SEC Company Response from PROTHENA CORP PUBLIC LTD (PRTA) — Apr 17, 2019
PROTHENA CORP PUBLIC LTD CO
Date: April 17, 2019 · CIK: 0001559053 · Accession: 0001193125-19-108573
AI Filing Summary & Sentiment
File numbers found in text: 001-35676
Referenced dates: April 3, 2019, December 19, 2018, January 22, 2019
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CORRESP 1 filename1.htm Correpondence FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 83 Prothena Corporation plc 77 Sir John Rogerson’s Quay, Block C Grand Canal Docklands Dublin 2, D02 T804, Ireland April 16, 2019 Via EDGAR Transmission and Overnight Delivery U.S. Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, N.E. Washington, DC 20549 Attention: Frank Wyman Tabatha McCullom Re: Prothena Corporation plc Form 10-K for the Fiscal Year Ended December 31, 2017 Filed February 26, 2018 Form 10-Q for the Quarterly Period Ended September 30, 2018 Filed November 6, 2018 File No. 001-35676 Ladies and Gentlemen: Prothena Corporation plc (the “Company” or “Prothena”) submits this letter in response to further comments received by letter dated April 3, 2019 from the Staff of the Securities and Exchange Commission (the “Staff”). A courtesy copy of this letter is being submitted to the Staff by overnight delivery. Each of the Staff’s comments is reproduced below in bold. The Company’s response follows each such Staff comment. Capitalized terms used but not defined herein have the meanings ascribed to them in the Master Collaboration Agreement by and between Prothena Biosciences Limited (“Prothena”) and Celgene Switzerland LLC (“Celgene”) dated March 20, 2018 (the “Agreement”) to which the Staff’s comments relate. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-1 Form 10-Q for the Quarterly Period Ended September 30, 2018 Item 1. Financial Statements (unaudited) Notes to the Condensed Consolidated Financial Statements 8. Significant Agreements Celgene Collaboration Agreement, page 18 1. Please propose revised disclosure that: • articulates consistently when Celgene would have “decision making authority over development activities and all regulatory, manufacturing and commercialization activities in the U.S.” We note that the first paragraph of the Overview section indicates this occurs upon Celgene’s exercise of the option to acquire U.S. Rights whereas the first paragraph of the Celgene U.S. and Global Rights and Licenses section indicates this occurs “following Phase 1.” • clarifies whether the exclusive license to develop and commercialize that Celgene will receive upon exercise of its options for U.S. Rights and Global Rights includes the right to manufacture. • quantifies the regulatory and commercial milestones per program the Company is eligible to receive after Celgene’s exercise of U.S. Rights. Company Response: Prothena proposes revising in its future filings its disclosure as shown in Exhibit A attached to this letter. 2. Please analyze for us whether your contract with Celgene includes one or more implied promises by Prothena to perform research and development services prior to the filing of an IND. We make this request because your response appears to be limited to whether an explicit promise exists, nonetheless promises may be implied by an entity’s customary business practices, published policies or specific statements (ASC 606-10-25-16); implied promises need not be enforceable at law (ASC No. 2014-09 BC87); and the illustrative statements below appear to imply such a promise. Company Response: There are no implied promises to Celgene. Prothena respectfully notes for the Staff that Section 12.10 of the Agreement states that the Agreement “contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, . . . .” [***] Certain of the below-quoted statements are from webcast presentations and ensuing question-and-answer sessions with research analysts and Prothena’s shareholders. These statements must be viewed in that overall context, as well as the specific context of the questions asked and the complete responses. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-2 Prothena does not view any of these statements as suggesting implied promises to Celgene, [***]. In other words, [***]. Please see the Company’s additional response below with respect to each statement. • “And that’s essentially the way we kind of move that into the R&D. So again to reiterate, we’re responsible for research and development through Phase I. So to be clear, that includes CMC, that includes regulatory, basically every other function in there.” – March 20, 2018 Prothena Corporation PLC Neuroscience R&D Collaboration Investor Call Company Response: The statement that “we are responsible for research and development” does not mean, and could not be reasonably read to imply, that Prothena has an obligation to undertake research and development. Rather, it was