Procedure for Potential Collaboration Targets
Procedure for Potential Collaboration Targets Sample Clauses
Related to Procedure for Potential Collaboration Targets
Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.
Procedure for Third Party Claims Any person that intends to claim indemnification under this Article 13 (an "Indemnitee") arising out of a Third Party claim shall promptly notify the indemnifying party (the "Indemnitor") of such claim in respect of which the Indemnitee intends to claim such indemnifi- cation, and the Indemnitor shall, to the extent applicable, assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an Indemnitee shall have the right to retain its own counsel, with the reasonable fees and expenses thereof to be paid by the Indemnitor, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. The parties' indemnity obligations under this Article 13 shall not apply to amounts paid in settlement of any loss, claim, liability or action if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld unreasonably. Any Indemnitee's failure to deliver notice to the Indemnitor within a reasonable time after the commencement of any such action, if materially prejudicial to the Indemnitor's ability to defend such action, shall relieve the Indemnitor of any liability to the Indemnitee under this Article 13, but not any liability that it may have to the Indemnitee otherwise than under this Article 13. The Indemnitee and its employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification.
Research Collaboration (a) GSK hereby grants to Anacor a non-exclusive, non-royalty bearing license under the GSK IP, solely as and to the extent necessary or important to conduct activities for which Anacor is responsible under the Research Plans during the Research Collaboration Term.
Research Plans The Research Plan for the [***] Designated Target is attached as Schedule 2.2.3-1. Subsequent Research Plans agreed upon in accordance with Section 2.4.2.4 will be attached as additional sequentially numbered schedules (Schedule 2.2.3-2, Schedule 2.2.3-3, etc.).
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:
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).
Procedure for Claims (a) Any person who desires to seek indemnification under any part of this Section 18 (each, an “Indemnified Party”) shall give written notice in reasonable detail (a “Claim Notice”) to each party responsible or alleged to be responsible for indemnification hereunder (an “Indemnitor”) and the Deposit Holder prior to any applicable Expiration Date (as defined below). Such notice shall briefly explain the nature of the claim and the parties known to be invoked, and shall specify the amount thereof. If the matter to which a claim relates shall not have been resolved as of the date of the Claim Notice, the Indemnified Party shall estimate the amount of the claim in the Claim Notice, but also specify therein that the claim has not yet been liquidated (an “Unliquidated Claim”). If an Indemnified Party gives a Claim Notice for an Unliquidated Claim, the Indemnified Party shall also give a second Claim Notice (the “Liquidated Claim Notice”) within 60 days after the matter giving rise to the claim becomes finally resolved, and the second Claim Notice shall specify the amount of the claim. Each Indemnitor to which a Claim Notice is given shall respond to any Indemnified Party that has given a Claim Notice (a “Claim Response”) within 30 days (the “Response Period”) after the later of (i) the date that the Claim Notice is given or (ii) if a Claim Notice is first given with respect to an Unliquidated Claim, the date on which the Liquidated Claim Notice is given. Any Claim Response shall specify whether or not the Indemnitor giving the Claim Response disputes the claim described in the Claim Notice. If any Indemnitor fails to give a Claim Response within the Response Period, such Indemnitor shall be deemed not to dispute the claim described in the related Claim Notice. If any Indemnitor elects not to dispute a claim described in a Claim Notice, whether by failing to give a timely Claim Response in accordance with the terms hereof or otherwise, then the amount of such claim shall be conclusively deemed to be an obligation of such Indemnitor.
Development Milestones Subject to the terms and conditions of this Agreement, no later than [**] following the first occurrence of each event described below (each, a “Development Milestone”), on Product-by-Product basis Moderna shall pay Carisma the non-refundable and non-creditable amounts set forth below for each Product to achieve such event (each, a “Development Milestone Payment”): Development MilestoneDevelopment Milestone Payment (in US$ millions) [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] Moderna shall provide written notice to Carisma of the achievement of each Development Milestone within [**] after such achievement. If a Development Milestone for a Product is achieved without the preceding Development Milestone(s) having been achieved for such Product, then the Development Milestone Payment for such preceding Development Milestone(s) shall be paid by Moderna to Carisma together with the Development Milestone Payment for the Development Milestone that was achieved. For example, if the [**] Development Milestone [**] in the table above is achieved for a Product but the [**] Development Milestone [**] in the table above had not been achieved for such Product, then Moderna would pay the Development Milestone Payment for both such [**] Development Milestone and [**] Development Milestone upon achievement of the [**] Development Milestone. Each of the Development Milestone Payments set forth above shall be payable one time only per Product. If Moderna or its Affiliates or Sublicensees Develops a Product that has achieved at least one Development Milestone and subsequently discontinues Development of such Product and Develops a different Product incorporating or directed to the same combination of Collaboration Targets (whether one Collaboration Target or multiple Collaboration Targets), then Moderna shall be required to pay Development Milestone Payments for such different Product only for Development Milestones that had not been achieved by such discontinued Product.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
