Program Target Substitution Sample Clauses

Program Target Substitution. On a Program Slot-by-Program Slot basis during the applicable Target Substitution Period, AbbVie shall have the one-time right, in its sole discretion, to select a substitute Target or Target Combination (a “Substitute Target” or “Substitute Targets,” as applicable, and a “Substitution”) for each applicable Program Slot, such Target(s) to be selected from either the Reserved Target list or other available Targets, subject to the selection procedures of Section 3.2.7(a) (Target Selection). Upon a Substitution, the JGC shall promptly agree on a Research Plan for the Program Slot for such Substitute Targets. Upon the JGC’s approval of such plan, such plan will be deemed a “Research Plan” under this Agreement and AbbVie will be deemed to have selected the applicable Substitute Target for such Program Slot under this Agreement as of the date on which the JGC approves such Research Plan. [***]
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Program Target Substitution. At any time until the second anniversary of the Effective Date, no more than one time per Collaboration Program upon written notice to Exicure, Allergan may, at its sole option, substitute one existing Program Target (each, a “Terminated Target”) in each Collaboration Program with one newly identified target (a “Substitute Target”), following good faith discussions at the JDC. Notwithstanding the foregoing, in the event that the Program Target to be substituted is a Program Target under both Collaboration Programs, then Allergan may elect to replace such Program Target with a Substitute Target in either or both Collaboration Programs, provided that if Allergan replaces such Program Target with the same Substitute Target in both Collaboration Programs, such substitution shall be deemed a single substitution for only one of the Collaboration Programs (i.e., Allergan may still substitute another Program Target in one of the Collaboration Programs). Subject to the provisions of this Section 2.2, effective as of Allergan’s delivery of such written notice, the Terminated Target will no longer constitute a Program Target hereunder, and the applicable Substitute Target will constitute a Program Target. The Parties, through the JDC, shall work in good faith to agree upon an amendment to the applicable Development Plan as appropriate in light of the termination of the Terminated Target and the addition of the Substitute Target to the applicable Collaboration Program. Notwithstanding the foregoing, if, at the time of Allergan’s notice under this Section 2.2, Exicure has already granted an exclusive license to a Third Party with respect to any proposed Substitute Target that would prevent Exicure from granting to Allergan the license under Section 3.3 with respect to such proposed Substitute Target, (a) Exicure shall provide Allergan with written notice thereof within ***** days of Allergan’s notice of such proposed Substitute Target, (b) such proposed Substitute Target shall not become a Substitute Target under this Agreement and (c) Allergan may again exercise its rights with respect to the applicable Collaboration Program under this Section 2.2 for one Substitute Target at any time until the second anniversary of the Effective Date.
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Related to Program Target Substitution

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput through the Pipelines, nor will Operator be obligated to accept Product that fails to meet the applicable quality specifications for the Berths under the BAUTA and any Terminal Service Orders issued thereunder.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Development Plan As defined in Section 3.2(a).

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

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