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Development
Development contract clause examples

Status as Business Development Company. The Borrower is a “closed-end fund” that has elected to be regulated as a “business development company” within the meaning of the Investment Company Act and qualifies as a RIC.

At the end of the fiscal year, the overall Company and each Business Area or Commercial Area’s actual performance for each financial component of the formula portion of the bonus awards will be calculated (based on the Company’s and each Business Area or Commercial Area’s performance as of year-end) and approved by the Chief Financial Officer, ("CFO"). The net revenue and operating margin for the Business Area or Commercial Area metrics must individually achieve a minimum performance of 80% against target to qualify for that component payout. If one net revenue metric achieves 80% or higher, and the corresponding operating margin metric does not, the component payout will be 0%. An acceleration/deceleration scale will then be applied to each individual metric as follows to develop the payout for each metric.

Additional Development Activities in the Territory. Licensee, at its own cost and expense, shall have the right, subject to Axsome’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed, to conduct Development activities of the Licensed Products in the Field in the Territory solely for the purposes of complying with any post-approval requirements imposed or agreed to with any Regulatory Authority in the Territory as a condition of granting or maintaining the Regulatory Approval in the Territory for such Licensed Product in the Field and for otherwise enhancing the label for, or adding additional indications (in the Field) to enable and support the Commercialization of the Licensed Products, in each case for use in the Field in the Territory. Prior to initiating any such Development activity, Licensee shall notify and consult with Axsome with respect thereto and Axsome shall have the right to review, and Licensee shall provide to Axsome for review, the plans and protocols for any such Development activities prior to Axsome providing its written consent to permit Licensee to conduct such Development activities. In the event Axsome provides written consent for such proposed Development activities, Licensee shall consider in good faith, and not unreasonably refuse to address, any of Axsome’s comments and suggestions provided by Axsome to Licensee with respect to the plans and protocols of any such Development activities. For clarity, # it shall be reasonable for Axsome to withhold its consent for Licensee to conduct any particular Development activity with respect to any Licensed Product if Axsome, in good faith, reasonably believes that such Development activity may have an adverse impact on any product containing the Licensed Compound (including on any Regulatory Approval with respect thereto) that Axsome, its Upstream Licensors or its or their Affiliates or licensees is developing or Commercializing or is planning to develop or Commercialize outside of the Territory and # Axsome is hereby deemed to have provided its consent for Licensee to conduct the studies listed on [Schedule 3.3.2]. Licensee shall use reasonable efforts to conduct all such approved Development activities and to conduct them in compliance with all applicable legal and regulatory requirements, good clinical practices, ethical requirements and industry guidelines.

Acquisition and Development Group; Construction Group. The Acquisition and Development Group (“A&D Group”) is composed of Employees of each of Saul Company and [[Saul Centers:Organization]]. Saul Company employees perform acquisition and development services for [[Saul Centers:Organization]]. Similarly, [[Saul Centers:Organization]] employees perform acquisition and development services for Saul Company. The Construction Group is composed of Saul Company employees, which employees perform construction management services for both Saul Company and [[Saul Centers:Organization]]. The A&D Group and the Construction Group shall be referred collectively herein as the “Industry Groups.”

Final Accounting of Total Development Costs. Promptly following completion of the Improvements, [[Landlord:Organization]] shall deliver a final accounting of the actual Total Development Costs and the actual [[Tenant:Organization]] Improvement Costs, each in reasonable detail together with supporting documentation regarding such costs, which final accounting shall include a statement of any variances on a line-item basis between the amounts shown on the Final Total Development Cost Budget and on the Final TI Cost Budget and the actual costs incurred for such line-item. [[Tenant:Organization]] and its auditors shall be permitted to review and/or conduct an audit of all books and records relating to the determination of the actual Total Development Costs for the Premises and the actual [[Tenant:Organization]] Improvement Costs for the [[Tenant:Organization]] Improvements. [[Landlord:Organization]] shall fully cooperate with [[Tenant:Organization]] in the course of [[Tenant:Organization]]’s review and/or audit of such books and records, and [[Tenant:Organization]] shall diligently prosecute such review and/or audit so that the same may be completed within a reasonable period after [[Landlord:Organization]] makes such books and records available to [[Tenant:Organization]], subject to [[Tenant:Organization]]’s right to further review and/or audit any items not initially provided by [[Landlord:Organization]] in such books and records. Any disagreement between [[Landlord:Organization]] and [[Tenant:Organization]]

