Combination Products. If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.
Appears in 4 contracts
Samples: Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.)
Combination Products. If a LICENSED PRODUCT , DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product LICENSED PRODUCT, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.
Appears in 4 contracts
Samples: Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.)
Combination Products. If a LICENSED PRODUCT In the event Ardelyx is sold entitled to receive royalties under this Agreement from any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product sold in the form of a Combination Product in any given country, then Net Sales for such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall will be calculated by multiplying the NET SALES actual Net Sales of the COMBINATION PRODUCT such Combination Product in such country by the fraction A/(A+B), where A is the average NET SALES standard sales price in such country of such LICENSED PRODUCT a Licensed Product, containing the same amount of Licensed Compound as the sole active ingredient as the Combination Product in the relevant countryquestion (a “Comparable Licensed Product”), as if sold separately, and B is the total average NET SALES standard sales price of all OTHER PRODUCTS in the COMBINATION PRODUCT given country of the ready for sale form of a product containing the same amount of the other therapeutically active ingredient(s) in the relevant countryCombination Product that are not Licensed Compounds (the “Other Ingredients”), as if sold separately. If, on a country-by-country basis, the Other Ingredients are not sold separately in any a country, any COMPONENT Net Sales in such [***] 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. 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 standard sales price in such country of a Comparable Licensed Product, if sold separately, and C is the standard sales price of the Combination Product in such country. If, on a country-by-country basis, a Comparable Licensed Product is not sold separately, NET SALES Net Sales in such country for royalty determination 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 standard sales price in such country of the Other Ingredients and C is the standard sales price in such country of the Combination Product. For the purpose of the above, the standard sales price 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, on a country-by-country basis, neither a Comparable Licensed 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 by the formula [C / (C+D)]Parties on the basis of a fair market value of such Comparable Licensed Product and Other Ingredient to be negotiated by the Parties in good faith, where C is the aggregate average fully absorbed cost taking into account costs, overheads and profit of the relevant Licensed Product components during Compound(s), the prior Royalty Period Other Ingredients and D is the aggregate average fully absorbed cost Combination Product. For purposes of the other essential functional components during calculations set forth in this Section 9.6, prior to the prior Royalty PeriodFirst Commercial Sale of a Combination Product, with the DCC (or the SCC, as applicable) shall discuss the calculations set forth herein, including the standard sale prices to be used in such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTcalculation.
Appears in 3 contracts
Samples: License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.)
Combination Products. If In the event Ardelyx is entitled to receive royalties under this Agreement from any Program Product sold in the form of a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Combination Product in any given country, then Net Sales for such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall will be calculated by multiplying the NET SALES actual Net Sales of the COMBINATION PRODUCT such Combination Product in such country by the fraction A/(A+B), where A is the average NET SALES gross invoice price in such country of such LICENSED PRODUCT a Program Product, containing the same amount of Program Compound as the sole active ingredient as the Combination Product in the relevant countryquestion (a “Comparable Program Product”), as if sold separately, and B is the total average NET SALES gross invoice price of all OTHER PRODUCTS in the COMBINATION PRODUCT given country of the ready for sale form of a product containing the same amount of the other therapeutically active ingredient(s) in the relevant countryCombination Product that are not Program Compounds (the “Other Ingredients”), as if sold separately. If, on a country-by-country basis, the Other Ingredients are not sold separately in any a country, any COMPONENT 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 Net Sales in such country for royalty determination 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 by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense ratio of the rights granted hereunder, based upon their relative importance cost of goods of the Program Compound to the sum of the cost of goods of the Program Compound and proprietary protection, which portion shall be the SUBLICENSE INCOMEcost of goods of the Other Ingredients. THE PARTIES shall have the right to dispute such sharing determination [***] Certain information in accordance this document has been omitted and filed separately with the dispute provisions of Securities and Exchange Commission. Confidential treatment has been requested with respect to the AGREEMENTomitted portions.
Appears in 3 contracts
Samples: License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.)
Combination Products. If a LICENSED PRODUCT Licensed Product under this Agreement is sold to any third party in combination with other productsform of a Combination Product, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with then Net Sales for such Combination Product shall be determined on a [***] as follows:
5.6.1 If the combination of products being referred to as “COMBINATION PRODUCTS” Licensed Product and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as are sold separately, and B the royalty payments due on the Net Sales of the Combination Product shall be equal to the applicable percentage (royalty rate) multiplied by the Net Sales of the Combination Product multiplied by the fraction, A/(A+B) where “A” is the total average NET SALES mean gross selling price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D “B” is the aggregate average fully absorbed cost mean gross selling price of the other essential functional components during Other Product.
5.6.2 If the prior Royalty PeriodLicensed Product and the Other Product are sold separately, with such costs being determined in accordance with generally accepted accounting principles. To but the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based mean gross selling price of the Other Product cannot be determined, the royalty payments due on the value Net Sales of one or more licenses or intellectual property rights held the Combination Product shall be equal to the applicable percentage (royalty rate) multiplied by the COMPANYNet Sales of the Combination Product multiplied by the fraction A/C wherein “A” is the mean gross selling price of the Licensed Product and “C” is the mean gross selling price of the Combination Product.
5.6.3 If the Licensed Product and the Other Product are sold separately, an AFFILIATE or SUBLICENSEEbut the mean gross selling price of the Licensed Product cannot be determined, COMPANY the royalty payments due on the Net Sales of the Combination Product shall determine be equal to the applicable percentage (royalty rate) multiplied by the Net Sales of the Combination Product multiplied by the following formula: one (1) minus B/C wherein “B” is the mean gross selling price of the Other Product and “C” is the mean gross selling price of the Combination Product.
5.6.4 If the Licensed Product and the Other Product are sold separately, but the mean gross selling price of neither the Licensed Product nor the Other Product can be determined, Net Sales of the Licensed Product shall be equal to Net Sales of the Combination Product multiplied by a percentage agreed to by the Parties, acting in good faith and report faith. If the Parties are unable to THE PARTIES agree upon such a percentage, the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion dispute shall be the SUBLICENSE INCOME. THE PARTIES shall have the right resolved by arbitration pursuant to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTSection 11.7.
Appears in 2 contracts
Samples: License, Development and Commercialization Agreement (Mersana Therapeutics, Inc.), License, Development and Commercialization Agreement (Mersana Therapeutics, Inc.)
