Common use of Development and Regulatory Milestone Payments Clause in Contracts

Development and Regulatory Milestone Payments. Buyer shall also pay the following development and regulatory milestone payments: (a) With respect to Non-ALS or Stroke Orphazyme Products and subject to the terms set forth in subsection (b) below, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: Milestone Event First Non-ALS or Stroke Orphazyme Product Milestone Payment Second Non-ALS or Stroke Orphazyme Product Milestone Payment [*] [*] [*] [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (b) Buyer shall pay to Seller the amounts set forth under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” when the first Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. Buyer shall pay to Seller the amounts set forth under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” when the second Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. A Non-ALS or Stroke Orphazyme Product will not be considered the second Non-ALS or Stroke Orphazyme Product for purposes of the preceding sentence unless it contains a different Compound than the first Non-ALS or Stroke Orphazyme Product. The amounts payable under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. The amounts payable under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party. (c) With respect to each ALS or Stroke Orphazyme Product, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: [*] [*] Each milestone payment shall be payable only once for each ALS or Stroke Orphazyme Product irrespective of the number of times the milestone events shall have been achieved by such ALS or Stroke Orphazyme Product. A subsequent ALS or Stroke Orphazyme Product is eligible to achieve the milestone payments listed above if: (i) it contains a Compound that is different than other ALS or Stroke Orphazyme Products previously achieving such milestone; or (ii) it contains the same Compound as another ALS or Stroke Orphazyme Product previously achieving such milestone, but such subsequent ALS or Stroke Orphazyme Product is for a different indication (i.e. ALS or Stroke) than such ALS or Stroke Orphazyme Product previously achieving such milestone. Notwithstanding the foregoing, an ALS or Stroke Orphazyme Product is eligible to achieve the milestone payments listed above even if such product contains a Compound that was used to develop a Non-ALS or Stroke Orphazyme Product that achieved one or more milestone payments pursuant to subsections (a) and (b) above. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party. (d) Buyer shall provide Seller with written notice of the achievement of each milestone and pay to Seller the corresponding milestone payment within [*] days after such milestone is achieved. [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Appears in 1 contract

Sources: Asset Purchase Agreement (Orphazyme a/S)

Development and Regulatory Milestone Payments. Buyer shall also pay the following development and regulatory milestone payments: (a) With respect to Non-ALS or Stroke Orphazyme Products and subject to the terms set forth in subsection (b) below, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: Milestone Event First Non-ALS or Stroke Orphazyme Product Milestone Payment Second Non-ALS or Stroke Orphazyme Product Milestone Payment dosing in the first Clinical Trial $[***] $[***] First dosing in the first Phase III Clinical Trial $[***] $[***] = Certain confidential information contained MAA Approval by the EMA or the applicable Regulatory Authority in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.a Major European Union Country $[***] $[***] MAA Approval in the United States $[***] $[***] MAA Approval in Japan $[***] $[***] (b) Buyer shall pay to Seller the amounts set forth under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” when the first Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. Buyer shall pay to Seller the amounts set forth under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” when the second Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. A Non-ALS or Stroke Orphazyme Product will not be considered the second Non-ALS or Stroke Orphazyme Product for purposes of the preceding sentence unless it contains a different Compound than the first Non-ALS or Stroke Orphazyme Product. The amounts payable under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. The amounts payable under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party. (c) With respect to each ALS or Stroke Orphazyme Product, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: First dosing in the first Phase III Clinical Trial $[***] Acceptance of Filing Submission by EMA $[***] MAA Approval by the EMA or the applicable Regulatory Authority in a Major European Union Country $[***] Acceptance of Filing Submission by FDA $[***] MAA Approval in the United States $[***] MAA Approval in Japan $[***] Each milestone payment shall be payable only once for each ALS or Stroke Orphazyme Product irrespective of the number of times the milestone events shall have been achieved by such ALS or Stroke Orphazyme Product. A subsequent ALS or Stroke Orphazyme Product is eligible to achieve the milestone payments listed above if: (i) it contains a Compound that is different than other ALS or Stroke Orphazyme Products previously achieving such milestone; or (ii) it contains the same Compound as another ALS or Stroke Orphazyme Product previously achieving such milestone, but such subsequent ALS or Stroke Orphazyme Product is for a different indication (i.e. ALS or Stroke) than such ALS or Stroke Orphazyme Product previously achieving such milestone. Notwithstanding the foregoing, an ALS or Stroke Orphazyme Product is eligible to achieve the milestone payments listed above even if such product contains a Compound that was used to develop a Non-ALS or Stroke Orphazyme Product that achieved one or more milestone payments pursuant to subsections (a) and (b) above. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party. (d) Buyer shall provide Seller with written notice of the achievement of each milestone and pay to Seller the corresponding milestone payment within [*] 30 days after such milestone is achieved. [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Appears in 1 contract

