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MANUFACTURING AND TECHNOLOGY TRANSFER AGREEMENT

Manufacturing Agreement

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XOMA (US) LLC

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Title: MANUFACTURING AND TECHNOLOGY TRANSFER AGREEMENT
Governing Law: California     Date: 3/11/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

MANUFACTURING AND TECHNOLOGY TRANSFER AGREEMENT, Parties: xoma (us) llc
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Exhibit 10.24D

MANUFACTURING AND TECHNOLOGY TRANSFER AGREEMENT

This Manufacturing and Technology Transfer Agreement (this “ Agreement ”) is effective as of July 1, 2008 (the “ Effective Date ”), by and between XOMA (US) LLC, a Delaware limited liability company with offices at 2910 Seventh Street, Berkeley, California 94710 (“ XOMA ”), and Novartis Vaccines and Diagnostics, Inc., a Delaware corporation with offices at 4650 Horton Street, Emeryville, California 94608 (“ NVDI ”). XOMA and NVDI are sometimes referred to herein individually as a “Party” and collectively as “Parties.”

RECITALS

WHEREAS, the Parties have entered into that certain Amended and Restated Research, Development and Commercialization Agreement effective as of the Effective Date (the “ Collaboration Agreement ”);

WHEREAS , XOMA has substantial expertise in product development and manufacturing of its own and its collaborators’ biopharmaceutical products and, in addition, has invested in biopharmaceutical manufacturing facilities; and

WHEREAS , NVDI desires to engage XOMA to perform technology transfer and other activities with respect to NVDI’s anti-[*] monoclonal antibody, known as [*] and its anti-CD40 monoclonal antibody, known as HCD122, and to manufacture and supply two (2) GLP Batches of [*] and XOMA desires to provide such services to NVDI, on the terms and subject to the conditions set forth herein;

NOW, THEREFORE , in consideration of the foregoing premises and the mutual promises and covenants set forth below, NVDI and XOMA mutually agree as follows;

ARTICLE 1

DEFINITIONS

Capitalized terms used but not defined herein shall have the meanings set forth in the Collaboration Agreement. As used in this Agreement, he following terms will have the following meanings:

1.1 “[*] Scale ” means the 2750 liter nominal volume fermentation bioreactor production scale for the [*] Drug Substance manufacturing process that will result from scale-up work carried out by XOMA as part of the Project.

1.2 AAA ” means the American Arbitration Association or its successor organization.

1.3 Affiliate ” means any person or entity that, directly or indirectly, through one or more intermediaries, owns, is owned by or is under common ownership with, a Party, where “own,” “owned” and “ownership” refer to (a) direct or indirect possession of at least fifty percent (50%) of the outstanding voting securities of a corporation or a comparable ownership in any other type of entity; or (b) the actual ability of an entity, person or group to control and direct the management of the person or entity, whether by contract or otherwise.


1.4 Batch ” means the quantity of [*] Drug Substance that is intended to have a uniform character and quality, within specified limits, and that is produced according to a single manufacturing order during the same cycle of manufacture.

1.5 Confidential Information ” of a Party means all confidential or proprietary information of such Party that the other Party receives or learns under this Agreement. Confidential Information shall include without limitation the manufacturing processes transferred to, used by or improved by XOMA under this Agreement. Confidential Information shall not include any information to the extent that the receiving Party can demonstrate by competent evidence:

1.5.1. is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party in breach of Article 9, generally known or available;

1.5.2. is known by the receiving Party at the time of receiving such information, as shown by written records predating such receipt;

1.5.3. is furnished after the Effective Date to the receiving Party by a Third Party, without breach of and not subject to any obligation of confidentiality; or

1.5.4. is independently developed by the receiving Party without use of or reference to Confidential Information of the other Party, as shown by independent written records contemporaneous with such development.

1.6 Control ,” “ Controls ” and “ Controlled ” mean, with respect to a particular item of information or Intellectual Property Right, that the applicable Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

1.7 CPR ” means the CPR Institute for Dispute Resolution or its successor organization.

1.8 Dedicated Equipment” has the meaning set forth in Section 2.9.1.

1.9 Delivery ” has the meaning set forth in Section 4.2.1.

1.10 Facility ” means XOMA’s appropriate facilities located in Berkeley and Emeryville, California.

1.11 FDA ” means the U.S. Food and Drug Administration or any successor agency.

1.12 FD&C Act ” means the U.S. Food, Drug and Cosmetics Act and applicable regulations and guidances promulgated thereunder, as amended from time to time.