Combination Products. If The earned royalty due on a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Combination Product shall be determined pro rata on a Combination Product-by-Combination Product and Licensed Product in such country-by-country basis, by multiplying Net Sales of the Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES invoice price of such LICENSED PRODUCT in the relevant country, as Royalty-Bearing Product when sold separately, separately and B is the total average NET SALES invoice price of all OTHER PRODUCTS the Supplemental Product when sold separately by a Party, its Affiliate or its Sublicensee or, if not sold by them, then the average invoice price when sold separately by Third Parties. If the Supplemental Product in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT Combination Product is not sold separatelyseparately by any Person, NET SALES for royalty determination Net Sales shall be determined calculated by multiplying actual net revenues derived from sales of the Combination Product by the formula [C / (C+D)]fraction A/C, where A is as previously defined and C is the aggregate average fully absorbed cost invoice price of the Licensed Combination Product components during sold by a Party, its Affiliate or its Sublicensee. For purposes of clarity, the prior Royalty Period average invoice price and D is the aggregate average fully absorbed cost actual net revenues for any Supplemental Product shall be for a quantity comparable to that contained in the Combination Product and shall be of the other essential functional components during same class, purity and potency as that contained in the prior Royalty PeriodCombination Product. If neither the Royalty-Bearing Product nor the Supplemental Product included in the Combination Product, with such costs being determined in accordance with generally accepted accounting principles. To or the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT Combination Product itself, or is otherwise both, are sold separately, Net Sales shall be calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense mutual written agreement of the rights granted hereunderParties as to a reasonable allocation between the Royalty-Bearing Product and the Supplemental Product, based upon their taking into account total manufacturing costs, proprietary protection and relative importance and proprietary protectioncontribution thereof. If the Parties are unable to reach agreement on an appropriate method of determining royalties for a Combination Product, which portion the matter shall be submitted to the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTJMC for resolution under Section 2.1.5.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Combination Products. For COMBINATION PRODUCTS, NET SALES will be calculated as follows: for reference only
(a) If a the LICENSED PRODUCT and all OTHER COMPONENTS of the COMBINATION PRODUCT were SOLD separately during the same or immediately preceding calendar quarter, the proration factor will be determined by the formula [A / (A+B)], where A is sold to any third party in combination with other products, devices, the weighted average invoice price of all LICENSED PRODUCT components or materials that are capable of being sold during such period when SOLD separately and are not subject to royalties hereunder (“from the OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”COMPONENT(S), and B is the NET SALES weighted average gross invoice price of the OTHER COMPONENTS during such period when SOLD separately from the LICENSED PRODUCT included (as applicable);
(b) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in such COMBINATION PRODUCT shall are not SOLD separately, then the proration factor will be calculated by multiplying the NET SALES of the COMBINATION PRODUCT determined by the fraction A/(A+B)formula [A / C], where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES gross sales price of all LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT during such period when SOLD separately from the OTHER PRODUCTS in COMPONENTS, and C is the average gross sales price of the COMBINATION PRODUCT during such period;
(c) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are not SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold such COMBINATION PRODUCT are SOLD separately, NET SALES for royalty determination shall then the proration factor will be determined by the formula [(C- B) / C], where B is the average gross sales price of the OTHER COMPONENTS included in such COMBINATION PRODUCT if SOLD separately from the OTHER COMPONENTS, and C / is the average gross sales price of the COMBINATION PRODUCT during such period; or
(C+Dd) If neither the LICENSED COMPOUND nor the OTHER COMPONENTS included in the COMBINATION PRODUCT were SOLD or provided separately during the relevant period, then the proration factor will be mutually agreed upon by the parties in good faith based on the relative value contributed by each component.
(e) In the event that such separate SALES were not made or performed during the immediately preceding calendar year (“CY”)], then the invoiced amounts for the COMBINATION PRODUCT for purposes of calculating NET SALES will be multiplied by the fraction C/(C + D), where C is the aggregate average fully absorbed burdened cost of manufacture of the Licensed Product components LICENSED PRODUCTS during the prior Royalty Period immediately preceding CY and D is the aggregate average fully absorbed burdened cost of manufacture of the other essential functional components additional items during the prior Royalty Periodimmediately preceding CY, with such costs being determined in each case calculated in accordance with generally accepted accounting principles. To U.S. GAAP.
(f) Notwithstanding anything in this AGREEMENT to the extent that any SUBLICENSE INCOME relates to contrary, in no event shall the NET SALES for a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense be less than 50% of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be NET SALES for the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTLICENSED PRODUCT.
Appears in 2 contracts
Samples: Exclusive License Agreement, Exclusive License Agreement
Combination Products. If Notwithstanding anything to the contrary set forth herein, in the event either (a) a LICENSED PRODUCT Licensed Product is sold to by BioLine or an Affiliate of BioLine, or any third party entity on their behalf, in combination with other productsthe form of a Combination Product or (b) the grant of a Sublicense hereunder is part of a larger transaction also involving the grant by BioLine (or its Affiliates) of sublicenses in respect of Additional Ingredients for a Combination Product, devicesthen Net Sales and Sublicense Receipts, components as applicable, from such Combination Product, for purposes of determining payments hereunder, shall be determined by multiplying the actual Net Sales or materials that are capable Sublicense Receipts, as applicable, of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as during the applicable royalty reporting period, by the fraction A/(A+B) where: “COMPONENTS”), A” is the NET SALES average sale price of the Licensed Product contained in the Combination Product when sold separately by such LICENSED PRODUCT entity; and “B” is the average price of the other Additional Ingredients included in the Combination Product when sold separately by its supplier, in each case during the applicable royalty reporting period or if sales of both the Licensed Product and/or other Additional Ingredients did not occur in such COMBINATION PRODUCT period, then in the most recent royalty reporting period in which sales of both occurred. In the event that such average sale price cannot be determined for both the Licensed Product and all other Additional Ingredients included in the Combination Product, then Net Sales or Sublicense Receipts, as applicable, for the purpose of determining royalty payments shall be calculated by multiplying the NET SALES Net Sales or Sublicense Receipts, as applicable, of the COMBINATION PRODUCT Combination Products by the fraction A/(A+B), of C/(C+D) where A “C” is the average NET SALES price fair market value of such LICENSED PRODUCT the Licensed Product; and “D” is the fair market value of all other Additional Ingredients included in the relevant countryCombination Product. In such event, as sold separately, and B is the total average NET SALES price parties shall negotiate in good faith to arrive at a determination of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost respective fair market values of the Licensed Product components during and all other Additional Ingredients included in the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined Combination Product. Nothing in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion this section shall be interpreted as limiting or otherwise affecting Licensor's ownership rights in the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination Licensed Technology as set forth in accordance with the dispute provisions of the AGREEMENTSection 3.1.
Appears in 2 contracts
Samples: License Agreement (BioLineRx Ltd.), License Agreement (BioLineRx Ltd.)
Combination Products. If Merrimack, its Affiliate or the Product licensee or sublicensee of any of them sells any Product as a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components product containing one or materials more active ingredient(s) that are capable not Licensed Antibody(ies) (whether combined in a single formulation or sold as a bundle of being sold separately and are not subject to royalties hereunder separate formulations) (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in Combination Product”), Net Sales for such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES actual Net Sales of the COMBINATION PRODUCT such Combination Product by the fraction A/(A+B), ) where A is the average NET SALES invoice price of the Licensed Antibody(ies) in such LICENSED PRODUCT in the relevant country, as Combination Product if sold separately, and B is the total average NET SALES invoice price of all OTHER PRODUCTS any other active ingredient or ingredients in the COMBINATION PRODUCT in the relevant countrycombination, as if sold separately. If, in any on a country-by-country basis, any COMPONENT A or B is not sold separatelyavailable, NET SALES for royalty determination then (a) Net Sales of such Combination Product shall be determined calculated by multiplying actual Net Sales of such Combination Product by the formula [C / (C+D)], fraction of C/C+D where C is the aggregate average fully absorbed cost fair market value of the Licensed Product components during the prior Royalty Period Antibody(ies) and D is the aggregate average fully absorbed cost fair market value of all other drug product(s) included in the other essential functional components during the prior Royalty PeriodCombination Product and (b) Merrimack shall notify Adimab of its good faith determination of such fair market values and make any applicable royalty payments based on such determination; provided that, if Adimab disagrees with such costs being determined good faith determination, Adimab shall notify Merrimack of such disagreement and the Parties shall seek to resolve such disagreement in accordance with generally accepted accounting principlesSection 10.2; provided further that, if the Parties are unable to resolve such disagreement through Senior Executives Discussions, either Party may request that the Parties resolve such dispute by appointing a mutually agreeable Third Party with expertise in commercial pharmaceutical matters to resolve the dispute, in which case the Parties shall appoint such Third Party within [**] days after such request and instruct such Third Party to resolve the dispute as promptly as possible, and any such resolution shall be binding on both Parties. To [**]. Both Parties shall use all reasonable efforts to cause the extent process to be completed within [**] days after it begins. The Third Party dispute resolver shall be, and is hereby, instructed to fashion and cause the Parties to follow a procedure that any SUBLICENSE INCOME relates limits discovery, allows written submissions of no more than [**] pages from each Party, and allows a presentation by each Party of their position not to a COMBINATION PRODUCT or is otherwise calculated based on exceed [**] hours (though the value of one or more licenses or intellectual property rights held Parties’ may respond within time and page limits set by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report Third Party to THE PARTIES any questions the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTThird Party may have).
