Net Sales. “Net Sales” shall mean: the amount of revenue actually received by Licensee or its Affiliate(s), during any specified period in accordance with GAAP for the sale, transfer, or other disposition of a Licensed Product, less the following deductions to the extent applicable to such amounts: (i) all trade, cash and quantity credits, discounts, rebates or refunds; (ii) credits or allowances for returns, billing errors, damaged, outdated or recalled Licensed Products, in each case during such period; and (iii) packaging costs, handling fees, insurance and prepaid freight, sales taxes, duties and other governmental charges (including value- added tax), but excluding what is commonly known as income taxes; provided that if a Licensed Product is so sold or otherwise transferred for a single price in the form of a Combination Product, Net Sales shall be further calculated pursuant to Section 1.16(b) below; Notwithstanding the foregoing, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall be done in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among Licensee and its Affiliate; provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales by such Affiliate in accordance with GAAP in connection with the resale of such Licensed Product to a Third Party. Notwithstanding anything else in this in this section, the supply or other disposition of Licensed Products without charge as (i) samples, or (ii) for use in any tests or studies reasonably necessary to comply with any applicable law, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case shall not be included within the computation of Net Sales.
Appears in 2 contracts
Samples: Non Exclusive License Agreement, Non Exclusive License Agreement (GenMark Diagnostics, Inc.)
Net Sales. “The term "Net Sales” " shall mean: mean the total amount invoiced to third parties on sales of revenue actually received Licensed Products by Licensee or Licensee, its Affiliate(s), during any specified period in accordance with GAAP for the sale, transferAffiliates, or other disposition of a Licensed ProductSublicensees, for which royalties are due under Article 3 below, less the following reasonable and customary deductions to the extent applicable to such invoiced amounts: (i) all trade, cash and quantity credits, discounts, rebates refunds or refundsgovernment rebates; (ii) amounts for claims, allowances or credits or allowances for returns, billing errorsretroactive price reductions, damaged, outdated or recalled Licensed Products, in each case during such periodchargebacks; and (iii) packaging costspackaging, handling fees, insurance fees and prepaid freight, sales taxes, duties and other governmental charges (including value- value added tax); and (iv) provisions for uncollectible accounts determined in accordance with reasonable accounting practices, but excluding what is commonly known as income taxesconsistently applied to all products of the selling party; provided provided, however, that if a Licensed Product is so sold or otherwise transferred for a single price in the form case of a Combination ProductPatient-Specific Licensed Products, "Net Sales" shall equal thirty percent (30%) of the foregoing amounts (after the deductions described in (i) through (iv) above). For purposes of the foregoing, it is understood that Net Sales shall include only the amount invoiced for materials consisting of Licensed Products (less the foregoing deductions and adjustments) and shall not include charges related to services (other than cell separation and expansion) performed in connection with the sale of such Licensed Products; accordingly, Net Sales shall be further calculated pursuant to Section 1.16(b) below; Notwithstanding not include, without limitation, charges for apheresis, reinfusion, surgical procedures, hospital stays or the foregoinglike. For the removal of doubt, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall be done in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among by Licensee and to its Affiliate; Affiliates for resale, provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales the amounts invoiced by such Affiliate in accordance with GAAP in connection with to third parties on the resale of such Licensed Product to Product. In the event that Licensee grants a Third Party. Notwithstanding anything else in this in this sectionsublicense hereunder, and receives payments based upon the supply or other disposition Sublicensee's sales of Licensed Products without charge as (i) samplesProducts, or (ii) for use in any tests or studies reasonably necessary to comply with any applicable lawLicensee may upon approval by Scripps, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case which approval shall not be included within unreasonably withheld, substitute the computation definition of "Net Sales," used by the Sublicensee to calculate payments to Licensee in place of the foregoing definition of "Net Sales" for purposes of calculating royalties payable to Scripps on such Sublicensee's sales.
Appears in 2 contracts
Samples: Annual Report, License Agreement (Cytotherapeutics Inc/De)
Net Sales. (i) Net Sales shall be calculated as set forth in this Section 1(b) and shall be determined in accordance with the then-current generally accepted accounting principles in the United States, consistently applied during the applicable calculation period throughout the Corporation’s organization, except as otherwise provided in Section 2 below. For clarity, as used in this Section 1, “products” refers to both products and services, and “sales” refers to any sale, transfer, lease or other disposition by the Corporation, its Affiliates (as defined below) or their sublicensees of a product or service.
