpatented, relating to the Genentech Proprietary Materials, the Manufacturing Process, the Technology and/or the Product, Genentech processes, methods, operations, technologies, forecasts and business information, in the case of each of the foregoing that (a) are disclosed or supplied to Wyeth by or on behalf of Genentech pursuant to this Agreement and/or the Quality Agreement, (b) Wyeth may first become aware through the presence of its employees or agents at Genentech offices or facilities or at other facilities (other than Wyeth's facilities) that manufacture the Product for Genentech or (c) is Genentech Data generated hereunder. The foregoing may include, without limitation, trade secrets, know-how, processes, concepts, experim ental methods and results, business and scientific plans and information, designs, algorithms, software and facility layout and schematics. Notwithstanding the foregoing, "Genentech Confidential Information" shall not include any information that: (i) at the time of disclosure, is known publicly or thereafter becomes known publicly through no breach of this Agreement by Wyeth, its Affiliates or agents; (ii) becomes available to Wyeth from a Third Party which is not legally prohibited from disclosing such information, provided such information was not acquired directly or indirectly from Genentech under obligations of confidentiality; (iii) was developed by Wyeth independently of information obtained from Genentech as evidenced by competent proof; (iv) was already known to Wyeth before receipt from Genentech, as shown by competent proof, provided that such information was not acquired directly or indirectly from Genentech under obligations of confidentiality; or (v) is released with the prior written consent of Genentech. In determining whether or not Genentech's Confidential Information has entered the public domain and is therefore no longer falls within the definition of Genentech Confidential Information, only that portion of said Genentech Confidential Information that has become public shall cease to be within the definition of Genentech Confidential Information, and any information remaining confidential (including, without limitation, the organization of such information, the existence of such public information within the Genentech Confidential Information or information regarding the relationships between individual pieces of Genentech Confidential Information and information that is in the public domain) shall retain their status as Genentech Confidential Information.
1.33 " Genentech Data " means (i) those elements of Manufacturing Data that pertain to the Manufacturing Process, the conduct of the Manufacturing Process at the Facility, the Genentech Proprietary Materials, the Raw Materials or the Product (ii) those elements of other data generated by Wyeth in the performance of its obligations hereunder that pertain to the Manufacturing Process, the conduct of the Manufacturing Process at the Facility, the Genentech Proprietary Materials, the Raw Materials or the Product (iii) data generated by Genentech hereunder that pertain to the Manufacturing Process, the conduct of the Manufacturing Process at the Facility, the Genentech Proprietary Materials, the Raw Materials, the Product or (iv) information generated by Genentech that pertains to any equipment, processes, algorithms or software installed or used in the Facility, in the case of each the foregoing, excluding the Wyeth Data.
1.34 " Genentech Proprietary Materials " means the Cell Line, Master Cell Bank, Working Cell Bank and all Genentech proprietary reagents, reference standards and assays required to implement the Technology Transfer, utilize the Technology, conduct the Manufacturing Process and/or manufacture Product, all in accordance with the Manufacturing Documentation, and as each is further defined in Exhibit B to the Technology Transfer Project Plan.
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"Genentech Proprietary Materials" shall also include any other proprietary materials of Genentech provided to Wyeth hereunder that are identified in writing by Genentech as "proprietary" at the time of delivery.
1.35 " GMP Commissioning " means the acceptance of the Facility by Genentech for cGMP activities as required by and in accordance with the Quality Agreement.
1.36 " Herceptin " means those pharmaceutical formulations containing the Product, currently marketed by Genentech in the United States and currently marketed by Roche outside of the United States each as the commercial product Herceptin.
1.37 " Manufacturing Data " means either or both, as the case requires: (i) all data and information (including the Batch Records) related to the conduct of the Manufacturing Process at the Facility that is generated by Wyeth in the performance of its obligations hereunder from the Effective Date through the date of achievement of PAI Readiness and that would be necessary or useful for Genentech to complete the filing of the sBLA with the FDA, including without limitation data related to the Commissioning and validation of the Facility, and/or (ii) all data and information (including the Batch Records) related to the manufacture of Product at the Facility that is generated by Wyeth in the performance of its obligations hereunder following achievement of PAI Readiness and that would be necessary or useful for Genentech to comply with all laws and regulations pertaining to th e manufacture, use, storage or sale of Product manufactured by Wyeth under this Agreement.
1.38 " Manufacturing Documentation " means all documents and records describing or otherwise related to the Manufacturing Process or any part of the Manufacturing Process provided to Wyeth by or on behalf of Genentech under this Agreement or the Quality Agreement, including, without limitation, documents and records consisting of or containing process descriptions, requirements and specifications, process flow diagrams (" PFDs "), piping and instrumentation diagrams (" P&IDs ") for Genentech's facilities, Genentech's facility layout schematics, equipment and instrumentation specifications, software logic and requirements specifications, bills of materials, raw material, in-process, and final Product specifications, process trend and variability data, validation protocols and reports, process development reports, batch records, and standard operating procedures (" SOPs "), including, without limitation, SOPs for Raw Material handling, manufacturing operations, equipment operation, Raw Material, in-process, and final Product quality control testing, quality assurance, validation, storage, and shipping.