Appears in 2 contracts
Samples: Collaboration Agreement (Merrimack Pharmaceuticals Inc), Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Combination Products. If The earned royalty due on a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Combination Product shall be determined pro rata on a Combination Product-by-Combination Product and Licensed Product in such country-by-country basis, by multiplying Net Sales of the Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES invoice price of such LICENSED PRODUCT in the relevant country, as Royalty-Bearing Product when sold separately, separately and B is the total average NET SALES invoice price of all OTHER PRODUCTS the Supplemental Product when sold separately by a Party, its Affiliate or its Sublicensee or, if not sold by them, then the average invoice price when sold separately by Third Parties. If the Supplemental Product in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT Combination Product is not sold separatelyseparately by any Person, NET SALES for royalty determination Net Sales shall be determined calculated by multiplying actual net revenues derived from sales of the Combination Product by the formula [C / (C+D)]fraction A/C, where A is as previously defined and C is the aggregate average fully absorbed cost invoice price of the Licensed Combination Product components during sold by a Party, its Affiliate or its Sublicensee. For purposes of clarity, the prior Royalty Period average invoice price and D is the aggregate average fully absorbed cost actual net revenues for any Supplemental Product shall be for a quantity comparable to that contained in the Combination Product and shall be of the other essential functional components during same class, purity and potency as that contained in the prior Royalty PeriodCombination Product. If neither the Royalty-Bearing Product nor the Supplemental Product included in the Combination Product are sold separately, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise Net Sales shall be calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense mutual written agreement of the rights granted hereunderParties as to a reasonable allocation between the Royalty-Bearing Product and the Supplemental Product, based upon their taking into account total manufacturing costs, proprietary protection and relative importance and proprietary protectioncontribution thereof. If the Parties are unable to reach agreement on an appropriate method of determining royalties for a Combination Product, which portion the matter shall be submitted to the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTJSC for resolution under Section 2.1.6.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Combination Products. If Aveo or its Affiliate sells any Licensed Product as a LICENSED PRODUCT is sold combination product containing one or more active ingredients in addition to any third party a Licensed Compound (which may be either combined in combination a single formulation or bundled with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder separate formulations) (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in Combination Product”), Net Sales for such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES actual Net Sales of the COMBINATION PRODUCT such Combination Product by the fraction A/(A+B), ) where A is the average NET SALES invoice price of such LICENSED PRODUCT in the relevant country, as Licensed Compound thereof if sold separately, and B is the total average NET SALES invoice price of all OTHER PRODUCTS any other active ingredient or ingredients in the COMBINATION PRODUCT in the relevant countrycombination, as if sold separately. If, on a country-by-country basis, the other active ingredient or ingredients in any the combination are not sold separately in such country, any COMPONENT 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 fraction A/C where A is not the invoice price of the Licensed Product if sold separately, NET SALES and C is the invoice price of the Combination Product. If, on a country-by-country basis, neither the Licensed Compound nor the other active ingredient or ingredients of the Combination Product is sold separately in such country, or the mechanics provided above are otherwise inapplicable, Net Sales for royalty determination the purposes of determining royalties of the Combination Product shall be determined by the formula [C / (C+D)]Parties in good faith, where C is based on the aggregate average fully absorbed cost relative fair market values of the Licensed different active ingredients and in accordance with standard and customary practice if any, and in looking in particular to the relative list prices in other countries if available. If the immediately preceding sentence applies, Aveo shall in good faith propose to Kirin a Net Sales allocation for such Combination Product components during based on the prior Royalty Period principles set forth in the immediately preceding sentence, Kirin shall in good faith consider such proposal, and D is the aggregate average fully absorbed cost Parties shall seek to reach agreement on such allocation. If the Parties are unable to reach such agreement within sixty (60) days of Aveo’s proposal, then the matter shall be referred for non-binding resolution to a mutually agreeable individual (not affiliated with either Party) having expertise in the research, development, marketing and sales of similar pharmaceutical products (including experience in pricing and reimbursement), such resolution to occur within sixty (60) days after such referral. Such individual shall be instructed to determine the Net Sales allocation for such Combination Product using the following standard: the allocation shall be made based on the relative fair market value contribution made by each of the other essential functional components during the prior Royalty Perioddifferent active ingredients contained in such Combination Product to its overall sales price, with such costs being determined in accordance with generally accepted accounting principlesstandard customary practice (if any), and looking in particular to the relative list prices in other countries, if available (the “Standard”). To If either Party disagrees with the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share conclusions of such payments reasonably attributable individual, then such Party shall refer the matter for resolution in accordance with Article 11. The standard to COMPANY’s or such AFFILIATE’s sublicense be applied in any arbitration of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion this allocation under Article 11 shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination Standard (defined above in accordance with the dispute provisions of the AGREEMENTthis Section 5.8).
Appears in 1 contract
Combination Products. If a LICENSED PRODUCT Licensed Product under this Agreement is sold to any third party in combination with other productsform of a Combination Product, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with then Net Sales for such Combination Product shall be determined on a [**] as follows:
5.6.1 If the combination of products being referred to as “COMBINATION PRODUCTS” Licensed Product and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as are sold separately, and B the royalty payments due on the Net Sales of the Combination Product shall be equal to the applicable percentage (royalty rate) multiplied by the Net Sales of the Combination Product multiplied by the fraction, A/(A+B) where “A” is the total average NET SALES mean gross selling price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D “B” is the aggregate average fully absorbed cost mean gross selling price of the other essential functional components during Other Product.
5.6.2 If the prior Royalty PeriodLicensed Product and the Other Product are sold separately, with such costs being determined in accordance with generally accepted accounting principles. To but the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based mean gross selling price of the Other Product cannot be determined, the royalty payments due on the value Net Sales of one or more licenses or intellectual property rights held the Combination Product shall be equal to the applicable percentage (royalty rate) multiplied by the COMPANYNet Sales of the Combination Product multiplied by the fraction A/C wherein “A” is the mean gross selling price of the Licensed Product and “C” is the mean gross selling price of the Combination Product.
