Development Milestones. Company shall pay, or cause to be paid, to Licensor the following one-time (except with respect to the last event in the table below), non-refundable, non-creditable milestone payments with respect to the first achievement of the milestone events described in the table below (the “Development Milestones”). Company shall notify Licensor in writing of the achievement of any such Development Milestone within ten (10) Business Days and Licensor shall issue Company an invoice for the amount of the corresponding milestone payment, which invoice Company shall pay within [***] days following Company’s receipt of such invoice. Enrollment of [***] patients in the Planned Phase III Clinical Trial [***] Filing of an NDA with the FDA for the Existing Product [***] Approval by the FDA of an NDA for the Existing Product for PAH [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* [***] Approval by the FDA of an NDA for any additional Product* [***] With respect to each Development Milestone, the corresponding milestone payments to be made under this Agreement shall be due and payable only once (except with respect to the Development Milestones marked with an asterisk). For purposes of the Development Milestones, an additional Product entitled to [***] in the foregoing table shall mean a Product with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Product in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons).
Appears in 2 contracts
Sources: License Agreement (Liquidia Corp), License Agreement (Liquidia Corp)
Development Milestones. Company Eiger shall pay, or cause pay to be paid, to Licensor BMS the following one-time (except with respect to the last event milestone payments set forth in the table below), non-refundable, non-creditable milestone payments with respect to below within [ * ] after the first achievement of the specified milestone events described event by Eiger, its Affiliates, and Sublicensees for the first Licensed Product to achieve such milestone event in any Indication. Eiger shall provide written notice to BMS within [ * ] after the first achievement of the specified milestone event by Eiger, Affiliates, and Sublicensees. Each milestone payment shall not be refundable or returnable in any event. [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] Total Development Milestones for First Indication [ * ] For purposes of this Section:
(i) A [ * ] means that [ * ].
(ii) The set of milestone payments in the table below above shall be payable by Eiger to BMS once per Indication upon the first achievement of each such milestone event for the first such Licensed Compound (whether the “Development Milestones”)first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) to achieve the milestone event. Company shall notify Licensor in writing Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] of the achievement of any such Development Milestone within ten (10) Business Days and Licensor shall issue Company an invoice above milestone payment amounts for the amount first Indication. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the corresponding Securities Act of 1933, as amended.
(iii) If a particular milestone payment, which invoice Company shall pay within [***] days following Company’s receipt of such invoice. Enrollment of [***] patients in the Planned Phase III Clinical Trial [***] Filing of an NDA with the FDA for the Existing Product [***] Approval by the FDA of an NDA for the Existing Product for PAH [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* [***] Approval by the FDA of an NDA for any additional Product* [***] With respect to each Development Milestone, the corresponding milestone payments to be made under this Agreement shall be due and payable only once (except event is not achieved with respect to an Indication (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the Development Milestones marked occurrence of the next most successive milestone with an asterisk). respect to such Indication, and payment for such Skipped Milestone then shall be due.
(iv) For purposes of the Development Milestonesthis Section 8.2.1, an additional Product entitled to [***] in the foregoing table “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a Product separate marketing authorization application may be filed with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Product in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons)Regulatory Authority.
Appears in 2 contracts
Sources: License Agreement (Eiger BioPharmaceuticals, Inc.), License Agreement (Eiger BioPharmaceuticals, Inc.)
Development Milestones. Company Eiger shall pay, or cause pay to be paid, to Licensor BMS the following one-time (except with respect to the last event milestone payments set forth in the table below), non-refundable, non-creditable milestone payments with respect to below within [ * ] after the first achievement of the specified milestone events described event by Eiger, its Affiliates, and Sublicensees for the first Licensed Product to achieve such milestone event in any Indication. Eiger shall provide written notice to BMS within [ * ] after the first achievement of the specified milestone event by Eiger, Affiliates, and Sublicensees. Each milestone payment shall not be refundable or returnable in any event. Milestone Amount of Milestone Payment (Dollars) [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] Total Development Milestones for First Indication [ * ] $ 61 million For purposes of this Section:
(i) A [ * ] means that [ * ].