meant to convey that as between Prothena and Celgene, Prothena would be responsible for any research and development that it chooses to undertake under the Agreement, and that [***]. Finally, the activities performed by Prothena through completion of Phase 1 clinical trials for a program, should Prothena choose to undertake them, [***]. • “Prothena will lead and have final decision-making authority over all programs through Phase I, unless Celgene elects otherwise at its expense.” - March 20, 2018 Prothena Corporation PLC Neuroscience R&D Collaboration Investor Call Company Response: The statement is accurate and consistent with the terms of the Agreement and does not imply that Prothena has any obligation beyond what is set forth in the Agreement. In fact, the statement that Prothena has “final decision-making authority” is consistent with [***]. Moreover, Prothena having final decision-making authority regarding the conduct of the programs prior to Celgene exercising its option rights is not consistent with [***]. Finally, the portion of the statement that reads “unless Celgene elects otherwise at its expense” refers to the limited right of Celgene (through its Phase 1 Portion Participation Right) to take over the conduct of a program through Phase 1 clinical trials for that program after it exercises its IND Option and obtains US Rights for that program. Currently, Celgene has no such decision-making right as it has not exercised an IND Option and has no right to take over the Phase 1 clinical trials for any program. • “And as you may recall, Prothena is responsible for the execution of these programs through the preclinical and early clinical stages, dependent upon various clinical option exercise [indiscernible] by Celgene.” –Q4 2018 Earnings Transcript Company Response: Consistent with the response above, the reference to Prothena being “responsible for” does not imply a promise by Prothena to proceed with any of these programs. Rather, it conveys that as between Prothena and Celgene, Prothena would be responsible for the execution of any program that it chooses to undertake, and that Celgene cannot direct Prothena on that execution. Moreover, in order for an implied promise to constitute a performance obligation, Celgene would need to have [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-3 control of a distinct good or service; Celgene has no control over any research and development that Prothena chooses to undertake prior to Celgene’s exercise of an IND Option. • “… this collaboration provides Prothena the opportunity to work with a premier scientific partner and the resources and flexibility to advance these programs while continuing to expand our proprietary discovery activities ….” March 20, 2018 Press Release. Company Response: Similarly, the statement that Prothena has “the opportunity” to work with Celgene does not imply that Prothena has promised to undertake any activities beyond what is expressly stated in the Agreement. Importantly, the statement confirms Prothena’s “flexibility” to advance these programs – [***]. In fact, Prothena continuously evaluates the progress of its research and development and [***]. • “For Prothena, it offers the opportunity to work with a premier scientific partner with complementary biological expertise and also provides the resources and flexibility to advance in parallel both the programs within the scope of this collaboration as well as our proprietary discovery activities…” March 20, 2018 Press Release. Company Response: The previous response applies equally to this statement. • “…from the Prothena side, this provides an opportunity to accelerate and expand our discovery activities and to do it with expertise and input that we may not otherwise have access to. And so from our perspective, being able to work with a scientific team is actually quite attractive. And obviously from a resource perspective, we do think that this not only advantages the collaboration but advantages our discovery organization beyond the collaboration as well. So we actually see this as an opportunity to accelerate things that we were looking forward to working on. And actually these are targets that were obviously high on our list and we were doing an extensive amount of work on in any event.” - March 20, 2018 Prothena Corporation PLC Neuroscience R&D Collaboration Investor Call Company Response: These statements reflect reasons why Prothena might choose to proceed with one or more programs contemplated under the Agreement, but do not imply that Prothena will so proceed or create an implied promise to do so. Importantly, the statement that the transaction “advantages our discovery organization beyond the collaboration” conveys Prothena’s ability to [***]. 