ROYALTIES AND OTHER CONSIDERATION. 4.1 During the term of this Agreement, the Company shall pay to IGI royalties equal to six percent (6%) of annual Net Sales of the Licensed Products covered by at least one issued and unexpired claim under the PTH Patent Rights; provided, however, that in any calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company shall pay IGI royalties equal to nine percent (9%) of any and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in such calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect to each Licensed Product upon the expiration date of the last to expire of any patent included in the PTH Patent Rights covering the sale of such Licensed Product in such country. 4.2 As provided by and consistent with the terms of Article 1.7, on sales of Licensed Products by the Company to Affiliates that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for the sale of the same such Licensed Products. 4.3 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights. 4.4 In the event that a Licensed Product is sold in the form of a combination package together with companion products that are not themselves a License Product, the Net Sales for such combination package upon which the royalty due to IGI is based shall be calculated by multiplying the total sales price of such combination package by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separately, and B is the total invoice price of each of the other companion products included in the combination package if sold separately. 4.5 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGI. The Company shall furnish IGI with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate. 4.6 Consistent with Article 5 of this Agreement, the royalties payable by the Company to IGI under this Agreement shall be paid quarterly on or before sixty (60) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar year. Each such payment shall be for unpaid royalties which accrued within or prior to the Company's most recently completed fiscal quarter. 4.7 The Company shall make the following milestone payments to IGI: 4.7.1 $300,000 upon execution of the Novasome Sublicense Agreement; 4.7.2 $300,000 upon dosing of the first patient in a Phase II clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees; 4.7.3 $500,000 upon dosing of the first patient in a Phase III clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees; 4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees; 4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees; 4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees; 4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and 4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees. 4.8 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country. 4.9 To the extent that the Company is required by final order or judgment issued by a court of competent jurisdiction to obtain a royalty bearing license from a third party in order to sell any Licensed Product hereunder in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%) of the amount of royalties that the Company actually paid to the third party licensee in such jurisdiction; provided, however, that in no event shall the aggregate royalties payable to IGI in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) as a result of any such deduction pursuant to this Article 4.9 and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.
Appears in 1 contract
Sources: Sublicense Agreement (Igi Inc)
ROYALTIES AND OTHER CONSIDERATION. 4.1 During In consideration of the term of this Agreementrights, privileges and license granted hereunder, the Company shall pay to IGI royalties the Licensor as set forth in, and in accordance with the provisions of, this Article 4 until termination or expiration of this Agreement pursuant to Article 7 hereof.
4.2 The Company shall pay to the Licensor and/or its representatives a non-refundable quarterly royalty in an amount equal to six percent (6%) *** of annual Net Sales by the Company, or any Affiliate of the Company, of Licensed Products or Licensed Processes covered by at least one issued and unexpired claim under the PTH Patent Rights; provided, however, that .
4.3 The Company shall pay to the Licensor a non-refundable quarterly royalty in an amount equal to the lesser of (a) *** of the royalties received by Licensee or its Affiliate from sales by any calendar year in which sublicensee of Licensed Products or Licensed Processes and (b) *** of Net Sales exceed Two Hundred Million Dollars ($200,000,000)by any such sublicensee.
4.4 In addition, then the Company shall pay IGI royalties equal to nine percent the Licensor *** of all lump-sum payments received by the Company or an Affiliate from its sublicensees for the use, lease or sale of Licensed Products and Licensed Processes, excluding (9%a) payments used or reimbursed for research and development and (b) payments received from the issuance of any and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in such calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect to each Licensed Product upon the expiration date debt or equity securities of the last Company.
4.5 The Company agrees to expire pay to the Licensor the Milestone Payments set forth on Schedule C attached hereto, which shall be deducted from or credited against, as the case may be, payments made in accordance with section 4.4 above. [CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR INFORMATION REDACTED FROM THIS PAGE.]
4.6 On each anniversary of any patent included the Effective Date, the Company shall pay to the Licensor an annual fee in the PTH Patent Rights covering the sale of such Licensed Product in such countryfollowing amounts which shall be fully creditable against Milestones 2 through 5 as set forth on Schedule C attached hereto: (a) Year 1 - $100,000 (b) Year 2 - *** (c) Year 3 - *** (d) Year 4 and thereafter - ***.
4.2 As provided by and consistent with the terms of Article 1.7, on 4.7 On sales of Licensed Products by the Company to Affiliates or related parties that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for transaction, based on sales of like quantity and quality products at or about the sale time of the same such Licensed Productstransaction.
4.3 4.8 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product or Licensed Process is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights. In addition, royalties shall be paid for a Licensed Product or Licensed Process based upon only one of paragraphs 4.2 or 4.3 above (that is, royalties on direct sales of a Licensed Product or Licensed Process by the Company or its Affiliates shall be based only on paragraph 4.2, while royalties on sales of a Licensed Product or Licensed Process by the Company's sublicensees shall be based only on paragraph 4.3, so as to avoid double counting).
4.4 4.9 In the event that a Licensed Product is sold in the form of a combination package together with companion product containing one or more products or technologies that are themselves not themselves a License Licensed Product, the Net Sales for such combination package product shall be calculated by multiplying ***. In the case of a combination product which includes one or more Licensed Products, the Net Sales for such combination product upon which the royalty due to IGI the Licensor is based shall not be calculated by multiplying less than the total sales price of normal aggregate Net Sales for such combination package by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separately, and B is the total invoice price of each of the other companion products included in the combination package if sold separatelyProduct.
4.5 4.10 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI the Licensor may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which that the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGIthe Licensor. The Company shall furnish IGI the Licensor with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent . The Company will reasonably cooperate with Article 5 the Licensor in the Licensor's effort to avoid a double taxation, provided however that the Company shall not be required to pay any sums to or on behalf of the Licensor pursuant to this Agreement, section 4.10. Such assistance shall not be interpreted to include the royalties payable assistance or cooperation by the Company in any illegal activity or tax evasion by the Licensor.
4.11 Royalties payable to IGI under this Agreement the Licensor shall be paid quarterly on or before sixty forty-five (6045) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 from the end of each such calendar yearquarter. Each such quarterly payment shall be for unpaid royalties which that accrued within or prior to the Company's two most recently completed fiscal quarterquarters.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution of the Novasome Sublicense Agreement;
4.7.2 $300,000 upon dosing of the first patient in a Phase II clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.3 $500,000 upon dosing of the first patient in a Phase III clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No payment 4.12 Payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.the Territory
4.9 4.13 To the extent that the Company or any Affiliate of the Company is required required, by final order or judgment issued by a judgement of any court of competent jurisdiction to obtain a royalty bearing in any jurisdiction any license from a third party in order to make, use or sell any Licensed Product or Licensed Process, then up to *** of the royalties payable hereunder with respect to such Licensed Product or Licensed Process in such jurisdiction, then in such case the Company jurisdiction may deduct be deducted from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%) of the amount of royalties that the Company actually paid to the third party licensee in such jurisdiction; providedLicensor hereunder, however, provided that in no event shall the aggregate royalties payable to IGI the Licensor in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) *** as a result of any such deduction pursuant to this Article 4.9 deduction, and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.
4.14 In the event that the Licensor or any sublicensee registers, makes, has made, uses, leases, markets and/or sells any product in Germany, Switzerland, Greece, Sweden, Norway, Finland, Denmark, the United Kingdom, Ireland, France and/or Benelux, which incorporates information or know-how provided to the Licensor by the Company pursuant to paragraph 5.1 hereof, then the Licensor shall pay to the Company royalties in an amount equal to *** of Net Sales by the Licensor or any such sublicensee and *** of any lump-sum payments received by the Licensor from such sublicensee. Notwithstanding the foregoing, any novel indication (which is defined as any indication different from intraperitoneal dialysis and not included in the Field of Use and/or in the Field of Not Novel Indications) discovered by the Company shall be and remain the property of the Company for which it shall have exclusive world-wide rights to such indication.
(a) In the event that the Company develops proprietary information and data including but not limited to pre-clinical studies and clinical studies with applications outside the Field of Use and/or in the Field of Not Novel Indications ("Company Proprietary Information"), the Licensor shall be entitled to use the Company Proprietary Information within the Field of Use and/or in the Field of Not Novel Indications and outside the Territory but excluding those territories referred to in Section 4.14 above. In consideration for the use of the Company Proprietary Information, the Licensor shall pay the Company a fee in U.S. dollars equal to *** of the Company's expenses actually incurred for such information and data development, payable upon delivery thereof by the Company to the Licensor. The Licensor shall not be entitled to sublicense, assign, transfer, market or commercially exploit the Company Proprietary Information. The provisions of this section 4.15, shall not limit the Company's right to receive royalties pursuant to Section 4.14 above. [CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR INFORMATION REDACTED FROM THIS PAGE.]
(b) In the event that the Licensor discovers and develops novel indications outside the Field of Use and/or in the Field of Not Novel Indications but including the field of interperitoneal dialysis, the Licensor may have the option to purchase any relevant Company Proprietary Information relating thereto. In consideration for the use of the Company Proprietary Information, the Licensor shall pay the Company a fee in U.S. dollars equal to *** of the Company's expenses actually incurred for such information and data development, payable upon delivery thereof by the Company to the Licensor.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 During For the term of this Agreementrights, privileges and license granted hereunder, the Company shall pay to IGI the Licensor as set forth below, and in accordance with the provisions of Articles 4.4 and 4.5, to the end of the term of the Patent Rights or until this License Agreement shall be terminated as hereinafter provided:
4.1.1 The Company shall pay to the Licensor non-refundable semi-annual royalties in an amount equal to six * percent (6*%) of annual Net Sales by the Company, or any Affiliate of the Company, of the Licensed Products or Licensed Processes covered by at least one issued and unexpired claim under the PTH Patent RightsRights and * percent (*%) of Net Sales by the Company or any Affiliate of the Company covered by pending patent claims.