 

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1.13 FTE ” has the meaning set forth in Section 5.1.

1.14 GLP ” means the then current standards for laboratory practice in relation to biologicals, as set forth in the FD&C Act, and such standards of good laboratory practice as are required by the FDA.

1.15 Governmental Authority ” means any supranational, national, regional, state or local regulatory agency, department, bureau, or other governmental entity.

1.16 Indemnitee ” has the meaning set forth in Section 8.3.

1.17 Indemnitor ” has the meaning set forth in Section 8.3.

1.18 Innovations ” means inventions, discoveries, works of authorship, trade secrets and other know-how or developments.

1.19 Intellectual Property Rights ” means Patents, copyrights, trademarks, service marks, trade secrets, mask works and applications for the foregoing, in any country, supra-national organization or territory of the world.

1.20 “[*] Drug Substance ” means the anti-[*] monoclonal antibody known as [*] in purified bulk form that has been manufactured and processed to the stage where it meets the Master Production Records and is suitable for further processing to yield Product.

1.21 Losses ” means losses, claims, suits, damages, costs, fees and expenses (including without limitation reasonable attorneys’ fees).

1.22 Master Production Records ” or “ MPRs ” means the documentation generated by XOMA that collectively defines the manufacturing methods, test methods, specifications, materials, and other procedures, directions and controls associated with the manufacture and testing of [*] Drug Substance. The Master Production Records shall also include or incorporate by reference, without limitation, such information as the specifications of raw materials, resins and other consumables to be used in the manufacture of [*] Drug Substance, in process and final [*] Drug Substance sampling standards, equipment and instrumentation specifications and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing and [*] Drug Substance packaging and aliquoting procedures.

1.23 Monthly Report ” means a detailed report which shall set forth the costs for the Services performed during such calendar month.

1.24 NVDI Indemnitees ” means NVDI and its Affiliates and their respective directors, officers, employees and agents.

1.25 NVDI Innovations ” means all Innovations that NVDI either Controls as of the Effective Date or gains Control of independently of activities under this Agreement, including all Intellectual Property Rights in any of the foregoing.

 

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1.26 NVDI IP ” means, to the extent Controlled by NVDI, Intellectual Property Rights claiming or covering NVDI Innovations or NVDI-owned Project Innovations that, in the absence of a license thereunder, would be infringed or misappropriated by XOMA’s performance of its obligations under this Agreement.

1.27 Patents ” means (a) United States issued patents, re-examinations, reissues, renewals, extensions, patent term restorations, and foreign counterparts of each of the foregoing; and (b) pending applications for United States patents and foreign counterparts thereof, whether issued or not.

1.28 Process ” means the process and technology used to manufacture and test [*] Drug Substance under this Agreement.

1.29 Product ” means the finished dosage form of (a) NVDI’s [*] antibody product candidate and/or (b) NVDI’s HCD122 antibody product candidate, as the context requires.

1.30 Project ” means the product development (including preclinical and production related activities, technology transfer and regulatory and clinical oversight) and manufacturing relationship established by this Agreement.

1.31 Project Innovations ” shall mean all Innovations, whether or not patentable, that are conceived in the course and as a result of the Services.

1.32 Project Team ” means a group constituted pursuant to Section 2.4 and comprised of an appropriate number of representatives of each Party with expertise appropriate to the current stage of the Project.

1.33 Quality Agreement ” means that certain Quality Agreement between the Parties dated as of the Effective Date, a copy of which is attached hereto as Appendix B and which is incorporated herein by this reference.

1.34 Quarterly Invoice ” has the meaning set forth in Section 5.2.

1.35 Regulatory Approval ” means all approvals, product and/or establishment licenses, registrations or authorizations of all Regulatory Authorities necessary for the manufacture, use, storage, import, export, transport and sale of a biological product in a jurisdiction.

1.36 Regulatory Authority ” means a supranational, national or local regulatory agency or other governmental entity with the authority to grant a Regulatory Approval.

