Development Matters. (a) All preclinical and clinical studies conducted by or on behalf of the Company to support approval for commercialization of the Company’s products have been conducted by the Company, or to the Company’s knowledge by third parties, in compliance with all applicable federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in compliance which would not reasonably be expected to have, singly or in the aggregate, a Material Adverse Effect.
(b) The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Company SEC Documents (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Company SEC Documents are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Company SEC Documents, the results of which are inconsistent with or call in question the results described or referred to in the Company SEC Documents; and the Company has not received any notices or correspondence from the United States Food and Drug Administration (the “FDA”) or any foreign, state or local governmental authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable governmental authorities outside of the United States to which the Company is subject.
Development Matters. (a) The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Company SEC Documents (the “Company Studies and Trials”) were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with experimental protocols, procedures and controls designed and approved for such Company Studies and Trials; the descriptions of the results of the Company Studies and Trials contained in the Company SEC Documents are, to the Company’s knowledge, accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Company SEC Documents, the results of which are inconsistent with or call in question the results described or referred to in the Company SEC Documents; the Company has made all such filings and obtained all such approvals as may be required by the United States Food and Drug Administration (the “FDA”) or any committee thereof and from any foreign, state or local governmental authority exercising comparable authority, or health care facility Institutional Review Board, except as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect.
Development Matters. To the extent required by applicable law, the Mortgagee, without incurring any obligation to file or record any documentation and at Mortgagor's cost and expense, shall join in the execution of subdivision plats, easements and declarations covering all or any part of the Mortgaged Property and other documents with respect to which Mortgagee's joinder is necessary for the development of the Mortgaged Property as contemplated in the Business Plan, PROVIDED that such subdivision plats, easements, declarations and other documents are in form and substance reasonably satisfactory to Mortgagee and Mortgagor shall have complied in all respects with all applicable provisions of law with respect thereto.
Development Matters. (a) The City hereby confirms its approval of up to 531 residential units together with governmental, retail, and office uses within the Land. The Developer shall apply for zoning related to this approval. The Project shall comply with all Applicable Rules unless otherwise modified by this Agreement or future approvals.
Development Matters. (a) Throughout the period of construction of the Buildings, Seller shall provide Buyer with a reasonable opportunity to attend regular periodic construction meetings between Seller’s representatives and representatives of its contractor(s). To the extent time and convenience permits, Seller also will give Buyer a reasonable opportunity to attend other special meetings between Seller’s representatives and representatives of its contractor(s) concerning the construction of the Buildings. In no event shall the provisions of this Section be allowed to impede or delay the course of development, construction or completion of the Buildings or other improvements at the Project.
(b) Subject to Seller’s express representations, warranties and covenants set forth elsewhere in this Agreement, upon the Closing Buyer hereby shall waive, relinquish and release Seller and its members and their respective officers, directors, shareholders, employees and agents (the “Released Parties”) from and against any and all claims, demands, causes of action (including causes of action in tort), losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees) of any and every kind or character, known or unknown, which Buyer might have asserted or alleged against the Released Parties at any time by reason of or arising out of any latent or patent construction defects or physical conditions, violations of any applicable laws and any and all other acts, omissions, events, circumstances or matters concerning the Property. In connection therewith, Buyer expressly waives all rights under California Civil Code Section 1542, which provides that: “A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor.”
(c) Notwithstanding the foregoing provisions of this Section 18, Buyer is not agreeing to waive any claims it may have against Seller for any loss or liability to Buyer to the extent caused by Seller’s acts of fraud or breach of its express covenants, representations or warranties set forth in this Agreement. Buyer specifically acknowledges Seller’s current intention that the parties who will be actually constructing and installing the Buildings and related facilities and improvements will be unaffiliated contractors and subcontractors. Accordingly, although Seller will be oblig...
Development Matters. (a) All Kv7 Compounds existing as of the Execution Date (collectively, the “Company Compounds”) are being, and at all times have been, developed, tested, processed, manufactured, stored, and shipped, as applicable, in material compliance with all applicable Laws, including all Healthcare Laws. No Company Compounds are currently in commercial distribution by or on behalf of Seller, or to the Knowledge of Seller.
(b) Seller has made available to Buyer all material facts, data and information known to Seller relating to the efficacy, toxicity, stability, synthesis and selectivity of [**].
(c) No facts, data or information materially adverse to the Kv7 Discovery Platform and known to Seller have been omitted from disclosures made to Buyer and its Affiliates prior to the Closing Date.
(d) All analyses, presentations and results that have been provided by Seller to Buyer and its Affiliates were unbiased and complete with respect to the efficacy, toxicity, stability, synthesis and selectivity of [**].
(e) Any facts, data or information materially adverse to the Kv7 Discovery Platform and known to Seller have been specifically identified and disclosed to Buyer or its Affiliates.
