Meetings with Governmental Authorities Sample Clauses

Meetings with Governmental Authorities. Seller shall represent the Facility as necessary in all meetings with and proceedings before all Governmental Authorities.
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Meetings with Governmental Authorities. With respect to any discussions with any governmental authority involving data from or the conduct of any Clinical Study, [***] will take the initiative in arranging such discussion. Formal meetings with governmental authorities concerning the design or data from a Clinical Study will be discussed and agreed upon in advance by [***]. With the prior written consent of [***] will have the right to participate in all formal meetings with governmental authorities relating to a Clinical Study unless legally precluded from doing so.
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Meetings with Governmental Authorities. Except in case of a surprise visit by a Governmental Authority, the Purchaser shall send prior notice to the Sellers' Agent of any meeting with any Governmental Authorities responsible for environmental matters to which it or the Company is invited to participate and which pertains to the facilities occupied, or to the business operated, by the Business or the Company, and the Sellers' Agent shall be entitled to attend such meeting. The Purchaser shall not, and shall cause its Affiliates (including the Company) not to initiate any discussion regarding, or provide any information (including, for the avoidance of doubt, following a surprise visit by a Governmental Authority) to, any Governmental Authority with respect to any Release of Hazardous Materials or Remedial Action or step which would reasonably be expected to give rise to an indemnification by the Sellers without the Sellers' Agent's prior consent (which shall not be unreasonably withheld, conditioned or delayed having given due consideration to the emergency of the situation and the constraints imposed by the Governmental Authority). More generally, from the date hereof and for the duration defined in Section 7.7 (Claims Period), and except for the implementation of an Emergency Measure, the Purchaser shall not and shall cause the Company not to seek, request or take any action expected to provoke or result in any administrative inquiry, investigation, audit or Remedial Action or similar compliance order of any Governmental Authority without the Sellers' Agent's prior consent (which shall not be unreasonably withheld, conditioned or delayed).
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Meetings with Governmental Authorities. “RA Sponsor” means the party that is the sponsor of an IND or other RA under applicable law. With respect to any discussions with any governmental authority involving data from or the conduct of any Collaboration Project, the RA Sponsor in consultation with the COG will take the initiative in arranging such discussion. Formal meetings with governmental authorities concerning material matters relating to the design or conduct of or data from a Collaboration Project will be discussed and agreed upon in advance by the RA Sponsor, the party that is not the RA Sponsor and the COG. With the prior written consent of the COG, the party that is not the RA Sponsor will have the right to participate in any such formal meetings with governmental authorities relating to a Collaboration Project unless legally precluded from doing so.
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Meetings with Governmental Authorities. (a) Except as otherwise set forth in this Agreement, the applicable Regulatory/Reimbursement Responsible Party for a Product in a country will be responsible for all meetings, conferences, and discussions with Regulatory Authorities and other Governmental Authorities related to Regulatory Approval and, where applicable, Reimbursement Approval of such Product in such country; except that the Parties’ regulatory teams will work in collaboration with the JDC and JCC to review, discuss, and coordinate all strategies, material communications, and contents of all material meetings, conferences, and discussions with such Regulatory Authorities and other Governmental Authorities in the Apellis Territory, [**], and the Major European Countries related to each Product. (b) Sobi shall provide Apellis with prompt prior written notice of any material scheduled meeting, conference, or discussion (including any advisory committee meeting, pre-submission meeting, product development meeting, or oral argument) with the EMA or the Regulatory Authority in [**] relating to any Product as soon as practicable after Sobi or any of its Affiliates first receives notice of the scheduling of such meeting, conference, or discussion. Sobi shall provide to Apellis copies of any material correspondence relating to such meetings, conferences, or discussions, including meeting requests, briefing materials, and questions, no later than [**] after Sobi’s receipt thereof and in any event prior to the applicable meeting, conference, or discussion. To the extent permitted by Applicable Law, one (1) representative of Apellis selected by Apellis and reasonably acceptable to Sobi will have a right to attend (as an observer) such meetings, conferences, and discussions with the EMA or the Regulatory Authority in [**] related to any Product in any country in the European Union or [**]. (c) Prior to any assignment of the EMA PNH Regulatory Approval in accordance with Section 5.2.6 (Assignment of EMA PNH Regulatory Approval): (i) Apellis shall provide Sobi with prompt prior written notice of any scheduled meeting, conference, or discussion (including any advisory committee meeting, pre-submission meeting, product development meeting, or oral argument) with the EMA relating to the EMA PNH Regulatory Approval as soon as practicable after Apellis or any of its Affiliates first receives notice of the scheduling of such meeting, conference, or discussion; (ii) Apellis shall provide to Sobi copies of any co...
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Meetings with Governmental Authorities. LICENSEE will take the initiative in arranging discussions with any governmental authority involving data from or the conduct of any RESEARCH PROGRAM or CLINICAL TRIAL. Formal meetings with governmental authorities concerning the design or data from a RESEARCH PROGRAM or CLINICAL TRIAL will be discussed and agreed upon in advance by the JSC. With the prior written consent of LICENSEE, UTMDACC will have the right to participate in all formal meetings with governmental authorities relating to RESEARCH PROGRAM or CLINICAL TRIAL unless legally precluded from doing so.
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Meetings with Governmental Authorities. With respect to any discussions with any governmental authority involving data from or the conduct of any Collaboration Project, [***] will take the initiative in arranging such discussion. Formal meetings with governmental authorities concerning the design or data from a Collaboration Project will be discussed and agreed upon in advance by [***]. With the prior written consent of [***] will have the right to participate in all formal meetings with governmental authorities relating to a Collaboration Project unless legally precluded from doing so.
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Meetings with Governmental Authorities. At Tenant's request, Landlord shall cooperate with Tenant in scheduling and attending a reasonable number of meetings with the applicable Governmental Authority regarding the proposed Environmental Construction Activity.
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Related to Meetings with Governmental Authorities