1.37 SEC ” means the U.S. Securities and Exchange Commission or any successor agency.

1.38 Services ” means those services to be performed by XOMA hereunder pursuant to the Work Plan.

 

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1.39 Start Date ” means, with respect to a scheduled production run, the date on which a cell bank vial is scheduled in the Work Plan to be thawed for such production run, provided that such date shall be adjusted to account for any actual delays in the start of such production run.

1.40 Third Party ” means any person or entity other than the Parties or their respective Affiliates.

1.41 Third Party Claim ” means any Third Party claim, demand, suit, action or proceeding.

1.42 Waste” means any “hazardous substance” and/or “hazardous material” as provided under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), any “hazardous waste” as provided under the Resource Conservation and Recovery Act (RCRA), and/or any other waste material, pollutant and/or contaminant of any kind including, without limitation, any routine process waste or any by-product arising from any activities conducted pursuant to this Agreement.

1.43 Work Plan ” means the Work Plan attached hereto as Appendix A and incorporated herein by this reference (as such Work Plan may be amended from time to time by mutual written agreement of the Parties).

1.44 XOMA Indemnitees ” means XOMA and its Affiliates and their respective directors, officers, employees and agents.

1.45 XOMA Innovations ” means all Innovations that XOMA either Controls as of the Effective Date or gains Control of independently of activities under this Agreement, including all Intellectual Property Rights in any of the foregoing.

1.46 XOMA IP ” means, to the extent Controlled by XOMA, Intellectual Property Rights claiming or covering XOMA Innovations or XOMA-owned Project Innovations that, in the absence of a license thereunder, would be infringed or misappropriated by the development, manufacture, use or sale of [*] Drug Substance or Product.

ARTICLE 2

OVERVIEW; GOVERNANCE.

2.1 Project; Schedule . XOMA and NVDI are entering into this Agreement with the purpose of having XOMA perform technology transfer and other activities as provided in the Work Plan and produce [*] in compliance with the Master Production Records at [*] Scale for NVDI. Subject to the terms and conditions of this Agreement, XOMA will carry out the Project in accordance with this Agreement and the Work Plan. XOMA will commit to the Project appropriate personnel (including without limitation those with expertise in technical development, manufacturing, operations, quality control, quality assurance and regulatory affairs) and conduct the Services at the Facility. NVDI will commit such of its personnel with appropriate expertise to provide monitoring and, as appropriate, technical consultation for the

 

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Project. XOMA and NVDI recognize the importance of timely execution of the Project, and accordingly each Party will give priority to the Project, assign adequate staffing and other resources and use all diligent, commercially reasonable efforts to maximize the potential of achieving successful completion of the Project (including without limitation timely provision of all deliverables in accordance with the Work Plan), it being understood that the efforts and resources used to date by XOMA satisfy such standard. More specifically:

2.1.1. NVDI and XOMA each will give priority to completion, as promptly as reasonably practicable, of the development and implementation of the Work Plan. NVDI has delivered to XOMA certain materials and information and will deliver to XOMA any further materials and information necessary for XOMA to undertake its responsibilities hereunder, together with relevant details of any hazards and/or characterization relating to the materials delivered or to be delivered by NVDI to be used, and the storage and use of such materials. With this information, XOMA has initiated and will continue the process development efforts.

2.1.2. Upon successful completion of cell banking, process development and preparation for scale-up work, XOMA will produce [*] and in each case according to the Work Plan. For the avoidance of doubt, the GLP batch under production in November of 2008 shall count as one (1) [*]. In connection with the foregoing, XOMA will also conduct related testing and deliver related regulatory documentation to NVDI.

2.2 Work Plan .

2.2.1. Attached hereto as Appendix A is the Work Plan for the technology transfer, manufacturing and other activities as provided therein in accordance with the terms and conditions of this Agreement. The Parties acknowledge that the initial Work Plan attached hereto at the time of execution of this Agreement is a preliminary version included for guidance but not yet fully agreed to by the Parties. The Parties agree to use commercially reasonable efforts to finalize such initial Work Plan within [*] following full execution of this Agreement. For the avoidance of doubt, once such initial Work Plan is agreed, it may be further amended as provided herein.

