Class Generic Claims; Investigator’s Brochure Sample Clauses

Class Generic Claims; Investigator’s Brochure. To the extent Novartis intends to make any claims in a Product label or regulatory filing that are class generic to Oligonucleotides, Akcea’s or its Affiliate’s generation 2.0 or 2.5 chemistry platform(s), Conjugate Technology, or any other Akcea technology included in a Product, Novartis will provide such claims and regulatory filings to Akcea in advance and will [***] any proposals and comments made by Akcea (or its Affiliates). Novartis will provide Akcea updated versions of the investigator’s brochure when Development of the Products results in any substantive change to the safety or risk to the Products. To the extent Akcea or Affiliates or licensors of Akcea intends to make any claims in a label or regulatory filing that (i) is reasonably likely to [***], and (ii) are [***], or any other [***], Akcea will provide such claims and regulatory filings to Novartis in advance and will consider in good faith any proposals and comments made by Novartis (or its Affiliates).
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Class Generic Claims; Investigator’s Brochure. To the extent Novartis intends to make any claims in a Licensed Product label or regulatory filing that are class generic to Oligonucleotides, Ionis’ or its Affiliate’s chemistry platform(s), Conjugate Technology, or any other Ionis technology included in a Licensed Product, Novartis will provide such claims and regulatory filings to Ionis in advance and will consider in good faith any proposals and comments made by Ionis (or its Affiliates). Novartis will provide Xxxxx updated versions of the investigator’s brochure [***].
Sample 1

Related to Class Generic Claims; Investigator’s Brochure

  • 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.

  • Product Claims You acknowledge that Company, not an App Distributor, is responsible for addressing any claims of yours or any third party relating to the Company application or your possession and/or use of the Company application, including, but not limited to: (i) product liability claims; (ii) any claim that the Company application fails to conform to any applicable legal or regulatory requirement; and (iii) claims arising under consumer protection or similar legislation. (5)

  • Presentation of Potential Target Businesses The Company shall cause each of the Initial Shareholders to agree that, in order to minimize potential conflicts of interest which may arise from multiple affiliations, the Initial Shareholders will present to the Company for its consideration, prior to presentation to any other person or company, any suitable opportunity to acquire an operating business, until the earlier of the consummation by the Company of a Business Combination or the liquidation of the Company, subject to any pre-existing fiduciary obligations the Initial Shareholders might have.

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