Form 10-Q Vaxcyte, Inc. For: Mar 31

 

Exhibit 10.1

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

Development and Manufacturing Services Agreement

(the “Agreement”)

Effective as of October 21, 2016 (the “Effective Date”)

Table of Contents

Appendix A

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Appendix B

Appendix C

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Recitals

WHEREAS, Customer is engaged in the development and research of certain products and requires assistance in the development and manufacture of product;

WHEREAS, Lonza and its Affiliates have expertise in the evaluation, development and manufacture of products;

WHEREAS, Customer wishes to engage Lonza for Services relating to the development and manufacture of the Product as described in this Agreement; and

WHEREAS, Lonza, or its Affiliate, is prepared to perform such Services for Customer on the terms and subject to the conditions set out herein.

NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the parties intending to be legally bound, agree as follows:

 

 

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In this Agreement references to the Parties are to the Parties to this Agreement, headings are used for convenience only and do not affect its interpretation, references to a statutory provision include references to the statutory provision as modified or re-enacted or both from time to time and to any subordinate legislation made under the statutory provision, references to the singular include the plural and vice versa, and references to the word “including” are to be construed without limitation.

2Performance of Services

 

2.1Performance of Services. Subject to Clause 2.3, Lonza shall itself and through its Affiliates, diligently carry out the Services as provided in the Project Plan and use commercially reasonable efforts to perform the Services without any material defect and according to the estimated timelines as set forth in the Project Plan. Lonza shall retain appropriately qualified and trained personnel with the requisite knowledge and experience to perform the Services in accordance with this Agreement. Lonza may subcontract or delegate any of its rights or obligations under this Agreement to perform the Services; provided, that any External Laboratories shall be subject to the same obligations and other provisions contained in this Agreement or any applicable Project Plan, including obligations of confidentiality at least as stringent, and as protective of Customer, as those obligations of confidence and non-use imposed upon Lonza and provided that such External Laboratories shall be subject to obligations to act diligently. Lonza shall not be responsible for analytical lab services performed by External Laboratories.

 

2.2Technology Transfer. The Parties expressly agree that they shall work together to transfer the Manufacturing Process to the Facility, including implementing the technology transfer plan set forth in Project Plan. Customer shall fully support such technology transfer as reasonably requested by Lonza.

 

2.3Engineering Batches. Lonza shall manufacture Engineering Batches in accordance with the Project Plan. Customer shall have the- right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that Customer pays for such Batches, such use is not for human use and does not violate any Applicable Laws. Lonza makes no warranty that Engineering Batches will meet cGMP or the Specifications. If Lonza determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch. Regardless of whether any Engineering Batch meets cGMP or the Specifications, Customer shall pay to Lonza the Price for such Engineering Batch that were executed in accordance with mutually agreed plans and meet a mutually agreed specification for bioburden, plus the Raw Materials Fee associated with such Engineering Batches. If the Engineering Batch was not performed in accordance with mutually agreed plans or does not meet the agreed bioburden specification, then Lonza shall bear the costs of replacing the Batch, the Raw Materials and Customer Materials for any replacement Engineering Batch. For each CRM12 batch, the Raw Materials liability may be up to a maximum amount of [***]. For each bioconjugate batch, the Raw Materials liability (i) during storage of each bioconjugate batch is limited to [***], (ii) for manufacturing of each bioconjugate batch is limited to [***] and (iii) per manufacturing campaign is limited to [***].

 

2.4cGMP Batches. Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least [***] has been manufactured in compliance with cGMP and Specifications. Lonza will bear the risk of replacing any Raw Materials or Customer Materials that were consumed in any cGMP Batch that does not meet the Specifications and is not released to Customer, and after [***], Lonza will bear the risk of replacing any Batch that does not meet the Specifications. For each CRM12 batch, the Raw

 

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Materials liability may be up to a maximum amount of [***]. (i) during storage of each bioconjugate batch is limited to [***], (ii) for manufacturing of each bioconjugate batch is limited to [***] and (iii) per manufacturing campaign is limited to [***]. Prior to commencement of cGMP manufacturing, Lonza shall review the process assumptions. In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch Price to reflect such difference.

 

2.5Process Validation Batches. Lonza shall manufacture and deliver Process Validation Batches as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.

 

2.5.1Prior to commencement of Process Validation Batches, Lonza and Customer shall agree a process validation plan identifying the validation requirements of the Manufacturing Process. All process validation activities are excluded from the Price of Process Validation Batches shall be approved by the Customer in advance and shall be paid for by the Customer at the Price set out in the applicable Project Plan.

 

 

2.5.2Any regulatory support activities (including pre-Approval inspection) required and agreed to by Customer to support the Approval of the Product from the Facility shall be performed and supported by Lonza as reasonably requested by Customer. All such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by the Customer in advance, and shall be paid for by the Customer at the Price set out in the applicable Project Plan.

 

2.6Supply of Customer Information and Customer Materials. Customer shall supply to Lonza all Customer Information and Customer Materials and other information or materials that may be reasonably required by Lonza to perform the Services. Lonza shall not be responsible for any delays arising out of Customer’s failure to provide such Customer Information, Customer Materials, or other information or materials reasonably required to perform the Services to Lonza, and [***]. Lonza hereby undertakes not to use the Customer Materials or Customer Information (or any part thereof) for any purpose other than the performance of the Services under this Agreement. With respect to any Customer Materials, title shall remain with the Customer and shall not transfer to Lonza.

 

2.7Raw Materials. Lonza shall procure all required Raw Materials as well as consumables other than those Raw Materials that are Customer Materials. Customer shall be responsible for payment for all consumables and Raw Materials ordered or irrevocably committed to be procured by Lonza hereunder. Upon cancellation of any Batch or termination of the Agreement, all unused Raw Materials shall be paid for by Customer within [***] days of invoice and at Customer’s option will either be (a) held by Lonza for future use for the production of Product, (b) delivered to Customer, or (c) disposed of by Lonza.

 

 

3Project Management / Steering Committee

 

3.1Project Plans. With respect to a new project to be governed by this Agreement, a new Project Plan shall be added by agreement in a writing signed by the Parties and appended to Appendix A. Each Project Plan shall include a description of the Services to be provided, the Product to be manufactured, Specifications, a schedule for completion of the Project Plan, pricing details, and such other information as is necessary for relevant Services. In the event of a conflict between the terms of a Project Plan and this Agreement, the terms of this Agreement will govern.

 

3.2Project Management. With respect to each Project Plan, each party will appoint a project manager who will be the party responsible for overseeing the Project Plan.

 

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3.3Steering Committee. Each Party shall name a mutually agreed upon equal number of representatives for the Steering Committee, which shall meet twice per calendar year, or as otherwise mutually agreed by the Parties. In the event that a Steering Committee dispute cannot be resolved, such dispute shall be escalated to a senior executive of each of Customer and Lonza.

The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also take on the following responsibilities:

3.3.1discuss and seek resolution of issues around management of the Services;

3.3.2agree and monitor deadlines and milestones for the Services; and

3.3.3discuss and recommend any changes to the Services (although such changes will not take effect until they have been incorporated into a written amendment to the Project Plan which has been signed by the Parties).

 

 

3.4Person in Plant. Customer shall be permitted to have, [***], [***] at the Facility as reasonably requested by Customer, [***] for the purpose of observing, reporting on, and consulting as to the performance of the Services. Such [***] shall be subject to and agree to abide by confidentiality obligations to Third Parties and Lonza’s customary practices and operating procedures regarding persons in plant, and such [***] agrees to comply with all instructions of Lonza’s employees at the Facility.