2.2.2. Each Party agrees to perform its obligations under this Agreement in accordance with the Work Plan and the Quality Agreement. The Project Team members shall review the Work Plan and consult as to its continuing suitability at their meetings pursuant to Section 2.4 and shall propose appropriate revisions thereto. Any such revised Work Plan or amendment or supplement to the Work Plan shall be in writing and shall become effective only upon execution by both Parties.

2.3 Cooperation. Adherence to the schedules set out in the Work Plan is contingent in part on each Party’s reasonably expedient reviews, decisions and approvals of the requisite documents, data and paths, where such review and approval is necessary, it being understood and agreed that, in order to maintain adherence to the schedules set forth in the Work Plan (taking into consideration the custom and practice of the industry as well as XOMA’s standard operating procedures), this may require a prompt response from either NVDI or XOMA following a request from the other Party.

 

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2.4 Project Team . As of the Effective Date, the Parties have formed a Project Team. Each Party may replace or supplement its members on the Project Team and will at all times ensure that its current Project Team members have expertise appropriate to the current stage of the Project. Each Party shall use commercially reasonable efforts to maintain the same Project Team manager throughout the term of this Agreement unless such individual leaves the employ of such Party. The Project Team will be responsible for reviewing progress of the Project under the Work Plan and to discuss and decide on any potential revisions to the Work Plan. The Project Team shall seek to make decisions by consensus. The Project Team shall hold monthly meetings by teleconference or in person unless otherwise agreed by Project Team members. At each such meeting, a representative of XOMA shall be responsible for keeping the minutes of such meeting and for circulating a draft of such minutes thereafter for approval by the attendees.

2.5 Senior Management Oversight and Dispute Resolution . In the event that the Project Team is unable to reach consensus regarding any matter, either Party may, by written notice to the other Party, refer such matter to the CEOs of the Parties (or to their respective senior executive designees) for attempted resolution. If a Party refers any matter to the CEOs of the Parties (or such designees) pursuant to this Section 2.5, then the CEOs of the Parties (or such designees) will attempt in good faith to resolve such matter within [*]. If the matter remains unresolved at the end of such [*] period, the matter may be submitted for resolution pursuant to Section 11.3.

2.6 Master Production Records; Changes to Master Production Records and Work Plan .

2.6.1. NVDI or XOMA may change the Master Production Records or the Work Plan from time to time, with the review and approval of the other Party in advance as to such changes, and such revised MPRs or Work Plan, as the case may be, shall replace the previous MPRs or Work Plan, as applicable, and shall be deemed to be part of this Agreement. The work of each Party hereunder will be performed in a professional and workmanlike manner in accordance with the standards of performance in the industry.

2.6.2. NVDI shall be responsible for any incremental costs incurred by XOMA as a result of any changes to the MPRs or the Work Plan pursuant to Section 2.6.1. If such changes significantly and adversely affect the ability of XOMA to manufacture [*] Drug Substance in compliance with the MPRs or require significant modifications to the Facility in order to permit XOMA to manufacture [*] Drug Substance in accordance with the MPRs, then at XOMA’s election, the Parties will renegotiate the terms of this Agreement so as to permit XOMA to perform its obligations under this Agreement with substantially the same proportional economic benefit for its efforts.

2.7 NVDI Representatives . NVDI shall be allowed to have, at its cost, such number of representatives [*] escorted by XOMA personnel, with reasonable access to the Facility during the manufacture of [*] Drug Substance for the purpose of observing, reporting on, and consulting as to such manufacturing efforts. Prior to receiving such access, NVDI representative(s) will enter into XOMA’s standard form of confidentiality agreement, which will be commercially reasonable and will permit XOMA personnel to disclose information learned to NVDI. XOMA will reasonably cooperate in enabling (e.g., providing necessary training to allow for compliance with XOMA procedures) NVDI representatives to carry out their responsibilities and will make adequate temporary desk space and other reasonable resources available to these representatives during the periods they are working at the Facility.

 

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2.8 Other Manufacturing Relationships . The manufacturing relationship set forth in this Agreement will be non-exclusive.