(ii) Subject to the conditions set forth below, “Net Sales” shall mean: mean the gross amount of revenue actually received by Licensee the Corporation, its Affiliates and their sublicensees for or its Affiliate(s), during any specified period in accordance with GAAP for on account of sales of the sale, transfer, or other disposition of a Licensed Product, Corporation’s products less the following deductions amounts to the extent separately stated on the xxxx or invoice or actually paid by the Corporation, without duplication, in effecting such sale:
(A) amounts repaid or credited by reason of actual rejection or return of applicable to such amounts: products;
(iB) all reasonable and customary trade, quantity or cash and quantity credits, discounts, rebates or refunds; discounts to the extent allowed and taken;
(iiC) credits or allowances amounts for returnsoutbound transportation, billing errors, damaged, outdated or recalled Licensed Products, in each case during such period; and (iii) packaging costsinsurance, handling fees, insurance and prepaid freight, sales shipping; and
(D) taxes, customs duties and other governmental charges levied on or measured by sales of products, as adjusted for rebates and refunds.
(including value- added taxiii) Specifically excluded from the definition of “Net Sales” are amounts attributable to any sale of any product between or among the Corporation and any of its Affiliates (for purposes hereof, “Affiliate” shall mean any other person who or which, directly or indirectly, controls, is controlled by, or is under common control with the Corporation), but excluding what unless the transferee is commonly known as income taxes; provided the end purchaser, user or consumer of such product. In such cases, “Net Sales” shall be determined based on the billed or invoiced sales price by the transferee to the first third party purchaser, less the deductions allowed under Section 1(b)(ii) above. If any other sales of products are made in transactions that if a Licensed Product is so sold or otherwise transferred for a single price are not at arm’s length between the buyer and seller, then the gross amount to be included in the form calculation of a Combination ProductNet Sales will be based on the average non-discounted cash amount charged to independent third parties for the product during the same period in the same country or, in the absence of such transaction, on the fair market value of the product in that country.
(iv) If any product is sold for non-cash consideration, Net Sales shall be further calculated pursuant based on the average non-discounted cash amount charged to Section 1.16(b) below; Notwithstanding independent third parties for the foregoingproduct during the same period in the same country or, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall be done in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among Licensee and its Affiliate; provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales by such Affiliate in accordance with GAAP in connection with the resale absence of such Licensed Product to a Third Party. Notwithstanding anything else transaction, on the fair market value of the product in this in this section, the supply or other disposition of Licensed Products without charge as (i) samples, or (ii) for use in any tests or studies reasonably necessary to comply with any applicable law, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case shall not be included within the computation of Net Salesthat country.
Appears in 2 contracts
Samples: Royalty Agreement (Histogenics Corp), Royalty Agreement (Histogenics Corp)
Net Sales. The term “Net Sales” shall mean: mean the amount of revenue actually received gross amounts invoiced by (i) Licensee or its Affiliate(s), during any specified period in accordance with GAAP for the sale, transfer, Affiliates or other disposition Sublicensees to Third Parties on sales of a Licensed Product, less the following deductions to the extent applicable to such amounts: (i) all trade, cash and quantity credits, discounts, rebates or refunds; (ii) credits or allowances for returns, billing errors, damaged, outdated or recalled Licensed Products, in each case during such period; and (iii) packaging costs, handling fees, insurance and prepaid freight, sales taxes, duties and other governmental charges (including value- added tax), but excluding what is commonly known as income taxes; provided that if a Licensed Product is so sold or otherwise transferred for a single price in the form of a Combination Product, Net Sales shall be further calculated pursuant to Section 1.16(b) below; Notwithstanding the foregoing, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall be done