 

4Quality

 

4.1Responsibility for quality assurance and quality control of Product shall be allocated between Customer and Lonza as set forth in the Quality Agreement and in Lonza standard operating procedures. If there is a conflict between the terms and conditions of this Agreement and the Quality Agreement, the terms and conditions of this Agreement shall prevail. If the Quality Agreement is not in place at the Effective Date, Lonza and Customer commit to enter into the Quality Agreement in a timely manner, but in no event later than the commencement of cGMP manufacturing.

 

4.2Provisions regarding inspections by Regulatory Authorities and audits shall be set out in the Quality Agreement.

 

5Insurance

 

5.1Customer shall, during the Term prior to any clinical use of the Product, obtain and maintain at its own cost and expense from a qualified insurance company, comprehensive general liability insurance in the amount of at least [***]. Customer shall at least [***] days prior to the first clinical use of a Product manufactured or Services provided under this Agreement, and for [***] years after delivery of the last such Product, obtain and maintain at its own cost and expense from a qualified insurance company, comprehensive general liability insurance including, but not limited to product liability coverage in the amount of at least [***]. Lonza shall, during the Term and for [***] years after delivery of the last Product manufactured or Services provided under this Agreement, obtain and maintain at its own cost and expense from a qualified insurance company, comprehensive general liability insurance including, but not limited to product liability coverage in the amount of at least [***]. Each Party shall provide the respective other Party with a certificate of such insurance upon reasonable request.

 

6Forecasting, Ordering and Cancellation

 

6.1Forecasting. No later than the[***] day of each [***], Customer shall supply Lonza with a written forecast showing Customer’s good faith estimated [***] requirements for Batches for the following [***] month period (the “Forecast”). No later than [***] following Lonza’s receipt of a Forecast, Lonza shall provide written notice to Customer of [***] and shall provide Customer with an estimated production schedule showing the estimated Commencement Date and delivery date of each Batch. The forecast and [***] given in this Section 6.1 shall not be binding on Customer or Lonza.

 

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6.2Purchase Orders. Customer shall place purchase orders binding on Customer for the number of Batches it wishes to order at least [***] months (or earlier as may be [***]) prior to the Commencement Date for such Batches in accordance with Lonza’s most recent response to the Forecast. Each binding purchase order shall be signed by Customer and shall authorize Lonza to manufacture such Batches of the Product as are set forth therein. Lonza shall not be obligated to commence manufacture of any Batch unless and until such written purchase order is accepted in writing by Lonza. Any delivery date set forth in Lonza’s written confirmation of a purchase order shall be an estimated delivery date only. All ordered Batches shall be scheduled in a single Campaign in each calendar year unless otherwise agreed by Lonza. Any additional or inconsistent terms or conditions of any Customer purchase order, acknowledgement or similar standardized form given or received pursuant to this Agreement shall have no effect and such terms and conditions are hereby rejected.

 

6.3Rescheduling. Lonza shall have the right to reschedule a Commencement Date of any Batch or Campaign upon reasonable prior written notice to Customer, provided that the rescheduled Commencement Date is no earlier or no later than [***] from the Commencement Date originally estimated at the time of Lonza’s acceptance of the binding purchase order, and further provided that Customer is able to provide the necessary Customer Materials. If the Customer requests to change the Commencement Date, Lonza will make all reasonable attempts to accommodate the request; provided, however, in the event that this change would impact other projects scheduled for occupancy in the designated suite or suites, manufacture of the Customer’s Batch or Campaign may be delayed until an adequate time period is available in the Facility schedule. Any such change requested by Customer may result in a rescheduling fee. Any delay requested by Customer of more than [***] shall be considered a cancellation pursuant to Section 6.5.

 

6.4Cancellation of a Binding Purchase Order for Polysaccharide + CRM12 Conjugates. Customer may cancel a binding purchase order for Polysaccharide + CRM12 Conjugates upon written notice to Lonza, subject to the payment of a cancellation fee as calculated below (the “Cancellation Fee”):

6.4.1In the event that Customer provides written notice of cancellation to Lonza less than or equal to [***] prior to the Commencement Date of one or more Batches, then [***] of the Batch Price of each such Batch cancelled is payable;

6.4.2In the event that Customer provides written notice of cancellation to Lonza more than [***] but less than or equal to [***] prior to the Commencement Date of one or more Batches, then [***] of the Batch Price of each such Batch cancelled is payable; and

6.4.3In the event that Customer provides written notice of cancellation to Lonza more than [***] but less than or equal to [***] prior to the Commencement Date of one or more Batches, then [***] of the Batch Price of each such Batch cancelled is payable; and

6.4.4In the event Customer provides written notice of cancellation more [***] prior to the Commencement Date of a subject Batch, then [***].

6.4.5Notwithstanding the provisions of this Clause 6.4, Lonza will use commercially reasonable efforts to reschedule its Facility to mitigate any losses from a cancellation, and if Lonza is able to reallocate any reserved capacity for the performance of services for any third party during the applicable period, then Customer’s obligation to pay the amounts under Sections 6.4.1, 6.4.2 or 6.4.3, shall be reduced pro-rata based on the use of such capacity for such third party during the applicable period.

 

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6.5Cancellation of a Binding Purchase Order for CRM 12. Customer may cancel a binding purchase order for CRM 12 upon written notice to Lonza, subject to the payment of a cancellation fee as calculated below (the “Cancellation Fee’):

6.5.1In the event that Customer provides written notice of cancellation to Lonza less than or equal to [***] prior to the Commencement Date of one or more Batches, then [***] of the Batch Price of each such Batch cancelled is payable;

6.5.2In the event Customer provides written notice of cancellation more than [***] prior to the Commencement Date of a subject Batch, then [***].

Notwithstanding the provisions of this Clause 6.4, Lonza will use commercially reasonable efforts to reschedule its Facility to mitigate any losses from a cancellation, and if Lonza is able to reallocate any reserved capacity for the performance of services for any third party during the applicable period, then Customer’s obligation to pay the amounts under Sections 6.4.1, 6.4.2 or 6.4.3, shall be reduced pro-rata based on the use of such capacity for such third party during the applicable period

6.6Payment of Cancellation Fee. Any Cancellation Fee shall be payable within [***] following the written notice of cancellation associated with the cancelled Batch. Any Cancellation Fee shall include all costs associated with the cancelled Batch, including any Raw Materials.

6.7Replacement Project. Notwithstanding the foregoing, Lonza will use commercially reasonable efforts to secure a new project [***] for the cGMP manufacturing space, [***], and then, in such case, the Cancellation Fee for each Batch cancelled that is replaced by a Batch of the new project shall be reduced by an amount equal to [***] of the production fees associated with such replacement Batch.

6.8Preferred Partnership. Customer and Lonza recognize the mutual strategic value of forging a long-term business relationship (hereinafter a “Preferred Partnership”). Reflecting this Preferred Partnership, Customer agrees [***] from the Effective Date of this Agreement to contract exclusively with Lonza for the manufacture of any and all [***] provided that Lonza can manufacture said product a) [***], b) [***], and c) [***].

7Delivery and Acceptance

7.1Delivery. All Product shall be delivered [***] (as defined by Incoterms® 2010). Lonza shall deliver to Customer the Certificate of Analysis and such other documentation as is reasonably required to meet all applicable regulatory requirements of the Governmental Authorities not later than the date of delivery of Batches (the “Release”). With respect to any Customer Materials, title and risk of loss shall remain with the Customer and shall not transfer to Lonza. With respect to Product, title and risk of loss shall remain with Lonza until Release, and shall transfer to Customer upon Release in accordance with this provision.