4.1.2 The Company shall pay to the Licensor semi-annual royalties in an amount equal to * percent (*%) of the royalties received by the Company or its Affiliate from sales by any sublicensee of Licensed Products or Licensed Processes. In addition, the Company shall pay to the Licensor * percent (*%) of all sublicensing fees or other lump sum payments or other compensation received by the Company or an Affiliate from its sublicensees for the use, lease or sale of Licensed Products and Licensed Processes; provided, however, that in any calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company shall pay IGI royalties equal to nine the Licensor * percent (9*%) of any lump sum payments, if any, that are made within six (6) months from the Execution of this Agreement and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in such calendar yearreceived by the Company or its Affiliate; provided * This material has been omitted pursuant to a request for confidential treatment. The Company's royalty obligations under material has been filed with the Securities and Exchange Commission. further, however, that no amounts shall be due and payable to the Licensor pursuant to this Article 4.1 paragraph 4.1.2 on account of (a) payments made to the Company solely for bona fide research and development (but which shall terminate on a country by country basis with respect not include option or other similar fees/consideration for access to each Licensed Product upon or rights to the expiration date Patent Rights or Know-how and (b) purchases of debt or equity securities of the last to expire of any patent included in the PTH Patent Rights covering the sale of such Licensed Product in such countryCompany.
4.2 As provided by and consistent with the terms of Article 1.7, on On sales of Licensed Products by the Company to Affiliates that or related parties which are end users of such Licensed Products, Products the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for transaction, based on sales of like quantity and quality products at or about the sale time of the same such Licensed Productstransaction.
4.3 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product or Licensed Process is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights. In addition, royalties shall be paid for a Licensed Product or Licensed Process based upon only one of paragraphs 4.1.1 or 4.1.2 above (that is, royalties on direct sales of a Licensed Product or Licensed Process by the Company or its Affiliates shall be based only on paragraph 4.1.1, while royalties on sales of a Licensed Product or Licensed Process by the Company's sublicensees shall be based only on paragraph 4.1.2, so as to avoid double counting).
4.4 In the event that a Licensed Product is sold in the form of a combination package together with companion product containing one or more products that or technologies which are themselves not themselves a License Licensed Product, the Net Sales for such combination package upon which the royalty due to IGI is based product shall be calculated by multiplying the total sales price of such combination package product by the fraction A/(A+B), ) where A is the invoice price of the Licensed Product or the Fair Market Value of the Licensed Product if sold separately, to an Affiliate and B is the total invoice price of each the other products or technologies or the Fair Market Value of the other companion products included in or technologies if purchased from an Affiliate. In the case of a combination package if sold separatelyproduct which includes one or more Licensed Products, the Net Sales for such combination product upon which the royalty due to the Licensor is based shall not be less than the normal aggregate Net Sales for such Licensed Product.
4.5 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI the Licensor may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGIthe Licensor. The Company shall furnish IGI the Licensor with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, Royalties payable to the royalties payable by the Company to IGI under this Agreement Licensor shall be paid quarterly on or before within sixty (60) days following each from the end of the fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar yearquarter. Each such payment shall be for unpaid royalties which accrued within or prior to the Company's two most recently completed fiscal quarterquarters.
4.7 Subject to the terms of this paragraph 4.7, the Company shall pay to the Licensor a non-refundable minimum annual royalty (the "Minimum Annual Royalty") equal to * dollars ($*) per year.
4.7.1 The Minimum Annual Royalty shall be fully creditable against (a) any payments owing to the Licensor by the Company on account of any payments due and owing under this Article 4, which payments are earned by the Licensor in such year; (b) any payments in such year paid or payable under any CRADA and (c) any payments in such year paid or payable on account of Sponsored Research with any of the Co-owners.
4.7.2 Such minimum annual royalties shall be payable in accordance with paragraph 5.
1. Notwithstanding the provisions of the above paragraph 4.6, any payment required to be made to the Licensor to meet the Minimum Annual Royalty owed shall be due and payable within sixty (60) days from the end of each calendar year.
4.7.3 Notwithstanding anything else to the contrary, in the event that the Company is not granted access to the N.C.I. Clinical Data and pre-clinical data owned by N.I.H. relating to potential Licensed Products and Licensed Processes, then no Minimum Annual Royalty shall be due or payable to the Licensor until the calendar year in which the first Phase II clinical trial pursuant to a Company sponsored IND has commenced, thereafter, the Minimum Annual Royalty shall be reduced to * dollars ($*) until the First Commercial Sale. * This material has been omitted pursuant to a request for confidential treatment. The material has been filed with the Securities and Exchange Commission.
4.8 The Company shall make pay to the Licensor the following milestone payments which shall be credited against or deducted from royalties otherwise owed or which may in the future be owing payable to IGIthe Licensor on account of sublicensing royalties and/or lump sum payments received by the Company or its Affiliate from sublicensees pursuant to paragraph 4.1.2:
4.7.1 4.8.1 dollars ($300,000 *) as an up-front licensing fee, payable upon the earlier to occur of (a) receipt by the Company of the N.C.I. Clinical Data and pre-clinical data or (b) the date that is six (6) months from the Effective Date, in accordance with paragraph 5.
1. Any shares of Common Stock (as defined below) issued to the Licensor in satisfaction of the payment due pursuant to this paragraph 4.8.1 shall be priced at the closing price per share of the Common Stock for the ten (10) consecutive trading days preceding (i) the execution of this Agreement and (ii) the Novasome Sublicense Agreementdate on which payment is made, whichever is lower;
4.7.2 4.8.2 dollars ($300,000 *) upon dosing approval of the first patient in a Phase II clinical trial of a Company sponsored IND for any Licensed Product for with the treatment of psoriasis sponsored by United States Food and Drug Administration (FDA) or on behalf of the Company or any of its Affiliates or sublicenseesforeign equivalent, payable in accordance with paragraph 5.1;
4.7.3 4.8.3 dollars ($500,000 *) upon dosing the date of initiation of the first patient in a Company sponsored Phase III clinical trial of Clinical Trial in the United States for a Licensed Product Product, payable in accordance with paragraph 5.1; * This material has been omitted pursuant to a request for confidential treatment. The material has been filed with the treatment of psoriasis sponsored by or on behalf Securities and Exchange Commission.
4.8.4 dollars ($*) upon the filing of the first Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a sponsored New Drug Application ("NDA") for a Licensed Product for with the treatment of psoriasis filed by United States FDA or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient foreign equivalent, payable in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicenseesaccordance with paragraph 5.1; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicenseesand 4.
4.8 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 To the extent that the Company is required by final order or judgment issued by a court of competent jurisdiction to obtain a royalty bearing license from a third party in order to sell any Licensed Product hereunder in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%) of the amount of royalties that the Company actually paid to the third party licensee in such jurisdiction; provided, however, that in no event shall the aggregate royalties payable to IGI in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) as a result of any such deduction pursuant to this Article 4.9 and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 During In consideration of the term of this Agreementrights, privileges and license granted hereunder, the Company shall pay to IGI royalties the Licensor as set forth in, and in accordance with the provisions of, this Article 4 until termination or expiration of this Agreement pursuant to Article 7 hereof.
4.2 The Company shall pay to the Licensor and/or its representatives a non-refundable quarterly royalty in an amount equal to six percent (6%) *** of annual Net Sales by the Company, or any Affiliate of the Company, of Licensed Products or Licensed Processes covered by at least one issued and unexpired claim under the PTH Patent Rights; provided, however, that .
4.3 The Company shall pay to the Licensor a non-refundable quarterly royalty in an amount equal to the lesser of (a) *** of the royalties received by Licensee or its Affiliate from sales by any calendar year in which sublicensee of Licensed Products or Licensed Processes and (b) *** of Net Sales exceed Two Hundred Million Dollars ($200,000,000)by any such sublicensee.
4.4 In addition, then the Company shall pay IGI royalties equal to nine percent the Licensor *** of all lump-sum payments received by the Company or an Affiliate from its sublicensees for the use, lease or sale of Licensed Products and Licensed Processes, excluding (9%a) payments used or reimbursed for research and development and (b) payments received from the issuance of any and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in such calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect to each Licensed Product upon the expiration date debt or equity securities of the last Company.
4.5 The Company agrees to expire pay to the Licensor the Milestone Payments set forth on Schedule C attached hereto, which shall be deducted from or credited against, as the case may be, payments made in accordance with section 4.4 above.
4.6 On each anniversary of any patent included the Effective Date, the Company shall pay to the Licensor an annual fee in the PTH Patent Rights covering the sale of such Licensed Product in such countryfollowing amounts which shall be fully creditable against Milestones 2 through 5 as set forth on Schedule C attached hereto: (a) Year 1 - *** (b) Year 2 - *** (c) Year 3 - *** (d) Year 4 and thereafter - ***.
4.2 As provided by and consistent with the terms of Article 1.7, on 4.7 On sales of Licensed Products by the Company to Affiliates or related parties that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for transaction, based on sales of like quantity and quality products at or about the sale time of the same such Licensed Productstransaction.
4.3 4.8 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product or Licensed Process is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights. In addition, royalties shall be paid for a Licensed Product or Licensed Process based upon only one of paragraphs 4.2 or 4.3 above (that is, royalties on direct sales of a Licensed Product or Licensed Process by the Company or its Affiliates shall be based only on paragraph 4.2, while royalties on sales of a Licensed Product or Licensed Process by the Company's sublicensees shall be based only on paragraph 4.3, so as to avoid double counting).
4.4 4.9 In the event that a Licensed Product is sold in the form of a combination package together with companion product containing one or more products or technologies that are themselves not themselves a License Licensed Product, the Net Sales for such combination package product shall be calculated by multiplying ***. In the case of a combination product which includes one or more Licensed Products, the Net Sales for such combination product upon which the royalty due to IGI the Licensor is based shall not be calculated by multiplying less than the total sales price of normal aggregate Net Sales for such combination package by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separately, and B is the total invoice price of each of the other companion products included in the combination package if sold separatelyProduct.
4.5 4.10 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI the Licensor may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which that the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGIthe Licensor. The Company shall furnish IGI the Licensor with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent . The Company will reasonably cooperate with Article 5 the Licensor in the Licensor's effort to avoid a double taxation, provided however that the Company shall not be required to pay any sums to or on behalf of the Licensor pursuant to this Agreement, section 4.10. Such assistance shall not be interpreted to include the royalties payable assistance or cooperation by the Company in any illegal activity or tax evasion by the Licensor.
