Innovator Protection definition

Innovator Protection means, with respect to the applicable Licensed Product having Regulatory Approval in a given country, that either or both of the following protections pertaining to an Achillion Single API component of the Licensed Product or the Licensed Product itself is/are in force in such country: (a) at least one Valid Claim of the Achillion Background Patent Rights or Development Program Patent Rights in such country Covers either (i) any Achillion Single API contained in the Licensed Product, or the combination of Single Agents in the Licensed Product, as a composition of matter, or (ii) a method of using an Achillion Single API or the Licensed Product corresponding to any indication for the Licensed Product approved by the Regulatory Authority in such country; and/or (b) Regulatory Exclusivity Rights protect the Licensed Product, an Achillion Single API of the Licensed Product (e.g., as a new chemical entity, data exclusivity, pediatric exclusivity, or the like), or any indication (e.g., if an orphan drug indication) approved for the Licensed Product by the Regulatory Authority in such country.

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Innovator Protection means, with respect to a given Product in a given country in the Territory, that at least one (1) Valid Claim of an Egalet Patent Right (including a Patent Right covering the Egalet Core Technology Improvements) in such country claims the manufacture, use, sale, offer for sale or importing of such Product in the Field.

Innovator Protection means, with respect to the applicable Licensed Product having Regulatory Approval in a given country, that either or both of the following protections pertaining to the Active Substance of the Licensed Product is/are in force in such country: (a) at least one Valid Claim of the Geron Product Patent Rights or Development Program Patent Rights in such country Covers either (i) the Active Substance contained in the Licensed Product as a composition of matter, or (ii) a method of using the Active Substance or the Licensed Product corresponding to its First Indication approved by the Regulatory Authority in such country; and/or (b) Regulatory Exclusivity Rights protect the Active Substance of the Licensed Product (e.g., as a new chemical entity, data exclusivity, pediatric exclusivity, or the like) or its First Indication (e.g., if an orphan drug Indication) approved for the Licensed Product by the Regulatory Authority in such country.

Examples of Innovator Protection in a sentence

The following royalty rates shall apply to the specified tiers of incremental worldwide aggregate annual (in a ▇▇▇▇▇▇▇ Calendar Year) Net Sales of Licensed Products in countries during the Royalty Term while there is Innovator Protection.
The Finance Working Group shall review Geron’s quarterly Detail reports for a given ▇▇▇▇▇▇▇ Calendar Year while there is Innovator Protection in the Co-Promote Territory, and advise the JMC of any true-up of Promoting Costs owed to ▇▇▇▇▇▇▇ to satisfy Geron’s obligation to contribute the equivalent of 20% of the Sales Representative Details during such year in which any Co-Promoting occurs hereunder.
In the event a Generic Product is sold by a Third Party in a given country where a Licensed Product is sold by ▇▇▇▇▇▇▇ (directly or through an Affiliate or Third Party sublicensee) while there is Innovator Protection during the Royalty Term (and therefore the royalty rates under 8.4.2(a) apply), and only if and for the duration that Generic Erosion persists for such Licensed Product in such country, the applicable royalty rate for such country under Section 8.4.2 shall be reduced by [**] percent ([**]%).
Each such monthly Co-Promotion Report shall be due to ▇▇▇▇▇▇▇ within [*] ([*]) days after the end of each month while there is Innovator Protection in the Co-Promote Territory.
On a country-by-country basis, if there is no Innovator Protection for a Product in a country, then Incline shall pay to ALZA during the Royalty Period applicable to such Product in such country a reduced royalty rate on Net Sales by Incline, its Affiliates and sublicensees in such country equal to [**] percent ([**]%) of the royalty rate applicable under Section 5.3.1 or 5.3.2.
Shionogi’s royalty obligations under this Section 5.3 shall, on a Product-by-Product and country-by-country basis, commence on the First Commercial Sale of a Product in a country and expire upon the latest of (a) the expiration of Innovator Protection for such Product in such country, (b) the expiration of Regulatory-Based Exclusivity for such Product in such country, and (c) ** of the date of First Commercial Sale of such Product in such country (the “Royalty Period”).

More Definitions of Innovator Protection

Innovator Protection means, with respect to a given Product in a given country in the Territory, that (a) at least one Valid Claim of a Licensed Patent in such country covers such Product, its manufacture, or use, and/or (b) such Product has Regulatory Exclusivity in such country.

Innovator Protection means, with respect to a given Product sold by Ajinomoto, its Affiliates or its Sublicensees in a given country in the Territory, that (i) at least one Valid Claim of an Albireo Patent Right (other than an Albireo Patent Right that is Controlled by Albireo or its Affiliates non-exclusively with respect to such Product in such Portions of this Exhibit, indicated by the ▇▇▇▇ “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. country) or a Joint Patent Right in such country Covers [***]; (ii) such [***] in such country; and/or (iii) at least one Valid Claim of an Ajinomoto Patent Right (other than an Ajinomoto Patent Right that is Controlled by Ajinomoto non-exclusively pursuant to a Third Party License with respect to such Product in such country) in such country Covers [***]; provided, however, that any Innovator Protection provided pursuant to clause (iii) of this Section 1.66 shall expire no later than fifteen (15) years after the First Commercial Sale of the first Product sold under this Agreement in such country. For purposes of this Section 1.66 and Section 5.3.2(b), “[***]” means, with respect to a Product, [***] by Ajinomoto, its Affiliates or its Sublicensees, or a Third Party acting on their behalf; and, for purposes of this Section 1.66 and Section 10.3.1(d), “[***]” means, with respect to a Product in a country in the Territory, [***].