7.2Storage. Customer shall arrange for shipment and take delivery of such Batch from the Facility, at Customer’s expense, within [***] after Release or pay applicable storage costs. Lonza shall provide storage on a bill and hold basis for such Batch(es) at no charge for up to [***]; provided that any additional storage beyond [***] will be subject to availability and, if available, will be charged to Customer and will be subject to a separate agreement. In addition to Section 8.2, Customer shall be responsible for all value added tax (VAT) and any other applicable taxes, levies, import, duties and fees of whatever nature imposed as a result of any storage. Notwithstanding anything to the contrary contained in this Agreement, in no event shall Lonza be required to store any Batch for more than [***] after Release. Within [***] following a written request from Lonza, Customer shall provide Lonza with a letter in form satisfactory to Lonza confirming the bill and hold status of each stored Batch.

 

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7.3Acceptance/Rejection of Product.

7.3.1Promptly following Release of Batches, Customer shall inspect such Batches and shall have the right to test such Batches to determine compliance with the Specifications. Customer shall notify Lonza in writing of any rejection of a Batch based on any claim that it fails to meet Specifications within [***] of Release, after which time all unrejected Batches shall be deemed accepted.

7.3.2In the event that Lonza believes that a Batch has been incorrectly rejected, Lonza may require that Customer provide to it Batch samples for testing. Lonza may retain and test the samples of such Batch. In the event of a discrepancy between Customer’s and Lonza’s test results such that Lonza’s test results fall within relevant Specifications, or there exists a dispute between the Parties over the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and/or analyses on samples of the Product that allegedly fails to conform to Specifications. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules.

7.3.3Lonza shall replace any Batch that failed to conform with the Specifications (a “Failed Batch”), in the event that it is determined (by the Parties or the independent laboratory) that such failure was [***] (“Lonza Responsibility”). If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***]. Such replacement shall be made as promptly as practicable, in light of available manufacturing capacity, after the confirmation of Lonza Responsibility, and in any case as soon as reasonably possible after confirmation of Lonza Responsibility. Where possible, such replacement Batch shall be manufactured with the next scheduled cGMP Batch or Campaign. [***] acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***], and in furtherance thereof, [***]. Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3.

 

8Price and Payment

 

8.1Pricing for the Services provided by Lonza are set out in, and based on the assumptions and information set out in, the applicable Project Plan. In the event of changes to the Services based on Customer’s request, Customer shall bear all additional costs.

 

8.2Unless otherwise indicated in writing by Lonza, all Prices and charges are exclusive of value added tax (VAT) and of any other applicable taxes, levies, import, duties and fees of whatever nature imposed by or under the authority of any government or public authority and all such charges applicable to the Services (other than taxes on Lonza’s income) shall be paid by Customer. When sending payment to Lonza, the Customer shall quote the relevant invoice number in its remittance advice.

 

8.3Lonza shall issue invoices to Customer for [***] of the Price for Products or Services upon commencement thereof and [***] upon Release of applicable Batches or completion of applicable Services, unless otherwise stated in the Project Plan. Charges for Raw Materials and the Raw Materials Fee for each Batch shall be invoiced upon the Release of each Batch. Charges for Resins shall be invoiced by Lonza upon placement of purchase orders for such Resins by Lonza at cost plus a fee of [***]. All invoices are strictly net and payment must be made within [***] of date of invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim.

 

8.4If in default of payment of any undisputed invoice on the due date, interest shall accrue on any amount overdue at the lesser of (i) rate of [***] per month above the London Interbank Offered Rate (LIBOR) or (ii) the maximum rate allowable by applicable law, interest to accrue on a day to day basis until full payment; and Lonza shall, at its sole discretion, and without prejudice to any other of its accrued rights, be entitled to suspend the provision of the Services and or delivery of Product until all overdue amounts have been paid in full including interest for late payments.

 

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8.5Price adjustments.

8.5.1Not more than once per calendar year, Lonza may adjust the Price in accordance with the [***] for the previous calendar year. The new Price reflecting such Batch Price adjustment shall be effective for any Batch for which the Commencement Date is on or after the date of Lonza’s notice to Customer of the Price adjustment.

 

8.5.2In addition to the above, the Price may be changed by Lonza, upon reasonable prior written notice to Customer (providing reasonable detail in support thereof), to reflect (i) an increase in variable costs (such as energy or Raw Materials) by more than [***] (based on the initial Price or any previously amended Price), or for a process adjustment or assumption changes, and (ii) any material change in an environmental, safety or regulatory standard that substantially impacts Lonza’s cost and ability to perform the Services.

 

9Capital Equipment

 

9.1Any Capital Equipment required for the performance of the Services shall be acquired on terms to be agreed by the Parties prior to commencement of the relevant Services.

 

10Intellectual Property

 

10.1Except as expressly otherwise provided herein, neither Party will, as a result of this Agreement, acquire any right, title, or interest in any Background Intellectual Property of the other Party.

 

10.2Subject to Clause 10.3, Customer shall own all right, title, and interest in and to any and all Intellectual Property that Lonza and/or its Affiliates, the External Laboratories or other contractors or agents of Lonza develops, conceives, invents, first reduces to practice or makes, solely or jointly with Customer or others, in the performance of the Services, to the extent such Intellectual Property is a direct derivative of or improvement to the Product, Customer Materials, Customer Information and/or Customer Background Intellectual Property (collectively, the “New Customer Intellectual Property”). For avoidance of doubt, “New Customer Intellectual Property” shall include any material, processes or other items that solely embody, or that solely are claimed or covered by, any of the foregoing Intellectual Property, but excluding any New General Application Intellectual Property.

 

10.3Notwithstanding Clause 10.2, and subject to the license granted in Clause 10.5, Lonza shall own all right, title and interest in Intellectual Property that Lonza and/or its Affiliates, the External Laboratories or other contractors or agents of Lonza, solely or jointly with Customer, develops, conceives, invents, or first reduces to practice or makes in the course of performance of the Services to the extent such Intellectual Property (i) [***], or (ii) [***] (“New General Application Intellectual Property”). For avoidance of doubt, “New General Application Intellectual Property” shall include any material, processes or other items that embody, or that are claimed or covered by, any of the foregoing Intellectual Property.

 

10.4Lonza hereby assigns to Customer all of its right, title and interest in any New Customer Intellectual Property. Lonza shall execute, and shall require its personnel as well as its Affiliates, External Laboratories or other contractors or agents and their personnel involved in the performance of the Services to execute, any documents reasonably required to confirm Customer’s ownership of the New Customer Intellectual Property, and any documents required to apply for, maintain and enforce any patent or other right in the New Customer Intellectual Property.

 

10.5Subject to the terms and conditions set forth herein (including the payment of the Price as required above), Lonza hereby grants to Customer a non-exclusive, world-wide, fully paid-up, irrevocable, transferable license, including the right to grant sublicenses, under the New General Application Intellectual Property, to research, develop, make, have made, use, sell and import the Product manufactured under this Agreement.

 

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10.6Customer hereby grants Lonza the non-exclusive right to use the Customer Information, Customer Background Intellectual Property and New Customer Intellectual Property during the Term solely for the purpose of fulfilling its obligations under this Agreement; provided, however, that no license is granted to any Customer Background Intellectual Property that is owned or controlled by Sutro Biopharma, Inc.