4.11 Royalties payable to IGI under this Agreement the Licensor shall be paid quarterly on or before sixty forty-five (6045) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 from the end of each such calendar yearquarter. Each such quarterly payment shall be for unpaid royalties which that accrued within or prior to the Company's two most recently completed fiscal quarterquarters.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution of the Novasome Sublicense Agreement;
4.7.2 $300,000 upon dosing of the first patient in a Phase II clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.3 $500,000 upon dosing of the first patient in a Phase III clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No payment 4.12 Payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.the Territory
4.9 4.13 To the extent that the Company or any Affiliate of the Company is required required, by final order or judgment issued by a judgement of any court of competent jurisdiction to obtain a royalty bearing in any jurisdiction any license from a third party in order to make, use or sell any Licensed Product or Licensed Process, then up to *** of the royalties payable hereunder with respect to such Licensed Product or Licensed Process in such jurisdiction, then in such case the Company jurisdiction may deduct be deducted from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%) of the amount of royalties that the Company actually paid to the third party licensee in such jurisdiction; providedLicensor hereunder, however, provided that in no event shall the aggregate royalties payable to IGI the Licensor in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) *** as a result of any such deduction pursuant to this Article 4.9 deduction, and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.
4.14 In the event that the Licensor or any sublicensee registers, makes, has made, uses, leases, markets and/or sells any product in Germany, Switzerland, Greece, Sweden, Norway, Finland, Denmark, the United Kingdom, Ireland, France and/or Benelux, which incorporates information or know-how provided to the Licensor by the Company pursuant to paragraph 5.1 hereof, then the Licensor shall pay to the Company royalties in an amount equal to *** of Net Sales by the Licensor or any such sublicensee and *** of any lump-sum payments received by the Licensor from such sublicensee. Notwithstanding the foregoing, any novel indication (which is defined as any indication different from intraperitoneal dialysis and not included in the Field of Use and/or in the Field of Not Novel Indications) discovered by the Company shall be and remain the property of the Company for which it shall have exclusive world-wide rights to such indication.
(a) In the event that the Company develops proprietary information and data including but not limited to pre-clinical studies and clinical studies with applications outside the Field of Use and/or in the Field of Not Novel Indications ("Company Proprietary Information"), the Licensor shall be entitled to use the Company Proprietary Information within the Field of Use and/or in the Field of Not Novel Indications and outside the Territory but excluding those territories referred to in Section 4.14 above. In consideration for the use of the Company Proprietary Information, the Licensor shall pay the Company a fee in U.S. dollars equal to *** of the Company's expenses actually incurred for such information and data development, payable upon delivery thereof by the Company to the Licensor. The Licensor shall not be entitled to sublicense, assign, transfer, market or commercially exploit the Company Proprietary Information. The provisions of this section 4.15, shall not limit the Company's right to receive royalties pursuant to Section 4.14 above.
(b) In the event that the Licensor discovers and develops novel indications outside the Field of Use and/or in the Field of Not Novel Indications but including the field of interperitoneal dialysis, the Licensor may have the option to purchase any relevant Company Proprietary Information relating thereto. In consideration for the use of the Company Proprietary Information, the Licensor shall pay the Company a fee in U.S. dollars equal to *** of the Company's expenses actually incurred for such information and data development, payable upon delivery thereof by the Company to the Licensor.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 During 3.1 In consideration of the term license herein granted, LICENSEE shall pay fees and royalties to UNIVERSITY as follows:
(a) License issue fee of $[*****]) is due to UNIVERSITY within sixty (60) days of the Effective Date of this Agreement.
(b) Past patent expenses incurred by UNIVERSITY in the amounts and at the times as set forth in Appendix B.
(c) Running royalty in an amount equal to [*****] of the annual Net Sales of the Product(s) leased or sold by or for LICENSEE or its Sublicensees ("Running Royalty"), subject to reduction as set forth in the Company shall next sentence. In the event LICENSEE is required to pay royalties to a third party or third parties for the same Product or Process as licensed under this Agreement, then LICENSEE may reduce the Running Royalty by [*****] for each one dollar ($1.00) in royalties which LICENSEE is obligated to pay to IGI a third party or third parties under such licenses, provided however, that the royalties equal payable to six percent (6%) UNIVERSITY under this section shall not be reduced to less than [*****] of annual Net Sales of the Licensed Products covered Product(s) leased or sold by at least one issued and unexpired claim under the PTH Patent Rights; providedor for LICENSEE or its Sublicensees. If, however, that in any calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company shall pay IGI royalties equal to nine percent (9%) of any and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in such one calendar year. The Company's royalty obligations under this Article 4.1 , LICENSEE is not able to fully recover its [*****] portion of the payments due to a third party, it shall terminate on a country by country basis be entitled to carry forward such right of off-set to future calendar years with respect to the excess amount. [*****]. However, the parties agree that Licensee may only apply one of the aforementioned (i) royalty rate reduction of not less than [*****] of annual Net Sales or (ii) Combination Product reduction of Net Sales, as described above, at Licensee's option. For clarity, Licensee may either apply a royalty rate reduction in connection with royalties to a third party or third parties or a Combination Product reduction of Net Sales, as described above. In any event, the royalty rate shall not be less than [*****].
(d) By the first (1st) day of each Licensed Product upon anniversary of the Effective Date and until expiration or termination of this Agreement, LICENSEE agrees to pay UNIVERSITY an annual fee of:
(i) [*****] on the third (3rd) and fourth (4th) anniversaries;
(ii) [*****] on the fifth (5th) and sixth (6th) anniversaries;
(iii) [*****] on the seventh (7th) and eighth (8th) anniversary;
(iv) [*****] on the ninth (9th) and tenth (10th) anniversaries; and
(v) [*****] on the eleventh (11th) anniversary and every anniversary thereafter. This amount shall be decreased by [*****] in the event that clinical trials are ongoing but regulatory authority approval has not been granted, despite best efforts on part of LICENSEE. Such annual fees are creditable towards any other consideration, including royalty and milestone payments that are, as set forth herein, due to the UNIVERSITY by LICENSEE.
(e) Royalties are payable on a country-by-country basis beginning on the date of first commercial sale and ending on expiration of the last to expire of any patent included in the PTH Patent Rights covering the sale of such Licensed Product in such country.
4.2 As provided by and consistent with the terms of Article 1.7, on sales of Licensed Products by the Company to Affiliates that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 3.2 All payments hereunder shall be that gross sales amount which would have been received by the Company from a third party made in an arms-length transaction for the sale of the same such Licensed ProductsU.S. dollars.
4.3 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights.
4.4 3.3 In the event that a Licensed Product is sold in the form of a combination package together with companion products that any taxes, withholding or otherwise, are not themselves a License Product, the Net Sales for such combination package upon which the royalty due to IGI is based shall be calculated levied by multiplying the total sales price of such combination package by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separately, and B is the total invoice price of each of the other companion products included in the combination package if sold separately.
4.5 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGI. The Company shall furnish IGI with the original copies of all official receipts for such taxes. If any currency conversion shall be required taxing authority in connection with the accrual or payment of any royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period payable to which such royalty payments relate.
4.6 Consistent with Article 5 of UNIVERSITY under this Agreement, the royalties payable by the Company to IGI under this Agreement LICENSEE shall be paid quarterly on or before sixty (60) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar year. Each solely responsible to pay such payment shall be for unpaid royalties which accrued within or prior taxes to the Company's most recently completed fiscal quarter.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution of the Novasome Sublicense Agreement;
4.7.2 $300,000 upon dosing of the first patient in a Phase II clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or local tax authorities on behalf of the Company or any of its Affiliates or sublicensees;
4.7.3 $500,000 upon dosing of the first patient UNIVERSITY, as a nonprofit, tax-exempt organization as defined in a Phase III clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 To the extent that the Company is required by final order or judgment issued by a court of competent jurisdiction to obtain a royalty bearing license from a third party in order to sell any Licensed Product hereunder in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%Section 501(c)(3) of the Internal Revenue Code. Should LICENSEE be required under any law or regulation of any government entity or authority to withhold or deduct any portion of the payments on royalties due to UNIVERSITY, then the sum payable to UNIVERSITY shall be increased by the amount of royalties that the Company actually paid necessary to yield to UNIVERSITY an amount equal to the third party licensee sum it would have received had no withholdings or deductions been made. UNIVERSITY shall cooperate reasonably with LICENSEE in such jurisdiction; providedthe event LICENSEE elects to assert, howeverat its own expense, that in no event shall the aggregate royalties payable to IGI in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) as a result of exemption from any such deduction pursuant to this Article 4.9 and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periodstax or deduction.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 During (a) As consideration for the term licenses granted to BioTime from USCN in Article 2 of this Agreement, the Company BioTime shall pay to IGI royalties USCN a royalty equal to six percent (6%) to[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]% of annual the Net Sales of the Licensed Products covered received by at least one issued BioTime and unexpired claim under the PTH Patent Rights; providedits AFFILIATES for all LICENSED PRODUCTS sold, howeverperformed, that in or leased by BioTime or any calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company shall pay IGI royalties equal to nine percent (9%) of any and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in such calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect to each Licensed Product upon the expiration date of the last to expire of any patent included in the PTH Patent Rights covering the sale of such Licensed Product in such countryAFFILIATE.
4.2 As provided by and consistent with the terms of Article 1.7, on sales of Licensed Products by the Company to Affiliates that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for the sale of the same such Licensed Products.
4.3 (b) No multiple royalties shall be payable because on the basis that any LICENSED PRODUCT, its manufacture, use, lease lease, sale or sale of any Licensed Product is, performance is or shall be, be covered by more than one valid and unexpired claim contained in patent or patent application within the PTH Patent RightsPATENT RIGHTS.
4.4 In (c) If the event that use of PATENT RIGHTS or LICENSED TECHNOLOGY, or the use, manufacture, production, distribution, or sale of LICENSED MATERIALS or a Licensed Product is sold in LICENSED PRODUCT, within the form of FIELD OF USE would infringe a combination package together with companion products that are not themselves patent issued to a License Productthird party, the Net Sales for or if a third party alleges such combination package upon which the royalty due to IGI is based shall be calculated by multiplying the total sales price of such combination package by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separatelyinfringement, and B is the total invoice price of each of the other companion products included in the combination package if sold separately.
