Discovery Projects. 3.9.1 Numab shall use Reasonable Best Efforts to execute each Discovery Project pursuant to its respective Research Plan and to meet the applicable IND Ready Criteria. 3.9.2 For each Discovery Project, an Antibody shall be produced in a generic lab-scale process in amounts and quality sufficient to characterize its pharmacodynamic and biophysical properties according to the agreed IND Ready Criteria. In the event that Sucampo needs additional quantity of the Antibody or Compound, Sucampo may either negotiate with Numab or with a third party to produce additional amounts of the Antibody. If necessary, upon Sucampo’s request Numab shall grant such third party the right to manufacture such additional amounts of the Antibody or Compound, provided that such third party is not a direct competitor of Numab and agrees to reasonable confidentiality and non-use obligations of the Intellectual Property Rights to be licensed to such third party for such manufacturing of Compound. The Parties agree that Contract Manufacturing Organizations (CMOs) shall not be considered direct competitors of Numab, provided that such CMO is not otherwise an Affiliate of a non-CMO direct competitor of Numab. Confidential Loan Guarantee & Development Agreement 3.9.3 Upon Numab‘s achievement of the IND Ready Criteria for a Discovery Project, Sucampo shall, within thirty (30) days after Numab provides written notification of the achievement of the IND Ready Criteria, notify Numab in writing whether Sucampo agrees that the IND Ready Criteria have been met for a given Discovery Project. In the event that Sucampo has not replied to such written notification by Numab at the expiration of the thirty (30) day period, the achievement of the IND Ready Criteria shall be deemed accepted by Sucampo. (a) In the event Sucampo agrees that the IND Ready Criteria have been met, Sucampo shall pay the Success Fee for the achievement of the respective IND Ready Criteria in accordance with Section 5.1 or 5.2, respectively. Upon payment of the applicable Success Fee, Sucampo may at any time until the expiration of the Commercialization Option Period exercise its Commercialization Option with respect to such Discovery Project. (b) In the event IND Ready Criteria for a Discovery Project are not met, Sucampo may elect, within sixty (60) days after Numab has provided written notice of its failure to meet the IND Ready Criteria, to continue to pursue the Discovery Project. The JSC will, after such election by Sucampo, determine whether additional research is needed to achieve the IND Ready Criteria and/or determine New IND Ready Criteria for such Discovery Project. Each Party shall have the opportunity to approve any additional research and New IND Ready Criteria, such approval shall not be unreasonably withheld or delayed and shall not be conditioned on Numab’s other research obligations. (c) Notwithstanding the above, if Sucampo does not elect to continue with such Discovery Project or the Parties agree to abandon a Discovery Project with respect to a Sucampo Target because the IND Ready Criteria or the New IND Ready Criteria (as the case may be) were not met (but not for any other reason) and thereafter Numab elects to re-initiate on its own behalf or on behalf of a third party further research on the abandoned Sucampo Target, Numab shall be required to obtain a license from Sucampo to the Intellectual Property Rights (if any) developed for such Sucampo Target prior to the Discovery Project having been abandoned on such commercial terms as the Parties may reasonably agree. In the event that Numab obtains access to substantial new or additional research tools and technology that may increase the chances of success to meet the IND Ready Criteria or the New IND Ready Criteria for an abandoned Discovery Project as agreed to by the JSC, Sucampo shall have the right of first negotiation to initiate a new Discovery Project for the Sucampo Target. In the event that Sucampo elects not to exercise its right of first negotiation, or the Parties cannot agree on the terms discussed under the right of first negotiation within seventy-five (75) days of the election of Sucampo to exercise its right of first negotiations, Sucampo may elect either to retain the Intellectual Property Rights to such Target upon the […***…] of the agreed Success Fee for that Target, or to relinquish any further rights to the such Target and the Intellectual Property Rights related thereto. Confidential Loan Guarantee & Development Agreement
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Sources: Loan Guarantee and Development Agreement (Sucampo Pharmaceuticals, Inc.)