5.6.3 If the Licensed Product and the Other Product are sold separately, an AFFILIATE or SUBLICENSEEbut the mean gross selling price of the Licensed Product cannot be determined, COMPANY the royalty payments due on the Net Sales of the Combination Product shall determine be equal to the applicable percentage (royalty rate) multiplied by the Net Sales of the Combination Product multiplied by the following formula: one (1) minus B/C wherein “B” is the mean gross selling price of the Other Product and “C” is the mean gross selling price of the Combination Product.
5.6.4 If the Licensed Product and the Other Product are sold separately, but the mean gross selling price of neither the Licensed Product nor the Other Product can be determined, Net Sales of the Licensed Product shall be equal to Net Sales of the Combination Product multiplied by a percentage agreed to by the Parties, acting in good faith and report faith. If the Parties are unable to THE PARTIES agree upon such a percentage, the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion dispute shall be the SUBLICENSE INCOME. THE PARTIES shall have the right resolved by arbitration pursuant to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTSection 11.7.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Mersana Therapeutics, Inc.)
Combination Products. If a LICENSED PRODUCT Collaboration Product under this Agreement is sold to any third party in combination with other productsform of a Combination Product, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder then Net Sales for such Combination Product shall be determined on a country-by-country basis as follows:
(“OTHER PRODUCTS,” with a) If the combination of products being referred to as “COMBINATION PRODUCTS” Collaboration Product and the Other Product and Licensed Product in such are sold separately, the royalty payments due on the Net Sales of the Combination Product being referred shall be equal to as the applicable percentage (royalty rate) multiplied by the Net Sales of the Combination Product multiplied by the fraction, A/(A+B) where “COMPONENTS”)A” is the mean gross selling price of the Collaboration Product and “B” is the mean gross selling price of the Other Product.
(b) If the Collaboration Product and the Other Product are sold separately, but the mean gross selling price of the Other Product cannot be determined, the NET SALES royalty payments due on the Net Sales of such LICENSED PRODUCT included in such COMBINATION PRODUCT the Combination Product shall be calculated equal to the applicable percentage (royalty rate) multiplied by multiplying the NET SALES Net Sales of the COMBINATION PRODUCT Combination Product multiplied by the fraction A/(A+B), where A A/C wherein “A” is the average NET SALES mean gross selling price of such LICENSED PRODUCT in the relevant country, as Collaboration Product and “C” is the mean gross selling price of the Combination Product.
(c) If the Collaboration Product and the Other Product are sold separately, and B but the mean gross selling price of the Collaboration Product cannot be determined, the royalty payments due on the Net Sales of the Combination Product shall be equal to the applicable percentage (royalty rate) multiplied by the Net Sales of the Combination Product multiplied by the following formula: one (1) minus B/C wherein "B" is the total average NET SALES mean gross selling price of all OTHER PRODUCTS in the COMBINATION PRODUCT in Other Product and "C" is the relevant country, as sold separately. If, in any country, any COMPONENT is not mean gross selling price of the Combination Product.
(d) If the Collaboration Product and the Other Product are sold separately, NET SALES for royalty determination but the mean gross selling price of neither the Collaboration Product nor the Other Product can be determined, Net Sales of the Collaboration Product shall be determined equal to Net Sales of the Combination Product multiplied by a percentage agreed to by the formula [C / (C+D)]Parties, where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine acting in good faith and report faith. If the Parties are unable to THE PARTIES agree upon such a percentage, the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion dispute shall be the SUBLICENSE INCOME. THE PARTIES shall have the right resolved by arbitration pursuant to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTSection 14.3.
Appears in 1 contract
Samples: Collaboration and License Agreement (Seres Therapeutics, Inc.)
Combination Products. If a LICENSED PRODUCT is sold When LICENSEE uses royalty-bearing or patented components licensed by third parties to any third party in combination with other products, devices, components or materials that are capable of being sold separately LICENSEE and are not subject to royalties licensed by BCM hereunder (“OTHER PRODUCTS,” with the Extrinsic Licensed Product”) to form a product that is a combination of products being referred to as “COMBINATION PRODUCTS” Licensed Products and the Other Product and Extrinsic Licensed Product in such (“Combination Product being referred to as the “COMPONENTSProduct”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT Royalties payable by LICENSEE to BCM shall be calculated by multiplying based upon a ratio equaling the NET SALES following: (A/A+B) x (the actual Net Sales of the COMBINATION PRODUCT by Combination Product) where “A” is the fraction A/(A+BNet Sales price of the Licensed Product and “B” is the sum of the Net Sales prices of all Extrinsic Licensed Products, subject to the following: (i) if the Licensed Product and Extrinsic Licensed Product components are not sold separately (and thus Net Sales are not available), where A is the average NET SALES price of such LICENSED PRODUCT “A” in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS formula shall be LICENSEE’s collective manufacturing costs for such Licensed Product used in the COMBINATION PRODUCT Combination Product and “B” shall be LICENSEE’s manufacturing cost for such Extrinsic Licensed Product used in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination Combination Product; (ii) the manufacturing cost of each included product manufactured by LICENSEE shall be LICENSEE’s fully allocated production costs; provided that such fully allocated costs shall be determined by using LICENSEE’s standard accounting procedures; and (iii) in the event LICENSEE shall purchase Licensed Product or Extrinsic Licensed Product instead of manufacturing same, LICENSEE’s net costs for the amount of Licensed Product used in the Combination product shall be included in the formula [C / (C+D)], where C is as “A,” and LICENSEE’s net costs for the aggregate average fully absorbed cost amount of the Extrinsic Licensed Product components during used in the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion Combination Product shall be included in the SUBLICENSE INCOME. THE PARTIES formula as “B.” In no event shall have the right to dispute such sharing determination in accordance with the dispute provisions Royalties due for a Combination Product be less than [***] percent ([***]%) of the AGREEMENTthose otherwise due under Paragraph 4.3 above.