4.5 Royalty payments shall be paid in United States dollars in New York, New York or at after negotiation with such other place as IGI may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGI. The Company shall furnish IGI with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, the royalties payable by the Company to IGI under this Agreement shall be paid quarterly on or before sixty (60) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar year. Each such payment shall be for unpaid royalties which accrued within or prior to the Company's most recently completed fiscal quarter.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution of the Novasome Sublicense Agreement;
4.7.2 $300,000 upon dosing of the first patient in a Phase II clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.3 $500,000 upon dosing of the first patient in a Phase III clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 To the extent that the Company is required by final order or judgment issued by a court of competent jurisdiction to obtain third party a royalty bearing license from a to use the third party’s patent is required to eliminate or avoid such infringement or claim of infringement or to settle any lawsuit or other proceeding alleging patent infringement, then BioTime and any AFFILIATE or sublicensee may deduct the royalties paid to the third party in order to sell any Licensed Product hereunder in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction USCN pursuant to this Agreement up to to, but not more than, fifty percent (50%) of the amount royalties otherwise payable to USCN under this Agreement. Before entering into any such royalty bearing license with the third party, BioTime shall seek the opinion of royalties that legal counsel mutually acceptable to both BioTime and USCN as to whether the Company actually paid use of PATENT RIGHTS or LICENSED TECHNOLOGY, or the use, manufacture, production, distribution, or sale of LICENSED MATERIALS or a LICENSED PRODUCT, within the FIELD OF USE would infringe the patent issued to the third party, but no such opinion shall preclude BioTime or its AFFILIATES from entering into a royalty bearing license with such third party licensee in such jurisdiction; provided, however, that in no event shall the aggregate royalties payable to IGI in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) as a result settlement of any such deduction pursuant to this Article 4.9 and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periodslawsuit or other proceeding alleging patent infringement.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 During 3.1 In consideration of the term license herein granted, LICENSEE shall pay fees and royalties to UNIVERSITY as follows:
(a) License issue fee of $20,000 (twenty thousand dollars) is due to UNIVERSITY within sixty (60) days of the Effective Date of this Agreement.
(b) Past patent expenses incurred by UNIVERSITY in the amounts and at the times as set forth in Appendix B.
(c) Running royalty in an amount equal to five percent (5%) of the annual Net Sales of the Product(s) leased or sold by or for LICENSEE or its Sublicensees ("Running Royalty"), subject to reduction as set forth in the Company shall next sentence. In the event LICENSEE is required to pay royalties to a third party or third parties for the same Product or Process as licensed under this Agreement, then LICENSEE may reduce the Running Royalty by fifty cents ($0.50) for each one dollar ($1.00) in royalties which LICENSEE is obligated to pay to IGI a third party or third parties under such licenses, provided however, that the royalties equal payable to six UNIVERSITY under this section shall not be reduced to less than two and a half percent (62.5%) of annual Net Sales of the Licensed Products covered Product(s) leased or sold by at least one issued and unexpired claim under the PTH Patent Rights; providedor for LICENSEE or its Sublicensees. If, however, that in any one calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000)year, then the Company shall pay IGI royalties equal LICENSEE is not able to nine fully recover its fifty percent (950%) portion of any and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in the payments due to a third party, it shall be entitled to carry forward such right of off-set to future calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis years with respect to each Licensed Product upon the expiration date of the last to expire of any patent included in the PTH Patent Rights covering the sale of such Licensed Product in such country.
4.2 As provided by and consistent with the terms of Article 1.7excess amount. Further, on sales of Licensed Products by the Company to Affiliates that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from if a third party in an arms-length transaction for the sale of the same such Licensed Products.
4.3 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights.
4.4 In the event that a Licensed Product is sold in the form or provided as part of a system, package, or combination package together with companion product or service that involve one or more products that are or services not themselves covered by the Patent Rights (each, a License "Combination Product"), the Net Sales for such combination package upon which the royalty due to IGI is based shall be calculated by multiplying the total sales price Net Sales of such combination package Combination Product by the fraction A/(A+B), where A "A" is the invoice average unit selling price during the period in which Net Sales are being calculated for the Product included in such Combination Product when sold separately from any other products or services not covered by the Licensed IP and "B" is the total average unit selling price of the Licensed Combination Product if sold during the same period. In the event that no market price is available for the Product included in such Combination Product when supplied or priced separately, University and B is Licensee shall use best efforts to determine in good faith the total invoice price fair market value thereof and if they cannot determine the fair market value thereof within ten days of each either parties request of a determination they shall select a third party mutually acceptable to make such determination. However, the parties agree that Licensee may only apply one of the other companion products included in the combination package if sold separately.
4.5 Royalty payments shall be paid in United States dollars in New Yorkaforementioned (i) royalty rate reduction of not less than two and a half percent (2.5%) of annual Net Sales or (ii) Combination Product reduction of Net Sales, New York or as described above, at such other place as IGI Licensee's option. For clarity, Licensee may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the either apply a royalty payments shall be deducted from such royalty payment to IGI. The Company shall furnish IGI with the original copies of all official receipts for such taxes. If any currency conversion shall be required rate reduction in connection with royalties to a third party or third parties or a Combination Product reduction of Net Sales, as described above. In any event, the payment of royalties hereunder, such conversion royalty rate shall not be made by using less than two and a half percent (2.5%).
(d) By the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business first (1st) day of each anniversary of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 Effective Date and until expiration or termination of this Agreement, LICENSEE agrees to pay UNIVERSITY an annual fee of:
(i) $2,000 (two thousand dollars) on the third (3rd) and fourth (4th) anniversaries;
(ii) $4,000 (four thousand dollars) on the fifth (5th) and sixth (6th) anniversaries;
(iii) $10,000 (ten thousand dollars) on the seventh (7th) and eighth (8th) anniversary;
(iv) $25,000 (twenty thousand dollars) on the ninth (9th) and tenth (10th) anniversaries; and
(v) $50,000 (fifty thousand dollars) on the eleventh (11th) anniversary and every anniversary thereafter. This amount shall be decreased by $25,000 (twenty-five thousand dollars) in the event that clinical trials are ongoing but regulatory authority approval has not been granted, despite best efforts on part of LICENSEE. Such annual fees are creditable towards any other consideration, including royalty and milestone payments that are, as set forth herein, due to the UNIVERSITY by LICENSEE.
(e) Royalties are payable on a country-by-country basis beginning on the date of first commercial sale and ending on expiration of the last to expire Patent Rights in such country.
3.2 All payments hereunder shall be made in U.S. dollars.
3.3 In the event that any taxes, withholding or otherwise, are levied by any taxing authority in connection with accrual or payment of any royalties payable by the Company to IGI UNIVERSITY under this Agreement Agreement, the LICENSEE shall be paid quarterly on or before sixty (60) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar year. Each solely responsible to pay such payment shall be for unpaid royalties which accrued within or prior taxes to the Company's most recently completed fiscal quarter.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution of the Novasome Sublicense Agreement;
4.7.2 $300,000 upon dosing of the first patient in a Phase II clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or local tax authorities on behalf of the Company or any of its Affiliates or sublicensees;
4.7.3 $500,000 upon dosing of the first patient UNIVERSITY, as a nonprofit, tax-exempt organization as defined in a Phase III clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 To the extent that the Company is required by final order or judgment issued by a court of competent jurisdiction to obtain a royalty bearing license from a third party in order to sell any Licensed Product hereunder in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%Section 501(c)(3) of the Internal Revenue Code. Should LICENSEE be required under any law or regulation of any government entity or authority to withhold or deduct any portion of the payments on royalties due to UNIVERSITY, then the sum payable to UNIVERSITY shall be increased by the amount of royalties that the Company actually paid necessary to yield to UNIVERSITY an amount equal to the third party licensee sum it would have received had no withholdings or deductions been made. UNIVERSITY shall cooperate reasonably with LICENSEE in such jurisdiction; providedthe event LICENSEE elects to assert, howeverat its own expense, that in no event shall the aggregate royalties payable to IGI in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) as a result of exemption from any such deduction pursuant to this Article 4.9 and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.tax or deduction.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 During For the term of this Agreementrights, privileges and license granted hereunder, the Company shall pay to IGI the Licensor as set forth below, and in accordance with the provisions of Articles 4.4 and 4.5, to the end of the term of the Patent Rights or until this License Agreement shall be terminated as hereinafter provided:
4.1.1 The Company shall pay to the Licensor non-refundable semi-annual royalties in an amount equal to six percent (6%) of annual Net Sales by the Company, or any Affiliate of the Company, of the Licensed Products or Licensed Processes covered by at least one issued and unexpired claim under the PTH Patent RightsRights and three percent (3%) of Net Sales by the Company or any Affiliate of the Company covered by pending patent claims.
4.1.2 The Company shall pay to the Licensor semi-annual royalties in an amount equal to twenty two and one half percent (22.5%) of the royalties received by the Company or its Affiliate from sales by any sublicensee of Licensed Products or Licensed Processes. In addition, the Company shall pay to the Licensor fifteen percent (15%) of all sublicensing fees or other lump sum payments or other compensation received by the Company or an Affiliate from its sublicensees for the use, lease or sale of Licensed Products and Licensed Processes; provided, however, that in any calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company shall pay IGI royalties equal to nine the Licensor fifty percent (950%) of any lump sum payments, if any, that are made within six (6) months from the Execution of this Agreement and all Net Sales greater than Two Hundred Million Dollars received by the Company or its Affiliate; provided further, however, that no amounts shall be due and payable to the Licensor pursuant to this paragraph 4.1.2 on account of ($200,000,000a) in such calendar year. The Company's royalty obligations under this Article 4.1 payments made to the Company solely for bona fide research and development (but which shall terminate on a country by country basis with respect not include option or other similar fees/consideration for access to each Licensed Product upon or rights to the expiration date Patent Rights or Know-how and (b) purchases of debt or equity securities of the last to expire of any patent included in the PTH Patent Rights covering the sale of such Licensed Product in such countryCompany.
4.2 As provided by and consistent with the terms of Article 1.7, on On sales of Licensed Products by the Company to Affiliates that or related parties which are end users of such Licensed Products, Products the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for transaction, based on sales of like quantity and quality products at or about the sale time of the same such Licensed Productstransaction.