RA Development Prior to In-Licensing. In the event [[Organization A:Organization]] does not proceed with the In-Licensing in respect of RA after delivery of the RA Complete Data Package, then [[Party:Organization]], in its sole discretion, shall have the option, at its sole cost and expense, to further Develop the Licensed Compound for RA; provided, that [[Party:Organization]] provides to [[Organization A:Organization]] and the Parties mutually agree upon # a final budget incorporating all costs associated for such Development, # the final protocol and a detailed synopsis for each Clinical Study for RA, # the relevant success criteria for such Clinical Studies, and # the tentative timelines to complete such Clinical Studies (collectively, the “RA Phase 3 Development Plan”). In the event the Parties are unable to agree despite good faith discussions upon the RA Phase 3 Development Plan, neither Party shall have the right to resolve the dispute unilaterally or through ADR and the proposed RA Phase 3 Development Plan shall be deemed rejected. Following initiation of the RA Phase 3 Development Plan # as part of the JDC meetings, [[Party:Organization]] shall keep [[Organization A:Organization]] regularly updated regarding the status, progress, timelines and clinically validated results for each Clinical Study for RA, and # any amendment to the RA Phase 3 Development Plan shall be discussed in good faith between the Parties, with [[Party:Organization]] having the right to make the final determination with respect to such amendment, unless the amendment would affect or could reasonably be expected to affect [[Organization A:Organization]]’s interests in the Initial Indications pursuant to this Agreement. If the Parties are unable to agree on whether an amendment to the RA Phase 3 Development Plan would affect or could reasonably be expected to affect [[Organization A:Organization]]’s interests in the Initial Indications pursuant to this Agreement, then such amendment shall be referred to the JDC for further discussion. In the event the JDC is unable to agree upon a resolution for such amendment, then the dispute shall be resolved pursuant to Section 13.8. In the event [[Organization A:Organization]] # proceeds with the In-Licensing following the receipt of the SLE Complete Data Package, and # subject to [Section 6.2.1(iii)(c)], moves forward with the Development of the Licensed Compound for RA ([subsections (1) and (2)])], collectively, the “RA Election”), then, in addition to the milestone and royalty payment obligations set forth in Article 6 related to RA, [[Organization A:Organization]] shall be required to pay [[Party:Organization]] the RA Phase 3 Payment pursuant to Section 6.2.3. Upon [[Organization A:Organization]]’s RA Election, [[Organization A:Organization]] shall have the option to either # permit [[Party:Organization]] to continue the Development activities pursuant to the RA Phase 3 Development Plan; provided, that the Parties shall negotiate in good faith the financial consideration to be provided to [[Party:Organization]] for such services in accordance with the budget set forth in the RA Phase 3 Development Plan, or # take over the Development activities under the RA Phase 3 Development Plan and [[Party:Organization]] shall effectuate and coordinate a smooth and efficient transition of relevant obligations and rights to [[Organization A:Organization]] as CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...​...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Development, Distribution and Hosting Licenses Restrictions. The following restrictions apply to the licenses granted under sections 4.1, 4.2, 4.3 and 4.4 above:

“Early Clinical Development Program” means, as to each Development Candidate, the program of Development activities for such Development Candidate in accordance with the associated Early Clinical Development Plan during the Early Clinical Development Term. For clarity, the Early Clinical Development Program will not include activities conducted under the Research Plan or Late Clinical Development Program or relating to Manufacturing.

“Development IP” means Development Know-How and Development Patents.

allocate primary responsibility as between the Parties for tasks relating to the Research and Development of Research Candidates and Development Candidates where not already specified in the Research Plan, Early Clinical Development Plans or Late Clinical Development Plans therefor;

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