(ii) The set of milestone payments in the table below above shall be payable by Eiger to BMS once per Indication upon the first achievement of each such milestone event for the first such Licensed Compound (whether the “Development Milestones”)first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) to achieve the milestone event. Company shall notify Licensor in writing Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] of the achievement of any such Development Milestone within ten (10) Business Days and Licensor shall issue Company an invoice above milestone payment amounts for the amount first Indication. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the corresponding Securities Act of 1933, as amended.
(iii) If a particular milestone payment, which invoice Company shall pay within [***] days following Company’s receipt of such invoice. Enrollment of [***] patients in the Planned Phase III Clinical Trial [***] Filing of an NDA with the FDA for the Existing Product [***] Approval by the FDA of an NDA for the Existing Product for PAH [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* [***] Approval by the FDA of an NDA for any additional Product* [***] With respect to each Development Milestone, the corresponding milestone payments to be made under this Agreement shall be due and payable only once (except event is not achieved with respect to an Indication (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the Development Milestones marked occurrence of the next most successive milestone with an asterisk). respect to such Indication, and payment for such Skipped Milestone then shall be due.
(iv) For purposes of the Development Milestonesthis Section 8.2.1, an additional Product entitled to [***] in the foregoing table “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a Product separate marketing authorization application may be filed with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Product in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons)Regulatory Authority.
Appears in 1 contract
Sources: License Agreement
Development Milestones. Company shall payAs additional consideration for the Purchased Assets, Lantern agrees to make additional payments (the “Development Milestone Payments,” and, together with the IP License Payments, collectively, the “Milestone Payments”) to Allarity as set forth below upon the achievement by or on behalf of Lantern or its sublicensees, successors, or cause to be paid, to Licensor assigns of the following one-time (except with respect to the last event in the table below), non-refundable, non-creditable milestone payments with respect to the first achievement of the milestone events described in the table below (the “Development Milestones,” and together with the IP License Milestones, collectively, the “Milestones”). Company shall notify Licensor in writing of the achievement of any such ): Development Milestone within ten (10) Business Days and Licensor shall issue Company an invoice for the amount of the corresponding milestone payment, which invoice Company shall pay within Payment Amount Development Milestones $[***] days following Company’s receipt First filing for regulatory approval for commercialization of such invoicethe Compound or Product in one Class A Country. Enrollment In the event that the first filing for regulatory approval is made in a Class B Country, then one-half of the $[***] patients in payment shall be paid and the Planned Phase III Clinical Trial second-half of the $[***] Filing payment shall be paid upon a second filing for regulatory approval in a second Class B Country. The Development Milestone shall arise, as applicable, from a regulatory filing by Lantern or its sublicensees, assigns, or successors after the Effective Date for regulatory approval for commercialization of the Compound or Product in an NDA with the FDA for the Existing Product applicable Class A Country or Class B Country. $[***] Approval First filing for regulatory approval for commercialization of the Compound or Product in the United States arising from a regulatory filing by Lantern or its sublicensees, assigns, or successors after the FDA of an NDA for the Existing Product for PAH Effective Date. $[***] Approval by First regulatory approval for commercialization of the FDA Compound or Product in one Class A Country. In the event that the first regulatory approval occurs in a Class B Country, then one-half of an NDA for the Existing Product for PH-ILD $[***] Approval by payment shall be paid and the FDA second-half of an NDA for the Existing Product for each additional Indication (other than PAH and PH-ILD)* $[***] Approval payment shall be paid upon a second regulatory approval in a second Class B Country. The Development Milestone shall arise, as applicable, from a regulatory filing by Lantern or its sublicensees, assigns, or successors after the FDA Effective Date for commercialization of the Compound or Product in an NDA for any additional Product* applicable Class A Country or Class B Country. $[***] With respect to each Development Milestone, the corresponding milestone payments to be made under this Agreement shall be due and payable only once (except with respect to the Development Milestones marked with an asterisk). For purposes First regulatory approval for commercialization of the Development Milestones, an additional Product entitled to [***] in the foregoing table shall mean a Product with new dosage form, new formulation, new combination and the next generation version of Existing Product. Notwithstanding the foregoing, such Development Milestone payment shall not apply to the Existing Compound or Product in the following instances: (a) United States arising from a different dosage amount; (b) different batch size; regulatory filing by Lantern or (c) a manufacturing change to its sublicensees, assigns, or successors after the Existing Product in consideration of supply issues (e.g., a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons)Effective Date.
