[***] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed.
Exhibit 10.1
(1) FUJIFILM DIOSYNTH BIOTECHNOLOGIES CALIFORNIA, INC.
AND
(2) ATARA BIOTHERAPEUTICS, INC.
CONTENTS
1. |
|
DEFINITIONS AND INTERPRETATION |
|
2 |
2. |
|
FRAMEWORK AND SCOPE OF SERVICES |
|
12 |
3. |
|
TERM |
|
12 |
4. |
|
PERFORMANCE OF PROGRAM |
|
13 |
5. |
|
QUALITY AND REGULATORY MATTERS |
|
16 |
6. |
|
CONFORMING BATCHES AND NON-CONFORMING BATCHES |
|
17 |
7. |
|
DELIVERY, TITLE, RISK, STORAGE AND INVENTORY |
|
20 |
8. |
|
PRICE AND PAYMENT |
|
21 |
9. |
|
WARRANTIES |
|
23 |
10. |
|
INDEMNIFICATION & LIMITATION OF LIABILITY |
|
25 |
11. |
|
INTELLECTUAL PROPERTY |
|
28 |
12. |
|
CONFIDENTIALITY |
|
29 |
13. |
|
CHANGE |
|
32 |
14. |
|
DELAY, CANCELLATION, TERMINATION AND CONSEQUENCES |
|
33 |
15. |
|
FORCE MAJEURE |
|
37 |
16. |
|
DISPUTE RESOLUTION |
|
38 |
17. |
|
AUDIT |
|
39 |
18. |
|
NOTICES |
|
40 |
19. |
|
EXPORT/IMPORT CONTROLS AND SANCTIONS COMPLIANCE |
|
40 |
20. |
|
MODERN SLAVERY AND CORRUPTION |
|
41 |
21. |
|
ASSIGNMENT AND SUB-CONTRACTING |
|
42 |
22. |
|
GENERAL |
|
43 |
23. |
|
GOVERNING LAW |
|
44 |
Schedule 1 |
- |
Charges |
|
1 |
Schedule 2 |
- |
Forecasting and Orders |
|
2 |
Schedule 3 |
- |
Addresses for Notice |
|
3 |
Schedule 4 |
- |
Atara Deliverables |
|
4 |
Schedule 5 |
- |
Statement of Work Template |
|
5 |
1
THIS AGREEMENT IS BETWEEN
(1) |
FUJIFILM DIOSYNTH BIOTECHNOLOGIES CALIFORNIA, INC., incorporated and registered in Delaware whose principal place of business is at 200 Summit Lake Drive, Valhalla, NY 10595 (“Fujifilm”); and |
(2) |
ATARA BIOTHERAPEUTICS, INC., incorporated and registered in Delaware with a principal place of business office at 611 Gateway Boulevard, Suite 900, South San Francisco, CA 94080, USA (“Atara”). |
WHEREAS
(A) |
Fujifilm is a biopharmaceutical contract development and manufacturing organization and, Atara and Fujifilm are agreeing to enter into this Agreement under which Fujifilm is appointed to carry out agreed clinical and commercial services for Atara in relation to certain of Atara’s Products, including manufacturing, testing, storage, AL&P, new product introductions and supply of Products to Atara, as more specifically set forth herein. |
(B) |
Capitalized terms used in these Recitals are defined below. |
NOW, THEREFORE, in consideration of the respective covenants, representations, warranties and agreements set forth herein, the parties hereto agree as follows:
AGREED TERMS
1.1 |
In this Agreement the following words have the following meanings unless inconsistent with the context: |
2
“APA” |
means the Asset Purchase Agreement between Atara and Fujifilm dated January 26, 2022. |
“Atara Deliverable(s)” |
one or more of the deliverables set forth on Schedule 4 to be supplied by Atara to Fujifilm for the performance of a Program and identified in its corresponding SOW; |
“Atara Release” |
Atara quality’s review of the Batch Documentation and final approval to release of the Product, following Fujifilm Disposition, in accordance with the Quality Agreement; |
“Atara-Supplied Consumable(s)” |
the Product-specific Consumable(s) agreed by Atara to be supplied to Fujifilm for the performance of a Program following a Consumables Delay in such Program pursuant to clause 14.1.2; |
“Authorized Third Party” |
has the meaning given to it in clause 12.112.1.3; |
all Intellectual Property Rights owned or controlled by a party, whether solely or jointly, prior to the Effective Date or arising after the Effective Date independently of the Fujifilm Services performed under this Agreement and without reliance upon, use of or reference to any Confidential Information or Background IP of the other party; |
|
“Batch” |
a specific quantity of a given Product that is intended to be of uniform character and quality, within specified limits, and is produced under cGMP conditions during the same cycle of manufacture and from the same donor material as defined by the applicable QA Documents. For clarity and, where applicable, Batches obtained from the same donor material but from different cycles of manufacture constitute separate (i.e. not the same) Batches; |
“Batch Documentation” |
has the meaning given to it in clause 6.4; |
“Batch Fee” |
the agreed Batch Fee set out in Part 3 of Schedule 1; |
3
4
5
6
“Fujifilm Services” |
the services described in the applicable Scope of Work executed by the parties, that may include: (a)manufacturing and testing (manufacturing/processing, in process and release testing, environmental monitoring, material management); (b)storage (including, storage, material management, including receipt and issuance to manufacturing, QC testing or for AL&P and shipment; (c)AL&P; (d)new production introductions (tech transfer, engineering and project management oversight, equipment qualification and validation, batch record and SOP generation, training, operator qualification, process validation); and (e)additional support and testing (additional release testing, stability testing, sample management, investigational testing, method support and transfer, NC/CAPA/CC investigation and coordination); |
“Gross Negligence” |
a conscious and voluntary disregard of the need to use reasonable care, which is reasonably likely to cause foreseeable grave injury or harm to persons, property, or both; |
7
8
9
10
a stage of a Program as described in a SoW. For the purposes of clause 10, a sub-stage described in a SoW (for example a Stage that is clearly identified as a sub-stage and including a suffix such as Stage 1A) shall be deemed to be an independent Stage in its own right; |
|
“Subcontracted Work” |
work subcontracted by Fujifilm under clause 21.3; |
all duty, sales, use or excise taxes, charges, levies, assessments and other fees of any kind imposed by any governmental or other authority (including, value added tax, sales tax or any other similar type of turnover tax) excluding taxes based on the income of Fujifilm; |
|
“Term” |
has the meaning given to in clause 3.1; and |
“Willful Misconduct” |
a knowing violation of a reasonable and uniformly enforced rule or policy, or intentionally doing that which should not be done or intentionally failing to do that which should be done, or knowing that injury will probably result or recklessly disregarding the possibility that injury may result. |
1.3 |
Insofar as this Agreement or a Scope of Work obliges any party to this Agreement to negotiate, take action or to do something, that party shall conduct such communications, negotiations, take such action or do such thing in good faith acting professionally and, in the case of Fujifilm, using Commercially Reasonable Efforts to achieve the result contemplated in this Agreement. There shall be a general obligation on the parties to act in good faith and with professionalism in relation to the matters contemplated in this Agreement. |
1.5 |
In the case of conflict or ambiguity between the terms of this Agreement or any specific Scope of Work and the terms of the QA Documents, the terms of the QA Documents shall prevail solely in relation to cGMP quality matters subject to clause 10.11. |
1.6 |
Where a defined term is used in clause 10 (Indemnification & Limitation of Liability) it shall retain its meaning even when the entire word that is a defined term is in capitals. |
1.7 |
Where a provision requires agreement, consent and/or approval of a party, such agreement, consent and/or approval, unless expressly stated otherwise, may not be unreasonably withheld, delayed or conditioned. |
11
|
2.1.1 |
This Agreement establishes (i) a framework to enable Atara to order Fujifilm Services from Fujifilm and (ii) the general terms and conditions applicable to Fujifilm’s performance of the Fujifilm Services and, in connection therewith, each Program for Atara. |
|
2.1.2 |
This Agreement is structured so that a separate, numbered, Scope of Work shall be entered into by the parties for the provision of a Program. |
|
2.1.3 |
The provisions of this Agreement shall apply to each Scope of Work and no Scope of Work shall be effective or binding on any party until it has been signed by an authorized representative of each contracting party. |
|
2.1.4 |
Nothing in this Agreement or any Scope of Work shall oblige any party to enter into any Scope of Work and each Scope of Work constitutes a separate contract that is deemed a part of this Agreement. |
2.2 |
Scope of the Fujifilm Services |
|
2.2.1 |
