Patent Term Extensions definition
Patent Term Extensions has the meaning set forth in Section 7.8.
Patent Term Extensions shall have the meaning described in Section 10.6(a).
Patent Term Extensions means any and all extensions of a term of a Patent granted under the Patent laws or regulations of any country, the European Union, or any other Governmental Entity;
Examples of Patent Term Extensions in a sentence
Upon request of a Party and at such requesting Party’s cost and expense, the other Party will provide support, assistance, and all necessary documents, in full, executed form if needed, to the requesting Party for the purpose of supporting, filing, obtaining, and maintaining Patent Term Extensions.
The Parties will discuss the strategy with respect to Patent Term Extensions, and, after considering the other Party’s comments in good faith, (a) Licensee will have the sole right to determine and control all filings with respect thereto in any country of the Licensee Territory and (b) Eureka will have the sole right to determine and control all filings with respect thereto in any country of the Eureka Territory.
Eureka will have the full and exclusive right and discretion to determine and control all filings of requests for Patent Term Extensions, for the Eureka Controlled Patent Rights in any country of the Eureka Territory, in each case, where applicable to a Licensed Product.
All costs and expenses relating to the Patent Term Extensions will be born solely by the Party controlling the filings with respect thereto.
More Definitions of Patent Term Extensions
Patent Term Extensions means the interim or permanent extension ofthe term of any Licensed Patents or claims covered by any Licensed Patents for any Licensed Product for which MAYO may be eligible under 35 U.S.C. § 156 or any otherU.S. or non-U.S. statute providing for extensions of patent terms;
Patent Term Extensions has the meaning set forth in Section 9.9. “Person” means any corporation, limited or general partnership, limited liability company, joint venture, trust, unincorporated association, governmental body, authority, bureau or agency, any other entity or body, or an individual. “Phase 1 Study” means a clinical study of an investigational product in human subjects which provides for the first introduction into humans of such investigational product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as described in 21 C.F.R. § 312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 1 Study shall be deemed commenced when Initiated. “Phase 1b Study” or “Phase 2 Study” means: (a) the expansion of a Phase 1 Study to include additional patient(s) following the selection of one or more dose(s) and regimen(s) during the dose escalation part of the Phase 1 Study (such as a maximum tolerated dose) or (b) a clinical study of an investigational product that is prospectively designed to establish the safety, dose ranging and efficacy of a product as further defined in 21 C.F.R. § 312.21(b), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a “Phase 1b Study” or “Phase 2 Study” shall be deemed commenced when Initiated. “Phase 3 Study” means a clinical study of an investigational product that is designed to generate statistically significant evidence of the efficacy of such investigational product for one or more Indications or uses (as well as additional safety information) and that is intended to form the primary scientific support for filing a BLA to obtain Marketing Approval to market the investigational product, (or any MAA for the non-United States equivalent thereof). The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 3 Study shall be deemed commenced when Initiated. For clarity, a Phase 1b Study or Phase 2 Study that enables Accelera...
Patent Term Extensions is defined in Section 15.7 (Patent Term Extensions).
Patent Term Extensions means all available patent term extensions, adjustments or restorations, or supplementary protection certificates. Regeneron shall have the sole right, but not the obligation, to file for Patent Term Extensions with respect to the Products in the Regeneron Patent Territory. The Parties will share all of Regeneron’s [* * *] for such Patent Term Extensions [* * *]. Roche shall have the sole right, but not the obligation, to file for Patent Term Extensions, including Supplementary Protection Certifications, with respect to the Products in the Roche Territory; provided, that if filing for any such Patent Term Extension would reasonably be expected to have a negative impact on the Product in the US then Regeneron’s prior approval, in its sole discretion, shall be required for such Patent Term Extension. The Parties will share all of Roche’s [* * *] for such Patent Term Extensions [* * *]. With respect to Patent Term Extensions with respect to the Products in the Roche Territory, subject to Roche obtaining Regeneron’s approval if necessary, Regeneron shall (a) ▇▇▇▇▇ ▇▇▇▇▇ the right to file for such Patent Term Extension and (b) execute such authorizations and other documents and take such other actions as may be reasonably requested by Roche to obtain such Patent Term Extensions. Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Patent Term Extensions. The Parties shall cooperate with each other in gaining Patent Term Extensions with respect to the Products. With respect to any filings made to Regulatory Authorities with respect to any Compounds or Products, including, as required or allowed in the US, the FDA’s Purple Book, if applicable, or outside the US, other international equivalents, Regeneron will have the sole right to make any such decision whether to list Regeneron Patent Rights, but in all events will comply with Applicable Law, provided that Regeneron will consider in good faith any timely comments received from on behalf of Roche with respect to such filings in the Roche Territory prior to submission. Upon Regeneron’s request, Roche will reasonably cooperate in the implementation of Regeneron’s decision made under this Section 14.16.
Patent Term Extensions. Patent term adjustments (typically called extensions) significantly delay market entry of generic medicines and restrict access to affordable medicines. While they are allocated ostensibly for “delays” in regulatory review or patent prosecution, variance in review periods is a normal part of each system, and patent terms are not shortened when review proceeds more quickly than usual.
Patent Term Extensions shall have the meaning set forth in Section 5.06(a). “Payment Recipient” has the meaning set forth in Section 8.14(a).
Patent Term Extensions. Section 9.3.