Discovery Projects. 3.9.1 Numab shall use Reasonable Best Efforts to execute each Discovery Project pursuant to its respective Research Plan and to meet the applicable IND Ready Criteria.
3.9.2 For each Discovery Project, an Antibody shall be produced in a generic lab-scale process in amounts and quality sufficient to characterize its pharmacodynamic and biophysical properties according to the agreed IND Ready Criteria. In the event that Sucampo needs additional quantity of the Antibody or Compound, Sucampo may either negotiate with Numab or with a third party to produce additional amounts of the Antibody. If necessary, upon Sucampo’s request Numab shall grant such third party the right to manufacture such additional amounts of the Antibody or Compound, provided that such third party is not a direct competitor of Numab and agrees to reasonable confidentiality and non-use obligations of the Intellectual Property Rights to be licensed to such third party for such manufacturing of Compound. The Parties agree that Contract Manufacturing Organizations (CMOs) shall not be considered direct competitors of Numab, provided that such CMO is not otherwise an Affiliate of a non-CMO direct competitor of Numab. *Confidential Treatment Requested Confidential Loan Guarantee & Development AgreementAgreement Numab AG and Sucampo AG 1109.08
3.9.3 Upon Numab‘s achievement of the IND Ready Criteria for a Discovery Project, Sucampo shall, within thirty (30) days after Numab provides written notification of the achievement of the IND Ready Criteria, notify Numab in writing whether Sucampo agrees that the IND Ready Criteria have been met for a given Discovery Project. In the event that Sucampo has not replied to such written notification by Numab at the expiration of the thirty (30) day period, the achievement of the IND Ready Criteria shall be deemed accepted by Sucampo.
(a) In the event Sucampo agrees that the IND Ready Criteria have been met, Sucampo shall pay the Success Fee for the achievement of the respective IND Ready Criteria in accordance with Section 5.1 or 5.2, respectively. Upon payment of the applicable Success Fee, Sucampo may at any time until the expiration of the Commercialization Option Period exercise its Commercialization Option with respect to such Discovery Project.
(b) In the event IND Ready Criteria for a Discovery Project are not met, Sucampo may elect, within sixty (60) days after Numab has provided written notice of its failure to meet the IND Ready Criteria, to continue to pursue the Discovery Project. The JSC will, after such election by Sucampo, determine whether additional research is needed to achieve the IND Ready Criteria and/or determine New IND Ready Criteria for such Discovery Project. Each Party shall have the opportunity to approve any additional research and New IND Ready Criteria, such approval shall not be unreasonably withheld or delayed and shall not be conditioned on Numab’s other research obligations.
(c) Notwithstanding the above, if Sucampo does not elect to continue with such Discovery Project or the Parties agree to abandon a Discovery Project with respect to a Sucampo Target because the IND Ready Criteria or the New IND Ready Criteria (as the case may be) were not met (but not for any other reason) and thereafter Numab elects to re-initiate on its own behalf or on behalf of a third party further research on the abandoned Sucampo Target, Numab shall be required to obtain a license from Sucampo to the Intellectual Property Rights (if any) developed for such Sucampo Target prior to the Discovery Project having been abandoned on such commercial terms as the Parties may reasonably agree. In the event that Numab obtains access to substantial new or additional research tools and technology that may increase the chances of success to meet the IND Ready Criteria or the New IND Ready Criteria for an abandoned Discovery Project as agreed to by the JSC, Sucampo shall have the right of first negotiation to initiate a new Discovery Project for the Sucampo Target. In the event that Sucampo elects not to exercise its right of first negotiation, or the Parties cannot agree on the terms discussed under the right of first negotiation within seventy-five (75) days of the election of Sucampo to exercise its right of first negotiations, Sucampo may elect either to retain the Intellectual Property Rights to such Target upon the […***…] of the agreed Success Fee for that Target, or to relinquish any further rights to the such Target and the Intellectual Property Rights related thereto. *Confidential Treatment Requested Confidential Loan Guarantee & Development AgreementAgreement Numab AG and Sucampo AG 1109.08
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