The scope of this Agreement covers ad hoc services (including new product introductions activities), clinical supply of Product, commercial supply of Product, and additional services such as AL&P and storage. |
|
2.2.2 |
On a Program-by-Program basis, if Atara requires Fujifilm Services or Pass Through Related Services, the parties will enter into a Scope of Work under this Agreement. Each Scope of Work shall clearly identify the type of Fujifilm Services and/or Pass Through Services to be provided). |
2.3 |
Forecasting and Orders |
2.4 |
Co-operative Management |
|
2.4.1 |
Each party will be responsible for its internal decision making process and for reasonably informing the other party of decisions made affecting any or all of the Fujifilm Services in a regular and timely manner. |
|
2.4.2 |
Without limiting the foregoing, the parties will establish the joint committees/teams set forth in Schedule 6 to advise the parties and to execute on certain matters pertaining to the delivery of Fujifilm Services. |
3.1 |
This Agreement shall come into force on the Effective Date and will continue for an initial term of ten (10) years (the “Term”). |
3.2 |
[***]: |
12
|
3.2.1 |
[***]; and |
|
3.2.2 |
[***]. |
3.3 |
Each Scope of Work will take effect from the SoW Effective Date and shall continue until the earlier of: |
|
3.3.1 |
the date specified in such Scope of Work, or if no such date is specified, the date the Program, or part of the Program referred to in such Scope of Work is completed; or |
|
3.3.2 |
termination of this Agreement or the relevant Scope of Work in accordance with the terms of this Agreement. |
|
4.1.1 |
shall perform the Fujifilm Services and Pass Through Related Services (if any) and carry out each Program, or parts of each Program, in accordance with: |
|
(a) |
the terms of this Agreement and any Scope of Work for such Program, |
|
(b) |
Applicable Laws, |
|
(d) |
the Process Specification for the applicable cGMP Batch (if any), |
|
4.1.2 |
[***] Notwithstanding the foregoing, if Fujifilm does supply Non-Conforming Batches to Atara hereunder then clause 6 shall apply and in the case of [***], these shall be resolved in accordance with clause 6.6). |
13
|
4.4.1 |
provide Atara Deliverables within the timeframe(s) set out in the SoW; |
|
4.4.2 |
meet all its obligations and responsibilities under this Agreement, any Scopes of Work and the Quality Agreement; and |
|
4.4.3 |
comply with Applicable Laws. |
4.6 |
Each party shall ensure that its staff involved in the delivery of the Program do not bypass processes or controls (including operating and corporate policies and procedures and Facility-specific policies) put in place under the Quality Agreement, this Agreement or a Scope of Work by virtue of direct action enabled by their familiarity with the Facility and personnel. |
4.7 |
Fujifilm will keep complete and accurate records (including [***]) of all work done by it under this Agreement, in form and substance as specified in the applicable Scope of Work, the Quality Agreement, and this Agreement (collectively, the “Records”). All such Records will be the property of Atara. Except as required by or necessary to comply with Applicable Law, enforce its rights or perform its obligations under this Agreement, any Scope of Work or the Quality Agreement, Fujifilm will not transfer, deliver or otherwise provide any such Records to any party other than Atara, without the prior written consent of Atara. All original Records of the performance of the Fujifilm Services, including, the manufacture of Product under this Agreement will be retained and archived by Fujifilm in accordance with cGMP (if applicable), Applicable Law and the Quality Agreement, but in no case for less than a period of [***] following completion of the applicable Program. Atara will be provided electronic copies of completed Records via an Atara-specific Fujifilm-hosted data room. For the sake of clarity, [***] in connection with Atara’s review of Records via the Atara-specific Fujifilm-hosted data room in connection with the Release of a Batch or Fujifilm Disposition [***]. Upon Atara’s request [***], Fujifilm will promptly provide Atara with hard copies of such Records following written request therefor. [***] after completion of a Program, and upon Atara’s written request, all of the aforementioned records will be sent to Atara or Atara’s designee [***]; provided, however, that Atara may elect to have such Records retained in Fujifilm’s archives for an additional period of time at a reasonable charge to Atara. Fujifilm will retain copies of all of such Records and Atara will provide Fujifilm full access to all original Records if Fujifilm is required or compelled to furnish any of such original Records in connection with a regulatory inspection by any Authority or otherwise in connection with Applicable Law. |
4.8 |
All Fujifilm Services shall be performed at the Facility. Fujifilm shall notify Atara of and shall obtain Atara’s prior written consent (such consent not to be unreasonably withheld, conditioned or delayed) to any proposed change in the location of the Facility or use of any replacement or additional facility for the performance of the Fujifilm Services under this Agreement. |
14
4.10 |
Fujifilm shall be responsible, [***], for obtaining and maintaining throughout the Term, any Facility or other licenses or permits, and any regulatory and government approvals necessary for the performance of the Fujifilm Services under this Agreement (but for the avoidance of doubt not Product specific applications, for example IND or BLA). At Atara’s reasonable request, Fujifilm shall, within [***], provide Atara with copies of all such relevant licenses, permits and approvals that are ordinarily required by the relevant Regulatory Authorities and Atara requires in connection with its Regulatory Applications. Subject to the obligations of confidentiality set out in clause 12, Atara will have the right to use any and all information contained in such licenses, permits and approvals to the extent required in connection with its Regulatory Applications, regulatory approval, and clinical and commercial development of Product. |
4.11 |
As specified in the Batch Documentation, on a Program-by-Program basis, Fujifilm will take and retain, for such period and in such quantities as may be required by cGMP (if applicable) and the Quality Agreement, samples of Product from the Process produced under such Program. Further, upon Atara’s written request, Fujifilm will submit such samples to Atara and/or contract testing laboratories specified by Atara in the applicable SoW for such Program or Quality Agreement (but for the avoidance of doubt Fujifilm shall be entitled to retain the samples set forth in the applicable sampling plan required to be retained at the Facility in accordance cGMP and shall not be obliged to submit all such samples to Atara and/or contract testing laboratories). |
4.12 |
During the Term, and in accordance with the Quality Agreement and Fujifilm’s then current person-in-plant SOP for the Facility, Fujifilm will permit Atara or its duly authorized representatives to oversee the performance of the Fujifilm Services related to and including cGMP manufacture of Product at the Facility, including the manufacturing of any Batch; provided, that, Atara will (a) use only common areas and those areas of the Facility where the Fujifilm Services are performed and (b) will not enter or attempt to access any areas indicated by Fujifilm as accessible to authorized personnel only. Notwithstanding the foregoing, during the [***] the Term, Fujifilm agrees to permit up to [***] Atara representatives to be at the Facility to observe up to two different Processes (or parts of a Process), for up to [***], unless otherwise agreed by Fujifilm. Atara will and will cause its duly authorized representatives to comply with the Fujifilm’s reasonable instructions and/or monitoring policies (as the same may be amended from time to time) at all times any Atara representatives are in the Facility. |
4.13 |
In the event of Product recalls (as determined in accordance with the Quality Agreement), Fujifilm and Atara shall reasonably cooperate to enable Atara to complete the recall and shall thereafter [***]. The costs and expenses of conducting any recall shall be treated as follows: |
|
(a) |
