Additional Compounds Sample Clauses

Additional Compounds. If, at any time during the Term, Paratek reasonably determines in good faith that a Paratek Compound is potentially more suitable for Development and Commercialization than the then specified Lead Candidates (such compound, an “Additional Compound”), Paratek shall promptly inform WCCI (the “Additional Compound Notification”) of such determination and WCCI shall have the right to designate such Additional Compound as a Lead Candidate hereunder (which shall be reflected in an amendment to Schedule 1 hereto), it being understood that WCCI must notify Paratek in writing of such designation within forty-five (45) days of receipt of the Additional Compound Notification in order to exercise its rights under this Section 3.6.2. For the avoidance of doubt, Paratek shall have no obligation under this Section 3.6.2 to engage in research activities it would not otherwise conduct in the ordinary course of its research and development with respect to Paratek Compounds.
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Additional Compounds. (i) If (A) MyoKardia has Initiated a clinical trial of a Compound under a POC Development Plan and has not terminated Development thereof, (B) another Compound is designated as a Development Candidate for the same Program, and (C) either Party desires to conduct IND-enabling studies and clinical trials of such second Compound, such Party shall notify the other Party in writing. If both Parties desire to initiate such further Development activities, then the Parties shall revise the POC Development Plan and budget therein for such Program accordingly to include the Development of such second Compound, and Sanofi shall reimburse all such Pre-POC Development Costs on a Calendar Quarterly basis in accordance with Section 9.5(a), mutatis mutandis, and such additional costs (if incurred after 2018) will not count toward the Post-2018 POC Cost Cap. The estimated amount to be so reimbursed shall be provided by MyoKardia in advance of the decision whether to so initiate further Development thereof. If instead Sanofi does not elect to bear such costs, then MyoKardia shall have the right, but not obligation, to conduct such Development of such additional Compound under the POC Development Plan for such Program at its sole discretion and expense, provided that upon the earlier of (y) discontinuation of Development of the first Compound for the same Program or (z) completion of the final study report for a Phase 2a Clinical Trial of such second Compound and delivery of the results and an accounting of amounts required to be reimbursed, Sanofi shall reimburse all Pre-POC Development Costs then incurred by MyoKardia in the conduct of the Development of such second Compound after its designation as a Development Candidate, and thereafter Sanofi shall reimburse all Pre-POC Development Costs for such Compound subsequently incurred by MyoKardia on a Calendar Quarterly basis in accordance with Section 9.5(a), mutatis mutandis. For clarity, the requirement of reimbursement under this provision applies only with respect to one additional Compound per Program. In no event shall reimbursement be due to MyoKardia under this Section 5.4(b)(i) in the case in which Sanofi has delivered a notice of termination with respect to this Agreement in its entirety or with respect to the applicable Program prior to the delivery to Sanofi of such final study report.
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Additional Compounds. [***], Theravance may propose that such Additional Compound be included in this Agreement by providing Xxxxxxx with written notice of such Additional Compound (each, an “Additional Compound Notice”), which notice shall include any Data that has been generated by or on behalf of Theravance or its Affiliates that is reasonably necessary for Xxxxxxx to assess whether to include such Additional Compound under this Agreement. Upon receipt of an Additional Compound Notice, Xxxxxxx shall have a period of [***] (the “Assessment Period”) to assess whether it desires to include such Additional Compound within the Compounds and provide notice to Theravance of such determination. Such Assessment Period can be mutually extended by the Parties. [***].
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Additional Compounds. 10.1.1 (a) Ardent may develop one or more Delta/Mu Opioid Receptor Agonist compounds (other than the Compound) outside of the Program that have potential antinociceptive activity and safety as specified below ("New Compound"). Unless and until ALZA enters into any Additional Compound License, ALZA will have no rights with respect to such New Compound or any know-how or information disclosed by Ardent with respect thereto except as expressly provided in this Article X (including without limitation Section 10.1.5). If Ardent develops a New Compound, at any time prior to the date which is [***], Ardent will deliver written notice (the "Additional Compound Notice") to ALZA at the time Ardent has received data from pre-clinical animal pharmacological studies specified below regarding such New Compound describing [***] potency and safety of the New Compound measured against the following criteria:
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Additional Compounds. (i) In the event that, after Signal exercises the Option, Axys desires to engage in any additional research or clinical development with respect to any additional Collaboration Compound (such as a Back-Up Compound or a second generation compound), Axys will prepare and present to the JDC (and the JRC to the extent additional research is contemplated) an initial Product Development Plan for such additional Collaboration Compound. The JDC (and, if applicable, the JRC) will review, revise and approve such Product Development Plan or additional research (as the case may be) for such additional Collaboration Compound in good faith. Any disagreements with respect to approval of such proposed Product Development Plan will be resolved in the manner that disagreements over Major Changes are resolved under Section 4.2(f). Following approval of such Product Development Plan, updates, revisions and modifications will be governed by Sections 4.2(e), (f) and (g).
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Additional Compounds. The Additional Compounds shall be treated as Compounds for the purposes of the Collaboration Agreement except, in addition to the terms and conditions of the Collaboration Agreement, COR shall pay to Kyowa Hakko [*] royalty on Net Sales of any Additional Products, to be [*] . Upon request by either party, the parties shall negotiate in good faith [*] for the applicable Additional Product. Such royalty shall be payable as follows:
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Additional Compounds. Under Section 3.1.2 of the BI License, BI has an exclusive worldwide license to any Additional Compounds selected by BI for use in the BI Field, the terms of which license are subject to an agreement to be negotiated in good faith.
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Additional Compounds 
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Related to Additional Compounds

