Development and Commercialisation Clause Samples
The Development and Commercialisation clause outlines the parties' obligations and rights regarding the creation, improvement, and marketing of a product or technology. It typically specifies timelines, milestones, and responsibilities for research, development, and bringing the product to market, as well as how revenues or intellectual property will be managed. This clause ensures that both parties are aligned on the process and expectations for turning an idea or invention into a commercially viable product, thereby reducing misunderstandings and facilitating successful collaboration.
Development and Commercialisation. 4.1 Within [***] days following the Effective Date, the Parties shall agree to a research and technical development plan (the “Research and Technical Development Plan”) that sets forth the Parties’ respective Research and Technical Development Plan Activities, which may be amended from time to time by the JDC in accordance with this Agreement. The Parties shall perform and complete, or cause the performance and completion of, their respective Research and Technical Development Plan Activities, and deliver to each other a summary of the results (including raw data if reasonably requested by a Party), samples and reports arising therefrom in accordance with each Research and Technical Development Plan within [***] ([***]) days following completion thereof.
4.2 The Licensee shall provide Ascendis with a draft of each Research and Technical Development Plan. The Licensee shall consider, in good faith, any comments regarding each draft Research and Technical Development Plan that Ascendis provides to the Licensee within [***] ([***]) days of Ascendis’ receipt of such draft Research and Technical Development Plan. In addition, the Licensee shall keep Ascendis informed of the progress of the development of each Licensed Product against the applicable Research and Technical Development Plan at each meeting of the JDC pursuant to Clause 4.6(A).
4.3 The Licensee shall be solely responsible for any clinical trial activities carried out as part of its development and commercialisation activities in the Territory.
4.4 The Licensee shall use Diligent Efforts to develop and commercialise Licensed Product in the Field in the Territory.
4.5 Each Party shall conduct all development of Licensed Product in compliance with current Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice, in each case, where applicable. Neither Party shall use any person that has been debarred, disqualified or banned from practising medicine to perform activities under this Agreement, and each Party shall immediately notify the other Party in writing if any person performing activities under this Agreement is disqualified, debarred or banned from practising medicine.
Development and Commercialisation. During the Term, Nuvectis shall use Diligent and Reasonable Endeavours to:
5.1.1 carry out the Development Plan;
5.1.2 develop, promote, distribute, supply and sell one or more Licensed Products within the Field in each Major Market in the Territory and provide such marketing resources as may reasonably be expected to bring the Licensed Products to the attention of as many buyers and potential buyers as possible to maximise Net Sales and Sub-Licensee Revenue;
5.1.3 pursue Regulatory Approval in each Major Market in the Territory for those Licensed Products in the Field in clinical development;
5.1.4 pursue market penetration in each Major Market in the Territory for Licensed Products in the Field to maximise availability to patients;
5.1.5 without prejudice to the generality of the foregoing, develop and commercialise in each Major Market at least one Licensed Product with an application in an Oncology Indication;
5.1.6 provide such production facilities as may be reasonably necessary in Nuvectis’s discretion to meet all reasonable demands for the development, manufacture and commercialisation of Licensed Products in the Field in the Territory;
5.1.7 produce the Licensed Products in accordance with good industry standards;
5.1.8 subject to obtaining required Regulatory Approval in the United Kingdom with respect to a Licensed Product:
(i) make such Licensed Product available in commercial markets in the United Kingdom within [***] of that Licensed Product being made available anywhere else in the Territory provided that such period shall be extended to the extent of any delays caused by any Regulatory Authority;
(ii) [***]; and
5.1.9 [***]
Development and Commercialisation. 4.1 Cyclacel shall use commercially reasonable endeavours to pursue the development and commercialisation of Product. For the purposes of this Clause 4 such reasonable endeavours shall mean those efforts to develop and commercialise Product which are at least the same as the efforts used by Cyclacel in relation to the development and commercialisation of other Cyclacel pharmaceutical products under similar commercial circumstances that have similar commercial value and development status to the Product. Cyclacel shall carry out such development in accordance with the key elements of the Development Plan which plan may be updated and/or amended from time to time by Cyclacel and Cyclacel shall provide Sankyo with a copy of any such updated or amended plan.