  • Governmental Authorities From the date of this Agreement and until the End Date, the Company shall duly observe and conform in all material respects to all valid requirements of governmental authorities relating to the conduct of its business or to its properties or assets.

  • Consents and Approvals of Governmental Authorities No consent, approval, or authorization of, or declaration, filing, or registration with, any governmental or regulatory authority is required to be made or obtained by the Seller in connection with the execution, delivery, and performance of this Agreement or any of the other Acquisition Documents by the Seller.

  • Authorization of Governmental Authorities No action by (including any authorization, consent or approval), in respect of, or filing with, any governmental authority or regulatory body is required for, or in connection with, the valid and lawful authorization, execution, delivery and performance by it of this Agreement, subject to, in the case of the Debtors, the entry by the Bankruptcy Court of the Approval Order.

  • Compliance; Governmental Authorizations The Seller has complied in all material respects with all applicable Federal, state, local or foreign laws, ordinances, regulations and orders. The Seller has all Federal, state, local and foreign governmental licenses and permits necessary in the conduct of the Subject Business the lack of which would have a material adverse effect on the Buyer's ability to operate the Subject Business after the Closing on substantially the same basis as presently operated, such licenses and permits are in full force and effect, no violations are or have been recorded in respect of any thereof and no proceeding is pending or threatened to revoke or limit any thereof. None of such licenses and permits shall be affected in any material respect by the transactions contemplated hereby.

  • Approvals of Governmental Bodies As promptly as practicable after the date of this Agreement, Buyer will, and will cause each of its Related Persons to, make all filings required by Legal Requirements to be made by them to consummate the Contemplated Transactions (including all filings under the HSR Act). Between the date of this Agreement and the Closing Date, Buyer will, and will cause each Related Person to, cooperate with Sellers with respect to all filings that Sellers are required by Legal Requirements to make in connection with the Contemplated Transactions, and (ii) cooperate with Sellers in obtaining all consents identified in Part 3.2 of the Disclosure Letter; provided that this Agreement will not require Buyer to dispose of or make any change in any portion of its business or to incur any other burden to obtain a Governmental Authorization.

  • Governmental Authorities; Consents No action by, consent, approval, permit or authorization of, or designation, declaration or filing with, any Governmental Authority or notice, approval, consent waiver or authorization from any Governmental Authority is required on the part of Acquiror with respect to the execution or delivery and performance of this Agreement by Acquiror or any Transaction Agreement to which any of Acquiror is a party, as applicable, or the consummation of the Transactions or the transactions contemplated thereby, except for (a) applicable requirements of the HSR Act, (b) the filing with the SEC of (i) the Proxy Statement (and the expiration of the waiting period in Rule 14a-6(a) under the Exchange Act or, if the preliminary Proxy Statement is reviewed by the SEC, receipt of oral or written notification of the completion of the review by the SEC) and (ii) such reports under Section 13(a) or 15(d) of the Exchange Act as may be required in connection with this Agreement, the Transaction Agreements or the Transactions or the transactions contemplated thereby, (c) such filings with and approval of Nasdaq to permit the Acquiror Common Stock to be issued in connection with the Transactions and the other Transaction Agreements to be listed on the Nasdaq, (d) the Acquiror Stockholder Approval, or (e) any actions, consents, approvals, permits or authorizations, designations, declarations or filings, the absence of which would not, individually or in the aggregate, reasonably be expected to have an Acquiror Material Adverse Effect.

