Exhibit 10.4
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MASTER SERVICES AGREEMENT
This Master Services Agreement (the “Agreement”) is entered into as of February 10th, 2023 (the “Effective Date”) by and between 89BIO, INC., a Delaware corporation (“89bio”), with its principal place of business located at 142 Sansome Street, 2nd Floor, San Francisco, CA 94104, USA, and BiBo Biopharma Engineering Co., Ltd. with its principal place of business located at Building 6,22,28, No.356 Zhengbo Road, China (Shanghai) Pilot Free Trade Zone LIN-GANG Special Area, Shanghai 201413, P.R. China (“Provider”). 89bio and Provider are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
Recitals
Whereas, 89bio is engaged in the development of pharmaceutical products and intends to perform development and scale up work and then to manufacture 89bio Product (defined below), which is formulated bulk drug substance so that 89bio may further process the formulated bulk drug substance to make 89bio Drug Product (as defined below), which would be used to conduct clinical trials of the 89bio Drug Product;
Whereas, Provider has represented that it has the requisite infrastructure, licenses, permits and capabilities, including trained and experienced personnel and technical skills, to develop, manufacture and supply the 89bio Product (as defined below) to 89bio in accordance with this Agreement; and
Whereas, the Parties desire that Provider develop, manufacture and supply 89bio with the 89bio Product under this Agreement on the terms and subject to the conditions set forth below.
Agreement
Now, Therefore, in consideration of the foregoing and the mutual covenants and premises contained in this Agreement, the receipt and sufficiency of which are hereby expressly acknowledged, the Parties hereto agree as follows:
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Price per item per transaction | Handling fee (%) |
[***] | [***] |
[***] | [***] |
[***] | [***] |
For example, one item per transaction is [***], then the handling fee will be [***].
89bio shall be deemed to be the owner of all such Components, upon payment of the relevant invoice issued by Provider. Provider shall manage the use of Components in accordance with cGMP “first in-first out” rules. The Components shall meet the specifications agreed upon by the Parties. Provider shall perform testing and evaluation of the Components as required to meet the foregoing obligations. Any Components paid for by 89bio that are remaining at the termination or expiration of a Work Order shall be delivered to 89bio.
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If 89bio at any time cancels (for convenience) any campaign set forth in the Work Oder for the manufacture of Product in the [***], the following cancelation charge shall apply.
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Cancelation of Services (other than batches or campaigns in the [***]) and the first cGMP run shall be permitted without cost or fee in any event.
Notice of cancelation prior to start of scheduled manufacture of batch or campaign (on a batch by batch basis) | Cancelation charge as a percentage of fees |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
For clarity, the date that is deemed to be the scheduled start of manufacture of the batch or campaign must be agreed by both parties in writing. Email writing will be deemed sufficient for confirmation of the date of the scheduled start of manufacture of the batch or campaign.
Provider shall seek to reuse the reserved capacity as soon as practicable, and if Provider is successful in using the reserved capacity, Provider will reduce the cancellation charge proportionately based upon the number of days the capacity was repurposed.
89bio may delay the manufacture of batches or campaigns under a Work Order up to [***] without any cost or fee by providing notice at least [***] prior to the scheduled start of manufacture of batch or campaign, on a batch-by-batch basis (a “Permitted Manufacturing Delay”). If 89bio gives notice of a [***] Permitted Manufacturing Delay, a fee of [***] will be charged. If 89bio provides notice less than [***] prior to such scheduled start date such delay shall be assessed a cancelation charge equivalent to if 89bio had canceled the batch or campaign under Section 12.11. Provided however that in the event of that the delay is due to material supplies (including without limitation capital equipment., Components, or 89bio Materials), facility readiness, process readiness, or analytical readiness, regardless of whether such delay results from responsibilities of Provider, 89bio, both or neither Party, such delay shall be excluded from this Section 2.12, and shall be permitted without any fee and without restriction on number of delays. By way of example, if 89bio provides notice of delay [***] prior to the scheduled start date of manufacture of a batch under a Work Order, this would not be a Permitted Manufacturing Delay and shall be assessed a fee equivalent to a cancelation fee of [***] of the fees for such batch (if such capacity cannot be reused). As a second example, if 89bio provides notice [***] days prior to the scheduled start of the manufacture of a batch under a Work Order, this would be a Permitted Manufacturing Delay and shall be [***] for the first and second time, and if it occurred a third or more time would be assessed a [***]. As a third example, if 89bio provides notice [***] prior to the scheduled start of the manufacture of a batch under a Work Order due to the unavailability of Components needed
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for manufacture, the fees under this Section 12.11 would be inapplicable, and there would be [***] due whether it was the first or third such delay. For clarity, this Section 12.12 is applicable solely to the manufacture of batches or campaigns under a Work Order. Delays of other Services shall be [***] in any event.