4.2 Without limiting the generality of the foregoing Cyclacel shall use its reasonable endeavours [*] If Cyclacel, its Affiliates or Cyclacel Licensees have not [*] then provided such failure is not due to an Exceptional Cause Sankyo shall be entitled to notify Cyclacel that it intends to terminate this Agreement, Cyclacel shall have sixty (60) days to reply to Sankyo’s notification and demonstrate that such failure was due to an Exceptional Cause. In the event that the Parties agree that no such Exceptional Cause has been demonstrated then Sankyo will have the right to terminate this Agreement upon thirty (30) days written notice. [*] The Parties shall, no later the fifth (5th) anniversary of the Commencement Date discuss, in good faith and review such time periods and, if appropriate, extend such period to [*]
4.3 Cyclacel shall within thirty (30) days of each anniversary of the Commencement Date provide Sankyo with a written summary of the progress which Cyclacel, its Affiliates and/or Cyclacel Licensees has made against the Development Plan in the previous twelve (12) month period. In addition, Cyclacel shall provide Sankyo within seven (7) months of each annual written report with a brief update of such progress, which update may be given in writing by facsimile or by e-mail.
4.4 In the event that Cyclacel decides to appoint a Third Party, or if Cyclacel receives an offer from a Third Party, in either case to develop and/or commercialise Product solely in Japan or in Japan as part of a multi-territory sub-licence, it shall so notify Sankyo which notification shall not be made prior to the first Successful Completion of a [*] Clinical Trial or the decision by Cyclacel or a Cyclacel Licensee to initiate...
Development and Commercialisation. 12.1. Subject to the Company receiving the HMO Cells of the quality and in the quantity as provided in clause 2.6 above and Appendix E hereto, the Company undertakes, at its own expense, to use reasonable commercial efforts in order to develop, produce and commercialise the Licensed Products, including, the performance of the necessary tests, clinical trials and other steps required for obtaining regulatory approvals from the relevant authorities.
12.2. Notwithstanding anything to the contrary contained herein, the Company undertakes to achieve at least the following development and commercialisation milestones (“the Milestones”):
12.2.1. in the case of Implantation Products for Diabetes:
(a) within 3 (three) years of the Effective Date, the Company shall complete the stage of development of the protocols to derive pancreatic cells from HMO Cells that are functional in vitro and in vivo in a diabetic animal model and are in appropriate numbers for implantation in human patients; and
(b) the Company shall commence clinical trials with respect to at least one Licensed Product within 6 (six) years of the Effective Date; and
(c) the Company shall submit a New Drug Application to the FDA or a Marketing Authorisation Application to the EMEA within 10 (ten) years of the Effective Date; and
12.2.2. in the case of Other Implantation Products:
(a) within 3 (three) years of the Effective Date, the Company shall complete the stage of development of the protocols to derive cells of the pancreatic, hepatic endoderm lineages (other than the pancreatic cells referred to in clause 12.2.1(a) above) from HMO Cells that are functional in vitro and in vivo in an appropriate animal model and in appropriate numbers for implantation in human patients; and
(b) the Company shall commence clinical trials with respect to at least one Licensed Product within 6 (six) years of the Effective Date; and
(c) the Company shall submit a New Drug Application to the FDA or a Marketing Authorisation Application to the EMEA within 10 (ten) years of the Effective Date. Within 3 (three) months of the Effective Date, the Company shall provide Hadasit with: (i) a Development Program with respect to Implantation Products for Diabetes which incorporates the Milestones set out in clause 12.2.1 above; and (ii) a Development Program with respect to Other Implantation Products, which incorporates the Milestones set out in clause 12.2.2 above.
12.3. The Parties hereby extend the Milestones by 3 (three) addi...
Development and Commercialisation. As partial consideration for the rights and licenses granted hereunder, Dynavax and B▇▇▇▇ agree to the following terms for development and commercialisation, as follows:
Development and Commercialisation