 

10.7Customer will have the right to transfer the Manufacturing Process to itself and/or to any Third Party; provided, however, to the extent such technology transfer includes Lonza Confidential Information, or Lonza Background Intellectual Property, such technology transfer shall be subject to [***], and a reasonable royalty and/or licensing fee and terms to be agreed upon by the Parties. [***]. If [***] the Manufacturing Process includes the use of any such additional royalty-bearing Lonza Confidential Information or Lonza Background Intellectual Property, then Customer will pay to Lonza an agreed royalty and/or other agreed payments for the use of Lonza Confidential Information or Lonza Background Intellectual Property. Lonza shall provide reasonably necessary documents to complete such technology transfer, including transfer of New General Application Intellectual Property, if applicable, and, subject to the terms and conditions of this Clause 10.7, Lonza Confidential Information or Lonza Background Intellectual Property, [***] and Customer shall reimburse Lonza for any costs [***] and expenses, provided that the total cost of such assistance (excluding any costs paid to Lonza for the use of Lonza’s Confidential Information or Lonza Background Intellectual Property) will not exceed [***].

 

11Warranties

 

11.1Lonza warrants that:

 

11.1.1the Services shall be performed in a professional and workmanlike manner and in accordance with all Applicable Laws;

 

11.1.2Lonza will not knowingly include in the Manufacturing Process any elements that infringe any such intellectual or industrial property rights vested in any Third Party;

 

11.1.3except with respect to any development services and Engineering Batches, the manufacture of Product shall be performed in accordance with cGMP and will meet the Specifications at the date of delivery;

 

11.1.4it or its Affiliate holds all necessary permits, approvals, consents and licenses to enable it to perform the Services at the Facility;

 

11.1.5it has the necessary corporate authorizations to enter into and perform this Agreement;

 

11.1.6Lonza has never been debarred under the Generic Drug Enforcement Act of 1992, 21 U.S.C. Sec. 335a (a) or (b) (the “Act”). In the event that during the term of this Agreement, Lonza (i) becomes debarred, suspended, excluded, sanctioned, or otherwise declared ineligible under the Act; Lonza agrees to promptly notify Customer. Lonza also agrees that in the event that it becomes debarred, suspended, excluded, sanctioned, or otherwise declared ineligible under the Act, it shall promptly cease all activities relating to this Agreement;

 

11.1.7subject to payment of undisputed invoices, title to all Product and all New Customer Intellectual Property provided to Customer under this Agreement shall pass free and clear of any security interest, lien or other encumbrance in favour of Lonza; and

 

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11.2Customer warrants that:

 

11.2.1as of the date of this Agreement to the best of the Customer’s knowledge and belief, the Customer has all the rights necessary to permit Lonza to perform the Services without infringing the Intellectual Property rights of any Third Party and the performance of the Services shall not infringe any Third Party Intellectual Property rights;

 

11.2.2Customer will promptly notify Lonza in writing if it receives or is notified of a formal written claim from a Third Party that Customer Information and/or Customer Intellectual Property or that the use by Lonza thereof for the provision of the Services infringes any Intellectual Property or other rights of any Third Party; and

 

11.2.3Customer has the necessary corporate authorizations to enter into this Agreement.

 

11.3DISCLAIMER: THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, AND ALL OTHER WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE EXPRESSLY DISCLAIMED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

11.4Debarment.

 

11.4.1In the event a party receives a notice from the other party (“Defaulting Party”) or otherwise becomes aware that a debarment, suspension, exclusion, sanction, or declaration of ineligibility action has been brought against the Defaulting Party; then the party receiving such notice shall have the right to terminate this Agreement immediately; provided that if such event shall occur, the party receiving such notice shall not have such right of termination. If the Defaulting Party is disputing and defending such action and the Defaulting Party is otherwise able to perform its services in the manner required under this Agreement.

11.4.2Each party shall ensure that it will not knowingly use in any capacity the services of any individual, corporation, partnership or association which has been debarred under 21 U.S.C. Sec. 335a(a) or (b), or listed in the DHHS/OIG List of Excluded Individuals/Entities or the General Services Administration’s Listing of Parties Excluded from Federal Procurement and Non-Procurement Programs.

 

12Indemnification and Liability

 

12.1Indemnification by Lonza. Lonza shall indemnify the Customer, its Affiliates, and their respective officers, employees and agents (“Customer Indemnitees”) for any loss, damage, costs and expenses (including reasonable attorney fees) that Customer Indemnitees may suffer as a result of any Third Party claim arising directly out of [***] except, in each case, to the extent that such claims resulted from the negligence, intentional misconduct or breach of this Agreement by any Customer Indemnitees. Notwithstanding the foregoing, Lonza shall have no obligations under this clause 12.1 for any liabilities, expenses, or costs to the extent arising out of or relating to claims covered under clause 12.2.

 

12.2Indemnification by Customer. Customer shall indemnify Lonza, its Affiliates, and their respective officers, employees and agents (“Lonza Indemnitees”) from and against any loss, damage, costs and expenses (including reasonable attorney fees) that Lonza lndemnitees may suffer as a result of any Third Party claim arising directly out of [***]; except, in each case, to the extent that such claims resulted from the negligence, intentional misconduct or breach of this Agreement by any Lonza Indemnitees. Notwithstanding the foregoing, Customer shall have no obligations under this clause 12.2 for any liabilities, expenses, or costs to the extent arising out of or relating to claims covered under clause 12.1.

 

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12.3Indemnification Procedure. If the Party to be indemnified intends to claim indemnification under this Clause 12, it shall promptly notify the indemnifying Party in writing of such claim. The indemnitor shall have the right to control the defense and/or settlement thereof; provided, however, that (i) the indemnitor must obtain the prior written consent of the indemnitee (not to be unreasonably withheld) before entering into any settlement of such third party claim, and (ii) any indemnitee shall have the right to retain its own counsel at its own expense. The indemnitee, its employees and agents, shall reasonably cooperate with the indemnitor in the investigation of any liability covered by this Clause 12. The failure to deliver prompt written notice to the indemnitor of any claim, to the extent prejudicial to its ability to defend such claim, shall relieve the indemnitor of any obligation to the indemnitee under this Clause 12.

 

12.4DISCLAIMER OF CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, LOST PROFITS OR LOST REVENUES ARISING FROM OR RELATED TO THIS AGREEMENT, EXCEPT TO THE EXTENT RESULTING FROM FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT AND/OR FOR EITHER PARTY’S BREACH OF ARTICLE 13 HEREOF.

 

12.5LIMITATION OF LIABILITY. LONZA’S LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED, IN THE AGGREGATE, [***], EXCEPT TO THE EXTENT RESULTING FROM LONZA’S FRAUD, GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT.

13Confidentiality

 

13.1A Party receiving Confidential Information (the “Receiving Party”) agrees to strictly keep secret any and all Confidential Information received during the Term from or on behalf of the other Party (the “Disclosing Party”) using at least the same level of measures as it uses to protect its own Confidential Information, but in any case at least commercially reasonable and customary efforts. Confidential Information shall include information disclosed in any form including but not limited to in writing, orally, graphically or in electronic or other form to the Receiving Party, observed by the Receiving Party or its employees, agents, consultants, or representatives, or otherwise learned by the Receiving Party under this Agreement, which the Receiving Party knows or reasonably should know is confidential or proprietary.

 

13.2Notwithstanding the foregoing, Receiving Party may disclose to any courts and/or other authorities Confidential Information which is or will be required pursuant to applicable governmental or administrative or public law, rule, regulation or order. In such case the Party that received the Confidential Information will, to the extent legally permitted, inform the other Party promptly in writing and cooperate with the Disclosing Party in seeking to minimize the extent of Confidential Information which is required to be disclosed to the courts and/or authorities.

