Back-Up Candidates Clause Samples

The Back-Up Candidates clause establishes a process for identifying and designating alternative individuals or entities who can step in if the primary candidate is unable or unwilling to fulfill their role. Typically, this clause requires the party responsible for providing candidates to submit a list of qualified alternates, ensuring that replacements are readily available without significant delay. Its core practical function is to minimize disruptions and maintain continuity by ensuring that suitable substitutes are pre-approved and can be quickly appointed if necessary.
Back-Up Candidates. Concurrently with the decision to develop a proposed Clinical Candidate as Collaboration Product or Unilateral Product, as applicable, the Joint Research Committee (if both Parties wish to develop such Clinical Candidate) or the Interested Party (if only one Party wishes to develop such Clinical Candidate) shall be entitled to also designate [***] further Clinical Candidate (if available) as Back-up Candidate for the respective Target Combination (and in such event, the Joint Research Committee or the Interested Party, as applicable, may decide at any time that the Back-up Candidate shall replace the originally selected Clinical Candidate as Collaboration Product or Unilateral Product for the purposes of this Agreement).
View SourceView Similar (3)
Back-Up Candidates. Adagio may designate a Product as a Back-Up Candidate to another Product designated by Adagio as a Lead Product, which Lead Product is further in development than the Back-Up Candidate and is directed to the same Target (or, with respect to a multispecific Product, the same set of Targets) as the Back-Up Candidate. In the event that a Milestone Event that was already achieved with respect to a Lead Product is also achieved with respect to a Back-Up Candidate to such Lead Product prior to receipt of Marketing Approval for the Lead Product, then Adagio’s obligation to pay the corresponding Milestone Payment with respect to the achievement of the applicable Milestone Event with respect to such Back-Up Candidate will be deferred until receipt of Marketing Approval of the Lead Product. If Adagio continues to develop such Back-Up Candidate after receipt of Marketing Approval for the Lead Product, all deferred Milestone Payments for such Back-Up Candidate will become payable within [***] after receipt of such Marketing Approval and all subsequent Milestone Payments for such Back-Up Candidate will be payable within [***] after achievement of the corresponding Milestone Event with respect to such Back-Up Candidate. If Adagio promptly discontinues all development activities with respect to a Back-Up Candidate upon Marketing Approval of the Lead Product and provides Adimab with written notice thereof within [***] after receipt of such Marketing Approval, Adagio will not be obligated to pay the deferred Milestone Payments for such Back-Up Candidate. If Adagio continues to develop such Back-Up Candidate after discontinuation of development of the Lead Product (but prior to Marketing Approval of such Lead Product), Adagio will not be obligated to pay any Milestone Payments already paid with respect to such Lead Product, but all Milestone Payments for Milestone Events achieved with respect to such Back-Up Candidate that were not paid to Adimab with respect to such Lead Product will be payable within [***] after achievement of the corresponding Milestone Event.
View SourceView Similar (3)
Back-Up Candidates. In the event that a Milestone Event that was already achieved with respect to a Lead Product is also achieved with respect to a Back-Up Candidate to such Lead Product prior to receipt Marketing Approval for the Lead Product, then [***]. If Flame continues to develop such Back-Up Candidate after receipt of Marketing Approval for the Lead Product, [***]. If Flame promptly discontinues all development activities with respect to a Back-Up Candidate upon Marketing Approval of the Lead Product and provides Adimab with written notice thereof [***]. If Flame continues to develop such Back-Up Candidate after discontinuation of development of the Lead Product (but prior to Marketing Approval of such Lead Product), [***]. ​ ​
View SourceView Similar (2)
Back-Up Candidates. Wave and Pfizer will together designate one (1) back-up candidate (the “Back-Up Candidate”), selected from the structure and activity relationships discovered by Wave during the work under the Research Plan for each Pfizer Program. In the event of the termination of the Development of any Candidate Compound for any reason, Pfizer will have the right to replace the Candidate Compound with the Back-Up Candidate for continued Development for each Pfizer Program. In the event that Pfizer elects to replace the original Candidate Compound with a Back-Up Candidate, Wave will prepare and inform Pfizer of a good faith estimate of the projected costs to Wave to replace the Candidate Compound with the Back-Up Candidate. For progressing the Back-Up Candidate, Pfizer will reimburse Wave each Pfizer Quarter for the actual costs for the Back-Up Candidate, beyond the costs already expended for the original candidate.
View Source

Related to Back-Up Candidates

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, ▇▇▇▇▇ may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable. (b) To the extent a recall is required by applicable Law, or due to a potential safety hazard, non-compliance or Serial Defect, which is caused by Supplier, Supplier shall indemnify and hold Buyer harmless from all reasonable costs and expenses incurred in connection with any recall, repair, replacement or refund program, including all costs related to: (i) investigating and/or inspecting the affected goods; (ii) notifying Buyer’s customers; (iii) repairing, or where repair of the goods is impracticable or impossible, repurchasing or replacing the recalled goods; (iv) packing and shipping the recalled goods; and (v) media notification. Each party shall consult the other before making any statements to the public or a governmental agency relating to such recall, potential safety hazard, non- compliance or Serial Defect, except where such consultation would prevent timely notification required by Law.

  • Product Testing No later than [**] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [**] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [**] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [**] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [**] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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