Sources: Asset Purchase Agreement (Cytrx Corp)

Development and Regulatory Milestone Payments. Buyer shall also pay the following development and regulatory milestone payments: (a) With respect to Non-ALS or Stroke Orphazyme Products and subject 6.4.1. Subject to the terms set forth in subsection (b) belowof this Agreement, Buyer following Option Exercise for a Collaboration Program, Allergan shall make the following non-refundable cash payments to Seller following Exicure (the “Development and Regulatory Milestone Payments”) after the achievement by Allergan or any of the corresponding milestone event by Buyer, its Affiliates or their licensees: Sublicensees of the applicable event set forth below with respect to a Licensed Product (the “Development and Regulatory Milestone Event First Non-ALS or Stroke Orphazyme Product Milestone Payment Second Non-ALS or Stroke Orphazyme Product Milestone Payment [Events”): THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*] [*] [*] [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed*”. 1. ***** ***** 2. ***** ***** 3. ***** ***** 4. ***** ***** 5. ***** ***** 6. ***** ***** 7. ***** ***** 8. ***** ***** * *****. (b) Buyer shall pay to Seller the amounts set forth under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” when the first Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event6.4.2. Buyer shall pay to Seller the amounts set forth under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” when the second Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. A Non-ALS or Stroke Orphazyme Product will not be considered the second Non-ALS or Stroke Orphazyme Product for purposes Each of the preceding sentence unless it contains a different Compound than the first Non-ALS or Stroke Orphazyme Product. The amounts payable under the column entitled “First Non-ALS or Stroke Orphazyme Product Development and Regulatory Milestone Payment” will be paid only once. The amounts payable under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party. (c) With respect to each ALS or Stroke Orphazyme Product, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: [*] [*] Each milestone payment shall be Payments is payable only once for each ALS with respect to the Licensed Products arising out of or Stroke Orphazyme from a given Collaboration Program upon the first achievement of such Development and Regulatory Milestone Event by a Licensed Product irrespective arising out of or from such Collaboration Program, regardless of the number of times Licensed Products arising out of or from such Collaboration Program that achieve the milestone events shall applicable Development and Regulatory Milestone Event; provided, however, that *****. 6.4.3. Each of Development and Regulatory Milestone Events 1 and 2 as set forth in Section 6.4.1 is intended to be successive. If a Licensed Product is not required to undergo such Development and Regulatory Milestone Event, such skipped Development and Regulatory Milestone Event will be deemed to have been achieved upon the achievement by such ALS or Stroke Orphazyme Licensed Product of the next successive Development and Regulatory Milestone Event. The Development and Regulatory Milestone Payment corresponding to any such skipped Development and Regulatory Milestone Event that is owed in accordance with the provisions of the foregoing sentence with respect to a given Licensed Product will be due concurrently with the Development and Regulatory Milestone Payment for the next successive Development and Regulatory Milestone Event by such Licensed Product. A subsequent ALS or Stroke Orphazyme , it being agreed that if a Licensed Product is eligible not required to achieve undergo Development and Regulatory Milestone Event 2, the milestone payments listed above if: (i) it contains a Compound that is different than other ALS corresponding Development and Regulatory Milestone Payment will be made upon the first to occur of Development and Regulatory Milestone Events 3, 4 or Stroke Orphazyme Products previously achieving such milestone; or (ii) it contains the same Compound as another ALS or Stroke Orphazyme Product previously achieving such milestone, but such subsequent ALS or Stroke Orphazyme Product is for a different indication (i.e. ALS or Stroke) than such ALS or Stroke Orphazyme Product previously achieving such milestone. Notwithstanding the foregoing, an ALS or Stroke Orphazyme Product is eligible to achieve the milestone payments listed above even if such product contains a Compound that was used to develop a Non-ALS or Stroke Orphazyme Product that achieved one or more milestone payments pursuant to subsections (a) and (b) above. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party5. (d) Buyer 6.4.4. Allergan shall provide Seller with deliver to Exicure written notice of the achievement of each milestone any Development and pay to Seller Regulatory Milestone Event for which a Development and Regulatory Milestone Payment is payable hereunder, together with the corresponding milestone payment Development and Regulatory Milestone Payment, within [*] **** days after such milestone is achieved. [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material achievement of the applicable Development and (ii) would be competitively harmful if publicly disclosedRegulatory Milestone Event.

