Common use of Development Milestones Clause in Contracts

Development Milestones. Eiger shall pay to BMS the following milestone payments set forth in the table below within [ * ] after the first achievement of the specified milestone 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 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 first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) to achieve the milestone event. Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] of the above milestone payment amounts for the 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 Securities Act of 1933, as amended. (iii) If a particular milestone event is not achieved with respect to an Indication (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the occurrence of the next most successive milestone with respect to such Indication, and payment for such Skipped Milestone then shall be due. (iv) For purposes of this Section 8.2.1, “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate marketing authorization application may be filed with a Regulatory Authority.

Appears in 2 contracts

Sources: License Agreement (Eiger BioPharmaceuticals, Inc.), License Agreement (Eiger BioPharmaceuticals, Inc.)

Development Milestones. Eiger Company shall pay pay, or cause to BMS be paid, to Licensor the following milestone payments set forth one-time (except with respect to the last event in the table below within [ * ] after below), non-refundable, non-creditable milestone payments with respect to the first achievement of the specified milestone event by Eiger, its Affiliates, 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 Sublicensees Licensor shall issue Company an invoice 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 amount of the specified corresponding milestone event 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 Eigerthe 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, Affiliatesthe 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 Sublicenseesthe next generation version of Existing Product. Each milestone Notwithstanding the foregoing, such Development 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 apply to the Existing Product in the table above shall be payable by Eiger following instances: (a) a different dosage amount; (b) different batch size; or (c) a manufacturing change to BMS once per Indication upon the first achievement Existing Product in consideration of each such milestone event for supply issues (e.g., a change in liposomes used to manufacture the first such Licensed Compound (whether the first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) Existing Product due to achieve the milestone event. Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] insufficient supply of the above milestone payment amounts existing liposomes or for the 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 Securities Act of 1933, as amendedcost reasons). (iii) If a particular milestone event is not achieved with respect to an Indication (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the occurrence of the next most successive milestone with respect to such Indication, and payment for such Skipped Milestone then shall be due. (iv) For purposes of this Section 8.2.1, “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate marketing authorization application may be filed with a Regulatory Authority.

Appears in 2 contracts

Sources: License Agreement (Liquidia Corp), License Agreement (Liquidia Corp)

Development Milestones. Eiger shall pay to BMS the following milestone payments set forth in the table below within [ * ] after the first achievement of the specified milestone 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 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 first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) to achieve the milestone event. Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] of the above milestone payment amounts for the 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 Securities Act of 1933, as amended. (iii) If a particular milestone event is not achieved with respect to an Indication (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the occurrence of the next most successive milestone with respect to such Indication, and payment for such Skipped Milestone then shall be due. (iv) For purposes of this Section 8.2.1, “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate marketing authorization application may be filed with a Regulatory Authority.