Appears in 1 contract
Samples: Exclusive License Agreement (Fate Therapeutics Inc)
Combination Products. If Notwithstanding anything to the contrary, if a LICENSED PRODUCT Licensed Product is sold to in any third party in combination with other productscountry that includes one or more active ingredients that is not a Macrolide Covered by the Licensed Patent Rights (such a Macrolide, devicesa “Licensed Macrolide”; such a Licensed Product, components or materials that are capable a “Combination Product”), then Net Sales of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred for purposes of determining royalty payments to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT TSRI shall be calculated by multiplying the NET SALES Net Sales of the COMBINATION PRODUCT Combination Product (as calculated without reference to this Section 3.4) by the fraction A/(A+B), where A is the weighted average NET SALES gross sale price of such LICENSED PRODUCT the Licensed Product(s) including solely the Licensed Macrolide(s) (and not the other active pharmaceutical ingredient(s)) included in the relevant countryCombination Product (the “Basic Product(s)”) in such country during the royalty period in question, as when sold separatelyseparately from such other active ingredient(s) in finished form in the same strength and dosage form, and B is the total weighted average NET SALES gross sale price of all OTHER PRODUCTS product(s) including the other active pharmaceutical ingredient(s) included in the COMBINATION PRODUCT Combination Product (and not any Licensed Macrolide(s)) (such products, “Other Product(s)”) in that country during the royalty period in question, when sold separately from the Basic Product(s) in finished form in the relevant same strength and dosage form. In the event that, with respect to any Combination Product sold in a particular country, 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 Product(s) in such country 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 (as calculated without reference to this Section 3.4) by the fraction A/C where A is the weighted average gross sale price of the Basic Product(s) when sold separately. If, separately during the royalty period in any question in finished form in the same strength and dosage form in such country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where and C is the aggregate weighted average fully absorbed cost gross sale price of the Licensed Combination Product components during the prior Royalty Period and D 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 (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)), where B is the aggregate weighted average fully absorbed cost gross sale price(s) of the other essential functional components Other Product(s) when sold separately during the prior Royalty Periodroyalty period in question in finished form in the same strength and dosage form in such country, and C is the 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 costs being determined country of neither the Basic Product(s) nor the Other Product(s) in accordance the Combination Product can be determined, the Net Sales of the Combination Product shall, for the purposes of determining royalty payments to TSRI with generally accepted accounting principles. To respect to such Combination Product, be the extent that any SUBLICENSE INCOME relates portion of Net Sales of such Combination Product reasonably attributable to a COMBINATION PRODUCT or is otherwise calculated 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 one a Basic Product, Other Product, or more licenses or intellectual property rights held 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 COMPANYnumber of units of Basic Product(s), Combination Product, or Other Product(s) sold in such country during the preceding twelve (12) calendar months (or the number of calendar months sold if there have not been such sales in a country for an AFFILIATE entire 12 calendar months before the Combination Product calculation contemplated hereunder is made for such country) for the respective Basic Product, Other Product, or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTCombination Product .
Appears in 1 contract
Samples: License Agreement (Cempra, Inc.)
Combination Products. If Notwithstanding anything to the contrary set forth herein, in the event either (a) a LICENSED PRODUCT Licensed Product is sold to by BioLine or an Affiliate of BioLine, or any third party entity on their behalf, in combination with other productsthe form of a Combination Product or (b) the grant of a Sublicense hereunder is part of a larger transaction also involving the grant by BioLine (or its Affiliates) of sublicenses in respect of Additional Ingredients for a Combination Product, devicesthen Net Sales and Sublicense Receipts, components as applicable, from such Combination Product, for purposes of determining payments hereunder, shall be determined by multiplying the actual Net Sales or materials that are capable Sublicense Receipts, as applicable, of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as during the applicable royalty reporting period, by the fraction A/(A+B) where: “COMPONENTS”), A” is the NET SALES average sale price of the Licensed Product contained in the Combination Product when sold separately by such LICENSED PRODUCT entity; and “B” is the average price of the other Additional Ingredients included in the Combination Product when sold separately by its supplier, in each case during the applicable royalty reporting period or if sales of both the Licensed Product and/or other Additional Ingredients did not occur in such COMBINATION PRODUCT period, then in the most recent royalty reporting period in which sales of both occurred. In the event that such average sale price cannot be determined for both the Licensed Product and all other Additional Ingredients included in the Combination Product, then Net Sales or Sublicense Receipts, as applicable, for the purpose of determining royalty payments shall be calculated by multiplying the NET SALES Net Sales or Sublicense Receipts, as applicable, of the COMBINATION PRODUCT Combination Products by the fraction A/(A+B), of C/(C+D) where A “C” is the average NET SALES price fair market value of such LICENSED PRODUCT the Licensed Product; and “D” is the fair market value of all other Additional Ingredients included in the relevant countryCombination Product. In such event, as sold separately, and B is the total average NET SALES price parties shall negotiate in good faith to arrive at a determination of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost respective fair market values of the Licensed Product components during and all other Additional Ingredients included in the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined Combination Product. Nothing in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion this section shall be interpreted as limiting or otherwise affecting Licensor’s ownership rights in the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination Licensed Technology as set forth in accordance with the dispute provisions of the AGREEMENTSection 3.1.
Appears in 1 contract
Samples: License Agreement (BioLineRx Ltd.)
Combination Products. If In the event that a LICENSED PRODUCT Royalty-Bearing Product is sold to as part of a Combination Product, where “Combination Product” means any third party in combination with other products, devices, components or materials that are capable unified dose (e.g. not a kit of being sold separately two separate and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination distinct drug dosage forms) of products being referred to as “COMBINATION PRODUCTS” and the Other a pharmaceutical product which is comprised of Royalty-Bearing Product and Licensed Product in such Combination Product being referred to as one or more other compound(s) and/or ingredients having independent therapeutic effect (collectively the “COMPONENTSOther Products”), Net Sales of Royalty-Bearing Product, for the NET SALES purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product by the fraction, [***] where [***]. In the event that no such LICENSED PRODUCT included in separate sales are made of either the Royalty-Bearing Product or the Other Products, the reasonably estimated commercial value thereof will be used instead of the sale price. Each of “weighted average sale price” and “reasonably estimated commercial value” shall be determined as follows: “Weighted average sale price” and “reasonably estimated commercial value,” as the case may be, for a Royalty-Bearing Product and Other Products shall be calculated once at the commencement of each Calendar Year and such COMBINATION PRODUCT amount shall be used during all applicable royalty reporting periods for the entire following Calendar Year. When determining the weighted average sale price of a Royalty-Bearing Product or Other Products, the weighted average sale price shall be calculated by multiplying dividing the NET SALES Net Sales (translated into U.S. dollars in accordance with Section 4.6.5 hereof) by the units of active ingredient sold during the [***] (or the number of [***]) of the COMBINATION PRODUCT by preceding Calendar Year for the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separatelyrespective Royalty-Bearing Product or Other Products. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination “Reasonably estimated commercial value” shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost agreement of the Licensed Product components during Parties using criteria to be mutually agreed upon by the prior Royalty Period and D is Parties. If the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty PeriodParties do not agree, with such costs being determined dispute shall be resolved in accordance with generally accepted accounting principlesSection 12.1 hereof. To [***] a forecasted weighed average sale price will be used for the extent that any SUBLICENSE INCOME relates Royalty-Bearing Product and Other Products, if applicable. Any over or under payment due to a COMBINATION PRODUCT difference between forecasted and actual weighted average sale prices will be paid or is otherwise calculated based on credited in the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTfirst royalty payment [***].
Appears in 1 contract
Samples: Collaboration Agreement (Ariad Pharmaceuticals Inc)
Combination Products. For COMBINATION PRODUCTS, NET SALES will be calculated as follows:
(a) If a the LICENSED PRODUCT and all OTHER COMPONENTS of the COMBINATION PRODUCT were SOLD separately during the same or immediately preceding calendar quarter, the proration factor will be determined by the formula [A / (A+B)], where A is sold to any third party in combination with other products, devices, the weighted average invoice price of all LICENSED PRODUCT components or materials that are capable of being sold during such period when SOLD separately and are not subject to royalties hereunder (“from the OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”COMPONENT(S), and B is the NET SALES weighted average gross invoice price of the OTHER COMPONENTS during such period when SOLD separately from the LICENSED PRODUCT included (as applicable); for reference only
(b) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in such COMBINATION PRODUCT shall are not SOLD separately, then the proration factor will be calculated by multiplying the NET SALES of the COMBINATION PRODUCT determined by the fraction A/(A+B)formula [A / C], where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES gross sales price of all LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT during such period when SOLD separately from the OTHER PRODUCTS in COMPONENTS, and C is the average gross sales price of the COMBINATION PRODUCT during such period;
(c) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are not SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold such COMBINATION PRODUCT are SOLD separately, NET SALES for royalty determination shall then the proration factor will be determined by the formula [(C- B) / C], where B is the average gross sales price of the OTHER COMPONENTS included in such COMBINATION PRODUCT if SOLD separately from the OTHER COMPONENTS, and C / is the average gross sales price of the COMBINATION PRODUCT during such period; or
(C+Dd) If neither the LICENSED COMPOUND nor the OTHER COMPONENTS included in the COMBINATION PRODUCT were SOLD or provided separately during the relevant period, then the proration factor will be mutually agreed upon by the parties in good faith based on the relative value contributed by each component.