Appears in 1 contract
Sources: Asset Purchase Agreement (Allarity Therapeutics, Inc.)
Development Milestones. Company shall pay, or cause to be paid, to Licensor the following one-time (except with respect to the last event in the table below), non-refundable, non-creditable milestone payments with respect to the first achievement of the milestone events described in the table below (the “Development Milestones”). Company A) The Licensee shall notify Licensor in writing of the achievement of any such Development Milestone within ten (10) Business Days and Licensor shall issue Company an invoice for the amount of the corresponding milestone payment, which invoice Company shall pay Ascendis within [***] days following Company’s receipt of such invoice. Enrollment the first satisfaction of the applicable development milestones under sections [***] patients in the Planned Phase III Clinical Trial below, and within [***] Filing of an NDA with the FDA for first satisfaction of the Existing Product applicable commercialisation milestones under sections [***] Approval by below, with the FDA first Licensed Product in a particular Class for each Target. For example, if the Licensee develops a particular Licensed Product to a Target, which Licensed Product incorporates a Large Molecule, and pays development milestones [***], no payment shall be due under such development milestones on the Licensee’s development of an NDA for another Licensed Product to the Existing same Target, which Licensed Product for PAH incorporates a Large Molecule, including the same or different Large Molecule. Likewise, if the Licensee develops a particular Licensed Product to a Target, which Licensed Product incorporates a Large Molecule, and pays development milestones [***], payment shall be due under such development milestones on the Licensee’s development of another Licensed Product to the same Target, which Licensed Product incorporates a Small Molecule or a Polypeptide.
(i) [***] Approval by the FDA of an NDA for the Existing Product for PH-ILD [***]
(ii) [***] Approval by the FDA of an NDA for the Existing Product for each additional Indication [***]
(other than PAH and PH-ILD)* iii) [***] Approval by the FDA of an NDA for any additional Product* [***]
(iv) [***] With respect to each Development Milestone, the corresponding milestone payments to be made under this Agreement shall be due and payable only once [***]
(except with respect to the Development Milestones marked with an asterisk). For purposes of the Development Milestones, an additional Product entitled to v) [***] [***]
(vi) [***] [***]
(vii) [***] [***] Total milestones [***]
(B) Milestones paid for Other Licensed Products shall be paid at [***] of the amounts indicated in the foregoing table shall mean above. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(C) Where any development milestone [***] for a Licensed Product with new dosage formin a particular Class and Target is not achieved before the next development milestone is achieved, new formulation, new combination the sum of the milestone payments due for both the non-achieved and the next generation version of Existing achieved development milestone shall be paid to Ascendis for such Licensed Product. Notwithstanding For example, should a Licensed Product go directly to development milestone [***] without going through development milestone [***], the foregoingsum of the milestone payments due for development milestone [***] and development milestone [***] would be payable to Ascendis upon achievement of development milestone [***] for such Licensed Product.
(D) In any event, such Development Milestone payment the total development milestones shall not apply exceed [***] per Class and Target for a Ranibizumab Licensed Product and [***] per Class and Target for any Other Licensed Product.
(E) Following receipt by Ascendis of notice in accordance with Clause 7.3(A), Ascendis shall submit an invoice to the Existing Product Licensee for the amount of such development milestone payment, and the Licensee shall pay the respective payment for such event within [***] after receipt of such invoice from Ascendis. All invoices shall identify the associated Licensed Product, the fee being invoiced and the description of the milestone event. Unless otherwise requested by the Licensee in writing, Ascendis shall send invoices to Genentech at the address in the following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change preamble of this Agreement, to the Existing Product in consideration attention of supply issues (e.g.Finance Manager, a change in liposomes used to manufacture the Existing Product due to insufficient supply of the existing liposomes or for cost reasons)Business Development, M/S 53.
Appears in 1 contract