Regulatory Updates definition
Regulatory Updates means material information and developments with respect to any Regulatory Filing.
Regulatory Updates means a summary of any and all material information and developments that materially impact a Product with respect to any regulatory filings or submissions made to any Regulatory Authority.
Regulatory Updates means a summary of any and all material information and developments that materially impact the Product or any Related Product with respect to any regulatory filings or submissions made to the FDA and EMA (or, to the extent the EMA is not applicable, the Regulatory Authority for any Major EU Country).
Examples of Regulatory Updates in a sentence
The CCO will create and maintain a detailed, compliance program, perform testing of compliance policies and procedures, complete Regulatory Filings as required, communicate Regulatory Updates and Alerts to members of the Board, conduct employee training and perform ongoing Consulting.
The the CCO will create and maintain a detailed, compliance program, perform testing of compliance policies and procedures, complete Regulatory Filings as required, communicate Regulatory Updates and Alerts to members of the Board, conduct employee training and perform ongoing Consulting.
Altera shall provide Regulatory Updates within a reasonable timeframe after the applicable regulatory authority has enacted and publicly released the final and binding regulatory requirement.
Sellers shall, subject to this Section 5.1, provide the Buyer: promptly following the end of the each calendar quarter of each calendar year, but in any event, in each case, no later than seventy (70) calendar days after the end of such calendar quarter, a reasonably detailed report (the “Quarterly Report”) setting forth, with respect to such calendar quarter, (a) the Intellectual Property Updates, (b) the Regulatory Updates, (c) the Clinical Updates, and (d) the Commercial Updates.
Any Regulatory Updates shall not include any products or services that add on to or function separately from the Allscripts Software.
More Definitions of Regulatory Updates
Regulatory Updates means [***].
Regulatory Updates means a summary of any and all material information and developments that materially impact the Product with respect to any regulatory filings or submissions made to the FDA and EMA (or, to the extent the EMA is not applicable, the Regulatory Authority for Germany, the United Kingdom, France, Spain and Italy). Serious adverse events in the Clinical Trials shall be included in the Regulatory Update in each Quarterly Report and adverse events in the Clinical Trials shall be included in each annual report. Copies of internal presentations or reports of summaries of such material information or developments, and copies of presentations or reports received by the Seller from any Third Party, may constitute Regulatory Updates.
Regulatory Updates means a summary of any and all material information and developments that materially impact the Product with respect to any regulatory filings or submissions made to any Regulatory Authority. “Related Party” is defined in the definition of “Net Sales”. “Report” is defined in Section 6.1(a). “Representative” means, with respect to any Person, (a) any direct or indirect member or partner of such Person and (b) any manager, director, trustee, officer, employee, agent, advisor or other representative (including attorneys, accountants, consultants, contractors, actual and potential lenders, investors, co-investors and assignees, bankers and financial advisers) of such Person. “Restricted Indebtedness” means any (a) financing, sale, or loan of royalty, revenue or profit interests on the Product, or (b) any Indebtedness, in each case ((a) and (b)), other than Permitted Indebtedness. “Revenue Participation Right” means the right to receive the Revenue Share Payments. “Revenue Share Payments” means, for each Calendar Quarter beginning on the First Commercial Sale in the Territory, an amount payable to the Buyer equal to the amount of all aggregate Net Sales of the Product in the Territory during such Calendar Quarter multiplied by the applicable Revenue Share Rate. “Revenue Share Rate” means the percentage based on the applicable level of aggregate Net Sales of the Product in the Territory in a Calendar Year as set forth in the chart below: Payment Tiers based on Annual Net Sales Revenue Share Rate Annual Net Sales less than or equal to [***] (“Tier 1”) 7.5%*
Regulatory Updates means material information and developments with respect to any Regulatory Filing relating to Troriluzole. 87
Regulatory Updates means a summary of any and all material information and developments that materially impact a Product with respect to any regulatory approvals, filings or submissions made to the FDA, EMA (or, to the extent the EMA is not applicable, the Regulatory Authority for Germany, the United Kingdom, France, Spain and Italy) and the Regulatory Authority for Japan. Copies of internal presentations or reports of summaries of such material information or developments, and copies of presentations or reports received by Company from any Third Party, to the extent such presentations or reports include any applicable information required in the immediately preceding sentence, may constitute Regulatory Updates with respect to such applicable information.
Regulatory Updates means a summary of any and all material information and developments that materially impact a Product with respect to any regulatory filings or submissions made to any Regulatory Authority. “Related Party” is defined in the definition of “Net Sales”. “Relevant Obligations” means, with respect to the disclosure of any notice, demand, certificate, correspondence, report, information, opinion or other communication contemplated to be disclosed to the Buyer under this Agreement, Seller’s confidentiality obligations owed to any Third Party (including under any In-License, Out-License, or any applicable protective order). “Report” means, collectively, the Clinical, Commercial and CMC Quarterly Update, the Regulatory and IP Semi-Annual Update, and the Royalty Report. “Representative” means, with respect to any Person, (i) any direct or indirect stockholder, member or partner of such Person and (ii) any manager, director, officer, employee, agent, advisor or other representative (including attorneys, accountants, consultants, bankers, financial advisors and actual and potential lenders and investors) of such Person. “Revenue Participation Right” means the right to receive the Royalty Payments and the Purchased Daré Clinical Fees. “Royalty Payments” means, for each Calendar Quarter during the Synthetic Royalty Term, an amount payable to the Buyer equal to the amount of all aggregate Net Sales of (i) OVAPRENE during such Calendar Quarter multiplied by 4% and (ii) SILDENAFIL during such Calendar Quarter multiplied by 2%, in each case of clauses (i) and (ii) above, less any applicable Royalty Reductions [***] in accordance with Section 6.3. “Royalty Report” is defined in Section 6.2(b). “Safety Notices” means any recalls, field notifications, market withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action issued or instigated by the Seller, any of its Affiliates or any Regulatory Authority relating to an alleged lack of safety or regulatory compliance of any Product. “Secured Debt Provider” is defined in Section 6.10(a). “Securities Act” means the Securities Act of 1933.
Regulatory Updates means a summary of any and all material information and developments that materially impact a Target Product with respect to any regulatory filings or submissions made to any Regulatory Authority. Copies of internal presentations or reports of summaries of such material information or developments, and copies of presentations or reports received by the Company from any Third Party, may be used as Regulatory Updates.