Combination Products. In the event Ardelyx is entitled to receive royalties under this Agreement from any Program Product sold in the form of a Combination Product in any given country, then Net Sales for such Combination Product will be calculated by multiplying the actual Net Sales of such Combination Product in such country by the fraction A/(A+B), where A is the average gross invoice price in such country of a Program Product, containing the same amount of Program Compound as the sole active ingredient as the Combination Product in question (a “Comparable Program Product”), if sold separately, and B is the average gross invoice price in the given country 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 Program Compounds (the “Other Ingredients”), if sold separately. If, on a country-by-country basis, the Other Ingredients are not sold separately in a country, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/C where A is the average gross invoice price in such country of a Comparable Program Product, if sold separately, and C is the average gross invoice price of the Combination Product in such country. If, on a country-by-country basis, a Comparable Program Product is not sold separately, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction (C-B)/C, where B is the average gross invoice price in such country of the Other Ingredients and C is the average gross invoice price in such country of the Combination Product. For the purpose of the above, the average gross invoice price for a Comparable Program 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, on a country-by-country basis, neither a Comparable Program Product nor the Other Ingredients are sold separately in a country, Net Sales in such country for the purposes of determining royalties of such Combination Product shall be determined based on the ratio of the cost of goods of the Program Compound to the sum of the cost of goods of the Program Compound and the cost of goods of the Other Ingredients. [***] Certain information in this document 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 3 contracts
Samples: License Option and License Agreement (Ardelyx, Inc.), License Option and License Agreement (Ardelyx, Inc.), License Option and License Agreement (Ardelyx, Inc.)
Combination Products. In Notwithstanding anything to the event Ardelyx contrary, if a Licensed Product is entitled to receive royalties under this Agreement from any Program Product sold in any country that includes one or more active ingredients that is not a Macrolide Covered by the form of Licensed Patent Rights (such a Macrolide, a “Licensed Macrolide”; such a Licensed Product, a “Combination Product in any given countryProduct”), then Net Sales for such Combination Product will be calculated by multiplying the actual Net Sales of such Combination Product in such country for purposes of determining royalty payments to TSRI shall be calculated by multiplying Net Sales of the Combination Product (as calculated without reference to this Section 3.4) by the fraction A/(A+B), where A is the weighted average gross invoice sale price of the Licensed Product(s) including solely the Licensed Macrolide(s) (and not the other active pharmaceutical ingredient(s)) included in the Combination Product (the “Basic Product(s)”) in such country of a Program Productduring the royalty period in question, containing when sold separately from such other active ingredient(s) in finished form in the same amount of Program Compound as the sole active ingredient as the Combination Product in question (a “Comparable Program Product”), if sold separatelystrength and dosage form, and B is the weighted average gross invoice sale price in the given country of the ready for sale form of a product containing the same amount of product(s) including the other therapeutically active pharmaceutical ingredient(s) included in the Combination Product that are (and not Program Compounds any Licensed Macrolide(s)) (the such products, “Other IngredientsProduct(s)”)) in that country during the royalty period in question, if when sold separatelyseparately from the Basic Product(s) in finished form in the same strength and dosage form. IfIn the event that, on with respect to any Combination Product sold in a particular country-by-country basis, the weighted average gross sale price of the Basic Product(s) in such country can be determined but the weighted average gross sale price(s) of the Other Ingredients are Product(s) in such country cannot sold separately in a countrybe determined, Net Sales in such country for the purpose purposes of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of royalty payments to TSRI for such Combination Product in such country shall be calculated by multiplying the Net Sales of the Combination Product in such country (as calculated without reference to this Section 3.4) by the fraction A/C where A is the weighted average gross invoice sale price of the Basic Product(s) when sold separately during the royalty period in question in finished form in the same strength and dosage form in such country of a Comparable Program Product, if sold separatelycountry, and C is the weighted average gross invoice sale price of the Combination Product during the royalty period in question in such country. In the event that, with respect to any Combination Product sold in a particular country, the weighted average gross sale price(s) of the Other Product(s) in such country can be determined, but the weighted average gross sale price of the Basic Product cannot be determined, Net Sales for purposes of determining royalty payments to TSRI for such Combination Product in such country shall be calculated by multiplying the Net Sales of the Combination Product in such country. Ifcountry (as calculated without reference to this Section 3.4) by the following formula: one (1) minus B/C (which may be otherwise