Combination Products. If an Aclara Licensed Product is sold in combination with another product or products where one or more of such products are not Aclara Licensed Products (a "Combination Product") and could reasonably be deemed to be separate product(s), Net Sales under such circumstances shall be calculated by multiplying the Net Sales of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A/(A + B) where A is the average sale price of the Aclara Licensed Product when sold separately and B is the average sale price of the other product(s) when sold separately. When determining the average sale price of a product, the average sale price shall be calculated using data arising from the twelve (12) months preceding the calculation. In the event that the average sale price of the products in a Combination Product cannot reasonably be so determined, then Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by the fraction, A/(A+B) where A is the fair market value of the Aclara Licensed Product and B is the fair market value of the other product(s). The fair market value of a product shall be determined by taking all relevant factors into account, including, without limitation, any method of allocation used by Aclara and/or its commercial partners for its or their own financial purposes. By way of example, for purposes of the first sentence of this Section 3.3 and without limiting the generality of such sentence, the Parties agree and acknowledge that (a) ***, (b) ***, (c) ***, (d) ***, (e) ***, (f) ***, (g) ***, (h) ***, (i) ***, (j) ***; all ((a) through (j)) can reasonably be deemed to be separate product(s). For purposes of this Section 3.3, *** shall not be construed to include***. -------- *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 2 contracts
Samples: Cross License Agreement (Aclara Biosciences Inc), Cross License Agreement (Aclara Biosciences Inc)
Combination Products. If an Aclara Licensed In the event that a Royalty-Bearing Product is sold in combination with another as part of a Combination Product, where “Combination Product” means any unified dose (e.g. not a kit of two separate and distinct drug dosage forms) of a pharmaceutical product or products where which is comprised of Royalty-Bearing Product and one or more of such products are not Aclara Licensed Products other compound(s) and/or ingredients having independent therapeutic effect (a "Combination Product") and could reasonably be deemed to be separate product(scollectively the “Other Products”), Net Sales under such circumstances of Royalty-Bearing Product, for the purposes of determining royalty payments, shall be calculated by multiplying the Net Sales of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A/(A + B) where A is the average sale price of the Aclara Licensed Product when sold separately and B is the average sale price of the other product(s) when sold separately. When determining the average sale price of a product, the average sale price shall be calculated using data arising from the twelve (12) months preceding the calculation. In the event that the average sale price of the products in a Combination Product cannot reasonably be so determined, then Net Sales shall be calculated determined by multiplying the Net Sales of the Combination Product by the fraction, A/(A+B) [***] where A is the fair market value weighted average sale price of the Aclara Licensed Royalty-Bearing Product when sold separately in finished form, and B is the fair market value weighted average sale price of the other product(s). The fair market value Other Products when sold separately in finished form, in each case in the country of a product shall be determined by taking all relevant factors into account, including, without limitation, any method of allocation used by Aclara and/or its commercial partners for its or their own financial purposes. By way of example, for purposes sale of the first sentence Combination Product. In the event that no such separate sales are made of this Section 3.3 and without limiting either the generality of such sentenceRoyalty-Bearing Product or the Other Products, the Parties agree and acknowledge that (a) ***, (b) ***, (c) ***, (d) ***, (e) ***, (f) ***, (g) ***, (h) ***, (i) ***, (j) ***; all ((a) through (j)) can reasonably estimated commercial value thereof will be deemed to be separate product(s)used instead of the sale price. For purposes of this Section 3.36.5.1(c)(iii), *** (A) “weighted average sale price” and “reasonably estimated commercial value,” as the case may be, for a Royalty-Bearing Product and Other Products shall not be construed to includecalculated once at the commencement of each Calendar Year and such amount shall be used during all applicable royalty reporting periods for the entire following Calendar Year, (B) the weighted average sale price shall be calculated by dividing the Net Sales in the ten countries with the highest Net Sales or such other countries as collectively comprise [***. -------- ] percent ([*** Certain information on this page has been omitted *]%) or more of Net Sales by the units of active ingredient sold during the twelve (12) months (or the number of months sold in a partial Calendar Year) of the preceding Calendar Year for the respective Product or Other Products, and filed separately (C) “reasonably estimated commercial value” shall be determined by agreement of the Parties using criteria to be mutually agreed upon by the Parties; provided, that if the Parties do not agree, such dispute shall be resolved in accordance with Section 2.1.5 hereof. For purposes of clarity, in the Securities first Calendar Year of sale, a forecasted weighted average sale price will be used for the Royalty-Bearing Product and Exchange Commission. Confidential treatment has been requested with respect Other Products, if applicable, and any over or under payment due to a difference between forecasted and actual weighted average sale prices will be paid or credited in the omitted portionsfirst royalty payment of the following Calendar Year.