3. With respect to your assertion that the license rights conveyed to Celgene are not material in the context of the contract, please reconcile for us why the following rights granted to Celgene would nonetheless not be viewed as important by Celgene. Company Response: Prothena respectfully notes that [***]. Please also see the Company’s additional response below with respect to each subpart to the Staff’s comment. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-4 • right to access intellectual property for six years through the requirement to be notified on a regular basis of the Company’s ongoing research activities, material developments, and new material data or information (see for example Section 2.2.2.a. and b.) Company Response: No licenses are granted by Prothena to Celgene under Sections 2.2.2(a) or 2.2.2(b) of the Agreement. These subsections reflect only Prothena’s obligations to keep Celgene informed, and do not grant to Celgene any license to use any intellectual property of Prothena. While Celgene has the right under these subsections to receive updates on Prothena’s ongoing collaboration activities, this right is intended to enable Celgene to monitor program activities so that it could prepare efficiently to decide whether or not to exercise its options under the Agreement within the limited option exercise periods. If Celgene did not have ongoing access to such data and information, [***]. In such case, [***] • right to use the Company’s licensed intellectual property to conduct its activities and perform its obligations under the Agreement (see for example Section 7.1.1) Company Response: As discussed in Prothena’s January 22, 2019 response letter and February 28, 2019 addendum to that response letter, the licenses granted to Celgene under Sections 7.1.1 and 7.1.2 of the Agreement are limited, [***] and do not constitute distinct or material performance obligations under the Agreement. The first such license granted to Celgene (under Section 7.1.1) is intended to enable Celgene to perform its obligations under the Agreement and undertake diligence to decide whether or not to exercise its option rights under the Agreement, without being concerned about its freedom to do so in light of Prothena’s intellectual property rights. [***]. As such, this license is merely an ancillary right that may never be utilized by Celgene and is not material. This provision is analogous to a real estate investor entering into an option to buy a building and being granted customary access rights to inspect that property. These rights are integral to the option and not separate performance obligations. The second license granted to Celgene (under Section 7.1.2) is solely for the use of [***] Prothena’s understanding is that this license is [***]. The important limitations that no such license is granted under intellectual property (a) developed by Prothena independently outside of the collaboration, or (b) that is [***], as well as the fact that [***].1 1 As discussed in Prothena’s February 28, 2019 addendum to its letter dated January 22, 2019, in response to comments received by letter dated December 19, 2018 from the Staff, [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-5 • right to use the Company’s licensed intellectual property for six years for purposes other than evaluating whether to exercises its option (see for example Section 2.9.1) Company Response: As with the licenses under Sections 7.1.1 and 7.1.2 of the Agreement, the license to Celgene under the last sentence of Section 2.9.1 of the Agreement is limited, [***] and does not constitute a distinct or material performance obligation under the Agreement. Specifically, this license is solely for the use of data generated by Celgene from Transferred Prothena Materials that is provided pursuant to Section 2.9.1, which may be provided by Prothena to Celgene and used by Celgene only for the Permitted Celgene Purposes specified in Section 2.9.1 and subject to a separately negotiated material transfer agreement to be executed by the parties. [***]. Again, as with Section 7.1.2, the origin of the license in Section 2.9.1 was that [***] • right to use for research and development purposes (see page PRTA 1003 of your January 22, 2019 response). Company Response: Please see the responses above. 4. Please reconcile for us the statements in your most recent disclosure in Note 8 to the financial statements included in your December 31, 2018 Form 10-K that the options for U.S. Rights and Global Rights represent material rights and the Company’s conclusion that it does not have a material distinct performance obligation at the inception of the Collaboration Agreement. In your reply, please provide your analysis as to whether one or more material rights exists, including whether the exercise price of each option reflects the standalone selling price for the goods and services subject to each option and how you made that determination. Company Response: According to