(e) In the event that such separate SALES were not made or performed during the immediately preceding calendar year (“CY”)], then the invoiced amounts for the COMBINATION PRODUCT for purposes of calculating NET SALES will be multiplied by the fraction C/(C + D), where C is the aggregate average fully absorbed burdened cost of manufacture of the Licensed Product components LICENSED PRODUCTS during the prior Royalty Period immediately preceding CY and D is the aggregate average fully absorbed burdened cost of manufacture of the other essential functional components additional items during the prior Royalty Periodimmediately preceding CY, with such costs being determined in each case calculated in accordance with generally accepted accounting principles. To U.S. GAAP.
(f) Notwithstanding anything in this AGREEMENT to the extent that any SUBLICENSE INCOME relates to contrary, in no event shall the NET SALES for a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense be less than 50% of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be NET SALES for the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTLICENSED PRODUCT.
Appears in 1 contract
Samples: Exclusive License Agreement
Combination Products. For COMBINATION PRODUCTS, NET SALES will be calculated as follows:
(a) If a the LICENSED PRODUCT and all OTHER COMPONENTS of the COMBINATION PRODUCT were SOLD separately during the same or immediately preceding calendar quarter, the proration factor will be determined by the formula [A / (A+B)], where A is sold to any third party in combination with other products, devices, the weighted average invoice price of all LICENSED PRODUCT components or materials that are capable of being sold during such period when SOLD separately and are not subject to royalties hereunder (“from the OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”COMPONENT(S), and B is the NET SALES weighted average gross invoice price of the OTHER COMPONENTS during such period when SOLD separately from the LICENSED PRODUCT included (as applicable);
(b) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in such COMBINATION PRODUCT shall are not SOLD separately, then the proration factor will be calculated by multiplying the NET SALES of the COMBINATION PRODUCT determined by the fraction A/(A+B)formula [A / C], where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES gross sales price of all LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT during such period when SOLD separately from the OTHER PRODUCTS in COMPONENTS, and C is the average gross sales price of the COMBINATION PRODUCT during such period; for reference only
(c) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are not SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold such COMBINATION PRODUCT are SOLD separately, NET SALES for royalty determination shall then the proration factor will be determined by the formula [(C- B) / C], where B is the average gross sales price of the OTHER COMPONENTS included in such COMBINATION PRODUCT if SOLD separately from the OTHER COMPONENTS, and C / is the average gross sales price of the COMBINATION PRODUCT during such period; or
(C+Dd) If neither the LICENSED COMPOUND nor the OTHER COMPONENTS included in the COMBINATION PRODUCT were SOLD or provided separately during the relevant period, then the proration factor will be mutually agreed upon by the parties in good faith based on the relative value contributed by each component.
(e) In the event that such separate SALES were not made or performed during the immediately preceding calendar year (“CY”)], then the invoiced amounts for the COMBINATION PRODUCT for purposes of calculating NET SALES will be multiplied by the fraction C/(C + D), where C is the aggregate average fully absorbed burdened cost of manufacture of the Licensed Product components LICENSED PRODUCTS during the prior Royalty Period immediately preceding CY and D is the aggregate average fully absorbed burdened cost of manufacture of the other essential functional components additional items during the prior Royalty Periodimmediately preceding CY, with such costs being determined in each case calculated in accordance with generally accepted accounting principles. To U.S. GAAP.
(f) Notwithstanding anything in this AGREEMENT to the extent that any SUBLICENSE INCOME relates to contrary, in no event shall the NET SALES for a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense be less than 50% of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be NET SALES for the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTLICENSED PRODUCT.
Appears in 1 contract
Samples: Exclusive License Agreement
Combination Products. If a LICENSED PRODUCT In the event Ardelyx is sold entitled to receive royalties under this Agreement from any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product sold in the form of a Combination Product in the Territory, then Net Sales for such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall will be calculated by multiplying the NET SALES actual Net Sales of such Combination Product in the COMBINATION PRODUCT Territory by the fraction A/(A+B), where A is the average NET SALES standard sales price of such LICENSED PRODUCT in the relevant countryTerritory 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 total average NET SALES standard sales price of all OTHER PRODUCTS in the COMBINATION PRODUCT Territory of the ready for sale form of a product containing the same amount of the other therapeutically active ingredient(s) in the relevant countryCombination Product that are not Licensed Compounds (the “Other Ingredients”), as if sold separately. IfIf the Other Ingredients are not sold separately in the Territory, 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 fraction A/C where A is the standard sales price in any countrythe Territory of a Comparable Licensed Product, any COMPONENT 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 Net Sales for royalty determination 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 standard sales price in the Territory of the Other Ingredients and C is the standard sales price in the Territory of the Combination Product. For the purpose of the above, the standard sales price 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 formula [C / (C+D)]Parties on the basis of a fair market value of such Comparable Licensed Product and Other Ingredient to be negotiated by the Parties in good faith, where C is the aggregate average fully absorbed cost taking into account costs, overheads and profit of the relevant Licensed Product components during Compound(s), the prior Royalty Period Other Ingredients and D is the aggregate average fully absorbed cost Combination Product. For purposes of the other essential functional components during calculations set forth in this Section 6.05, prior to the prior Royalty PeriodFirst Commercial Sale of a Combination Product, with the SC shall discuss the calculations set forth herein, including the standard sale prices to be used in such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTcalculation.
Appears in 1 contract
Samples: License Agreement (Ardelyx, Inc.)
Combination Products. If a LICENSED PRODUCT is sold to any third party (i) For Combination Products containing one or more Exclusive Market Product(s), in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product each country in which such Combination Product being referred to as the “COMPONENTS”)is sold, the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT Net Sales shall be calculated adjusted as follows:
(A) Net Sales shall be multiplied by multiplying the NET SALES Net Sales of the COMBINATION PRODUCT Combination Product during the applicable Calendar Quarter by the fraction A/(A+B), where A is the average NET SALES price Standard Sales Price of the Product containing the same amount of Compound as the sole active ingredient as the Combination Product in question in such LICENSED PRODUCT in the relevant country, as sold separately, country and B is the total average NET SALES price Standard Sales Price of all OTHER PRODUCTS the ready for sale product containing the same amount of the other therapeutically active ingredient that is contained in the COMBINATION PRODUCT Combination Product in question in such country, in each case during the applicable Calendar Quarter. For clarity, if a Combination Product contains three or more active ingredients (including the Product), the Standard Sale Price of such additional Exclusive Market Products , calculated in the relevant same manner as described above, shall be included in the denominator so that such fraction shall be A/(A+B1+ B2+...).