in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among Licensee and its Affiliate; provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales by such Affiliate in accordance with GAAP in connection with the resale of such Licensed Product to a Third Party. Notwithstanding anything else in this in this section, the supply or other disposition of Licensed Products without charge as (i) samples, or (ii) Licensee or its Affiliates to Third Parties on sales of Company Products; in each case, less the following items, to the extent attributable to such sales of Products (if not previously deducted from the amount invoiced): (a) […***…]; (b) […***…]; (c) […***…]; (d) […***…]; (e) […***…]; (f) […***…]; and (g) […***…]. Net Sales shall include all consideration charged by Licensee, its Affiliate, or, solely in the case of Licensed Products, a Sublicensee (in each case, a “Selling Party”), in exchange for use any Products, including without limitation any monetary payments or, with regard to any other property paid in exchange for any Products an amount in cash equal to the fair market value of such property. For purposes of determining Net Sales, a sale shall be deemed to have occurred when an invoice therefor shall be generated or the Product is shipped for delivery. Sales of Products by one Selling Party to another Selling Party for resale shall be excluded, and only the subsequent sale of such Products to unrelated parties shall be included in the calculation of Net Sales hereunder. The deductible items listed in sub-clauses (a)-(g) above shall be either (i) included as line items on the invoice, or (ii) reasonably supported by other appropriate documentation as being specifically attributable to sales of Products in accordance with United States Generally Accepted Accounting Principles (“GAAP”) or International Financing Reporting Standards (“IFRS”), as applicable, consistently applied throughout the organization of the Selling Party; and such amounts shall be included in the quarterly Royalty Reports that Licensee sends to TSRI pursuant to Section 6.3. If Licensee or another Selling Party receives refunds or reimbursements of any amounts deducted as set forth herein, then such refunded or reimbursed amounts shall be considered Net Sales in the applicable reporting period in which such refunded or reimbursed amounts are received. Products distributed as free promotional samples or in any tests compassionate use program, donated to non-profit institutions or studies reasonably necessary to comply with any applicable lawgovernment agencies, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industrywhich, in each case case, no monetary or other consideration is paid to or received by the Selling Party, and Products used in research or development activities, including, without limitation, clinical trials, shall not be included within the computation of disregarded in determining Net Sales.
Appears in 2 contracts
Samples: License Agreement (Synthorx, Inc.), License Agreement (Synthorx, Inc.)
Net Sales. “Net Sales” shall mean: the amount of revenue actually received by Licensee or its Affiliate(s), during any specified period in accordance with GAAP for the sale, transfer, or other disposition of a Licensed Product, less the following deductions to the extent applicable to such amounts: (i) all trade, cash and quantity credits, discounts, rebates or refunds; (ii) credits or allowances for returns, billing errors, damaged, outdated or recalled Licensed Products, in each case during such period; and (iii) packaging costs, handling fees, insurance and prepaid freight, sales taxes, duties and other governmental charges (including value- value-added tax), but excluding what is commonly known as income taxes; provided that if a Licensed Product is so sold or otherwise transferred for a single price in the form of a Combination Product, Net Sales shall be further calculated pursuant to Section 1.16(b) the below; Notwithstanding the foregoing, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall be done in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among Licensee and its Affiliate; provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales by such Affiliate in accordance with GAAP in connection with the resale of such Licensed Product to a Third Party. Notwithstanding anything else in this in this section, the supply or other disposition of Licensed Products without charge as (i) samples, or (ii) for use in any tests or studies reasonably necessary to comply with any applicable law, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case shall not be included within the computation of Net Sales.
Appears in 1 contract
Samples: Exclusive License Agreement (Blue Line Holdings, Inc.)