If any Product is recalled solely as a result of the supply by Fujifilm of Product that was not manufactured in compliance with the terms of this Agreement or the Quality Agreement or of Fujifilm’s negligence, Gross Negligence or Willful Misconduct, [***]. [***]. If Atara and/or its Affiliates elect to utilize a Third Party to conduct a recall, Atara shall notify Fujifilm of such intent and take into account Fujifilm’s comments and suggestions regarding such Third Party in good faith. Upon selection of a Third Party by Atara Fujifilm will work with and reasonably cooperate with such Third Party as directed by Atara. |
|
(b) |
If each party has contributed to the cause of a recall, [***]. |
|
(c) |
All recalls of Product other than those described in clauses (a) or (b) above shall [***]. Fujifilm will work with and reasonably cooperate with Atara in accordance |
15
|
with the Quality Agreement and any Third Party assisting in the conduct of a recall, as designated and directed by Atara, at Atara’s sole cost. |
4.14 |
During the Term, Atara may request, and Fujifilm shall provide, technology transfer services as contemplated and in accordance with clause 14.6.2(c). |
|
5.1.1 |
The parties will execute the Quality Agreement on or prior to the Effective Date. |
|
5.1.2 |
Atara acknowledges that Fujifilm shall not commence any cGMP activity under this Agreement until the Quality Agreement is executed by both parties. |
5.2 |
Regulatory Assistance |
|
5.2.2 |
During a Program, Atara may request assistance from Fujifilm in respect of the CMC Section. Such assistance will be documented in a Scope of Work together with the Charges payable for such assistance. However, no advice or assistance given by Fujifilm shall be deemed to be or construed as a guarantee that a Product will receive regulatory approval. |
|
5.2.3 |
Fujifilm will provide one electronic (PDF) copy of any documents which may be reasonably required by Atara in support of its regulatory filing activities within [***] of Atara’s request (email being sufficient). If Atara requires copies of the laboratory notebooks, provision of these will be subject to discussion and agreement by the parties and agreement of an additional fee associated with copying. |
|
5.2.4 |
|
(a) |
Atara shall have the exclusive right and responsibility for determining regulatory strategy, decisions and actions relating to each Program and each Product, including any Regulatory Application. |
|
(b) |
Fujifilm shall have the exclusive right and responsibility for determining regulatory strategy, decisions and actions to the extent relating to: |
16
|
1. |
the Facility (including in particular utilities and equipment); |
|
2. |
Fujifilm’s quality systems, policies and internal procedures; |
|
3. |
any requirement imposed on Fujifilm by a Regulatory Authority; or |
|
4. |
any other commitments to Third Party customers made by Fujifilm after the Effective Date, |
(each a “Fujifilm Regulatory Responsibility”).
6.1 |
Each cGMP Batch will be determined to be a Conforming Batch or a Non-Conforming Batch in accordance with the Quality Agreement. |
6.2 |
As set forth in the applicable Scope of Work, each cGMP Batch of Product will be sampled and tested by Fujifilm, a Permitted Subcontractor, or its Affiliates, including conducting stability testing as per the provisions of the Quality Agreement, against the Product Specification, and Fujifilm will review the documentation relating to the manufacture of the Batch and will assess if the manufacture has taken place in compliance with cGMP (if applicable) and the Process as summarized in the Certificate of Analysis. |
6.3 |
If during cGMP manufacturing Fujifilm discovers any Deviation, Fujifilm will inform Atara in accordance with the reporting requirements set out in the Quality Agreement. For the avoidance of doubt, Atara acknowledges that the occurrence of a Deviation does not automatically mean that a Batch is a Non-Conforming Batch. |
6.4 |
In respect of Conforming Batches, Fujifilm will complete Fujifilm Disposition, and issue to Atara a Certificate of Analysis, a Certificate of Compliance and a complete copy of Batch |
17
records and applicable analytical data (collectively, the “Batch Documentation”). The provisions of clauses 6.5 to 6.9 shall apply to Non-Conforming Batches only. |
6.8 |
If a Batch is a Non-Conforming Batch and the cause of the Batch being a Non-Conforming Batch is a failure by Fujifilm to comply with clause 4.1.1 then: |
|
6.8.1 |
Fujifilm shall use Commercially Reasonable Efforts to manufacture a replacement cGMP Batch (“Replacement Batch”) as soon as is reasonably practicable [***]; and |
|
6.8.2 |
if the Non-Conforming Batch is produced before the [***]: |
|
(a) |
the Pass Through Costs and Pass Through Services Cost relating to the Replacement Batch shall be payable by [***]; and |
|
(b) |
in the event a Replacement Batch which is a Conforming Batch cannot be produced within [***] of the original planned Delivery Date for such Batch then [***] shall apply. |
18
|
6.8.3 |
If the the Non-Conforming Batch is produced after the [***]: |
|
(a) |
the Pass Through Costs and Pass Through Services Cost relating to the Replacement Batch shall be borne by [***]; and |
|
(b) |
in the event a Replacement Batch which is a Conforming Batch cannot be produced within [***] of the original planned Delivery Date for such Batch then [***] shall apply. |
|
6.9.1 |
the parties will first exhaust the investigation/resolution options set out in the Quality Agreement including reference to the MRB under the Quality Agreement and transparent disclosure of all applicable reports and analysis on which their respect opinion is based; |
|
6.9.2 |
if the MRB is unable to resolve this matter then the documentation related to the applicable Batch will be reviewed by an independent cGMP consultant acceptable to both parties (acting reasonably). The result of such independent review will be binding for both parties solely for the purpose of determining whether the Batch is a Non-Conforming Batch and/or if a Non-Conforming Batch is caused by a failure by Fujifilm to comply with clause 4.1.1; |
|
6.9.3 |
if the independent cGMP consultant finds that the Batch is not a Non-Conforming Batch or that the Non-Conforming Batch was not caused by a failure by Fujifilm to comply with clause 4.1.1, Atara will pay Fujifilm for the Batch in question in accordance with clause 6.7 plus the reasonable cost to Fujifilm of the investigation; |
|
6.9.4 |
if the independent cGMP consultant finds that the Batch is a Non-Conforming Batch and that the Non-Conforming Batch is caused by a failure by Fujifilm to comply with clause 4.1.1, the remedial procedure set out in clause 6.8 will be applied; and |
|
6.9.5 |
all fees and expenses of the independent cGMP consultant incurred in making such determination, will be paid by the party against whom the determination is made. If, however, the independent cGMP consultant cannot establish the root cause of the non-conformance, then [***]. |
19
|
7.1.3 |
Physical delivery of Materials to Atara (or its designee) out of Inventory will occur in accordance with an indicative delivery schedule which shall be agreed by the parties’ Program teams in advance. Unless otherwise expressly agreed by the parties in writing, Fujifilm will not make Product available for collection out of Inventory by Atara until both: (a) Fujifilm Disposition is complete; and (b) Atara’s quality assurance team has approved such Product for Atara Release in a written notice in accordance with clause 6.6. Materials for which a license is required under clause 11.3 will not be made available for collection by Atara until a license has been signed by the parties. |
7.2 |
Risk and Title |
|
7.2.1 |
Risk in Materials shall pass to Atara on the Delivery Date (save for risk in Process-Specific-Equipment in relation to which risk shall pass as set forth in Section 5.2 of Part 3 of Schedule 1. |
|
7.3.2 |
Atara will at all times retain title to and ownership of the Atara Deliverables, and the Atara-Supplied Consumables. |
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7.4 |
Inventory |
|
7.4.1 |
Fujifilm will store the Consumables, Atara Deliverables, the Atara-Supplied Consumables, Products (including intermediates (PBMC, BLCL, vectors) of Product), Inventory, and any materials delivered to Fujifilm under a SoW and any work in process at each and every stage of the Process in accordance with cGMP and the Quality Agreement (in both cases if applicable). |
|
7.4.2 |
