Correspondence 0001193125-23-110534 from Atara Biotherapeutics, Inc. (ATRA) (CIK 0001604464) (ATRA)
Atara Biotherapeutics, Inc. (ATRA) (CIK 0001604464)
Date: April 21, 2023 · CIK: 0001604464 · Accession: 0001193125-23-110534
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File numbers found in text: 001-36548
Referenced dates: March 27, 2023
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CORRESP 1 filename1.htm CORRESP 2380 Conejo Spectrum St, Suite 200 Thousand Oaks, CA 91320 Phone: (805) 623-4211 www.atarabio.com April 21, 2023 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Ibolya Ignat and Angela Connell Re: Atara Biotherapeutics, Inc. Form 10-K for Fiscal Year Ended December 31, 2022 Filed February 8, 2023 File No. 001-36548 Dear Ms. Ignat and Ms. Connell: Atara Biotherapeutics, Inc. (the “Company” or “Atara”) is providing this letter in response to the comment received from the staff (the “Staff”) of the United States Securities and Exchange Commission (“SEC”) by letter dated March 27, 2023 (the “Comment Letter”) relating to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 Form 10-K”). To facilitate your review, we have reproduced each relevant comment in bold italics and have followed each comment with the Company’s response in ordinary type. We have referenced the comments as numbered in the Comment Letter. Form 10-K for the Fiscal Year Ended December 31, 2022 Notes to Consolidated Financial Statements 5. Out-license Agreements, Page 109 1. With respect to the Pierre Fabre Commercialization Agreement, we note your conclusion that the promises within the agreement are not distinct because Pierre Fabre cannot benefit from the license without the other services and vice versa, and that consequently, the license, manufacture and supply, cell selection and participation in the JSC together form a single performance obligation. Please explain to us how you considered the guidance in ASC 606-10-25-19 through 25-21 in reaching your conclusion. As it specifically relates to the manufacture and supply agreement, explain whether another company could perform the manufacturing services and how this impacts your determination as to whether the license is capable of being distinct given that Pierre Fabre would appear to be able to benefit from the license together with other resources that are readily available. In this regard, we note your disclosure that following the minimum contract period of seven years from first commercial sale, the manufacturing responsibility could be transferred to a third party CMO or Pierre Fabre may elect to directly assume manufacturing responsibility. Please also explain how you determined the performance period over which revenue under this contract will be recognized to be 12 years. 1 In determining whether the license is distinct and separable from the manufacture and supply of Ebvallo, cell selection services and participation in the JSC, we considered the guidance in ASC 606-10-25-14 and ASC 606-10-25-19 through 25-22. We also referred to ASC 606-10-55-368 through 55-374, specifically Example 56. First, we considered ASC 606-10-25-14, which states the following: 606-10-25-14 At contract inception, an entity shall assess the goods or services promised in a contract with a customer and shall identify as a performance obligation each promise to transfer to the customer either: a. A good or service (or a bundle of goods or services) that is distinct. b. A series of distinct goods or services that are substantially the same and that have the same pattern of transfer to the customer. Under the Pierre Fabre Commercialization Agreement, we identified optional purchases related to the manufacture and supply of Ebvallo and related cell selection services that will be priced below standalone selling price (“SSP”) for a specified period of time and therefore represent a material right. Therefore, the license, participation in the JSC, and the material right (manufacture and supply of Ebvallo and related cell selection services) represent the promised goods or services in the Pierre Fabre Commercialization Agreement. Note, the Company does not provide the manufacture and supply of Ebvallo and cell selection services on a standalone basis and such services are not available from third party vendors; that is, the performance of such activities requires the Company’s familiarity and expertise with its own intellectual property due to the proprietary nature of its intellectual property. Also note that participation in the JSC is highly specialized in nature such that it cannot be performed by a third party. That is, a third party does not have the authority, technical credentials, experience, knowledge and familiarity with the license, manufacture and supply of Ebvallo and related cell selection to participate in the JSC. We next considered ASC 606-10-25-19, which states the following: 606-10-25-19 A good or service that is promised to a customer is distinct if both of the following criteria are met: a. The customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct). b. The entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In applying paragraph 25-19, we also considered the guidance found in ASC 606-10-25-20, which elaborates