4.3 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product or Licensed Process is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights. In addition, royalties shall be paid for a Licensed Product or Licensed Process based upon only one of paragraphs 4.1.1 or 4.1.2 above (that is, royalties on direct sales of a Licensed Product or Licensed Process by the Company or its Affiliates shall be based only on paragraph 4.1.1, while royalties on sales of a Licensed Product or Licensed Process by the Company's sublicensees shall be based only on paragraph 4.1.2, so as to avoid double counting).
4.4 In the event that a Licensed Product is sold in the form of a combination package together with companion product containing one or more products that or technologies which are themselves not themselves a License Licensed Product, the Net Sales for such combination package upon which the royalty due to IGI is based product shall be calculated by multiplying the total sales price of such combination package product by the fraction A/(A+B), ) where A is the invoice price of the Licensed Product or the Fair Market Value of the Licensed Product if sold separately, to an Affiliate and B is the total invoice price of each the other products or technologies or the Fair Market Value of the other companion products included in or technologies if purchased from an Affiliate. In the case of a combination package if sold separatelyproduct which includes one or more Licensed Products, the Net Sales for such combination product upon which the royalty due to the Licensor is based shall not be less than the normal aggregate Net Sales for such Licensed Product.
4.5 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI the Licensor may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGIthe Licensor. The Company shall furnish IGI the Licensor with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, Royalties payable to the royalties payable by the Company to IGI under this Agreement Licensor shall be paid quarterly on or before within sixty (60) days following each from the end of the fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar yearquarter. Each such payment shall be for unpaid royalties which accrued within or prior to the Company's two most recently completed fiscal quarterquarters.
4.7 Subject to the terms of this paragraph 4.7, the Company shall pay to the Licensor a non-refundable minimum annual royalty (the "Minimum Annual Royalty") equal to seventy-five thousand dollars ($75,000) per year.
4.7.1 The Minimum Annual Royalty shall be fully creditable against (a) any payments owing to the Licensor by the Company on account of any payments due and owing under this Article 4, which payments are earned by the Licensor in such year; (b) any payments in such year paid or payable under any CRADA and (c) any payments in such year paid or payable on account of Sponsored Research with any of the Co-owners.
4.7.2 Such minimum annual royalties shall be payable in accordance with paragraph 5.
1. Notwithstanding the provisions of the above paragraph 4.6, any payment required to be made to the Licensor to meet the Minimum Annual Royalty owed shall be due and payable within sixty (60) days from the end of each calendar year.
4.7.3 Notwithstanding anything else to the contrary, in the event that the Company is not granted access to the N.C.I. Clinical Data and pre-clinical data owned by N.I.H. relating to potential Licensed Products and Licensed Processes, then no Minimum Annual Royalty shall be due or payable to the Licensor until the calendar year in which the first Phase II clinical trial pursuant to a Company sponsored IND has commenced, thereafter, the Minimum Annual Royalty shall be reduced to thirty-seven thousand five hundred dollars ($37,500) until the First Commercial Sale.
4.8 The Company shall make pay to the Licensor the following milestone payments which shall be credited against or deducted from royalties otherwise owed or which may in the future be owing payable to IGIthe Licensor on account of sublicensing royalties and/or lump sum payments received by the Company or its Affiliate from sublicensees pursuant to paragraph 4.1.2:
4.7.1 4.8.1 One hundred fifty thousand dollars ($300,000 150,000) as an up-front licensing fee, payable upon the earlier to occur of (a) receipt by the Company of the N.C.I. Clinical Data and pre-clinical data or (b) the date that is six (6) months from the Effective Date, in accordance with paragraph 5.
1. Any shares of Common Stock (as defined below) issued to the Licensor in satisfaction of the payment due pursuant to this paragraph 4.8.1 shall be priced at the closing price per share of the Common Stock for the ten (10) consecutive trading days preceding (i) the execution of this Agreement and (ii) the Novasome Sublicense Agreementdate on which payment is made, whichever is lower;
4.7.2 4.8.2 Seventy-five thousand dollars ($300,000 75,000) upon dosing approval of the first patient in a Phase II clinical trial of a Company sponsored IND for any Licensed Product for with the treatment of psoriasis sponsored by United States Food and Drug Administration (FDA) or on behalf of the Company or any of its Affiliates or sublicenseesforeign equivalent, payable in accordance with paragraph 5.1;
4.7.3 4.8.3 One hundred fifty thousand dollars ($500,000 150,000) upon dosing the date of initiation of the first patient in a Company sponsored Phase III clinical trial of Clinical Trial in the United States for a Licensed Product for Product, payable in accordance with paragraph 5.1;
4.8.4 Two hundred fifty thousand dollars ($250,000) upon the treatment of psoriasis sponsored by or on behalf filing of the first Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a sponsored New Drug Application ("NDA") for a Licensed Product for with the treatment of psoriasis filed by United States FDA or on behalf of the Company or any of its Affiliates or sublicensees;foreign equivalent, payable in accordance with paragraph 5.1; and
4.7.5 4.8.5 One-million five hundred thousand dollars ($2,400,000 1,500,000) upon the first final approval by the FDA of a Company sponsored NDA for a Licensed Product for by the treatment of psoriasis filed by United States FDA or on behalf of the Company or its equivalent in any of its Affiliates or sublicensees;Foreign Major Market Country, payable in accordance with paragraph 5.1.
4.7.6 $500,000 upon dosing of the first patient 4.9 Notwithstanding anything in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission this Agreement to the FDA of the first NDA for a Licensed Product for the treatment of any diseasecontrary, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No no payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product or Licensed Process in a country if there if:
4.9.1 There are no issued PTH Patent Rights underlying such Licensed Product in such country; or
4.9.2 To the extent that a patent application is pending, there is no claim within such patent application on which a royalty herein can reasonably be based which has been pending for less than seven (7) years since the initial filing date.
4.9 4.10 To the extent that the Company or any Affiliate of the Company is required required, by final order or judgment issued by a judgement of any court of competent jurisdiction to obtain a royalty bearing in any jurisdiction any license from a third party in order to sell any Licensed Product practice the rights purported to be granted to the Company by the Licensor hereunder under issued patents in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to fifty percent (50%) of the amount of royalties that the Company actually paid payable under such license in such jurisdiction may be deducted from royalties otherwise payable to the third party licensee in such jurisdiction; providedLicensor hereunder, however, provided that in no event shall the aggregate royalties payable to IGI the Licensor in any quarterly semi-annual period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent percent (50%) as a result of any such deduction pursuant to this Article 4.9 and deduction, provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.
4.11 For a period of three (3) years from the date of execution of this Agreement the Company agrees to use its reasonable efforts to supply up to ten thousand dollars ($10,000) worth of O6 Benzyl guanine to the N.C.I. at the Company's expense and calculated at the Company's cost. Any requirements of O6 Benzyl guanine on the part of the N.C.I. in excess of such amount shall be provided to the N.C.I. by the Company at the Company's cost. The Company's obligation to supply O6 Benzyl guanine to the N.C.I. shall terminate upon the earlier to occur of (a) five (5) years from the date of execution of this Agreement, (b) termination of this Agreement pursuant to Article 8 or (c) the establishment of a CRADA, which shall supersede this paragraph 4.11.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 During In consideration of the term of this Agreementrights, privileges and the license granted hereunder, the Company Licensee shall pay to IGI royalties the Licensors as set forth in, and in accordance with the provisions of, this Article 4 until termination of this Agreement as hereinafter provided.
4.2 The Licensee shall pay to Licensors:
4.2.1 a non-refundable semi-annual royalty in an amount equal to six [***] percent (6[***]%) of annual Net Sales by the Licensee, or any Affiliate of the Licensee, of the Licensed Products covered or Licensed Processes;
4.2.2 With respect to any royalties received by at least one issued and unexpired claim under the PTH Patent Rights; provided, however, that in Licensee or its Affiliate from sales by any calendar year in which Net Sales exceed Two Hundred Million Dollars sublicensee of Licensed Products or Licensed Processes ($200,000,000“Sublicense Royalties”), then the Company Licensee shall pay IGI remit to Licensors a non-refundable semi-annual royalties in an amount equal to nine the greater of (a) [***] percent (9[***]%) of any the Sublicense Royalties and all (b) [***] percent ([***]%) of Net Sales greater than Two Hundred Million Dollars ($200,000,000) in by any such calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect to each Licensed Product upon the expiration date of the last to expire of any patent included in the PTH Patent Rights covering the sale of such Licensed Product in such countrysublicense.
4.2 As provided 4.3 The Licensee agrees to pay to the Licensors, or its designee(s) the following additional consideration:
4.3.1 The Milestone Payments set forth on Exhibit A attached hereto; and
4.3.2 [***] percent ([***]%) of all sublicensing fees or other lump sum payments or other compensation received by and consistent with the terms of Article 1.7Licensee or an Affiliate from its sublicensees for the use, on sales lease or sale of Licensed Products by the Company to Affiliates that are end users of such and Licensed ProductsProcesses, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been excluding (i) payments used or reimbursed for research and development and (ii) payments received by the Company from as a third party in an arms-length transaction for the sale result of the same such Licensed Productsissuance of debt or equity securities of the Licensee.
4.3 4.4 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product or Licensed Process is, or shall be, covered by more than one valid and unexpired claim Valid Claim contained in the PTH Patent Rights.
4.4 In the event that a Licensed Product is sold in the form of a combination package together with companion products that are not themselves a License Product. Additionally, the Net Sales for such combination package upon which the royalty due to IGI is based shall be calculated by multiplying the total sales price of such combination package by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separately, and B is the total invoice price of each of the other companion products included in the combination package if sold separately.
