Common use of Combination Products Clause in Contracts

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, 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.)

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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, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT 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: Patent License Agreement (MetaStat, Inc.), Patent License Agreement (MetaStat, Inc.), Patent License Agreement (MetaStat, Inc.)

Combination Products. If a LICENSED PRODUCT , DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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 PRODUCTa Licensed Product, DISCOVERY PRODUCT and/or THERAPEUTIC 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 LICENSED PRODUCTrelevant Licensed Compound(s), DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during 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 Notwithstanding anything to the contrary set forth herein, in the event either (a) a LICENSED PRODUCT , DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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 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 parties shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the 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 negotiate in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense arrive at a determination of the rights granted hereunder, based upon their relative importance respective fair market values of the Licensed Product and proprietary protection, which portion all other Additional Ingredients included in the Combination Product. Nothing in 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 The earned royalty due on 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 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, 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 invoice price of such LICENSED PRODUCT, DISCOVERY PRODUCT and/or THERAPEUTIC 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 PRODUCTCombination Product sold by a Party, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during 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 The earned royalty due on 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 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, 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 invoice price of such LICENSED PRODUCT, DISCOVERY PRODUCT and/or THERAPEUTIC 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 PRODUCTCombination Product sold by a Party, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during 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. If a LICENSED PRODUCT , DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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 Confidential Portions of this Exhibit marked as [***] have been omitted 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 LICENSED PRODUCTrelevant Licensed Compound(s), DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during 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 Aveo or its Affiliate sells any Licensed Product as a LICENSED PRODUCT , DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, EXECUTION COPY 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 PRODUCTdifferent active ingredients and in accordance with standard and customary practice if any, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during and in looking in particular to the prior Royalty Period 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 based on the 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

Samples: License Agreement (Aveo Pharmaceuticals Inc)

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Combination Products. If With respect to Combination Products, the Net Sales used for the calculation of the royalties under Section 10.2 shall be determined as follows: A Net Sales of the Combination ----- X Product, where: A+B A = *** of the Licensed Product, containing the ***, in the given country. B = *** of the ready-for-sale form of a LICENSED PRODUCT product containing the ***, DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT is sold to any third party in combination with the given country. In the event, however, that, in a specific country, (a) the 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 therapeutically active ingredient(s) in such Combination Product being referred to as the “COMPONENTS”)are not sold separately in such country, the NET SALES Net Sales shall be adjusted by multiplying *** of such LICENSED PRODUCTCombination Product by the fraction ---------- *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. A/C, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT included in where C is the ***, and (b) if a Licensed Product containing such COMBINATION PRODUCT Licensed Compound(s) is not sold separately, Net Sales shall be calculated by multiplying the NET SALES actual Net Sales of the COMBINATION PRODUCT such Combination Product by the fraction A/(A+B)(C-B)/C, 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 *** and C is the ***. The standard sales price for the Licensed Product containing such Licensed Compound(s) and for each other active ingredient shall be for a quantity comparable to that used in such Combination Product and of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant countrysame class, as sold separatelypurity and potency. If, in any a specific country, any COMPONENT is both a Licensed Product containing the Licensed 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 Licensed Product and such other active ingredients shall be determined negotiated by the formula [C / (C+D)]Parties in good faith based upon the costs, where C is overhead and 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 such Licensed Product or such other active ingredients, as applicable. If, in a specific country, the aggregate average fully absorbed cost foregoing calculations do not fairly represent the value of the LICENSED PRODUCTvarious active ingredients included in a Combination Product or such prices cannot be determined for all active ingredients by using such aforesaid method, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during the prior Royalty Period and D is allocation of Net Sales for such Combination Product shall be negotiated by the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined Parties in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated good faith based on the relative value of one contributed by each component, such agreement not to be unreasonably withheld 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 AGREEMENTdelayed.

Appears in 1 contract

Samples: And Licence Agreement (Avanir Pharmaceuticals)

Combination Products. If a LICENSED PRODUCT Kirin or its Affiliate sells any Combination Product, DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT is sold to any third party 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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 PRODUCTdifferent active ingredients and in accordance with standard and customary practice if any, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components during and in looking in particular to the prior Royalty Period 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 based on the 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

Samples: License Agreement (Aveo Pharmaceuticals Inc)

Combination Products. If Notwithstanding anything to the contrary set forth herein, in the event either (a) a LICENSED PRODUCT , DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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 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 parties shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the 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 negotiate in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense arrive at a determination of the rights granted hereunder, based upon their relative importance respective fair market values of the Licensed Product and proprietary protection, which portion all other Additional Ingredients included in the Combination Product. Nothing in 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 a LICENSED PRODUCT , DISCOVERY PRODUCT and/or THERAPEUTIC PROUCT 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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 Extrinsic Licensed Product used in the 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 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. 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, DISCOVERY the proration factor will be determined by the formula [A / (A+B)], where A is the weighted average invoice price of all LICENSED 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 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 PRODUCTPRODUCT (as applicable); If the LICENSED PRODUCT components containing only the LICENSED COMPOUND as its ACTIVE INGREDIENT are SOLD separately from the OTHER COMPONENTS, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT included 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, DISCOVERY PRODUCT and/or THERAPEUTIC 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, DISCOVERY PRODUCT and/or THERAPEUTIC PRODUCT components 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

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