written as 1-(B/C)), on a country-by-country basis, a Comparable Program Product where B is not the weighted average gross sale price(s) of the Other Product(s) when sold separately, Net Sales separately during the royalty period in question in finished form in the same strength and dosage form in such country for country, and C is the purpose of determining royalties weighted average gross sale price of the Combination Product during the royalty period in question in such country (if there is more than one Other Product, B shall equal the sum of all such Other Products’ weighted average gross sale prices in such country). In the event that, with respect to any Combination Product sold in a particular country, the weighted average gross sale price(s) in such country of neither the Basic Product(s) nor the Other Product(s) in the Combination Product can be calculated by multiplying actual determined, the Net Sales of the Combination Product shall, for the purposes of determining royalty payments to TSRI with respect to such Combination Product, be the portion of Net Sales of such Combination Product reasonably attributable to the Licensed Macrolides contained therein and not the other active ingredient(s) contained therein, as mutually agreed upon by Licensee and TSRI in writing based on the relative value contributed by each active ingredient. When determining the weighted average gross sale price of a Basic Product, Other Product, or Combination Product in a particular country, the weighted average gross sale price shall be so calculated by dividing the gross sales dollars (converted into U.S. dollars) by the fraction (C-B)/Cnumber of units of Basic Product(s), where B is the average gross invoice price Combination Product, or Other Product(s) sold in such country during the preceding twelve (12) calendar months (or the number of the Other Ingredients and C is the average gross invoice price calendar months sold if there have not been such sales in such a country of the Combination Product. For the purpose of the above, the average gross invoice price for a Comparable Program Product and for each Other Ingredient shall be for a quantity comparable to that used in an entire 12 calendar months before the Combination Product in question and of the same class, purity and potency. If, on a calculation contemplated hereunder is made for such country-by-country basis, neither a Comparable Program Product nor the Other Ingredients are sold separately in a country, Net Sales in such country ) for the purposes of determining royalties of such respective Basic Product, Other Product, or Combination Product shall be determined based on the ratio of the cost of goods of the Program Compound to the sum of the cost of goods of the Program Compound and the cost of goods of the Other Ingredients. [***] Certain information in this document 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 1 contract
Samples: License Agreement (Cempra, Inc.)
Combination Products. In the event Ardelyx is entitled to receive royalties under this Agreement from any Program Licensed Product sold in the form of a Combination Product in any given countrythe Territory, then Net Sales for such Combination Product will shall be calculated by multiplying the actual Net Sales of such Combination Product in such country the Territory by the fraction A/(A+B), where A is the average gross invoice [***] price (“[***] Price”) in such country the Territory of a Program Licensed Product, containing the same amount of Program Licensed Compound as the sole active ingredient as the Combination Product in question (a “Comparable Program Licensed Product”), if sold separately, and B is the average gross invoice [***] price in the given country 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 Program Licensed Compounds (the “Other Ingredients”), if sold separately. If, on a country-by-country basis, If the Other Ingredients are not sold separately in a countrythe Territory, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/C where A is the average gross invoice standard sales price in such country the Territory of a Comparable Program Licensed Product, if sold separately, and C is the average gross invoice standard sales price of the Combination Product in such countrythe Territory. If, on a country-by-country basis, If a Comparable Program Licensed Product is not sold separately, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction (C-B)/C, where B is the average gross invoice [***] price in such country the Territory of the Other Ingredients and C is the average gross invoice [***] price in such country the Territory of the Combination Product. For the purpose of the above, the average gross invoice price XXX xxxxx for a Comparable Program 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, on a country-by-country basis, If neither a Comparable Program Licensed Product nor the Other Ingredients are sold separately in a countrythe Territory, Net Sales in such country for the purposes of determining royalties of such Combination Product shall be determined based by the Parties on the ratio basis of a fair market value of such Comparable Licensed Product and Other Ingredient to be negotiated by the Parties in good faith, taking into account costs, overheads and profit of the cost of goods relevant Licensed Compound(s), the Other Ingredients and the Combination Product. For purposes of the Program Compound calculations set forth in this Section 6.05, prior to the sum First Commercial Sale of a Combination Product, the cost of goods of JDC shall discuss the Program Compound and calculations set forth herein, including the cost of goods of the Other Ingredients. [***] Certain information standard sale prices to be used in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionssuch calculation.
Appears in 1 contract
Samples: License Agreement (Ardelyx, Inc.)