For clarity, the date that is the scheduled start of manufacture of batch or campaign must be in writing and agreed by both parties. Email writing will be deemed sufficient for confirmation of the date of the scheduled start of manufacture of batch or campaign.
Provider shall seek to reuse the reserved capacity as soon as practicable, and if Provider is successful in using the reserved capacity, Provider will reduce the delay charge proportionately based upon the number of days the capacity was repurposed.
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If to 89bio:
89bio, Inc.
142 Sansome Street, 2nd Floor
San Francisco, CA 94104
Attn: [***]
If to Provider:
BiBo Biopharma Engineering Co., Ltd.
Building 6,22,28, No.356 Zhengbo Road,
China (Shanghai) Pilot Free Trade Zone
LIN-GANG Special Area, Shanghai 201413
P. R. China
Attn: [***]
Any such notice will be deemed given on the date delivered. A Party may add, delete (so long as at least one person is remaining), or change the person or address to which notices should be sent at any time upon written notice delivered to the other Party in accordance with this Section 14.15.
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In Witness Whereof, the Parties hereto have duly executed this Master Services Agreement on the Effective Date.
89bio, Inc. | BiBo Biopharma Engineering Co., Ltd. |
By: /s/ Quoc Le-Nguyen________________ | By: /s/ Qi Xu________________ |
Printed Name: Quoc Le-Nguyen | Printed Name: Qi Xu |
Title: CTO & Head of Quality | Title: SVP |
[Signature Page To Master Services Agreement]
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Exhibit A
Work Order No. ___
A-1
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AMENDMENT NO. 1
TO
MASTER CONTRACT SERVICES AGREEMENT
This Amendment (the “Amendment”) is made as of the 24th of February 2023, by between 89bio, Inc., a Delaware corporation (“89bio”), with its principal place of business located at 142 Sansome Street, 2nd Floor, San Francisco, CA 94104, USA, and BiBo Biopharma Engineering Co., Ltd. with its principal place of business located at Building 6,22,28, No.356 Zhengbo Road, China (Shanghai) Pilot Free Trade Zone LIN-GANG Special Area, Shanghai 201413, P.R. China (“Provider”).
BACKGROUND
Provider and 89bio are parties to that certain Master Services Agreement dated as February 10, 2023 (the “Agreement”) and they now desire to amend such Agreement to clarify responsibility with respect to dedicated equipment and to clarify venue for any disputes.
NOW, THEREFORE, in consideration of the mutual agreement, Provider and 89bio agree to amend the Agreement as follows:
The Agreement shall be amended as follows.
Section 2.11 is hereby amended and restated Section 2.11 as follows:
2.11 Dedicated Equipment
(a) Selection, Procurement, Warranties. To the extent set forth in a Work Order, Provider shall select and procure the Dedicated Equipment at [***] as set forth more explicitly in the Work Order. Dedicated Equipment shall be charged to 89bio at cost (plus any applicable VAT tax and/or customs duty paid or payable by Provider) and without any markup. Provider shall determine whether the Dedicated Equipment conforms to the applicable specifications and will work in the Facility for purpose set forth in the applicable Work Order. Unless explicitly set forth in the Work Order, Provider warrants that the Dedicated Equipment shall be new, not previously used by Provider, nor purchased by Provider as “used equipment” by Provider. Provider shall pass through any all manufacturer’s warranties for the Dedicated Equipment. Provider shall use Dedicated Equipment only for services performed for 89bio, including the Services for as long as it shall remain Dedicated Equipment.
