XML 22 R10.htm IDEA: XBRL DOCUMENT
v3.19.2

FORMER COLLABORATION AGREEMENT | 6 Months Ended
--- | ---
Jun. 30, 2019
Former Collaborative Arrangement Disclosure [Abstract] |
FORMER COLLABORATION AGREEMENT | 3. FORMER COLLABORATION AGREEMENT On November 13, 2014, we and Janssen entered into the Collaboration Agreement under which we granted to Janssen exclusive worldwide rights to develop and commercialize imetelstat for all human therapeutic uses, including hematologic myeloid malignancies. Under the Collaboration Agreement, Janssen initiated two clinical trials of imetelstat: a Phase 2 trial in relapsed/refractory myelofibrosis, referred to as IMbark, and a Phase 2/3 trial in lower risk myelodysplastic syndromes, referred to as IMerge. Under the terms of the Collaboration Agreement, prior to the termination, development costs for IMbark and IMerge were shared between us and Janssen on a 50/50 basis, including costs related to patents licensed to Janssen. Janssen terminated the Collaboration Agreement effective September 28, 2018. Upon the effective date of termination, we regained the global rights to the imetelstat program and plan to continue development of imetelstat on our own. As a result of the termination of the Collaboration Agreement, we will not receive any further milestone payments or royalties from Janssen for the development or commercialization of imetelstat, including any clinical development or sales milestones, and Janssen has no further obligations to us or any third parties, such as clinical sites or vendors, to fund any potential future imetelstat clinical trials. Under the termination provisions of the Collaboration Agreement, Janssen is required to provide certain operational support for the imetelstat program during transition of the program to us. As of May 14, 2019, we assumed the imetelstat investigational new drug, or IND, sponsorship from Janssen. In the second quarter of 2019, we assumed sponsorship in certain countries outside of the United States. We expect to obtain country-specific health authority and ethics committee approvals for change of sponsorship to us in the remaining countries outside of the United States on a country-by-country basis during the third quarter of 2019. The transition process is expected to be completed by the end of the third quarter of 2019, including transfer of the remaining non-clinical, manufacturing, and ex-U.S. clinical operational responsibilities from Janssen. Each company is responsible for its own costs incurred related to transition activities unless otherwise specified in the Collaboration Agreement. On June 14, 2019, we entered into a Clinical Supply Agreement, or Supply Agreement, with Janssen to purchase certain inventories of drug product, drug substance and raw materials for imetelstat manufacturing. Under the Supply Agreement, we will pay Janssen approximately $7,500,000 for drug product upon shipment of the product to our specified drug distribution centers, which is expected to occur in the third quarter of 2019. We have also agreed to pay up to approximately $6,700,000 for drug substance and raw materials upon testing and confirmation such materials meet certain specifications and expect such testing to occur in the third and fourth quarters of 2019. We are not obligated to purchase materials that do not pass testing and conform to our specifications. Until the sponsorship responsibilities for imetelstat fully transfer from Janssen to us, Janssen will continue supporting ongoing clinical trials of imetelstat. Since September 28, 2018, our responsibility for imetelstat development costs incurred by Janssen, including continuing support of ongoing clinical trials of imetelstat, increased from 50% to 100%. As of June 30, 2019, the amount due to Janssen of $1,576,000 on our condensed balance sheet primarily represents the amount owed to Janssen for operational support of the imetelstat program for the three months ended June 30, 2019.

X
- Definition Former collaborative arrangement disclosure. + References No definition available. + Details
Name: | gern_FormerCollaborativeArrangementDisclosureAbstract
Namespace Prefix: | gern_
Data Type: | xbrli:stringItemType
Balance Type: | na
Period Type: | duration

X
- Definition The entire disclosure for former collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for such arrangements; and d) the income statement classification and amounts attributable to transactions arising from the former collaborative arrangement between participants. + References No definition available. + Details
Name: | gern_FormerCollaborativeArrangementDisclosureTextBlock
Namespace Prefix: | gern_
Data Type: | nonnum:textBlockItemType
Balance Type: | na
Period Type: | duration