Net Sales. “Net Sales” shall mean: For the amount purposes of revenue actually received this Section 8.3, net sales means, in any case where a Licensor Improvement Product is sold or commercially disposed of for value by Licensee Licensor or its Affiliate(sany sublicensee of Licensor in an arm's length transaction with a third party (other than an Affiliate of Licensor or sublicensee of Licensor), during any specified period in accordance with GAAP the gross invoice price for the sale, transfer, or other disposition of a Licensed such Licensor Improvement Product, less the following deductions to the extent applicable to such amountsfollowing: (i) all trade, cash and quantity credits, discounts, chargebacks, Medicare or other [*] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED. government rebates, and rebates to purchasers actually taken or refundsallowed; (ii) credits or allowances given or made for returnsrejections or return of any previously sold products actually taken or allowed; (iii) to the extent included in such gross invoice price any tax or government charge imposed on the production, billing errorsimport, damagedexport, outdated sale, delivery or recalled Licensed Productsuse of such products, in each case during such periodincluding, without limitation, any value added or similar tax or government charge, but not including any tax levied with respect to income; and (iiiiv) to the extent included in such gross invoice price any reasonable and documented packaging costs, handling fees, insurance and prepaid freight, distribution charges. Net sales taxes, duties shall also include and other governmental charges be deemed to have been made with respect to (including value- added tax), but excluding what is commonly known as income taxes; provided that if a Licensed A) any Licensor Improvement Product is so not sold or otherwise transferred to any third party but rather used by Licensor to provide a commercial service and (B) any other transfer of a Licensor Improvement Product for a single price less than arm's length value other than intercompany transfers where the transferee is not the end user. The amount of any net sale as defined in the form of a Combination Product, Net Sales preceding sentence shall be further calculated pursuant to Section 1.16(b) below; Notwithstanding imputed using the foregoing, price or prices at which the Licensor Improvement Product at issue is then being sold in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product transactions covered by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales first sentence of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall or, if no such transactions have occurred, on a reasonable basis to be done in good faithdetermined at the time by the Parties. Notwithstanding any other provision of this Section, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales net sales shall not include sales between or among Licensee and its Affiliate; provided that if Licensee sells a Licensed the transfer without consideration of any Licensor Improvement Product to an Affiliate for resale, Net Sales shall include sales by such Affiliate in accordance with GAAP in connection with the resale of such Licensed Product to a Third Party. Notwithstanding anything else in this in this section, the supply or other disposition of Licensed Products without charge as Licensor (i) samples, or (iix) for use in any tests clinical trial or studies reasonably necessary in any preclinical or other research, (y) as detailing samples or other use to comply promote additional net sales in amounts consistent with any applicable lawthe normal business practices of Licensor, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case shall not be included within the computation of Net Sales(z) for compassionate use.
Appears in 1 contract
Samples: License Agreement (pSivida LTD)
Net Sales. “The phrase Net Sales” Sales shall mean: mean the amount amounts invoiced for End Products by members of revenue actually received the RMS Group to purchasers and other transferees after deduction of volume discounts, sales rebates, reimbursements for returns, and sales taxes (e.g., value added taxes) and other taxes directly linked to the sales (provided that such taxes are invoiced to and paid by Licensee such purchasers or its Affiliate(sother transferees), during any specified period in accordance with GAAP for the salebut excluding discounts, transferrebates, or other disposition price reductions and/or credits to customers on account of a Licensed Productsettlement of complaints, less the following deductions for. a) "Sales Expenses" in the amount of [***] percent ([***]%), provided that this percentage shall be reduced in accordance with each general reduction by RMS of such Sales Expenses in connection with the calculation of royalties payable with respect to the extent applicable sale of diagnostic kits; b) "Reagent Rental Deduction" in the amount of [***] percent ([***]%), provided that this percentage shall be reduced in accordance with each general reduction by RMS of such Reagent Rental Deductions in connection with the calculation of royalties payable with respect to such amounts: (i) all trade, cash and quantity credits, discounts, rebates or refunds; (ii) credits or allowances for returns, billing errors, damaged, outdated or recalled Licensed Products, in each case during such periodthe sale of diagnostic kits; and (iiic) packaging costs, handling fees, insurance and prepaid freight, sales taxes, duties and other governmental charges (including value- added tax), but excluding what is commonly known as income taxes; provided that if a Licensed Product is so sold or otherwise transferred deductions for a single price in the form of a Combination Product, "Third Party Royalty Expenses". Net Sales shall be further calculated pursuant to Section 1.16(b) below; Notwithstanding determined from the foregoing, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part books and records of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, RMS and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarterits Affiliates. In the event that an End Product is sold together with one or more other product(s) at a single price (a "Combination Product"), such separate sales of components single price shall be allocated among the End Product(s) and the other product(s) in a the Combination Product were based upon the relevant market prices for such products when sold separately. If any such product is not made sold separately, RGI and RMS shall in good faith discuss and agree upon a fair market price for that product and that price shall be used to calculate the Net Sales. When End Products are not sold, or performed during the applicable Calendar Quarterare not sold and itemized separately, then the amount of revenue received for a Licensed Product that is but are otherwise transferred or sold together with one or more other products as part of a Combination Product sales transaction, the Net Sales of such End Products shall be calculated according to their sale prices when sold separately, or, if there are no such prices, then according to the average of prices at which products of the most similar kind and quality, sold in similar quantities, are then being offered for sale by multiplying the amount of revenue received for the Combination Product by *** percent (***%)RMS and/or its Affiliates. The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) If a selling price cannot thus be determined, then it shall be done the fair market value of the End Product in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among Licensee and its Affiliate; provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales by such Affiliate in accordance with GAAP in connection with the resale of such Licensed Product to a Third Party. Notwithstanding anything else in this in this section, the supply or other disposition of Licensed Products without charge as (i) samples, or (ii) for use in any tests or studies reasonably necessary to comply with any applicable law, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case shall not be included within the computation of Net Salesquestion.
Appears in 1 contract
Net Sales. The term “Net Sales” shall mean: mean the gross amount of revenue actually received invoiced by Licensee Licensee, its Affiliates or its Affiliate(sSublicensees, or any of them (in each case, a “Selling Party”), during any specified period in accordance with GAAP for the sale, transfer, or other disposition to Third Parties on all sales of a Licensed ProductProducts, less the following deductions to the extent applicable to such amounts: (ia) all trade, cash and quantity credits, discounts, rebates discounts actually granted or refundsallowed; (iib) credits or allowances for returnsclaims, billing errorsallowances, damagedretroactive price reductions, outdated or recalled Licensed rejected or returned goods; (c) rebates and chargebacks granted or allowed to managed health care organizations, [***], pharmacy benefit managers (or equivalents thereof), national, state/provincial, local, and other governments and their agencies, and purchasers and reimbursers, or to trade customers; (d) transportation charges for the delivery of Products, including handling charges and insurance premiums relating thereto; (e) sales, use, excise or value added taxes (except for any value added taxes that are reimbursable or reimbursed to the Selling Party) actually paid in connection with sales of Products (but excluding what are commonly known as income taxes or gross receipt taxes); (f) duties imposed and paid on the import of Products for sale; and (g) a reasonable allowance for bad debts directly attributable to sales of Products, provided that such allowance shall not exceed [***] of Net Sales amounts for the applicable reporting period. Licensee agrees to use, and to cause its Affiliates to use, commercially reasonable efforts to collect and enforce such bad debts from the debtors. Net Sales shall include all consideration charged by Licensee, its Affiliates or Sublicensees in exchange for any Products, including without limitation any monetary payments or, with regard to any other property paid in exchange for any Products, an amount in cash equal to the fair market value of such property. For purposes of determining Net Sales, a sale shall be deemed to have occurred when an invoice therefor is generated or the Product shipped for delivery. Sales of Products by one Selling Party to another Selling Party for resale shall be excluded, and only the subsequent sale of such Products to unrelated parties shall be included in the calculation of Net Sales hereunder. Notwithstanding the foregoing, Products used in any clinical, pre-clinical or non-clinical research or development activities, donated to non-profit institutions or government agencies, or provided in a sampling program or compassionate use program, in each case during such period; and (iii) packaging costsin which no monetary or other consideration is paid to or received by Licensee, handling feesits Affiliates or any Sublicensee, insurance and prepaid freight, sales taxes, duties and other governmental charges (including value- added tax), but excluding what is commonly known as income taxes; provided that if a Licensed Product is so sold or otherwise transferred for a single price in the form of a Combination Product, Net Sales shall be further calculated pursuant to Section 1.16(bdisregarded in determining Net Sales. The deductible items listed in sub-clauses (a)-(g) below; Notwithstanding the foregoing, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product above shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall be done in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among Licensee and its Affiliate; provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales by such Affiliate in accordance with GAAP in connection with the resale of such Licensed Product to a Third Party. Notwithstanding anything else in this in this section, the supply or other disposition of Licensed Products without charge as either (i) samplesincluded as line items in the invoice, or (ii) for use reasonably supported by other appropriate documentation as being specifically attributable to actual sales of Products in accordance with U.S. Generally Accepted Accounting Standards (“GAAP”) or International Financing Reporting Standards (“IFRS”), as applicable, consistently applied throughout the organization of the Selling Party., and the deductible item listed in sub-clause (g) above shall be taken in accordance with GAAP or IFRS, as applicable, consistently applied throughout the organization of the Selling Party. If the Selling Party receives refunds or reimbursements of any tests amounts deducted as set forth herein, then such refunded or studies reasonably necessary to comply with any applicable law, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary reimbursed amounts shall be considered Net Sales in the industry, applicable reporting period in each case shall not be included within the computation of Net Saleswhich such refunded or reimbursed amounts are received.
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Net Sales. “The term "Net Sales” " shall mean: mean the total amount invoiced to third parties on sales of revenue actually received Licensed Products by Licensee or Licensee, its Affiliate(s), during any specified period in accordance with GAAP for the sale, transferAffiliates, or other disposition of a Licensed ProductSublicensees, for which royalties are due under Article 3 below, less the following reasonable and customary deductions to the extent applicable to such invoiced amounts: (i) all trade, cash and quantity credits, discounts, rebates refunds or refundsgovernment rebates; (ii) amounts for claims, allowances or credits or allowances for returns, billing errorsretroactive price reductions, damaged, outdated or recalled Licensed Products, in each case during such periodchargebacks; and (iii) packaging costspackaging, handling fees, insurance fees and prepaid freight, sales taxes, duties and other governmental charges (including value- value added tax); and (iv) provisions for uncollectible accounts determined in accordance with reasonable accounting practices, but excluding what is commonly known as income taxesconsistently applied to all products of the selling party; provided provided, however, that if a Licensed Product is so sold or otherwise transferred for a single price in the form case of a Combination ProductPatient-Specific Licensed Products, "Net Sales" shall equal [* ] of the foregoing amounts (after the deductions described in (i) through (iv) above). For purposes of the foregoing, it is understood that Net Sales shall include only the amount invoiced for materials consisting of Licensed Products (less the foregoing deductions and adjustments) and shall not include charges related to services (other than cell separation and expansion) performed in connection with the sale of such Licensed Products; accordingly, Net Sales shall be further calculated pursuant to Section 1.16(b) below; Notwithstanding not include, without limitation, charges for apheresis, reinfusion, surgical procedures, hospital stays or the foregoinglike. For the removal of doubt, in the event that, in any given Calendar Quarter, a Licensed Product is sold as part of a Combination Product, the amount of revenue received for such Licensed Product shall be calculated by multiplying the revenue received for such Combination Product by the fraction A/(A+B) where “A” is the average revenue received for such Licensed Product(s) sold separately during such Calendar Quarter, and “B” is the average revenue received for the other items included in such Combination Product sold separately during such Calendar Quarter. In the event that such separate sales of components in a Combination Product were not made or performed during the applicable Calendar Quarter, then the amount of revenue received for a Licensed Product that is sold as part of a Combination Product shall be calculated by multiplying the amount of revenue received for the Combination Product by *** percent (***%). The parties agree that any allocation of revenue from the sale or other disposition of Combination Products pursuant to this Section 1.16(b) shall be done in good faith, and shall take into consideration revenue recognition guidance under GAAP which is applicable to multiple-deliverable revenue arrangements. Net Sales shall not include sales between or among by Licensee and to its Affiliate; Affiliates for resale, provided that if Licensee sells a Licensed Product to an Affiliate for resale, Net Sales shall include sales the amounts invoiced by such Affiliate in accordance with GAAP in connection with to third parties on the resale of such Licensed Product to Product. In the event that Licensee grants a Third Party. Notwithstanding anything else in this in this sectionsublicense hereunder, and receives payments based upon the supply or other disposition Sublicensee's sales of Licensed Products without charge as (i) samplesProducts, or (ii) for use in any tests or studies reasonably necessary to comply with any applicable lawLicensee may upon approval by Scripps, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case which approval shall not be included within unreasonably withheld, substitute the computation definition of "Net Sales," used by the Sublicensee to calculate payments to Licensee in place of the foregoing definition of "Net Sales" for purposes of calculating royalties payable to Scripps on such Sublicensee's sales.
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