“Regulatory Materials” means the China, U.S. and foreign regulatory applications, submissions and approvals (including all INDs, NDAs, Regulatory Approval and all foreign counterparts thereof) for any Compound or Product, correspondence with the FDA and other Regulatory Authorities relating to any Compound or Product or any of the foregoing regulatory applications, submissions and approvals, in each case owned by GSK or any of its Affiliates or held on GSK’s or any of its Affiliates’ behalf as of the Effective Date.

Additional Submissions – Information Access. The Claimant shall then have the opportunity to submit written comments, documents, records and other information relating to the claim. The Administrator shall also provide the Claimant, upon request and free of charge, reasonable access to, and copies of, all documents, records and other information relevant (as defined in applicable ERISA regulations) to the Claimant’s claim for benefits.

Licensee shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA and other regulatory authorities in the Field in the Territory with respect to Licensed Product.

for submissions and other filings with Regulatory Authorities for the approval or other exploitation of a Product or Final Product as contemplated by this Agreement; or

“NDA” means a New Drug Application or Supplemental New Drug Application filed with the FDA (including amendments and supplements thereto) to obtain Regulatory Approval in the U.S., or any corresponding applications or submissions filed with the relevant Regulatory Authorities to obtain Regulatory Approvals in any other country or region in the Territory.

“Regulatory Materials” means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture, market, sell or otherwise Commercialize a Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, MAAs and NDAs (as applications, but not the approvals with respect thereto) and DMFs, or the equivalent applications to the equivalent Regulatory Authority in any other regulatory jurisdiction.

The JDC will develop and implement procedures for drafting and review of Regulatory Materials for Development Candidates and Products in the Territory, which procedures will provide sufficient time for each Party to provide substantive comments prior to the filing of such Regulatory Materials. Such procedures will provide each Party with full and complete access, on a real-time basis, to all Regulatory Materials and Regulatory Approvals as such materials are being drafted, and, after those materials have been submitted to a Regulatory Authority, will permit each Party to obtain copies of all such materials, including in electronic format, at reasonable times. Such procedures and related timelines will accommodate each Party’s reasonable requests to obtain the feedback of Regulatory Authorities with respect to potential submissions in order to permit each Party to ensure that submissions and Regulatory Approvals for Products throughout the Territory are reasonably consistent.

Regulatory Allocations. The allocations set forth in [Sections 4.3(a)-(d)])] (the “Regulatory Allocations”) are intended to comply with certain requirements of Sections 1.704-1(b))]and 1.704-2 of the Treasury Regulations. The Regulatory Allocations may not be consistent with the manner in which the Unitholders intend to allocate Profit and Loss of the Company or make the Company distributions. Accordingly, notwithstanding the other provisions of this Article IV, but subject to the Regulatory Allocations, income, gain, deduction, and loss shall be reallocated among the Unitholders so as to eliminate the effect of the Regulatory Allocations and thereby cause the respective Capital Accounts of the Unitholders to be in the amounts (or as close thereto as possible) they would have been if Profit and Loss (and such other items of income, gain, deduction and loss) had been allocated without reference to the Regulatory Allocations. In general, the Unitholders anticipate that this will be accomplished by specially allocating other Profit and Loss (and such other items of income, gain, deduction and loss) among the Unitholders so that the net amount of the Regulatory Allocations and such special allocations to each such Unitholder is zero. In addition, if in any Fiscal Year or Fiscal Period there is a decrease in partnership Minimum Gain, or in partner nonrecourse debt Minimum Gain, and application of the Minimum Gain chargeback requirements set forth in [Section 4.3(a)] or [Section 4.3(b)]would cause a distortion in the economic arrangement among the Unitholders, the Board may, if it does not expect that the Company will have sufficient other income to correct such distortion, request the Internal Revenue Service to waive either or both of such Minimum Gain chargeback requirements.If such request is granted, this Agreement shall be applied in such instance as if it did not contain such Minimum Gain chargeback requirement.

Regulatory Proceedings. The Parties shall, and shall cause their Affiliates and each of their respective Representatives to, use reasonable best efforts to cooperate with each other in connection with the prompt withdrawal of any applications to, or termination of proceedings before, any Governmental Entity or under any applicable Law, in each case to the extent applicable and requested by a Party, in connection with the transactions contemplated by the SPA.

Regulatory Matters. The Company’s obligations under this Agreement are subject to the orders, rules and regulations of the federal and state banking regulators as may be in effect from time to time, including without limitation FDIC regulations governing “golden parachute payments” set forth at 12 CFR Part 359. If the Company is prevented from discharging its obligations hereunder as a result of any such orders, rules or regulations, the Company shall be released from its obligations and shall not be deemed to have breached this Agreement, to that extent. The Company shall have no obligation to petition the FDIC (and/or other regulatory agency having jurisdiction over the Company) for permission to treat any payments as “permissible golden parachute payments.”