4.5 Royalty payments royalties shall be paid in United States dollars in New York, New York or at such other place as IGI may reasonably designate consistent with to Licensors for the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGI. The Company shall furnish IGI with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, the royalties payable by the Company to IGI under this Agreement shall be paid quarterly on or before sixty (60) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar year. Each such payment shall be for unpaid royalties which accrued within or prior to the Company's most recently completed fiscal quarter.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution of the Novasome Sublicense Agreement;
4.7.2 $300,000 upon dosing of the first patient in a Phase II clinical trial sale of a Licensed Product for the treatment based upon only one of psoriasis sponsored by Articles 4.2.1 or 4.2.2 above, but in no case both (that is, royalties due to Licensors on behalf of the Company or any of its Affiliates or sublicensees;
4.7.3 $500,000 upon dosing of the first patient in a Phase III clinical trial direct sales of a Licensed Product for by the treatment of psoriasis sponsored by Licensee or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of to a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or Third Party shall be based only on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or Article 4.2.1, while royalties on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial sales of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for Licensee’s Sublicensees to a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No payment obligations Third Party shall be due with respect based only on Article 4.2.2, so as to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such countryavoid double counting).
4.9 To the extent that the Company is required by final order or judgment issued by a court of competent jurisdiction to obtain a royalty bearing license from a third party in order to sell any Licensed Product hereunder in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%) of the amount of royalties that the Company actually paid to the third party licensee in such jurisdiction; provided, however, that in no event shall the aggregate royalties payable to IGI in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) as a result of any such deduction pursuant to this Article 4.9 and provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.
Appears in 1 contract
Sources: Exclusive License Agreement (Dare Bioscience, Inc.)
ROYALTIES AND OTHER CONSIDERATION. 4.1 During (a) In consideration of the term assignment to Assignee in Paragraph 2 above and the other grants to Assignee hereunder, Assignor shall be entitled to (i) the membership interests in Assignee pursuant to the Subscription Agreement of this even date (the "Subscription Agreement") and executed contemporaneously herewith; and (ii) the Assignor Royalty as described in Paragraph 5 hereof; provided that Assignor does not materially breach any of its representations, warranties or agreements hereunder (but subject to the limitations on Assignor's liability described in Paragraph 8(c) below).
(b) As of even date herewith, the Assignor and MM Companies have entered into a Limited Liability Company shall pay to IGI royalties equal to six percent Agreement (6%the "LLC Agreement") of annual Net Sales with respect to, among other things, the operations and the sharing of the Licensed Products covered by at least one issued resultant profits, losses and unexpired claim under cash flow of the PTH Patent Rights; provided, however, Assignee. The Assignor and MM Companies contemplate not only that in any calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company shall pay IGI royalties equal to nine percent (9%) of any and all Net Sales greater than Two Hundred Million Dollars business relating to the exploitation and use of the Traditional Licenses, as described more fully herein ($200,000,000the "Traditional Licensing Business"), shall be conducted exclusively through the Assignee, but that the Assignee shall also conduct such other business activities and operations as the Board of Managers of the Assignee shall determine from time to time to be appropriate and suitable to be carried on by the Assignee (the "Non-Traditional Businesses"). Under the LLC Agreement, (i) income equal to the Assignor Royalty payable hereunder in respect of any fiscal year of the Assignee shall be treated as a specially allocated item of income solely allocable to the Assignor, and (ii) in such calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect to each Licensed Product upon the expiration date of any fiscal year of the last Assignee, income equal to expire the amount of any patent included the Net Traditional License Payments (after deduction of the Assignor Royalty payable to the Assignor in the PTH Patent Rights covering the sale respect of such Licensed Product year in such country.
4.2 As provided by and consistent accordance with the terms of Article 1.7, on sales of Licensed Products this Agreement) to be retained by the Company Assignee shall be treated as specially allocated items of income solely allocable to Affiliates MM Companies.
(c) Notwithstanding anything to the contrary contained herein and in that are end users certain Services Agreement (the "Services Agreement") entered into as of even date herewith by and between George Foreman Productions, Inc. ("GFPI") and Assignee, in the ev▇▇▇ ▇▇▇▇ (▇) ▇he Assignee shall enter into and conduct Non-Traditional Businesses, (ii) a tax distribution (the "Tax Distribution") is distributed in accordance with the terms of the LLC Agreement by the Assignee to the Assignor in respect of the Assignor's share of the taxable income of such Licensed ProductsNon-Traditional Businesses for a given fiscal year of the Assignee and (iii) in accordance with the terms of the LLC Agreement, MM Companies elects not to receive a Tax Distribution with respect to its share of the taxable income of such Non-Traditional Businesses for a given fiscal year of the Assignee, then the following shall occur: (x) first, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for the sale of the same such Licensed Products.
4.3 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights.
4.4 In the event that a Licensed Product is sold in the form of a combination package together with companion products that are not themselves a License Product, the Net Sales for such combination package upon which the royalty due to IGI is based shall be calculated by multiplying the total sales price of such combination package by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separately, and B is the total invoice price of each of the other companion products included in the combination package if sold separately.
4.5 Assignor Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI may reasonably designate consistent with the laws and regulations controlling in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGI. The Company shall furnish IGI with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, the royalties otherwise payable by the Company Assignee to IGI under this Agreement the Assignor in respect of such year shall be paid quarterly on or before sixty reduced by the amount of such Tax Distribution to the Assignor (60hereinafter the amount by which the Assignor Royalty is to be reduced is referred to as the "Reduction Amount"), and (y) days following each fiscal quarter ending March 31second, June 30, September 30 and December 31 of each calendar year. Each such payment income in an amount equal to the Reduction Amount shall be for unpaid royalties which accrued within or prior allocated in accordance with the provisions of the LLC Agreement.
(d) In addition, notwithstanding anything to the Company's most recently completed contrary contained in this Assignment Agreement and the Services Agreement, if the Reduction Amount for any fiscal quarter.
4.7 The Company shall make the following milestone payments to IGI:
4.7.1 $300,000 upon execution year of the Novasome Sublicense Agreement;
4.7.2 $300,000 upon dosing Assignee shall exceed the amount of the first patient in a Phase II clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.3 $500,000 upon dosing of the first patient in a Phase III clinical trial of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon the final approval by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees.
4.8 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 To the extent that the Company is required by final order or judgment issued by a court of competent jurisdiction to obtain a royalty bearing license from a third party in order to sell any Licensed Product hereunder in such jurisdiction, then in such case the Company may deduct from the royalties otherwise Assignor Royalty payable hereunder to IGI for the License Products sold Assignee in respect of such jurisdiction year, such excess (the "Excess Reduction Amount") shall next be applied to reduce up to percent (50%but not in excess of) of the amount of royalties the Bonus (as such term is defined in the Services Agreement) that the Company actually paid to the third party licensee in such jurisdiction; provided, however, that in no event shall the aggregate royalties would otherwise be payable to IGI GFPI for such year under the Services Agreement, and any resultant increase in any quarterly period on the sales income of Licensed Products in such jurisdiction be reduced by more than fifty per cent (50%) as a result of any such deduction pursuant to this Article 4.9 and provided further that any excess deduction remaining as a result the Assignee from the reduction of such foregoing limitation may Bonus shall be carried forward to subsequent periodsallocated in accordance with the provisions of the LLC Agreement.
Appears in 1 contract
Sources: Assignment Agreement (George Foreman Enterprises Inc)
ROYALTIES AND OTHER CONSIDERATION. 4.1 During As consideration for the term of this Agreementlicense granted hereunder, on the Effective Date, the Company shall pay issue to IGI royalties equal to six Licensor a number of shares of common stock of the Company, par value $.001 per share (“Common Stock”) representing [*] percent (6[*]%) of the outstanding shares of Common Stock of the Company, on a fully diluted basis, as of the Effective Date. Licensor agrees to execute such other documents and to provide such additional information as may be required by law to issue the Common Stock.
4.2 As further consideration for the license granted hereunder, the Company agrees to pay to Licensor the royalties set forth below, and in accordance with the provisions of Articles 4.5 and 4.6, to the end of the term of the Patent Rights or until this Agreement shall be terminated as hereinafter provided:
4.2.1 The Company shall pay to Licensor non-refundable semi-annual royalties in an amount equal to [*] percent ([*]%) of Net Sales by the Company, or any Affiliate of the Company, of the commercialized Licensed Products or commercialized Licensed Processes covered by at least one issued and unexpired claim under the PTH Patent Rights; provided.
4.2.2 If the Licensed Product or Licensed Process is commercialized by a sublicensee, however, that in any calendar year in which Net Sales exceed Two Hundred Million Dollars ($200,000,000), then the Company shall pay IGI insure that Licensor receives semi-annual royalties in an amount equal to nine [*] percent (9[*]%) of any and all the Net Sales greater than Two Hundred Million Dollars ($200,000,000) in of such calendar yearsublicensee covered by at least one issued and unexpired claim under the Patent Rights. The Company's Accordingly, it is intended that royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect payments due to each Licensed Product upon the expiration date of Licensor will be the last to expire of any patent included in same as if the PTH Patent Rights covering the sale of Company had not sublicensed such Licensed Product in such country.
4.2 As provided by and consistent with the terms of Article 1.7, on sales of or Licensed Products by the Company to Affiliates that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been received by the Company from a third party in an arms-length transaction for the sale of the same such Licensed ProductsProcess.
4.3 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product or Licensed Process is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights. In addition, royalties shall be paid for a Licensed Product or Licensed Process based upon only one of paragraphs 4.2.1 or 4.2.2 above (that is, royalties on direct sales of a Licensed Product or Licensed Process by the Company or its Affiliates shall be based only on paragraph 4.2.1, while royalties on sales of a Licensed Product or Licensed Process by the Company’s sublicensees shall be based only on paragraph 4.2.2, so as to avoid double counting). [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
4.4 In the event that a Licensed Product is sold in the form of a combination package together with companion product containing one or more products that or technologies which are themselves not themselves a License Licensed Product, the Net Sales for such combination package upon which the royalty due to IGI is based product shall be calculated by multiplying the total sales price of such combination package product by the fraction A/(A+B), ) where A is the invoice price of the Licensed Product or the fair market value of the Licensed Product if sold separately, to an Affiliate (if the Fair Market Value is greater than the invoice price) and B is the total invoice price of each the other products or technologies or the Fair Market Value of the other companion products included in or technologies if purchased from an Affiliate (if the Fair Market Value is greater than the invoice price). In the case of a combination package if sold separatelyproduct which includes one or more Licensed Products, the Net Sales for such combination product upon which the royalty due to Licensor is based shall not be less than the normal aggregate Net Sales for such Licensed Product.