(B) If sales of the Product or the Exclusive Market Product did not occur in such Calendar Quarter, then the most recent previous Standard Sales Price of the Product containing the same amount of Compound as the sole active ingredient as the Combination Product in question in the given country, as sold separatelyshall be used. If, in any a specific country, any COMPONENT is both a Product containing the Compound(s) and a product containing the other active ingredients in such Combination Product are not sold separately, NET SALES a market price for royalty determination such Product and such other active ingredients shall be determined negotiated by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine Parties in good faith based upon the costs, overhead and report profit as are then incurred for such Combination Product and all Products then being made and marketed by AstraZeneca and having an ascertainable market price that are comparable to THE PARTIES such Product or such other active ingredients, as applicable; provided, however, that in no event shall the share Royalty due to AGIX for such Combination Product be less than [****] of what the Royalty would have been if the Net Sales for such Combination Product were calculated by multiplying the number of units of the Combination Product sold times the selling price of such payments reasonably attributable Product as if sold alone.
(C) Notwithstanding anything else in this Section 8.4(f)(i) to COMPANY’s the contrary, if AstraZeneca or one of its Affiliates or Sublicensees sells such AFFILIATE’s sublicense a Combination Product in a country for less than [****] of the rights granted hereundersum of the then-Standard Sales Prices of the Product and the Exclusive Market Product(s) that make up such Combination Product as sold separately in finished form in such country, based upon their relative importance then in no event shall the Royalty due to AGIX for such Combination Product be less than [****] of what the Royalty would have been if ------- [****] indicates that certain confidential information contained in this document has been omitted pursuant to a request for confidential treatment and proprietary protectionfiled separately with the Securities and Exchange Commission. the Net Sales for such Combination Product were calculated by multiplying the number of units of the Combination Product sold times the selling price of the Product as if sold alone. If the Product is not then sold separately in such country, which portion then the most recent previous Standard Sales Price in such country of such Product shall be used.
(ii) For Combination Products containing, as active pharmaceutical ingredients, only Non-Exclusive Market Product(s) and a Product, in each country in which such Combination Product is sold, the SUBLICENSE INCOME. THE PARTIES Net Sales for such Combination Product shall have be calculated by multiplying the right to dispute such sharing determination in accordance with the dispute provisions number of units of the AGREEMENTCombination Product sold by the selling price of the Product as if sold alone.
Appears in 1 contract
Samples: License and Collaboration Agreement (Atherogenics Inc)
Combination Products. For COMBINATION PRODUCTS, NET SALES will be calculated as follows:
(a) If a the LICENSED PRODUCT and all OTHER COMPONENTS of the COMBINATION PRODUCT were SOLD separately during the same or immediately preceding calendar quarter, the proration factor will be determined by the formula [A / (A+B)], where A is sold to any third party in combination with other products, devices, the weighted average invoice price of all LICENSED PRODUCT components or materials that are capable of being sold during such period when SOLD separately and are not subject to royalties hereunder (“from the OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”COMPONENT(S), and B is the NET SALES weighted average gross invoice price of the OTHER COMPONENTS during such period when SOLD separately from the LICENSED PRODUCT included (as applicable);
(b) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in such COMBINATION PRODUCT shall are not SOLD separately, then the proration factor will be calculated by multiplying the NET SALES of the COMBINATION PRODUCT determined by the fraction A/(A+B)formula [A / C], where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES gross sales price of all LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT during such period when SOLD separately from the OTHER PRODUCTS in COMPONENTS, and C is the average gross sales price of the COMBINATION PRODUCT during such period;
(c) If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are not SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold such COMBINATION PRODUCT are SOLD separately, NET SALES for royalty determination shall then the proration factor will be determined by the formula [(C- B) / C], where B is the average gross sales price of the OTHER COMPONENTS included in such COMBINATION PRODUCT if SOLD separately from the OTHER COMPONENTS, and C / is the average gross sales price of the COMBINATION PRODUCT during such period; or
(C+Dd) If neither the LICENSED COMPOUND nor the OTHER COMPONENTS included in the COMBINATION PRODUCT were SOLD or provided separately during the relevant period, then the proration factor will be mutually agreed upon by the parties in good faith based on the relative value contributed by each component.
(e) In the event that such separate SALES were not made or performed during the immediately preceding calendar year (“CY”)], then the invoiced amounts for the COMBINATION PRODUCT for purposes of calculating NET SALES will be multiplied by the fraction C/(C + D), where C is the aggregate average fully absorbed burdened cost of manufacture of the Licensed Product components LICENSED PRODUCTS during the prior Royalty Period immediately preceding CY and D is the aggregate average fully absorbed burdened cost of manufacture of the other essential functional components additional items during the prior Royalty Periodimmediately preceding CY, with such costs being determined in each case calculated in accordance with generally accepted accounting principles. To GAAP.
(f) Notwithstanding anything in this AGREEMENT to the extent that any SUBLICENSE INCOME relates to contrary, in no event shall the NET SALES for a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense be less than 50% of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be NET SALES for the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTLICENSED PRODUCT.
Appears in 1 contract
Samples: Exclusive License Agreement
Combination Products. For COMBINATION PRODUCTS, NET SALES will be calculated as follows: If a the LICENSED PRODUCT and all OTHER COMPONENTS of the COMBINATION PRODUCT were SOLD separately during the same or immediately preceding calendar quarter, the proration factor will be determined by the formula [A / (A+B)], where A is sold to any third party in combination with other products, devices, the weighted average invoice price of all LICENSED PRODUCT components or materials that are capable of being sold during such period when SOLD separately and are not subject to royalties hereunder (“from the OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”COMPONENT(S), and B is the NET SALES weighted average gross invoice price of the OTHER COMPONENTS during such period when SOLD separately from the LICENSED PRODUCT included (as applicable); If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in such COMBINATION PRODUCT shall are not SOLD separately, then the proration factor will be calculated by multiplying the NET SALES of the COMBINATION PRODUCT determined by the fraction A/(A+B)formula [A / C], where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES gross sales price of all LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT during such period when SOLD separately from the OTHER PRODUCTS in COMPONENTS, and C is the average gross sales price of the COMBINATION PRODUCT during such period; If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are not SOLD separately from the OTHER COMPONENTS, but the OTHER COMPONENTS in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold such COMBINATION PRODUCT are SOLD separately, NET SALES for royalty determination shall then the proration factor will be determined by the formula [(C- B) / C], where B is the average gross sales price of the OTHER COMPONENTS included in such COMBINATION PRODUCT if SOLD separately from the OTHER COMPONENTS, and C / is the average gross sales price of the COMBINATION PRODUCT during such period; or If neither the LICENSED COMPOUND nor the OTHER COMPONENTS included in the COMBINATION PRODUCT were SOLD or provided separately during the relevant period, then the proration factor will be mutually agreed upon by the parties in good faith based on the relative value contributed by each component. In the event that such separate SALES were not made or performed during the immediately preceding calendar year (C+D“CY”)], then the invoiced amounts for the COMBINATION PRODUCT for purposes of calculating NET SALES will be multiplied by the fraction C/(C + D), where C is the aggregate average fully absorbed burdened cost of manufacture of the Licensed Product components LICENSED PRODUCTS during the prior Royalty Period immediately preceding CY and D is the aggregate average fully absorbed burdened cost of manufacture of the other essential functional components additional items during the prior Royalty Periodimmediately preceding CY, with such costs being determined in each case calculated in accordance with generally accepted accounting principlesU.S. GAAP. To Notwithstanding anything in this AGREEMENT to the extent that any SUBLICENSE INCOME relates to contrary, in no event shall the NET SALES for a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense be less than 50% of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be NET SALES for the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTLICENSED PRODUCT.
