Competing Drugs. In the event that one or more Third Parties (other than an Affiliate or licensee of Kiniksa) sell a Competing Drug (as defined below) in any country in which a Product is then being sold by Kiniksa then, (i) during any Calendar Quarter in which sales of the Competing Drug by such Third Parties are equal to or greater than [***] of aggregate unit sales of Products and Competing Drugs in such country (as measured by prescriptions or other similar information available from a Third Party data provider and applicable to such country) the applicable royalties in effect with respect to such Product in such country as specified in Section 5.3.1 shall be reduced by [***] and (ii) during any Calendar Quarter in which sales of the Competing Drug by such Third Parties are equal to or greater than [***] of aggregate unit sales of Products and Competing Drugs in such country (as measured by prescriptions or other similar information available from a Third Party data provider and applicable to such country) the applicable royalties in effect with respect to such Product in such country as specified in Section 5.3.1 shall be reduced by [***]. Notwithstanding the foregoing, (a) Kiniksa’s obligation to pay royalties at [***] of the applicable royalty rates shall be reinstated on the first day of the Calendar Quarter immediately following the Calendar Quarter in which sales of such Competing Drugs account for less than [***] but equal to or greater than [***] of aggregate unit sales of Products and Competing Drugs in such country and (b) Kiniksa’s obligation to pay royalties at the full royalty rates shall be reinstated on the first day of the Calendar Quarter immediately following the Calendar Quarter in which sales of such Competing Drugs account for less than [***] of aggregate unit sales of Products and Competing Drugs in such country. For purposes of this Section 5.3.2(c), (a) a “Competing Drug” means, with respect to a Product, a therapeutic product that (i) [***], (ii) [***] and (iii) [***] and (b) “Bioequivalent” or “Bioequivalence” means, a biological product that (i) is highly similar to the Product notwithstanding minor differences in clinically inactive components; and (ii) has no clinically meaningful differences between the biological product and the Product in terms of the safety, purity, and potency.
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Samples: Asset Purchase Agreement (Kiniksa Pharmaceuticals, Ltd.), Asset Purchase Agreement (Kiniksa Pharmaceuticals, Ltd.), Asset Purchase Agreement (Kiniksa Pharmaceuticals, Ltd.)
Competing Drugs. In the event that one or more Third Parties (other than an Affiliate or licensee of Kiniksa) sell a Competing Drug (as defined below) in any country in which a Royalty-Bearing Product is then being sold by Kiniksa GSK, then, (iA) during any Calendar Quarter in which sales of the Competing Drug by such Third Parties are equal to or greater than [***] percent ([***]%) but less than [***] percent ([***]%) of aggregate unit sales of Royalty-Bearing Products and Competing Drugs in such country (as measured by prescriptions or other similar information available from a Third Party data provider Data Provider and applicable to such country) the applicable royalties in effect with respect to such Royalty-Bearing Product in such country as specified in Section 5.3.1 6.5.1(a) or (b) or 6.5.1(c)(i) shall be reduced by [***] percent ([***]%) and (iiB) during any Calendar Quarter in which sales of the Competing Drug by such Third Parties are equal to or greater than [***] percent ([***]%) of aggregate unit sales of Royalty-Bearing Products and Competing Drugs in such country (as measured by prescriptions or other similar information available from a Third Party data provider Data Provider and applicable to such country) the applicable royalties in effect with respect to such Royalty-Bearing Product in such country as specified in Section 5.3.1 6.5.1(a) or (b) or 6.5.1(c)(i) shall be reduced by [***] percent ([***]%). Notwithstanding the foregoing, (aI) KiniksaGSK’s obligation to pay royalties at [***] percent ([***]%) of the applicable royalty rates shall be reinstated on the first day of the Calendar Quarter Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. immediately following the Calendar Quarter in which sales of such Competing Drugs account for less than [***] percent ([***]%) but equal to or greater more than [***] percent ([***]%) of aggregate unit sales of Royalty-Bearing Products and Competing Drugs in such country and (bII) KiniksaGSK’s obligation to pay royalties at the full royalty rates shall be reinstated on the first day of the Calendar Quarter immediately following the Calendar Quarter in which sales of such Competing Drugs account for less than [***] percent ([***]%) or less of aggregate unit sales of Royalty-Bearing Products and Competing Drugs in such country. For purposes of this Section 5.3.2(c6.5.1(c)(iv), (a) a “Competing Drug” meansmeans [***]. For purposes of this Section 6.5.1(c)(iv), with respect the amount of royalties owing to SYNTA under Sections 6.5.1(a)(i), 6.5.1(b)(i) or 6.5.1(c)(i) for Annual Net Sales of any Royalty-Bearing Product in a Productgiven country (prior to any [***]% adjustment provided for herein) shall be deemed to be that amount which would be owed if Annual Net Sales of such Royalty-Bearing Product in such country subject to each of the royalty rates under Sections 6.5.1(a)(i), 6.5.1(b)(i) or 6.5.1(c)(i) were proportional to Net Sales of such Royalty-Bearing Product in all countries subject to royalties under Sections 6.5.1(a)(i), 6.5.1(b)(i) or Section 6.5.1(c)(i), whichever is applicable. For purposes of clarity, an example of the application of the preceding sentence is as follows: If sales in a therapeutic product that Calendar Year in the United Kingdom are $[***] and no Competing Drug is sold in the United Kingdom and sales in a Calendar Year in Germany are $[***] and sales of a Competing Drug in Germany are greater than [***] percent (i[***]%) of aggregate unit sales of Royalty-Bearing Products and Competing Drugs in Germany, the royalties will be $[***], calculated as follows: (ii) $[***] and (iii) x [***]% + [***] and x [***]%) + (b$[***] x [***]% + [***] x [***]%) “Bioequivalent” or “Bioequivalence” means, a biological product that (i) is highly similar to the Product notwithstanding minor differences in clinically inactive components; and (ii) has no clinically meaningful differences between the biological product and the Product in terms of the safety, purity, and potency= $[***].
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Samples: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)