 

13.3The obligation to maintain confidentiality under this Agreement does not apply to Confidential Information, which:

 

13.3.1at the time of disclosure was publicly available; or

 

13.3.2is or becomes publicly available other than as a result of a breach of this Agreement by the Receiving Party; or

13.3.3as the Receiving Party can establish by competent proof, was rightfully in its possession at the time of disclosure by the Disclosing Party and had not been received from or on behalf of Disclosing Party; or

13.3.4is supplied to a Party by a Third Party which was not in breach of an obligation of confidentiality to Disclosing Party or any other party; or

13.3.5is developed by the Receiving Party independently from and without use of the Confidential Information, as evidenced by contemporaneous written records.

 

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13.4The Receiving party will use Confidential Information only for the purposes of this Agreement and will not make any use of the Confidential Information for its own separate benefit or the benefit of any Third Party including, without limitation, with respect to research or product development or any reverse engineering or similar testing. The Receiving Party agrees to return or destroy promptly (and certify such destruction) on Disclosing Party’s request all written or tangible Confidential Information of the Disclosing Party, except that one copy of such Confidential Information may be kept by the Receiving Party in its confidential files for record keeping purposes only.

 

13.5Each Party will restrict the disclosure of Confidential Information to such officers, employees, professional advisers, finance-providers, consultants and representatives of itself and its Affiliates who have been informed of the confidential nature of the Confidential Information and who have a need to know such Confidential Information for the purpose of this Agreement or an applicable financing or acquisition. Both Parties may disclose Confidential Information of the other Party and its Affiliates to potential and actual acquirers provided such disclosure is limited to the terms of this Agreement. Customer also may disclose to its potential and actual: (i) acquirers and (ii) bona fide collaborators in the research, development and commercialization of the Products, the work product provided to Customer by Lonza as a consequence of the provision of the Services. Prior to disclosure to such persons, the Receiving Party shall inform the Disclosing Party and it shall bind its and its Affiliates’ officers, employees, consultants and representatives to confidentiality and non-use obligations no less stringent than those set forth herein. The Receiving Party shall notify the Disclosing Party as promptly as practicable of any unauthorized use or disclosure of the Confidential Information.

 

13.6The Receiving Party shall at any time be fully liable for any and all breaches of the confidentiality obligations in this Clause 13 by any of its Affiliates or the employees, consultants, potential and actual acquirers, and representatives of itself or its Affiliates.

 

13.7Each Party hereto expressly agrees that any breach or threatened breach of the undertakings of confidentiality provided under this Clause 13 by a Party may cause irreparable harm to the other Party and that money damages may not provide a sufficient remedy to the non-breaching Party for any breach or threatened breach. In the event of any breach and/or threatened breach, then, in addition to all other remedies available at law or in equity, the non-breaching Party shall be entitled to seek injunctive relief and any other relief deemed appropriate by the non-breaching Party.

 

14Term and Termination

 

14.1Term. This Agreement shall commence on the Effective Date and shall end on the fifth (5th) anniversary of the Effective Date unless terminated earlier as provided herein or extended by mutual written consent of the Parties (the “Term”). Notwithstanding the foregoing, each Project Plan may have separate term and termination provisions so long as the term of any Project Plan does not extend beyond the Term.

 

14.2Termination. This Agreement may be terminated as follows:

 

14.2.1by either Party for any reason upon [***] prior written notice; provided that Lonza may not provide such notice until after [***]. In such an event all cancellation terms in this Agreement shall apply (except, in the case of termination by Lonza pursuant to Clause 14.2.1, the Cancellation Fees shalt not apply), and the Customer shall make payments for work commenced and performed under any purchase order(s) by Lonza prior to the termination notice date;

 

14.2.2by either Party if the other Party breaches a material provision of this Agreement or a Project Plan and fails to cure such breach to the reasonable satisfaction of the non-breaching Party within [***] following written notification of such breach from the non-breaching party to the breaching party; provided, however, that such [***] period shall be extended as agreed by the Parties if the identified breach is incapable of cure within [***] and if the breaching Party provides a plan and timeline to cure the breach, promptly commences efforts to cure the breach and diligently prosecutes such cure [***];

 

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14.2.3by either Party, immediately, if the other Party becomes insolvent, is dissolved or liquidated, makes a general assignment for the benefit of its creditors, or files or has filed against it, a petition in bankruptcy or has a receiver appointed for a substantial part of its assets; or

 

14.2.4by either Party pursuant to Clause 15.

 

14.3Consequences of Termination. In the event of termination hereunder, Lonza shall be compensated for (i) Services rendered up to the date of termination, including in respect of any Product in-process; (ii) all costs incurred through the date of termination, including Raw Materials costs and Raw Materials Fees for Raw Materials used or purchased for use in connection with the Project Plan; (iii) all unreimbursed Capital Equipment and related decommissioning charges incurred pursuant to Clause 9; (iv) all amounts due under Clause 6.4, without proration of the final calendar year and (v) any applicable Cancellation Fees. In the case of termination by Lonza for Customer’s material breach, Cancellation Fees shall be calculated as of the date of written notice of termination.

 

14.4Survival. The rights and obligations of each Party which by their nature survive the termination or expiration of this Agreement shall survive the termination or expiration of this Agreement, including Clauses 5, 10-13 and 16 (to the extent relevant).

 

15Force Majeure

 

15.1If Lonza is prevented or delayed in the performance of any of its obligations under the Agreement by Force Majeure and gives written notice thereof to Customer specifying the matters constituting Force Majeure together with such evidence as Lanza reasonably can give and specifying the period for which It Is estimated that such prevention or delay will continue, Lonza shall be excused from the performance or the punctual performance of such obligations as the case may be from the date of such notice for so long as such cause of prevention or delay shall continue. Provided that, if such Force Majeure persists for a period of [***] or more, Customer may terminate this Agreement by delivering written notice to Lonza.

 

15.2“Force Majeure” shall be deemed to include any reason or cause beyond Lonza’s reasonable control affecting the performance by Lonza of its obligations under the Agreement, including, but not limited to, any cause arising from or attributable to acts of God, strike, labor troubles, restrictive governmental orders or decrees, riots, insurrection, war, terrorist acts, or the inability of Lonza to obtain any required raw material, energy source, equipment, labor or transportation, at prices and on terms deemed by Lonza to be reasonably practicable, from Lonza’s usual sources of supply.

 

15.3With regard to Lonza, any such event of Force Majeure affecting services or production at its Affiliates or suppliers shall be regarded as an event of Force Majeure.

 

16Miscellaneous

 

16.1Severability. If any provision hereof is or becomes at any time illegal, invalid or unenforceable in any respect, neither the legality, validity nor enforceability of the remaining provisions hereof shall in any way be affected or impaired thereby. The Parties hereto undertake to substitute any illegal, invalid or unenforceable provision by a provision which is as far as possible commercially equivalent considering the legal interests and the Purpose.

 

16.2Amendments. Modifications and/or amendments of this Agreement must be in writing and signed by the Parties.

 

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16.3Assignment. Lonza shall be entitled to instruct one or more of its Affiliates to perform any of Lonza’s obligations contained in this Agreement, but Lonza shall remain fully responsible in respect of those obligations. Neither Party may assign its interest under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, provided, however that either Party may assign this Agreement to (i) any Affiliate of such Party or (ii) any third party in connection with the sale or transfer (by whatever method) of all or substantially all of the assets of the business or Product of such Party to which this Agreement relates, whether by merger, consolidation, acquisition or other form of business combination. Any purported assignment without a required consent shall be void. No assignment shall relieve any Party of responsibility for the performance of any obligation that accrued prior to the effective date of such assignment. Lonza shall be entitled to sell, assign and/or transfer its trade receivables resulting from this Agreement without the consent of the Customer.