Appears in 1 contract
Samples: Exclusive License Agreement
Combination Products. If a LICENSED PRODUCT is (i) Licensed Protein Products. In the event that the Licensed Protein Products are sold to any third party by Novartis in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”)Products, the NET SALES Net Sales value of such LICENSED PRODUCT the Licensed Protein Products included in such COMBINATION PRODUCT the Combination Products shall be calculated determined using the following formulae:
(A) If the Licensed Protein Products and other components ("Other Components") contained in the Combination Products are available separately, the Net Sales value for the purpose of calculating royalty payments shall be the result obtained by multiplying the NET SALES Net Sales of the COMBINATION PRODUCT Combination Products by the fraction A/(A+B), A/A+B where A is the average NET SALES invoice price of such LICENSED PRODUCT the Licensed Protein Products in the relevant country, as sold separately, Combination Products and B is the total average NET SALES price of all OTHER PRODUCTS Other Components in the COMBINATION PRODUCT in Combination Products.
(B) If the relevant country, as sold separately. If, in any country, any COMPONENT is Combination Products include Other Components which are not sold separately, NET SALES but the Licensed Protein Products contained in the Combination Products are available separately, the Net Sales value for the purposes of calculating royalty determination payments shall be determined the result of multiplying the Net Sales of the Combination Products by the formula [fraction A/C / (C+D)], where A is the price of the Licensed Protein Products and C is the aggregate average fully absorbed cost invoiced price of the Combination Products.
(ii) Licensed Gene Therapy Product components during or a Licensed Organ or Tissue Product: In the prior Royalty Period and D event that a Licensed Gene Therapy Product or a Licensed Organ or Tissue Product is sold in a Combination Product, then the aggregate average fully absorbed cost Net Sales value for the purposes of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated calculating royalty payments shall be based on the value portion of one the total invoice price for the Combination Product which is fairly allocable to the Licensed Gene Therapy Product or more licenses Licensed Organ or intellectual property rights held by Tissue Product in comparison with the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY Other Components. Such portion shall determine be set in good faith and report to THE PARTIES negotiations between the share Parties at such time as the filing of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense applications for marketing approval of the rights granted hereunderCombination Product are seriously being considered by Novartis and shall take into account all relevant factors, based upon their including, but not limited to, relative importance cost and proprietary protectiontherapeutic contributions of the components and the relative contributions of the Parties to the development of the components. In the event that the Parties are unable to agree on such a portion within six (6) months, which portion shall the matter will be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination decided in accordance with the dispute provisions of the AGREEMENTresolution procedures set forth hereinafter.
Appears in 1 contract
Combination Products. If In the event a LICENSED PRODUCT Royalty Product is sold as part of a Combination Product in a country, the Net Sales with respect to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Combination Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT country shall be calculated determined by multiplying the NET SALES of Net Sales amount for the COMBINATION PRODUCT Combination Product during the applicable reporting period, calculated as set forth above, by the fraction A/(A+B), where A is the weighted average NET SALES sale price (by sales volume) of the Royalty Product in such LICENSED PRODUCT in the relevant country, as country when sold separately, and B is the total weighted average NET SALES sales price of all OTHER PRODUCTS the other active ingredient(s) in the COMBINATION PRODUCT Combination Product in such country when sold separately, in each case in the relevant country, same dosage and dosage form and in the same country as sold separatelythe Combination Product during the applicable reporting period. If, If the other active ingredient(s) in any country, any COMPONENT the Combination Product is not sold separately in such country during the applicable reporting period, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product by a fraction A/C where A is the weighted average sale price (by sales volume) of the Royalty Product in such country when sold separately, NET SALES and C is the weighted average sale price (by sales volume) of the Combination Product in such country. If neither the Royalty Product nor the 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 royalty determination 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 for the applicable Combination Product shall be allocated based on the 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 formula [C / (C+D)], where C is the aggregate average fully absorbed cost rules of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENTAAA).
Appears in 1 contract
Samples: Exclusive License Agreement (Candel Therapeutics, Inc.)
Combination Products. If a LICENSED PRODUCT is sold to Kirin or its Affiliate sells any third party Combination Product, as defined in combination with other productsSection 5.8 of the Agreement, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in Net Sales for such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES actual Net Sales of the COMBINATION PRODUCT such Combination Product by the fraction A/(A+B), ) where A is the average NET SALES invoice price of such LICENSED PRODUCT in the relevant country, as Licensed Compound thereof if sold separately, and B is the total average NET SALES invoice price of all OTHER PRODUCTS any other active ingredient or ingredients in the COMBINATION PRODUCT in the relevant countrycombination, as if sold separately. If, on a country-by-country basis, the other active ingredient or ingredients in any the combination are not sold separately in such country, any COMPONENT Net Sales for the purpose of determining royalties for the Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/C where A is not the invoice price of the Licensed Product if sold separately, NET SALES and C is the invoice price of the Combination Product. If, on a country-by-country basis, neither the Licensed Compound nor the other active ingredient or ingredients of the Combination Product is sold separately in such country, or the mechanics provided above are otherwise inapplicable, Net Sales for royalty determination the purposes of determining royalties of the Combination Product shall be determined by the formula [C / (C+D)]Parties in good faith, where C is based on the aggregate average fully absorbed cost relative fair market values of the Licensed different active ingredients and in accordance with standard and customary practice if any, and in looking in particular to the relative list prices in other countries if available. If the immediately preceding sentence applies, Kirin shall in good faith propose to Aveo a Net Sales allocation for such Combination Product components during based on the prior Royalty Period principles set forth in the immediately preceding sentence, Aveo shall in good faith consider such proposal, and D is the aggregate average fully absorbed cost Parties shall seek to reach agreement on such allocation. If the Parties are unable to reach such agreement within sixty (60) days of Kirin’s proposal, then the matter shall be referred for non-binding resolution to a mutually agreeable individual (not affiliated with either Party) having expertise in the research, development, marketing and sales of similar pharmaceutical products (including experience in pricing and reimbursement), such resolution to occur within sixty (60) days after such referral. Such individual shall be instructed to determine the Net Sales allocation for such Combination Product using the following standard: the allocation shall be made based on the relative fair market value contribution made by each of the other essential functional components during the prior Royalty Perioddifferent active ingredients contained in such Combination Product to its overall sales price, with such costs being determined in accordance with generally accepted accounting principlesthe Standard as defined in Section 5.8 of the Agreement. To If either Party disagrees with the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share conclusions of such payments reasonably attributable to COMPANY’s or individual, then such AFFILIATE’s sublicense Party shall refer the matter for resolution in accordance with Article 11 of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion Agreement. The standard to be applied in any arbitration of this allocation under Article 11 shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination Standard as defined in accordance with the dispute provisions of the AGREEMENTSection 5.8.
Appears in 1 contract