on paragraph 25-19(a) and whether the promises are capable of being distinct: 606-10-25-20 A customer can benefit from a good or service in accordance with paragraph 606-10-25-19(a) if the good or service could be used, consumed, sold for an amount greater than scrap value, or otherwise held in a way that generates economic benefits. For some goods or services, a customer may be able to benefit from a good or service on its own. For other goods or services, a customer may be able to benefit from the good or service only in conjunction with other readily available resources. A readily available resource is a good or service that is sold separately (by the entity or another entity) or a resource that the customer has already obtained from the entity (including goods or services that the entity will have already transferred to the customer under the contract) or from other transactions or events. Various factors may provide evidence that the customer can benefit from a good or service either on its own or in conjunction with other readily available resources. For example, the fact that the entity regularly sells a good or service separately would indicate that a customer can benefit from the good or service on its own or with other readily available resources. Further, ASC 606-10-25-22 states the following: 606-10-25-22 If a promised good or service is not distinct, an entity shall combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. In some cases, that would result in the entity accounting for all the goods or services promised in a contract as a single performance obligation. 2 In making the determination as to whether the license is capable of being distinct and separable from the material right (manufacture and supply of Ebvallo and related cell selection services) and participation in the JSC, we assessed whether Pierre Fabre could benefit from the license on its own or together with other resources that are readily available to Pierre Fabre. In particular, we considered whether the material right (manufacture and supply of Ebvallo and related cell selection services) or participation in the JSC could be provided by another third party such that the services, know-how and expertise provided by the Company would not be required in order for Pierre Fabre to benefit from the license. As noted above, the manufacture and supply of Ebvallo and related cell selection services are not provided by the Company on a standalone basis and such services are not available from third party vendors, and participation in the JSC is highly specialized in nature such that it cannot be performed by a third party. As such, we determined that Pierre Fabre receives no benefit of the license unless and until the European Commission Marketing Authorization Application (MAA) is received by Atara and transferred from Atara to Pierre Fabre. Once the MAA is transferred, Pierre Fabre can only benefit from the license to commercialize Ebvallo in the Territory through the provision of the proprietary manufacturing and cell selection services provided by Atara. Cell selection is the know-how and trade secret of the Company related to selecting the necessary human leukocyte antigen (HLA) profile for a patient, identifying the associated cell line from available inventory and communicating this to the customer. This service is required in order for the customer to benefit from the supply, as without it, Pierre Fabre is not able to identify which cell line from inventory should be used to treat a patient. Until such time that manufacturing technology transfer occurs (see below), Pierre Fabre is not capable of carrying out the manufacturing on their own. We believe our fact pattern is consistent with Example 56 Case A in ASC 606. Furthermore, we plan to include enhanced disclosure (see below proposed disclosure) within future periodic reports filed with the SEC around the identification of promises and associated performance obligations, specifically with respect to the material right (manufacture and supply of Ebvallo and related cell selection services), under the Pierre Fabre Commercialization Agreement. With regard to our determination of the period of time over which to recognize the related revenue, we note it relates to the period over which Pierre Fabre’s material right exists. One factor in determining this period is the “Term” of the Pierre Fabre Commercialization Agreement, which is defined in Section 16.1 as expiring “following the last Commercial Sale of the Product in the Field in the Territory by Partner, its Affiliates or their Approved Sublicensees.” Section 9.5 of the Agreement details our obligation to supply product until the end of the Term of the Agreement, with the option to transfer the related manufacturing technology after 7 years from the first Commercial Sale of Product. Given the inherent uncertainty of what could transpire over the next 7 years, we determined it was not probable as of the 2022 Form 10-K balance sheet date that we would exercise this option when first available to us. We also considered the period over which the Company would receive royalties based on the terms of the Pierre Fabre Commercialization Agreement. As the Company is not in the business