 

16.4Notice. All notices must be written and sent to the address of the Party first set forth above. All notices must be given (a) by personal delivery, with receipt acknowledged, (b) by facsimile followed by hard copy delivered by the methods under (c) or (d), (c) by prepaid certified or registered mail, return receipt requested, or (d) by prepaid recognized next business day delivery service. Notices will be effective upon receipt or at a later date stated in the notice.

 

16.5Governing Law/Jurisdiction. This Agreement is governed in all respects by the laws of [***], without regard to its conflicts of laws principles. The Parties agree to submit to the jurisdiction of the state and federal courts [***].

 

16.6Entire Agreement. This Agreement contains the entire agreement between the Parties as to the subject matter hereof and supersedes all prior and contemporaneous agreements with respect to the subject matter hereof. This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of which together shall constitute one and the same document. Each party acknowledges that an original signature or a copy thereof transmitted by facsimile or by .pdf shall constitute an original signature for purposes of this Agreement.

 

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IN WITNESS WHEREOF, each of the Parties hereto has caused this Development and Manufacturing Services Agreement to be executed by its duly authorized representative effective as of the date written above.

 

 

 

 

 

 

 

 

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APPENDIX A

Project Plan A—1

[Attached]

[***]

Project Plan A – 2

[Attached]

{16 pages omitted}

[***]

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APPENDIX B

Quality Agreement

[Attached]

{37 pages omitted}

[***]

 

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APPENDIX C

Specifications

{9 pages omitted}

[***]

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

FIRST AMENDMENT TO DEVELOPMENT AND MANUFACTURING SUPPLY

AGREEMENT

This First Amendment (“First Amendment”), which comes into effect on January 1, 2017 (the “First Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and SutroVax Inc (“SutroVax”). This First Amendment is to be incorporated as part of the Development and Manufacturing Agreement, dated October 21, 2016, between Lonza and SutroVax (the “Original Agreement”). Lonza and Sutrovax, hereafter referred to as a “Party” and collectively as the “Parties.”

Whereas:

1.Lonza and SutroVax entered into the Original Agreement, which the Parties now desire to amend;

2.Sutrovax wishes to extend the Original Agreement in order to add the conjugation to the protein development and manufacturing;

Parties hereby agree that the following amendments are made pursuant to the Original Agreement:

1.Project Plan A-2 (Polysaccharide + CRM12 Conjugates, Lonza code SUO-002), version 4, dated 04 January 2017 shall be added to Appendix A of the Original Agreement, in addition to the pre-existing Project Plan A-1 (Technology Transfer and cGMP Manufacturing of CRM12, Lonza code SUO-001). Project Plan A-2 is attached to this First Amendment as Annex 1.

 

2.All capitalized terms used herein shall have the meaning set forth in the Original Agreement.

 

3.All other terms and conditions of the Original Agreement shall remain in full force and effect. In the event of any conflict between the terms and conditions of this First Amendment and the Original Agreement, the terms and conditions set forth in the Original Agreement shall control.

 

4.No modification of or amendment to this First Amendment, nor any waiver of any rights under this First Amendment, will be effective unless in writing signed by the duly authorized representatives of both Parties, and the waiver of any breach or default will not constitute a waiver of any other right hereunder or any subsequent breach or default.

IN WITNESS WHEREOF, SutroVax and Lonza hereby enter into this First Amendment, effective as of the First Amendment Effective Date.

[Signatures on following page]

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Annex 1

Project Plan A-2

to

Development and Manufacturing Agreement

{24 pages omitted}

[***]

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

SECOND AMENDMENT TO DEVELOPMENT AND MANUFACTURING

SUPPLY AGREEMENT

This Second Amendment (“Second Amendment”), which comes into effect on July 1, 2017 (the “Second Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and SutroVax Inc (“SutroVax”). This Second Amendment is to be incorporated as part of the Development and Manufacturing Agreement, dated October 21, 2016, between Lonza and SutroVax (the “Original Agreement”). Lonza and SutroVax, hereafter referred to as a “Party” and collectively as the “Parties.”

Whereas:

 

Parties hereby agree that the following amendments are made pursuant to the Original Agreement:

Project Plan A-3 (Generation of RCB/PCB of 24 S. pneumoniae strains, Lonza code SUO-005), version 2, dated 19 June 2017 shall be added to Appendix A of the Original Agreement, in addition to the pre-existing Project Plan A-1 (Technology Transfer and cGMP Manufacturing of CRM12, Lonza code SUO-001) and Project Plan A-2 (Polysaccharide + CRM12 Conjugates, Lonza code SUO-002); Project Plan A-3 is attached to this Second Amendment as Annex 1.

1.All capitalized terms used herein shall have the meaning set forth in the Original Agreement.

2.All other terms and conditions of the Original Agreement shall remain in full force and effect. In the event of any conflict between the terms and conditions of this Second Amendment and the Original Agreement, the terms and conditions set forth in the Original Agreement shall control.

3.No modification of or amendment to this Second Amendment, nor any waiver of any rights under this Second Amendment, will be effective unless in writing signed by the duly authorized representatives of both Parties, and the waiver of any breach or default will not constitute a waiver of any other right hereunder or any subsequent breach or default.

 

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IN WITNESS WHEREOF, SutroVax and Lonza hereby enter into this Second Amendment, effective as of the Second Amendment Effective Date.

[Signatures on following page]

 

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Annex 1

Project Plan A-3

to

Development and Manufacturing Agreement

{11 pages omitted}

[***]

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

THIRD AMENDMENT TO DEVELOPMENT AND MANUFACTURING

SUPPLY AGREEMENT

This Third Amendment (“Third Amendment”), which comes into effect on September 26, 2017 (the “Third Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and SutroVax Inc (“SutroVax”). This Third Amendment is to be incorporated as part of the Development and Manufacturing Agreement, dated October 21, 2016, between Lonza and SutroVax (the “Original Agreement”). Lonza and SutroVax, hereafter referred to as a “Party” and collectively as the “Parties.”

Where

 

Parties hereby agree that the following amendments are made pursuant to the Original Agreement:

1.All capitalized terms used herein shall have the meaning set forth in the Original Agreement

2.Project Plan A-4 (cGMP Supply of 25 Polysaccharides for a Multi-Valent Pneumococcal Vaccine, Lonza code SUO-005), version 5, dated September 15, 2017 shall be added to Appendix A of the Original Agreement, in addition to the pre-existing Project Plan A-1 (Technology Transfer and cGMP Manufacturing of CRM12, Lonza code SUO-001), Project Plan A-2 (Polysaccharide + CRM12 Conjugates, Lonza code SUO-002), version 4, dated 22 December 2016, and Project Plan A-3 (Generation of RCB/PCB of 24 S. pneumonia strains, Lonza code SUO-005), version 2, dated 19 June 2017. Project Plan A-4 is attached to this Third Amendment as Annex 1.

3.The Parties hereby agree that the current definition of “Background Intellectual Property” shall be deleted in its entire and shall be replaced by the following:

 

4.The Parties hereby agree that the current definition of “Product” shall be deleted in its entire and shall be replaced by the following:

5.The Parties hereby agree that the current definition of “Raw Material Fee” shall be deleted in its entire and shall be replaced by the following:

 

6.The Parties hereby agree that the current clause 6.5 shall be deleted in its entire and shall be replaced by the following clause:

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“6.5Cancellation of a Binding Purchase Order for CRM12 and/or for the manufacturing of polysaccharides Batches. Customer may cancel a binding purchase order for CRM12 and/or for the manufacturing of polysaccharides Betches upon written notice to Lonza, subject to the payment of a cancellation fee as calculated below (the “Cancellation Fee”):

 

 

6.5.1In the event that Customer provides written notice of cancellation to Lonza less than or equal to [***] prior to the Commencement Date of one or more Batches, then [***] of the Batch Price of each such Batch cancelled is payable;

 

6.5.2In the event Customer provides written notice of cancellation more than [***] prior to the Commencement Date of a subject Batch, then [***]; and

 

6.5.3Notwithstanding the above, the Parties hereby agree that [***] shall apply with respect to [***], unless Customer [***], in which case [***].

