Provision Language
Definitions
“Atreca Antibodies” means (a) Atreca’s monoclonal antibodies [***], (b) the [***] set forth on Schedule 3 and (c) the amino acid sequences of those antibodies described in the foregoing subclauses ((a) and (b)).
“Atreca Biological Materials” means any and all biological materials embodying or derived from the Atreca Antibodies [***].
“Gates MRI Biological Materials” means any and all biological materials embodyingor derived from the Atreca Antibodies, including [***] .
3. Development, Manufacture, and Commercialization; Regulatory Matters
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3.4 Joint Coordination Committee.
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(c) Written Reports. The Gates MRI will provide Atreca with a written report [***] within [***] days of the [***] of the Effective Date documenting the progress made with respect to the Development of the Licensed Product.
4. Biological Materials; Data Sharing
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4.2 Shared Data. Each Party will share, on an ongoing basis during the term of this Agreement, and subject to any additional terms that may reasonably be required (e.g., pertaining to safety, pharmacovigilance, confidentiality, or privacy), Information specifically relating to (i) the Atreca Antibodies and their Development or Manufacture, including Atreca Biological Materials or (ii) the Gates MRI Biological Materials (subject to availability), as applicable, which is Controlled by a Party or its Affiliates (collectively, “Shared Data“). Shared Data shall include Regulatory Submissions related to the Licensed Product, provided that the Gates MRI shall only be required to share [***] upon Atreca’s written request and only if Atreca is [***] with actual or potential licensees, sublicensees or contractors [***] (“Atreca Sublicensees“). For the avoidance of doubt, [***] will be the only component of Shared Data that requires a written request. Gates MRI will share any Regulatory Submissions solely through a secure online data repository.
4.3 Use of Shared Data.
(a) By the Gates MRI. The Gates MRI may use, and permit use by its sublicensees and contractors of, Atreca’s Shared Data solely in connection with the exercise of its and their rights pursuant to this Agreement and for no other purpose. Atreca hereby grants to the Gates MRI (which the Gates MRI may extend to its sublicensees and contractors) a Right of Reference to Regulatory Submissions (and underlying Information) submitted by or on behalf of Atreca (including those of its Affiliates and Atreca Sublicensees) to the extent necessary or useful for the exercise of the Gates MRI’s rights granted pursuant to this Agreement.
(b) By Atreca.
(i) Except as set forth in Sections (ii) and (iii), Atreca may use the Gates MRI’s Shared Data for internal research purposes only.
(ii) Upon Atreca’s written notice, notwithstanding anything to the contrary in Section (i) or Section 6, the Gates MRI will permit Atreca to share the Gates MRI’s Shared Data with potential Atreca Sublicensees and contractors under confidentiality terms no less restrictive than those of this Agreement, only for the limited purpose of evaluating whether to exercise the Commercial License (as set forth below).
(iii) Atreca and the Atreca Sublicensees and contractors may use and reference the Gates MRI’s Shared Data (including data generated prior to and including clinical trial applications (e.g., IND submissions or comparable applications to a Regulatory Authority if filed outside of the United States), clinical trial data, documents pertaining to the design or implementation of clinical studies, including the Trial Master File (TMF) or equivalent, and any Regulatory Submissions) and the Gates MRI Biological Materials generated, made, or produced by [***] or other third parties, as sublicensees of the Gates MRI hereunder, in each case subject to the terms of Sections 5.2 and 5.3, and any additional terms as described in Section 4.2, for commercial purposes (i.e., any purposes other than internal research purposes, including Development, Manufacture, and Commercialization of the Atreca Antibodies) outside the Territory (“Commercial License“). Atreca or the Atreca Sublicensee shall have the right to exercise the Commercial License at any time during the term of this Agreement by providing written notification to Gates MRI of the commencement and status of commercial Development efforts (including notification of any sublicense entered into by Atreca with an Atreca Sublicensee for purpose of exercising the Commercial License). In such event, the Gates MRI will, as applicable, (A) grant to Atreca a Right of Reference to the applicable Shared Data and Regulatory Submissions, and (B) authorize [***] or other third parties to supply the applicable Gates MRI Biological Materials to Atreca, subject to availability. For clarity, the Parties agree that any such Gates MRI Biological Materials will be stored by [] and not by [***]. The Gates MRI will not be directly responsible for [***] such Gates MRI Biological Materials by [***].
(c) Atreca may, in connection with its exercise of the Commercial License, request that the Gates MRI cooperate in facilitating a technology transfer of CMC data related to the Licensed Products that is Controlled by the Gates MRI (“Gates MRI CMC Data“). In such event, the Gates MRI (or its contract manufacturer) will cooperate in transferring the Gates MRI CMC Data to Atreca in accordance with a CMC technology transfer plan to be mutually agreed by the Parties in writing (“CMC Technology Transfer“).
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5. Financial Terms
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5.2 Commercial License Royalties and Fees.
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(c) Reports; Payment Terms. No later than [***] days after the end of each calendar quarter, Atreca will provide to the Gates MRI a detailed report setting forth the calculation of amounts owed under this Section 5.2 for such calendar quarter and the basis for such calculation, which report will be signed by an authorized representative of Atreca. Each such report will be accompanied by the payment of the amounts owed for the applicable reporting period. For the avoidance of doubt, calendar quarters will end on the last day of March, June, September, and December of each calendar year.
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5.4 Audits. The Gates MRI will have the right, upon [***] days’ prior notice, to engage an independent certified public accountant reasonably acceptable to Atreca to conduct, during normal business hours, an audit of Atreca’s and its Affiliates’ records to verify the information contained in the reports provided pursuant to Section 5.2(c). Such audit may not (a) be conducted for any reports pertaining to any calendar quarter more than [***] years after the end of such calendar quarter, or (b) be conducted more than once with respect to such calendar quarter. Such accountant shall not disclose Atreca’s or its Affiliates’ Confidential Information to the Gates MRI, except to the extent such disclosure is necessary to verify the accuracy of such reports being audited. Each such audit will be at the Gates MRI’s expense unless the audit reveals an underpayment of [***] percent ([***]%) or more in any calendar quarter of any sums due to the Gates MRI hereunder, in which case the costs of such audit will be borne by Atreca. Any amounts shown to be owed but unpaid, or overpaid and in need of refund, as the case may be, together with any interest owed thereon as set forth below, will be made to or refunded by the Gates MRI within [***] days of the accountant’s report.