Combination Products. In the event Ardelyx a Royalty Product is entitled to receive royalties under this Agreement from any Program Product sold in the form as part of a Combination Product in any given a country, then the Net Sales for such Combination Product will be calculated by multiplying with respect to the actual Net Sales of such Combination Product in such country shall be determined by multiplying the Net Sales amount for the Combination Product during the applicable reporting period, calculated as set forth above, by the fraction A/(A+B), where A is the weighted average gross invoice sale price (by sales volume) of the Royalty Product in such country of a Program Product, containing the same amount of Program Compound as the sole active ingredient as the Combination Product in question (a “Comparable Program Product”), if when sold separately, and B is the weighted average gross invoice sales price in the given country 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 Program Compounds (the “Other Ingredients”), if in such country when sold separately, in each case in the same dosage and dosage form and in the same country as the Combination Product during the applicable reporting period. If, on a country-by-country basis, If the Other Ingredients are other active ingredient(s) in the Combination Product is not sold separately in a countrysuch country during the applicable reporting period, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/C where A is the average gross invoice price in such country of a Comparable Program Product, if sold separately, and C is the average gross invoice price of the Combination Product in such country. If, on a country-by-country basis, a Comparable Program Product is not sold separately, Net Sales in such country for the purpose of determining royalties of the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the a fraction (C-B)/C, A/C where B A is the weighted average gross invoice sale price (by sales volume) of the Royalty Product in such country of the Other Ingredients when sold separately, and C is the weighted average gross invoice sale price in such country (by sales volume) of the Combination Product. For the purpose of the above, the average gross invoice price for a Comparable Program Product and for each Other Ingredient shall be for a quantity comparable to that used in the Combination Product in question and of such country. If neither the same class, purity and potency. If, on a country-by-country basis, neither a Comparable Program Royalty Product nor the Other Ingredients are other active ingredient(s) were sold separately in such country during the applicable reporting period, then the respective average sales prices during the most recent reporting period in which sales of both occurred in the same country as the Combination Product shall be used. In the event that the weighted average sale price (by sales volume) of the Royalty Product is not available in a given country for any reporting period, then the average sales prices (weighted by sales volume) of the respective products described above (in the same dosage and dosage form as the Combination Product) in a proxy country to be agreed upon by both Parties will be used (such agreement not be unreasonably withheld, conditioned, or delayed), and if the Parties cannot agree upon such proxy country, or no such comparable sales figures are available in an appropriate proxy country, Net Sales in such country for the purposes of determining royalties of such applicable Combination Product shall be determined allocated based on the ratio relative value contributed by each component (such relative value to be to be agreed upon by the Parties or, if the Parties cannot agree, to be determined by through arbitration pursuant to the rules of the cost of goods of the Program Compound to the sum of the cost of goods of the Program Compound and the cost of goods of the Other Ingredients. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsAAA).
Appears in 1 contract
Samples: Exclusive License Agreement (Candel Therapeutics, Inc.)
Combination Products. In If Licensee, or Sublicensee as the event Ardelyx is entitled to receive royalties under this Agreement from any Program Product sold in the form of case may be, sells a Combination Licensed Product in any given countrycombination with another product or products where one or more of such products are not Licensed Products (a “Combination Product”), then Net Sales for under such Combination Product circumstances will be calculated by multiplying the actual Net Sales of such the Combination Product (as defined in such country the standard Net Sales definition) by the fraction A/(A+B)fraction, A/(A + B) where A is the average gross invoice sale price of the Licensed Product when sold separately in such country of a Program Product, containing the same amount of Program Compound as the sole active ingredient as the Combination Product in question (a “Comparable Program Product”), if sold separately, finished form and B is the average gross invoice sale price in the given country of the ready for sale form of a product containing the same amount of the other therapeutically active ingredient(sproduct(s) sold separately in finished form. In the event that the average sale price of the Licensed Product can be determined but the average sale price of the other product(s) in the Combination Product that are cannot Program Compounds (the “Other Ingredients”), if sold separately. If, on a country-by-country basis, the Other Ingredients are not sold separately in a countrybe determined, Net Sales in such country for the purpose purposes of determining royalties of the Combination Product shall royalty payments will be calculated by multiplying actual the Net Sales of such the Combination Product in such country Products by the fraction A/C/(C + D) where C where A is Licensee’s, or Sublicensee’s, average sales price of the Licensed Product and D is the average gross invoice price in such country of a Comparable Program Product, if sold separately, and C is difference between the average gross invoice selling price of the Combination Product and the average selling price of the Licensed Product. If the average sale price of the other product(s) in such country. If, on a country-by-country basis, a Comparable Program the Combination Product is can be determined but the average price of the Licensed Product cannot sold separatelybe determined, Net Sales in such country for the purpose purposes of determining royalties of the Combination Product shall royalty payment will be calculated by multiplying actual the Net Sales of such the Combination Product Products by the fraction following formula: one (C-B)/C, 1) minus C/(C + D) where B is the average gross invoice price in such country of the Other Ingredients and C is the average gross invoice selling price of the other product(s) and D is the difference between the average selling price of the Combination Products and the average selling price of the other product(s). Where neither the average sale price of the Licensed Product nor the average sale price of the other products in such country the Combination Product can be determined, Net Sales for purposes of determining royalty payment will be (a) the Net Sales received for Combination Products (b) multiplied by a fraction wherein the numerator is the fully burdened cost for the Licensed Product and the denominator is the fully burdened cost for the Combination Product. For The Net Sales price for a Combination Product will be calculated at the purpose beginning of each calendar year, and such price will be used during all applicable royalty reporting periods for that calendar year. When determining the aboveaverage sale price of a Licensed Product, the average gross invoice sale price will be calculated using data arising from the twelve (12) months (or such lesser number of months for which there may be sales data) preceding the calculation of the Net Sales price for a Comparable Program 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, on a country-by-country basis, neither a Comparable Program Product nor the Other Ingredients are sold separately in a country, Net Sales in such country for the purposes of determining royalties of such Combination Product shall be determined based on the ratio of the cost of goods of the Program Compound to the sum of the cost of goods of the Program Compound and the cost of goods of the Other Ingredients. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portionsProduct.”
Appears in 1 contract
Samples: License Agreement Template