Atara Deliverables, the Atara-Supplied Consumables, Product (including intermediates (PBMC, BLCL, vectors) of Product), Inventory, and any materials delivered to Fujifilm under clause a SoW and any work in process at each and every stage of the Process shall be stored in accordance with the Quality Agreement, the Facility’s segregation policies, and in such a way as to be able at all times to clearly distinguish such materials from products and materials belonging to Fujifilm, or held by it for a third party’s account. |
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7.4.3 |
Fujifilm shall ensure that such Atara-Supplied Consumables, Atara Deliverables and Product (including intermediates (PBMC, BLCL, vectors) of Product)), Inventory, any materials delivered to Fujifilm under a SoW, and any work in process are free and clear of any liens or encumbrances. Fujifilm will at all times take such reasonable measures as are required to protect the Atara-Supplied Consumables, Atara Deliverables, Product (including intermediates (PBMC, BLCL, vectors) of Product)), Inventory, any materials delivered to Fujifilm under a SoW, and any work in process from loss, damage and theft at all stages of the Process. Fujifilm will immediately notify Atara if at any time it believes any Product (including intermediates (PBMC, BLCL, vectors) of Product), Atara-Supplied Consumables, or Atara Deliverables, Inventory or any work in process have been damaged, lost or stolen. |
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7.4.4 |
During the term of this Agreement, Fujifilm shall provide to Atara real time inventory visibility for: (a) intermediates (PBMC, BLCL, vectors), components of Product; and (b) Product (Drug Product and Finished Drug Product). |
|
8.1.1 |
the “Charges” being: |
|
(b) |
the fees for the Fujifilm Services as set out in the applicable Scope(s) of Work; and |
|
8.1.2 |
the Pass Through Costs and Pass Through Services Costs; |
8.2 |
Fujifilm may invoice Atara for the Charges in respect of each Program in accordance with the terms set out in the Scope of Work (as applicable) and Schedule 1. |
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8.4 |
The Charges are exclusive of any Tax which may apply and which shall be payable by Atara to Fujifilm at the rate prescribed by law. |
8.5 |
If there is a change in the rate of Tax payable or in the Tax treatment of some or all of the Fujifilm Services, Pass Through Related Services or the Product, including due to a change of law or practice or interpretation of the existing legislation or revised determination of a relevant tax legislation or tax practice, then the appropriate party, as required by applicable law shall be responsible for such Tax (for clarity, the foregoing does not relieve Atara of its responsibility for such Taxes on Consumables purchases by Fujifilm under this Agreement or Pass Through Related Services that will be passed through to Atara pursuant to the terms of this Agreement) which becomes due on that supply and any fees and/or interest which is being levied in relation to the outstanding sums and/or non-payment. |
The responsible party, as required by applicable law, shall: be responsible for the collection, remittance and payment of any or all Taxes, in respect of the purchase, importation, exportation, sale or other distribution of any materials delivered to Atara by Fujifilm in connection with a Program
|
8.5.1 |
Atara shall: |
|
8.5.2 |
be responsible for payment of Taxes on purchases by Atara of Fujifilm Services, the purchase of Consumables under this Agreement and Pass Through Related Services from Fujifilm; and |
|
8.5.3 |
make all payments under this Agreement without withholding or deduction of, or in respect of, any Tax unless required by law. |
8.6 |
The parties shall exercise their reasonable efforts to ensure that any withholding Taxes imposed are reduced as far as possible under the provisions of any applicable tax treaty and shall cooperate in filing any forms required for such reduction. Each party shall cooperate with the other and furnish the other party with appropriate documents, including Tax documentation, to secure application of the most favorable rate of withholding Tax under Applicable Law (or exemption from such withholding tax payments, as applicable). |
8.7 |
Without prejudice to any other right or remedy that it may have, if Atara fails to pay any undisputed Charges, in whole or in part, to Fujifilm on the due date for payment: |
22
|
|
8.8.2 |
pay the amount of Charges not in dispute in accordance with clause 8.3, |
and the dispute shall be dealt with under the dispute resolution process set out in clause 16.
8.9 |
A party shall not be entitled to withhold, set off or reduce payment of any amounts payable under this Agreement to the other party by any amounts which it claims are owed to it by such other party under this Agreement or any other agreement. |
9.1 |
Fujifilm represents and warrants to Atara that: |
|
9.1.1 |
It has the full power and right to enter into this Agreement and that there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind held by other parties, private or public, that are inconsistent with the provisions of this Agreement. |
|
9.1.2 |
The execution and delivery of this Agreement by Fujifilm has been authorized by all requisite corporate action and this Agreement is and will remain a valid and binding obligation of Fujifilm, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors. |
|
9.1.3 |
Each Program will be performed, in all material respects, [***] by individuals who are [***]. |
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9.1.5 |
Unencumbered title to all Product (other than encumbrances not caused by Fujifilm, its Affiliates, or its permitted subcontractors) will be conveyed to Atara upon delivery. |
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9.1.6 |
It and its Affiliates have obtained, and shall maintain all requisite material licenses, authorizations and approvals required by federal, state or local government authorities, including the FDA and any other applicable Regulatory Authority, to provide the Fujifilm Services in accordance with this Agreement, and (ii) to its knowledge, there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Facility, which would cause Product to be misbranded or adulterated within the meaning of the U.S. Food, Drug & Cosmetics Act, or other applicable laws. |
|
9.1.7 |
To the best of its knowledge: Fujifilm, its Affiliates and subcontractors involved in the manufacture, processing or handling of Product, and each of their respective |
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officers and directors, as applicable, and any person used by Fujifilm or its subcontractors involved in the manufacture, processing or handling of Product under this Agreement: (a) have not been debarred and are not subject to a pending debarment pursuant to section 306 of the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 335a; (b) are not ineligible to participate in any federal and/or state healthcare programs or federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(0); (c) are not disqualified by any government or regulatory authorities from performing specific services, and are not subject to a pending disqualification proceeding; and (d) have not been convicted of a criminal offense related to the provision of healthcare items or services and are not subject to any such pending action. Fujifilm will notify Atara promptly upon becoming aware if Fujifilm, its subcontractors involved in the manufacture, processing or handling of Product, or any person involved in the manufacture, processing or handling of Product under this Agreement, or any of their respective officers or directors, as applicable, is so debarred, ineligible, disqualified or convicted. |
9.2 |
Atara represents and warrants to Fujifilm that: |
|
9.2.1 |
it has the full power and right to enter into this Agreement and that there are no outstanding agreements, assignments, licenses, encumbrances or rights held by other parties, private or public, that are inconsistent with the provisions of this Agreement; |
|
9.2.2 |
the execution and delivery of this Agreement by Atara has been authorized by all requisite corporate action and this Agreement is and will remain a valid and binding obligation of Atara, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors; |
|
9.2.3 |
it will not use, sell, market, promote, advertise, vend, trade, offer, or commercialize Product into any regulatory jurisdiction unless and until it receives the necessary (i) Product approvals from the applicable Regulatory Authority; (ii) express written permission from the applicable Regulatory Authority prior to receipt of Product approvals; or (iii) unless otherwise permitted under Applicable Law prior to receipt of Product approvals in a jurisdiction; and |