 

7.The Parties hereby agree that the current clause 7.2 shall be deleted in its entire and shall be replaced by the following clause:

“7.2 Storage. CRM12 and polysaccharide Batches (required intermediates for the production of Conjugate Drug Substances) will be stored at no charge for up to [***] after Release of Conjugate Drug Substances; provided that any additional storage beyond [***] will be subject to availability and, if available, will be charged to Customer and will be subject to a separate agreement. Except for CRM12 and polysaccharide Batches, Customer shall arrange far shipment and take delivery of such Batch from the Facility, at Customer’s expense, within [***] days after Release or pay applicable storage costs, unless otherwise agreed to by the Parties. Lonza shall provide storage on a bill and hold basis for such Batch(es) at no charge for up to [***]; provided that any additional storage beyond [***]) days will be subject to availability and, if available, will be charged to Customer and will be subiect to a separate agreement. In addition to Section 8.2, Customer shall be responsible for all value added tax (VAT) and any other applicable taxes, levies, import, duties and fees of whatever nature imposed as a result of any storage. Unless otherwise agreed to by the Parties, in no event shall Lonza be required to store any Batch for more than [***] calendar days after Release. Within [***] days following a written request from Lonza, Customer shall provide Lonza with a letter in form satisfactory to Lonza confirming the bill and hold status of each stored Batch.”

 

8.The Parties hereby agree that the current clause 8.3 shall be deleted in its entire and shall be replaced by the following clause:

 

“8.3 Lonza shall issue invoices to Customer for [***] of the Price for Products or Services upon commencement thereof (the “Initiation Payment”) and [***] upon Release of applicable Batches or completion of applicable Services (the “Completion Payment”), unless otherwise stated in the Project Plan. Charges for Raw Materials and the Raw Materials Fee for each Batch shall be invoiced upon the Release of each Batch. Charges for Resins shall be invoiced by Lonza upon placement of purchase orders for such Resins by Lonza at cost plus a fee of [***]. Charges for consumables and wearables, as well as charges for Services provided by External Laboratories, shall be invoiced upon the Release of the applicable Batch at cost plus a fee of [***]. Notwithstanding the above, Parties agree that in the event that Lonza does not complete stages of the IND enabling work (i.e. the stages necessary for Customer to submit the IND application, including in any event the Release of at least one (1) GMP Drug Product Batch plus one (1) month of GMP Drug Product stability testing before 31 December 2019), Lonza shall for any stage that commences after 31 December 2019 or has not been completed by 31 December 2019, invoice the Initiation Payment for Products or Services upon commencement thereof. The Completion Payment for Products or Services shall be invoiced by Lonza either (i) [***] or (ii) on [***]. All invoices are strictly net and payment must be made within [***] days of date of invoice. Payment shall be made without deduction, deferment, set-off, lien or counterclaim, except as set forth in the Agreement or any Amendments. The provisions of this Clause 8.3, including the rate of markup charges set forth herein and in the definition of Raw Materials Fees, shall apply prospectively to all Services under the Agreement, including those Services to be performed after the Amendment Three Effective Date under Work Plan A-1, Work Plan A-2, Work Plan A-3 and Work Plan A-4.”

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9.The Parties hereby agree that the current clause 10.3 shall be deleted in its entire and shall be replaced by the following clause:

“10.3 Nowithstanding Clause 10.2, and subject to the license granted in Clause 10.5, Lonza shall own all right, title and interest in Intellectual Property that Lonza and/or its Affiliates, the External Laboratories or other contractors or agents of Lonza, solely or jointly with Custorner, develops, conceives, invents, or first reduces to practice or makes in the course of performance of the Services to the extent such Intellectual Property (i) is generally applicable to the development or manufacture of chemieal or biological products or product components, and could reasanably have been made without the use of the Customer Materials, Customer Information, or Customer Baekground Intellectual Property or (ii) is an improvement of or direct derivative of, any Lonza Background Intellectual Praperty (“New General Application Intellectual Property”). For avoidance of doubt, “New General Application Intellectual Property” shall include any material, processes or other items that embody, or that are claimed or covered by, any of theforegoing Intellectual Property.”

 

10.The Parties hereby agree that the current clause 10.5 shall be deleted in its entire and shall be replaced by the following clause:

 

“10.5 Subject to the terms and conditions set forth herein (including the payment of the Price as required above), Lonza hereby grants to Customer a non-exclusive, world-wide, fully paid-up, irrevocable, transferable license, including the right to grant sublicenses, under the New General Application Intellectual Property, to research, develop, make, have made, use, sell and import the Product.”

 

11.The Parties hereby agree that the current clause 10.7 shall be deleted in its entire and shall be replaced by the following clause:

 

“10.7 Customer will have the right to transfer the Manufacturing Process to itself, its Affiliates and/or any third Party, provided, however, to the extent such technology transfer includes Lonza Confidential Information, or Lonza Background Intellectual Property, such technology transfer to any Third Party shall be subject to [***], and a reasonable royalty and/or licensing fee and terms to be agreed upon by the Parties. Lonza will not include in the Manufacturing Process any Lonza Confidential Information or Lonza Background Intellectual Property that would require Customer to pay any additional payment and/or royalty to Lonza in order to transfer the Manufacturing Process to itself, its Affiliates and/or any Third Party without first obtaining Customer’s prior written consent and advising Customer as to the royalty structure and any other payment that would apply for the use of such additional technologies. If Customer has provided such consent and the Manufacturing Process includes the use of any such additional payment-bearing or royalty-bearing Lonza Confidential Information or Lonza Background Intellectual Property, then Customer will pay to Lonza an agreed royalty and/or other agreed payments for the use of Lonza Confidential Information or Lonza Background Intellectual Property. Lonza shall provide reasonably necessary documents to complete such technology transfer, including transfer of New General Application Intellectual Property, if applicable, and subject to the terms and conditions of this Clause 10.7, Lonza Confidential Information or Lonza Background Intellectual Property, if incorporated into the Manufacturing Process with Customer’s consent, and Customer shall reimburse Lonza for any costs (based on a full-time employee rate for such support) and expenses, provided that the total cost of such assistance (excluding any costs paid to Lonza for the use of Lonza’s Confidential Information or Lonza Background Intellectual Property) will not exceed [***].”

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12.The Parties hereby agree that the current clause 14.2.1 shall be deleted in its entire and shall be replaced by the following clause:

 

“14.2.1 by either Party for any reason upon [***] prior written notice; provided that Lonza may not provide such notice until [***]. In such an event all cancellation terms in this Agreement shall apply (except, in the case of termination by Lonza pursuant to Clause 14.2.1, the Cancellation Fees shall not apply), and the Customer shall make payments for work commenced and performed under any purchase order(s) by Lonza prior to the termination notice date.”

 

13.All other terms and conditions of the Original Agreement shall remain in full force and effect. In the event of any conflict between the terms and conditions of this Third Amendment and the Original Agreement, the terms and conditions set forth in the Original Agreement shall control.

 

 

14.No modification of or amendment to this Third Amendment, nor any waiver of any rights under this Third Amendment, will be effective unless in writing signed by the duly authorized representatives of both Parties, and the waiver of any breach or default will not constitute a waiver of any other right hereunder or any subsequent breach or default.