2.9 Additional Equipment .

2.9.1. Dedicated Equipment Purchases . The Parties acknowledge that certain equipment has been obtained for the Project and do not expect that additional equipment will be needed. In the unlikely event that additional equipment is needed, XOMA shall purchase for delivery to the Facility all equipment that is to be dedicated to the Project, as either set forth in the Work Plan or otherwise approved in writing in advance by NVDI, which approval shall not be unreasonably withheld or delayed (any such additional equipment, the “Dedicated Equipment”) . NVDI will reimburse XOMA for the cost of Dedicated Equipment purchases (including, without limitation, reimbursement for the time and efforts of XOMA personnel, and the costs for delivery, installation and qualification) in accordance with the Work Plan or as otherwise approved in writing in advance by NVDI and NVDI will have ownership of the Dedicated Equipment. XOMA will operate and maintain the Dedicated Equipment as per approved procedures once such equipment is commissioned and in operation. NVDI shall be liable for repair of all damage and risk of any loss to Dedicated Equipment unless caused by XOMA’s negligence, willful misconduct or breach of this Agreement. NVDI shall be responsible for any delays to the Work Plan caused in whole or in part by delays in the delivery, testing, qualification or validation of Dedicated Equipment. If any piece of Dedicated Equipment is not or no longer used for the Project or for other NVDI products, then XOMA at its option will either transfer such Dedicated Equipment to NVDI or keep such Dedicated Equipment and reimburse NVDI for the depreciated cost thereof. NVDI will pay any costs of the physical transfer of such Dedicated Equipment to NVDI.

2.9.2. General Equipment Purchases . It may also be necessary to obtain additional equipment of general utility to XOMA for the development or scale-up of the Process or the manufacture of [*] Drug Substance. Upon mutual agreement of the Parties that additional equipment is needed for the Project, XOMA will purchase for its own account and for delivery to the Facility any such additional equipment. XOMA and NVDI will share the cost of purchasing this equipment in a [*] arrangement. However, NVDI’s portion of the purchase cost will be subtracted from future revenues to XOMA for work performed under this Agreement. XOMA will have ownership of such equipment from the date of purchase.

2.10 Handling of Materials; Wastes . At NVDI’s expense, XOMA or a designated Third Party contractor shall handle, label, package, store, transport and dispose of all Wastes generated through performance of the manufacturing and processing activities hereunder in material compliance with all federal, state and local laws, rules, and regulations applicable to such handling, labeling, packaging, storage, transport and disposal. Each Party shall promptly notify the other of any health hazards or potential health hazards of which it is or becomes aware concerning exposure to or handling of the [*] Drug Substance or Wastes.

 

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ARTICLE 3

TECHNOLOGY TRANSFER AND OTHER ACTIVITIES; PRODUCTION.

3.1 Technology Transfer to XOMA . To the extent not already completed, the Parties will complete as quickly as practicable the transfer from NVDI to XOMA of all relevant materials and information related to the Project. NVDI shall be responsible for obtaining all relevant technology, other necessary information and assistance from relevant Third Parties, if needed. Throughout the course of the Project, NVDI will make scientific and technical staff available as necessary and reasonably useful to assist XOMA’s efforts.

3.2 Technology Transfer to NVDI; Manufacture . In accordance with the provisions and timelines in the Work Plan, XOMA will perform technology transfer and other activities as provided therein and manufacturing at [*] and will take such actions and generate such data and documentation as are necessary to meet the MPRs.

ARTICLE 4

TESTING, DELIVERY AND REGULATORY MATTERS.

4.1 Raw Materials Services; In-Process Testing . XOMA has provided and will continue to provide in accordance with the Work Plan the ordering, testing, inventorying and releasing services for raw materials used in the manufacture of [*] Drug Substance under this Agreement and in-process testing for continued manufacture of [*] Drug Substance under this Agreement. XOMA shall obtain raw materials, resins, buffers, consumables and other like materials for manufacture of [*] Drug Substance under this Article 4. XOMA shall not be responsible for delays in the purchase and/or delivery of any such materials that occur outside of the reasonable control of XOMA and despite XOMA using commercially reasonable efforts to avoid such delays. All such materials shall be invoiced to NVDI by XOMA at one hundred percent (100%) of XOMA’s cost.