Appears in 1 contract

Sources: Collaboration, Option and License Agreement (Exicure, Inc.)

Development and Regulatory Milestone Payments. Buyer shall also pay the following development and regulatory milestone payments: (a) With respect to Non-ALS or Stroke Orphazyme Products and subject to the terms set forth in subsection (b) below, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: Milestone Event First Non-ALS or Stroke Orphazyme Product Milestone Payment Second Non-ALS or Stroke Orphazyme Product Milestone Payment [*] [*] [*] [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (b) Buyer shall pay to Seller the amounts set forth under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” when the first Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. Buyer shall pay to Seller the amounts set forth under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” when the second Non-ALS or Stroke Orphazyme Product developed by Buyer, its Affiliates or their licensees achieves the corresponding milestone event. A Non-ALS or Stroke Orphazyme Product will not be considered the second Non-ALS or Stroke Orphazyme Product for purposes of the preceding sentence unless it contains a different Compound than the first Non-ALS or Stroke Orphazyme Product. The amounts payable under the column entitled “First Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. The amounts payable under the column entitled “Second Non-ALS or Stroke Orphazyme Product Milestone Payment” will be paid only once. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party. (c) With respect to each ALS or Stroke Orphazyme Product, Buyer shall make the following non-refundable cash payments to Seller following the achievement of the corresponding milestone event by Buyer, its Affiliates or their licensees: [*] [*] Each milestone payment shall be payable only once for each ALS or Stroke Orphazyme Product irrespective of the number of times the milestone events shall have been achieved by such ALS or Stroke Orphazyme Product. A subsequent ALS or Stroke Orphazyme Product is eligible to achieve the milestone payments listed above if: (i) it contains a Compound that is different than other ALS or Stroke Orphazyme Products previously achieving such milestone; or (ii) it contains the same Compound as another ALS or Stroke Orphazyme Product previously achieving such milestone, but such subsequent ALS or Stroke Orphazyme Product is for a different indication (i.e. ALS or Stroke) than such ALS or Stroke Orphazyme Product previously achieving such milestone. Notwithstanding the foregoing, an ALS or Stroke Orphazyme Product is eligible to achieve the milestone payments listed above even if such product contains a Compound that was used to develop a Non-ALS or Stroke Orphazyme Product that achieved one or more milestone payments pursuant to subsections (a) and (b) above. For the avoidance of doubt, milestones achieved by Third Parties under investigator-sponsored studies shall not be deemed achieved by Buyer, its Affiliates or their licensees, even if Buyer provides product under a material transfer agreement to such Third Party. (d) Buyer shall provide Seller with written notice of the achievement of each milestone and pay to Seller the corresponding milestone payment within [*] days after such milestone is achieved. [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Appears in 1 contract

Sources: Asset Purchase Agreement (Orphazyme a/S)