Appears in 1 contract

Sources: License Agreement

Development Milestones. Eiger (A) The Licensee shall pay to BMS the following milestone payments set forth in the table below notify Ascendis within [ * [***] after of the first achievement satisfaction of the specified milestone event by Eiger, its Affiliatesapplicable development milestones under sections [***] below, and Sublicensees for within [***] of the first satisfaction of the applicable commercialisation milestones under sections [***] below, with the first Licensed Product in a particular Class for each Target. For example, if the Licensee develops a particular 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 Eigera Target, Affiliateswhich Licensed Product incorporates a Large Molecule, and Sublicensees. Each milestone pays development milestones [***], no payment shall not be refundable due under such development milestones on the Licensee’s development of another Licensed Product to the same Target, which Licensed Product incorporates a Large Molecule, including the same or returnable in any eventdifferent Large Molecule. [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] [ * ] Total Development Milestones for First Indication [ * ] For purposes 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 this Section:another Licensed Product to the same Target, which Licensed Product incorporates a Small Molecule or a Polypeptide. (i) A [ * [***] means that [ * [***]. (ii) The set [***] [***] (iii) [***] [***] (iv) [***] [***] (v) [***] [***] (vi) [***] [***] (vii) [***] [***] Total milestones [***] (B) Milestones paid for Other Licensed Products shall be paid at [***] of milestone payments the amounts indicated in the table 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 first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) to achieve the milestone event. Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] of the above milestone payment amounts for the first Indicationabove. [***] = Certain confidential information contained in this document, marked by brackets, document has been omitted and filed separately with the Securities and Exchange Commission pursuant Commission. Confidential treatment has been requested with respect to Rule 406 of the Securities Act of 1933, as amendedomitted portions. (iiiC) If Where any development milestone [***] for a Licensed Product in a particular milestone event Class and Target is not achieved before the next development milestone is achieved, the sum of the milestone payments due for both the non-achieved and the achieved development milestone shall be paid to Ascendis for such Licensed Product. For example, should a Licensed Product go directly to development milestone [***] without going through development milestone [***], the sum 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, the total development milestones shall not 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 respect to an Indication (“Skipped Milestone”Clause 7.3(A), Ascendis shall submit an invoice to the Licensee for the amount of such Skipped Milestone will be deemed to have been achieved upon the occurrence of the next most successive development milestone with respect to such Indicationpayment, and the Licensee shall pay the respective payment for such Skipped Milestone then event within [***] after receipt of such invoice from Ascendis. All invoices shall be due. (iv) For purposes 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 preamble of this Section 8.2.1Agreement, “Indication” shall mean any separately definedto the attention of Finance Manager, well-categorized class of human diseaseBusiness Development, syndrome or medical condition for which a separate marketing authorization application may be filed with a Regulatory AuthorityM/S 53.

Appears in 1 contract

Sources: Exclusive Licence Agreement (Ascendis Pharma a/S)

Development Milestones. Eiger shall pay As additional consideration for the Purchased Assets, Lantern agrees to BMS 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 assigns of the following milestone payments set forth events (the “Development Milestones,” and together with the IP License Milestones, collectively, the “Milestones”): Development Payment Amount Development Milestones $[***] First filing for regulatory approval for commercialization of the Compound or Product in one Class A Country. In the event that the first filing for regulatory approval is made in a Class B Country, then one-half of the $[***] payment shall be paid and the second-half of the $[***] 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 applicable Class A Country or Class B Country. $[***] First filing for regulatory approval for commercialization of the Compound or Product in the table below within [ * ] United States arising from a regulatory filing by Lantern or its sublicensees, assigns, or successors after the first achievement Effective Date. $[***] First regulatory approval for commercialization of the specified milestone Compound or Product in one Class A Country. In the event by Eiger, its Affiliates, and Sublicensees for that the first Licensed Product to achieve such milestone event regulatory approval occurs in any Indicationa Class B Country, then one-half of the $[***] payment shall be paid and the second-half of the $[***] payment shall be paid upon a second regulatory approval in a second Class B Country. Eiger The Development Milestone shall provide written notice to BMS within [ * ] arise, as applicable, from a regulatory filing by Lantern or its sublicensees, assigns, or successors after the first achievement Effective Date for commercialization of the specified milestone event by Eiger, Affiliates, and SublicenseesCompound or Product in an applicable Class A Country or Class B Country. Each milestone payment shall not be refundable $[***] First regulatory approval for commercialization of the Compound 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 Product in the table above shall be payable United States arising from a regulatory filing by Eiger to BMS once per Indication upon Lantern or its sublicensees, assigns, or successors after the first achievement of each such milestone event for the first such Licensed Compound (whether the first such Licensed Compound is the lead Licensed Compound or any back-up Licensed Compound) to achieve the milestone event. Milestones payments for additional Indications that achieve the above milestones events for such additional Indication will be at [ * ] of the above milestone payment amounts for the 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 Securities Act of 1933, as amendedEffective Date. (iii) If a particular milestone event is not achieved with respect to an Indication (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved upon the occurrence of the next most successive milestone with respect to such Indication, and payment for such Skipped Milestone then shall be due. (iv) For purposes of this Section 8.2.1, “Indication” shall mean any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate marketing authorization application may be filed with a Regulatory Authority.

Appears in 1 contract

Sources: Asset Purchase Agreement (Allarity Therapeutics, Inc.)