|
9.2.4 |
to the best of its knowledge: Atara, its subcontractors involved in the manufacture, processing or handling of Product, and each of their respective officers and directors, as applicable, and any person used by Fujifilm or its subcontractors involved in the manufacture, processing or handling of Product under this Agreement: (a) have not been debarred and are not subject to a pending debarment pursuant to section 306 of the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 335a; (b) are not ineligible to participate in any federal and/or state healthcare programs or federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. 1320a-7b(0); (c) are not disqualified by any government or regulatory authorities from performing specific services, and are not subject to a pending disqualification proceeding; and (d) have not been convicted of a criminal offense related to the provision of healthcare items or services and are not subject to any such pending action. Fujifilm will notify Atara promptly upon becoming aware if Fujifilm, its subcontractors involved in the manufacture, processing or handling of Product, or any person involved in the |
24
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manufacture, processing or handling of Product under this Agreement, or any of their respective officers or directors, as applicable, is so debarred, ineligible, disqualified or convicted. |
10.2 |
SUBJECT TO THE APPLICABLE PROVISIONS OF THIS CLAUSE 10 AND EXCEPT IN RESPECT OF THE FOLLOWING PROVISIONS/OBLIGATIONS [***] DUE IN ACCORDANCE WITH THIS AGREEMENT AND THE APPLICABLE SCOPE OF WORK: |
|
10.2.1 |
WITH RESPECT TO ATARA’S [***]; AND |
|
10.2.2 |
IN RESPECT OF ANY AND ALL [***]. |
|
10.3.2 |
EXCEPT AS SET FORTH IN CLAUSE 10.3.3 BELOW, AND NOTWITHSTANDING ANY PROVISION TO THE CONTRARY IN CLAUSE 10.3[***]; AND |
|
10.3.4 |
IN RESPECT OF ANY AND ALL LIABILITY RELATING TO THIS AGREEMENT (INCLUDING UNDER ALL SCOPE OF WORKS MADE HEREUNDER), FUJIFILM’S TOTAL AGGREGATE LIABILITY TO ATARA SHALL BE LIMITED [***]. |
|
10.5.1 |
THE PROVISIONS OF CLAUSE 6 SHALL APPLY TO NON-CONFORMING BATCHES AND FUJIFILM SHALL HAVE NO LIABILITY IN RESPECT OF NON-CONFORMING BATCHES |
25
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10.5.2 |
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER (WHETHER AS TO COMPLIANCE WITH CGMP OR OTHERWISE) IN RESPECT OF NON-CONFORMING BATCHES DELIVERED TO ATARA PURSUANT TO CLAUSE 6, OR THE USE BY ATARA OF SUCH NON-CONFORMING BATCHES. |
|
10.6.1 |
FUJIFILM GIVES NO, AND DISCLAIMS ANY, WARRANTIES, UNDERTAKINGS OR SIMILAR TERMS WHATSOEVER IN RESPECT OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY ATARA OF A DEMONSTRATION BATCH OR A DEMONSTRATION BATCH. |
|
10.6.2 |
[***], FUJIFILM SHALL HAVE NO LIABILITY TO ATARA IN CONNECTION WITH DEMONSTRATION BATCHES OR ENGINEERING BATCHES OR THE USE BY ATARA OF THE DEMONSTRATION BATCHES OR ENGINEERING BATCHES. |
|
10.9.1 |
[***]; |
|
10.9.2 |
[***]; |
26
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in each case, except to the extent Atara is liable under clause 10.10 and expressly subject to clauses 10.3 and 10.4.
|
10.10.1 |
[***]; |
|
10.10.2 |
[***]; |
|
10.10.3 |
use or resale of Product manufactured or delivered hereunder by or on behalf of Atara or its Affiliates [***]; |
in each case, except to the extent Fujifilm is liable under clause 10.9 and expressly subject to clauses 10.2 and 10.4.
10.12 |
Each party agrees to take all reasonable steps to mitigate any Liabilities that it may seek to claim from the other under or in connection with this Agreement including pursuant to any indemnity. |
10.13 |
If a party is entitled to benefit from an indemnity (the “Indemnified Party”) from the other party (the “Indemnifying Party”) in accordance with this Agreement (an “Indemnity Claim”), the Indemnified Party shall notify the Indemnifying Party in writing of the Indemnity Claim (providing all necessary details) and the Indemnifying Party shall at its own expense conduct all negotiations and any litigation arising in connection with the Indemnity Claim provided always that: |
|
10.13.1 |
the Indemnifying Party shall consult the Indemnified Party on all substantive issues which arise during the conduct of such litigation and negotiations and shall take due and proper account of the interests of the Indemnified Party; |
|
10.13.2 |
the Indemnifying Party shall not settle or compromise the Indemnity Claim without the Indemnified Party's prior written consent (not to be unreasonably withheld, conditioned or delayed) and shall ensure that any settlement or compromise does |
27
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not include a statement as to or an admission of fault, culpability or a failure to act by or on behalf of the Indemnified Party; |
|
10.13.4 |
the Indemnified Party shall fully cooperate and assist the Indemnifying Party, at the Indemnifying Party’s cost and expense (such expenses incurred by Indemnified Party to be reasonable, customary and documented), in relation to the Indemnity Claim (without limiting the extent of the indemnity). |
11.1 |
Subject to the limited licenses of clauses 11.2 and 11.3, neither party shall acquire any right, title or interest in the other party’s Background IP. |
11.5 |
All title to and all rights and interest in any Fujifilm Foreground IP shall vest in Fujifilm. [***]. |
11.6 |
If requested to do so by the other party, each party shall at the expense of the requesting party execute all documents and do all such further acts as the requesting party may reasonably require to perfect the assignment under clause 11.4 or 11.5. |
28
warrants to Atara that, to Fujifilm’s knowledge, such use of the Fujifilm Foreground IP does not violate any Intellectual Property Rights of any third party and it will notify Atara in writing should it become aware of any claims asserting such violation. |
11.9 |
If Atara elects to manufacture Product, or to have Product manufactured by a third party, then Fujifilm will provide to Atara or, subject to the execution of an appropriate confidentiality agreement, Atara’s designee, all necessary manufacturing know-how, information, including documentation, technical assistance, materials and cooperation by appropriate employees of Fujifilm as Atara or its designee may reasonably require in order to manufacture Product. Atara will compensate Fujifilm for such assistance. |
12.1 |
Each party (the “Receiving Party”) receiving Confidential Information of the other party agrees with the other party (the “Disclosing Party”): |
|
12.1.1 |
to keep the Disclosing Party’s Confidential Information confidential and exercise the same degree of care and safeguards with respect to such Confidential Information as used to maintain the confidentiality of the Receiving Party’s own information of like character, but, in any event, no less than a reasonable degree of care; |
|
12.1.2 |
not to access or use the Disclosing Party’s Confidential Information save for the purposes of: |
|
(a) |
complying with its obligations and exercising its rights under this Agreement and each SoW. |
|
12.1.3 |
not to disclose the Disclosing Party’s Confidential Information other than to the Receiving Party’s: |
|
(a) |
Affiliates that need to know the Confidential Information for the purpose of assisting such Receiving Party in performing its obligations under this Agreement or a SoW and are bound in writing to obligations of confidentiality at least as restrictive as the terms of this clause 12; |
|
(b) |
officers and employees that need to know the Confidential Information for the purpose of assisting such Receiving Party in performing its obligations under this Agreement or a SoW and are bound in writing to obligations of confidentiality at least as restrictive as the terms of this clause 12; |
|
(c) |
contractors and sub-contractors, professional advisers, consultants and agents who are engaged to advise the Receiving Party in connection with a Program or this Agreement and who have a bone fide need to know that Confidential Information to provide the contracted services and are bound in |
29
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writing to obligations of confidentiality at least as restrictive as the terms of this clause 12; and |
|
(d) |
solely where Atara is the Receiving Party, pursuant to clause 12.7; |
the “Authorized Third Parties”.