1.39 " Manufacturing Process " means the [*] production process for the conversion of certain Genentech Proprietary Materials using the Raw Materials into Product and testing of such Product, [*] and is to be used by Wyeth pursuant to this Agreement for the manufacture of Product, [*], as such process may be changed from time to time in accordance with this Agreement.
1.40 "Master Cell Bank" [*]
1.41 " Mechanical Completion " means that the Facility is ready for Commissioning, Qualification and validation according to criteria established by the TOC for those activities. For the Facility to be considered mechanically complete, (i) all equipment (except the HTST skid) and Programmable Logic Controller/Supervisory Control And Data Acquisition (" PLC/SCADA ") software required to implement the Manufacturing Process must be installed, tagged, and adjusted, (ii) mechanical and hydrostatic testing on said equipment (except the HTST skid) must be complete, and (iii) all applicable documentation must be compiled and complete. An element of Mechanical Completion shall be that the Manufacturing Execution System (" MES ") software is available as required to support Commissioning.
1.42 " Non-Conforming Product " means Product that fails to conform to any of the warranties set forth in Section 7.1 hereof as of the Warranty Date.
1.43 " Non-Portable Equipment " means the Genentech Equipment (as defined in Section 15.2 hereof), excluding any Portable Equipment and the Centrifuge. Components of the Non-Portable Equipment, such as valves, pumps, agitators and filter housings, shall also be deemed Non-Portable Equipment. Non-Portable Equipment also includes the related documentation regarding the design, validation, operation, calibration and maintenance of such equipment.
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1.44 " Operational Issue " means an issue, concern or problem related to or arising from the implementation or conduct of the Technology Transfer Project and/or the Manufacturing Process at the Facility or at any of Genentech's facilities that might or does adversely impact (i) the operation of the Facility, (ii) the conduct of the Manufacturing Process by Wyeth, or (iii) the manufacture of Product hereunder, with respect to each of the foregoing, including, without limitation, any contamination, regulatory or quality control issues, problems or concerns, materials shortages, any issues, concerns or problems that may arise from the performance of the obligations under this Agreement and/or the Quality Agreement.
1.45 " PAI " means the pre-approval inspection of the Facility that will be conducted by the FDA prior to FDA Approval.
1.46 " PHS Act " means the Public Health Service Act, Biological Products, as amended, as the same may be amended from time to time.
1.47 " Party" or "Parties " means Wyeth and/or Genentech, as the context requires.
1.48 " Patent Rights " means all United States and foreign issued patents and patent applications, including, but not limited to, provisionals, divisionals, continuations, continuations-in-part (to the extent the claims in such continuation-in-part application are directed to subject matter specifically described in such prior patent application), and patents issuing therefrom, reissues, reexaminations, substitutions, renewals, restorations, additions, registrations, and foreign counterparts thereof, as well as extensions and supplementary protection certificates based thereon.
1.49 " Pilot Batch " means a Batch produced from a Run that is completed through the [*] bioreactor, and which is subsequently harvested [*] and purified at the laboratory scale using an appropriate small scale laboratory model of the Manufacturing Process. For a Batch to be considered a Pilot Batch the Batch must be completed [*] and provide sufficient quantities of samples to enable the Parties to complete analytical testing [*]. A Pilot Batch may be processed through the final purification step at the laboratory scale.
1.50 " Portable Equipment " means the portable equipment described with particularity in the Technology Transfer Project Plan and referred to in Sections 5.7 hereof, including, without limitation, the related documentation regarding the design, validation, operation, calibration, and maintenance of such equipment. The Portable Equipment is a part of the Genentech Equipment, as defined in Section 15.2 hereof. Components of the Portable Equipment, such as valves, pumps, agitators and filter housings, shall also be deemed Portable Equipment.
1.51 " Pre-existing Defect " means a defect in (i) any Raw Material delivered to Wyeth by [*] Genentech or (ii) any Genentech Proprietary Material delivered to Wyeth by Genentech, where such defect, in the case of either (i) or (ii), could not have been detected by Wyeth performing those manufacturing steps and testing procedures to be performed by Wyeth as required by the Manufacturing Documentation.
1.52 " Product " means the bulk form of Genentech's proprietary biological drug substance anti-Her-2 antibody (as more particularly described in Genentech's BLA for Herceptin STN: BL 103792, including any successor filing thereto with the FDA, and any supplements to or amendments to any of the foregoing) which has been (i) manufactured by Wyeth pursuant to this Agreement, and (ii) purified to a concentrated form from one or more Batches by Wyeth pursuant to this Agreement.
1.53 " Product Specifications " means the specifications developed by Genentech for Product, including, without limitation, testing methods and acceptance criteria for each Batch, a copy of which shall be attached to the Quality Agreement prior to the start of Development Runs, as such specifications may be amended from time to time in accordance with Article 8 hereof, including, without limitation, such amendments as may be required to obtain and/or maintain FDA Approval.