(b) Use and Storage of Dedicated Equipment. Provider shall use and store the Dedicated Equipment in accordance with any written instructions prescribed by 89bio or the manufacturer of the Dedicated Equipment, and shall performed such routine maintenance and storage for the Dedicated Equipment in accordance with such written instructions at Provider’s expense as set forth in a Work Order. All costs for any -, extraordinary or non-routine maintenance that may be required will be approved in advance by 89bio, and the appropriate Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except: (i) in connection with such routine maintenance and
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storage, (ii) as required by the Services; or (iii) as directed in writing by 89bio, Provider shall not make any alterations, additions or improvements to the Dedicated Equipment.
(c) Ownership and Risk of Loss; Disposition of Equipment; Option. 89bio shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Provider shall not permit any liens or encumbrances to be made on the Dedicated Equipment. Provider is responsible for risk of loss, damage, theft or destruction of the Dedicated Equipment while that Dedicated Equipment is in Provider’s possession or on Provider’s premises, and shall provide customary and appropriate insurance therefor. Upon termination or expiration of the Work Order for any reason, if the cost of the Dedicated Equipment has been paid by 89bio, or 89bio has paid the option purchase price for the Dedicated Equipment, then 89bio shall have the right to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of physical transfer and any subsequent reinstallation and requalification costs). Provider shall reasonably cooperate with 89bio to remove and return such Dedicated Equipment to 89bio or its designee in accordance with 89bio’s written instructions and shall invoice 89bio for direct costs incurred. Notwithstanding the above, upon termination or expiration of this Agreement, 89bio may offer to sell to Provider, or Provider may offer to purchase from 89bio, the Dedicated Equipment at [***]. Neither Provider nor 89bio shall be obligated to make or accept such offers. In the event that 89bio has not removed the Dedicated Equipment within [***] after reasonable notice, the Dedicated Equipment shall be deemed to be abandoned and Provider may dispose of it or use it as it sees fit. If for any reason, the cost of Dedicated Equipment was not passed through to 89bio under a Work Order, upon termination of the Agreement, 89bio shall have option to purchase such Dedicated Equipment at the initial cost paid for such equipment by Provider, or such lesser amount as the Parties may agree on.
Section 12.10 is hereby amended and restated as follows:
12.10 Survival Upon Termination. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination or expiration. Such termination or expiration shall not relieve any Party from obligations which are expressly or by implication intended to survive termination or expiration of this Agreement and shall not affect or prejudice any provision of this Agreement which is expressly or by implication provided to come into effect on, or continue in effect after, such termination or expiration. Sections 2.7, 2.8, 2.9, 2.11, 7.7, 9, 10,12.6, 12.7, 12.8, 12.9, 12.10, 13 and 14 will survive expiration or termination of this Agreement.
Section 14.3 is hereby amended and restated as follows:
14.3 Choice of Law and Venue. This Agreement shall be governed by the laws of the State of Delaware, United States, excluding its conflicts of laws principles. The Parties hereby agree that any action arising out of this Agreement will be brought solely in any state or federal court located in Delaware, United States. Both Parties hereby submit to the exclusive jurisdiction and venue of any such court.
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Continuing Effectiveness. Except as expressly provided herein, the terms and provisions of the Agreement shall be unchanged and shall continue in full force and effect.
Counterparts. This Amendment may be executed in any number of counterparts, each of which shall be an original and all of which, taken together, shall constitute a single agreement.
Defined Terms. Capitalized terms shall have the meanings given to them in the Agreement.
[Signature Page Follows]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
BiBo Biopharma Engineering | 89bio, Inc. |
By: /s/ Qi Xu | By: /s/ Quoc Le-Nguyen |
Name: Qi Xu | Name: Quoc Le-Nguyen |
Title: SVP | Title: Chief Technical Operations Officer & Head of Quality |
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