The obligations of each party relating to the other party’s Confidential Information shall expire [***] after termination of this Agreement, provided that such obligations shall survive in perpetuity with respect to all trade secrets of a party so long as such party continues to protect such trade secrets as such. The disclosure of Confidential Information shall not constitute the grant of any license or any other rights, or generate any business arrangements, unless specifically set forth herein or in another writing.
12.3 |
The Receiving Party shall within [***] of receipt of the Disclosing Party’s written request (including after termination of this Agreement and any SoW): |
|
12.3.1 |
deliver up to the Disclosing Party all items and copies of all or any Confidential Information of the Disclosing Party; |
|
12.3.3 |
destroy all hard copies of notes, analyses or memoranda containing the Disclosing Party’s Confidential Information (and, if further requested, certify in writing signed by an authorized representative that it has done the same) |
provided that the Receiving Party shall be entitled to retain copies of the Confidential Information to enable it to monitor its obligations under this Agreement or which is required to be maintained by Applicable Laws or a Regulatory Authority subject always to the obligations of confidence under this Agreement.
12.4 |
Confidential Information shall not include information which: |
|
12.4.1 |
is, or becomes, generally available to the public other than as a direct or indirect result of the information being disclosed by the Receiving Party or its Authorized Third Parties in breach of this Agreement (except that any compilation of otherwise public information in a form not publicly known shall still be treated as Confidential Information); |
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|
12.4.2 |
was available to the Receiving Party on a non-confidential basis prior to disclosure by the Disclosing Party; |
|
12.4.3 |
was, is, or becomes available to the Receiving Party on a non-confidential basis from a person who, to the Receiving Party’s knowledge, is not under any confidentiality obligation in respect of that information; |
|
12.4.4 |
was lawfully in the possession of the Receiving Party before the information was disclosed by the Disclosing Party; |
|
12.4.5 |
is developed by or for the Receiving Party independently of the information disclosed by the Disclosing Party without use of, reference to, or reliance upon the Confidential Information of the Disclosing Party, as evidenced by the Receiving Party’s written records; or |
12.5 |
The Receiving Party may disclose Confidential Information of the Disclosing Party when required by any governmental authority or agency in compliance with any federal, state and/or local laws and/or regulations, or pursuant to an order of a court of competent jurisdiction, but then only to the extent of such required disclosure and save that the Receiving Party shall, to the extent it is lawful to do so, give prompt notice to the Disclosing Party of any such potential disclosure and reasonably cooperates with Disclosing Party to allow the Disclosing Party a reasonable opportunity to seek a protective order or otherwise limit such disclosure. |
12.6 |
Nothing in this clause 12 shall prevent a party from promptly making all disclosures and filings with government authorities as may, in its judgement be required or advisable in connection with the execution and delivery of this Agreement or the consummation of and the performance thereof the transactions contemplated hereby, including, without limitation, disclosures required by the rules and regulations of the Securities Exchange Commission (“SEC”), other government authority, or applicable stock exchange, provided that except where prohibited by Applicable Law or exigent circumstances, the Receiving Party takes reasonable efforts to provide the Disclosing Party at least [***] prior written notice of such disclosure (and the right to review and comment on the proposed disclosure), and discloses only that portion of the Confidential Information that the Receiving Party is legally required to disclose in the reasonable opinion of the Receiving Party’s legal counsel opinion. To the extent that this Agreement may need to be filed by Atara with the SEC, Atara shall, prior to making any such filing with the SEC, provide Fujifilm and its counsel with a proposed redacted version of this Agreement which it intends to file with the SEC and to give due consideration to any comments provided by Fujifilm or its counsel and use reasonable efforts to obtain confidential treatment for such required disclosure. Following filing of the Agreement with the SEC, Atara may describe or refer to portions of the Agreement for which confidential information is not obtained from the SEC without the prior review or approval of Fujifilm. |
31
Competitor without the prior written consent of Fujifilm, which shall not be unreasonably withheld, conditioned, or delayed; (c) no disclosures are made to contract development and/or manufacturing organizations in the biopharmaceutical industry without Fujifilm’s prior written consent; and (d) such recipients are treated as Authorized Third Parties for the purposes of clause 12.2. |
12.8 |
Each Party agrees that a breach of this clause 12 may result in irreparable harm to the Disclosing Party. In seeking enforcement of any of the other party’s obligations under this clause 12, the Disclosing Party shall therefore be entitled to seek injunctive and other equitable relief to prevent or restrain the breach of this Agreement. Notwithstanding the foregoing, nothing in this Agreement shall be construed as prohibiting the Disclosing Party from pursuing any other remedies that may be available to it, whether at law or in equity. |
12.9 |
To the extent that any Confidential Information may include materials subject to the attorney-client privilege, no party is waiving, and no party will be deemed to have waived or diminished, its attorney work-product protections, attorney-client privileges or similar protections and privileges as a result of disclosing any Confidential Information to any other party, its Affiliates or their respective representatives, regardless of whether the Disclosing Party has asserted or is or may be entitled to assert such privileges and protections. In furtherance of the foregoing, no party nor its Affiliates shall claim or contend, in any action involving any party, that any other party waived its attorney work-product protections, attorney-client privileges or similar protections and privileges with respect to any information, documents or other material (whether or not disclosed to any other party or its Affiliates) due to any party’s disclosure of Confidential Information (including Confidential Information related to pending or threatened litigation) to any other party, its Affiliates or their respective representatives. |
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13.2.1 |
if the change to Applicable Law specifically relates to the Product or Process, then Atara will be liable for the costs of the Change; and |
32
|
13.2.3 |
if the change to Applicable Law does not fall within either of clauses 13.2.1 or 13.2.2, the parties will discuss and agree on how those costs will be borne in the Change. |
|
14.2.1 |
Fujifilm or Atara shall be entitled to terminate this Agreement (and all Scope of Works made under it, together with any Orders made under the applicable Scope of Work(s)) in its entirety: |
33
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assets or ceasing to carry on business or, if the step or action is taken in another jurisdiction, in connection with any analogous procedure in the relevant jurisdiction; or |
|
14.2.2 |