1.54 " QC Laboratory " means either or both the laboratory facilities located in Wyeth's Andover, Massachusetts commercial manufacturing facility or any Third Party laboratory facilities approved by Genentech in accordance with Section 13.5, in each case to the extent that they are required for Wyeth to perform the testing of all
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Raw Materials and in-process and finished Product in accordance with the Transaction Agreements.
1.55 " Qualification " means establishing documented evidence that a piece of equipment or a manufacturing process operates within predetermined parameters consistently and reproducibly, and that such piece of equipment or manufacturing process is capable of producing Product that consistently meets all applicable quality specifications. Qualification may refer to Installation Qualification (" IQ "), Operational Qualification (" OQ "), and Performance Qualification (" PQ ") as those terms have been generally defined by the FDA and the pharmaceutical industry.
1.56 " Qualification Batch " or " Qualification Lot " means a Batch or Lot produced from a Qualification Run. Each Qualification Batch is intended to produce Product that is or is expected to be (following FDA Approval) commercially saleable.
1.57 " Qualification Run " means a Run conducted (i) to demonstrate and document the consistency and reproducibility of the Manufacturing Process at the Facility, (ii) to establish the comparability of the Product manufactured therefrom to Herceptin manufactured by Genentech as required by the FDA and (iii) to support licensure of both the Facility and the Manufacturing Process at the Facility under the sBLA. Each Qualification Run must be produced from an inoculation of the [*], all in accordance with cGMP and the Manufacturing Documentation.
1.58 " Quality Agreement " means the quality agreement entered into by and between the Parties of even date herewith that references this Agreement and relates to Wyeth's manufacture of the Product hereunder, as amended from time to time.
1.59 " Regulatory Agency " means any applicable supranational, national, federal, state or local regulatory agency, department, bureau or other governmental entity of any country or jurisdiction in the Territory having responsibility in such country or jurisdiction for any Regulatory Approval of any kind in such country or jurisdiction, and any successor agency or authority thereto.
1.60 " Regulatory Approval " means any approvals, licenses, registrations or authorizations of any Regulatory Agency necessary for the manufacture and sale of the Product in each regulatory jurisdiction in which the Product will be sold.
1.61 " Raw Materials " means those materials set forth on the Bill of Materials attached to the Technology Transfer Project Plan that are used in the Manufacturing Process, including, but not limited to, chemicals, reagents, chromatography resins, and specialty filters.
1.62 " Roche " means Roche Holdings, Inc., a Delaware corporation, and its "Affiliates" (as hereinafter defined) other than Genentech and Genentech's subsidiaries. Subject to the foregoing, with respect to Roche, "Affiliates" means any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with Roche Holdings, Inc.; and, for purposes of this definition, the term "control" means direct or indirect ownership of fifty percent (50%) or more of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, resolution or otherwise.
1.63 " Run " means a single fermentation run of the Manufacturing Process commencing at the [*] at the Facility and progressing through, as applicable, [*] harvest, recovery, purification, freezing and quality testing and release, and refers to a Commercial Run, Development Run and/or Qualification Run, as the context requires; [*]
1.64 " Run Start " [*]
1.65 " sBLA " means the supplemental biologics license application to be submitted to the FDA to permit the licensure of the Facility to manufacture the Product using the Manufacturing Process, any equivalent successor filing thereto with the FDA, and any supplements or amendments to any of the foregoing.
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1.66 " Sourcing Date " means the date that the FDA approves the sBLA.
1.67 " Specialized Raw Materials " means that subset of Raw Materials that are identified as such on the Bill of Materials attached to the Technology Transfer Project Plan and that require higher levels of inventory planning and control due to shortage of supply, long supplier lead times and criticality to Product quality. Examples include chromatography resins and certain media components.
1.68 " Successful " means, subject to Section 5.7, with respect to a single Qualification Run or Commercial Run, or a single Batch or Lot produced from such a single Qualification Run or Commercial Run, conformance of that Run to all elements of: (i) the quality requirements of this Agreement, the Technology Transfer Project Plan and the Quality Agreement; (ii) the Product Specifications as they exist at the time of the inoculation [*] bioreactor for such Batch (or such earlier time as may be appropriate in the event that there are any modifications to those portions of the Manufacturing Process occurring prior to the inoculation [*] bioreactor or which require changes to the materials used (or specifications therefor) prior to the inoculation [*] (bioreactor); and (iii) all applicable United States laws and regulations. For the avoidance of doubt, a Successful Batch will be or is expected to be (following FDA Approval) saleable following the Sourcing Date.
1.69 " Success Rate " means, with respect to a particular campaign or a specified period of time, the ratio of the number of Successful Batches produced during such campaign or period of time by the Party in question over the number of Run Starts made during such campaign or period of time by the Party in question.
1.70 " Technology " means the Manufacturing Process, assays, quality control analyses, specifications, transportation and storage requirements, and other know-how and information provided by Genentech to Wyeth (including, without limitation, the Manufacturing Documentation) and which is required to reproducibly manufacture, test, store and transport Product: (i) in compliance with cGMP; (ii) in conformity with the applicable Product Specifications; (iii) in compliance with Genentech's approved sBLA; and (iv) which meets the protocols for analytical comparability and bioequiv...
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