(f) Seller and its Subsidiaries have not received or been subject to any notice, warning, administrative proceeding, order, complaint, or other written communication of any actual or threatened Action, investigation or allegation that Seller or any of its Subsidiaries has violated any applicable Law related to the Company Compounds or Program Assets. To the Knowledge of Seller, no Person has filed or has threatened to file against Seller or any of its Subsidiaries any Action under any federal or state whistleblower statute or equivalent Law in the applicable jurisdiction. None of Seller or any of its Subsidiaries or any officer, employee, agent or clinical investigator thereof has been suspended, debarred, excluded or convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. Section 335a, exclusion under 42 U.S.C. Section 1320a-7 or any similar Action.
(g) All preclinical work related to the Company Compounds sponsored or conducted by Seller and its Subsidiaries have been and are being conducted in, and all Company Compounds used in connection with such investigations are and have been in, material compliance with all applicable Laws, including Good Laboratory Practices, other Healthcare Laws, applicable research protocols and...
Development Matters. Tenant hereby agrees and acknowledges that Landlord shall be permitted to improve or cause to be improved or to convey or lease to third parties for improvement (without the necessity of obtaining Tenant’s consent) the outlots, if any, depicted on EXHIBIT “B-1”, or any lots contiguous or adjacent to the Shopping Center to which legal or equitable title is acquired by Landlord at any time during the term hereof (individually, an “Outlot”, collectively, the “Outlots”), as separate and independent developments from the remainder of the Shopping Center with the understanding that the Outlots and the remainder of the Shopping Center shall nevertheless constitute an integrated shopping center and the same may not, at Landlord’s election, form part of the Shopping Center. In the event of a sale, transfer or other conveyance of any of the Outlots, Landlord may enter into an agreement with the transferee granting appropriate easement and other rights, and containing such other matters as Landlord and such transferee may agree, to the extent not inconsistent with this Lease. Further, Landlord and Tenant hereby agree and acknowledge that Landlord shall be permitted to sell, transfer or otherwise convey any portion of the Shopping Center as a separate and independent development from the remainder of the Shopping Center with the understanding that any such portion and the remainder of the Shopping Center shall nevertheless constitute an integrated shopping center and the same may not, at Landlord’s election, form part of the Shopping Center. In the event of a sale, transfer or other conveyance of any portion of the Shopping Center (separate from the balance of the Shopping Center), Landlord may enter into an agreement with the transferee granting appropriate easement and other rights, and containing such other matters as Landlord and such transferee may agree, to the extent not inconsistent with this Lease.
Development Matters. In connection with the development of the Property into single-family residential lots, Purchaser shall name three (3) streets in a manner acceptable to Seller and Purchaser to honor and remember the land owners of over sixty (60) years.
Development Matters. (a) Company Responsibilities during the Company Development Period.
(i) During the Company Development Period, Company shall be responsible for, and shall conduct, each of the Company Development Activities, including sponsorship and conduct of the Designated Clinical Trials. Subject to the authority of the JPT with respect to Critical Matters, during the Company Development Period, Company shall reasonably consult with, and consider in good faith any input provided by, Amgen regarding any material plans or decisions regarding the Company Development Activities.
(ii) During the Company Development Period, Company shall be responsible for all costs and liabilities (subject to Amgen’s indemnification obligations pursuant to Section 13.2) associated with the conduct of the Company Development Activities (which, for clarity, excludes any costs or liabilities incurred by or on behalf of Amgen in its performance of the Amgen Development Activities, its performance of its obligations under this Agreement or in its provision of assistance to Company as contemplated by this Agreement). From the Effective Date until two (2) years after the payment of the Company Development Milestone, Company shall keep complete and accurate records, in reasonable detail, pertaining to the costs and liabilities incurred by Company associated with the conduct of the Company Development Activities (such documented costs and liabilities in aggregate, the “Company Development Costs”).
(i) From the Effective Date until two (2) years after the payment of the Company Development Milestone, Amgen shall have the right, upon 30 days’ prior written notice to Company, to cause, at Amgen’s costs, an independent, certified international public accounting firm reasonably acceptable to Company to audit Company’s records relating to the Company Development Costs during Company’s normal business hours with the purpose of confirming the amount of the Company Development Costs. The accounting firm shall disclose to Company only whether the reported Company Development Costs are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Amgen. The accounting firm shall provide Company with a copy of any disclosures or reports made to Amgen and Company shall have an opportunity to discuss such disclosures or reports with Amgen and the accounting firm. Information, disclosures, or reports arising from any such examination shall be Confidential Inf...
Development Matters. AnaptysBio shall have the sole right, but not the obligation, to conduct all Development activities, with respect to Compounds and Products in the Field in the Territory, whether itself, or by or through or with any Affiliate, Sublicensee or Service Provider. 5.2