[Signatures on following page]

IN WITNESS WHEREOF, SutroVax and Lonza hereby enter into this Third Amendment, effective as of the Third Amendment Effective Date.

 

 

 

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Annex 1

Project Plan A-4

to

Development and Manufacturing Agreement

{23 pages omitted}

[***]

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

 

ALL REFERENCES TO THE “FIFTH AMENDMENT” CONTAINED HEREIN SHOULD BE READ AS THE “FOURTH AMENDMENT.”

 

FIFTH AMENDMENT TO DEVELOPMENT AND MANUFACTURING SUPPLY AGREEMENT

 

This Fifth Amendment ("Fifth Amendment"), which comes into effect retrospectively as per 10 June, 2018 (the "Fifth Amendment Effective Date"), is made by and between Lonza Ltd ("Lonza") and SutroVax Inc ("SutroVax"). This Fifth Amendment is to be incorporated as part of the Development and Manufacturing Agreement, dated October 21, 2016, between Lonza and SutroVax, as amended from time to time (the "Original Agreement''). Lonza and SutroVax, hereafter referred to as a "Party" and collectively as the "Parties."

 

Whereas

 

 

 

 

Parties hereby agree that the following amendments are made pursuant to the Original Agreement:

 

 

 

The stages 2-C, 2-D, 2-E and 2-F of the Proposal [***] will be replaced by the stages 2-C, 2-D, 2-E and 2-F as further set out in the proposal (cGMP Manufacturing of CRM12 in [***] facility, Lonza code SUO-001), version 1 dated 22nd June 2018 ("Proposal [***]"). This Proposal [***] shall be attached to the Original Agreement under Appendix A as Project Plan A-1.1, in addition to the existing Project Plans. For the avoidance of doubt, the remaining of Proposal [***] does not change and shall remain in full force and effect.

 

 

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For illustrative purposes:

 

 

 

 

 

IN WITNESS WHEREOF, SutroVax and Lonza hereby enter into this Fifth Amendment, effective as of the Fifth Amendment Effective Date.

 

 

SUTROVAX INC

 

By: /s/ Grant E. Pickering

Name: Grant E. Pickering

Title: President & CEO

 

LONZA LTD

 

By: /s/ Axel Evlev

Name: Axel Evlev

Title: Commercial Development

 

 

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Annex 1 – to Fifth Amendment

 

Project Plan A-1.1

 

{7 pages omitted}

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

 

ALL REFERENCES TO THE “SIXTH AMENDMENT” CONTAINED HEREIN SHOULD BE READ AS THE “FIFTH AMENDMENT.”

 

SIXTH AMENDMENT TO DEVELOPMENT AND MANUFACTURING SUPPLY AGREEMENT

 

 

This Sixth Amendment (“Sixth Amendment”), which comes into effect on March 16, 2020 (the “Sixth Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and SutroVax Inc (“SutroVax”). This Sixth Amendment is to be incorporated as part of the Development and Manufacturing Agreement, dated October 21, 2016, between Lonza and SutroVax (the “Original Agreement”). Lonza and SutroVax, hereafter referred to as a “Party” and collectively as the “Parties.”

 

Whereas:

 

 

 

Now, therefore, the Parties hereby agree that the following amendments are made to the Original Agreement:

 

 

 

 

"8.3 Lonza shall issue invoices to Customer for [***] of the Price for Products or Services upon commencement thereof (the “Initiation Payment”) and [***] upon Release of applicable Batches or completion of applicable Services (the “Completion Payment”), unless otherwise stated in the Project Plan. Charges for Raw Materials and the Raw Materials Fee for each Batch shall be invoiced upon the Release of each Batch. Charges for Resins shall be invoiced by Lonza upon placement of purchase orders for such Resins by Lonza at cost plus a fee of [***]. Charges for consumables and wearables, as well as charges for Services provided by External Laboratories, shall be invoiced upon the Release of the applicable Batch at cost plus a fee of [***]. Notwithstanding the above, Parties agree that in the event that Lonza does not complete stages of the IND enabling work, i.e. the stages necessary for Customer to submit the IND application, including in any event the Release of at least one (1) GMP Drug Product Batch plus one (1) month of GMP Drug Product stability testing before 31 December 2019 (the “IND-

 

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Enabling Activities”), Lonza shall for any stage that commences after 31 December 2019 or has not been completed by 31 December 2019, invoice the Initiation Payment for Products or Services upon commencement thereof. The Completion Payment for Products or Services shall be invoiced by Lonza upon release of such Products or completion of such Services, provided, however, that Customer shall not be required to effect any payment before either (i) within thirty (30) days following completion of all IND-Enabling Activities or (ii) 30 April 2021, whichever event occurs first. All invoices are strictly net and payment must be made [***]. Payment shall be made without deduction, deferment, set-off, lien or counterclaim, except as set forth in the Agreement or any Amendments. The provisions of this Clause 8.3, including the rate of markup charges set forth herein and in the definition of Raw Materials Fees, shall apply prospectively to all Services under the Agreement, including those Services to be performed after the Amendment Three Effective Date under Work Plan A-1, Work Plan A-2, Work Plan A-3 and Work Plan A-4.”

 

 

 

[Signatures on following page]

 

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IN WITNESS WHEREOF, SutroVax and Lonza hereby enter into this Sixth Amendment, effective as of the Sixth Amendment Effective Date.

 

By: /s/ Grant PickeringBy: /s/ Michael Stanek

Name: Grant PickeringName Michael Stanek

Title: President & CEOTitle: General Counsel

 

By: /s/ Bart van Aarnhem

Name Bart van Aarnhem

Title: Associate General Counsel

 

 

 

 

 

 

 

 

 

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

 

ALL REFERENCES TO THE “SEVENTH AMENDMENT” CONTAINED HEREIN SHOULD BE READ AS THE “SIXTH AMENDMENT.”

 

 

SEVENTH AMENDMENT TO DEVELOPMENT AND MANUFACTURING SUPPLY AGREEMENT

 

 

This Seventh Amendment (“Seventh Amendment”), which comes into effect as per April 1, 2021 (the “Seventh Amendment Effective Date”), is made by and between Lonza Ltd (“Lonza”) and Vaxcyte, Inc., having its principal place of business at 353 Hatch Drive, Foster City, CA 94404, USA (“Vaxcyte” or “Customer”). This Seventh Amendment is to be incorporated as part of the Development and Manufacturing Agreement, dated October 21, 2016, between Lonza and Vaxcyte (at that time known as SutroVax, Inc.), as amended from time to time (the “Original Agreement”). Lonza and Vaxcyte, hereafter referred to as a “Party” and collectively as the “Parties.”    

 

Whereas

 

 

 

 

Now, therefore, the Parties hereby agree that the following amendments are made to the Original Agreement:

 

 

 

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[Signatures on following page]

 

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IN WITNESS WHEREOF, Customer and Lonza hereby enter into this Seventh Amendment, effective as of the Seventh Amendment Effective Date.

 

 

 

By: /s/ Grant PickeringBy: /s/ Marina Eiting

Name: Grant PickeringName Marina Eiting

Title: CEOTitle: Senior Program Manager

 

By: /s/ Michael Stanek

Name Michael Stanek

Title: General Counsel

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Grant E. Pickering, certify that:

 

 

 

 

Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Andrew Guggenhime, certify that:

 

 

 

 

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Vaxcyte, Inc. (the “Company”) on Form 10-Q for the quarterly period ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. §Section 1350, as adopted pursuant to §Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

 

 

 

 

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Vaxcyte, Inc. (the “Company”) on Form 10-Q for the quarterly period ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. §Section 1350, as adopted pursuant to §Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

 

 

 

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