Appears in 1 contract
Samples: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)
Combination Products. If an Aclara Licensed Product is sold in combination with another product or products where one or more of such products are not Aclara Licensed Products (a "Combination Product") and could reasonably be deemed to be separate product(s), Net Sales under such circumstances shall be calculated by multiplying the Net Sales of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A/(A + B) where A is the average sale price of the Aclara Licensed Product when sold separately and B is the average sale price of the other product(s) when sold separately. When determining the average sale price of a product, the average sale price shall be calculated using data arising from the twelve (12) months preceding the calculation. In the event that the average sale price of the products in a Combination Product cannot reasonably be so determined, then Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by the fraction, A/(A+B) where A is the fair market value of the Aclara Licensed Product and B is the fair market value of the other product(s). The fair market value of a product shall be determined by taking all relevant factors into account, including, without limitation, any method of allocation used by Aclara and/or its commercial partners for its or their own financial purposes. By way of example, for purposes of the first sentence of this Section 3.3 and without limiting the generality of such sentence, the Parties agree and acknowledge that (a) ***, (b) ***, (c) ***, (d) ***, (e) ***, (f) ***, (g) ***, (h) ***, (i) ***, (j) ***; all ((a) through (j)) can reasonably be deemed to be separate product(s). For purposes of this Section 3.3, Each Party acknowledges that there is a *** shall not be construed Fixed-Dose Combination Products for the treatment of HIV, and potentially for HBV, and it is each Party's intent to include***. -------- *** Certain information on of Fixed-Dose Combination Products. Triangle agrees to keep Xxxxxx fully apprised of its activities with any Third Party concerning the development of Fixed-Dose Combination Products, and Xxxxxx shall have the right *** Portions of this page has have been omitted pursuant to a request for Confidential Treatment and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested to provide input with respect to these activities and, to the extent reasonably possible, the right to participate in meetings with such Third Party regarding such activities.
(b) Triangle may enter into any Fixed-Dose Combination Collaboration without Xxxxxx'x prior written consent if each of the following conditions is met: (i) the relevant Fixed-Dose Combination Product would be manufactured, marketed, promoted, sold and distributed by the Parties *** in accordance with the terms of the Triangle-Xxxxxx Alliance Agreements (except insofar as compounds (other than the Compound(s)) contained in the Fixed-Dose Combination Product are supplied by a Third Party); (ii) all of the consideration received by the Parties on account of the Compound(s) contained in the Fixed-Dose Combination Collaboration are allocated between them in accordance with the terms of this Agreement; and (iii) the rights set forth in clause (i) above apply throughout the Territories or substantially all of the Territories (i.e., *** of Triangle's good faith estimate of the unit market for the Fixed-Dose Combination Product) in the Territories, (iv) the U.S. Product Profit and International Product Profit with respect to the Compound(s) contained in the relevant Fixed-Dose Combination Product are reasonably projected by Triangle to increase ***, all as determined in accordance with the methodology set forth on Exhibit 2.6 and (v) the price of the Fixed-Dose Combination Product in the U.S. Territory is *** of the *** for all compounds contained therein when sold separately in the U.S. Territory (or if all compounds are not then being sold separately, the Parties' reasonable projection of the separate price of such compounds upon launch), all determined on a ***.