4.5 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI Licensor may reasonably designate consistent with the laws and regulations controlling in the United States and if applicable in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGILicensor. The Company shall furnish IGI Licensor with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, the royalties Royalties payable by the Company to IGI under this Agreement Licensor shall be paid quarterly semi-annually on or before sixty (60) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 of each calendar year. Each such payment shall be for unpaid royalties which accrued within or prior to the Company's ’s two most recently completed fiscal quarterquarters.
4.7 The As further consideration for the license granted hereunder, the Company shall make pay to Licensor the following milestone payments to IGIand licensing fee:
4.7.1 4.8.1 $300,000 [*] upon execution of the Novasome Sublicense Agreement;this Agreement as a licensing fee
4.7.2 4.8.2 $300,000 upon dosing [*] within fifteen (15) days of the first patient in a Phase II clinical trial date on which the Company [*];
4.8.3 $[*] within fifteen (15) days of the first date on which the Company [*];
4.8.4 $[*] within fifteen (15) days of the first date on which (x) the [*] relating to a Licensed Product for or (y) the Company’s first [*]. [*] Confidential treatment of psoriasis sponsored by or on behalf of requested; certain information omitted and filed separately with the Company or any of its Affiliates or sublicensees;SEC.
4.7.3 4.8.5 $500,000 [*] upon dosing of the first patient in a Phase III clinical trial to occur of a Licensed Product for the treatment of psoriasis sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance by the FDA of a New Drug Application ("NDA") [*] for a Licensed Product for or (y) a [*] (as applicable).
4.8.6 The Company shall also remit to Licensor (i) $[*] upon the treatment [*] anniversary of psoriasis filed by the License Agreement; (ii) $[*] upon the [*] anniversary of the License Agreement; and (iii) $[*] upon each of the[ *] anniversaries of the Licensing Agreement (collectively the “Inventor Payments”). The Inventor Payments described in 4.8.6(i) and 4.8.6(ii) shall be payable in cash. The Inventor Payments described in 4.8.6(iii) (the payments to begin upon the [*] anniversary of the License Agreement) shall be payable in either cash or on behalf shares of Common Stock at the sole discretion of the Company or any of its Affiliates or sublicensees;
4.7.5 $2,400,000 upon if the final approval Common Stock is publicly traded at the time each payment is due. If the Common Stock is not publicly traded at the time an Inventor Payment described in 4.8.6(iii) is due, then such Inventor Payment shall be made in cash. Notwithstanding anything in this Section 4.8, the foregoing milestone payments shall be applicable only to the first [*] Licensed Products developed by the FDA of a NDA for a Licensed Product for the treatment of psoriasis filed by or on behalf of Company. Additionally, in no event shall the Company or be obligated to pay any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of a Milestone Payment more than one time for each such Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is sponsored by or on behalf of the Company or any of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicensees; and
4.7.8 $2,400,000 upon the final approval by the FDA of the first NDA for a Licensed Product for the treatment of any disease, physical condition, ailment or illness other than psoriasis that is filed by or on behalf of the Company or any of its Affiliates or sublicenseesProduct.
4.8 4.9 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 4.10 To the extent that the Company or any Affiliate of the Company is required (i) in its sole discretion after appropriate legal analysis, or (ii) by final order or judgment issued by a of any court of competent jurisdiction in any jurisdiction, to obtain a royalty bearing license from a third party in order to sell any Licensed Product practice the rights purported to be granted to the Company by Licensor hereunder under Patent Rights in such jurisdiction, then in such case the Company may deduct from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to [*] percent (50[*]%) of the amount of royalties that the Company actually paid to the third party licensee payable under such license in such jurisdiction; providedjurisdiction may be deducted from royalties otherwise payable to Licensor hereunder, however, provided that in no event shall the aggregate royalties payable to IGI Licensor in any quarterly semi-annual period on the sales of Licensed Products in such jurisdiction be reduced by more than fifty [*] per cent (50[*]%) as a result of any such deduction pursuant to this Article 4.9 and deduction, provided further that any excess deduction remaining as a result of such foregoing limitation may be carried forward to subsequent periods.
Appears in 1 contract
ROYALTIES AND OTHER CONSIDERATION. 4.1 The Company agrees to pay to the Licensor the royalties set forth below, and in accordance with the provisions of Sections 4.5 and 4.6, to (i) the end of the term of the Patent Rights or (ii) [*] from first commercial sale of any Licensed Product, whichever is later, or until this Agreement terminates as hereinafter provided:
4.1.1 During the term of this the License Agreement, the Company shall pay to IGI the Licensor royalties equal to six percent (6%) [*] of annual Net Sales received by the Company resulting from the sale of any Licensed Product by or on behalf of the Company to an end user.
4.1.2 During the term of the License Agreement, the Company shall pay to the Licensor royalties equal to [*] of the royalties received by the Company resulting from sales by or on behalf of any sublicensee of Licensed Products covered by at least one issued and unexpired claim under the PTH Patent Rights; to an end user, provided, however, that in any calendar year in which no case shall the Licensor receive less than [*] of Net Sales exceed Two Hundred Million Dollars ($200,000,000)of Licensed Products from any sublicensee to an end user. Notwithstanding the foregoing, should the Company receive in excess of a [*] royalty on Net Sales of a Licensed Product from a sublicensee, then the Company shall will pay IGI royalties equal to nine percent (9%) of any and all Net Sales greater than Two Hundred Million Dollars ($200,000,000) in such calendar year. The Company's royalty obligations under this Article 4.1 shall terminate on a country by country basis with respect to each Licensed Product upon the expiration date of the last to expire of any patent included in the PTH Patent Rights covering the sale Licensor [*] of such Licensed Product in such country.
4.2 As provided by and consistent with the terms of Article 1.7, on sales of Licensed Products by the Company to Affiliates that are end users of such Licensed Products, the value of Net Sales attributed thereto under this Article 4 shall be that gross sales amount which would have been royalties received by the Company in excess of [*] of Net Sales of Licensed Products from the sublicensee. By way of example, should the Company receive a [*] royalty from a third party in sublicensee, then the Licensor shall be entitled to receive its [*] of Net Sales of Licensed Products from the sublicensee to an arms-length transaction for end user plus [*]of Net Sales of Licensed Products from such sublicensee to an end user (determined by giving the sale Licensor [*] of the same [*] royalty in excess of [*]) for a total royalty to the Licensor equal to [*] of Net Sales of Licensed Products from such Licensed Productssublicensee to an end user.
4.3 4.2 No multiple royalties shall be payable because the use, lease or sale of any Licensed Product or Licensed Process is, or shall be, covered by more than one valid and unexpired claim contained in the PTH Patent Rights. In addition, royalties shall be paid for a Licensed Product or Licensed Process based upon only one of Sections 4.1.1 or 4.1.2 above (that is, royalties on direct sales of a Licensed Product or Licensed Process by the Company or its Affiliates shall be based only on clause 4.1.1, while royalties on sales of a Licensed Product or Licensed Process by the Company's sublicensees shall be based only on clause 4.1.2, so as to avoid double counting).
4.4 4.3 In the event that a Licensed Product is sold in the form of a combination package together with companion product containing one or more products that or technologies which are themselves not themselves a License Licensed Product, the Net Sales for such combination package upon which the royalty due to IGI is based product shall be calculated by multiplying the total sales price of such combination package product by the fraction A/(A+B), ) where A is the invoice price of the Licensed Product or the Fair Market Value of the Licensed Product if sold separately, to an Affiliate and B is the total invoice price of each the other products or technologies or the Fair Market Value of the other companion products included in or technologies if purchased from an Affiliate. In the case of a combination package if sold separatelyproduct which includes one or more Licensed Products, the Net Sales for such combination product upon which the royalty due to the Licensor is based shall not be less than the normal aggregate Net Sales for such Licensed Product.
4.5 4.4 Royalty payments shall be paid in United States dollars in New York, New York or at such other place as IGI the Licensor may reasonably designate consistent with the laws and regulations controlling in the United States and if applicable in any foreign country. Any withholding taxes which the Company, its Affiliate or any sublicensee shall be required by law to withhold on remittance of the royalty payments shall be deducted from such royalty payment to IGIthe Licensor. The Company shall furnish IGI the Licensor with the original copies of all official receipts for such taxes. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at Citibank, N.A. N.A., in New York, New York on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
4.6 Consistent with Article 5 of this Agreement, 4.5 Royalties payable to the royalties payable by the Company to IGI under this Agreement Licensor shall be paid on a quarterly on or before sixty basis within thirty-five (6035) days following each fiscal quarter ending March 31, June 30, September 30 and December 31 of the end of each calendar yearquarter. Each such payment shall be for unpaid royalties which accrued within or prior to the Company's most recently completed fiscal calendar quarter.
