Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, license to a CRADA Subject Invention made solely by an IC employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).
Appears in 4 contracts
Samples: Cooperative Research and Development Agreement, Cooperative Research and Development Agreement (Tracon Pharmaceuticals, Inc.), Cooperative Research and Development Agreement (Tracon Pharmaceuticals Inc)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, or if applicable a co-exclusive, license to a CRADA Subject Invention made solely by an IC ICD employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).. The First Paragraph of Article 8.2 is modified to read as follows:
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Tracon Pharmaceuticals, Inc.), Cooperative Research and Development Agreement (Tracon Pharmaceuticals Inc)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, exclusive or co-exclusive, exclusive license to a CRADA Subject Invention made solely by an IC ICD employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Bavarian Nordic a/S / ADR), Cooperative Research and Development Agreement (Bavarian Nordic a/S / ADR)
Third Party License. Pursuant to 15 U.S.C. § (S) 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, exclusive license to a CRADA Subject Invention made solely wholly by an IC employee PHS employees or jointly with a Collaborator employeeunder this CRADA, pursuant to Articles 6.3 and 6.4, the Government will shall retain the right to require the Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention invention in Collaborator’s 's licensed field of use on terms that are reasonable under the circumstances; or, or if the Collaborator fails to grant such a license, to grant a the license itself. The exercise of these such rights by the Government will shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal Federal regulations, and such requirements are not reasonably satisfied by the Collaborator; or (iii) the Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph Article is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b203(2).
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Sequenom Inc), Cooperative Research and Development Agreement (Sequenom Inc)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, license to a CRADA Subject Invention made solely by an IC ICD employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b203(2). Paragraph 1 of Article 8.2 is modified to read as follows: .
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Tracon Pharmaceuticals, Inc.), Cooperative Research and Development Agreement (Tracon Pharmaceuticals Inc)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, exclusive license to a CRADA Subject Invention made solely by an IC ICD employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b203(2).
Appears in 2 contracts
Samples: Cooperative Research and Development Agreement (Bavarian Nordic a/S / ADR), Cooperative Research and Development Agreement (Bavarian Nordic a/S / ADR)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, exclusive license or co-exclusive, exclusive license to a CRADA Subject Invention made solely by an IC employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination PHS ICT-CRADA Case Ref. No. _____MODEL ADOPTED June 18, 2009 Thedetermination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Kite Pharma, Inc.)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, exclusive license to a CRADA Subject Invention made solely wholly by an IC employee PHS employees or jointly with a Collaborator employeeunder this CRADA, pursuant to Articles 6.3 and 6.4, the Government will shall retain the right to require the Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, or if the Collaborator fails to grant such a license, to grant a the license itself. The exercise of these such rights by the Government will shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal Federal regulations, and such requirements are not reasonably satisfied by the Collaborator; , or (iii) the Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph Article is subject to administrative appeal and judicial (review under 35 U.S.C. § 203(b203(2).
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Keryx Biopharmaceuticals Inc)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, exclusive license or co-exclusive, exclusive license to a CRADA Subject Invention made solely by an IC employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).PHS ICT-CRADA Case Ref. No. _____MODEL ADOPTED June 18, 2009
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Kite Pharma, Inc.)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, exclusive license or co-exclusive, exclusive license to a CRADA Subject Invention made solely by an IC employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Lion Biotechnologies, Inc.)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B3710a(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, exclusive license to a CRADA Subject Invention made solely wholly by an IC employee PHS employees or jointly with a Collaborator employeeunder this CRADA, pursuant to Articles 6.3 and 6.4, the Government will shall retain the right to require the Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention invention in Collaborator’s 's licensed field of use on terms that are reasonable under the circumstances; or, or if the Collaborator fails to grant such a license, to grant a the license itself. The exercise of these such rights by the Government will shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal Federal regulations, and such requirements are not reasonably satisfied by the Collaborator; or (iii) the Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph Article is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b203(2).
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Paracelsian Inc /De/)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B3710a (b)(1)(B), if PHS VA assigns title or grants Collaborator an exclusive, or co-exclusive, exclusive license to a CRADA Subject Invention subject invention made solely wholly by an IC employee VA employees or jointly with a Collaborator employeeIT, Inc. under this CRADA, pursuant to Articles 6.3 and 6.4, the Government will shall retain the right to require Collaborator IT, Inc. to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense license to use the CRADA Subject Invention invention in Collaboratorthe applicant’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator IT, Inc. fails to grant such a license, to grant a the license itself. The Government may exercise of these its rights by the Government will retained herein only be in exceptional circumstances and only if the Government determines that (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by CollaboratorIT, Inc., (ii) the action is necessary to meet requirements for public use specified by federal Federal regulations, and such requirements are not reasonably satisfied by CollaboratorIT, Inc.; or or, (iii) Collaborator IT, Inc. has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph Article is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b203(2).
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Inhibiton Therapeutics, Inc.)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B3710a(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, exclusive license to a CRADA Subject Invention made solely wholly by an IC employee PHS employees or jointly with a Collaborator employeeunder this CRADA, pursuant to Articles 6.3 and 6.4, the Government will shall retain the right to require the Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention invention in Collaborator’s 's licensed field of use on terms that are reasonable under the circumstances; or, or if the Collaborator fails to grant such a license, to grant a the license itself. The exercise of these such rights by the Government will shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal Federal regulations, and such requirements are not reasonably satisfied by the Collaborator; or (iii) the Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph Article is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b203(2).
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Introgen Therapeutics Inc)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS NIH grants Collaborator an exclusive, or co-exclusive, license to a CRADA Subject Invention made solely by an IC employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).
Appears in 1 contract
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, exclusive license or co-exclusive, exclusive license to a CRADA Subject Invention made solely by an IC employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).. Amend Section 8.3 to read as follows:
Appears in 1 contract
Samples: Cooperative Research and Development Agreement (Ziopharm Oncology Inc)
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive, or co-exclusive, exclusive license to a CRADA Subject Invention made solely wholly by an IC employee PHS employees or jointly with a Collaborator employeeunder this CRADA, pursuant to Articles 6.3 and 6.4, the Government will shall retain the right to require the Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention invention in Collaborator’s 's licensed field of use on terms that are reasonable under the circumstances; or, or if the Collaborator fails to grant such a license, to grant a the license itself. The exercise of these such rights by the Government will shall only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal Federal regulations, and such requirements are not reasonably satisfied by the Collaborator; or (iii) the Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph Article is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b203(2).
Appears in 1 contract