  • Compliance with Legal Requirements; Governmental Authorizations (a) Other than with respect to laws concerning Taxes (which are addressed in Section 3.9), laws concerning employee benefits (which are addressed in Section 3.10), and Environmental Laws (which are addressed in Section 3.14): (i) each Longhorn Entity is, and at all times since January 1, 2010 has been, in compliance in all material respects with each Legal Requirement that is or was applicable to it; (ii) no event has occurred or circumstance exists (with or without notice or lapse of time) (A) that is reasonably likely to constitute or result in a material violation by any Longhorn Entity of, or a material failure on the part of any Longhorn Entity to comply with, any Legal Requirement applicable to it or (B) that is reasonably likely to give rise to any material obligation on the part of any Longhorn Entity; and (iii) no Longhorn Entity has received, at any time since January 1, 2010, any written or other notice or other communication from any Governmental Entity or any other Person regarding (A) any actual or alleged violation of, or failure to comply with, any Legal Requirement applicable it or (B) any actual or alleged material obligation on the part of any Longhorn Entity. (b) Except as set forth on Schedule 3.11(b), each Longhorn Entity possesses all material Permits, all such material Permits are in full force and effect, and each Longhorn Entity is and at all times since January 1, 2010 has been in compliance in all material respects with all material Permits. No Longhorn Entity has received any notice to the effect that, or otherwise been advised of (i) any actual or alleged material violation of, or failure to comply with, any material Permits or (ii) any actual or alleged revocation, withdrawal, suspension, cancellation or termination of, or any modification to, any material Permit or the commencement or threatened commencement of any proceeding to do any of the foregoing. To the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time) is reasonably likely to (i) constitute or result directly or indirectly in a material violation by any Longhorn Entity of, or a failure on the part of any Longhorn Entity to comply with, any material Permits or (ii) result directly or indirectly in the revocation, withdrawal, suspension, cancellation or termination of, or any modification to, any material Permit.

  • Actions Before Governmental Authorities There are no actions, suits or proceedings at law or in equity or by or before any governmental authority now pending or, to the knowledge of Borrower, threatened against or affecting Borrower or its property, that is reasonably expected to result in a Material Adverse Effect.

  • Compliance with Laws; Governmental Authorizations 1.23.1 The Company is, and has at all times been, in compliance materially with all applicable Laws, except where non-compliance could not reasonably be expected to result in Material Adverse Effect. The Company has not received any notice or other communication from any Governmental Body or any other Person regarding (i) any actual, alleged, possible or potential material violation of, or failure to materially comply with, any Law; or (ii) any actual, alleged, possible or potential obligation on the part of the Company to undertake, or to bear all or any portion of the cost of, any cleanup or any remedial, corrective or response action of any nature under any applicable Law. The Company has provided to the Buyer a true, correct and complete copy of each report, study, survey or other document to which the Company has access that addresses or otherwise relates to the compliance of the Company with, or the applicability to the Company of, any Laws. To the knowledge of the Vendor, no Governmental Body has proposed or is considering any Law that, if adopted or otherwise put into effect, (A) may have an adverse effect on the business, condition, assets, liabilities, operations, financial performance, net income or prospects of the Company or on the ability of the Company to comply with or perform any covenant or obligation under any of ancillary documents contemplated by this Agreement; or (B) may have the effect of preventing, delaying, making illegal or otherwise interfering with the transactions contemplated by this Agreement. 1.23.2 The Company does not require any Governmental Authorizations to operate its business beyond what Governmental Authorizations it currently holds, which have all been listed on Section 1.23.2 of the Disclosure Schedule. The Governmental Authorizations held by the Company are valid and in full force and effect, and collectively constitute all Governmental Authorizations necessary (i) to enable the Company to conduct its business in the manner in which its business is currently being conducted and as contemplated to be conducted by the Company as of the Closing Date; and (ii) to permit the Company to own and use its assets in the manner in which it is currently owned and used. The Company is, and at all times since its incorporation has been, in material compliance with the terms and requirements of the Governmental Authorizations held by the Company. The Company has not received any notice or other communication from any Governmental Body regarding (A) any actual or possible violation of or failure to comply with any term or requirement of any Governmental Authorization; or (B) any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization. All of the Governmental Authorizations set forth or required to be set forth on Section 1.23.2 of the Disclosure Schedule will be available for use by the Company immediately after the Closing. In respect of approvals, licenses or permits requisite for the conduct of any part of the business of the Company which are subject to periodic renewal, the Company has no reason to believe that such renewals will not be timely granted by the relevant Governmental Body. (i) The Company has at all times been, in full compliance with all of the terms and requirements of each Governmental Authorization set forth or required to be set forth on Section 1.23.2 of the Disclosure Schedule; (ii) no event has occurred, and no condition or circumstance exists, that might (with or without notice or lapse of time or both) reasonably (A) constitute or result directly or indirectly in a violation of or a failure to comply with any term or requirement of any Governmental Authorization set forth or required to be set forth on Section 1.23.2 of the Disclosure Schedule; or (B) result directly or indirectly in the revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization set forth or required to be set forth on Section 1.23.2 of the Disclosure Schedule; (iii) the Company has not received, and no employee has ever received, any notice or other communication from any Governmental Body or any other Person regarding (x) any actual, alleged, possible or potential violation of or failure to comply with any term or requirement of any Governmental Authorization; or (y) any actual, proposed, possible or potential revocation, withdrawal, suspension, cancellation, termination or modification of any Governmental Authorization; and (iv) all applications required to have been filed for the renewal of the Governmental Authorizations required to be set forth on Section 1.23.2 of the Disclosure Schedule have been duly filed on a timely basis with the appropriate Governmental Bodies, and each other notice or filing required to have been given or made with respect to such Governmental Authorizations has been duly given or made on a timely basis with the appropriate Governmental Body.

  • Governmental Entities 19.1 For those customers, which are government entities, provisions within this agreement will apply to the extent the agency is not legally barred from executing such provisions by State or Federal law.

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