4.7 The 4.6 As further consideration for the license granted hereunder, the Company shall make pay to the Licensor the following one time milestone payments (which milestone payments shall not be deducted from royalties otherwise owed or which may in the future be owing to IGI:the Licensor on account of sublicensing royalties and/or lump sum payments received by the Company or its Affiliate from sublicensees pursuant to clause 4.1.2):
4.7.1 $300,000 upon execution 4.6.1 [*] within thirty (30) days of the Novasome Sublicense Agreementfirst date on which the Company doses the first patient in a Phase II clinical trial with a Licensed Product to treat a Category 1 medical condition under a Company sponsored or Company sublicensee sponsored IND;
4.7.2 $300,000 upon 4.6.2 [*] within thirty (30) days of the first date on which the Company doses the first patient in a Phase III clinical trial to determine efficacy with a Licensed Product to treat a Category 1 medical condition under a Company sponsored or Company sublicensee sponsored IND;
4.6.3 [*] within thirty (30) days of the first date on which (x) the United States Food & Drug Administration (the "FDA") accepts a biologics license or other marketing application (an "NDA"), (y) the European Medicines Evaluation Agency accepts the equivalent of an NDA or (z) the Japanese Food & Drug Administration accepts the equivalent of an NDA (and only the first of these three events to occur), in each case, submitted by the Company or its sublicensee relating to a Licensed Product for the treatment of a Category 1 medical condition;
4.6.4 [*] within thirty (30) days of the approval by the FDA of an NDA submitted by the Company or its sublicensee relating to a Licensed Product for the treatment of a Category 1 medical condition;
4.6.5 [*] within thirty (30) days of the approval of a marketing application by the European Medicines Evaluation Agency so that the Company or its sublicensee may commence commercial sales of Licensed Product to treat a Category 1 medical condition;
4.6.6 [*] within thirty (30) days of the first date on which the Company doses the first patient in a Phase III clinical trial to determine efficacy with a Licensed Product to treat a Category 2 medical condition under a Company sponsored or Company sublicensee sponsored IND (for the avoidance of doubt, no milestone payment shall be due as a result of the dosing of the first patient in a Phase II clinical trial to determine efficacy with a Licensed Product to treat a Category 2 medical condition);
4.6.7 [*] within thirty (30) days of the first date on which (x) the FDA accepts an NDA, (y) the European Medicines Evaluation Agency accepts the equivalent of an NDA or (z) the Japanese Food & Drug Administration accepts the equivalent of an NDA (and only the first of these three events to occur), in each case, submitted by the Company or its sublicensee relating to a Licensed Product for the treatment of psoriasis sponsored a Category 2 medical condition;
4.6.8 [*] within thirty (30) days of the approval by or on behalf the FDA of an NDA submitted by the Company or any its sublicensee relating to a Licensed Product for the treatment of its Affiliates or sublicenseesa Category 2 medical condition;
4.7.3 $500,000 upon dosing 4.6.9 [*] within thirty (30) days of the approval of a marketing application by the European Medicines Evaluation Agency so that the Company or its sublicensee may commence commercial sales of Licensed Product for the treatment of a Category 2 medical condition;
4.6.10 [*] within thirty (30) days of the first date on which the Company doses the first patient in a Phase II clinical trial with a Licensed Product to treat a Category 3 medical condition under a Company sponsored or Company sublicensee sponsored IND;
4.6.11 [*] within thirty (30) days of the first date on which the Company doses the first patient in a Phase III clinical trial to determine efficacy with a Licensed Product to treat a Category 3 medical condition under a Company sponsored or Company sublicensee sponsored IND;
4.6.12 [*] within thirty (30) days of the first date on which (x) the FDA accepts an NDA, (y) the European Medicines Evaluation Agency accepts the equivalent of an NDA or (z) the Japanese Food & Drug Administration accepts the equivalent of an NDA (and only the first of these three events to occur), in each case, submitted by the Company or its sublicensee relating to a Licensed Product for the treatment of psoriasis sponsored by or on behalf a Category 3 medical condition;
4.6.13 [*] within thirty (30) days of the Company or any of its Affiliates or sublicensees;
4.7.4 $1,500,000 upon the acceptance approval by the FDA of a New Drug Application ("NDA") for an NDA submitted by the Company or its sublicensee relating to a Licensed Product for the treatment of psoriasis filed a Category 3 medical condition;
4.6.14 [*] within thirty (30) days of the approval of a marketing application by or on behalf of the European Medicines Evaluation Agency so that the Company or any its sublicensee may commence commercial sales of its Affiliates or sublicenseesLicensed Product for the treatment of a Category 3 medical condition;
4.7.5 $2,400,000 upon 4.6.15 [*] within thirty (30) days of the final approval first date on which the Company doses the first patient in a Phase II clinical trial with a Licensed Product to treat a Category 4 medical condition under a Company sponsored or Company sublicensee sponsored IND;
4.6.16 [*] within thirty (30) days of the first date on which the Company doses the first patient in a Phase III clinical trial to determine efficacy with a Licensed Product to treat a Category 4 medical condition under a Company sponsored or Company sublicensee sponsored IND;
4.6.17 [*] within thirty (30) days of the first date on which (x) the FDA accepts an NDA, (y) the European Medicines Evaluation Agency accepts the equivalent of an NDA or (z) the Japanese Food & Drug Administration accepts the equivalent of an NDA (and only the first of these three events to occur), in each case, submitted by the FDA of a NDA for Company or its sublicensee relating to a Licensed Product for the treatment of psoriasis filed a Category 4 medical condition;
4.6.18 [*] within thirty (30) days of the first approval by or on behalf the FDA of an NDA submitted by the Company or any of its Affiliates or sublicensees;
4.7.6 $500,000 upon dosing of the first patient in the first Phase III clinical trial of sublicensee relating to a Licensed Product for the treatment of any disease, physical a Category 4 medical condition, ailment or illness other than psoriasis ; and
4.6.19 [*] within thirty (30) days of the first approval of a marketing application by the European Medicines Evaluation Agency so that is sponsored by or on behalf of the Company or any its sublicensee may commence commercial sales of its Affiliates or sublicensees;
4.7.7 $1,500,000 upon the submission to the FDA of the first NDA for a Licensed Product for the treatment of a Category 4 medical condition. Notwithstanding anything in this Section 4.6, in no event shall the Company be obligated to pay any diseaseMilestone Payment more than one time for the Licensed Products in Categories 1, physical condition2 or 3.
4.7 The Company shall pay to the Licensor an amount equal to [*] of all sublicensing fees and other lump sum payments (including milestones) or other compensation (excluding royalties) received by the Company or an Affiliate from its sublicensees or other third parties having a direct or indirect interest in the proceeds from the sale of any Licensed Products for the development, ailment manufacture, use, lease or illness sale of Licensed Products to end users, other than psoriasis that is filed by (a) payments received from the sale or on behalf issuance of debt or equity securities of the Company or any unless such payments are made at a premium to the Market Price, in which case, the Licensor shall be entitled to [*] of its Affiliates or sublicenseesthe difference between the Market Price and the purchase price of such securities; and
4.7.8 $2,400,000 upon the final approval and (b) payments received by the FDA Company that are (i) designated in any agreement with a third party to be dedicated to the research and development of the first NDA Technology or Licensed Products (including testing and FDA approvals), (ii) dedicated to establish a marketing and sales force for sales of Licensed Products, or (iii) in exchange for goods and/or services relating to a Licensed Product having a Fair Market Value equivalent to the amount received by the Company. All payments owing under this Section 4.7 shall be paid by the Company to the Licensor within ten (10) business days of receipt by the Company of payment from the relevant sublicensee or other third party.
4.8 The Company shall pay to the Licensor [*] of the gross proceeds the Company actually receives from the sale of its equity or debt securities until such time as the Licensor shall have received an aggregate of [*] from such proceeds (the "Accruable License Fee"). In addition to the foregoing obligation with respect to debt and equity financing that occurs after the date of this Agreement, if the Licensor shall have not yet received the entire Accruable License Fee (i) on or before [*], the Company shall pay the Licensor, as a license fee, the lesser of (a) the remaining balance of the Accruable License Fee and (b) an amount that when added to the aggregate Accruable License Fees paid through such date equals [*] and (ii) on or before [*], the Company shall pay the Licensor, as a license fee, the lesser of (a) the remaining balance of the Accruable License Fee and (b) an amount that when added to the aggregate Accruable License Fees paid through such date equals [*] (which includes all payments made under clause (i)(b) above). All amounts payable under this Section 4.8 shall be paid within ten (10) days of the applicable determination date and shall be credited against the Accruable License Fee and the remaining balance of the Accruable License Fee shall be proportionately reduced. The amount payable under Section 4.9 shall not be credited against the Accruable License Fee. Upon termination of the License Agreement, for any reason, the treatment Company will not be obligated to the Licensor to pay the remaining balance, if any, of any diseasethe Accruable License Fee.
4.9 In addition to the milestone payments and royalties payable under this Article 4, physical conditionafter the closing of the Qualified Financing, ailment or illness other than psoriasis that is filed by or on behalf the Company shall pay to the Licensor, as a license fee, [*] within five (5) days of the closing of such financing. For the avoidance of doubt, the obligations of the Company under Sections 4.8 and 4.9 of this Agreement relate to payments to be made after the date of this Agreement (the failure of which to be paid may provide the Licensor with a basis to assert a breach of this Agreement) and shall not (i) constitute a condition precedent to the grant of the license (or sublicense) rights granted to the Company under this Agreement or (ii) result in the termination of any license (or sublicense) rights granted hereunder, except as expressly provided in Article 7 of its Affiliates or sublicenseesthis Agreement.
4.8 No payment obligations shall be due with respect to any sale or sublicense covering any Licensed Product in a country if there are no issued PTH Patent Rights underlying such Licensed Product in such country.
4.9 4.10 To the extent that the Company or any Affiliate of the Company is required required, (i) after reasonable legal analysis, or (ii) by final order or judgment issued by a of any court of competent jurisdiction in any jurisdiction, to obtain a royalty bearing license from a third party in order to sell any Licensed Product practice the rights purported to be granted to the Company by the Licensor hereunder under Patent Rights in such jurisdiction, then up to [*] of the royalties payable under such license in such case the Company jurisdiction may deduct be deducted from the royalties otherwise payable hereunder to IGI for the License Products sold in such jurisdiction up to percent (50%) of the amount of royalties that the Company actually paid to the third party licensee in such jurisdiction; providedLicensor hereunder, however, provided that in no event shall the aggregate royalties payable to IGI the Licensor in any quarterly period on the sales of Licensed Products in such jurisdiction be reduced (i) by more than fifty per cent (50%) [*] as a result of any such deduction pursuant or (ii) by an amount that would reduce the Licensor's royalty payment to this Article 4.9 and provided further that less than [*] of Net Sales of Licensed Products from any excess deduction remaining license or sublicensee.
4.11 The Licensor shall remit [*] of net revenues received by it to the Company as a result of its sales, if any, to Homeland Security. For the purposes of this Section, net revenues shall be defined as gross revenues from Homeland Security minus (i) costs of goods sold ("COGS") determined according to GAAP, (ii) directly related packaging and freight charges and (iii) other directly related costs of such foregoing limitation may sales in an amount not to exceed [*] per annum. Such sublicense fees shall be carried forward paid quarterly, due thirty-five (35) days after the close of each calendar quarter and submitted along with a financial report equivalent to subsequent periodswhat is required of Company under this Agreement. The Licensor agrees to make such payments until (i) the end of the term of the Patent Rights or (ii) [*] years from first commercial sale of any Licensed Product, whichever is later.
4.12
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Sources: License Agreement (Xoma LTD /De/)