(c) Triangle may not enter into a Fixed-Dose Combination Collaboration which does not satisfy each of the conditions set forth in Section 2.6(b) without Xxxxxx'x prior written consent, which consent shall not be unreasonably withheld.
(d) Nothing in this Section 2.6 shall in any way restrict Triangle from entering into discussions with Third Parties regarding the viability of one or more Fixed-Dose Combination Collaborations including, but not limited to, exchanging data and information (e.g., Product Technology) regarding the potential Fixed-Dose Combination Product and undertaking feasibility studies relating to the such Fixed-Dose Combination Product. All reasonable and necessary expenses incurred by Triangle relating to the viability of such Fixed-Dose Combination Collaboration shall be borne exclusively by Triangle, unless such Fixed-Dose Combination Collaboration is entered into pursuant to Section 2.6(b) or (c) or otherwise with Xxxxxx'x consent, *** Portions of this page have been omitted portionspursuant to a request for Confidential Treatment and filed separately with the Commission. in which case, upon the execution of the Fixed-Dose Combination Collaboration agreement by Triangle, Xxxxxx shall reimburse Triangle for *** of all reasonable and necessary expenses incurred by Triangle. All expenses incurred after any Fixed-Dose Combination Collaboration is entered into pursuant to Section 2.6(b) or (c) or otherwise with Xxxxxx'x consent shall be included in the relevant Party's SG&A. Other than as permitted pursuant to this Section 2.6, neither Party shall have the right to enter into a Fixed-Dose Combination Collaboration. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Appears in 1 contract
Samples: Collaboration Agreement (Triangle Pharmaceuticals Inc)
Combination Products. If an Aclara In the event Ardelyx is entitled to receive royalties under this Agreement from any Licensed Product is sold in combination with another product or products where one or more the form of such products are not Aclara Licensed Products (a "Combination Product") and could reasonably be deemed to be separate product(s)Product in the Territory, then Net Sales under for such circumstances Combination Product shall be calculated by multiplying the actual Net Sales of such Combination Product in the Territory by the fraction A/(A+B), where A is the [***] price (“[***] Price”) in the Territory of a Licensed Product, containing the same amount of Licensed Compound as the sole active ingredient as the Combination Product in question (a “Comparable Licensed Product”), if sold separately, and B is the [***] price in the Territory of the ready for sale form of a product containing the same amount of the other therapeutically active ingredient(s) in the Combination Product that are not Licensed Compounds (the “Other Ingredients”), if sold separately. If the Other Ingredients are not sold separately in the Territory, Net Sales for the purpose of determining royalties of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A/(A + B) where A is the average sale price of the Aclara Licensed Product when sold separately and B is the average sale price of the other product(s) when sold separately. When determining the average sale price of a product, the average sale price shall be calculated using data arising from the twelve (12) months preceding the calculation. In the event that the average sale price of the products in a Combination Product cannot reasonably be so determined, then Net Sales shall be calculated by multiplying the actual Net Sales of such Combination Product by the fraction A/C where A is the standard sales price in the Territory of a Comparable Licensed Product, if sold separately, and C is the standard sales price of the Combination Product in the Territory. If a Comparable Licensed Product is not sold separately, Net Sales for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fractionfraction (C-B)/C, A/(A+B) where A B is the [***] price in the Territory of the Other Ingredients and C is the [***] price in the Territory of the Combination Product. For the purpose of the above, the XXX xxxxx for a Comparable Licensed Product and for each Other Ingredient shall be for a quantity comparable to that used in the Combination Product in question and of the same class, purity and potency. If neither a Comparable Licensed Product nor the Other Ingredients are sold separately in the Territory, Net Sales for the purposes of determining royalties of such Combination Product shall be determined by the Parties on the basis of a fair market value of the Aclara such Comparable Licensed Product and B is Other Ingredient to be negotiated by the fair market value Parties in good faith, taking into account costs, overheads and profit of the other product(srelevant Licensed Compound(s). The fair market value of a product shall be determined by taking all relevant factors into account, including, without limitation, any method of allocation used by Aclara and/or its commercial partners for its or their own financial purposes. By way of example, for purposes of the first sentence of this Section 3.3 and without limiting the generality of such sentence, the Parties agree Other Ingredients and acknowledge that (a) ***, (b) ***, (c) ***, (d) ***, (e) ***, (f) ***, (g) ***, (h) ***, (i) ***, (j) ***; all ((a) through (j)) can reasonably be deemed to be separate product(s)the Combination Product. For purposes of the calculations set forth in this Section 3.36.05, *** shall not be construed to include***. -------- *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect prior to the omitted portionsFirst Commercial Sale of a Combination Product, the JDC shall discuss the calculations set forth herein, including the standard sale prices to be used in such calculation.