If a party commits a material breach of a Scope of Work, the non-breaching party may give written notice to the other party, giving reasonable particulars of the breach and requiring it to be remedied. If the breaching party fails to start to diligently resolve issues caused by the breach within [***] after receipt of notice (including the implementation of a resolution plan) with ultimate resolution of those issues caused by the breach within [***] of receipt of the original notice, then the non-breaching party shall have the right, in its sole discretion, to immediately terminate that Scope of Work (provided, however, that the cure period shall be suspended during any time that a party seeks resolution of a dispute as to whether an alleged material breach occurred pursuant to clause 16). |
|
14.3.1 |
Atara may terminate this Agreement in its entirety for convenience upon giving Fujifilm [***] written notice in which case clause 14.4.1 shall apply. |
|
14.3.2 |
Atara may terminate or cancel a Scope of Work in its entirety for convenience by giving not less than [***] written notice to Fujifilm in which case clause 14.4.2 shall apply. |
|
14.3.3 |
Atara may terminate or cancel or one or more Stages of a Scope of Work for convenience by giving not less than [***] written notice to Fujifilm in which case clause 14.4.2 shall apply. |
|
(b) |
any amount of the [***] (which shall take into account monies due under clause 14.4.1(a); and |
34
|
(c) |
unpaid Pass Through Costs and Pass Through Services Costs (including any Pass Through Costs and Pass Through Services Costs which Fujifilm has already incurred or has committed to later incur under a non-cancellable order and unrecoverable costs and expenses not yet invoiced to Atara). |
|
(a) |
the Charges that are due for the Fujifilm Services that have been properly performed shall become due and payable in accordance with this Agreement and the applicable SoW; |
|
(b) |
Atara shall have no obligation to pay Fujifilm [***]; |
|
(c) |
unpaid Pass Through Costs and Pass Through Services Costs (including any Pass Through Costs and Pass Through Services Costs which Fujifilm has already incurred or has committed to later incur under a non-cancellable order and unrecoverable costs and expenses not yet invoiced to Atara) shall be due and payable in accordance with the terms of this Agreement and the applicable SoW; and |
|
(d) |
subject to the entry into a SoW for the services and entry into suitable confidentiality agreement, Fujifilm shall assist Atara in transferring the manufacturing responsibility for the Product(s) to Atara, an Affiliate of Atara or a Third Party designee, as determined by Atara. Such assistance shall include transfer of the Processes, procedures and reasonable data required to manufacture such Product(s) in accordance with the Product Specifications, Process Specifications and Regulatory Authority guidelines but shall not include Fujifilm’s Confidential Information or Background IP. Fujifilm will provide such transfer assistance (meaning, in brief, collation of Process documentation, analytical method summaries, provision of Bill of Materials and answering reasonable questions on the same) [***]. |
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|
14.5.1 |
If a party exercises any of its rights of termination in respect of only one or more SoWs: |
|
(a) |
this Agreement shall terminate in respect of those SoWs and the provisions of this Agreement relating to termination of this Agreement shall apply in relation to those SoWs; |
|
(b) |
in all other respects this Agreement shall continue in full force and those SoWs in respect of which the party has terminated this Agreement will be deemed to be removed from the definition of the SoWs; and |
|
(c) |
termination of any Scope of Work shall be without prejudice to the rights and remedies of any party which may have accrued up to the date of termination. |
|
14.5.2 |
If a party exercises any of its rights of termination in respect of one or more Stage of a SoW (but not the SoW in its entirety) the cancelled Fujifilm Services shall terminate but in all other respects the SoW shall continue in full force. |
|
14.6.1 |
The termination of this Agreement in its entirety shall be without prejudice to the rights and remedies of any party which may have accrued up to the date of termination. |
|
(b) |
each Receiving Party shall return the Confidential Information of the Disclosing Party in accordance with clause 12.3; |
|
(d) |
in the event of a termination of the Agreement as set out in clause 14.2.1(d), if requested by Fujifilm (i) Atara, the Competitor and Fujifilm will take customary and reasonable measures to protect the confidential and proprietary information of all parties and to address any applicable regulatory or legal matters, such as use of “clean” teams, limiting direct access to another party’s confidential or proprietary information, prohibiting “clean” |
36
|
team members from participating in competitive activity during the remaining term of this Agreement, and up to [***] thereafter (as may be required and permitted by law); and (ii) enter into a confidentiality agreement in customary form with respect to the same; and |
14.7 |
Potential Additional Consequences of an Atara Led Termination [***] |
15.2 |
If a party is delayed or prevented from performing its obligations due to a Force Majeure Event such party shall: |
37
|
(a) |
by referral in writing summarizing the nature of the dispute by a party in the first instance to the decision of each party’s Program Manager; |
|
(b) |
if the dispute is not resolved within [***] of its referral to the Program Managers it shall be referred to the decision of Fujifilm’s Chief Business Officer and Atara’s Head of Manufacturing and Supply for other business issues; and |
38
that it or its property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment or otherwise) and (c) that (i) the suit, action or proceeding in any such court is brought in an inconvenient forum, (ii) the venue of such suit, action or proceeding is improper or (iii) this Agreement, or the subject matter hereof, may not be enforced in or by such courts. |
17.2 |
Financial audits, evidence and assistance: |
|
17.2.1 |
Together with each invoice issued by Fujifilm to Atara hereunder, Fujifilm shall provide reasonably detailed documentation to validate the amounts included on each invoice which are subject to the true-up mechanism contemplated in Schedule 1 Atara may request reasonable additional validating information provided that (i) Atara shall not request such reasonable additional validating information for a given amount more than once and (ii) it is acknowledged that Fujifilm shall not be obligated to provide copies of vendor invoices if prevented from doing so by Applicable Law or by Fujifilm’s confidentiality obligations to such vendors and, following implementation of a new ERP system by Fujifilm at the Facility following the Effective Date, Fujifilm may elect not to provide copies of vendor invoices if those invoices do not accurately represent the amounts invoiced to Atara because of Fujifilm’s use of SAP weighted average "actual cost". |
|
17.2.2 |
Fujifilm will provide reasonable support to Atara in the event that Atara is audited by a third party or to support Atara’s maintenance of its financial regulatory obligations (for example Sarbanes Oxley compliance). |
39
18.1 |
Subject to clause 18.2 the parties may communicate with each other in any way that is normal in the course of their business. |
18.3 |
Notice may be given by hand or sent by email, recorded delivery, registered post or airmail and will be deemed to have been duly served: |
|
18.3.1 |
if delivered by hand, at the time and date of delivery; |
|
18.3.2 |
if sent by email, at the time and date of sending (with confirmation copy to be sent by the method of clause 18.3.3 or 18.3.4); |
|
18.3.3 |
if sent by recorded delivery or registered post, 48 (forty-eight) hours from the date of posting (such date as evidenced by postal receipt); and |
provided that, where in the case of delivery by hand or transmission by email, such delivery or transmission occurs either after 4.00pm on a Business Day, or on a day other than a Business Day, service will be deemed to occur at 9.00am on the next Business Day.