4.2 Delivery; Risk of Loss ; Storage Fees.

4.2.1. On or prior to the applicable date of delivery of [*] Drug Substance to NVDI or its designee, XOMA will deliver such [*] Drug Substance to NVDI or its designee F.O.B. the Facility, along with samples and copies of Batch production records. XOMA will test each Batch of [*] Drug Substance pursuant to the Master Production Records and will include with each Batch of [*] Drug Substance a certificate of analysis confirming that such Batch has been tested according to the MPRs. XOMA shall package for shipment each Batch of [*] Drug Substance in accordance with NVDI’s written instructions, and NVDI shall bear all packaging, shipping and insurance charges. Delivery of [*] Drug Substance by XOMA shall be deemed to have taken place upon the earlier to occur of (i) delivery to a carrier at the Facility or (ii) [*] after release by XOMA (“ Delivery ”). [Draft note to XOMA: Has this been resolved?] Title and risk of loss shall transfer to NVDI upon Delivery. XOMA shall accept no liability or responsibility and risk associated with the loss of any Batch of [*] Drug Substance once this transfer has occurred. XOMA shall retain representative samples of [*] Drug Substance for record keeping, testing and regulatory purposes, including in accordance with applicable laws, rules and regulations.

 

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XOMA shall bear the risk of loss prior to Delivery, except to the extent such loss is due to circumstances beyond its reasonable control, including without limitation earthquakes, governmental regulation, fire, flood, labor difficulties, interruption of supply of key raw materials, civil disorder, and acts of God. XOMA shall provide for the storage of any Batch, upon release of such Batch at the Facility in accordance with guidelines to be agreed to by the Parties at the Facility for up to [*]; provided , that any additional storage beyond such [*] period will be charged to NVDI at XOMA’s customary rates. Unless otherwise agreed in writing by the Parties, XOMA shall not be required to store any Batch for more than [*] after release of such Batch pursuant to this Section 4.2; provided that, XOMA will notify NVDI in writing before disposing of any Batch, and shall continue storage of the affected Batch for a reasonable period of time (not to exceed [*]) sufficient to allow NVDI to arrange for alternate disposition of the Batch. NVDI shall pay applicable storage costs for any portion of the Batch remaining. XOMA shall not be required to deliver any Batch to the carrier until the carrier informs XOMA that it has obtained all appropriate approvals and consents of any Governmental Authority necessary for the transportation or shipment of such Batch.

4.2.2. XOMA hereby agrees to obtain and carry general liability insurance with coverage in an amount equal to or greater than the aggregate amount of expected payments under this Agreement. Upon written request, XOMA shall provide NVDI a certificate evidencing such insurance.

4.3 Regulatory Matters. Upon NVDI’s decision to file regulatory documentation for Drug Substance or Product with the FDA or other Regulatory Authorities in accordance with the Collaboration Agreement, and upon NVDI’s request and at NVDI’s expense, XOMA will, in accordance with the applicable regulatory requirements, provide the necessary documentation according to the Work Plan.

ARTICLE 5

PRICES AND PAYMENT.

5.1 Price for Services, Batches and Technology Transfer . In consideration for XOMA’s performance of its obligations under this Agreement and the Work Plan, and subject to the terms and conditions of this Agreement, NVDI shall pay to XOMA an amount equal to the sum of (a) XOMA’s fully burdened costs, measured, where applicable, by its standard full-time equivalent (“ FTE ”) rates as set forth in the Work Plan for the functions providing the Services plus (b) [*] with respect to Services provided on or after the Effective Date and prior to November 1, 2008, ten percent (10%) or (ii) with respect to Services provided on or after November 1, 2008, twenty percent (20%). The Parties expressly acknowledge that the dollar amounts for expected time and materials set forth in the Work Plan are estimates. NVDI must approve in writing any deviations of [*] or more from either the aggregate amount in the Work Plan for manufacturing Services or the aggregate amount in the Work Plan for technology transfer Services.

5.2 Quarterly Invoices . Upon execution of this Agreement in full, and on a calendar quarterly basis thereafter, XOMA shall send to NVDI an invoice in an amount equal to the sum of (a) (in case of the first invoice only) XOMA’s fees for (i) the work undertaken on or after the

 

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Effective Date through such date of full execution, (ii) the actual costs of materials, other than materials procured under the Original Agreement as such term is defined in the Collaboration Agreement, procured before the Effective Date but used or to be


 
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