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Development Milestone Payments In partial consideration for the rights and licenses granted to Coya hereunder, within ten days after the first achievement of each milestone event in a given Indication set forth in this Section 5.2 (Development Milestone Payments) with respect to a Product (each, a “Development Milestone Event”) by or on behalf of Coya or any of its Affiliates or Sublicensees, Coya shall provide ARScience Bio written notice to ARScience Bio identifying the Development Milestone Event achieved. Upon receipt of any such notice of first achievement of a Development Milestone Event by Coya or its Affiliates or Sublicensees, ARScience Bio will promptly invoice Coya for the applicable Development Milestone Event and Coya will make a milestone payment to ARScience Bio in the amount set forth in this Section 5.2 (Development Milestone Payments) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”) within 45 days of receipt of such invoice. On an Indication-by-Indication basis, each Development Milestone Payment shall be payable only upon the first achievement of the corresponding Development Milestone Event by a Product, in any given Indication for which the Development Milestone Events have not been previously achieved (each such Indication, a “New Indication”). No amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same or different Mono Product or Combination Product, as applicable, in such Indication. Accordingly and for clarity, the Development Milestone Payment shall be paid only once, when first achieved by Coya, an Affiliate or a Sublicensee, but no payment shall be due if the same milestone is subsequently achieved by one of Coya, an Affiliate or a Sublicensee. For clarity, the amounts owed in Column (a) below shall be due for the first Combination Product to achieve the Development Milestone Events in a New Indication and the amounts owned in Column (c) below shall be due for the first Mono Product to achieve the Development Milestone Events in a New Indication. Any Combination Product or Mono Product to achieve the Development Milestone Events in a New Indication after the first achievement of the Development Milestone Events as described in the foregoing sentence will cause the amounts in Column (b) with respect to a Combination Product and Column (d) with respect to a Mono Product to be due and payable by Coya upon each such occurrence. If the first Product to achieve a Development Milestone Event in any Indication is a Combination Product, the amounts in Column (a) below shall be due and payable by Coya. If the next Product to achieve a Development Milestone Event in a New Indication is a Mono Product, the amounts in Column (c) below would be due and payable by Coya; provided, that if such next Product to achieve a Development Milestone Event in a New Indication is a Combination Product, the amounts in Column (b) would be due and payable by Coya. By way of example, if a Combination Product achieves IND Acceptance in ALS, and is the first Product to achieve a Development Milestone Event under this Agreement, [***] will be due and payable by Coya. If subsequently a Mono Product achieves IND Acceptance in ALS, no Development Milestone Payments will be due and payable by Coya under this Agreement. However, if subsequently any Combination Product achieves IND Acceptance in Alzheimer’s disease, [***] would be due and payable by Coya.

  • Additional Products Upon satisfying the minimum order requirements above, Enrolled Affiliate may order Additional Products.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Regulatory Milestones Celgene shall make the following approval milestone payments to Jounce that are set forth below upon the first achievement by or on behalf of Celgene, its Affiliates or Sublicensees of the Regulatory Milestone Events set forth below with respect to the first Co-Co Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Regulatory Milestone Event). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Regulatory Milestone Event (For the first Co-Co Product that achieves such event) Milestone Payments (in $ millions) [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] For each of Paragraphs (1) - (3) of this Exhibit C-2, the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event triggering a payment under this Jounce Lead Co-Co Agreement.

  • Research Collaboration Upon FibroGen’s request, the Parties will discuss conducting a research program funded by AstraZeneca and directed toward franchise enhancement and lifecycle management for HIF Compounds or other topics that the Parties determine relevant to the Products and the Field. Upon agreement on the terms of such research program, the Parties will enter into a separate agreement or amend this Agreement accordingly.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Commercialization Diligence Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to commercialize a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries. If Novartis commercializes a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries, Novartis will be deemed to satisfy all diligence obligations with respect to such Profile.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development Schedule The Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.

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