of being a contract manufacturer, without royalties as an economic incentive to continue performing manufacturing services, we determined it is probable that we will transfer the manufacturing technology by the end of the Term of the Pierre Fabre Commercialization Agreement. Based on these considerations, as of the 2022 Form 10-K balance sheet date, we estimate the material right will exist for approximately 12 years. The Company further advises the Staff that it will enhance its existing disclosure starting with the quarterly report on Form 10-Q for the period ended March 31, 2023 and will continue to be included in future filings as relevant. Refer to the enhanced disclosure below. Pierre Fabre Commercialization Agreement In October 2021, we entered into the Pierre Fabre Commercialization Agreement, pursuant to which we granted to Pierre Fabre an exclusive, field-limited license to commercialize and distribute Ebvallo in Europe and select emerging markets in the Territory following regulatory approval. Atara retains full rights to Ebvallo in other major markets, including North America, Asia Pacific and Latin America. In September 2022, we entered into Amendment No. 1 to the Pierre Fabre Commercialization Agreement (the “PF Amendment”). Under the terms of the PF Amendment, following European Commission approval of Ebvallo for EBV+ PTLD and subsequent filing of the Marketing Authorization Application (“MAA”) transfer to Pierre Fabre, we are entitled to receive an additional $30 million 3 milestone payment in exchange for, among other things, a reduction in: (i) royalties we are eligible to receive as a percentage of net sales of Ebvallo in the Territory, and (ii) the supply price mark up on Ebvallo purchased by Pierre Fabre. Additionally, we also agreed to extend the time period for provision of certain services to Pierre Fabre under the Pierre Fabre Commercialization Agreement. We are responsible at our cost for the conclusion of the ongoing Phase 3 ALLELE clinical study and the Phase 2 multi-cohort clinical study. We will also be responsible at our cost for certain other activities directed to obtaining regulatory approval for Ebvallo for EBV-positive lymphoproliferative disease pursuant to the terms of the Pierre Fabre Commercialization Agreement in Europe. Pierre Fabre will be responsible at its cost for obtaining and maintaining all other regulatory approvals and for commercialization and distribution of Ebvallo in the Territory. We will own any intellectual property rights developed solely by us under the Pierre Fabre Commercialization Agreement. We have formed a joint steering committee (“JSC”) with Pierre Fabre that provides oversight, decision making and implementation guidance regarding the commercialization activities covered under the Pierre Fabre Commercialization Agreement. Pierre Fabre paid us an upfront cash payment of $45.0 million for the exclusive license granted in the fourth quarter of 2021. In December 2022, we met the contractual right to receive $40.0 million in milestone payments upon certain regulatory milestones. Subject to the terms of the royalty purchase agreement with HCRx, as described in Note 6, we are entitled to receive an aggregate of up to $308.0 million in remaining milestone payments upon achieving certain regulatory and commercial milestones in addition to double-digit tiered royalties as a percentage of net sales of Ebvallo, until the later of 12 years after the first commercial sale in such country, the expiration of specified patent rights, or the expiration of all regulatory exclusivity for such product on a country-by-country basis. We have entered into a separate manufacturing and supply agreement with Pierre Fabre for us to manufacture Ebvallo for Pierre Fabre to use in the Territory based on a fixed price through December 31, 2023 and at a price equal to cost plus a margin for orders placed after December 31, 2023. At Pierre Fabre’s cost, we are responsible for manufacturing and supplying Pierre Fabre’s optional purchases of Ebvallo for commercialization in the Territory for a minimum of seven years from the first commercial sale, as defined in the Pierre Fabre Commercialization Agreement, of Ebvallo in the Territory. At any time following this period, we have the option to transfer the manufacturing responsibility and related manufacturing technology to Pierre Fabre, who may then elect to directly assume the manufacturing responsibility and receive the related manufacturing technology or utilize a third party contract manufacturing organization (“CMO”). Without transfer of the manufacturing technology, no other party can perform this obligation. We are also responsible for performing cell selection services for Pierre Fabre at our cost for a certain period of time unless the parties agree to transfer the related cell selection technology to Pierre Fabre prior to this date. Cell selection is the process of identifying the appropriate cell line from available inventory to be used for a patient. Without transfer of the cell selection technology, no other party can provide such services. After this period of time, if we agree to continue to provide cell selection services, it shall be at the sole expense of Pierre Fa