Following the Effective Date of this Agreement, but not before the payment of the consideration under Section 7.01 by Licensee to Merck, Merck shall transfer to Licensee, in a mutually agreed manner, the ​ reasonably within the possession and control of Merck and necessary for Licensee to make, use and sell the Licensed Product. Any obligation of Merck to transfer such tangible material to Licensee and to provide assistance and support with such materials will not extend beyond ​ days after the Effective Date and will only be to the extent possible by the expenditure of commercially reasonable efforts.

Regulatory Materials. The Opt-Out Party will grant to the Continuing Party a right of reference under all Regulatory Materials and Regulatory Approvals for such Reversion Product that are Controlled by the Opt-Out Party or its Affiliates (other than Regulatory Materials and Regulatory Approvals for the Manufacture of the ACTR T-cells or the SGI Antibodies, as applicable, which will be retained by Unum or SGI, respectively), unless and until assigned to the Continuing Party pursuant to any Transition Agreement.

Regulatory Filings. Graphite may request WuXi ATU to assist with authoring manufacturing and cGMP related sections of the regulatory filings. If such work is needed it will be included as a part of a Work Order. If the Services relate to any cGMP Manufacturing of Product, then prior to filing with the Regulatory Authority any clinical trial application, including any U.S. Investigational New Drug Application, amendments thereto, or EU Investigational Medicinal Product Dossier or Quality Module of the Common Technical Document (the “CTD”), Graphite will provide to WuXi ATU a copy of any documentation that is equivalent to these applications that relates to the application. This disclosure will permit WuXi ATU to review and verify, at Graphite’s reasonable cost, that the application accurately describes the Services that WuXi ATU has performed and the Manufacturing and testing processes that WuXi ATU will perform under a Work Order.

Regulatory Filings. The Purchaser acknowledges that any filing or submission required by the U.S. Securities and Exchange Commission (the “SEC”), NASDAQ, or any other governmental or regulating body related to the transaction contemplated by this Agreement remains the responsibility of the Purchaser.

Regulatory Filings. To the extent required in connection with any of the transactions or other matters contemplated by this Agreement or any of the other Transaction Documents, the Company and the Purchaser shall as soon as reasonably practicable make any filings and apply for any approvals or consents that are required under any applicable antitrust laws, stock exchange regulations or otherwise.

Regulatory Filings. To the extent required in connection with the exercise of any Warrants (the “Exercise Transactions”), the Company and the Holder shall as soon as reasonably practicable (but in no event more than 10 business days) following written request by Holder, make any filings and apply for any approvals or consents that are required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”) or any other applicable Antitrust Laws with respect to the Exercise Transactions and the Company and Holder shall, to the extent permitted under applicable law, # cooperate and coordinate, subject to all applicable privileges (including the attorney-client privilege), with the other in the making of any filings or submissions that are required to be made under any applicable Antitrust Laws or requested to be made by any Governmental Authority in connection with the Exercise Transactions, # supply the other or its outside counsel with any information that may be required or requested by any Governmental Authority in connection with such filings or submissions, # supply any additional information that may be required or requested by the Federal Trade Commission, the Department of Justice, or other Governmental Authorities in which any such filings or submissions are made under any applicable Antitrust Laws as promptly as practicable, and # use their respective reasonable best efforts consistent with applicable law to cause the expiration or termination of the applicable waiting periods under any applicable Antitrust Laws as soon as reasonably practicable. Subject to applicable law relating to the exchange of information, the Holder shall have the right, with reasonable consideration of the Company’s comments, # to direct all matters with any Governmental Authority relating to the Exercise Transactions and # to review in advance, and direct the revision of, any filing, application, notification, or other document to be submitted by the Company to any Governmental Authority under any Antitrust Law. Neither party shall, without the prior written consent of the other party (which shall not be unreasonably withheld), participate in any meeting or substantive discussion with any Governmental Authority relating to the Exercise Transactions unless such party consults with the other party in advance and, to the extent permitted by such Governmental Authority, grants the other party the opportunity to attend and participate in such discussions. In furtherance of this Section 8(a), if any objections are asserted with respect to the Exercise Transactions under the HSR Act, any other applicable Antitrust Law or any other applicable law or if any legal proceeding is instituted (or threatened to be instituted) by the Federal Trade Commission, the Department of Justice, or any other Governmental Authority challenging the Exercise Transactions or that would otherwise prohibit or materially impair or delay the consummation of the Exercise Transactions (an “Antitrust Restriction”), the Company and the Holder shall use their respective reasonable best efforts to resolve any such objections or lawsuits or other proceedings (or threatened proceedings) so as to permit consummation of the Exercise Transactions as soon as reasonably practicable. For as long as this Warrant is outstanding, the Company shall (subject to any restrictions on provision of such information under applicable law) as promptly as reasonably practicable provide such information regarding the Company and its subsidiaries as the Holder may reasonably request in order to determine what antitrust requirements may exist with respect to the Exercise Transactions. As used herein, # “Antitrust Laws” means the HSR Act and any applicable antitrust, competition or merger control laws or regulations, and # “Governmental Authority” means any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative functions of or pertaining to government, any securities exchange and any self-regulatory organization.

Certain Regulatory Filings. Either Party may disclose the terms of this Agreement to the extent required, in the reasonable opinion of such Party’s legal counsel, to comply with applicable laws, including the rules and regulations promulgated by the United States Securities and Exchange Commission or by any stock exchange or regulatory body to which the Party is subject. Before disclosing this Agreement or any of the terms hereof pursuant to this [Section 11(c)], the Parties will consult with one another regarding the terms in this Agreement to be redacted in making any such disclosure. If a Party discloses this Agreement or any of the terms hereof in accordance with this [Section 11(c)], such Party agrees, at its own expense, to seek confidential treatment of portions of this Agreement or such terms, as may be reasonably requested by the other Party.

and Legacy Royalty Products in the process of manufacture (except to the extent any of the foregoing may be sold by Legacy Licensees under the Existing Ag Agreement or any Downstream Agreements), Legacy Product Trademarks, Legacy Product-Related Materials, and Regulatory Filings and Regulatory Approvals concerning any VDCs, Derivatives thereof, CDCs, Derivatives thereof, or Legacy Royalty Products and, in the case of all of the foregoing, # not reasonably necessary or useful to enable Legacy and its Affiliates to comply with, and perform their obligations under, any Assigned Downstream Agreement(s) to which Legacy or an Affiliate become a party upon such termination of the Existing Ag Agreement, provided that, to the extent any Regulatory Filings or Regulatory Approvals are transferred and assigned to Primary in accordance with the foregoing, Primary shall promptly reimburse Legacy for Legacy’s reasonable, documented out of pocket expenses incurred in obtaining or maintaining such Regulatory Filings or Regulatory Approvals;

After [[Organization A:Organization]] proceeds with the In-Licensing, [[Organization A:Organization]] shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). ​ shall support [[Organization A:Organization]], as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products, and in the activities in support thereof, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the applicable Development Plan. Notwithstanding the foregoing, ​ shall retain the right to prepare, obtain, and maintain all regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities) solely for ​ to perform the Development activities undertaken pursuant to Sections 3.1.2, 3.1.4 and 3.1.7.

“Technology” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, filings and correspondence (including DMFs), including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable.