Product Net Sales means the gross amount invoiced for sales of Product instruments and related consumables in arm’s length sales by the Seller, any of its Affiliates or the Seller’s licensees, sublicensees, assignees, transferees or other commercial partners (or any of their respective Affiliates) to independent, unrelated third parties, less the following deductions from such gross amounts that are actually incurred, allowed, accrued or specifically allocated: (i) credits, price adjustments or allowances for damaged products (to the extent not covered by insurance), defective goods, returns or rejections of Product instruments and/or related consumables; (ii) normal and customary trade, cash and quantity discounts, allowances and credits (other than price discounts granted at the time of invoicing that have been already reflected in the gross amount invoiced); (iii) chargeback payments, rebates and similar allowances (or the equivalent thereof) granted to group purchasing organizations, managed health care organizations, distributors or wholesalers or to federal, state/provincial, local and other governments, including their agencies, or to trade customers; (iv) any fees paid to any third party logistics providers, wholesalers and distributors; (v) any freight, postage, shipping, insurance and other transportation charges incurred by the selling Person in connection with shipping Product instruments and/or related consumables to third party logistics providers, wholesalers and distributors and to customers; (vi) adjustments for billing errors or recalls; (vii) sales, value-added (to the extent not refundable in accordance with applicable Law), and excise taxes, tariffs and duties, and other taxes (including annual fees due under Section 9008 of the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-48) and other comparable Laws), levied on, absorbed, determined or imposed with respect to such sale (but not including taxes assessed against the income derived from such sale); and (viii) amounts written off by reason of uncollectible debt, provided that if the debt is thereafter paid, the corresponding amount shall be added to the Product Net Sales of the period during which it is paid. Product Net Sales, as set forth in this definition, shall be calculated applying, in accordance with GAAP, the standard accounting practices the selling Person customarily applies to other branded products sold by it or its Affiliates under similar trade terms an...
Product Net Sales means the gross amount invoiced by Seller, its Affiliates, licensees and sublicensees to Third Persons in bona fide arm’s length transactions for the sale of Product less the following items without duplication:
Product Net Sales means the gross amount invoiced by Purchaser or its Affiliates for Product sales, less: (i) reasonable and customary cash discounts consistent with the Seller’s past practices, (ii) customary rebates and Chargebacks, consistent with the Seller’s past practices and (iii) sales credits, refunds, returns and allowances accrued by Purchaser in accordance with GAAP. Such amounts shall be determined from books and records maintained by Purchaser in accordance with GAAP, consistently applied. To the extent that any accrual contemplated by the foregoing clause (iii) is subsequently adjusted in accordance with GAAP, Purchaser shall notify Seller thereof in writing and the Earnout owing hereunder in respect of the Product Net Sales corresponding to such accrued amounts shall be adjusted accordingly and the next subsequent Earnout payment hereunder shall be increased or decreased accordingly.
Examples of Product Net Sales in a sentence
In the event that such [**] be determined for both the Licensed Product and the other active ingredients included in the Combination Product, Net Sales for purposes of determining royalty payments hereunder shall be calculated by multiplying Net Sales of the Combination Product by the fraction of C/C+D, where C is [**] Licensed Product and D is [**] all other active ingredients included in the Combination Product.
The Seller shall promptly furnish to the Purchaser all relevant information and documentation in connection with this Royalty Right Agreement that the Purchaser may reasonably request in connection with the determination of whether or when the First Sale Date occurred and whether the calculation of Product Net Sales or a Royalty Right Payment Amount is in error.
If a Licensed Product is sold as part of a Combination Product, Net Sales shall be calculated by multiplying Net Sales for such Combination Product by the fraction A/(A+B) where A is the invoice price of the Licensed Product when sold separately, and B is the aggregate invoice price of the Independent Subproduct(s) in the combination when sold separately.
The Seller agrees to maintain books and records relevant to the calculation of Product Net Sales and Royalty Right Payment Amounts.
PFIZER shall, and shall cause its Affiliates and sublicensees to, keep accurate books and records setting forth gross sales of the Product, Net Sales of the Product, and amounts payable hereunder to PSIVIDA for the Product.
More Definitions of Product Net Sales
Product Net Sales means the gross amount received by Licensee and its Affiliates for sales of any Product under this Agreement, less any and all deductions actually taken by Licensee or any of its Affiliates with respect to such sales in accordance with GAAP, including, but not limited to, deductions for:
(i) trade, quantity and cash discounts, coupons, rebates and other price reductions for the Product;
(ii) credits and allowances for rejection or return of Products previously sold, price protection and shelf stock adjustments; reprocurement charges and other similar charges and inventory management fees; and
(iii) rebates and chargebacks, including, but not limited to, any payments required by law to be made under Medicaid, Medicare or other government medical assistance programs. Notwithstanding anything to the contrary, the transfer of a Product shall not be considered a sale of a Product under this Agreement to the extent such transfer (i) is in connection with the research, development or testing of a Product or (ii) is for sample purposes.
Product Net Sales means gross sales to resellers, distributors, OEMs, or customers of Product by the Company, minus discounts and returns.
Product Net Sales means the gross invoice price of Product sold by Merck, its Affiliates and their respective sublicensees to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:
1.72.1 trade and quantity discounts other than early pay cash discounts;
1.72.2 returns, rebates, chargebacks and other allowances;
1.72.3 the standard inventory cost of devices or delivery systems used for dispensing or administering Product (such as syringes or inhalation devices, but not packaging); [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.72.4 sales commissions paid to Third Party distributors and/or selling agents, in amounts customary to the trade and to the extent allocable to the Product;
1.72.5 retroactive price reductions that are actually allowed or granted; and
1.72.6 a fixed amount equal to [ * ] to cover bad debt, sales or excise taxes, early payment cash discounts, transportation and insurance, custom duties, and other governmental charges. With respect to sales of Combination Products, Net Sales shall be calculated on the basis of the gross invoice price of Product(s) containing the same strength of Profiled Compound sold, without other active ingredients. If the Therapeutic Product contained within any Product is not sold separately, Net Sales shall be calculated on the basis of the gross invoice price of the Combination Product multiplied by a fraction, the numerator of which shall be the [ * ] and the denominator of which shall be the [ * ] in the Combination Product. Inventory cost shall be determined in accordance with Merck’s regular accounting methods, consistently applied. The deductions set out in Sections 1.72.1 through 1.72.6 will be applied in calculating Net Sales for a Combination Product. If Product is sold only as a Combination Product and either Party reasonably believes that the calculation set forth in this paragraph does not fairly reflect the value of the Product relative to the other active ingredients in the Combination Product, the Parties shall negotiate, in good faith, other means of calculating Net Sales with respect to Combination Products
Product Net Sales means the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of Product in the Royalty Bearing Territory for use in the Field sold by Merck or its Related Parties to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:
(a) [**];
(b) [**];
(c) [**] that are [**];
(d) [**]; or any other [**]; provided, that for clarity, nothing in this clause (d) shall be deemed to exclude [**] to the [**];
(e) [**];
(f) [**], including [**]; provided that any such [**]; [**] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(g) [**] of the [**] and [**]; and
(h) [**]. Product Net Sales shall not include (i) sales of Product at low or no margin and/or (ii) sales, transfers or other dispositions of Product for test marketing, sampling, promotional, charitable, compassionate use (or similar programs), donations (for example, to non-profit institutions or government agencies), pre-clinical, clinical or regulatory purposes. With respect to sales of Combination Products, Product Net Sales shall be calculated on the basis of [**]. In the event that a Product is sold only as a Combination Product, Product Net Sales shall be calculated on the basis of [**] and the [**]. [**] shall be determined [**]. The deductions set forth above will be applied in calculating Product Net Sales for a Combination Product. In the event that a Product is sold only as a Combination Product and [**] to the [**], the Parties shall [**].
Product Net Sales means the gross amount received by Surviving Corporation, Acquiror, and/or any affiliate, sublicensee or successor in interest of either Surviving Corporation or Acquiror based upon the sale or other commercial disposition, during the applicable period, of any product containing Ceftaroline to unaffiliated third parties that are not sublicensees of the selling party, less the following deductions or allowances:
Product Net Sales means the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of Product in the Royalty Bearing Territory for use in the Field sold by Merck or its Related Parties to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:
(a) [*]; [*] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(b) [(];
(c) [*] that are [*];
(d) [*]; or any other [*]; provided, that for clarity, nothing in this clause (d) shall be deemed to exclude [*] to the [*];
(e) [*];
(f) [*], including [*]; provided that any such [*];
(g) [*] of the [*] and [*]; and
(h) [*]. Product Net Sales shall not include [*]. With respect to sales of Combination Products, Product Net Sales shall be calculated on the basis of [*]. In the event that a Product is sold only as a Combination Product, Product Net Sales shall be calculated on the basis of [*] and the [*]. [*] shall be determined [*]. The deductions set forth above will be applied in calculating Product Net Sales for a Combination Product. In the event that a Product is sold only as a Combination Product and [*] to the [*], the Parties shall [*].
Product Net Sales means, solely with respect to sales of Product described in clause (a)(i) of the definition of Product, as of any date of determination, the net consolidated product revenue (consistent with the calculation of same in the Borrower’s financial statements) of Borrower and its Subsidiaries of such Product for the period in question (excluding, for the avoidance of doubt, any (i) upfront or milestone payments received by Borrower or any of its Subsidiaries, (ii) advancements, payments or reimbursements of expenses of Borrower or any of its Subsidiaries, and (iii) any other non-sales-based revenue or proceeds received by Borrower or any of its Subsidiaries), as the context dictates, determined on a consolidated basis in accordance with GAAP as set forth in Borrower’s financial statements or as otherwise evidenced in a manner reasonably satisfactory to the Required Lenders. “Register” is defined in Section 2.8(a). “Registered Organization” means any “registered organization” as defined in the Code with such additions to such term as may hereafter be made. “Regulatory Agency” means a U.S. or foreign Governmental Authority with responsibility for the approval of the marketing and sale of pharmaceuticals or other regulation of pharmaceuticals, or otherwise having authority to regulate Product, including the FDA, Health Canada, European Medicines Agency, National Medical Products Administration in China and Medicines and Healthcare products Regulatory Agency in the UK. “Regulatory Approvals or Licensures” means all U.S., Canada, EU, UK and any other foreign approvals, exclusivities, authorizations, designations, licensures or clearances (including approval under FDCA § 505 or Orphan Drug exclusive approval under 21 C.F.R. § 316.34 or any foreign equivalents); Orphan Drug designation under 21 C.F.R. § 316.24 or any foreign equivalents); Fast Track designation, Breakthrough Therapy designation, and Priority Review designation under 21 U.S.C. § 356 and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents); and Qualified Infectious Disease Product designation under 21 U.S.C. § 355f (including an award of “GAIN” exclusivity) and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents)); and any product or establishment licenses, approvals, registrations or authorizations of any Regulatory Agency necessary for the manufacture, use, storage, import, export, transport,...