19.1 |
Each party shall at all times during the term of this Agreement comply with applicable Sanctions or Export/Import Laws and ensure that it has in place appropriate controls and safeguards to prevent any action being taken by it that would amount to or result in a violation of or non-compliance with any Sanctions or Export/Import Laws. |
19.3 |
Atara will not directly or indirectly use, sell, dispose of, (re)export, transship or otherwise transfer any Product, software, technology or Confidential Information: (i) unlawfully to any country in respect of which a Sanctions Authority maintains Sanctions or a Sanctioned Person; (ii) in a manner that would expose Fujifilm to the risk of negative consequences under Sanctions; or (iii) in violation of Export/Import Laws. |
40
19.6 |
In this clause 19 the following terms have the following meanings: |
20.1 |
In performing its respective duties under this Agreement each party shall (a) use commercially reasonable efforts to hold itself and its suppliers to the highest performance, ethical and compliance standards, (b) comply with all laws in all jurisdictions where such party operates, |
41
but at a minimum including all applicable anti-slavery laws in the United Kingdom or the U.S.A, and (c) use commercially reasonable efforts to encourage fair and equal treatment for all persons, the provision of safe and healthy working conditions, and respect for the environment, and adopt appropriate management systems to conduct business in an ethical manner. Further, in performing its duties under this Agreement, each party acknowledges the value and importance of performance and ethical behavior in its performance under this Agreement. |
20.2 |
Each party warrants that on the Effective Date and each SoW Effective Date, it, its directors, officers or employees have not offered, promised, given, authorized, solicited or accepted any undue pecuniary or other advantage of any kind (or implied that they will or might do any such thing at any time in the future) in any way connected with this Agreement or a SoW and that it has taken reasonable measures to prevent subcontractors, agents or other third parties, subject to its control or determining influence, from doing so. |
20.3 |
The parties agree that, at all times in connection with and throughout the term of this Agreement, they will comply with and that they will take reasonable measures to ensure that their subcontractors, agents or other third parties will comply with all applicable anti-corruption legislation including the U.K. Bribery Act 2010 and the U.S. Foreign Corrupt Practices Act 1977. |
20.4 |
Each party shall not do, or omit to do, any act that would cause one of the other parties to be in breach of any anti-corruption legislation including the U.K. Bribery Act 2010 and the U.S. Foreign Corrupt Practices Act 1977. |
21.1 |
Either party may, without prior written consent of the other party, assign or transfer its rights and responsibilities under this Agreement to: |
|
21.1.1 |
an Affiliate provided that such Affiliate has reasonable financial creditworthiness; or |
|
21.1.2 |
a purchaser of all or substantially all of the equity of the assigning party provided that such third party has reasonable financial creditworthiness and, in the case of assignment by Atara, is not a Competitor; or |
|
21.1.3 |
a purchaser of all or substantially all of assets to which this Agreement relates provided that such third party has reasonable financial creditworthiness and, in the case of assignment by Atara, is not a Competitor; or |
|
21.1.4 |
solely where Atara is such assigning party, an exclusive licensee of any Product provided that (i) such third party has reasonable financial creditworthiness and, in the case of assignment by Atara, is not a Competitor and (ii) that Atara no longer requires services from Fujifilm under this Agreement, |
but not otherwise without prior written consent of the other party (such consent not to be unreasonably withheld or delayed) and provided that (a) the assignee agrees in writing to assume all obligations undertaken by its assignor in this Agreement and (b) in relation to assignment in part no such assignment shall relieve the assigning party of responsibility for the performance of any of its obligations under this Agreement. For the avoidance of doubt, any Atara assignee with a market capitalization of greater than [***] as of the effective date of any such assignment shall be deemed to have “reasonable financial creditworthiness.”
42
21.2 |
If a party assigns or transfers all or any of its rights and responsibilities under clause 21.1 it shall promptly notify the other parties in writing. |
22.2 |
Third party rights: Save as expressly set out in this Agreement, the parties do not intend that any person who is not a party to this Agreement shall have any right to enjoy the benefit or enforce any of the terms of this Agreement. |
22.3 |
Variations: With the exception of Changes, which shall be subject to clause 13, no variation of this Agreement shall be valid unless in writing and signed by a duly authorized representative of each of the parties. A party is entitled to assume that a representative of another party is authorized to act on that party’s behalf if that individual is apparently or seemingly acting in the normal course of the business relationship. An exchange of emails shall not be capable of constituting an agreement to vary this Agreement. |
22.5 |
Severability: If any provision of this Agreement or a SoW is found by any court or administrative body of competent jurisdiction to be invalid, illegal or unenforceable in any |
43
22.6 |
Counterparts: |
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22.6.1 |
This Agreement may be executed in any number of counterparts. Any party may enter into this Agreement by executing a counterpart and all the counterparts taken together will constitute one and the same agreement. This Agreement shall not be effective until each party has signed one counterpart. |
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IN WITNESS of the above the parties have signed this Agreement on the dates set out next to their signature:
FUJIFILM DIOSYNTH BIOTECHNOLOGIES |
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CALIFORNIA, INC |
ATARA BIOTHERAPEUTICS, INC. |
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By: |
/s/ Andy Fenny |
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By: |
/s/ Pascal Touchon |
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Name: |
Andy Fenny |
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Name: |
Pascal Touchon |
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Title: |
Chief Business Officer |
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Title: |
CEO |
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Date: |
January 26, 2022 |
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Date: |
1/26/2022 |
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1.1 |
[***] |
1
Schedule 2 - Forecasting and Orders
[***]
2
Schedule 3 - Addresses for Notice
Fujifilm: [***] |
Copied to: [***] |
Atara: [***] |
Copied to: [***] |
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Schedule 4 - Atara Deliverables
Atara Deliverables will be described in each Scope of Work but may include:
[***]
4
Schedule 5 – Statement of Work Template
[***]
5
SCHEDULE 6: CO-OPERATIVE MANAGEMENT
1. |
Joint Steering Committee (“JSC”) |
1.1. |
The parties will establish a JSC to give direction and advice relating to the activities conducted under the terms of this Agreement. |
1.2. |
The JSC will be a cross functional committee composed of at least three representatives appointed by each of Atara and Fujifilm, with one representative from each of Atara and Fujifilm having oversight of quality activities, and with one representative from each of Atara and Fujifilm having oversight of the transfer and implementation of manufacturing Processes at the Facility. |
1.3. |
All such representatives will be of at least site leadership management level or director (or equivalent level of Atara or Fujifilm). |
1.4. |
The JSC will be responsible for: |
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1.4.1. |
reviewing the parties’ performance through agreed tracking of Key Performance Indicators that may include Quality metrics and Schedule Adherence |
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1.4.2. |
tracking adherence to the terms and conditions of this Agreement; |
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1.4.3. |
addressing unresolved issues escalated that materially impact critical milestones, budget, supply, inventory targets, regulatory compliance, and/or product quality; overseeing and monitoring the manufacturing activities pursuant to this Agreement; |
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1.4.4. |
settling disputes or disagreements (other than quality related disputes which shall be resolved in accordance with the Quality Agreement) that are unresolved by Program team; |
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1.4.5. |
investigating and advising on manufacturing and supply issues; |
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1.4.6. |
reviewing and recommending for approval by the parties any changes to this Agreement proposed by the Program team, and |
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1.4.7. |
performing such other functions as appropriate to fulfill the purposes of this Agreement as determined by the parties. |
2. |
Committee Administration |
2.1. |
All decisions of the JSC and any other joint subcommittee or team formed under this Agreement, except as expressly set forth herein, will be made by the unanimous agreement of all of its members or their designated representatives, and will be reflected in written meeting minutes which summarily address topics discussed, delegation of work, schedules and decisions of such committee or team. |
2.2. |
Such written minutes will be subject to approval by the authorized representatives of the parties; provided, however, that neither the JSC nor any joint committee or team herein may amend or waive any provision of this Agreement, including the financial terms, it being understood that this Agreement may be amended, and any provision of this Agreement may |
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be waived, only by a written amendment signed by authorized representatives of each party that specifically states that the parties are amending or waiving this Agreement. |
3. |
Disputes |
3.1. |
In the event of disputes at the JSC that it is unable, despite the good faith efforts of all members, to resolve within [***] then the dispute shall be referred to the dispute management process sunder clause 16 (in the case of a business escalation, commencing at clause 16.2.1(b)). |
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