Lead Product Sample Clauses

Lead Product. The term “
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Lead Product. 4.4.1.1. As of April 15, 2017, AstraZeneca will assume responsibility for all costs (including Pieris’ Out-of-Pocket Costs and FTE Costs) for the further Research, Development, and Manufacture (to the extent applicable), of the Lead Product as set forth in the initial Lead Product Development Plan, up to the amount of a mutually agreed budget which is set forth in the initial Lead Product Development Plan plus an overrun margin of [***] percent ([***]%) of the mutually-agreed budget, up to Completion of the Phase 1 Study for the Lead Product. Pieris shall notify AstraZeneca as soon as reasonably possible if Pieris becomes aware that the agreed budget is going to be exceeded. For avoidance of doubt, such costs shall be reimbursed by AstraZeneca as incurred by Pieris in accordance with its Accounting Standards. In case Pieris expects a cost overrun of more than [***] percent ([***]%) of the mutually agreed budget, Pieris shall inform AstraZeneca in writing before such cost above [***] percent ([***]%) overrun are incurred. AstraZeneca shall inform Pieris promptly whether it agrees to pay for such cost overrun above [***] percent ([***]%). For clarity, if AstraZeneca does not agree to pay for such cost overrun above [***] percent ([***]%), Pieris shall not be obligated to conduct the activities that would lead to such additional cost overrun above [***] percent ([***]%). In case AstraZeneca requests additional activities to be conducted by Pieris or a Third Party during such time, it shall also assume responsibility for all costs incurred in conducting such additional activities. Such Out-of-Pocket Costs and FTE Costs shall be reimbursed each Calendar Quarter within [***] ([***]) days of receipt by AstraZeneca of an invoice for such costs. AstraZeneca may request supporting documentation evidencing that such costs have been incurred and Pieris shall provide such information if requested. Should there be a dispute as to whether such costs have been incurred, the matter shall be addressed under the dispute resolution provisions in Section 15.1. In case any amount that has been paid by AstraZeneca is disputed and later shown not to have been incurred in accordance with this Agreement, AstraZeneca may credit such unjustified and paid amount against any future payments to Pieris under this Agreement. In the period between the Completion of the Phase 1 Study for the Lead Product and Pieris’ determination of whether it will exercise its Lead Product CoDev Option in ...
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Lead Product. Except as set forth on Schedule 5.14(e), the Company has not granted to any Person any license (including any sublicense), option, or other right, title or interest (including any right of first refusal or other preferential right or covenant not to sxx) in or to, or assigned or otherwise transferred to any Person, any Company Owned Intellectual Property or Company Licensed Intellectual Property that relates to, claims or covers the Lead Product (“Lead Product Agreements”) other than (i) immaterial non-exclusive licenses or other rights to use of Intellectual Property granted in the Ordinary Course of Business or (ii) confidentiality agreements entered into in the Ordinary Course of Business, and no Person other than the Company has any right, title or interest (including any option or right of first refusal or other preferential right) in or to any such Company Owned Intellectual Property or Company Licensed Intellectual Property (including any method of manufacturing the Lead Product) other than (i) immaterial non-exclusive licenses or other rights to use of Intellectual Property granted in the Ordinary Course of Business and (ii) rights granted pursuant to confidentiality agreements.
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Lead Product. Pieris shall be responsible for the filing, prosecution and maintenance of the Product Specific Patents Covering the Lead Product throughout the world. All costs and expenses of filing, prosecuting and maintaining such Patent Rights shall be shared in accordance with the Agreed Percentage until national stage, and then, each Party shall bear the costs of prosecuting and maintaining such Patent Rights in its respective Territory. Pieris shall provide Servier with the opportunity to review and comment on any and all such filing and prosecution efforts regarding such Patent Rights. Servier shall provide Pieris reasonable assistance in such efforts; provided that Pieris shall have final control over such filing and prosecution efforts for such Patents after reasonably considering Servier’s comments in good faith, provided that Pieris shall follow Servier’s instruction with respect to the opt-out procedure of the Unitary Patent System. In case of disagreement regarding the filing, maintenance or prosecution of such Patents, the issue will be discussed in the JIPC and may be escalated to the JSC and JEC in the event of continued disagreement. If Pieris determines to abandon or not maintain any such Patent Rights, Pieris shall provide Servier with prior written notice of such determination at least [***] before any loss of rights would occur with respect to such Patent Rights in any applicable patent office or patent granting authority and Servier shall have the right to assume the right to prosecute and maintain such Patent Rights at its sole discretion and expense.
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Lead Product. Pieris shall be responsible for the filing, prosecution and maintenance of the Product Specific Patents Covering the Lead Product throughout the world. All costs and expenses of filing, prosecuting and Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL TREATMENT REQUESTED maintaining such Patent Rights shall be shared in accordance with the Agreed Percentage until national stage, and then, each Party shall bear the costs of prosecuting and maintaining such Patent Rights in its respective Territory. Pieris shall provide Servier with the opportunity to review and comment on any and all such filing and prosecution efforts regarding such Patent Rights. Servier shall provide Pieris reasonable assistance in such efforts; provided that Pieris shall have final control over such filing and prosecution efforts for such Patents after reasonably considering Servier’s comments in good faith, provided that Pieris shall follow Servier’s instruction with respect to the opt-out procedure of the Unitary Patent System. In case of disagreement regarding the filing, maintenance or prosecution of such Patents, the issue will be discussed in the JIPC and may be escalated to the JSC and JEC in the event of continued disagreement. If Pieris determines to abandon or not maintain any such Patent Rights, Pieris shall provide Servier with prior written notice of such determination at least [***] before any loss of rights would occur with respect to such Patent Rights in any applicable patent office or patent granting authority and Servier shall have the right to assume the right to prosecute and maintain such Patent Rights at its sole discretion and expense.
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Lead Product. “Lead Product” shall mean the Company’s product designate as “IG-001” in any form, including any back-ups or other formulations thereof.
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Lead Product. 7.4.3 Back-Up Supply
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Lead Product. The Lead Manufacturing Party shall be the party to any such Third Party supply agreements for the manufacture and supply of Lead Product and MDX-1379 for use in the Territory and the Parties further anticipate that the Lead Manufacturing Party shall be the Party responsible for taking title to the supplied Lead Product and MDX-1379 and for paying for same, as well as for QA/QC and regulatory responsibilities consistent with the related Approvals for the Lead Product and MDX-1379 in the Territory. The terms of any such agreements shall include other customary terms and conditions consistent with this Agreement, including the provisions of this Article 7 and the representations and warranties set forth in Sections 8.2 and 8.3. BMS shall be solely responsible for the manufacture and supply of Lead Product and MDX-1379 in the Royalty Territory, and shall have the right to enter into Third Party supply agreements consistent with the terms of this Section 7.4 and the applicable Manufacturing Plan and Budget. With respect to inventory held by Medarex at the Effective Date, upon a paper review of Medarex’s QA/QC records with respect thereto, BMS will take title and, subject to Medarex’s rights and obligations under Section 3.2.4(a), possession as agreed upon by the Parties, and shall be responsible for all related QA/QC and other regulatory responsibilities on any such transferred inventory. The Manufacturing Costs with respect to all such inventory, whenever incurred, shall be included in Development Costs and shared by the Parties pursuant to Section 3.7.1.
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Related to Lead Product

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • 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.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • 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.

  • 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.

  • 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.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

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