sBLA Filing Clause Samples

sBLA Filing. The Target Date for Genentech to file the sBLA with the FDA ("sBLA Filing") shall be [*]

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Related to sBLA Filing

• Form 15 Filing Prior to January 30 of the first year in which the Depositor is able to do so under applicable law, the Depositor shall file a Form 15 relating to the automatic suspension of reporting in respect of the Trust Fund under the Exchange Act.

• Preparation and Filing If and whenever the Corporation is under an obligation pursuant to the provisions of Sections 3.5 and/or 3.6 to use its best efforts to effect the registration of any Registrable Shares, the Corporation shall, as expeditiously as practicable: (a) prepare and file with the Commission a registration statement with respect to such securities and use its best efforts to cause such registration statement to become and remain effective in accordance with Section 3.7(b) hereof; (b) prepare and file with the Commission such amendments and supplements to such registration statement and the prospectus used in connection therewith as may be necessary to keep such registration statement effective until the earlier of (i) the sale of all Registrable Shares covered thereby or (ii) nine months from the date such registration statement first becomes effective, and to comply with the provisions of the Securities Act with respect to the sale or other disposition of all Registrable Shares covered by such registration statement; (c) furnish to each holder whose Registrable Shares are being registered pursuant to this Section 3 such number of copies of any summary prospectus or other prospectus, including a preliminary prospectus, in conformity with the requirements of the Securities Act, and such other documents as such holder may reasonably request in order to facilitate the public sale or other disposition of such Registrable Shares; (d) use its best efforts to register or qualify the Registrable Shares covered by such registration statement under the securities or blue sky laws of such jurisdictions as each holder whose Registrable Shares are being registered pursuant to this Section 3 shall reasonably request, and do any and all other acts or things which may be necessary or advisable to enable such holder to consummate the public sale or other disposition in such jurisdictions of such Registrable Shares; provided, however, that the Corporation shall not be required to consent to general service of process for all purposes in any jurisdiction where it is not then subject to process, qualify to do business as a foreign corporation where it would not be otherwise required to qualify or submit to liability for state or local taxes where it is not otherwise liable for such taxes; (e) at any time when a prospectus covered by such registration statement and relating thereto is required to be delivered under the Securities Act within the appropriate period mentioned in Section 3.7(b) hereof, notify each holder whose Registrable Shares are being registered pursuant to this Section 3 of the happening of any event as a result of which the prospectus included in such registration, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing and, at the request of such holder, prepare, file and furnish to such holder a reasonable number of copies of a supplement to or an amendment of such prospectus as may be necessary so that, as thereafter delivered to the purchasers of such shares, such prospectus shall not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing; (f) if the Corporation has delivered preliminary or final prospectuses to the holders of Registrable Shares that are being registered pursuant to this Section 3 and after having done so the prospectus is amended to comply with the requirements of the Securities Act, the Corporation shall promptly notify such holders and, if requested, such holders shall immediately cease making offers of Registrable Shares and return all prospectuses to the Corporation. The Corporation shall promptly provide such holders with revised prospectuses and, following receipt of the revised prospectuses, such holders shall be free to resume making offers of the Registrable Shares; and (g) furnish, at the request of any holder whose Registrable Shares are being registered pursuant to this Section 3, on the date that such Registrable Shares are delivered to the underwriters for sale in connection with a registration pursuant to this Section 3 if such securities are being sold through underwriters, or on the date that the registration statement with respect to such securities becomes effective if such securities are not being sold through underwriters, (i) an opinion, dated such date, of the counsel representing the Corporation for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the holder or holders making such request, and (ii) a letter dated such date, from the independent certified public accountants of the Corporation, in form and substance as is customarily given by independent certified public accountants to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the holder or holders making such request.

• HSR Filing Each Party (or its “ultimate parent entity” as that term is defined under the HSR Act and its implementing regulations) shall, within ten (10) business days after the Execution Date (or such later time as may be agreed to in writing by the Parties), file, on an expedited basis (meaning, with a request for early termination of the waiting period), the filing fee of which shall be borne by the Parties equally, with the United States Federal Trade Commission (“FTC”) and the Antitrust Division of the United States Department of Justice (the “Division”), any HSR Filing required of it under the HSR Act with respect to the transactions contemplated hereby. The Parties shall cooperate with each other to the extent reasonably necessary in the preparation of any such HSR Filing. As promptly as is practicable after receiving any request from any appropriate Governmental Authority for information, documents, or other materials in connection with the review of the HSR Filing, each Party shall use its commercially reasonable efforts to comply with such request. Each Party shall each cooperate reasonably with the other in connection with resolving any inquiry or investigation by any Governmental Authority relating to the HSR Filing. Each Party agrees to use its commercially reasonable efforts to secure termination or expiration of any waiting periods under any Applicable Laws and/or to obtain the approval of any antitrust Governmental Authority, as applicable, for the transactions contemplated hereby. In furtherance and not in limitation of the foregoing, each Party shall promptly inform the other Party of any communication to or from any Governmental Authority regarding the Agreement and/or the transactions contemplated by the Agreement. Except as may be prohibited by any Governmental Authority or by any Applicable Law, the Parties will consult and cooperate with one another, and will consider in good faith the views of one another, in connection with preparing any submission or presentation to any Governmental Authority in connection with any such inquiry. Except as may be prohibited by any Governmental Authority or by any Applicable Law, the Parties will permit authorized representatives of the other Party to be present at any meeting, telephone call or conference with such Government Authority in connection with any such inquiry. Notwithstanding the foregoing, nothing contained in this Agreement shall require or obligate either Party to, and either Party shall not without the prior written consent of the other Party: (i) agree or otherwise become subject to any restrictions, conditions, limitations, licensing requirements, or other understandings required or requested by the FTC or the Division in connection the FTC’s or Division’s investigation of the transactions contemplated by the Agreement as part of the HSR process; or (ii) agree or otherwise be required to sell or otherwise dispose of, hold separate (through the establishment or a trust or otherwise), or divest itself of all or any portion of the business, assets, or operations of such Party. Notwithstanding anything to the contrary contained herein, in the event a Governmental Authority plans to enjoin the transaction contemplated herein, or if the HSR Clearance Date has not occurred within six (6) months following the Execution Date, the Parties may each terminate this Agreement upon written notice to the other Party.

• Regulatory Filing In the event that this Interconnection Service Agreement contains any terms that deviate materially from the form included in Attachment O of the Tariff, Transmission Provider shall file the Interconnection Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff within thirty days after execution. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix 2. An Interconnection Customer shall have the right, with respect to any Interconnection Service Agreement tendered to it, to request (a) dispute resolution under Section 12 of the Tariff or, if concerning the Regional Transmission Expansion Plan, consistent with Schedule 5 of the Operating Agreement, or (b) that Transmission Provider file the agreement unexecuted with the Commission. With the filing of any unexecuted Interconnection Service Agreement, Transmission Provider may, in its discretion, propose to FERC a resolution of any or all of the issues in dispute between or among the Interconnection Parties.

• Recording and Filing The County and Borrower shall cause this Agreement, and all amendments and supplements to it, to be recorded in the Official Records of the County of Contra Costa.