Appears in 1 contract
Samples: License Agreement (Ardelyx, Inc.)
Combination Products. If an Aclara Licensed a Product is sold in combination with another product or products where consists of components that are Covered by Licensor's Valid Claims, plus one or more additional active pharmaceutical Certain portions of such products this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission. ingredients that are not Aclara Licensed Products Covered by a Valid Claim, but that are Covered by Third Party Patent Rights then:
(a a) for purposes of the Sublicensing Fees under Section 4.4.4 for such Combination Products, such Sublicensing Fees, prior to the calculation set forth in Section 4.4.4, first shall be [***], and such resulting amount shall be the "Sublicensing Fees" for purposes of the calculation in Section 4.4.4 for such Combination Product"; provided that such allocations shall not reduce Sublicensing Fees below an effective rate of [***] percent ([***]%) and could reasonably of the total Sublicensing Fees for such Combination Product; provided further, that Sublicensing Fees shall only be deemed reduced to be separate product(s), Net Sales the extent of actual Third Party sublicensing fee payment obligations for such Combination Product; and
(b) for purposes of the royalty payments under such circumstances shall be calculated by multiplying the Section 4.4 for Net Sales of such Combination Products, such Net Sales, prior to the Combination Product royalty calculation set forth in Section 4.4.1, first shall be [***], and such resulting amount shall be the "Net Sales" for purposes of the royalty calculation in Section 4.4 for such Product.
(as defined in c) For purposes of this Section 4.4.3, the standard Net Sales definition) by value of a component shall be determined on a country-by-country basis, and calculated on the fraction, A/(A + B) where A is basis of the average sale price of the Aclara Licensed Product when each such component sold separately (without other active pharmaceutical ingredients) in finished form and B is containing the average sale price same weight of active pharmaceutical ingredient. If, on a country-by-country basis, the other product(scomponent(s) when sold separately. When determining the average sale price of a product, the average sale price shall be calculated using data arising from the twelve (12) months preceding the calculation. In the event that the average sale price of the products in a Combination Product cannot reasonably be so determined, then Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by are not each sold separately in said country, Net Sales for the fraction, A/(A+B) where A is the fair market value purposes of determining royalties of the Aclara Licensed combination Product and B is the fair market value of the other product(s). The fair market value of a product shall be determined by taking all relevant factors into accountthe parties in good faith based on the relative value, includingon the one hand, without limitation, any method of allocation used by Aclara and/or its commercial partners for its or their own financial purposes. By way of example, for purposes of the first sentence of this Section 3.3 and without limiting Product as formulated with such other active pharmaceutical ingredients and, on the generality of such sentenceother hand, the Parties agree and acknowledge additional active pharmaceutical ingredients that (a) ***, (b) ***, (c) ***, (d) ***, (e) ***, (f) ***, (g) ***, (h) ***, (i) ***, (j) ***; all ((a) through (j)) can reasonably be deemed to be separate product(s). For purposes of this Section 3.3, *** shall not be construed to include***. -------- *** Certain information on this page has been omitted and filed separately with are included in the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsCombination Product.
Appears in 1 contract