Patent Term Extension means any term extensions, supplementary protection certificates and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.
End of Term Extension means the time period defined in §2.D.
REO Extension As defined in Section 3.16(a).
Extension has the meaning specified in Section 2.18(a).
Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country which confers an exclusive Commercialization period during which AbbVie or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Compound or Licensed Product in such country through a regulatory exclusivity right.
Renewal Application means a document used to collect pertinent data for renewal of permits
Extension Term means the time period defined in §2.C.
Line Extension means the provision of facilities (including, but not limited to, poles, fixtures, wires, and appurtenances) necessary for delivering electrical energy from the point of origin to one or more of the customer's points of delivery. Facilities provided by the Company to maintain, protect, upgrade, or improve its overall distribution system (even if necessary due to a customer's load addition) are not considered part of a line extension.
Renewal means the terms on which the contract of insurance can be renewed on mutual consent with a provision of grace period for treating the renewal continuous for the purpose of gaining credit for pre-existing diseases, time-bound exclusions and for all waiting periods.
Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.
Royalty Term has the meaning set forth in Section 8.4(b).
Commercial Sale means for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.
Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.
Second Extension Period means a period of twelve (12) consecutive months following the First Extended Maturity Date.
Additional Term Loan has the meaning specified in Section 2.01(c).
Resolution Extension Period As defined in Section 2.03(b).
Initial Term Loan shall have the meaning provided in Section 2.1(a).
Exclusivity Period means the period beginning on the date hereof and ending on the first to occur of (a) the date six (6) months after the date hereof and (b) the mutually agreed termination of this Agreement pursuant to Section 6.01(b).
Extension Election has the meaning set forth in Section 2.16(c).
Service Extension shall have the meaning set forth in Section 7.1(c).
Extension Period has the meaning set forth in Section 2.11.
Extended Term Loan shall have the meaning assigned to such term in Section 2.21(e).
Extension Option shall have the meaning set forth in Section 2.5(c) hereof.
Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.