Research and Development Obligations Clause Samples
The Research and Development Obligations clause defines the responsibilities and expectations of the parties regarding the conduct of research and development activities under the agreement. It typically outlines the scope of work, timelines, resource commitments, and reporting requirements for any R&D efforts, and may specify milestones or deliverables that must be achieved. This clause ensures that both parties are clear on their roles and contributions, helping to prevent misunderstandings and disputes about the progress or outcomes of joint research projects.
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Research and Development Obligations. 7.1 OXIS shall conduct such research, development and preclinical and human clinical trials as OXIS determines are necessary or desirable to obtain regulatory approval to manufacture and market such Licensed Human Therapeutic Products as OXIS determines are commercially feasible in the Territory and as otherwise required to commence a Phase I clinical trial for a Licensed Human Therapeutic Product on or before the 3rd anniversary of the Effective Date, and shall use its commercially reasonable efforts to obtain regulatory approval to market, and following approval to commence marketing and market each such Licensed Human Therapeutic Product in such countries in the Territory as OXIS determines are commercially feasible.
7.2 OXIS shall maintain records, in sufficient detail and in good scientific manner, which shall reflect all work done and results achieved in the performance of its research and development regarding the Licensed Human Therapeutic Products.
7.3 No less often than every SIX (6) MONTH anniversary after the Effective Date OXIS shall report in writing to MCIT on progress made toward the objectives set forth above.
7.4 Notwithstanding anything else to the contrary, OXIS shall be required to commence a Phase I clinical trial for a Licensed Human Therapeutic Product anywhere in the Territory on or before the 3rd anniversary of the Effective Date.
Research and Development Obligations. 9 8.1 Development 9 8.2 Funding and Resources 9 8.3 Committee 9
Research and Development Obligations. 6.1 Research and Development Efforts 6.2 R&D Plan 6.3 Records
Research and Development Obligations. 8.1 CBMG (a) shall use its Commercially Reasonable Efforts to develop and conduct such research, development and validation studies as necessary or desirable to obtain all regulatory approvals to manufacture and market such Licensed Products in the Field in at least one country in a Major Market, and (b) upon receipt of such approvals, to use Commercially Reasonable Efforts to market, each such Licensed Product in the Field in such country. CBMG, at its sole expense, shall fund the costs of all research, development, preclinical and clinical trials, regulatory approval and commercialization of the Licensed Products.
8.2 CBMG shall maintain records, in sufficient detail and in good scientific manner appropriate for patent purposes, which shall reflect all work done and results achieved in the performance of its research and development regarding the Licensed Patent Rights and the Licensed Products (including all data in the form required under all applicable laws and regulations).
8.3 Within ninety (90) days following the end of each calendar year during the term of this Agreement, CBMG shall prepare and deliver to AURI a written report which shall describe, in reasonably sufficient detail, (a) the research performed to date employing the Licensed Patent Rights, (b) the progress of the development, and testing of Licensed Products, and (c) the status of obtaining the necessary approvals to market Licensed Products. In addition, CBMG shall provide AURI with written notice of all material regulatory filings and submissions prior to the date of such submissions, and written notice of all approvals obtained promptly after obtaining such approvals.
Research and Development Obligations. 8.1 NT-3 Development. Candel commits to the use of Commercially Reasonable Efforts to complete a human proof of concept clinical trial, consistent with Good Clinical Practices, of an NT-3 Asset (PGN-503 is an example of one such NT-3 Asset) for chemotherapy induced peripheral neuropathy (such clinical trial, the “NT-3 Trial”). The NT-3 Trial will be comprised of a number of subjects sufficient, as determined in good faith by Candel consistent with Good Clinical Practices prior to the launch of the NT-3 Trial, for management of Candel to evaluate, in its own reasonable discretion, whether resulting safety and potential efficacy and other data justify advancement to later stage clinical development. In furtherance of and subject to the foregoing, Candel will use Commercially Reasonable Efforts to:
8.1.1 File the IND for the NT-3 Trial no more than [***] months from a GMP NT-3 Asset product release and a clinical protocol approved by the designated principal investigator(s); and
8.1.2 Enroll the first patient in the NT-3 Trial within [***] months of the regulatory allowance of the IND corresponding to the clinical protocol specified in 8.1.1 above.
8.2 If Candel is found to be in violation of the foregoing obligations, it shall be entitled to a [***] month extension of any such deadline set forth in 8.1.1 or 8.1.2 above, provided, however, a four (4) member committee is promptly established consisting of the Researchers and two additional appointees by Candel management. Such committee shall determine if Candel is using Commercially Reasonable Efforts to timely complete the foregoing diligence obligations and may extend the foregoing diligence deadlines beyond [***] months if the committee deems it reasonable. However, should the Researchers disagree that such extension is reasonable in light of the circumstances, the committee will select an independent arbitrator with recognized experience in the drug approval process pursuant to Section 12 to determine if Candel’s further requested delay is scientifically and/or commercially reasonable in light of the circumstances. If such arbitrator determines that such delay is not scientifically and/or commercially reasonable in light of the circumstances and thereby Candel has not been using Commercially Reasonable Efforts to satisfy its obligations under 8.1.1 or 8.1.2, then within [***] days of such arbitrator’s decision, Candel may, in its sole discretion, remit [***] ($[***]) Dollars to Periphagen for an extension...
Research and Development Obligations. The parties agree if Stereotaxis should fail to make a payment when due under this Second Amendment or any Supplemental Payment, together with interest due thereon, and fails to cure within 30 days of receipt of written notice from Biosense ▇▇▇▇▇▇▇, then Biosense ▇▇▇▇▇▇▇ shall be relieved of its obligation to perform R&D under the Existing Agreements covered by the invoice that relates to such payment, until payment has been made.
Research and Development Obligations. (a) NEUROGEN shall be solely responsible for all future research and development and regulatory activities with respect to Compounds and Products, including adverse event reporting to the appropriate Regulatory Authorities in the countries in the Territory, in accordance with the appropriate laws and regulations of the relevant countries.
(b) NEUROGEN shall use Commercially Reasonable Efforts to commence a Phase II Clinical Trial within eighteen (18) months of the Transfer Completion Date and to further develop, manufacture and commercialize Products in the Field in the Territory. [***] Confidential treatment requested by Neurogen Corporation.
(c) If NEUROGEN does not commence a Phase II Clinical Trial within eighteen (18) months of the Transfer Completion Date, NEUROGEN shall make a one time payment to WYETH of [***] ($[***]), and thereafter, shall pay WYETH [***] ($[***]) on each anniversary of such date until a Phase II Clinical Trial is commenced.
Research and Development Obligations